JP2023184549A - Device for eliminating the left atrial appendage - Google Patents

Abstract

A device and method for occluding the left atrial appendage (LAA) is described. The device excludes the LAA from the bloodstream to prevent blood from forming clots within the LAA and subsequently causing emboli, particularly in patients with atrial fibrillation. The implantable device is delivered and secured within the LAA via transcatheter delivery. The implant includes an expandable compliant frame and an expandable conformable tubular foam body. The device may have an anti-thrombotic covering at the proximal end. The frame may have recapture struts that slope radially outward from the central hub. The frame may have axially extending sidewall struts, with adjacent pairs of sidewall struts joined at one or more apexes. Anchors extend from the frame and penetrate into the foam to engage tissue. [Selection diagram] Figure 87D

Description

INCORPORATION BY REFERENCE OF RELATED APPLICATIONS This application is filed in U.S. Application No. 15/969,654, filed May 2, 2018, which is hereby incorporated by reference in its entirety for all purposes and made a part hereof. , is an international application entitled "DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE" and claims priority.

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

Atrial fibrillation (Afib) is a condition in which the normal beating of the left atrium (LA) is disordered and ineffective. The left atrial appendage (LAA) is a cul-de-sac separate from the LA. In patients with Afib, blood flow stagnates within the LAA, promoting clot formation. These clots (or clot fragments) have a tendency to embolize the LAA or exit the LAA and enter the systemic circulation. A stroke occurs when a blood clot/piece of blood embolizes and blocks one of the arteries that supply the brain. Anti-blood clotting agents, such as Coumadin, have been shown to significantly reduce the risk of stroke in Afib patients. Although these drugs reduce clot formation, they also increase hemorrhagic complications, including hemorrhagic stroke, subdural hematoma, and bleeding within the gastrointestinal tract.

There are approximately 8 million Afib patients in the US and EU. Approximately 4.6 million of these patients are at high risk of stroke and would benefit from blood thinners. Most of these patients cannot take anticoagulants due to increased bleeding risk, and their stroke risk remains unresolved. The prevalence of Afib increases with age.

Existing devices for occluding the LAA have drawbacks. Existing devices come in many sizes and must closely fit the highly variable LAA anatomy. This is difficult to perform using fluoroscopy and often requires auxiliary imaging in the form of transesophageal echocardiography (TEE), cardiac CT and MRI, all with three-dimensional reconstruction. Perform configuration. If the device is significantly too large, the LAA entrance can become too stretched and tear, resulting in bleeding into the pericardial cavity. If the device is too small, it will not properly seal the inlet and may have a tendency to embolize. Even when sized correctly, the device forces the oval LAA inlet to assume the rounded shape of the device, often resulting in residue leakage from the edges due to poor sealing. .

Existing devices require sufficient spring force or stiffness to seal and secure to the surrounding tissue. If too rigid, these devices can become a source for blood to leak through the tissue into the pericardial cavity, which can cause cardiac tamponade. Additionally, the geometry of these devices prevents repositioning after the implant is fully expanded. Existing devices also require positioning within the LAA to be coaxial with the axis of the LAA, making delivery cumbersome.

Therefore, improved LAA occlusion devices are needed.

U.S. Application No. 14/203,187 U.S. Provisional Application No. 62/240,124 U.S. Patent Application No. 15/290,692 U.S. Patent Application No. 14/203,187 European Patent Application No. EP14779640.3 PCT Patent Application No. PCT/US2014/022865 U.S. Patent No. 7,803,395 U.S. Patent No. 8,337,487

The embodiments disclosed herein each have several aspects that do not alone address the desirable attributes of the disclosure. Next, without limiting the scope of the disclosure, its more salient features will be briefly described. After reviewing this description, and in particular after reading the section entitled ``Detailed Description,'' the features of the embodiments described herein are useful for left atrial appendage (LAA) occlusion. You will understand how it provides advantages over existing systems, devices, and methods.

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

A device and method is described for occluding the LAA and excluding it from the bloodstream, particularly in patients with atrial fibrillation, to prevent blood from forming clots within the LAA and subsequent embolization. Ru. The LAA occlusion device is delivered into the LAA via transcatheter delivery and secured using a compliant frame and foam body. Among other advantages, this device conforms to the oval shape of the LAA with excellent sealing effect, does not require excessive number sizes, and therefore eliminates the need for extensive preoperative imaging. can be delivered off-axis, thereby simplifying the delivery procedure.

A foam body that can be in a tubular shape and a compliant frame inside or within the foam body is described that is folded for delivery and then expanded in place within the LAA. The foam body can have a coating at least partially on an outer surface of the foam body. The coating may be a layer of polytetrafluoroethylene (PTFE). The device is secured by structural anchors in the frame and/or by tissue growth infiltration into the foam from the left atrium (LA) and LAA. Some embodiments are additionally or alternatively secured by separate or integrated repositionable anchors, by barbs, and/or by distal fixation elements. For example, an anchor extending from a compliant frame that deploys through a compressible foam plug is described. Also disclosed are embodiments of repositionable non-invasive anchor systems that, in some embodiments, may be free-standing structures or integral with the foam plug and/or skin.

The foam body may be at least partially covered by a proximal end cover. The cover may be an expanded polytetrafluoroethylene (ePTFE) cover. The cover offers several advantages, such as being strong enough to allow handling of the plug without tearing, allowing repositioning and removal of the plug, and promoting neointimal formation within the LA. Occlusion zone designed to promote clot resistance and endothelialization from blood and adjacent tissues resulting in an anti-thrombotic surface and promoting fast tenacious tissue growth infiltration into the compressible implant from adjacent non-blood tissues The advantage is that it can assist in the closure at the inlet, helping to form a fixed zone designed for this purpose. The cover, such as a layer, jacket, or skin, can be free-standing or attached to the foam body, for example, with sutures, adhesives, or the like. In some embodiments, a retrieval finial may be attached at one or more locations to aid in retrieval of the embolized device and to enhance radiopacity.

Some embodiments have a guidewire lumen within the foam that is expandable to track over the guidewire and allow placement of the guidewire, and then self-closes after removal of the guidewire. Some embodiments do not require a guidewire lumen. Additionally, some embodiments may be multifunctional and include features such as ablation, pressure sensing, drug elution, pacing, electrical shielding, etc.

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

Various embodiments of various aspects may be implemented. In some embodiments, the body may include a compressible sidewall extending between a proximal end and a distal end to define a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the body portion and configured to compress the sidewall against the wall of the left atrial appendage. The foam body portion may include a proximal surface having an area, and the series of openings in the cover may collectively form an open area that is at least 5% of the area of the proximal surface. The open area may be at least 10% of the area of the proximal face. The open area may be at least 15% of the area of the proximal face. The water flow may be along the flow axis and the tubular foam body may extend axially along the device axis. The device axis may have an angle of at least 30 degrees to the flow axis. The device may be configured to allow an off-axis flow rate of water through the device of at least 4 liters per minute, the water is at about 68°F, and the upstream pressure is about 25 milliliters of mercury (mmHg). be. The off-axis flow may be at an angle of at least 30 degrees from the axial flow.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and a cover. The tubular foam body extends axially from a proximal end to a distal end. The cover includes at least a portion covering the proximal end. The portion covering the proximal end includes a series of openings therethrough. The foam body includes a proximal surface at a proximal end having a region. The series of openings in the cover collectively form an open area that is at least 5% of the area of the proximal face.

Various embodiments of various aspects may be implemented. In some embodiments, the open area may be at least 10% of the area of the proximal face. The open area may be at least 15% of the area of the proximal face. The foam and cover are configured to allow a flow rate of water axially through the device of at least 4 liters per minute, the water is at approximately 68°F, and the upstream pressure is approximately 25 milliliters of mercury (mmHg). ). The body portion may include a compressible sidewall extending between a proximal end and a distal end to define a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the body portion and configured to compress the sidewall 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 a distal end of a delivery catheter, the loading body having a sidewall defining a channel therethrough, the loading body having a sidewall defining a channel therethrough; The distal opening of is larger than the proximal opening at the proximal end. The method includes proximally retracting a left atrial appendage occlusion device through a loading body, thereby radially compressing the device, the device comprising a foam body, and receiving the device within a distal end of a delivery catheter. further including.

Various embodiments of various aspects may be implemented. In some embodiments, the loading body can include a frustoconical portion. The loading body may define a central longitudinal axis and the sidewall may extend at an angle of at least 5 degrees with respect to the longitudinal axis. The sidewalls may extend at an angle of at least 10 degrees with respect to the longitudinal axis. The sidewalls may extend at an angle of at least 15 degrees with respect to the longitudinal axis. The sidewalls may define a total angle of at least 10 degrees, at least 20 degrees, or at least 30 degrees. The advancement step may include pulling the tether proximally through the delivery catheter. The device can be radially compressed within a delivery catheter having an outer diameter of 15 French or less. The inner surface of the loading body may be substantially smooth. The method may include radially compressing the device to a radially compressed width within the delivery catheter that is no more than 20% of the radially uncompressed width of the device. The radially compressed width within the delivery catheter may be 15 percent or less of the radially uncompressed width of the device.

In another embodiment, a left atrial appendage occlusion device includes a foam body, an expandable support, and at least one anchor. The foam body has tubular sidewalls that are radially uncompressed in thickness. An expandable support is coupled to the body. The at least one anchor is coupled to the support and penetrates the sidewall when the sidewall foam is compressed, and the at least one anchor has a radial height that is less than or equal to the radial uncompressed thickness of the sidewall. have

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

In another embodiment, a left atrial appendage occlusion device includes a foam body, an expandable support, and at least one anchor. The foam body portion has 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 a tubular sidewall comprising a portion. 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 various aspects may be implemented. In some embodiments, the device may define a central axis and the at least one anchor may be angled with respect to the central axis. The at least one anchor may extend radially outward in a proximal direction at an angle of at least 20 degrees with respect to the central axis. This angle may be at least 30 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 radially uncompressed thickness of the tubular sidewall. The support may include a tubular frame portion configured to expand radially outwardly to compress its sidewalls against the wall of the left atrial appendage after implantation of the device. The device may further include a proximal cover covering at least a portion of the proximal surface 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 inserted into a non-cylindrical opening of the test body having a non-cylindrical profile, extends radially within the non-cylindrical opening, and is shaped into a non-cylindrical profile at least at the opening of the test body. Constructed to fit.

Various embodiments of various aspects may be implemented. In some embodiments, the device conforms to the non-cylindrical contour of the test body at least at the opening, leaving no radial gap of more than 5 millimeters between the device and the test body opening. It can be configured as follows. The device may not have a radial gap of more than 4, 3, 2, and/or 1 millimeter. The device may be configured to be inserted into a non-cylindrical opening in the test body having a non-cylindrical profile with a size and shape substantially similar to that of the natural left atrial appendage. The device is inserted into a non-cylindrical opening in the test body having a radial stiffness substantially similar to that of the natural left atrial appendage, and is inserted into a non-cylindrical opening in the test body for at least 30 days, at least 60 days, and/or at least 120 days. may be configured to assume a non-cylindrical profile at least at the opening of the test body after the period of time. The device may further include at least one anchor coupled to the frame and extending at least partially within the tubular foam body.

In some embodiments, the foam body can include compressible sidewalls extending between proximal and distal ends to define a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the foam body and configured to compress the sidewall against the 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 radially compress to a radially compressed width that is no more than 50% of the radially uncompressed width.

Various embodiments of various aspects may be implemented. In some embodiments, the radially compressed width may be 40% or less 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 that is 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, with the proximal end having a radial uncompressed width. The distal end is configured to radially compress to a radially compressed width that is no more than 50% of the radially uncompressed width of the proximal end.

Various embodiments of various aspects may be implemented. In some embodiments, the distal end may be configured to radially compress to a radially compressed width that is no more than 40% of the radially uncompressed width of the proximal end. The radially compressed width may be 30% or less, 20% or less, 10% or less, and/or 5% or less of the radially uncompressed width of the proximal end.

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 uncompressed length in the axial direction. The device may be configured to axially compress to an axially compressed length that is no more than 50% of the axially uncompressed length.

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

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

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

In another aspect, a self-expandable non-invasive occlusion device is described. The device is configured to conform to the side wall of the left atrial appendage. The device includes a compressible open cell foam body, a self-expandable support, and a proximal end wall. The compressible open cell foam body has tubular foam sidewalls and a central cavity. The expandable support is within the cavity. The proximal end wall is on the foam body. The proximal end wall is positioned proximal to the proximal end of the support, and the foam sidewall extends distally beyond the distal end of the support such that the central longitudinal axis of the occlusion device is in the left atrial appendage. A distal non-invasive cushion is formed to prevent contact between the support and the wall of the left atrial appendage at the implant which is non-parallel to the main longitudinal axis.

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 endwall. The sidewall has a thickness of at least about 1.0 mm and a porosity of at least about 85% open porosity. The expandable frame is configured to compress the sidewall into conformal contact with the wall of the left atrial appendage.

In some embodiments, the tubular sidewall may have a thickness of at least about 2 mm. The tubular sidewall may have a porosity of at least about 90%. The tubular sidewall may have an average pore size of at least about 100 microns. The tubular sidewall may have an average pore size of at least about 200 microns. The tubular sidewall may be provided with an anti-thrombotic coating. The anti-thrombotic coating may include PTFE. The proximal end wall may be provided with an anti-thrombotic covering. The frame may further include at least three recapture struts that slope radially inward in a proximal direction to the hub. The frame may include a plurality of axially extending sidewall struts, with adjacent pairs of sidewall struts joined at an apex. The frame may include at least six proximally facing vertices and at least six distally facing vertices. Each recapture strut may be coupled to a unique proximally facing vertex on the frame. The recapture struts may be integrally formed with the frame. The device may further include a lumen through the hub. The device may further include anchors for securing the device to tissue. The anchor may be a flexible anchor configured to penetrate 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 porosity of at least about 90%, an average cell size in the range of about 250-500 microns, a wall thickness of at least about 2 mm, and a compressive strength of at least about 1 psi. In some embodiments, the compressive strength is within the range of about 1 psi 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 includes an open cell foam body and an internal locking system. The body has a proximal end, a distal end, and an outer skin. The proximal end is configured to face the left atrium and the distal end is configured to face the LAA after implantation within the LAA. The body portion 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 at least one deployable tissue anchor. The deployable anchor is configured to deploy from a constrained configuration within the body to a deployed configuration in which tissue-engaging segments of the anchor extend outside of the body to securely secure the body within the LAA. configured. The deployable anchor is configured to deploy to a deployed configuration after the body expands within the LAA. The deployable anchor may be retractable from a deployed configuration to a retracted configuration within the body.

In some embodiments, the internal locking system further comprises a plurality of deployable anchors rotatably coupled to the body, the plurality of anchors having a rotationally deployed configuration shape and a retracted configuration shape. Constructed to have a configuration shape. The internal locking system may include four of the deployable anchors. In some embodiments, the body further comprises a plurality of axially extending slots that accommodate a plurality of anchors, each of the plurality of anchors being configured to deploy and retract through a corresponding axial slot. Ru.

In some embodiments, the internal locking system further comprises a restraint that restrains the anchor to the constrained configuration shape, the anchor being deployed from the constrained configuration shape by removing the restraint from the anchor. Expanded into shape. The restrainer may be a sheath that constrains the anchor to a constrained configuration by covering the anchor, and the anchor moves from the constrained configuration to the deployed configuration by removing the sheath from covering the anchor. Be expanded. The restrainer may be a lasso that restrains the anchor to a constrained configuration shape by encircling the anchor, and the anchor can be a lasso that restrains the anchor from the constrained configuration shape by removing the lasso from surrounding the anchor. Expanded into shape.

In some embodiments, the internal locking system further comprises a movable mount coupled to an end of the anchor, the anchor being deployed from the constrained configuration shape by axially moving the mount. It is expanded into a configuration shape.

In some embodiments, the internal locking system further comprises a constraint configured to move over the anchor and cause it to retract. The constraint may be a ring configured to slide over the anchor and cause it to retract.

In some embodiments, the skin comprises ePTFE.

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

In some embodiments, the device further comprises a plurality of openings in the skin that allow tissue growth entry into the open cell foam body. The plurality of openings in the skin may be disposed within an anchoring region of the device disposed between at least a proximal end and a distal end of the device, the device being disposed at the proximal end of the device, and an occluded region configured to promote clot resistance and endothelialization from adjacent tissue.

In another embodiment, a LAA closure system is described. The system includes a delivery catheter and an LAA occlusion device. The delivery catheter includes an elongated flexible tubular body having a proximal end, a distal end, and at least one lumen extending therethrough. The LAA occlusion device is compressed within the delivery catheter and configured to self-expand after deployment from the delivery catheter. The device includes 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 shape to a deployed configuration shape after expansion of the body portion within the LAA, and the internal locking system configured to retract to a retracted position within the section.

In some embodiments, the system further comprises an axially movable deployment control through the lumen of the body to deploy the deployable anchor. The system may further include an axially movable deployment control through the lumen of the body for deploying the foam body from the distal end of the closure system. The internal locking system may further include a restraint for restraining the anchor in the constrained configuration, the anchor being restrained using an axially movable deployment control extending through the lumen of the body. The device is actively deployed from a constrained configuration to a developed configuration by removing the tool from the anchor. The internal locking system may further include a movable mount coupled to the end of the anchor, the anchor being axially movable through the lumen of the body. It is actively expanded from a constrained configuration to an expanded configuration by moving the mount axially.

In another embodiment, a method of eliminating LAA is described. The method includes the steps of advancing a guidewire into the LAA, advancing a distal end of a delivery catheter over the guidewire and into the LAA, and deploying an LAA occlusion device from the distal end of the delivery catheter. and a step of doing so. The device comprises an expandable foam body coupled with an internal locking system having a deployable anchor, the body expanding within the LAA after deployment from the distal end of the delivery catheter; The method further includes actively deploying the deployable anchor after expansion of the body within the LAA. The deployable anchor is configured to retract from a deployed configuration to a retracted position within the body. In some embodiments, the method further includes retracting the deployable anchor from the deployed configuration to a 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 portion 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 deploys from a constrained configuration within the body to a deployed configuration in which the anchors extend outside of the body to securely secure the body within the LAA. with a deployable anchor configured to The body portion is configured to expand after removal from the delivery catheter, and the deployable anchor is configured to deploy to a deployed configuration after the body portion is expanded.

In another aspect, a LAA occlusion device is described. The device includes an expandable foam body and an internal locking system. The body portion 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 configured to deploy from a constrained configuration within the body to a deployed configuration with anchors extending outside the body to securely secure the body within the LAA. with a deployable anchor configured to The deployable anchor is configured to retract from a deployed configuration to a retracted configuration within the body so 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. The expandable tubular foam layer is carried by the frame and has a thickness of at least about 0.5 mm. An emboli retention layer is carried by the frame and surrounds the lumen at the proximal end.

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

In some embodiments, the foam layer extends across the proximal end of the frame to form a tissue scaffold, and the frame may include a plurality of axially extending sidewall struts, with adjacent The paired sidewall struts are joined at the apex. The device may include at least six proximally facing vertices and at least six distally facing vertices. The device may include at least three recapture struts coupled at the proximal hub, each recapture strut having a distal end coupled to the frame. Each recapture strut may be coupled to a unique proximally facing vertex on the frame. The recapture struts may be integrally formed with the frame. The device may further include 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 that is configured to be deployed after deployment of the device from the delivery catheter. The anchor may be a constraint anchor that is configured to be controllably released to assume a deployed configuration after the foam expands. The anchor may be a dynamic anchor configured to be deployed from a collapsed configuration to a deployed configuration and further configured to be retracted back from the deployed configuration to the collapsed configuration. These anchors may be further configured to be retracted back from the deployed configuration to the collapsed configuration.

These and other features of the disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. With the understanding that these drawings depict only some embodiments according to the present disclosure and are not to be considered as a limitation on its scope, this disclosure has been incorporated herein by reference through the use of the accompanying drawings. It will be explained along with. In the following detailed description, reference is made to the accompanying drawings, which form a part of the detailed description. Similar symbols in the drawings typically identify similar components unless the context indicates otherwise. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made without departing from the spirit or scope of the inventive subject matter presented herein. The aspects of the present disclosure, as generally described herein and illustrated in the drawings, may be arranged, permuted, combined and designed in a variety of different configurations, all of which are expressly contemplated and illustrated herein. It will be readily understood that it forms part of the disclosure.

FIG. 2 is a diagram showing the anatomical structure of the left atrium (LA) and left atrial appendage (LAA). FIG. 3 shows an LAA with an embodiment of an LAA occlusion device implanted within the LAA using an adhesive. FIG. 3 shows an x-ray image of one embodiment of a LAA occlusion device. FIG. 12 shows an embodiment of a LAA occlusion device and a LAA with a distal anchor implanted within the LA. FIG. 3 illustrates one embodiment of a screw anchor that may be used with various LAA occlusion devices described herein. FIG. 1 is a longitudinal cross-sectional view of one embodiment of a LAA occlusion device. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustration of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustrations of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. Sequential illustration of one embodiment of a LAA and delivery system illustrating delivery and anchoring techniques that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. FIG. 3 is a side cross-sectional view of one embodiment of an LAA occlusion device having a foam body, a frame, and a proximal cover. FIG. 3 is a side cross-sectional view of one embodiment of an LAA occlusion device having a metal coil and a foam. FIG. 3 is a side view of one embodiment of a LAA occlusion device with a single metal coil. FIG. 3 is a side view of one embodiment of a LAA occlusion device with an inflatable distal tip. FIG. 3 is a side cross-sectional view of one embodiment of a LAA occlusion device having a proximal cap and a distal cap. 85A-90D are schematic diagrams illustrating one embodiment of an implant delivery system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are schematic diagrams illustrating one embodiment of delivery of an expanded foam system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 90D is a side view of a plug with barbs that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. FIG. 90D illustrates one embodiment of a LAA occlusion device with a retrieval suture attachment that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. be. 85A-90D illustrate embodiments of distal anchoring systems that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of distal anchoring systems that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of distal anchoring systems that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. Various figures depicting one embodiment of a LAA occlusion device with an internal locking system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is. 27A-27G depict various views of one embodiment of an internal locking system that may be used with the device of FIGS. 27A-27G. 27A-27G depict various views of one embodiment of an internal locking system that may be used with the device of FIGS. 27A-27G. 27A-27G depict various views of one embodiment of an internal locking system that may be used with the device of FIGS. 27A-27G. 27A-27G depict various views of one embodiment of an internal locking system that may be used with the device of FIGS. 27A-27G. 27A-27G are sequential side views illustrating an unlocking mechanism that may be used with the device of FIGS. 27A-27G. 27A-27G are sequential side views illustrating an unlocking mechanism that may be used with the device of FIGS. 27A-27G. 85A-90D are side views illustrating one embodiment of an LAA occlusion device with a flexible anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. be. One implementation of an LAA occlusion device having a flexible anchor and reinforcing tubular member configuration that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is a side view which shows a form. One implementation of an LAA occlusion device having a flexible anchor and reinforcing tubular member configuration that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is a side view which shows a form. LAA occlusion device having a discontinuous attachment of an outer skin to an inner foam that can be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D FIG. 2 is a side view showing one embodiment of the invention. FIG. 35 is a side view of the device of FIG. 34 with an outer rim. One implementation of an LAA occlusion device having an anchor with a deployed V-shaped tip that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is a side view which shows a form. One implementation of an LAA occlusion device having a deployed anchor with a V-shaped tip that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. It is a side view showing a form. 85A-90D are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. FIG. 3 is a side view of one embodiment of an LAA occlusion device implanted inside the LAA. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are perspective views illustrating one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D illustrate embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are sequential side views illustrating one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are sequential side views illustrating one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 85A-90D are sequential side views illustrating one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. 90D is a side view of one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. FIG. 90D is a side view of one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. FIG. 90D is a side view of one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices of FIGS. 85A-90D. FIG. FIG. 3 is a cross-sectional view of one embodiment of an LAA occlusion device illustrated in an expanded configuration and having a foam cup body, a proximal cover, and a deployable frame comprising a hub, a recapture strut, and a tubular body. be. FIG. 45B is a distal end view of the device of FIG. 45A. FIG. 45B is a proximal perspective view of the device of FIG. 45A. FIG. 45B is a distal end view of the LAA occlusion device of FIG. 45A. FIG. 45B is a perspective view of the LAA occlusion device of FIG. 45A with an integrally molded inner frame. FIG. 45B is a side view of the LAA occlusion device of FIG. 45A with an integrally molded inner frame. FIG. 45B is a perspective view of the device of FIG. 45A. 45B is a side view of the device of FIG. 45A as attached to a delivery catheter shown in an expanded configuration embodiment; FIG. 45B is a side view of the device of FIG. 45A as attached to a delivery catheter shown in a partially collapsed configuration embodiment; FIG. 85A is a schematic diagram illustrating various embodiments of static barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of static barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of static barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of static barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of static barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of constrained barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of constrained barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of constrained barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. 85A is a schematic diagram illustrating various embodiments of dynamic barbs that may be used with various occlusion devices described herein, such as the device of FIG. 45A or FIG. 85A. FIG. 45B is a side view of the implant of FIG. 45A with a proximal cover. FIG. 45B is a side view of the implant of FIG. 45A with a proximal cover. FIG. 45B is a side view of the implant of FIG. 45A with a proximal cover. FIG. 12 is a side and end view of an embodiment of an implant having an internal hook anchor. FIG. 3 is a side view of an embodiment of an implant with a thicker distal cushion. FIG. 4 is an end view of an embodiment of an implant with a thicker distal cushion. FIG. 4 is a side view of an embodiment of an implant with a constrained anchor deployed in a secondary step. FIG. 3 shows an embodiment of an implant with a distal anchor and a proximal deceleration bump. FIG. 3 shows an embodiment of an implant with a distal anchor and a proximal deceleration bump. FIG. 3 shows an embodiment of an implant with a distal anchor and a proximal deceleration bump. FIG. 3 shows an embodiment of an implant with a distal loop. FIG. 3 shows an embodiment of an implant with a distal loop. FIG. 3 shows an embodiment of an implant with a distal loop. FIG. 3 shows an embodiment of an implant with perfusion elements. FIG. 3 shows an embodiment of an implant with perfusion elements. FIG. 3 is a side view of one embodiment of an LAA occlusion device having ablation features that may be incorporated with various LAA occlusion devices described herein. FIG. 3 is a side view of one embodiment of an LAA occlusion device having pressure sensing features that may be incorporated with various LAA occlusion devices described herein. FIG. 3 is a side view of one embodiment of an LAA occlusion device having drug eluting features that may be incorporated with various LAA occlusion devices described herein. FIG. 3 is a side view of one embodiment of an LAA occlusion device having pacing/defibrillation features that may be incorporated with various LAA occlusion devices described herein. FIG. 4 illustrates various systems and methods for electrically isolating the LAA that may be used with the various LAA occlusion devices described herein. FIG. 4 illustrates various systems and methods for electrically isolating the LAA that may be used with the various LAA occlusion devices described herein. FIG. 4 illustrates various systems and methods for electrically isolating the LAA that may be used with the various LAA occlusion devices described herein. FIG. 3 is a proximal view of one embodiment of a LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. FIG. 3 is a distal view of one embodiment of a LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. FIG. 3 is a side view of an embodiment of an LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. 85C is a distal view of the embodiment of the LAA occlusion device of FIGS. 85A-85C additionally having an inner cover and a proximal marker. FIG. FIG. 85A is a side view of the compressible foam body of FIGS. 85A-85C. FIG. 85A is a cross-sectional view of the compressible foam body of FIGS. 85A-85C. 85A-85C is a cross-sectional view of the foam body of FIGS. 85A-85C with an expandable frame. FIG. FIG. 6 is a perspective top view of another embodiment of a LAA occlusion device. FIG. 4 is a side view of another embodiment of a LAA occlusion device. FIG. 4 is a cross-sectional view of another embodiment of a LAA occlusion device. 85D is a cross-sectional view of various embodiments of the LAA occlusion device of FIG. 85D. 85D is a cross-sectional view of various embodiments of the LAA occlusion device of FIG. 85D. FIG. 7 is a top view of one embodiment of a proximal cover shown in a flat configuration that may be used with various LAA occlusion devices described herein. FIG. 7 is a top view of another embodiment of a proximal cover shown in a flat configuration and assembled with an LAA occlusion device. FIG. 7 is a top view of another embodiment of a proximal cover shown in a flat configuration and assembled with an LAA occlusion device. FIG. 7 is a side view of another embodiment of a proximal cover shown assembled with a LAA occlusion device. FIG. 6 is a perspective view of another embodiment of a proximal cover shown assembled with a LAA occlusion device. FIG. 85C is a side perspective view of the frame of FIGS. 85B and 85C shown in a deployed configuration. 86C is a proximal perspective view of the frame of FIGS. 85B and 86C shown in a deployed configuration; FIG. 85A-88E are sequential proximal perspective views of one embodiment of a frame illustrating a cap and pin assembly that includes a frame that may be used with the LAA occlusion device of FIGS. 85A-88E; FIG. 85A-88E are sequential proximal perspective views of one embodiment of a frame illustrating a cap and pin assembly that includes a frame that may be used with the LAA occlusion device of FIGS. 85A-88E; FIG. 85A-88E are sequential proximal perspective views of one embodiment of a frame illustrating a cap and pin assembly that includes a frame that may be used with the LAA occlusion device of FIGS. 85A-88E; FIG. FIG. 90C is a distal perspective view of the cap of FIGS. 90A-90C. 85A-88E is a side view of one embodiment of a loading system for loading the device of FIGS. 85A-88E into a delivery catheter. FIG. 88E is a schematic side view of a transcatheter delivery system for delivering the devices of FIGS. 85A-88E via an artery or vein. FIG. 92B is a proximal perspective view of the delivery system of FIG. 92A showing the associated tether release mechanism and method; FIG. 92A is a distal perspective view of the delivery system of FIG. 92A showing the associated tether release mechanism and method; FIG. FIG. 88E is a proximal perspective view of another embodiment of a tether release system that may be used with the device of FIGS. 85A-88E. FIG. 88E is a distal perspective view of another embodiment of a tether release system that may be used with the device of FIGS. 85A-88E. 85A-88E illustrate various embodiments of anchor/foam interfaces that may be used with the LAA occlusion devices of FIGS. 85A-88E. 85A-88E illustrate various embodiments of anchor/foam interfaces that may be used with the LAA occlusion devices of FIGS. 85A-88E. 85A-88E illustrate various embodiments of anchor/foam interfaces that may be used with the LAA occlusion devices of FIGS. 85A-88E. FIG. 2 is a schematic diagram illustrating one embodiment of the inlet section and the outer shape of the LAA. 85A-88E are schematic illustrations of the LAA occlusion device of FIGS. 85A-88E as implanted within the entrance section and LAA of FIG. 95A, illustrating the conformability of the device. 85A-88E are schematic diagrams of LAA occlusion devices illustrating the radial compression capabilities of the devices of FIGS. 85A-88E. 85A-88E are schematic diagrams of LAA occlusion devices illustrating the axial compression capabilities of the devices of FIGS. 85A-88E. FIG. FIG. 88E is a top view of one 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 FIGS. 85A-88E.

Although the above drawings depict presently disclosed embodiments, other embodiments are also contemplated, as noted in the description. This disclosure presents exemplary embodiments by way of representation, not limitation. Numerous other modifications and embodiments may be devised by those skilled in the art that fall within the scope and spirit of the principles of the presently disclosed embodiments.

The following detailed description is directed to some specific embodiments of this work. In this description, reference is made to the drawings, where like parts or steps may be designated with like numbers throughout for clarity. References herein to "one embodiment," "an embodiment," or "in some embodiments" refer to the particular feature, structure, or characteristic described with respect to that embodiment. is meant to be included in at least one embodiment of the invention. The appearances of the phrases "one embodiment," "an embodiment," or "in some embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, alternative or alternative embodiments are not necessarily mutually exclusive of other embodiments. Additionally, various features are described that are exhibited by some embodiments and may not be exhibited by other embodiments. Similarly, various requirements are also described that may be requirements for some embodiments but not for other embodiments. Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.

Devices and related methods are described for use in occluding or eliminating LAA. Various figures depict various embodiments of LAA occlusion devices, systems and methods for delivery of LAA occlusion devices, and/or methods of occluding the LAA using the devices. The various systems, devices, and methods described herein are described, for example, in U.S. Application No. 14/203,187, filed March 10, 2014, entitled "DEVICES AND METHODS FOR EXCLUDING THE LAA." and/or other LAA occlusion systems, such as those described in U.S. Provisional Application No. 62/240,124, filed October 12, 2015, entitled DEVICES AND METHODS FOR EXCLUDING THE LAA; The devices and methods may include the same or similar features and/or functionality, the entire disclosure of each of which is incorporated by reference and made a part of this specification for all purposes.

Some embodiments of the LAA occlusion device 3000 include a foam body 3002, a deployable compliant frame 3040, and a proximal cover 3100, as illustrated and described exclusively with respect to FIGS. 85A-90D, for example. Be prepared. Other features and functionality that device 3000 may include and use are illustrated and described with respect to FIGS. 1-84 and 91-93B.

A heart 100 is shown in FIG. 1 having a left atrial appendage (LAA) 102, a cavity arising from a left atrium (LA) 104. LAA102 is highly variable in shape in all dimensions. When the heart is not beating normally, a condition called atrial fibrillation, blood in the LAA stagnates, promoting clot formation. When blood clots within the LAA, the clot travels from LAA 102 to LA 104, to left ventricle 106, and then exits heart 100 and enters the aorta. Blood vessels that carry blood to the brain branch off from the aorta. If a blood clot travels to the brain through these blood vessels, it becomes clogged, occluding small blood vessels in the brain, and then causing an ischemic stroke. Strokes have severe morbidity associated with them. The opening from LAA 102 to LA 104 is called inlet section 110. The inlet section 110 is oval shaped and highly variable, depending on the loading conditions, ie, left atrial pressure. The purpose of the LAA occlusion device described herein is to occlude inlet portion 110, thereby sealing LA 104 from LAA 102.

One embodiment of the LAA occlusion device is shown in FIG. 2. An occlusion device or plug 204 is placed within LAA 200 at the opening to LA 202. A "plug" described herein, such as plug 204, may be used to connect other implantable "devices" described herein, such as device 10, device 1020, device 3000, foam body 3002, etc. ” or “implant” and vice versa. Plug 204 comprises an expandable medium, such as open cell foam, that allows for folding and expansion of plug 204 and also enhances tissue growth penetration into the foam. Foam plug 204 is at least partially encapsulated within a strong thin layer 206 such as ePTFE (expanded polytetrafluoroethylene), polyolefin, or polyester. Layer 206 may be referred to herein as a "skin" or "cover," or the like. Alternatively, bioabsorbable materials such as PLA, PGA, PCL, PHA, or collagen may be utilized. This thin sealing layer 206 may be oriented or otherwise modified to be elastic in at least one direction, such as radially. Layer 206 may have the same or similar features and/or functionality as cover 3100, and vice versa.

Plug 204 may be made from polyurethane, polyolefin, PVA, collagen foam, or blends thereof. One suitable material is a polycarbonate polyurethaneurea foam with a pore size of 100 μm to 250 μm or ~250 μm to 500 μm and a porosity of 90 to 95%. The foam can 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. The plug 204 may be cylindrical in shape with unconstrained expansion, but may also be conical, for example, with its distal end being smaller than its proximal end, or vice versa. It can also be oval in cross-section to better fit into the opening of the LAA.

The foam plug 204 is radially oversized with unconstrained expansion to fit snugly within the LAA and may be 5-50 mm in diameter depending on the diameter of the target LAA. In the free, unconstrained state, the plug's axial length "L" is less than its outer diameter "D" such that the L/D ratio is less than 1.0. In some embodiments, this ratio may be greater than 1.0. The compliance of the foam material is designed such that it presses against the LAA wall with sufficient force to keep the plug 204 in place, but without unduly stretching the LAA wall. The foam and/or skin also conforms to the irregular surface of the LAA as it expands, imparting a complementary surface structure to the natural LAA wall to reinforce fixation and facilitate sealing. Thus, the expandable foam plant described herein conforms to the natural configuration shape of the LAA. In one embodiment, the structure of the foam may be processed to increase the diameter of the foam by axially compressing opposite ends of the foam.

The ePTFE or foam material may be equipped with one or more radiopaque markers, such as a radiopaque thread 210, or an operator can place the plug under x-rays to ensure proper alignment within the anatomy. It can be filled or impregnated with a radiopaque filler such as barium sulfate, bismuth subcarbonate, or tungsten, which makes it possible to see if it is in place. An x-ray image is shown in Figure 3, where the foam plug 300 is not visible, but the threads 302 and crimp 304 (described below) are clearly visible. The thread 302 or ribbon may be made from radiopaque metal wire or tube such as platinum, platinum iridium or tungsten or polymers with radiopaque fillers such as barium, bismuth, tantalum, tungsten, titanium, or platinum. .

The outer ePTFE layer may be formed from a tube having a wall thickness ranging from about 0.0001" to about 0.001" in diameter and thickness that is approximately the same diameter as the foam plug, without tearing the foam material. It functions to allow 204 to be folded and pulled. The ePTFE material also acts as a blood-contacting surface facing the LA202, allowing blood components to coagulate on the surface and a tissue intima or neointimal covering to grow onto the surface and become firmly anchored to the material. have similar pores or nodules. Pore sizes range from about 4μ to about 110μ, but ideally 5-35μ is useful for neointimal formation and attachment.

The outer covering 206 may be fabricated from materials other than ePTFE, such as fabric, mesh, or perforated film made from FEP, polypropylene, polyethylene, polyester, or nylon. The coating 206 should have at least low longitudinal compliance (inelasticity), sufficient strength to allow removal of the plug, low coefficient of friction, and clot resistance. The outer covering 206 acts as a matrix to enable plug removal since most foams do not have sufficient strength to resist tearing when pulled. Plug 204 may also be coated with or include a material such as PTFE. Such materials may enhance the ultrasound echo brightness profile, clot resistance, and/or lubricity of the plug 204. Plug 204 may also be coated with or include materials to facilitate echocardiographic visualization and promote cell growth invasion and coverage.

The outer covering 206 has pores therein that allow LAA tissue to contact the foam plug 204, encourage tissue to grow into the foam plug pores, and/or allow blood flow to pass through. have These holes may be 1 to 5 mm in diameter or oval-shaped, with their long axis aligned with the axis of the foam plug, and whose length is 80 mm of the length of the foam plug. %, and the width may be 1 to 5 mm. The holes may be as large as possible so that the outer covering maintains sufficient strength to transmit the tension required for removal. The holes may be preferentially placed along the device. In one embodiment, the holes are placed sufficiently distally to enhance tissue growth penetration from the LAA wall.

In one implementation, the implant comprises a proximal end cap and/or a distal end cap of ePTFE joined together by two or three or more axially extending strips of ePTFE. . The axially extending strips are circumferentially spaced and have at least two, three or more transverse windows through which the open cell foam body is in direct contact with the tissue wall of the LAA. form. This outer covering can also be a mesh or netting. As shown in FIG. 20, coating 2004 is only on the proximal and distal surfaces of plug 2000. These can be glued to the foam plugs and then crimped to the center tube 2002.

The implantable plug 204 or device 10, 1020, 3000 (as described below) is fixed and secured in place within the LAA by tissue growth invasion and/or by additional fixation features. obtain. In some embodiments, the plug 204 or device 10, 1020, 3000 may be secured by tissue growth invasion alone.

In some embodiments, other fixation means may also be implemented. One means of gluing 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 place along the sidewall near the distal end of the foam plug 208. The pores in the ePTFE coating allow the adhesive to interact between the foam plug 204 and the LAA wall 200. Injection of the adhesive can be accomplished in several ways, one of which is through a catheter into the central lumen 212. Channels 214 serve to direct the adhesive to the correct location. The distal end of the foam plug may be restricted at that point to prevent adhesive from coming out of the distal crimp 216. Alternatively, FIG. 21 shows a tube 2104 pre-placed through a guide catheter 2102 through the central lumen of a plug 2106 and bent back within the LAA to reach the distal end of the plug 2100. These tubes 2104 extend to the proximal end of the guide catheter 2102, where fittings are attached to allow injection of adhesive, which then exits through smaller tubes 2104 at the desired location of the plug. . These tubes are made from polyethylene, polypropylene, or FEP so that the adhesive will not stick to the tube. Tube 2104 is withdrawn from the patient's body after injection through the guide catheter.

Other one-component adhesives may be used, including water-soluble cross-linked adhesives, polyurethanes, PEG, PGA, PLA, polycaprolactone, or lysine-derived urethanes. In addition, these adhesives can be made of two components such that one component adheres to the foam and the second component is injected in vivo. Additionally, these two-component adhesives can be injected simultaneously and mix in vivo to prevent fouling of the injection tube.

An alternative fixation means, such as for plug 400 or device 3000, is one or more distal anchors as shown in FIG. 4. Wire 404 is threaded through central lumen 410, fed into the LAA, and attached to the distal wall of the LAA. In this case, screw wire 408 is threaded into the wall of LAA 406. More detail on this point is shown in FIG. 5, where the screw 502 is shown embedded within the LAA wall 504 but not through the entire epicardial plane 506.

Additional means of fixation include using multiple hooks or barbs or graspers to engage the distal wall and a basket, maleco, that opens within the LAA and pushes the wall outward or engages with a protrusion of the LAA. Includes grasping a distal foam plug and a nitinol wire bird nest. It may be desirable to deploy the plug and then engage the anchor as a secondary step. One such embodiment can include multiple nitinol wires with a ball or catch welded proximal to the anchor tip. These can be collected with the delivery catheter and then released when the ideal plug position is confirmed.

A cross-section of one embodiment is shown in FIG. 6 with a foam plug 600 and LA side 602 and LAA side 610. ePTFE material 604 encapsulates a foam plug 600 whose open end is connected to an attachment structure such as a wire, suture, or tubular crimp 606 on an inner tube 608. The inner tube 608 may be made from implant grade stainless steel such as 304 or 316 grade or a cobalt chromium alloy such as MP35n, and the crimp 606 may be made from annealed 304 or 316 stainless steel or a cobalt chromium alloy such as MP35n. It's okay to be rejected. This crimp also acts as an element that can be captured if the device needs to be removed.

Referring to FIG. 6, a tubular ePTFE layer 604 extends along an inner layer 612 that aligns the guidewire lumen and is everted around the left atrial surface 602 to form an outer layer 614. In some embodiments, layer 604 covers all and/or a portion of the proximal surface of the sidewall, such as cover 3100 or a cover on proximal surface 1064', as further described herein. Good as a thing. As further shown in FIG. 6, a first end 616 of the inner layer 612 is concentrically disposed within a second end 618 of the outer layer 614. First end 616 and second end 618 are clamped between inner tube 608 and outer clamp 606. In this manner, the implant may be encapsulated in a manner that presents a seamless left atrial surface 602 and preserves the integrity of the guidewire lumen and inner tube 608.

One embodiment of a technique for LAA occlusion device placement is shown in FIGS. 7-15. To close the LAA, the LA is first accessed through the venous system. One approach is to use a Brockenbrough-style needle to puncture the atrial septum and access the LA from the right atrium (RA). Basic needle puncture techniques are typically performed with venous access obtained through the right femoral vein. The Mullins sheath and dilator are then tracked over a 0.025" or 0.032" guidewire already placed in the superior vena cava (SVC). Fluoroscopic and echocardiographic imaging methods are typically utilized, such as transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). If echocardiography is not utilized, it is common to place a pigtail catheter within the aortic root to locate the aortic valve, a step that is not necessary when using echocardiography.

After the Mullins sheath and dilator are in the SVC, the guidewire is removed and a transseptal needle is placed through the dilator. The needle houses a stylet to prevent polymeric material from being stripped from the dilator lumen as it traverses to the tip. After the needle approaches the dilator tip, the stylet is removed and the needle is connected to the manifold and flushed. The Mullins sheath/dilator set and needle (positioned within the dilator tip) are withdrawn as a unit into the SVC toward the RA. After the system is pulled down the SVC wall and positioned within the fossa ovalis, it is at the preferred puncture location.

After proper position within the fossa ovalis is observed, the needle is advanced over the fossa ovalis and into the LA. Successful transseptal puncture can be confirmed by echo, manometry, _O2 saturation, and contrast agent injection. After the needle position is confirmed to be within the LA, the sheath and dilator may be advanced over it and into the LA. In some cases, the user first passes the guidewire through the needle into the LA and into the superior pulmonary vein (typically the left) before crossing. Alternative options include the use of a high frequency transseptal needle, which is useful for crossing very thick or enlarged septa, or the use of a safety wire placed through the needle and utilized for the initial puncture.

Referring to FIGS. 8-15, a guide catheter 802 is placed into the right atrium of the heart through the femoral vein and across the intraatrial septum as described above and positioned near the LAA inlet 804. Enter LA. A guidewire 902, typically 0.035" in diameter, is threaded through a guide catheter 900 and placed within the LAA 904. The guidewire 1002 is inflated within the LAA as the guide catheter 1100 punctures the wall of the LAA. The guide catheter 1100 is then advanced over the guide wire 1108 and into the LAA 1104. Under fluoroscopy, the catheter A radiopaque marker 1102 is used to guide placement.

The foam plug 1204 is then pushed through the guide catheter 1200 with the pusher 1202 and is shown slowly exiting the guide catheter 1300 in FIG. 13 until fully deployed as shown in FIG. 14. . The position of the foam plug 1404 is then determined by using the distal balloon 1408 and guide catheter 1400, by sliding the foam plug proximally by pulling the balloon 1408 through the shaft 1412, or by sliding the foam plug proximally through the guide catheter 1400. It can be adjusted in place by pushing distally and sliding distally. The guidewire may also house a pressure sensor therein so that the seal of the LAA is monitored and confirmation of an adequate seal is made. After satisfactory placement, adhesive 1514 may be injected and/or mechanical anchors may be deployed to secure plug 1404 to the wall. Guidewire balloon 1508 is deflated, and then the guidewire is removed. In an alternative embodiment, a two-component adhesive system may be used, with one component of the two-component system being adhered 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 wall of the LAA so that adhesion occurs only at the interface, minimizing the risk of adhesive embolism. In some embodiments, adhesives and balloons may or may not be used, eg, with the device 3000 described further herein.

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

For alternative anchors, these can be deployed and the shaft cut and removed. The cutting mechanism may be any of several types, such as screwing, electrolytic desorption, or others known in the art. In some embodiments, a suture attachment may be implemented as described with respect to FIG. 24, for example.

As shown in FIG. 16, some embodiments may include a foam body 1600 and a metal frame, such as a stent 1602. Foam body 1600 and stent 1602 may have the same or similar features and/or functionality as foam body 3002 and tubular body 3080, respectively (see FIGS. 85A-90D), and The opposite is also possible. The foam 1600 is designed to provide tissue ingrowth and cushion the metal stent 1602 over the tissue of the LAA. The proximal surface 1604' of the plug is covered with ePTFE, polyester, or another anti-thrombotic tissue scaffolding material to facilitate sealing and encourage overgrowth with the desired pore size.

Stent 1602 can be made from nitinol to allow it to be packed into a 10, 12, 14, 16, 18, or 20F delivery catheter and expanded to its desired diameter. Stent 1602 may be braided, laser cut, or wire formed. Any of a variety of stent wall patterns may be utilized depending on the desired performance. Stent 1602 may be a balloon expandable stent or a self-expanding stent. In the illustrated embodiment, self-expanding stent 1602 includes a plurality of proximal vertices 1608 and distal vertices 1610 connected by a plurality of zigzag struts 1612. Hole 1606 allows passage of a guidewire for delivery. This design can be advantageous in that the expansion force exerted on the LAA by the plug can be controlled separately from the foam properties. It may also be easy to pack this concept into smaller geometries. For example, plugs can be packed into smaller geometries 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 made from two pieces of foam. One denser core provides a force, e.g. a radial force, while the outer softer foam engages the tissue irregularities. Softer foam can also be placed on the proximal and/or distal ends to facilitate removal.

Another means of adding stiffness to a foam plug is shown in FIG. 17, in which a cavity 1704 within the foam plug 1700 is formed and a coil of wire 1702 is advanced at the proximal end 1706 to guide A catheter may be delivered into cavity 1704. Once the wire is inside the cavity, it expands to a predetermined size and applies a force radially outward to the foam. The type and amount of wire may be determined in-vivo using x-ray guidance, thereby examining radial expansion of the foam into the LAA.

Instead of a wire as shown in Figure 17, a balloon is fed into the foam and inflated while the outer foam serves to engage the tissue irregularities and tissue growth intrusions. It may generate a radial force. Following inflation, the balloon can be detached from the deployment catheter and the deployment catheter withdrawn. The balloon is preferably equipped with a valve to prevent leakage of inflation medium. The expansion medium may be any of a variety of media convertible between a first flowable state and a second hardened state, such as by in situ crosslinking or polymerization.

Another LAA plug is illustrated in FIG. 18 as a spring-like implant wire 1800 covered with foam 1802 to encourage ingrowth. The proximal surface of the implant is covered with a sheet of ePTFE or other tissue scaffolding material. The implant can be stretched and released in place for delivery.

Rather than using foam, a low porosity outer bag without perforations can be placed within the LAA and then filled with a substance to cause radial expansion. This material may be a hydrogel, cellulose, or polyvinyl acetate.

Rather than requiring a separate expansion device to be used to cross the septum, the distal crimp element 1902 may be tapered so that it extends from the distal end of the catheter 1200. and acts as a dilating tip to dilate the opening in the septum as the catheter is advanced. See Figure 19.

Alternative plug designs use foam, such as cellulose sponge material, that is compacted and dehydrated so that it can be stuffed into the guide catheter. Foam material 2202 can be packed into the guide catheter as shown in FIG. 22. Foam plug 2202 is then advanced from the distal end of guide catheter 2204 with plunger 2206 into the LAA. The plug exits the guide catheter and opens into a disk shape 2210. As the foam absorbs fluid in the blood, it expands in length to form a cylinder 2220 that fills the LAA. The expansion ratio for the compressed cellulosic material can be as high as 17:1 and can be expanded to the compressed length.

It may be advantageous to use the small barb 2302 in FIG. 23 to further engage the plug 2304 into the LAA. The barbs may be unidirectional or bidirectional to resist movement in either the proximal or distal direction. These barbs are embedded within the foam plug and their height may be from 0.1 to 1 mm. It may be desirable to deploy the plug and then engage the barb as a secondary step. One such embodiment can include multiple nitinol barb wires with balls or catches welded proximal to the barb tips. These can be collected with the delivery catheter within the sleeve, or the sutures can then be released when the ideal plug position is confirmed.

One means of removing a device that is not functioning properly is to releasably attach a retrieval suture 2400 to an implant, such as a proximal cap 2402 that extends proximally over the entire length of guide catheter 2404 in FIG. 24. If the device is to be removed, pulling on the ends of suture 2400 draws the outer covering into guide catheter 2404, which can then be removed from the patient. If the device is properly placed, the suture 2400 can be cut and removed, leaving the plug in place.

Deployment of occlusion devices has been described exclusively in the context of transvascular access. However, the implant may alternatively be deployed via direct surgical access or various minimally invasive access routes (eg, jugular vein). For example, the area overlying the xiphoid and adjacent costal cartilages may be prepared and draped using standard techniques. A local anesthetic may be administered and a skin incision typically made over a length of about 2 cm. A percutaneous penetration is passed under the costal cartilage and a sheath can be introduced into the pericardial space. The pericardial cavity may be perfused with saline, preferably saline lidocaine solution, to provide additional anesthesia and reduce the risk of irritating the heart. The occlusion device can then be introduced through the sheath and through the access path formed through the wall of the LAA. From this point on, closure of the wall and access path may be accomplished using art-understood techniques.

Depending on the desired clinical outcome, any of the LAA occlusion devices described herein may be supplied with drugs or other bioactive agents, and these agents may be injected through the deployment catheter. or impregnated into open cell foam or coated onto an implant. The bioactive agent may be eluted or otherwise released from the implant into adjacent tissue over a delivery period appropriate for the particular agent as understood in the art. Useful bioactive agents can include agents that modulate thrombosis, promote cell growth invasion, penetration growth, and endothelialization, and potentially, agents that resist infection. For example, collagen (type I or type II), heparin, a combination of collagen and heparin, extracellular matrix (ECM), fibronectin, laminin, vitronectin, peptides or other biomolecules that act as chemoattractants, the molecule MCP-1, Promote endothelial, smooth muscle, fibroblast, and/or other cell growth into the implant, including plasma treatment with VEGF, FGF-2, and TGF-beta, recombinant human growth factors, and/or various gases It is a drug that can

Antithrombotic agents can typically be divided into anticoagulants and antiplatelet agents. Anticoagulants include inhibitors of factors in the coagulation cascade, including heparin, heparin fractions and fractions, as well as inhibitors of thrombin, including hirudin, hirudin derivatives, dabigatran, argatroban and bivalurudin, and the low molecular weight heparin, rivaroki. Including factor X inhibitors such as Saban and Apixaban.

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

Antibiotics include, but are not limited to, penicillins, cephalosporins, vancomycin, aminoglycosides, quinolones, polymyxins, erythromycin, tetracyclines, chloramphenicol, clindamycin, lincomycin, sulfonamides, and their homologues and analogues. , derivatives, pharmaceutical salts, and combinations thereof.

A biological agent, such as those outlined above, may perhaps be added to the implant 204 and injected into the space between the proximal cap 206 and the foam plug 204 through a delivery catheter. This may serve as a reservoir to minimize thrombus formation during initial implantation and reduce the need for systemic anticoagulation after device implantation.

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

Another means of fixation is shown in FIG. 25A, where a foam plug 2500 is placed within the LAA. Distal screw lead 2502 is advanced and screwed into the LAA wall. Guide 2506 is pulled proximally as shown in FIG. 25B. When this guide 2506 is pulled back, the screw lead wires made of Nitinol are grouped together in a "bird nest" 2508 or form a coil inside the foam plug 2500. The screw lead wire 2502 is pushed distally from the guide catheter 2504 with a pusher 2510 to keep it together in one place within the foam. Catheter systems 2504, 2506, and 2510 are then removed.

Another means of securing the distal anchor element to the foam is shown in FIG. 26. Two barbed leads 2604 are attached to anchors 2602 such that when advanced into position within the foam plug 2600, the barbs 2604 dig into the foam plug.

27A-27G are various views of one embodiment of a device 10 for occluding the LAA. Device 10 may include the same or similar features as other devices for LAA occlusion described herein, such as plug 204, device 1020, device 3000, and vice versa. . Device 10 includes an internal locking system 101 for securing device 10 within the LAA. In some embodiments, device 10 may not include an internal locking system 101 or other fixation features; for example, device 10 may be secured by tissue ingrowth penetration alone. Occlusion device 10 comprises an open cell foam body 15, eg, an expandable medium such as a plug. Body portion 15 allows folding and expansion of device 10 and also enhances tissue growth penetration into the foam.

The body portion 15 of the device 10 shown in FIGS. 27A-27F assumes its expanded configuration. Body portion 15 takes the compressed configuration shape of FIG. 27G. Device 10 includes a foam body 15, a skin 20, a central lumen 25, a finial 30, and a dynamic internal locking system 101 that secures device 10 within the LAA. FIG. 27A is a side cross-sectional view of device 10 showing body portion 15 and internal locking system 101 in an expanded configuration. FIG. 27B is an end view of the proximal end of device 10 showing body portion 15 and internal locking system 101 in an expanded configuration. FIG. 27C is a side view of device 10 showing body portion 15 and internal locking system 101 in an expanded configuration. FIG. 27D is a side cross-sectional view of device 10 showing body portion 15 in an expanded configuration and internal locking system 101 in a constrained configuration. FIG. 27E is an end view of the distal end of device 10 showing body portion 15 and internal locking system 101 in an expanded configuration. FIG. 27F is a cross-sectional view of device 10 taken along line 1F-1F as shown in FIG. 27C. FIG. 27G shows the body portion 15 and internal locking system 101 being loaded and compressed within the delivery sheath 1. Device 10 may be delivered via a delivery catheter in the configuration shown in FIG. 27G. The body 15 of the device 10 may then expand with the internal locking system 101 remaining constrained, as shown in FIG. 27D. Internal locking system 101 may then be deployed to a deployed configuration as shown in FIG. 27A.

FIG. 27G shows the body portion 15 and internal locking system 101 being loaded and compressed within one embodiment of the delivery sheath 1. In some embodiments, delivery sheath 1 may be an outer delivery catheter. Body portion 15 and internal locking system 101 are loaded into delivery catheter 5 and compressed. Device 10 may be completely or partially inside delivery catheter 5. In some embodiments, delivery catheter 5 may be an internal delivery catheter. Device 10 may be loaded and compressed with delivery catheter 5 inside delivery sheath 1. For example, the body 15 of the device 10 may be expanded by removing the delivery sheath 1 by retracting the delivery sheath 1 proximally. Body portion 15 expands while internal locking system 101 remains constrained, eg, by delivery catheter 5. FIG. 27D shows body portion 15 in a deployed state with internal locking system 101 in a constrained configuration within delivery catheter 5. FIG. This represents the first step in the deployment process, specifically the placement of the device 10 within the LAA, where the body portion 15 is expanded and the internal locking system 101 is constrained, so the anchor is not deployed. The second step of the deployment process is shown in FIG. 27A, where internal locking system 101 has already been deployed through body portion 15. In some embodiments, this second step is reversible to retract the anchor, eg, if placement of device 10 within the LAA is not acceptable. Internal locking system 101, e.g., a fixation component or system as further described herein, is deployed from within body portion 15 to thereby engage adjacent anatomical structures of the LAA. At least one, and in some implementations, at least two or four or six or more anchors are deployed in the internal locking system 101 on the exterior of the body portion 15.

Internal locking system 101 may be controllably deployed after a period of time after body portion 15 is expanded. For example, the placement, orientation, etc. of the device 10 can be determined by various techniques such as fluoroscopy by injection of contrast medium through the central lumen before the internal locking system 101 is deployed and the anchor secures the device 10 within the LAA. Can be verified with imaging techniques. In some embodiments, even after deployment of the internal locking system 101 and its anchors, the anchors may be removed from the body portion 15 for repositioning within the LAA and/or for removal of the device 10 from within the LAA. can be withdrawn to an internal position.

FIG. 27F shows one embodiment of a device with slot 17. A slot 17 is formed within the foam body 15. For example, material of foam body 15 may be removed to facilitate deployment of internal locking system 101, such as outward expansion of the anchor to engage tissue.

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

Body portion 15 may be made from polyurethane, polyolefin, PVA, collagen foam, or blends thereof. One suitable material is polycarbonate polyurethane urea foam with a pore size of 100-250 μm and a porosity of 90-95%. The body portion 15 can 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 body 15 and replace the foam over time. The body portion 15 may be cylindrical in shape at unconstrained expansion, but its distal end may be smaller than its proximal end, or it may be inversely conical. The body portion 15 may also be oval in cross-section to better fit into the opening of the LAA.

Device 10 is radially oversized with unconstrained expansion to fit snugly within the LAA. Device 10 can be, for example, 5 to 50 millimeters (mm) in its open configuration, depending on the diameter of the target LAA, and typically at least about 10 mm or 15 mm in diameter. The length "L" of device 10 is greater than its diameter "D" such that the L/D ratio is less than, approximately or greater than 1.0, greater than about 1.5, or greater than about 2.0. It can be smaller, similar, or larger, such as larger. 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, such as 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 material compliance of the device 10 is designed such that it pushes against the LAA wall with sufficient force to keep the plug in place, but without overstretching the LAA wall. The foam body 15 and/or skin 20 also conform to the irregular surfaces of the LAA when expanded, imparting a complementary surface structure to the natural LAA walls to further strengthen the fixation and seal. Promote stopping. The expandable foam body 15 thus conforms to the LAA's natural irregular configuration shape. In some embodiments, the structure of the foam body 15 is configured to increase the diameter of the foam by axially compressing opposing ends of the body 15, such as by proximally retracting a pull wire or inner concentric tube. It can be processed into

Body portion 15 and/or skin 20, e.g., foam material and/or ePTFE, may be provided with one or more radiopaque markers, such as radiopaque threads 210 (see FIG. 2), or manipulated. A radiopaque material such as barium sulfate, bismuth subcarbonate, or tungsten that allows the operator to visualize under x-rays that the device 10 is placed in the proper position within the anatomy It can be filled or impregnated with fillers. Visualization of device 10 may be used to verify the position of device 10 before deploying anchors to secure device 10 in place.

Skin 20, such as the outer ePTFE layer, can have a thickness ranging from about 0.0001 inch to about 0.0030 inch. In some embodiments, the thickness of skin 20 may range from about 0.0003 inches to about 0.0020 inches. In some embodiments, the thickness of skin 20 may range from about 0.0005 inches to about 0.0015 inches. The thickness of the skin 20 may be uniform, eg, the same or approximately the same regardless of where the thickness is measured. In some embodiments, the thickness of the skin 20 may be non-uniform, eg, the thickness may be different in different portions of the skin 20.

A skin 20, such as an outer ePTFE layer, may also serve as a blood contacting surface on the proximal end of the device 10 facing the LA. The skin 20 may have pores or nodules such that blood components can clot on the surface and an intimal or neointimal coating of tissue can grow onto the surface and become firmly anchored to the skin material. Pore size may range from about 4μ to about 110μ. In some embodiments, the pore size is within the range of about 30μ to about 90μ. In some embodiments, the pore size is within the range of about 30μ to about 60μ. Such a range of pore sizes is useful for neointimal formation and attachment. In some embodiments, the skin 20, such as the outer ePTFE layer, may be formed from a tube having a diameter approximately the same as the diameter of the foam body 15, allowing the body 15 to be folded and pulled without tearing the foam material. make it possible.

The skin 20 can be fabricated from materials other than ePTFE, such as fabrics, meshes, or perforated films made from FEP, polypropylene, polyethylene, polyester, or nylon. The skin 20 may have low compliance (e.g., inelastic), e.g., low longitudinal compliance, may have sufficient strength to allow removal of the plug, and may have a low coefficient of friction. and/or may have blood clotting resistance. The skin 20 acts as a matrix to allow plug removal since most foams do not have sufficient strength to resist tearing when pulled. The body portion 15 is coated with a material to enhance the ultrasound echo brightness profile, clot resistance, lubricity, and/or to facilitate echocardiographic visualization, promote cell growth invasion and coverage, or can be included.

The skin 20 may include pores that allow contact between the LAA tissue and the foam body 15. Exposure of the foam 15 to the LAA or other tissue may have the benefit of, for example, encouraging tissue to grow into the foam plug pores and/or increasing friction to hold the body portion 15 in place. have These holes may be 1 to 5 mm in diameter or oval-shaped, with their long axis aligned with the axis of the foam plug, and whose length is 80 mm of the length of the foam plug. %, and the width may be 1 to 5 mm. The holes may be as large as possible so that the outer covering maintains sufficient strength to transmit the tension required for removal. The holes may be preferentially located along the device 10. In some embodiments, the holes are placed sufficiently distally to enhance tissue growth penetration from the distal LAA wall.

In some embodiments, device 10 includes an occlusion region and a fixation region. The proximal portion of the device 10 facing the LA after the device is implanted within the LAA may include an occluded region. The occlusion region may be a blood contacting surface on the proximal end of the device 10 that is antithrombotic while promoting neointimal formation in the occlusion region. The occlusion zone promotes antithrombotic and endothelialization from blood and adjacent tissues. The fixation zone facilitates fast and tough tissue growth infiltration into the device 10 from adjacent non-vascular tissue. The fixation zone may be the outer surface of the device 10 adjacent to and/or in contact with tissue within the LAA. The fixation zone may also include the distal end of the device 10 that faces the distal wall of the LAA after implantation.

28A-28D are various views illustrating one embodiment of an internal locking system 101 that may be used with device 10. FIG. In some embodiments, multiple internal locking systems 101 may be used with device 10. FIG. 28A is a side view of the internal locking system shown in an expanded configuration. FIG. 28B is an end view of the distal end of internal locking system 101 in its deployed configuration. FIG. 28C is a side view of the internal locking system 101 in a constrained configuration. FIG. 28D is a side view of one embodiment of anchor 120 of internal locking system 101.

Any of a variety of structures may be utilized with device 10 as dynamic internal locking system 101. Generally, at least approximately two or four or six or more tissue anchors 120 may be actively or passively advanced from implantable device 10 into adjacent tissue surrounding the implantation site. Following deployment of device 10 and expansion of body portion 15, tissue engaging segment 121 of tissue anchor 120 extends beyond the skin by at least about 1 mm, and in some implementations at least about 2 or 4 mm or more. . The tissue engagement segment 121 is carried by a support segment 122 of the tissue anchor 120 that extends through the foam body 15 and is supported by a pull wire, push wire, tubular support or other control structure depending on the desired configuration. Can be attached to the deployment control.

The locking system 101 described exclusively herein is a passively deployable structure. Upon removal of the constraint, tissue anchor 120 can self-expand laterally and deploy into adjacent tissue. Self-expansion may be accomplished by fabricating tissue anchor 120 using Nitinol, Elgiloy, stainless steel, or other shape memory or spring bias materials. The constraint may be removed by proximal retraction or distal advancement until the tissue anchor 120 is no longer engaged by the constraint, depending on the structure of the locking system 101.

Alternatively, the tissue anchor 120 may be actively deployed, such as by distal advancement, proximal retraction or rotation of the control, or inflation of a balloon positioned within the device 10, which causes the anchor 120 to be exposed to the skin. 20 or through a corresponding opening on the skin 20 and into the tissue. For example, a plurality of support segments 122, such as struts, may be connected at a distal end to central hub 111 and slope radially outwardly and proximally. Proximal retraction of hub 111 advances tissue engaging segment 121 along the axis past skin 20 and into adjacent tissue. The angle of inclination of the support segments 122, e.g., struts, may be reversed in another construction such that distal advancement of the hub 111 deploys the tissue engagement segments 121 beyond the skin 20. Proximal or distal advancement of hub 111 may be accomplished by proximal or distal advancement of a control, such as a control wire or inner tube, that is releasably engaged with hub 111.

Depending on the desired clinical performance, tissue anchor 120 may be retractable, such as by axial distal or proximal movement of the control depending on the angle of inclination of anchor 120. In embodiments exclusively illustrated herein, re-sheathing the anchor 120 includes advancing the tubular constraint along the sloped surface of the tissue anchor 120 to direct the anchor 120 radially inwardly into the device 10. This can be achieved by moving towards the central longitudinal axis. For anchors 120 that deploy by advancement along a longitudinal axis, anchors 120 may be retracted by advancing the control in a direction opposite to the direction in which anchors 120 are advanced to deploy.

Referring to FIGS. 28A-28D, internal locking system 101 includes a central tubular element or hub 111 and an anchor 120. Referring to FIGS. Anchor 120 may be an arm, segment, or other member extending from hub 111. Each anchor 120 may include a tissue engaging segment 121 and a support segment 122 extending to the hub 111 or other control. Internal locking system 101 has a single central tubular hub 111 and multiple anchors 120. There are four anchors 120 as shown. There may be two, three, four, five, six, seven, eight or more anchors 120. Anchor 120 may be rotatably, hingedly, or in some other movable manner coupled to hub 111. Accordingly, anchor 120 may move relative to hub 111, eg, after being released from restraints holding anchor 120 in a constrained configuration and deployed to a deployed configuration. As a further example, anchor 120 may be moved from a deployed configuration to a retracted position, as further described herein. Anchor 120 may be curved, as shown, and may assume, for example, the geometric shape shown in FIG. 28A when anchor 120 is unconstrained.

The illustrated anchor 120 may have a distal region 130, a hinge region 135, and/or a proximal region 125. Distal region 130 interacts with hub element 111. The hinge region 135 and curved geometry as shown allows the end of the proximal region 125 to extend beyond the body portion 15, for example beyond the sidewalls of the body portion 15. do. Proximal region 125 includes tissue engaging segments 121 configured to engage adjacent tissue. Tissue engaging segment 121 may be the entire proximal region 125 or a portion thereof, such as the tip. Accordingly, the proximal region 125 includes a sharpened tissue engaging segment 121, a shaped tissue engaging segment 121, an angled tissue engaging segment 121, a thickness configured to provide tissue engagement, and and/or other suitable features. In some embodiments, proximal region 125 may be retracted back into body portion 15, as further described herein. In the illustrated embodiment, anchor 120 and central tube 111 are distinct elements that are affixed to each other as shown. In other embodiments, anchor 120 and tube 111 are a single integral unit.

The internal locking system 101 is made from a biocompatible metal 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, the internal locking system 101 is cut from a single tubular piece of metal that is processed via machining or laser cutting, followed by secondary forming or annealing using similar materials. The next step is to do this.

Internal locking system 101 may assume a constrained configuration when device 10 is placed in place within the LAA and body portion 15 is expanded therein. Then, in a secondary step, internal locking system 101 locks or otherwise secures device 10 within the LAA by engaging anchors 120. If the position is not considered optimal, or if the device 10 needs to be repositioned within and/or removed from the LAA in some other way, the internal locking system 101 and its anchors 120 Unlocked, device 10 may be repositioned and/or removed.

29A-29B are sequential side views of an axially movable loop-type unlocking mechanism that may be used with device 10 to release a tissue anchor. FIG. 29A is a side cross-sectional view of device 10 showing the tissue anchor of internal locking system 101 in a deployed configuration. FIG. 29B is a side cross-sectional view of device 10 showing the tissue anchor in a retracted configuration. One embodiment of an unlocking system 140 is illustrated. Unlocking system 140 includes a ring 145. Ring 145 may be moved over anchor 120 to move anchor 120 to a retracted configuration. Ring 145 may be moved by pull rod 147. Ring 145 may be releasably attached to pull rod 147. Pull rod 147 may pass through the catheter and engage ring 145. Unlocking system 140 may be utilized when it is desired to unlock device 10 from within the LAA in order to reposition and/or remove device 10 after internal locking system 101 is deployed. .

In the illustrated construction, deployment of the tissue anchor by distal advancement of the restraint allows for reversible deployment, thereby retracting the tissue anchor with subsequent proximal retraction of the restraint. Alternatively, retracting the restrainer proximally and releasing the tissue anchor irreversibly releases the tissue anchor.

FIG. 30 is a side view of one embodiment of a device 10 having a flexible anchor 401. The device 10 shown in FIG. 30 may have the same or similar features and/or functionality as other devices for eliminating LAA described herein, and vice versa. . Device 10 may take the configuration shown in FIG. 30 adjacent to or within LA 201. The device 10 of FIG. 30 includes an expandable body 15, such as an open cell foam body, which allows the device 10 to fold and expand, and which aids in healing, fixation, and retrieval. ), which may be a strong thin layer fabricated from polyolefin, or polyester, is at least partially confined within the skin 20. The device 10 may also be deployed, repositioned, and/or removed if desired, or the device 10 may be deployed, as described herein, with an internal locking system 101, etc. It may be permanently fixed within the LAA by engaging a fixation system. Anchor 401 may be made of metal and may be fabricated from Nitinol. Anchor 401 may be a small diameter Nitinol wire from about 0.001 inches to about 0.010 inches in diameter. In some embodiments, anchor 401 may be about 0.0005 inches to about 0.020 inches in diameter. Anchor 401 may be deployed after expansion of body portion 15. For example, anchor 401 may self-deploy after deployment of device 10 from a delivery catheter. Anchor 401 may be relatively short and extremely flexible. Anchors 401 may not be able to penetrate tissue or provide fixation immediately after deployment of device 10.

FIG. 31 is a side view of one embodiment of a device 10 for LAA occlusion having an anchor 401 with a tube 500. Device 10 may be positioned adjacent to or within LA 201. Anchor 401 may be a flexible anchor, or in some embodiments anchor 410 may be relatively rigid, as further described. Tube 500 may be a stationary or movable tube, as further described. In some embodiments, tube 500 is a hypotube. Tube 500 may be stainless steel, polyamide, or other suitable material. Tube 500 may surround a corresponding anchor 401, as further described.

In some embodiments, anchor 401 may be fixed against axial movement. For example, anchor 401 may have a portion, such as a fixed length tissue engaging segment 121, that extends outside body portion 15. The portions of anchor 401 that extend outside body portion 15 may be bent when compressed within the delivery catheter and/or sheath, and those portions of anchor 401 then bend after deployment of body portion 15. It may extend straight into the configuration shown in FIGS. 31 and 32. The fixed length portion of anchor 401 that extends beyond body portion 15 may be about 1 mm to about 5 mm, or about 1.5 mm to about 4 mm, or about 2 mm to about 3 mm. This length of anchor 401 exposed outside body portion 15 may be effectively reduced by deployment of the corresponding tube 500, as further described. The deployment of the corresponding tube 500 around the corresponding anchor 401 extends beyond the end of the tube 500 after deployment of the tube 500, resulting in an effective length of the exposed anchor 401 of about 0.5 mm to about 1 mm. The length of the anchor 401 can be shortened. These are just examples of different lengths of anchor 401, and other suitable lengths may be implemented.

In some embodiments, anchor 401 may be axially movable. For example, anchor 401 may not be deployed or otherwise extend outside of body portion 15 immediately after deployment of body portion 15. Following acceptable positioning of device 10 within the LAA, flexible anchor 401 may then be advanced and threaded through corresponding tube 500. Anchor 401 may be axially moved in any suitable manner, including as described elsewhere herein. Anchor 401 may be moved through tube 500 either before or after tube 500 is moved outside of body portion 15 and deployed, as described below.

In some embodiments, tube 500 is movable and deploys outside body portion 15. Tube 500 may be movable in embodiments with either fixed anchors or movable anchors 401. Tubes 500 may be preloaded on corresponding wire anchors 401, eg, one tube 500 per anchor 401, as shown in FIG. 31. Tube 500 may then be moved over the corresponding anchor 401 as shown in FIG. 32. Tube 500 may straighten anchor 401 and add mechanical integrity. Tube 500 may also act as a puncture protector to prevent anchor 401 from puncturing the wall of the LAA. As described, movement of tube 500 over a corresponding anchor 401 may shorten the exposed length of anchor 401. This may result in a more rigid tissue-engaging segment of anchor 401 due to the reduced exposed length.

In some embodiments, tube 500 extends from the delivery catheter to or near the outer surface of body portion 15, but does not extend outside of body portion 15. Instead, tube 500 simply guides anchor 401, eg, around a curve, and supports wire 401 until tissue penetration. Tube 500 may have a launch angle such that anchor 401 does not buckle and hits tissue at right angles. In this embodiment, anchor 401 may have a relatively high stiffness compared to embodiments where anchor 401 is relatively flexible to provide more secure fixation of device 10 to tissue. Tube 500 may impart this guiding function to a corresponding anchor in any of the embodiments described herein having a movable anchor, such as movable anchor 401, anchor 120, etc.

The flexible anchor 401 and/or the external reinforcement tube 500 may be made of a biological material such as Nitinol, implant-grade stainless steel such as 304V or 316LVM, a cobalt-chromium alloy such as MP35N or Elgiloy, other suitable materials, or combinations thereof. Can be made from compatible metallic materials. Anchor 401 can vary in length from 0.1 mm to 5 mm, with external reinforcing tube 500 covering 10% to 90% of the exposed length of anchor 401.

Skin 20 at least partially surrounds body portion 15, and portions of skin 20 may or may not be attached to body portion 15. In the various devices 10 described herein, the body 15 has a skin 20 that can be fabricated from materials such as ePTFE (expanded polytetrafluoroethylene), polyolefin, or polyester to aid in healing, fixation, and removal. may be at least partially confined. FIG. 33 is a side view of one embodiment of a device 10 for LAA occlusion having discrete attachment points 700 of the skin 20 to the inner foam body 15. For clarity, attachment point 700 is shown as a dot in the figure. Attachment point 700 may not be visible from the outside of device 10; for example, skin 20 may be adhered to body portion 15 at attachment point 700, etc. In some embodiments, in addition to or as an alternative to adhesion, the skin 20 may be secured to the body portion 15 at the attachment points 700, such as with sutures, such that some or Everything may be visible outside the device 10. Device 10 may take the configuration shown in FIG. 33 adjacent to or within LA 201. Skin 20 may be attached to body portion 15 at a variety of separate attachment points 700. As shown in FIG. 33, the skin 20 may be partially attached to the body portion 15, with portions thereof not attached at all. This may, for example, allow the skin 20 to move upon expansion of the body 15 that occurs after deployment of the device 10 from the delivery catheter. The skin 20, in some embodiments, is placed near the proximal side of the device 10 to help facilitate closure of the entrance portion of the LAA, such as by a rim 800 as described below. Attachment points 700 may be located. The skin 20 may be applied, for example, in place at one or more attachment points 700 near the proximal surface, such that during implantation, bundling of the skin 20 occurs near the entrance but within the LAA. Make it. This may be accomplished using sutures, adhesives, heat bonding, other suitable approaches, or a combination thereof.

Selective placement of attachment points 700 may facilitate formation of rim 800 around the circumference of skin 20. The rim 800 is shown schematically as a triangle in FIG. 34 for clarity. The rim 800 can take a variety of different shapes depending on the configuration of the device 10, the shape of the LAA, etc. Additionally, rim 800 may extend completely or partially around device 10. A rim 800 may surround the entrance portion of the LAA. Formation of the rim 800 may help completely seal the entrance to the LAA around the device 10, thereby preventing leakage. The attachment points 700 between the skin 20 and the body portion 15 prevent the formation of irregular bundles of fabric and instead direct excess material to the device 10, as shown in FIG. A sealing rim 800 can be formed around or near the proximal surface of the. Rim 800 may form upon expansion of body portion 15 after deployment from a delivery catheter, as described herein. Alternatively, the attachment points 700 may be designed to prevent all of the fabric from bunching and provide a smooth surface, such as a smooth proximal surface.

35-36 are side views of an embodiment of a device 10 having an anchor 120 with a V-shaped tip 901 shown in a deployed configuration. As described herein, the V-shaped tip may be disposed within proximal region 125 and/or may form all or a portion of tissue engaging segment 121 of anchor 120. The V-shaped tip 901 forms a V-shaped point. V-shaped tip 901 generally takes the shape of a "V" or some other angled segmented shape. V-shaped tip 901 may be a sharp barb or hook. V-shaped tip 901 may be formed from wire or laser cut tubing or other suitable methods. As shown in FIG. 35, one or more of the V-shaped tips 901 are attached to the body 15 that is enclosed within the skin 20. V-shaped tip 901 may be attached to body 15 and/or skin 20. In some embodiments, V-shaped tip 901 is the end of anchor 1000. For example, V-shaped tip 901 may be part of anchor 1000 within body 15 and skin 20, as shown in FIG. The distal end of the V-shaped tip 901 may be free to slide, fold, or expand. The distal end of the V-shaped tip 901 may be attached to the body 15, the skin 20, and/or the anchor 1000, thereby allowing the V-shaped tip 901 to be folded and retracted. Upon removal into a catheter or sheath, the V-shaped tip 901 can flatten as it engages the inner diameter of the catheter or sheath. V-shaped tip 901 can be formed from Nitinol, implant grade stainless steel such as 304 or 316, cobalt chromium based alloys such as MP35N or Elgiloy, other suitable materials, or combinations thereof. V-shaped tip 901 may then restore the preset shape after deployment or redeployment.

37A-37C are side views illustrating various embodiments of V-tips that may be used with the anchors described herein. FIG. 37A is a side view of one embodiment of a V-shaped tip 901. V-shaped tip 901 comprises two angled segments. The segment may form its angle in a free state. The angle may have various angular amounts. In some embodiments, the angle formed by the V-shaped tip 901 is approximately 170°, 160°, 150°, 140°, 130°, 120°, 110°, 100°, 90°, 80° , 70°, 60°, or smaller, larger, or intermediate angular amounts. FIG. 37B is a side view of one embodiment of a wavy V-shaped tip 1101. The wavy V-shaped tip 1101 may include curved segments and angled straight segments. FIG. 37C is a side view of one embodiment of a dual wave V-shaped tip 1103. The dual-wave V-shaped tip 1103 may include two curved segments. The curved segment may facilitate engagement of the tip with the inner wall of the LAA. The ends of the various V-tips may be smooth, rounded, or sharp to facilitate tissue penetration. In some embodiments, all of the V-shaped tips can have the same shape. In some embodiments, some of the V-tips may have a first shape and other V-tips may have a second shape that is different from the first shape. . In some embodiments, some of the V-shaped tips may be attached to the skin 20 and/or the body 15. In some embodiments, some of the V-shaped tips may be attached to anchor 1000.

FIG. 38 is a side view of another embodiment of a device 10 for LAA occlusion implanted inside LAA 1201. Device 10 includes a body portion 15 in which a skin 20 and a finial 30 are placed within LAA 1201. The LAA includes a thicker proximal portion 1203 closer to the entrance. The internal locking system 101, eg, its anchor, may be configured to engage the thicker proximal portion 1203 of the LAA. Various anchors, V-shaped tips, etc., described herein for various embodiments of device 10 may be used to secure the anchor within thicker proximal portion 1203. In some embodiments, device 10 may be deployed from a catheter such that body 15 expands. Placement, orientation, etc. of expanded body portion 15 within the LAA may be verified by imaging, for example, as described herein. The placement, orientation, etc. of the expanded body portion 15 within the LAA may be verified to ensure engagement of the internal locking system 101, eg, its anchor, with the thicker proximal portion 1203. Internal locking system 101, eg, its anchor, may then be deployed to engage thicker proximal portion 1203. If the internal locking system 101, e.g., after deployment of that anchor, determines that the anchor does not engage the thicker proximal portion 1203, the anchor is retracted, as described herein; Device 10 may be relocated and/or removed.

In some embodiments, the internal locking system 101, e.g., its anchors, may be releasably constrained in a collapsed or constrained position or configured shape, or may be previously locked down in some other manner. It may be a loaded surface element. Internal locking system 101, eg, its anchors, may be restrained using restraints. The restraint may be a dissolvable polymer, a lasso, or a wire that can be retracted to release the anchor. The restraint may be similar to a deadbolt. Other fastening concepts include Velcro integrated with ePTFE, electrically orientable/ratcheting fastening elements, unidirectional Gecko tape, or wire pre-attached to the finial 30. In some embodiments, the body 15 with the skin 20 is secured within the LAA by weaving the body 15 and exposing the body 15 to the tissue through holes in the skin 20, thereby connecting it to the cardiac surface. friction can be increased to a sufficiently high level to prevent implant migration.

39A-39B illustrate constrained configuration shapes and 1302 is a perspective view of one embodiment of a deployable anchor 1302 shown in a deployed configuration. FIG. The two-stage fixation system allows deployment of anchors 1302 after implantation and expansion of body portion 15. This embodiment incorporates one or more hinged anchors 1302. Anchors 1302, which may be barbs or other fixation elements, may be flattened upon delivery and deployment of body portion 15. Then, when pulled or pushed, anchor 1302 bends at hinge 1306 and penetrates outward from the surface of body portion 15 into the LAA tissue. The anchor 1302 has a hollow constraining element 1304, which may be a thin, metallic, round or rectangular box, such as a round or rectangular shaped tube, and a pull wire 1301, for example a slide, which may be a wire or suture. It can be bent at the hinge 1306 using a dynamic element. Pull wire 1301 is attached to the proximal end of anchor 1302 and returns through the delivery catheter or sheath. When pull wire 1301 is retracted, anchor 1302 slides back through slot 1308 in tube 1304 and bends at preformed hinge 1306. A portion of anchor 1302 then extends out and through slot 1308.

FIGS. 40A-40B illustrate each constrained configuration shape activated by a lock wire 1401 that may be used with various devices 10, 1020, 3000, etc. for LAA occlusion described herein. FIG. 14 is a perspective view of one embodiment of a deployable anchor 1405 shown in the and deployed configuration. Anchors 1405, which may be barbs or other anchoring elements, may be formed from a wire or flat sheet of Nitinol or other shape memory material and heat set to an expanded configuration shape. One or more of the anchors 1405 may be placed along the skin 20 or in some other manner along the outer surface of the body portion 15. One or more corresponding guides 1402, such as loops, may be placed along the skin 20 or body portion 15. Guides 1402 may be placed on either side of anchor 1405 as shown. A guide 1402 on a first side of anchor 1405 may secure anchor 1405 in place. A second opposing side guide 1402 of anchor 1405 may serve as a guide for locking wire 1401, which may be a restraining wire, suture, or the like. Lock wire 1401 may be used to constrain anchor 1405 in a constrained configuration, for example, in a flat position as shown in FIG. 40A. When lock wire 1401 is retracted, anchor 1405 deploys as shown in FIG. 40B. Anchor 1405 may extend perpendicularly to body portion 15 or at an angle.

41A-41B illustrate a sheath 1502 activated, constrained configuration shape and FIG. 16 is a perspective view of one embodiment of a deployable anchor 1506 shown in a deployed configuration. Anchors 1506, which may be barbs or other anchoring elements, may be formed from a wire or flat sheet of Nitinol or other shape memory material and heat set to an expanded configuration shape.

One or more of the anchors 1506 may be placed along the skin 20 or along the outer surface of the body portion 15 in some other manner. One or more corresponding guides 1500 and locking loops 1504 may be disposed along the skin 20 or body portion 15. Guide 1500 may be disposed on a first side of anchor 1506 and locking loop 1504 may be disposed on a second, opposing side of anchor 1506, as shown. Anchor 1506 is held in a constrained or restrained configuration or position by sheath cover 1502. Sheath cover 1502 may be tubular or rectangular in shape. Sheath cover 1502 constrains anchor 1506. Sheath cover 1502 may constrain anchor 1506 to a flat position as shown in FIG. 41A. When sheath cover 1502 is retracted, anchors 1506 are deployed as shown in FIG. 41B. Anchor 1506 may extend at an angle to body portion 15 or perpendicularly.

42A-42D show various embodiments of a device 10 for occlusion of the LAA having external deployable anchors 1601, 1604 that can be collapsed and expanded by retracting into or withdrawing from a sheath or outer catheter. This is a diagram. FIG. 42A is a side view of device 10 with anchor 1601 constrained by delivery sheath 1603. FIG. 42B is a side view of device 10 unconstrained by delivery sheath 1603 with anchor 1601 deployed. FIG. 42C is a side view of device 10 with anchor 1604 constrained by delivery sheath 1603. FIG. 42D is a side view of device 10 unconstrained by delivery sheath 1603 with anchor 1604 deployed. As shown in FIGS. 42B and 42D, the body portion 15 with the skin 20 houses anchors 1601 or 1604 that are fixed to the surface of the skin 20 and are unconstrained and therefore expandable in a free state. be able to. A delivery sheath 1603, such as a catheter, can be used to constrain anchor 1601 or 1604. Anchors 1601 or 1604 may then expand when body portion 15 is unconstrained by delivery sheath 1603, for example, when body portion 15 is released from delivery sheath 1603. Anchor 1601 may be deployed into a curved shape as shown in FIG. 42B. Anchor 1604 may be deployed into an angular configuration as shown in FIG. 42D. Anchors 1603 or 1604 may point toward either the proximal or distal side of body portion 15 after deployment.

43A-43C are sequential side views of one embodiment of the illustrated device 10 for occlusion of the LAA, each constrained by a lasso 1707, deployed and adjusted at a mount 1705. . One or more anchors 1709 may be preloaded within body portion 15 and attached distally to mount 1705. Mount 1705 may be a ring-like member with an opening therethrough. Mount 1705 is positioned on rod 1701 having end 1711. Mount 1705 may move, e.g., slide, on rod 1701 in a proximal direction, for example. In some embodiments, mount 1705 may be pulled proximally, eg, by a pull wire. In some embodiments, mount 1705 may move when rod 1701 is rotated. In some embodiments, the mount 1705 and/or the end 1711 of the rod 1701 may be threaded. When mount 1705 moves, anchor 1705 moves. The device may include a tapered cone 1708. Cone 1708 may be attached to the end of rod 1701. Mount 1705 may be moved toward cone 1708 to adjust the height of anchor 1709. Therefore, anchor 1709 is more angled in FIG. 17C with respect to FIG. 17B. Anchor 1709 may travel through body portion 15 and into tissue. Anchor 1709 may be adjusted to increase or decrease the amount of tissue penetration, for example, by moving mount 1705 as described. For extraction, this process can be reversed. In some embodiments, the lasso 1707, which is attached to the wire 1703, passes through, e.g., screws into, the threaded rod 1701 to retract the anchor 1709 into the body portion 15. can be placed around the In some embodiments, lasso 1707 may be used to first constrain anchor 1709 and then retract to allow anchor 1709 to be deployed.

44A-44C illustrate one embodiment of a device 10 for occlusion of the LAA having an adjustable two-stage anchor system with an anchor 1801 activated by moving a mount 1803 along a rod 1804 FIG. Anchor 1801 may be an internal grappling hook type structure that is retained within body portion 15 and skin 20. Anchor 1801 may be introduced through central lumen 1003 through body portion 15, as shown in FIG. 43A. Anchor 1801 may then pass through body 15 and skin 20 to engage tissue, as shown in FIG. 43B. Anchor 1801 may be adjusted to increase or decrease the amount of tissue penetration. Anchor 1801 is attached to a movable mount 1803 at its distal end. Mount 1803 is prevented from rotating; for example, mount 1803 can be provided with a notch to prevent rotation of mount 1830 within finial 30, as shown in FIG. 43C. Mount 1803 is threaded onto a threaded rod 1804 that can be rotated clockwise or counterclockwise to change the linear position of mount 1803. The distal end of rod 1804 may be coupled with cap 1807. Cap 1807 may rotate with rotation of rod 1804. Mount 1803 may be moved proximally so that anchor 1801 passes over the surface of body 15 and skin 20, as shown in FIG. 43B. Mount 1803 may be moved distally to pull anchor 1801 back into or below the surface of skin 20. The depth of penetration of anchor 1801 may be controlled, for example, to account for the non-circular cross-section of the LAA. In some embodiments, anchors 1801 may be individually deployed. Another option is to deploy anchors 1801 distal to body portion 15 with skin 20 and control the stiffness of anchors 1801 to apply a sufficiently uniform penetration force to the contacting tissue.

The entire disclosure of each is expressly incorporated and made a part of this specification by reference for all purposes, such as U.S. Patent Application No. No. 15/290,692, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA" (Docket Number: CNFRM.001P1), U.S. Patent Application No. 14/203,187, filed March 10, 2014, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA” (Docket Number: CNFRM.001A), European Patent Application No. EP14779640.3 filed on August 24, 2015, titled “DEVICES AND METHODS FOR EXCLUDING THE LAA” (Docket Number: CNFRM.001EP), 2014 LAA (LAA) occlusions, such as those described in PCT Patent Application No. PCT/US2014/022865 filed March 10, entitled DEVICES AND METHODS FOR EXCLUDING THE LAA (Docket Number: CNFRM.001WO) may include various features for. Further additions and improvements to these and other concepts are described below. Unless the context points out or indicates otherwise, the embodiments described in the following sections may have the same or similar features and/or functionality as the embodiments described above, and vice versa. It is also possible.

A. Basic Plug Design Components and Improvements Various occlusion devices and associated features are described with respect to FIGS. 45A through 77. The same or similar features and/or functionality of the various devices as illustrated and described with respect to FIGS. 45A-77 may be found in the various devices illustrated and described with respect to FIGS. 1-44C and 78-93B. It may reside within the device and vice versa.

As shown in FIGS. 45A-45C, device 1020 (sometimes referred to herein as an "implant") may utilize a foam "cup" with an interior removed. In some embodiments, this may be similar to the foam 1600 design shown and described with respect to FIG. 16 and/or the foam body 3002 described with respect to FIGS. 85A-93B. A "cup" design may be contrasted with a solid or generally solid tubular foam plug, such as those described and shown in FIGS. 2 and 6. For the cup designs of FIGS. 45A-45C, the approximate thickness of the foam may be about 2.5 mm, but may be within the range of about 0.25 mm to about 10 mm. Note that the thickness may be significantly thicker than typical stent coatings or coverings such as those utilized in other applications (eg, coronary stents, peripheral stents, AAA liners, etc.). In this application, where occlusion is being performed, the thickness of the foam adds some desired structure between the gaps of the internal support structure 1032, such as a stent. In some embodiments, the thickness is at least about 0.25 mm, in some embodiments at least about 0.50 mm, 0.75 mm, 1.0 mm, or 2.0 mm or more in an unconstrained state, and in one implementation: It may be about 2.5 mm, the thickness being selected depending on the desired performance.

FIG. 45A is a cross-sectional view of a preferred embodiment showing components of an implant 1020 having a proximal (atrial) end 1022, a distal (LAA) end 1024, and an internal cavity 1026 in an expanded configuration. Expandable tubular wall 1028 defines an internal cavity 1026 that, after deployment, spans the entrance portion and is connected to the proximal end 1022 by a tissue scaffold 1030 or other barrier configured to separate the LAA from the atrium. You can be surrounded. The proximal edge of the tubular wall 1030 preferably includes an angled reentry or recapture surface, such as an annular chamfer 1031 that extends continuously over or in some other way around the proximal edge of the implant 1020. may be included to facilitate proximal retraction of the implant into the deployment sheath to permit repositioning or removal if desired. A distal extension 1029 of tubular wall 1028 extends distally beyond the internal support (described below) to form an atraumatic leading edge.

Tissue scaffold 1030 may be integrally formed with tubular wall 1028 or may be adhered thereto. Tissue scaffold 1030 and tubular wall 1028 may have approximately the same thickness and porosity characteristics as described below. Alternatively, the tissue scaffold is configured to support tissue growth infiltration and separate the LAA, and has tubular walls that are thinner than ePTFE, PTFE, Dacron, or other materials known in the art. It may be made of materials such as.

An expandable, internal support structure 1032, such as a corrugated stent 1034 or other frame, may be provided. The illustrated wavy stent 1034 includes a plurality of struts 1038, with adjacent pairs of struts joining to form a plurality of proximal apexes 1041 and distal apexes 1042. Stent 1034 may be laser cut from tube stock as known in the art. Each of the at least three, preferably at least four or six or eight or more proximally facing vertices 1040 slopes radially inwardly in a proximal direction with respect to the central hub 1046. Or equipped with recapture strut 1044. Recapture struts can be cut from the same tubing stock as the stent. Hub 1046 may include a central lumen, such as for delivery over a guidewire or for releasable engagement with a deployment device (not shown). Alternatively, hub 1046 may include an attachment such as an eyelet 1048 for receiving a suture loop. The suture or other retention element may extend distally from the deployment catheter, through the tissue scaffold 1028, through the eyelet 1048, back proximally through the tissue scaffold 1028, and into the deployment catheter. . After satisfactory positioning of the implant 1020, the suture may be removed, releasing the implant 1020 from the deployment catheter, leaving a homogeneous tissue scaffold 1030 when the suture track is closed due to the resiliency of the material. . In one preferred implementation, the implant 1020 is deployed from the delivery catheter without advancement over a 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 within a socket attachment mechanism that may also pivot. .

Tubular wall 1028 may be attached to stent 1034 by adhesive, suture, or other adhesive techniques known in the art. In the illustrated embodiment, tubular wall 1028 is sutured to stent 1034, tissue scaffold 1030 is sutured to recapture struts 1044, and support structure 1032 is carried within cavity 1026. Alternatively, at least a portion of the support structure 1032 may be carried on the tubular wall 1028 or the outer surface of the tissue scaffold 1030. The corrugated stent may be embedded within the tubular wall 1028, such as by sandwiching the stent between an inner and outer layer of foam that are then glued together. Similarly, the recapture struts can be encapsulated between an inner polymer layer and an outer polymer layer. The polymeric material can also form a foam around the stent so that a secondary attachment process is not required.

FIG. 45B is a distal end view of one embodiment of an implant 1020 showing an internal metallic structure having a central hub 1046 and eight recapture struts 1044 angled radially inward relative to the hub 1046. . A plurality of suture retainers, such as apertures 1050, are attached to or formed within struts 1044 to receive sutures used to secure tissue scaffold 1030. This reduces the tendency for the tissue scaffold 1030 material to slide distally along the struts 1044 when the implant 1020 is retracted proximally into the deployment catheter.

The frame may be expandable from a collapsed delivery configuration to an expanded deployed configuration. The frame may be retractable from an expanded, deployed configuration to a collapsed delivery configuration. The frame may be generally tubular in the unconstrained expanded configuration, e.g., circular, circular, segmented, polygonal, other shapes, or combinations thereof, and preferably compresses the foam. to match the shape of the inner surface of LAA. This allows the deployed implant to minimize leakage, with its maximum size being approximately 4 mm or less or 3 mm or 2 mm or less, and in some deployments essentially There are no leaks.

FIG. 45C is an outer proximal end perspective view of an embodiment of an implant 1020 having an integral foam shell and showing proximal chamfer 1028 in unconstrained expansion. Anchors deployed near the distal end of the frame are discussed in more detail below.

Some advantages of gutted foam "cups" compared to solid foam plugs are: This still behaves like a complete foam plug in terms of conformability and sealing. It has an internal metal frame that can be optimized to provide the desired amount of expansion for sealing and anchoring by providing optimal radial force and attachment points for the anchor, as well as foam for retrieval. Allows for the incorporation of an inner anterior surface of the proximal surface that aids in folding. By sizing the metal frame to be shorter in length than the foam cup, a non-invasive distal cushion that is entirely foam and can be pushed out of the sheath tip is advanced within the LAA. formed when The overall volume of the material is then reduced, making it easier to: This significantly reduces the delivery profile, making it easier to flush to remove air before delivery into the vasculature, allowing more blood to flow into the cardiovascular system in the event of an embolus. Increases porosity to blood.

In one embodiment, the proximally facing edges of the foam plug 1040 are beveled to aid in loading and unloading. There may also still be a central location to allow tracking of the implant 1020 on a guidewire type device, but in some embodiments there is no lumen or only a slit within the foam plug 1040. However, it is undesirable to have a significant residual central hole that could cause thrombus formation or allow leakage. The slit may be a single slit, a double cross-shaped slit, or multiple slits. The goal is to still allow tracking on the guidewire, but ensure that the hole closes completely after the guidewire is removed. In the case of a solid surface, the implant 1020 cannot be tracked over a guidewire and instead can be delivered through a long transseptal sheath, for example.

The term "guidewire," as utilized above, can mean an actual medical device sold as a guidewire, or it can be a catheter, such as a pigtail catheter, which is an LAAC (LAA Note that the closure) implant 1020 is first placed within the LAA to be tracked.

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

Depth: The preferred length of the plug 1040 (generally the depth of the occluder within the LAA along the proximal-distal direction) is 20 mm, independent of the diameter of the implant 1020. This may provide good stability for the implant 1020 while still being able to accommodate most of the anatomy. The distal tip of the foam plug 1040 is very soft and provides an atraumatic tip when entering the LAA when the distal tip of the implant 1020 is allowed to protrude beyond the distal recess of the delivery catheter or sheath. Becomes a department. This short depth makes placement of the plug 1040 more secure since there is less need to align the delivery catheter with the LAA, as is required with longer devices.

Foam and porosity: The average pore size of the foam is 250-500 microns. The foam has very high porosity (90-95%) to promote rapid and thorough tissue growth penetration. Open cell foam allows blood to flow inside. If the plug 1040 is to embolize, it opens far enough to safely allow sufficient blood flow until it can be removed. In addition, a large porosity may be beneficial in properly flushing the implant 1020 to prevent air from entering the vasculature. The porosity and cell size may be as described for the foam body 3002 of the device 3000, illustrated and described for examples with respect to FIGS. 85A-90D.

The compliance and thickness of the foam is designed to form a good seal against tissue with minimal compression. While other devices require significant oversizing to obtain a seal, this implant 1020 requires only less than 1 mm of oversizing.

LA-facing surface: ePTFE (expanded polytetrafluoroethylene) or PTFE as a skin/layer to the implant 1020, such as over the plug 1040 or partially over the plug 1040, as described above, is clot-forming. may be ideal for supporting neointimal formation without Although embodiments may be described with respect to ePTFE, it is understood that PTFE may also be used. However, even though blood flow may be enabled around the outer surface of the cup, the low porosity of ePTFE may not allow blood flow through the surface of the embolized implant 1020 or its It can reduce safety because it reduces performance. The ePTFE porosity is considerably lower than that of open cell foams, so blood flow across the membrane may be negligible. However, it is hydrophobic and is beneficial for antithrombotic properties. One option to add the antithrombotic properties of ePTFE and/or PTFE while maintaining the desired open porosity of the foam structure is to add a PTFE coating via vapor deposition onto the foam. The anti-thrombotic coating may include ePTFE or PTFE. This forms a highly porous surface that simulates ePTFE morphology. Attachment methods may include vapor deposition as described above, or elastomeric adhesives (although this may eliminate porosity at the attachment point). If ePTFE is preferred, it could be attached by wrapping the metal frame with ePTFE, then wrapping it through the center around the OD and attaching via sutures.

As discussed further herein, it may be desirable to reduce the pore size of the foam to within the range of about 30-200 μm.

Barb/Anchor: There are several options or types of barb designs that can be implemented to secure the implant 1020 within the LAA. Here are some examples: 1) Static: Always engages tissue when the plug is deployed. This makes it difficult to re-sheath and reposition the implant 1020. 2) Constraints: The implant 1020 can be deployed with barbs constrained. Implant 1020 may be repositioned as needed. The barb is then released when the plug 1040 is in its final position. 3) Dynamic: The barb can be expanded or retracted as desired without moving the plug. Dynamic barbs may allow deployment and retraction, for example, to reposition and/or remove implant 1020.

In some embodiments, implant 1020 may have different characteristics than other implants described herein. In some embodiments, the implant 1020 may include any or all of the following features: no central lumen and a proximal surface inside the cup in addition to a wavy stent. The proximal surface 1604' shown in FIG. 16 or the proximal surface 1604' shown in FIG. 85A has a spoked element and has anchors/barbs that can be actuated preferably as a secondary step after deployment of the plug itself. having a layer on the proximal surface that may be similar to layer 3100, but in some embodiments the PTFE is applied via a vapor deposited coating as opposed to expanded PTFE (ePTFE) applied as a secondary material. obtain.

B. Endoskeleton with Proximal Spokes The implant 1020 may include a foam plug 1040 with a central endoskeleton with a proximal spoke surface 1080 with a number of radial struts. This configuration improves the ability to remove (re-sheath) the foam implant 1020. The stent versions shown in Figures 45A and 45B may be laser cut from superelastic nitinol tubing, but may also be made from a number of other biocompatible metallic materials such as shape memory nitinol, stainless steel, MP35N, or Elgiloy. may be used. Although this embodiment is self-expandable, balloon-expandable designs can also be utilized. In addition, the frame can also be fabricated from drawn wire as opposed to laser cut from tube. A loop could be formed along each strut to attach it to the foam via suture, although other attachment processes could be used, such as adhesive bonding. The loops located in the middle of the struts are oval shaped and staggered, which may make them easier to load into the delivery catheter and easier to process. In addition, as shown in FIG. 46, there may be no loops. The embodiment shown in FIG. 45A has 8 struts, but anywhere from 4 to 32 struts can be utilized. Generally, it is preferred that the foam be attached to the frame at multiple points, including the center. This facilitates removing the foam without damaging it, and suture loops are beneficial for this purpose. In other embodiments, the foam can be formed around the endoskeleton so that it is within the foam, thereby eliminating the need for a secondary attachment step. As shown in FIG. 45A, the proximal foam face preferably has a chamfer at the edge to minimize the bulk of the material in this area to aid in reinsertion into the sheath.

47A-47B are perspective and side views, respectively, of an embodiment of an LAA occlusion device 1020 having an internal frame 1032, which may be a single piece. Although the design shown in FIG. 45B is fabricated from two separate pieces--a proximal spoke face 1080 with eight struts and a wavy stent, in some embodiments, FIGS. There may be a one-piece unit frame 1032, such as that shown at 47B. In some embodiments, the proximal spoke surface 1080 may support reinsertion into the sheath, and eight crown wave cage stents 1060 support the foam cylinder plug 1040 and the cylinder Eight to sixteen, or fewer or more, barbs or anchors 1100 disposed within provide embolization-resistant anchoring. Anchors 1100 may be positioned proximally, distally, and/or centrally along the length of the cylinder. The size of anchor 1100 can preferably range from about 0.003" to about 0.009" in thickness and about 0.007" to about 0.015" in width when fabricated from Nitinol tubing. In some embodiments, the anchor 1100 may extend about 1 mm from the surface of the implant 1020, but may extend from about 0.5 mm to about 2 mm, or less or more, from the surface of the implant 1020. It may be. Anchors 1100 may be in a single location along the length of the cylinder, as shown in FIG. 48, or may be staggered. The in vitro anchoring movement resistance with these designs may be in the range of 0.51b to 1.51b force. As shown, anchor 1100 may be a single row. There may be multiple columns.

FIG. 49 shows an implant 1020 having a central endoskeleton with a proximal spoke surface 1080 in a fully expanded configuration when attached to a delivery catheter. FIG. 50 shows an embodiment of the implant 1020 in a collapsed configuration. A modification includes an outer sheath component of the delivery catheter that may be telescoping, or a slit in the tip to aid in tapering and folding. Reducing the coefficient of friction of the foam surface may reduce the force required to fold the implant into the catheter. This can be achieved, for example, by applying a layer of PTFE to the foam via vapor deposition or other processes, or by applying expanded PTFE (ePTFE) to the proximal surface using adhesives or mechanical methods such as suturing. ) layers. Secure attachment of the foam surface to the spoke system may be provided by suture attachment or other methods, including adhesive bonding, which results in increased forces and potential tearing of the foam. To prevent the foam from clumping together in one place when taking it out. If not securely attached with distributed force, the metal spoke elements can pull through the foam during resheathing and potentially destroy the implant.

C. Proximal (Blood Contacting) Surface of the Foam The foam implant 1020 may be constructed from porous open cell foam. The foam can be any of a variety of currently available materials, including polyurethane or polycarbonate polyurethane, or polyurethane-based biomaterials, such as polyvinyl acetal (PVA) (Ivalon®). The foam may be reticulated such as a net. One embodiment utilizes a non-resorbable reticulated polyurethane biomaterial. In addition, resorbable foams containing polyhydroxyalkanoates (PHA) such as poly-4-hydroxybutyrate (P4HB) or cross-linked resorbable polyester urethane urea scaffolds are also available.

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. Such high porosity (eg, about 90% to about 95%) materials promote rapid and tenacious tissue growth invasion and effectively mimic the extracellular matrix. Although such high porosity materials are desirable for tissue growth infiltration, they may not be ideal for the antithrombotic properties required for left atrial (LA) surfaces. An antithrombotic surface is desirable for the side facing the LA. If modifications are made to the LA-facing surface to promote blood compatibility, those modifications are extended to the sides of the implant 1020 by about 1 mm to about 20 mm, preferably about 1 mm to about 5 mm, and the implant 1020 When deployed, a portion of the side of the implant 1020 may protrude outside the LAA to ensure anti-thrombotic properties when it enters the blood environment. If a hole, such as a guidewire lumen, is in the proximal surface, the antithrombotic surface may penetrate at least partially into the lumen. In addition, the antithrombotic layer will promote tissue growth invasion and endothelialization.

Various methods can be used to form the antithrombotic proximal surface of the implant 1020, including but not limited to: For example, an expanded PTFE (ePTFE) skin or layer may be applied to the outer surface of the foam implant as described elsewhere herein. This could also be attached by wrapping a metal frame with ePTFE, then wrapping it through the center around the OD and attaching it to the frame. This can be done using a variety of methods including suture or adhesive bonding, including the use of elastomeric adhesives (although this may eliminate porosity at the point of attachment). This ePTFE layer, if present, can penetrate into the guidewire lumen. In addition to ePTFE, electrospun, meltdown, nonwoven, knitted or woven fibers of PTFE, polyester, PGA, PLA, poly-4-hydroxybutyrate (P4HB) or other biocompatible fiber materials can be can be utilized to form biocompatible surfaces.

In some embodiments, a coating of hydrophobic material, such as PTFE, is applied on the proximal surface using any of a number of processes known to those skilled in the art, including vapor deposition coating. Ideally, this coated layer also extends partially over the sides of the implant. Some embodiments may not include a guidewire lumen, but if a central lumen is present, the coating preferably extends at least partially (eg, about 1 mm) into it. To promote antithrombotic properties, the coated layer 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. Possible materials for this include PTFE applied to a thickness of approximately 50-100 microns, polyurethane spray or dip coatings, albumin, polyethylene glycol (PEG), or composites such as poly(ethylene oxide) (PEO). Including formal coatings, all with or without heparin or nitric oxide. PEG or PEO is ideally attached via a grafting process. In preferred embodiments, the outer layer is also smooth to aid in re-sheathing of the implant. This can be accomplished with both hydrophobic materials such as ePTFE and PTFE, and hydrophilic materials such as PEO and PEG. To create the desired combination of porosity and hemocompatibility, a two-step process may be utilized in which the foam is first coated with a base layer, such as a polyurethane-based biocompatible material, and then coated with a second The step utilizes PTFE, PEG, or PEO to create a smooth surface that is more antithrombotic. Heparin or other anticoagulant may be added to the final blood contacting surface.

Another option to create smaller pore sizes in ePTFE-like materials is to attach an electrospun layer of PTFE to the face of the foam using sutures. Very thin layers (<1 mm) are formed and can be attached via sutures or adhesive bonding.

Another desirable property of the foam of the plug 1040 is to impart echoluminosity to the implant 1020, which allows echocardiographic visualization. Although porous surfaces may be sufficient to promote echobrightness, in some cases hydrophilic surfaces may be beneficial. To promote blood compatibility and a hydrophilic surface, a preferred embodiment is a foam implant with a PEO or PEG grafted surface.

D. Static Barb (Anchor) Design Static barbs engage tissue when plug 1040 is deployed, eg, expanded. Although this simplifies processing, it makes it difficult to reposition the implant back into the sheath.

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

Referring to FIG. 52, in some embodiments, a laser cut dual barb 2000 system may be utilized. This is a stent 1034, a nitinol tube 2002 cut to allow two crimp ends with one barb 2000 near each crimp 2004 with a continuous nitinol connection that follows the curvature of the stent, in this example a wavy shape. It can be processed from. The advantage of this embodiment is that the barb requires less effort to process and shape, it is easier to form a sharp tip, and the curvature of the tube wall results in a stiffer barb. FIG. 53 shows one embodiment of the laser cut portion of FIG. 52 prior to forming the crown-shaped curvature.

Referring to FIG. 54, in some embodiments, the wireform follows the curvature of the corrugated support cage 1034 (stent) and terminates in two barbs 2000. This can be crimped to the corrugated cage, or sutured, welded, or glued in place on the corrugated cage (stent). The advantage of this is that no crimp is required to prevent rotation of the barb.

Referring to FIG. 55, in some static barb embodiments, a laser cut corrugated support cage (stent) may be fabricated with an integrated barb 2000. An advantage of this concept is that no secondary attachment step is required to attach the barb to the cage. It may also be relatively easy to add more barbs. A limitation is that it may be difficult to prepare 8 crowns (corrugations) with barbs on all struts as not enough material may be available, so 6 A crown part may be preferred.

E. Constraint Barb (Anchor) Design With constraint barb 2010, implant 1020 may be deployed into the LAA with barb 2010 constrained and, therefore, repositioned as necessary prior to barb release. obtain. Barb 2010 is released when implant 1020 is in the final position.

In one embodiment, a lasso-style constraint system can be added to a static barb to form a constrained deployable barb 2010, as shown in FIG. 56. Suture material may be tucked between the barbs 2010 and the struts to prevent spinning after deployment. Removal of the lasso can release multiple barbs in a circular array.

As shown in FIG. 57, the barb may be formed with a loop approximately halfway along the barb 2010, which allows a suture or thread to be placed through the loop to form a lasso. enable. This prevents full expansion of barb 2010 until the body of the implant is in its final desired position within the LAA.

The flipping-barb option is shown in FIG. 58. In this embodiment, barb 2010 may be an elongated design that is folded back inside the gutted foam opening prior to loading into the delivery system. This may require a drawstring or other locking element to hold the barb in the constrained configuration. After the implant 1020 is placed in the final desired configuration, the constraints are removed and the barbs are no longer constrained and flip into place to engage tissue.

F. Dynamic Barb (Anchor) Design The dynamic barb 2020 can be deployed or retracted as desired without moving the implant. Dynamic barb 2020 may be a preferred option for some procedures, such as recapturing implant 102 within a delivery catheter and/or sheath.

One embodiment is a tube within a tube. In this embodiment, as shown in FIG. 59, a laser cut tube 1030 may be utilized to construct an integral front spoke surface 1080 and a corrugated stent 1032 from an integral molding of preferably superelastic nitinol tubing. . Other materials may also be utilized, including shape memory Nitinol, stainless steel, MP35N, or Elgiloy. A second smaller laser cut tube 1040 can be utilized to form an inner spoke barb array, as shown in FIG. 60.

As shown in FIG. 61, upon deployment of the foam implant, the anterior spoke surface and wavy stent may be deployed while the spoke barb array remains in the constrained position. Implant 1020 may be repositioned as desired, and then inner tube 1040 is moved distally with respect to outer tube 1030, causing barb 2020 to expand and engage as shown in FIG. It is good if it matches. The inner spoke barb array can be repeatedly re-constrained and re-released until it is disconnected from the delivery catheter's transmission line.

In another embodiment, as shown in FIG. 63, a dynamic barb 2020 design is illustrated that can preferably be fabricated from a single component. This embodiment may be cut from a laser cut tube 1045, preferably superelastic Nitinol, with half of the front spokes connected to the corrugations of the stent cage 1032 and the other half of the spokes formed within the barbs 2020. Supports re-sheathing during this period.

Recapture or resheathing of the implant 1020 may initiate barb retraction by folding the anterior spoke surface, thereby simultaneously retracting the barb 2020 from the tissue, as shown in FIG. 64. This allows for safe repositioning of the implant 1020 with minimal re-sheathing (limiting the length of the implant required to fully retract within the sheath).

In another embodiment, as shown in FIG. 65, a dynamic hinged barb system is illustrated. This is a laser cut corrugated integrated barb 2020 with living hinges and constraints. Once the constrained end is heat set, it may curl inward and rest on or under the corrugated struts. When positioned on the corrugated strut, its sharp barbed end may face the inner diameter of the assembly. Once flipped into place under the strut, the opposing barb ends can seesaw upwardly and engage tissue. Actuation of the hinged barb 2020 may be accomplished through the use of lasso sewn in a circular array between each barb and the corresponding strut. Tightening the lasso inwardly flips the retention constraint from above the strut to below the strut, thereby lifting the opposing barb ends above the surface of the strut and engaging the tissue surface. can.

G. Embodiments with Foam Cups, Corrugated Stents, and ePTFE Layers As shown in FIGS. 66A-66C, internal corrugated or zigzag anchors (e.g., as shown in and described with respect to FIG. The foam cup plug 1040 can be modified to be completely covered on the outer surface by an ePTFE layer 2060. This layer 2060 can be attached to the distal end 1024 of the foam via suture or adhesive bonding as opposed to relying solely on the proximal surface 1022. It wraps around the entire exterior surface, enters the central lumen on the proximal surface, and can be attached to the proximal portion of the corrugated stent by lamination or adhesive bonding. Other biocompatible materials or coatings may also be utilized, including but not limited to PTFE or polyurethane.

H. Dynamic and Static Anchor Concepts The embodiments of the implant 2300 shown in the side cross-sectional and end views of FIG. 67 may be tied, welded, or crimped at the proximal end, respectively. Equipped with anchor 2310. Anchor 2310 may be made from Nitinol wire to allow loading into the delivery system without warping or distorting. It is possible for 8 to 16 wires to be formed in the bend. An anchor may act like a "grab hook." The assembly is loaded into the delivery catheter in the straightened position. As they are extruded from the delivery catheter, they assume the shape shown in FIG. 67 and penetrate through the foam 2320 and into the tissue. Foam 2320 is gutted as shown to reduce the amount of foam needed to press fit into the delivery system and still maintain sufficient radial force to seal tissue.

The embodiment of the implant 2350 shown in FIGS. 68A and 68B is gutted and thickened on the distal end, is crushed and penetrates into a delivery catheter, but is partially deployed from the delivery catheter. The corrugated stent has internal anchors with barbs within the foam plug that create a larger non-invasive foam tip cushion 2360 when combined. Proximal surface 2363 can have an internal lumen 2365 as shown in FIG. 68A, but may not include an internal lumen as shown in FIG. 68B.

I. Constraint Anchors Deployed in a Secondary Step The embodiment of implant 2370 shown in FIG. 69 has barbs/anchors 2371 pre-attached to corrugated stent 2372 inside foam 2374. Suture 2375 forms a loop around the distal end of wavy stent 2372, compressing stent 2372 and pulling barbs 2371 inward. Suture 2375 is tied with a pull knot. After device 2370 is delivered in place, one end of suture 2375 is pulled, the knot is free, and the suture is removed, allowing stent 2372 to radially open and barbs 2371 to engage tissue. enable. Barb 2371 may be disposed distal to foam 2370 as shown or may be pre-engaged with and extend through foam 2374.

J. Internal Stents with Enhanced Embolic Resistance A metal stent-like frame 2380 with distal static barbs 2381 and proximal "deceleration bumps" 2382 is disclosed as shown in FIGS. 70-72. This can also be a zigzag stent (as shown) or a wavy stent or other similar expandable embodiments. The bumps 2382 placed on the exterior of the metal stent frame 2380 can be of rounded or pointed design. Its purpose is to increase resistance and stability to the implant when deployed within the LAA to prevent embolization. In a preferred embodiment, the foam "cup" 2384 is shaped as shown in FIG. It is possible to provide additional material 2385 on the edge. It may or may not have an internal lumen for a guidewire.

K. Constrained Non-Invasive Anchors As shown in Figures 73 and 74, a wavy or zigzag or other stent 2390 engages tissue within the LAA to secure the implant in place and move It can be fabricated with a distally located loop 2391 that prevents resistance. Since they are round and not sharp, this limits the risk of perforation, but the tips can be modified to incorporate sharp features, as fully round loops do not provide sufficient movement resistance. Loop anchors 2391 can be placed on each stent end or just a few, so anywhere from 4 to 16 anchors can be placed.

Upon delivery of the implant through the vasculature into the heart and LAA, the loops 2291 are folded toward the center of the constrained stent and lined up next to each other, as shown in FIG. 75. The inner catheter is placed through loop 2391 to remain constrained. When the system is within the LAA, the outer catheter/sheath is retracted to deploy the proximal portion of the implant. If the positioning appears acceptable, the inner catheter is removed, allowing the distal portion of the implant to fully expand and the loop anchor to engage the LAA tissue.

L. Perfusion Element & Barb Options
If the implant moves after deployment in the LAA, the device will move into the LA, cross the mitral valve, enter the left ventricle, then exit the left ventricular outflow tract, cross the aortic valve, and cross the aorta and distal ventricle. is expected to enter the circulatory system. In this path, the device can lodge within any of the above structures, blocking flow and causing distal ischemia and possibly hemodynamic collapse. Therefore, it is desirable for implant 2392 to have design features that allow for distal perfusion, such as those shown in FIGS. 76 and 77.

FIG. 76 is a top view of one embodiment of the implant showing the left atrial surface. A valve is visible in the surface, but in the illustrated embodiment this is a simple cut (A) that opens when sufficient pressure is applied to allow flow to the device 2392. This flow may be bidirectional or unidirectional and may depend on specific conditions allowing flow rates from 10 mL/min to 5 L/min. In the illustrated embodiment, this is accomplished without loss of structural integrity, and loading conditions result in device 2392 being divided into multiple subsections, each of which is removable using standard techniques. be. It is also possible that a particular device has a single valve element or an array (as shown).

As shown in FIG. 77, in some embodiments, a series of side ports (B) are provided in the foam 2393 of the implant 2932 to allow blood flow in the event of migration and distal embolization. Can be cut into the side wall. These can vary in size and number, with port diameters from about 0.1 mm to about 5 mm, and from 1 to 20 ports. They may also take on a variety of shapes including, but not limited to, circular, oval, and rectangular.

Regarding barb designs as described herein, in addition to having arrays of barbs deployed at different distances from the LA surface, barbs that penetrate to different depths within the tissue can be incorporated. In one embodiment, the most proximally placed barb on the implant is longer and therefore penetrates deeper into the thicker proximal LAA tissue, whereas the most distally placed barb on the implant is shorter and therefore Does not penetrate too deeply into delicate distal tissues, maximizing embolic resistance while minimizing risk of perforation. In another embodiment, the proximal and distal barbs may be the same length, but may be fabricated from wire of different diameters or cut from tubing material at different thicknesses and therefore more delicate. Barbs that engage distal LAA tissue have greater flexibility, or barbs that are designed to engage exclusively with internal trabecular formations within the LAA, but are located proximally. penetrates the tissue. Alternatively, two barbs may be placed at each crown point of the stent, one against the other.

M. Multifunctional Occlusion Devices FIGS. 78-84 may be used with any of the LAA occlusion devices and methods described herein, used alone, or in combination. It shows various characteristics. In some embodiments, the features of FIGS. 78-84 may be incorporated into the device 3000 and associated features and methods shown and described with respect to FIGS. 85A-94B.

FIG. 78 is a side view of one embodiment of a LAA occlusion device 3000 with an ablation feature. LAA occlusion device 3000 has an array of ablation elements 3005. Ablation element 3005 delivers energy to the tissue in and around the LAA entrance and electrically isolates the LAA. In the illustrated embodiment, an array of ablation elements 3005 is positioned at the proximal end 3004 of the body portion 3002. Ablation element 3005 may be electrically connected to an energy source through a deployment catheter. Energy may be supplied via radio frequency, ultrasound, electricity, or other suitable methods. Internal lumen 3003 extends through body portion 3002. In some embodiments, lumen 3003 may be absent.

FIG. 79 is a side view of one embodiment of a LAA occlusion device 3000 with pressure sensing features. Device 3000 has a pressure sensor 3007 on proximal surface 3008. In some embodiments, the sensor 3007 may be on the proximal surface 3102 of the proximal cover 3100 (see FIG. 85A). In some embodiments, the sensor 3007 does not protrude into the LAA, such as a flat sensor on the proximal face 3008 or 3102. Sensor 3007 is electrically connected to electronic element 3011 via electrical wire 3009. Electronic element 3011 has the function of converting and storing the signals generated by sensor 3007. This information may be transmitted by signal 3013 to the remote. Electronic element 3011 may be powered remotely or by an internal battery.

FIG. 80 is a side view of one embodiment of a LAA occlusion device 3000 with drug eluting features. Device 3000 has a sensor 3007 on a proximal surface 3008. Sensor 3007 may be on proximal face 3102 of proximal cover 3100 (see Figure 85A). Sensor 3007 is electrically connected to electronic element 3011 via first electrical wire 3009. Electronic element 3011 is electrically connected via second electrical wire 3015 to drug reservoir 3017 which is fluidly connected to drug outlet port 3021 via conduit 3019. This allows drugs to be delivered into the LA, as well as monitoring the concentration and/or status of certain chemicals and delivering the drug in response, for example with blood glucose driven insulin delivery. Sensor 3007 may detect levels of various chemicals, and reservoir 3017 may be controlled by, for example, electronic component 3011 to elute drugs through port 3021 in response.

FIG. 81 is a side view of one embodiment of a LAA occlusion device 3000 with pacing/defibrillation features. Device 3000 has electrical pacing elements 3025, such as electrodes. Pacing element 3025 extends circumferentially of body portion 3002. Pacing element 3025 may take other configurations. Pacing element 3025 is connected to pace generator 3029 via electrical wire 3027. Generator 3029 is attached to battery 3033 by electrical wire 3031. The pacing system may rhythm the atria during atrial fibrillation and stop the atria from fibrillating. Generator 3029 and/or battery 3033 may include components for control, communication, commands, etc.

In some embodiments, the LAA may be electrically isolated. The LAA is electrically isolated by an occlusion device incorporating one or more ablation elements as shown and described with respect to FIGS. 78-81, directing the ablation to electrically isolate the LAA; Occlusion device 3000 may then be disengaged, leaving it in place within the heart. In some embodiments, the LAA may be first electrically isolated and then the device 3000 implanted, eg, as described herein with respect to FIGS. 82-84. In some embodiments, conformable circumferential ablation via foam plugs with ablation elements may be incorporated.

82-84 illustrate various systems and methods for electrically isolating LAA that may be used with device 3000. In some embodiments, the LAA may be electrically isolated and then the LAA may be closed. For example, the systems and methods shown in FIGS. 82-84 may be used to guide separation and then LAA occlusion using various LAA occlusion devices described herein, such as device 3000. It is acceptable to do so.

FIG. 82 is a side view of one embodiment of an over the wire circumferential ablation balloon system. An over-the-wire balloon catheter 3035 is placed over the guidewire 3037 and inserted into the LAA. Balloon 3039 can have one or more circumferential ablation elements 3041, such as juxtaposed RF elements, to electrically isolate the LAA and treat atrial fibrillation using radiofrequency (RF). can. Ablation element 3041 extends around the circumference of balloon 3039. Ablation element 3041 may take other configurations. The guidewire 3037 may be attached to the distal end of a balloon 3043 that is inflated within the LAA and acts as a buffer to prevent guide catheter 1100 from perforating the wall of the LAA. These features may be similar to those described with respect to FIGS. 8-11.

FIG. 83 is a side view of one embodiment of an over-the-wire circumferential ablation ultrasound balloon system. An over-the-wire balloon catheter 3035 is placed over the guidewire 3037 and inserted into the LAA. Balloon 3045, such as a circumferential ablation ultrasound balloon, is used to electrically isolate the LAA using ultrasound (US) to treat atrial fibrillation. Guidewire 3037 may have a balloon 3043 attached to its distal end, as described with respect to FIG. 82.

FIG. 84 is a side view of one embodiment of an over-the-wire circumferential ablation helical wire system with an ablation element. An over-the-wire circumferential ablation helical wire 3047 comprising one or more ablation elements is placed within the LAA. Wire 3047 may be used to electrically isolate the LAA and treat atrial fibrillation using radiofrequency.

N. Embodiment with Compressible Foam Body with Proximal Recapture Struts and Distal Tubular Body, Proximal Cover, and Compliant Frame FIGS. 85A-93B illustrate another embodiment of the LAA occlusion device 3000. 1 illustrates an embodiment. Devices 3000 described herein may have the same or similar features and/or functionality as other LAA occlusion devices described herein, and vice versa. Accordingly, any features of the device 3000 described with respect to FIGS. 85-93B may apply to the features of the device described with respect to FIGS. 1-84, such as the implant 1020, and vice versa.

85A-85C illustrate a LAA occlusion device 3000 having a foam body 3002, an expandable support or frame 3040, and a proximal cover 3100. FIG. 85D shows a LAA occlusion device 3000 that additionally has an inner cover 3101 and a proximal marker 3023A. Figures 86A-86C show a foam body 3002, which is shown in cross-section in Figures 86B and 86C. FIG. 86C additionally includes a panoramic view (ie, not a cross-sectional view) of frame 3040. Device 3000 is shown in an expanded configuration in these figures. Device 3000 has a longitudinal axis as shown, which may be defined by a foam body 3002, as further described.

1. Compressible Foam Body The body 3002 is formed from a compressible material, such as foam. The body portion 3002 may be a foam formed from reticulated (eg, net-like) polycarbonate polyurethane urea. The body portion 3002 may be cut, formed, or assembled into a cup shape, as further described. The body portion 3002 is of sufficient thickness and compression to engage surrounding tissue and conform to anatomical irregularities under radial forces applied by the inner frame, as further described. It is good to have a gender. As further described, the use of a compressible material such as foam for the body portion 3002 forms a complete seal of the LAA, resulting in superior performance against LAA occlusion over existing devices. . The foam structure of body portion 3002 comprises a three-dimensional network of interconnected meshes spaced apart to form a network of interconnected open pores, as further described. The mesh can carry a coating such as PTFE while preserving open pores, as further described.

The foam material of body portion 3002 has high porosity. "Porosity" as used herein has its ordinary and conventional meaning and refers to the open porosity between the interconnected networks of the foam. The porosity of the body portion 3002 can be at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or more. . The porosity may be 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%. The benefits of high porosity, among other things, are that it facilitates fast and tenacious tissue growth penetration, that it can be compressed and forced into small catheters, and/or that it can reduce blood flow in the event of an embolization of the implant. It is something that can be passed through.

Foam body portion 3002 has pores or cells formed between an interconnected network of foam material. Foam body 3002 has cells in a size range of about 250 μm to about 500 μm. The foam can 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 more than 750 μm. These sizes may refer to the size of the cells prior to application of any coating, such as PTFE. Cell size may therefore change, eg, decrease, after applying the coating. The desired porosity and/or cell size may be determined based on allowing blood to pass through while blocking debris of a size that could potentially cause an ischemic stroke. The acceptable size of such debris may drive the selection of particular porosity and/or cell size. For example, a cell size of about 250 μm to about 500 μm may be based on preventing debris of a certain size from passing through the body portion 3002.

In one embodiment, the foam body portion 3002 is made from a non-resorbable, reticulated, cross-linked, polycarbonate polyurethane urea matrix that is structurally designed to support fibrovascular tissue growth invasion and completely The interconnected macroporous morphology has a porosity greater than 90-95%, and the cell size is in the range of 250 to 500 μm.

Body portion 3002 has a proximal end 3004 and a distal end 3006. In some embodiments, the axial length of device 3000 from proximal end to distal end in the free, unconstrained state is 20 mm. As used herein, a "free, unconstrained" state, and the like, refers to any external force other than a normal or reaction force from the surface on which the device 3000 is placed (e.g., a table surface). Refers to the state of device 3000 in which nothing is added to device 3000. In some embodiments, the axial length is about 10 mm to about 30 mm, about 12 mm to about 28 mm, about 14 mm to about 26 mm, about 16 mm to about 24 mm, about 18 mm to about 22 mm, or about 20 mm. good. Body portion 3002 may have any of these lengths regardless of the outer diameter of body portion 3002.

The proximal end 3004 of the body portion 3002 has a proximal end wall or surface 3008. Proximal face 3008 generally faces toward the LA when device 3000 is implanted within the LAA. Device 3000 may be implanted off-axis, as further described, in which case proximal surface 3008 may not remain perpendicular to the LA's longitudinal axis. Thus, proximal surface 3008 provides a closed proximal end 3004 of body portion 3002. The closed proximal end 3004 is configured to span the inlet section, but the porosity blocks debris of a size that could potentially cause an ischemic stroke, as further described. large enough to allow blood to pass through. This membrane may be formed by body portion 3002 and/or cover 3100. In some embodiments, proximal surface 3008 or a portion thereof may be open. For example, there may be no proximal surface 3008, a partial proximal surface 3008, a partially removed proximal surface 3008, etc. In some embodiments, proximal surface 3008 or a portion thereof is not included and one or more openings are covered by cover 3100. Sizing any such openings in the proximal surface 3008 may be driven by the desired size of embolization-causing debris to be prevented from leaking out of the LAA, as further described.

Proximal surface 3008 is flat or generally planar and generally perpendicular to the longitudinal axis of device 3000. Proximal surface 3008 is circular or has a generally circular shape when viewed from proximal end 3004 at unconstrained expansion. In some embodiments, the proximal surface 3008 is flat, rounded, segmented, angled with respect to the longitudinal axis, or other shapes. It may be a combination of Proximal surface 3008 may have a non-circular shape, polygonal shape, other round shape, other shape, or combinations thereof when viewed from proximal end 3004.

Proximal surface 3008 has an outer surface 3010 and an opposing inner surface 3012. The outer surface 3010 faces proximally away from the device 3000 and the inner surface 3012 faces distally toward the frame 3040. Surfaces 3010, 3012 may define the outer and inner sides of proximal surface 3008. The thickness of proximal surface 3008 may be measured axially between outer surface 3010 and inner surface 3012. This thickness in a free, unconstrained state (e.g., uncompressed and expanded) may be about 0.5 mm to about 5 mm, about 1 mm to about 4 mm, about 2 mm to about 3 mm, about 2.5 mm, or 2.5 mm. . In some embodiments, the thickness may be less than 0.5 mm or greater than 5 mm. The thickness of proximal surface 3008 may be uniform or non-uniform. Thus, the thickness may be thicker or thinner in different regions of the proximal surface 3008.

Body portion 3002 includes a sidewall 3014 extending distally from proximal surface 3008. Sidewall 3014 extends circumferentially of proximal surface 3008 and forms a closed cross section (ie, extends circumferentially 360 degrees about the axis). Sidewall 3014 extends axially to define a tubular body concentrically about the longitudinal axis of device 3000. The longitudinal axis passes through the geometric center of the tubular body defined by sidewall 3014. The sidewall 3014 is tubular or generally tubular, eg, cylindrical, along its axis. In some embodiments, the sidewall 3014 can be conical or frustoconical, such as when the proximal end is wider than the distal end or vice versa. The sidewall 3014 may have an outer contour at its proximal end, when viewed from the proximal or distal end, that matches the outer circumferential contour of the proximal surface 3008.

In some embodiments, the cross-section of sidewall 3014 cannot be closed, such as when sidewall 3014 has an opening. Thus, cross-sections taken at various locations along the longitudinal axis may or may not represent closed sections. In some embodiments, the sidewall 3014 may be non-tubular, non-cylindrical, non-circular, polygonal, other rounded shapes, other shapes, or combinations thereof. In some embodiments, the sidewall 3014 may extend continuously the entire length from the proximal end 3004 to the distal end 3006, as shown. In some embodiments, sidewall 3014 may not extend continuously the entire length from proximal end 3004 to distal end 3006. For example, the sidewall 3014 may include a plurality of unconnected sections, such as an annular portion of the sidewall, spaced apart along the longitudinal axis and connected to the frame 3040.

Sidewall 3014 has an outer surface 3016 and an opposing inner surface 3018. Outer surface 3016 faces radially outward from the axis. The inner surface 3018 faces radially inwardly toward the axis. The thickness of sidewall 3014 may be measured radially between outer surface 3016 and inner surface 3018. This thickness in a free, unconstrained state (eg, uncompressed) may be about 0.5 mm to about 5 mm, about 1 mm to about 4 mm, about 2 mm to about 3 mm, about 2.5 mm, or 2.5 mm. In some embodiments, the thickness may be less than 0.5 mm or greater than 5 mm. The thickness of sidewall 3014 may be uniform or non-uniform. Thus, the thickness may be thicker or thinner in different regions of the sidewall 3014. The thickness of the sidewall 3014 may be the same as or different from the thickness of the proximal surface 3008. In some embodiments, the proximal surface 3008 has a thickness of 2.5 mm and the sidewall 3014 has a thickness of 2.5 mm. In some embodiments, the proximal surface 3008 has a thickness of about 2.5 mm and the sidewall 3014 has a thickness of about 2.5 mm.

Sidewall 3014 has a distal free end 3020 having a distal surface 3022. Distal surface 3022 is flat or generally flat and perpendicular to the longitudinal axis of device 3000. In some embodiments, the distal surface 3022 is uneven, angled with respect to the axis of the device 3000, curved, rounded, segmented, or otherwise shaped. or a combination of these.

Body portion 3002 may have a distal opening 3024. Opening 3024 is formed by distal free end 3020 of sidewall 3014. Opening 3024 is at the distal end of an interior central volume or cavity 3028 of body portion 3002 that is defined at least in part by sidewall 3014, proximal surface 3008, and/or step 3030. Frame 3040 may be placed within cavity 3028, as further described. Distal opening 3024 may be fully open. In some embodiments, the distal opening 3024 is substantially open or substantially open, for example, when the body portion 3002 has a distal surface similar to the proximal surface 3008 so as to surround or partially surround the cavity 3028. , may be partially open or closed.

Body portion 3002 has a step 3030, shown as a bevel, extending between proximal surface 3008 and sidewall 3014. Step 3030 may be the intersection of the proximal end of sidewall 3014 and proximal surface 3008. The stepped portion 3030 extends around the entire circumference of the intersection. Step 3030 has an outer surface 3032. The outer surface 3032 may be a beveled surface. The outer surface 3032 is axially flat or generally flat. The outer surface 3032 extends around the entire circumference of the step 3030. In some embodiments, the step 3030 and/or the outer surface 3032 may be uneven, rounded, other axial shapes, or combinations thereof. The step 3030 and/or the outer surface 3032 may extend over a portion of the entire circumference of the step 3030. The thickness of the step 3030 may be measured inwardly perpendicular to the outer surface 3032. The thickness of step 3030 may be the same as the thickness of proximal surface 3008 and/or sidewall 3014, as described herein. In some embodiments, the thickness of step 3030 may be different than the thickness of proximal surface 3008 and/or sidewall 3014. Step 3030 may function as a recapture ramp to facilitate proximal pulling of the implant into the deployment catheter.

The compressibility of body portion 3002 contributes to the superior sealing capabilities of device 3000. The foam may be compressible to form a larger radial "footprint" and spread radial forces from the struts on the frame 3040, as further described. The foam body 3002 can have a compressive strength within the range of at least 1 pound per square inch (psi) or about 1 psi to about 2 psi, or less than or equal to about 2 psi. "Compressive strength" herein refers to the pressure that compresses the foam to produce a 50% strain. With some foam material for the body portion 3002, the pressure may not vary from 50% strain to at least 80% strain, and the pressure vs. strain relationship may be flat or generally flat. Therefore, even though the foam is thicker for the body 3002, the body 3002 does not exert as much outward force on the tissue due to its increased thickness. In one embodiment, the foam body 3002 has a porosity of at least about 90%, an average cell size in the range of about 250-500 microns, a wall thickness of at least about 2 mm, and a compressive strength of at least 1 psi. is a cross-linked matrix. In one embodiment, body portion 3002 is formed from a foam material having or substantially having the material properties shown in Table 1. In some embodiments, the body portion 3002 is described, for example, in U.S. Pat. 8,337,487, issued December 25, 2012, entitled “Reticulated elastomeric matrices, their manufacture and use in implantable devices” .

Device 3000 includes markers 3023 (see Figures 85B and 87D; for clarity, only some of the markers 3023 are labeled in the figures) for visual clarity during delivery. obtain. Marker 3023 can be a radiopaque marker band sewn into distal free end 3020 of body portion 3002. Marker 3023 may be for visualization using fluoroscopic imaging of distal end 3006 of device 3000 during delivery. A series of markers 3023 may be disposed circumferentially along the distal surface 3022 of the body portion 3002 (for clarity, only some of the markers 3023 are labeled in FIG. 85B). ). In some embodiments, markers 3023 may additionally or alternatively be located in other areas of body portion 3002 or other parts of the device, such as cover 3100 or frame 3040.

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

As shown in FIGS. 85D and 87D, device 3000 can include one or more markers 3023A. By way of example only, three markers 3023A are shown. In some embodiments, there can be one marker 3023A. There can be two, four, five, or more markers 3023A. In some embodiments, there is one proximal marker 3023A and ten distal markers 3023. Marker 3023A may have the same or similar features and/or function as other markers described herein, such as marker 3023, and vice versa, unless otherwise specified. Marker 3023A may be placed at or near the proximal end of device 3000. As shown, the marker 3023A is disposed on the inner surface 3012 of the proximal end 3004 of the foam body 3002. Marker 3023A may be placed at or near the inner surface of step 3030 (see FIG. 86B) of foam body 3002. The markers 3023A may be distributed circumferentially, eg, equidistant or equiangular with respect to each other, or they may be at different relative distances from each other. These may be radially arranged in the same or different arrangement with respect to each other. In some embodiments, there is only one marker 3023A. There may be one proximal marker 3023A and four distal markers 3023. One or more markers 3023A may be placed inside, outside, or within the foam body portion 3002, or a combination thereof. One or more markers 3023A may be disposed on or at the distal surface 3022 of the foam body 3002. Marker 3023A may be circumferentially elongated as shown. In some embodiments, marker 3023A may be straight when device 3000 is viewed from a particular angle, such as a side view. Markers 3023a may be aligned or oriented in the same or similar orientation, or in different orientations. Some or all of the markers 3023 may be oriented circumferentially, laterally, axially (e.g., along the inner surface 3018 of the sidewall 3014), other orientations, or a combination thereof; Or none can be oriented.

As further shown in Figure 87D, there can be one or more markers 3023B. One or more markers 3023B have the same or similar features and/or function as other markers described herein, such as marker 3023 or 3023A, and vice versa, unless otherwise specified. obtain. Marker 3023B may be placed along sidewall 3014 of body portion 3002. There may be one or more markers 3023B disposed along the inner surface 3018 of the sidewall 3014.

As shown, two markers 3023B are visible on either side of the interior of the foam body portion 3002. Marker 3023B is attached through the foam and around frame 3040. Marker 3023B is attached, eg, sutured, around a member of proximal surface 3060 of frame 3040, such as one of struts 3061. Marker 3023B may be attached to frame 3040 immediately proximate one of the proximal vertices 3084 of frame 3040, eg, at the outer curved portion 3066 of strut 3061. There can be just one marker 3023B, or two, three, four, or more markers 3023B. There can be one marker 3023B for each strut 3061. Marker 3023B may additionally be used to connect frame 3040 to foam body 3002. Marker 3023B may be a suture as described herein.

One or more markers 3023A and/or 3023B at or near the proximal end of device 3000 provide various desirable features. For example, marker 3023A at step 3030 facilitates visualization of device 3000 during and after implantation. The typical non-circular shape of the opening (entrance) of the LAA may compress the proximal end 3004 of the device and cause the proximal end 3004 to protrude slightly in the proximal direction. However, the step 3030 may provide an arrangement for the marker 3023A where proximal linear bulge of the foam body 3002 is reduced or prevented. Therefore, the marker 3023A in its placement can provide more useful visualization of the positioning of the device 3000 and reduce complexity. For example, in some embodiments, the marker 3023A at the step 3030 (e.g., on the inner surface as shown) may be marked with only fluoroscopic imaging without the need for echo or other ultrasound imaging. may be particularly useful during delivery. One or more markers 3023B may provide similar benefits.

As further shown in FIGS. 85D and 87D, device 3000 can include an inner cover 3101. Inner cover 3101 may have the same or similar features and/or functionality as cover 3100 (described in further detail below, see "Proximal Cover" section) unless otherwise noted. Inner cover 3101 may be a cover for hub 3050 (see, eg, FIGS. 86C and 89A-90C). Inner cover 3101 may be formed from expanded polytetrafluoroethylene (“ePTFE”). Inner cover 3101 may be a separate piece of the same material as proximal cover 3100.

Inner cover 3101 may be positioned between foam body 3002 and frame 3040. As shown, the inner cover 3101 is disposed between the inner surface 3012 of the foam body 3002 and the proximal end of the hub 3050 of the frame 3040. Inner cover 3101 may be circular or other shapes. Inner cover 3101 may have sufficient area to provide a barrier between hub 3050 and proximal end 3004 of foam body portion 3002. In some embodiments, the inner cover 3101 extends radially to the outer circumference of the hub 3050 or to the sidewall 3014, such as the inner surface 3018 of the foam body portion 3002, or to any radial location in between. It is possible. Inner cover 3101 can have a diameter of about 4 mm to about 22 mm, about 5 mm to about 15 mm, about 6 mm to about 10 mm, about 8 mm, or 8 mm. Inner cover 3101 may be flat or generally flat. Inner cover 3101 can have a thickness of about 0.0001" to about 0.0020", about 0.0002" to about 0.0010", about 0.0005", or 0.0005". Inner cover 3101 may include one or more openings 3103, such as holes therethrough. Inner cover 3101 may include two holes 3103 for receiving tether 3240 (see, eg, FIGS. 93A-93B) therethrough. Two holes 3103 in cover 3101 allow sutures, such as sutures, to penetrate distally into hub 3050 through one hole 3103 in inner cover 3101 and exit proximally back out of hub 3050 through the other hole 3103 in inner cover 3101. Tether 3240 may be aligned.

Inner cover 3101 may prevent hub 3050 and/or other features of frame 3040 from directly contacting the foam material. Cover 3101 may protect the integrity of foam body portion 3002 from stresses that may be applied to the foam material by hub 3050. This protection may be desirable, for example, when loading, deploying, unloading, redeploying the device 3000, etc. Inner cover 3101 may prevent or reduce damage to foam body 3002 from hub 3050.

Foam body 3002 can be attached to various features of device 3000. Body portion 3002 may be attached to frame 3040 at various points, including, for example, at the center of the proximal end of frame 3040, as further described. Attachment may be performed using sutures such as polypropylene monofilament sutures, although other methods known in the art such as adhesive bonding are also available. A proximal row of proximal anchors 3090 may be individually attached to (eg, threaded through) foam body 3002 to prevent relative movement between foam body 3002 and frame 3040. In other embodiments, the foam body 3002 can be formed around the endoskeleton such that a metal frame is within the foam body 3002, thereby eliminating the need for a secondary attachment step. The advantage of attaching the body portion 3002 to the frame 3040 is, among other advantages, to facilitate removal without damaging the foam body portion 3002. This attachment also ensures that the buffer 3026, described further herein, extends beyond the frame 3040 at all times, including upon initial exposure of the device 3000 after proximal retraction of the delivery sheath. make sure that.

As shown in FIG. 87D, device 3000 may include one or more fittings 3001. Fittings 3001 may connect frame 3040 to foam body 3002. Attachment 3001 may be a suture. Other suitable attachment sutures may be used, including staples, ties, wires, components of frame 3040, other mechanical attachments, adhesives, other suitable means, or combinations thereof. The fitting 3100 may extend around the frame 3040 and pass through the foam body 3002, for example, through the sidewall 3014.

As illustrated, four fixtures 3001 are shown in Figure 87D. Two proximal fittings 3001 and two distal fittings 3001 are visible. Proximal fittings 3001 are each positioned at the base of a respective proximal anchor 3090. Distal fittings 3001 are each located at the base of a respective distal anchor 3094. There can be one, two, three, four, five, six, seven, eight, or more fixtures 3001. There may be 20 fixtures 3001. There can be one fixture 3001 for each anchor 3090, 3094 of device 3000. Each of the fittings 3001 may be positioned at a proximal apex 3084 or a distal apex 3088 of the frame 3040, eg, with respect to FIG. 89A, as further described herein. For example, the fixture 3001 may be wrapped around one or more of the struts 3082, 3086, as further described herein. The fitting 3001 may locally compress the foam body portion 3002 at and/or around the placement of the fitting, eg, with respect to FIG. 95C, as further described herein. An attachment 3001, such as a suture, extends from within the cavity 3028, through the foam body 3002, out of the foam body 3002, and along an outer surface 3016 of the foam body 3002; It can penetrate into the foam body 3002 and pass back through the foam body 3002 into the cavity 3028 and be tied around the frame 3040 or otherwise connected together. In some embodiments, similar attachment paths for the fixtures 3001 may be used with the fixtures 3001 tied around and outside the foam body 3002 or otherwise connected together. In some embodiments, fitting 3001 may also penetrate cover 3300, or other covers as described herein. Fittings 3001 may penetrate the material of cover 3300. The fitting 3001 may pass through an opening in the cover 3300, such as a side opening 3324, or a window 3177 (see, eg, FIGS. 88B-88E). As shown, the proximal fitting 3001 may pass through the foam body 3002 and through an opening in the cover 3300, and the distal fitting 3001 may not pass through the cover 3300 and may extend through the foam body 3002 and through the opening in the cover 3300. It can penetrate only the main body portion 3002.

Foam body portion 3002 may include a coating. In some embodiments, there may be no coating. In coating embodiments, the coating is applied to an interconnected network of foam material. Body portion 3002 may be coated with pure polytetrafluoroethylene (PTFE). The PTFE coating minimizes thrombus formation on the LA surface while reducing friction of the foam body 3002 against the delivery system to facilitate deployment and removal. The body portion 3002 may be coated with conformal, vacuum deposited, pure PTFE. Additionally or alternatively, body portion 3002 may be coated with a coating other than PTFE. The coating, whether PTFE or other, may be about 0.5 μm thick and covers at least a portion of the surface of the interconnected network of the foam without blocking the pores. The coating may be applied to some or all of the foam body 3002. The coating may be applied to some or all of the exterior surface of the foam body 3002.

In some embodiments, the thickness of the coating is about 0.1 μm to about 1 μm, about 0.2 μm to about 0.9 μm, about 0.3 μm to about 0.8 μm, about 0.4 μm to about 0.7 μm, about 0.4 μm to about 0.6 μm. μm, or about 0.5 μm thick. In some embodiments, the thickness of the coating applied may be thicker or thinner. The coating has a uniform or substantially uniform thickness. In some embodiments, the coating may have a non-uniform thickness. For example, portions of body portion 3002 that face the LA when implanted, such as proximal surface 3008 and/or step 3030, have a thicker coating compared to the coating along sidewalls 3014 of body portion 3002. You may do so. In some embodiments, the outer surface 3010 of the proximal surface 3008 has a PTFE coating, and the proximal surface 3008 also has an ePTFE cover 3100.

The coating is applied using a vapor deposition process. In some embodiments, the coating is applied through coating, vapor deposition, plasma deposition, grafting, other suitable processes, or combinations thereof. The coating is applied to outer surfaces 3010, 3032, and 3016 of proximal surface 3008, step 3030, and sidewall 3014, respectively. In some embodiments, the coating is applied to the outer surfaces 3010, 3032 and only partially applied to the outer surface 3016. In some embodiments, the coating is applied to the exterior and interior surfaces of body portion 3002.

In some embodiments, other biocompatible, antithrombotic, and/or lubricious materials can also be applied to the surface of the foam body 3002 and/or the cover 3100. These materials can promote tissue growth invasion. Such materials include, for example, heparin, albumin, collagen, polyethylene oxide (PEO), hydrogels, hyaluronic acid, nitric oxide, oxygen, nitrogen, amines, bioabsorbable polymers, and other biomaterial releasing materials; It may include pharmacologically active substances as well as surface-modifying materials. In addition, the surface of the body portion 3002 can be roughened, textured, or some other form of modification or coating to promote healing or enhance echoluminescence generation. .

2. Proximal Cover Device 3000 may include a cover 3100, which may be an ePTFE cover as further described. Other embodiments of this outer cover 3100 are described herein, including covers 3101, 3300, 3150, 3151, and the like. The various embodiments of this cover may have the same or similar features and/or functionality to each other unless otherwise specified. Cover 3100 may have a series of openings. In some embodiments, cover 3100 may be solid and have no openings. In some embodiments, the cover 3100 may only have openings therethrough to receive anchors and/or tethers, as described further herein. In some embodiments, device 3000 may include an inner cover, such as inner cover 3101, as illustrated and described with respect to FIG. 85D.

Outer cover 3100 is a generally flat material applied over and covering at least a portion of body portion 3002. Cover 3100 is on proximal end 3004 of device 3000. Cover 3100 covers proximal surface 3008 of body portion 3002 and at least a portion of sidewall 3014. Cover 3100 covers a proximal portion of sidewall 3014. Cover 3100 has a proximal surface 3102 that faces at least a portion of the LA when implanted. The cover 3100 has an outer edge 3104 forming an outer apex 3106 (only a portion of the outer edge 3104 and outer apex 3106 are labeled in the figure for clarity). In some embodiments, the cover 3100 may cover only the proximal surface 3008 or a portion thereof. In some embodiments, the cover 3100 may extend over a majority of the sidewall 3014, such as the middle or distal portion thereof, or the entire sidewall 3014.

The cover 3100 may have a thickness measured vertically from the proximal surface 3102 to the opposing distal surface of the cover 3100 facing the body portion 3002. The cover 3100 can have a thickness of 0.001" (inch). In some embodiments, the cover 3100 has a thickness of about 0.00025" to about 0.005", about 0.0003" to about 0.004", about 0.0004" to about 0.003". The thickness may be from about 0.0006" to about 0.002", from about 0.0008" to about 0.0015", or about 0.001". In some embodiments, the cover 3100 may have a thickness of 0.0005". In some embodiments, the cover 3100 may have a thickness of about 0.0002" to about 0.0008", about 0.0003" to about 0.0007", about 0.0004". The thickness may be from about 0.0006" to about 0.0005".

Cover 3100 may be attached to frame 3040 through foam body 3002. Cover 3100 may additionally or alternatively be attached to body portion 3002. The cover 3100 may be attached at least two or four or six or more of the outer apexes 3106. The cover 3100 is attached to the frame 3040 and/or the body portion 3002 in various configurations, including at the outer apex 3106, through the proximal surface 3100, the proximal surface 3008 of the body portion 3002, other configurations, or combinations thereof. obtain. Cover 3100 is attached using mechanical attachments, such as sutures. In some embodiments, polypropylene 6-0 sutures are used throughout the device to attach the foam body 3002, proximal cover 3100, and RO marker 3023 to the foam body 3002 and/or frame 3040. Ru. In some embodiments, the cover 3100 is attached to the frame 3040 via standard braided or monofilament suture material, such as polypropylene, ePTFE, or polyester. In some embodiments, polypropylene filaments are utilized. A proximal anchor 3090 of the frame 3040 (described further herein) may pass through the outer apex 3106 of the cover 3100. Such penetrating anchors 3090 may further secure cover 3100 in place with respect to body portion 3002. In some embodiments, cover 3100 may be attached to various parts of device 3000 by mechanical attachments, fasteners, adhesives, chemical bonding, other suitable techniques, or combinations thereof.

As shown, cover 3100 is formed from expanded polytetrafluoroethylene ("ePTFE"). ePTFE Cover 3100 has many advantages. For example, the ePTFE cover 3100 may enhance the ability to recapture the device 3000 in vivo by dispersing proximal retraction forces applied by the catheter. The cover 3100 may be an ePTFE material approximately 0.001" thick, similar to the underlying PTFE coated foam, with appropriate porosity to promote healing and minimize clot formation.

The ePTFE cover 3100 can aid in recapturing the implant within the access sheath while providing a smooth anti-thrombotic surface that facilitates tissue coverage and integration. The ePTFE may cover the entire proximal surface and partially cover the sides, as shown in FIG. 85C. The ePTFE cover 3100 is fabricated from an already laminated sheet of two or more sheets of oriented material that are offset to form a biaxially oriented material. Alternatively, it is possible to use a tube, preferably a biaxially oriented tube, which is then cut to form a sheet. The thickness of the final structure may be between 0.0005'' and 0.005'', but is preferably about 0.001''.

In some embodiments, the cover 3100 is made of a knitted or woven polyester cloth, polypropylene, polyethylene, nonwoven vascular scaffold, porous film, or bioabsorbable material such as polylactic acid, polyglycolic acid, and copolymers. fabricated from other antithrombotic high strength biocompatible materials, such as synthetic scaffolds. The shape of the cover prior to attachment with the device 3000, as shown in FIGS. 88A and 88B, minimizes wrinkling and provides a smooth surface after attachment to the implant. This shape may be a star, an outwardly pointed shape, or some other shape.

The cover 3100 may be perforated with a series of openings 3120 (only some of the openings 3120 are labeled in the figure for clarity). Openings 3120 are perforations or holes formed in cover 3100 via laser or mechanical cutting. The opening 3120 includes a proximal opening 3122 and a side opening 3124 (only a portion of the proximal opening 3122 and side opening 3124 are labeled for clarity). ). When cover 3100 is assembled with body portion 3002, proximal opening 3122 is disposed over proximal surface 3008 and/or step 3030, and side opening 3124 is positioned over sidewall 3014. Ru. In some embodiments, cover 3100 includes 40 proximal openings 3122. In some embodiments, the cover 3100 includes 40 side openings 3124. The number of apertures 3120 disposed on the proximal surface 3008 and/or the step 3030 when assembled with the body portion 3002 is from 10 to 80, from 20 to 70, from 30 to 60, There may be in the range of 35 to 50 or 40 apertures 3120. The number of openings 3120 disposed on the side wall 3014 is in the range of 10 to 80, 20 to 70, 30 to 60, 35 to 50, or 40 openings. 3120.

Aperture 3120 can have various sizes. The width of the aperture 3120, e.g., the short axis, or diameter of a circular aperture, is 0.070". The width of the aperture 3120 is about 0.010" to about 0.200", about 0.020" to about 0.150", about 0.030". from about 0.110", from about 0.040" to about 0.100", from about 0.050" to about 0.090", from about 0.060" to about 0.080", or about 0.070". In some embodiments, the width may be less than 0.010" or greater than 0.200", such as 0.25", 0.5", or more. These widths may apply to circular and even non-circular shaped openings 3120.

In some embodiments, opening 3120 may take on a variety of shapes. Opening 3120 may be an elongated slot. The opening 3120 may extend radially along the cover 3100 from or near a central portion of the proximal face 3102 toward and/or to the outer edge 3104. The opening 3120 may be an annular opening extending circumferentially along the cover 3100 and having different radial positions. Openings 3120 may be of uniform size and shape. Some of the openings 3120 may have different sizes and/or shapes with respect to other of the openings 3120. The openings 3120 may have various distributions or concentrations around the cover 3100. For example, the openings 3120 may be more densely arranged in various regions, such as along the LA-facing proximal surface 3102, along the step 3030, etc.

Opening 3120 allows blood to flow within device 3000. The opening 3120 may allow blood to flow properly through the device 3000, thereby reducing the risk of occlusion in the blood flow if the device 3000 embolizes within the vasculature. In some embodiments, if the device 3000 embolizes, it may act as a static filter at low pressures, but may pass through the bloodstream at higher pressures. In some embodiments, the device 3000 passes about 2 to about 14 liters, about 4 to about 12 liters, about 6 to about 10 liters, or about 8 liters of blood per minute with a pressure drop of <30 mmHg; Makes it possible to prevent shock in case of embolization of the device. In some embodiments, there are 40 circular openings 3120, each having a diameter of 0.070", allowing approximately 8 liters of blood per minute to pass through with a pressure drop of <30 mm Hg. In embodiments, the proximal end of the device 3000 can be a foam layer, such as a foam proximal surface 3008 or a membrane, such as a cover 3100, or both, defined within the tube sidewall 3014 of the body portion 3002. Surrounding the cavity 3028. In one implementation having both a foam proximal surface 3008 and a cover 3100, the foam body portion 3002 can allow blood to pass through but block the leakage of embolization-causing debris. The cover 3100 may be occlusive to blood flow and provide structural integrity and friction reduction for pulling the expanded body portion 3002 back into the deployment catheter. It exists to bring about.

In one implementation, the cover 3100 is ePTFE in a form that is substantially occlusive to blood flow, as described. Thus, in this embodiment, the cover 3100 comprises multiple perfusion windows or openings 3120 such that blood may pass through the open cell foam and the cover 3100, but the device 3000 still benefit from.

In some embodiments, the device 3000 may allow a certain flow rate of water under specified conditions to test the perfusion performance of the device 3000. Device 3000 can have a foam body 3002 and cover 3100 configured to allow a flow rate of water axially through device 3000 of at least 4 liters per minute. The water may be at or about 68 degrees Fahrenheit (F) and its upstream pressure may be at or about 25 milliliters of mercury (mmHg). In some embodiments, the device 3000 pumps from about 1 liter to about 7 liters, from about 2 liters to about 6 liters, from about 3 liters to about 5 liters per minute of water under such conditions, It may be configured to allow flow rates of greater than 2 liters, greater than 3 liters, or greater than 4 liters. The particular flow rate may depend on the porosity of the foam body 3002 and the open area of the cover 3100. The particular flow rate may depend on the features of the inner cover 3101 as well. The cover 3100 may have a certain percentage coverage area with a series of openings, as further described herein, to achieve a certain desired flow rate. The flow rate of water under the specified conditions is determined by extrapolating the corresponding expected flow rate of intracorporeal blood through the device 3000 if it embolizes, as further described herein; or otherwise may be used to calculate. The device 3000 may tolerate a heart rate of about 1.6-2.4, about 1.7-2.3, about 1.8-2.2, about 1.9-2.1, about 2.0, or 2.0 liters per square meter per minute. Device 3000 may be aligned or approximately aligned with the direction of fluid flow, or off-axis, as further described herein, e.g., in the "Off-Axis Delivery and Deployment" section. With certain of these and other flow capabilities, device 3000 may be angled with respect to the direction of fluid flow (flow axis).

87A-87C illustrate one embodiment of a LAA occlusion device 3000 with another embodiment of a cover 3300. Device 3000 includes a foam body 3002 and frame 3040 and features thereof, as described herein, and in addition includes a cover 3300. Cover 3300 may have the same or similar features and/or functionality as cover 3100, and vice versa. Cover 3300 is on proximal end 3004 of device 3000. Cover 3300 covers proximal surface 3008 of body portion 3002 and a proximal portion of sidewall 3014. Cover 3300 has a proximal surface 3302. The cover 3300 has an outer edge 3304 forming a plurality of at least two, or four, or six, or eight, or ten, or more outer apexes 3306 (for clarity, some of the outer apexes 3306 are only some of them are labeled). Cover 3300 is attached to body portion 3002 at an outer apex 3306. Proximal anchor 3090 passes through side opening 3324 at outer apex 3106 of cover 3100.

Cover 3300 includes a series of openings 3320. Opening 3320 includes a proximal opening 3322, a step opening 3323, and a side opening 3324. Proximal opening 3322 is positioned over proximal end 3004 of body portion 3002. Step opening 3323 is disposed over step 3030, eg, a bevel, of body portion 3002. Side opening 3324 is disposed on a proximal portion of side wall 3014 of body portion 3002. Proximal anchor 3090 may pass through side opening 3324 located at outer apex 3106. Aperture 3320 may have the same or similar features and/or functionality as aperture 3120, and vice versa. In some embodiments, proximal anchor 3090 may penetrate cover 3300 at or near outer apex 3106.

FIG. 88A shows another embodiment of a cover 3150 that may be used with device 3000. Cover 3150 may have the same or similar features and/or functionality as cover 3100 and/or cover 3300, and vice versa. Cover 3150 may be used to cover proximal surface 3008 of body portion 3002 and a portion of sidewall 3014. Cover 3150 has a proximal surface 3152. Cover 3150 has an outer edge 3154 forming an outer apex 3156. Cover 3150 may be attached to body portion 3002 at an outer apex 3156. Proximal anchor 3090 may pass through outer apex 3156 of cover 3100. Cover 3150 includes a series of openings 3170. Opening 3170 includes a proximal opening 3172 and a side opening 3174 (only some of openings 3170, 3172, 3174 are labeled in the figure for clarity). When cover 3150 is assembled with body portion 3002, proximal opening 3172 is positioned over proximal end 3004 and side opening 3174 is positioned over sidewall 3014. As shown, the openings 3174 may be substantially uniformly distributed along the cover 3150 except in the central region of the proximal surface 3152.

FIG. 88B is a top view of another embodiment of a proximal cover 3151 that may be used with various LAA occlusion devices described herein. FIG. 88C is a top view showing cover 3151 assembled with device 3000. Cover 3151 may have the same or similar features and/or functionality as other covers described herein, such as cover 3100 and/or cover 3300, and vice versa, unless otherwise noted. . For example, cover 3151 may include a proximal surface 3152 and an outer edge 3154 forming an outer apex 3156.

Cover 3151 further includes another embodiment of a series of openings 3171. The opening 3171 includes a smaller opening 3175 and a larger opening 3173. Openings 3175, 3173 have the same or similar features and/or functionality as other cover openings, such as openings 3120, 3122, 3124, 3320, 3322, 3324, 3170, 3172, and/or 3174. And vice versa. The smaller opening 3175 is relatively smaller in width and/or area than the larger opening 3173. There may be openings with widths or areas smaller than smaller opening 3175 or larger than larger opening 3173, or any size in between. As shown, the openings 3173, 3175 may be generally uniformly distributed about the proximal surface 3152 of the cover 3151. The openings 3173, 3175 may be evenly spaced or approximately evenly spaced circumferentially around the cover 3151.

Each of the openings 3173, 3175 may have a variety of different amounts. A total of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 300, 400 of the series of openings 3171 There can be one or more apertures, or fewer, more, or any number of apertures in between. The series of openings 3171 may be holes as shown. These may have a circular shape. These may have other shapes, including non-circular shapes, segmented shapes, other shapes, or combinations thereof. The openings 3171 may all have the same general shape or different shapes. In some embodiments, cover 3151 may be without holes.

When the cover 3151 is assembled with the foam body 3002, the large opening 3173 and the small opening 3175 may be disposed on the proximal end 3004 and/or sidewall 3014 of the foam body 3002. There can be a total of or about 140 openings 3173, 3175 in the proximally facing portion of the cover 3151 when assembled with the foam body 3002. On this proximally facing portion of the cover 3151, 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, or about 135 to about 155 There may be several openings 3173, 3175. There can be about 30 to about 50, about 35 to about 45, about 40, or 40 large openings 3173 in this proximally facing portion of cover 3151. There can be about 60 to about 140, about 80 to about 120, about 90 to about 110, about 100, or 100 small openings 3175 on this proximally facing portion of cover 3151.

The portion of the cover 3151 that, when assembled with the foam body 3002, is located over and/or near the step 3030, such as over the outer surface 3032 of the foam body 3002 (see, e.g., FIG. 86B) There can be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 smaller openings 3175 on the top. In some embodiments, there can be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 larger openings 3173 at this same portion of cover 3151. .

on the portion of the cover 3151 that, when assembled with the foam body 3002, is located on and/or near the sidewall 3014, such as on the outer surface 3016 of the foam body 3002 (see, e.g., FIG. 86B); There can be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 larger openings 3173. In some embodiments, this same portion of the cover 3151 can have about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 smaller openings 3175. .

Larger aperture 3173 and smaller aperture 3175 can have a variety of different sizes, for example, as described herein with respect to aperture 3122. In some embodiments, the openings 3173, 3175 can have a diameter ranging from about 0.025 inches to about 0.040 inches. In some embodiments, the larger opening 3173 may be at or about 0.040 inches in diameter. The larger opening 3173 may have a diameter of about 0.030 inch to about 0.050 inch, or about 0.035 inch to about 0.045 inch. These values may refer to the width, eg, maximum width, of the non-circular larger opening 3173. In some embodiments, the smaller opening 3175 may be at or about 0.025 inches in diameter. The smaller opening 3175 may have a diameter of about 0.015 inch to about 0.035 inch, or about 0.020 inch to about 0.030 inch. These values may refer to the width, eg, maximum width, of the non-circular smaller opening 3175.

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

The open area may be at least 5% of the area of the proximal face 3008 of the foam body 3002. The open area is 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% of the area of the proximal surface 3008. , 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%. 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 proximal surface 3008. The “area” of the proximal surface 3008 is understood herein to refer to an area equal to Pi×R ² , where R is the radius of the proximal surface 3008, extending perpendicularly from the longitudinal axis of the device 3000. . Further, “R” may be measured to the inner boundary of step 3030, the outer boundary of step 3030, or the outer surface 3016 of sidewall 3014. Additionally, as mentioned above, some embodiments may not include a cover at all.

Cover 3151 may include one or more windows 3177. There may be ten windows 3177 as shown. There can be one window 3177 for each proximal anchor 3090. There may be 4, 6, 8, 12, 14, or more windows 3177, or fewer or any number in between. Window 3177 may be an opening in cover 3151. Window 3177 may be located at or near outer edge 3154 of cover 3151. Window 3177 may be positioned along a portion of outer edge 3154, for example, at or near outer apex 3156. The windows 3177 may have a shape that matches the shape of the cover 3151 at each portion of the outer edge 3154. As shown, the window 3177 may be diamond or generally diamond-shaped. The window 3177 may be square, rectangular, triangular, rounded, circular, arcuate, flattened diamond, other polygonal shapes, other shapes, or combinations thereof. Cover 3150 may be attached to body portion 3002 at outer apex window 3177. Window 3177 may have the same or similar features and/or functionality as side opening 3324, described and illustrated in FIG. 87B. Proximal anchor 3090 may pass through window 3177 of cover 3151 to retain cover 3151 on device 3000.

88D-88E are respective side views of another embodiment of a proximal cover 3153 shown assembled with a device that may be used with various LAA occlusion devices described herein. FIG. 2 is a diagram and a perspective view. Cover 3153 has the same or similar features and/or functionality as other covers described herein, such as covers 3100, 3151 and/or cover 3300, and vice versa, unless otherwise noted. could be. For example, cover 3151 may include a proximal surface 3152, an outer edge 3154 forming an outer apex 3156, and a window 3177.

Device 3000 with cover 3151 can have proximal anchor 3090 passing through window 3177. A proximal anchor 3090 may pass through an opening in each window 3177. Proximal anchor 3090 may pass through the distal portion of window 3177 and help secure cover 3151 on device 3000, for example. Proximal anchor 3090 may pass through window 3177 at the distal edge or apex of window 3177. In some embodiments, the proximal anchor 3090 may penetrate the material of the cover 3151, eg, adjacent (such as distal to) the window 3177. In some embodiments, proximal anchor 3090 may pass through various other locations within, adjacent to, or near window 3177. A portion of proximal anchor 3090 may pass through a first arrangement and another portion of proximal anchor 3090 may pass through a second arrangement of cover 3153 that is different than the first arrangement. For example, one or more anchors 3090 may pass through a first region of window 3177, one or more other anchors 3090 may pass through a second region of window 3177, and one or more anchors 3090 may pass through a second region of window 3177; One or more other anchors 3090 may penetrate other areas such as the material of cover 3153.

Cover 3153 may include a proximal apex 3155. Proximal apex 3155 may be formed by outer edge 3154. The proximal apex 3155 may be a recess along the outer edge 3154 of the cover 3153, for example, angled as shown or other shape, configuration, etc. Proximal apex 3155 may define region 3106A of outer surface 3106 of sidewall 3104. Region 3016A may be partially enclosed by outer edge 3154 of cover 3153. Region 3016A may receive one or more distal anchors 3094 therethrough. Distal anchor 3094 may penetrate the distal portion of region 3106A or into other arrangements within, adjacent to, or near region 3106A. In some embodiments, distal anchor 3094 may not extend through or near region 3016. There may be multiple such regions 3016A of foam body 3002 circumferentially defined around device 3000 by cover 3153.

Cover 3153 may include a series of openings 3320, for example, as described with respect to FIG. 87A. The series of openings 3320 may include a proximal opening 3172, a step opening 3323, and/or a side opening 3174. Cover 3153 may include different patterns, sizes, distributions, etc. of apertures 3320, for example, as illustrated and described with respect to FIGS. 88B-88C.

3. Compliant Frame An expandable compliant support or frame 3040 is shown, for example, in FIGS. 85B, 85D, 86C, and 87C-87E. 89A and 89B are side and proximal perspective views, respectively, of frame 3040 shown separated from the remainder of device 3000 in a deployed configuration. The frame 3040 facilitates delivery, anchoring, and removal, and the foam body 3002 compresses the anchor to compress LAA tissue and facilitate sealing, among other things, as further described. A compliant structure having the following structure. Frame 3040 is positioned inside cavity 3028 formed by foam body 3002. In some embodiments, the frame 3040 is partially or entirely within one or more portions of the body portion 3002, e.g., the proximal surface 3008 and/or the sidewall 3014, as further described. may be placed within. For example, frame 3040 may be partially disposed within sidewall 3014 as shown in FIG. 87C.

Frame 3040 has a proximal end 3042 and an opposing distal end 3004. Frame 3040 may be tubular, eg, cylindrical, in its free, unconstrained state. Accordingly, the width of proximal end 3042 may be the same as or similar to the width of distal end 3004 in a free, unconstrained state. In some embodiments, the frame 3040 or a portion thereof is conical or frustoconical, such as when the width of the proximal end 3042 is wider than the width of the distal end 3004 or vice versa in the free, unconstrained state. It's fine.

At the proximal end 3042, the frame 3040 has a proximal hub 3050, illustrated as a cylindrical nipple. Hub 3050 is a round structural end piece. The hub 3050 can be tubular, e.g., circular, having a cylindrical shape as shown, or rounded, non-circular, segmented, other shapes, or combinations thereof. It may be. The hub 3050 may extend axially and have a central lumen. The hub 3050 may be wide compared to its length, or vice versa. The hub 3050 is hollow and has sidewalls defining a space therethrough, such as a longitudinal opening. In some embodiments, hub 3050 may be partially hollow, solid, or other configurations. Hub 3050 facilitates delivery and removal of device 3000, as further described. The hub 3050 may include a central structural attachment, as further described herein. Hub 3050 may be positioned within cavity 3028 at the proximal end. In some embodiments, the hub 3050 may be disposed partially or completely within the foam body 3002, such as within the proximal surface 3008.

A pin 3051 may be placed within the hub 3050 (shown in FIGS. 89A and 89B). Pin 3051 is an elongated round structural element that extends laterally across the central lumen. "Transverse" refers to a direction that is perpendicular or generally perpendicular to a longitudinal axis. Pin 3051 has a cylindrical shape. Pin 3051 includes a rounded outer surface configured to form a smooth engagement surface for the tether, as further described. Pin 3051 provides a high strength connection with frame 3040 that allows device 3000 to be pulled with sufficient force to resheath device 3000. Pin 3051 may be formed from Nitinol. Pin 3051 is secured across the width, eg, diameter, of proximal hub 3050. The pin 3051 may be secured to the side wall of the hub at two opposite ends. Pin 3051 is configured to be engaged by tether 3240, which is wrapped around pin 3051 in sliding engagement for temporary attachment to a delivery catheter, as further described. In some embodiments, pin 3051 is assembled with cap 3180, eg, as described further herein with respect to FIGS. 90A-90C.

Frame 3040 at proximal end 3042 includes a proximal surface 3060. Proximal surface 3060 may be disposed within cavity 3028 at its proximal end. In some embodiments, proximal surface 3060 may be disposed partially or completely within foam body 3002, such as within proximal surface 3008 and/or sidewall 3014. Proximal surface 3060 includes a series of recapture or reentry struts 3061. Strut 3061 is located at the proximal end of cavity 3028. In some embodiments, struts 3061 or portions thereof may be disposed partially or completely within foam body 3002, such as within proximal surface 3008 and/or sidewall 3014.

Struts 3061 are elongated structural members. Struts 3061 may have rectangular, circular, or other shaped cross-sectional shapes. In some embodiments, the struts 3061 have a cross-section, eg, a rectangular shape, that has a greater width relative to its thickness such that the struts 3061 are stiffer in one direction than in another direction. The width may be lateral or generally perpendicular to the longitudinal axis of the device 3000 when the device 3000 is in the expanded configuration, and the thickness is perpendicular to the width. Struts 3061 may be less stiff in bending or bending directions, for example, to facilitate contraction and expansion of device 3000 in delivery and expansion configurations. Struts 3061 may be elongated pins. Struts 3061 may, for example, extend from hub 3050 and slope radially outwardly in a direction distal from hub 3050. Struts 3061 may be attached to the inside, outside, and/or ends of the sidewalls of hub 3050. Struts 3061 may be discrete parts that are subsequently attached to hub 3050, for example, by welding, gluing, clamping, other suitable means, or combinations thereof. In some embodiments, some or all of the struts 3061 and hub 3050 may be a single continuous structure formed from the same raw material, such as a laser cut hypotube. Some or all of the struts 3061 may be attached to the body portion 3002 and/or the cover 3100 at one or more attachment locations, for example, with sutures as described herein.

Each recapture strut 3061 may include an inner curved portion 3062, a middle straight portion 3064, and/or an outer curved portion 3066 connected to the distal end of the hub 3050 (for clarity) In the figure, only some of the sections 3062, 3064, 3066 are labeled). In the deployed configuration, the inner curved portion 3062 extends from the hub 3050 exclusively in a distal direction and then curves further outwardly and radially. A middle straight section 3064 extends from the inner curved section 3062 exclusively radially, but also slightly distally. The outer curved portion 3066 extends exclusively radially from the middle straight portion 3064 and then curves in a distal direction. These portions may have different shapes in the delivery configuration inside the delivery catheter. In the delivery configuration, these portions may extend exclusively distally. These portions may then be deployed from the delivery catheter and then assume the deployed configuration as described. In some embodiments, strut 3061 may include fewer or more portions than portions 3062, 3064, 3066.

Device 3000 may include ten of proximal recapture struts 3061. Such a configuration may involve a device 3000 having a foam body 3002 with an outer diameter of 27 mm in the free, unconstrained state. Such a configuration may involve a device 3000 having a foam body 3002 with an outer diameter of 35 mm in the free, unconstrained state. In some embodiments, the devices 3000 include about 2 to about 30, about 4 to about 20, about 6 to about 18, about 8 to about 16, about 10 to about 14, or other numbers of struts 3061.

In the deployed configuration, each strut 3061 may extend radially outwardly and distally at an angle to the axis. This angle is about 60° to about 89.9°, about 65° to about 88.5°, about 70° to about 85°, about 72.5° when measured with respect to the portion of the axis extending distally from device 3000. It may be from about 82.5° to about 82.5°, from about 75° to about 80°, or some other angular amount. This angle may be fairly small when device 3000 is within the delivery catheter. The struts 3061 may bend or flex when transitioning between or positioned in the delivery and expanded configurations. The struts 3061 may bend or bend at an inner curved portion 3062, a middle straight portion 3064, and/or an outer curved portion 3066.

Accordingly, the proximal end 3042 of the frame 3040, such as the proximal surface 3060, may have a conical shape in the expanded configuration. Conical proximal surface 3060 may facilitate recapture of device 3000 into a delivery catheter. For example, the orientation of the struts 3061 to slope distally and radially outward from the hub 3050 in the expanded configuration means that distal movement of the delivery sheath on the device 3000 biases the struts 3061 inwardly and the device 3000 provides an advantageous conical shape to the proximal surface 3008 for backpacking to the delivery configuration and size for removal within a catheter.

Proximal surface 3060 shortens considerably after expansion of device 3000 for the delivery configuration. "Foreshortening" herein refers to the difference in axial length of the proximal surface 3060 between the foreshortened delivery configuration and the expanded configuration (expanded either freely or when implanted) . This length may be measured axially from the distal or proximal end of the hub 3050 to the distal end of the outer curved portion 3066 of the recapture strut 3061. Proximal surface 3060 may be shortened by 50%, 60%, 70%, 80%, 90%, or more. The proximal surface 3060 has significantly more foreshortening after expansion than the tubular body 3080, the latter may be referred to as the "working length" or "landing zone." The landing zone is further described herein with respect to tubular body portion 3080.

As shown, the struts 3061 are angularly spaced about the axis in even angular increments. That is, the angles between the struts may be equal when viewing the frame 3040 from the distal or proximal end. In some embodiments, the struts 3061 may not be evenly spaced around the axis as described. The struts 3061 may or may not be arranged symmetrically about an axis or about a plane containing the axis.

In some embodiments, portions of frame 3040 may be at varying distances from the proximal end of foam body portion 3002, such as at a proximal end wall having proximal surface 3008. As shown in FIG. 87D, there can be an axial gap of size Z between the proximal surface 3060 of the frame 3040 and the inner surface 3012 of the proximal surface 3008. The length of Z may be 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, or more. The length of Z may vary depending on the radial distance over which it is measured. For example, the length of Z may decrease, increase, or a combination thereof when measured along the length of strut 3061. In some embodiments, the length of Z may be zero at more points along the length of strut 3061. As shown in FIG. 87E, proximal surface 3060, or a portion thereof, may contact proximal inner surface 3012 of foam body portion 3002. Inner curved portion 3062, straight portion 3064, and/or outer curved portion 3066 may contact a proximal end wall, such as inner surface 3012 and/or other portions of foam body portion 3002. The hub 3050 may slightly compress the proximal face 3008 or proximal end wall of the foam body 3002 in the proximal direction as shown. Accordingly, the proximal surface 3008 may have a smaller thickness in the compressed region compared to other portions of the proximal surface 3008, such as adjacent the compressed portion. Hub 3050 may be positioned based on the axial position connecting anchors 3090, 3094 to sidewall 3014 as described herein. In some embodiments, the hub 3000 may not compress the foam body 3002 as shown. In some embodiments, proximal surface 3060 may extend radially outward as shown. For example, struts 3061, or portions thereof, such as straight portions 3064, may extend radially outwardly perpendicular or generally perpendicular to the longitudinal axis of device 3000. Proximal surface 3060 extends radially outward and may be sloped distally or sloped proximally as described herein. Device 3000 may have any of these characteristics in a constrained configuration, an unconstrained configuration, and/or an implanted configuration.

Frame 3040 includes a tubular body portion 3080. Body portion 3080 provides a mechanical base structure for device 3000, as further described. A tubular body portion 3080 is attached to the distal end of the proximal surface 3060 of the frame 3040. Tubular body portion 3080 extends to distal end 3044 of frame 3040. A tubular body portion 3080 is attached to the distal end of the proximal surface 3060 of the frame 3040. Tubular body portion 3080 extends to distal end 3044 of frame 3040. Tubular body portion 3080 is attached at the proximal end to the outer curved portion 3066 of recapture strut 3061, as further described. Tubular body portion 3080 may be attached to other portions of recapture strut 3061. The tubular body portion 3080 of the frame 3040 is attached to the body portion 3002 and/or the cover 3100 with one or more sutures, as further described, for example, using sutures as described herein. may be mounted in any mounting arrangement. A tubular body portion 3080 may be disposed within the cavity 3028. In some embodiments, tubular body 3080 may be disposed partially or completely within foam body 3002, such as within sidewall 3014.

The tubular body 3080 includes a series of proximal struts 3082 and distal struts 3086 (only some of the struts 3082, 3086 are labeled in the figure for clarity). Proximal struts 3082 and/or distal struts 3086 may have rectangular, circular, or other shaped cross-sectional shapes. In some embodiments, the proximal struts 3082 and/or the distal struts 3086 have a greater width relative to their thickness such that the struts 3061 are stiffer in one direction than in another direction, or It has an opposite cross-section, for example a rectangular shape. Struts 3061 may be less stiff in bending or bending directions, for example, to facilitate contraction and expansion of device 3000 in delivery and expansion configurations. The proximal ends of pairs of adjacent proximal struts 3082 join at a proximal apex 3084. Each proximal strut 3082 is connected to a respective outer curved portion 3066 of one of the recapture struts 3061 at a respective proximal apex 3084. Each distal end of a proximal strut 3082 connects to the distal end of an adjacent proximal strut 3082 and to the proximal ends of two distal struts 3086 at an intermediate apex 3087. Pairs of adjacent distal struts 3086 extend distally and join at respective distal apexes 3088. Repeating pattern 3089, shown as diamonds, may be formed by adjacent pairs of proximal struts 3082 and adjacent pairs of distal struts 3086. Some or all of proximal struts 3082 and/or distal struts 3086 may be attached to body portion 3002 and/or cover 3100 with one or more sutures, e.g., as described herein. It can be mounted in any mounting position. Some or all of proximal struts 3082 and/or distal struts 3086 may be disposed within cavity 3028. In some embodiments, some or all of the proximal struts 3082 and/or distal struts 3086 may be partially or fully disposed within the foam body 3002, e.g., within the sidewalls 3014. .

There are as many proximal vertices 3084 as distal vertices 3088. As shown, there are 11 proximal vertices 3084 and 11 distal vertices 3088. The number of proximal vertices 3084 and distal vertices 3088 are at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, and at least 15, respectively. , there may be at least 16 vertices, or there may be fewer or more vertices. In some embodiments, there may not be as many proximal vertices 3084 as distal vertices 3088. In some embodiments, multiple rows of the pattern, eg, a diamond pattern, may be formed by proximal struts 3082 and distal struts 3086. There may be two, three, four, or more rows of patterns. Some or all of proximal apex 3084 and/or distal apex 3088 may be attached to body portion 3002 and/or cover 3100 with one or more sutures, e.g., as described herein. It can be mounted in any mounting position.

Body portion 3080 may be tubular, such as cylindrical or generally cylindrical, in the expanded configuration. The tubular body portion 3080 may be cylindrical, round, segmented, polygonal, tubular, other shapes, or combinations thereof, all non-exclusively falling under the category "tubular" Included. A tubular shape is formed by proximal struts 3082 and distal struts 3086 in the expanded configuration. A tubular shape may also be formed by the outer curved portion 3066 of the recapture strut 3061 in the expanded configuration. The tubular shape may also be formed by a foam body 3002 that applies a radially outward force on the frame 3040. Thus, frame 3040 may have a proximal conical section and a cylindrical working length. In some embodiments, the body portion 3080 can be conical or frustoconical, such as when the distal end is wider than the proximal end or vice versa.

The tubular body portion 3080 may be referred to as a "landing zone" as described. This landing zone may refer to the axial length of the body portion 3080 from the most distal end to the most proximal end at the transition point to the recapture strut 3061 in the expanded configuration. The landing zone may have an axial length as measured from proximal apex 3084 to distal apex 3088. The length of the landing zone may be at or about 10 mm. The landing zone may have a length of about 5 mm to about 15 mm, about 6 mm to about 14 mm, about 7 mm to about 13 mm, about 8 mm to about 12 mm, about 9 mm to about 11 mm, or other lengths. Tubular body portion 3080 may shorten slightly after expansion of device 3000 for the delivery configuration. The tubular body 3080 has significantly less foreshortening after expansion than the length of the proximal surface 3060. Tubular body portion 3080 may be shortened by about 5% or less, 10%, 15%, 20%, or 30%.

Frame 3040 self-expands after delivery from the sheath. Proximal surface 3060 and tubular body 3080 are self-expanding. After expansion, the radially outwardly directed portion of the tubular body 3080 contacts the tissue of the LAA wall and forces the foam body 3002 against the tissue of the LAA wall. The tubular body 3080, eg, proximal struts 3082 and distal struts 3086, contact and compress the inner surface 3018 of the sidewall 3014, and the outer surface 3016 of the sidewall 3014 contacts and compresses the LAA wall.

When pressed against the LAA wall, the foam body portion 3002 provides a larger "footprint" than the components of the skeletal frame 3040, forming a complete seal. Thus, the sidewalls 3014 act as force dissipating layers and extend over a large area compared to only the area of each of the struts 3082, 3086 (e.g., a large area compared to only the area of the radially outward facing surfaces of the struts 3082, 3086). Spread radial force from struts 3082, 3086 of 3040. The use of a foam material within the body portion 3002 and its thickness, such as 2.5 mm, provides an advantage in this regard over devices that use thinner, less resilient materials compared to foam. For example, a thin cloth or similar material that is pressed against an LAA wall in a skeletal frame will not spread the radial forces and may even sag or otherwise bend, creating gaps and unsealing the LAA wall. Form a stop part. The foam body 3002 as described herein takes the shape of an LAA wall and forms a complete circumferential seal, spreading radial forces from the frame 3040 and connecting the foam body 3002 with the foam body 3002. Forms a stronger seal and maintains holding power.

Additionally, the device 3000 described herein with the compressible body 3002 allows for a compliant structural frame 3040 because less radial force is required from the frame 3040. For example, existing devices with incompressible fabric materials have less effective seals, and therefore the structural elements of those devices must exert greater radial forces to compensate and ensure an effective seal. This results in a less compliant device. In contrast, the device 3000 of the present invention is advantageous in this regard by having a compressible foam body 3002, which, among other things, allows for more separation from the frame 3040 while forming an effective seal. It can result in lower radial forces and therefore better compliance. This structural configuration has a cascading effect on performance benefits. For example, the compliance of device 3000 allows for off-axis delivery while forming an effective seal, among other benefits as further described herein.

Frame 3040 includes a series of proximal anchors 3090. Each proximal anchor 3090 extends from a respective intermediate apex 3087. Proximal anchor 3090 may extend from other portions of tubular body portion 3080. As shown, in the deployed configuration, proximal anchor 3090 extends radially and proximally from tubular body 3080. Proximal anchor 3090 may penetrate into an adjacent region of sidewall 3014. Proximal anchor 3090 can penetrate outer surface 3106 of sidewall 3014 and penetrate tissue adjacent device 3000.

Frame 3040 includes a series of distal anchors 3094. Each distal anchor 3094 extends from a respective distal apex 3088. Distal anchor 3094 may extend from other portions of tubular body portion 3080. As shown, in the deployed configuration, distal anchor 3094 extends radially and proximally from tubular body 3080. Distal anchor 3094 may penetrate into an adjacent region of sidewall 3014. Distal anchor 3094 can penetrate outer surface 3106 of sidewall 3014 and penetrate tissue adjacent device 3000. Anchors 3090, 3094 may slope radially outward in a proximal direction to engage tissue and resist proximal movement of device 3000.

Anchors 3090, 3094 are elongate structural members. The distal ends of the anchors 3090, 3094 may be sharpened to facilitate tissue engagement and penetration. Anchors 3090, 3094 may be straight and generally extend along their local axis. Anchors 3090, 3094 may have curved or other non-straight proximal portions that attach to tubular body 3080. In some embodiments, the anchors 3090, 3094, or portions thereof, may be non-straight, curved, rounded, segmented, other trajectories, or combinations thereof. In some embodiments, the tissue-engaging tip may be curved. In some embodiments, the anchors 3090, 3094 may have engagement features that extend radially away from the anchors 3090, 3094, such as barbs, hooks, or other features.

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

In some embodiments, the anchors 3090, 3094 in the deployed configuration are tilted at an oblique angle of about 30° with respect to the portion of the central axis extending proximally from the device 3000. The tilt angle may be about 10 degrees to about 50 degrees, about 15 degrees to about 45 degrees, about 20 degrees to about 40 degrees, about 25 degrees to about 35 degrees, or about 30 degrees. This angle of inclination of the anchors 3090, 3094 in the delivery configuration may be less than in the deployed configuration. Anchors 3090, 3094 may have an angle B as shown and described with respect to FIGS. 94A-94C.

Anchors 3090, 3094 can have various lengths. The length of the anchors 3090, 3094 is measured from the proximal end connecting to the tubular body 3080 to the distal tissue engaging tip of the anchor. In some embodiments, the length of the anchors 3090, 3094 is about 0.5 mm to about 10 mm, about 1 mm to about 9 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm, or other lengths, longer or shorter. In some embodiments, anchors 3090, 3094 are 5 mm long. In some embodiments, anchors 3090, 3094 are approximately 5 mm long. In some embodiments, the anchors 3090, 3094 have a length of at least 2.5 mm, at least 3 mm, at least 3.5 mm, at least 4 mm, at least 4.5 mm, at least 5 mm, or more. Anchors 3090, 3094 may each have the same or similar length. In some embodiments, anchors 3090, 3094 may not be the same length. In some embodiments, some or all of the proximal anchors 3090 may have a length that is shorter or longer than some or all of the lengths of the distal anchors 3094. Anchors 3090, 3094 may have a length L as shown and described with respect to FIGS. 94A-94C. Additionally, the outer tips of the anchors 3090, 3094 are smaller than, equal to, or more than the radially outermost surface of the foam body 3002, as illustrated and described with respect to FIGS. 94A-94C. It may extend to a larger outer radial configuration.

In the expanded configuration, anchors 3090, 3094 extend the length of the outside of uncompressed sidewall 3014. This length of the anchors 3090, 3094 is measured along the local longitudinal axis of the anchor from the outer surface 3016 of the body portion 3002 to the distal tip of the anchor. Anchors 3090, 3094 may pass through sidewall 3014 and/or cover 3100 and then be trimmed such that anchors 3090, 3094 extend beyond sidewall 3014 and/or cover 3100 by a desired length. In the free, unconstrained state, the anchors 3090, 3094 extend beyond the outer surface 3016 of the sidewall 3014 by approximately 0.5 mm. In some embodiments, in the free, unconstrained state, the anchors 3090, 3094 have a diameter of about 0.1 mm to about 1.5 mm, about 0.2 mm to about 1.25 mm, about 0.3 mm to about 1.0 mm, about 0.4 mm to about 0.8 mm. mm, about 0.5 mm to about 0.6 mm, or other lengths greater or less than the outer surface 3016 of the sidewall 3014. In a compressed state, such as in the delivery configuration or after implantation, the anchors 3090, 3094 extend beyond the outer surface 3016 of the sidewall 3014 by approximately 1.0 mm. In some embodiments, in the compressed state, the anchors 3090, 3094 have a diameter of about 0.25 mm to about 2.5 mm, about 0.5 mm to about 2 mm, about 0.75 mm to about 1.5 mm, about 0.875 mm to about 1.125 mm, or more. It extends beyond the outer surface 3016 of the sidewall 3014 for another length, which may be longer or shorter.

The geometry of the anchors 3090, 3094 provides several advantages. For example, relatively long lengths allow anchors 3090, 3094 to be flexible. This can potentially reduce trauma to the LAA tissue if the device 3000 needs to be unanchored and/or removed. Anchors 3090, 3094 are less susceptible to loss of strength with off-axis orientation within the LAA. Additionally, anchors 3090, 3094 provide high resistance to pull-out. For example, device 3000 can provide at least about 0.5 lb of force of movement resistance from the LAA. Such withdrawal tests can be simulated in vitro or in benchtop models, as described further below.

The anchors 3090, 3094 in the illustrated embodiment are arranged in two circumferential rows. One row is disposed proximal to the other distal row. Each column has 10 anchors each. This configuration may be incorporated into a device 3000 having a foam body 3002 with a free unconstrained outer diameter of 27 mm, for example. Each column may have 14 anchors each. This configuration may be incorporated into a device 3000 having a foam body 3002 with a free unconstrained outer diameter of 35 mm, for example. In some embodiments, a single row of anchors 3090, 3094 can include 2 to 24, 4 to 22, 5 to 20, 6 to 18, 7 to 16, 8 to 15 anchors, 9 to 14 anchors, 10 to 13 anchors, or more or less anchors 3090 or 3094. In some embodiments, there may be only one column or more than two columns of anchors. The anchors 3090, 3094 may be circumferentially spaced in a single row.

In embodiments having multiple rows of anchors 3090, 3094, the rows may be circumferentially offset as shown. That is, when viewed from the proximal or distal end of the device 3000, the anchors 3090, 3094 are angularly spaced from each other about the axis. The anchors 3090, 3094 may not be circumferentially offset, for example, may be evenly spaced apart when viewed as described. Anchors 3090, 3094 are axially positioned at or near the intermediate portion of sidewall 3014. The anchors 3090, 3094 may be positioned such that the distal ends of the anchors 3090, 3094 extend into the adjacent tissue at the middle portion of the sidewall 3014. Offset and intermediate placement of anchors 3090, 3094 may ensure engagement with LAA tissue distal to the entrance. Placing anchors 3090, 3094 at their maximum width increases the stability of device 3000. By using a cylindrical or generally cylindrical shaped device 3000, the anchors 3090, 3094 effectively rest on the largest diameter of the device 3000. The cylindrical shape has advantages over typical LAA occluvers that taper distally, thereby reducing implant stability, and also place the anchor at a diameter smaller than the entrance diameter of the occlusion surface. There is. In addition to stability, the cylindrical shape of the device 3000 along its axial length aids in movement resistance by allowing the anchors 3090, 3094 to be placed in the largest diameter section of the device 3000. In some embodiments, anchors 3090, 3094 may be positioned proximally, distally, or centrally along the length of frame body 3080. In some embodiments, anchors 3090, 3094 may not be offset and/or evenly spaced apart.

Anchors 3090, 3094 may provide advantageous flexibility compared to existing devices, as demonstrated by pull-out testing. For example, device 3000 was tested from a simulated tissue model to determine the force required to move device 3000 by pulling device 3000 proximally and outwardly from the model. A low durometer silicone tube with a circular internal diameter (ID) was used as a model. Tubes with IDs of 16.5 mm, 21 mm, and 25 mm were tested for a device 3000 having a foam body 3002 with an outer diameter of 27 mm in the free, unconstrained state. Extraction forces for existing devices are significantly reduced, going up to the 21mm model, while forces for Device 3000 are only slightly reduced.

For the largest diameter (25mm) models, if there is not much interference to the fit, the forces on the existing device will be reduced as the anchor rests on the trailing edge of the device at a smaller diameter so the device engages the model wall. As it disappears, it approaches zero. Device 3000 consistently resists movement with approximately 0.7 lbs of force. The friction resisting withdrawal is so small that the force is almost entirely resisted by the anchors 3090, 3094. When examining failure modes, all devices eventually begin to slide out of the model. After failure, the anchors 3090, 3094 fold back or fold sideways before slipping begins. Assuming that 0.7 lbs of force is required to fold back all 20 anchors 3090, 3094, the force per anchor is estimated to be approximately 0.035 lbs.

Frame 3040 may be laser cut. Tubular body portion 3080 may be laser cut from a single tube. The body portion 3080 can be cut from a tube having a thickness of about 0.002" to about 0.014", or about 0.008". The tube can have an outside diameter (OD) of about 0.05" to about 0.30". The tube can have an outer diameter (OD) of about 0.05" to about 0.30". may have an outer diameter (OD) of 0.124" for the device 3000 of 27 mm (i.e., an embodiment of the device 3000 has a foam body portion 3002 with an OD of 27 mm in the unconstrained free state) . The tube may have an OD of 0.163" for a 35 mm device 3000 (ie, an embodiment of the device 3000 has a foam body 3002 with an OD of 35 mm in the unconstrained free state).

In some embodiments, the body portion 3080 is laser cut from superelastic nitinol tubing, although numerous other biocompatible metallic materials may be utilized, such as shape memory nitinol, stainless steel, MP35N, or Elgiloy. good. Frame 3040 is self-expandable. In some embodiments, a balloon expandable frame 3040 may also be utilized. Additionally, the body portion 3080 can be fabricated from drawn wire as opposed to laser cut from a tube.

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

In one embodiment, the frame 3040 includes a proximal hub 3050, a tether pin 3051, a front surface with 10 or 14 recapture struts 3061, a cylindrical body portion 3080 in a diamond pattern, and 20 or 28 anchors 3090. Equipped with 3094. The proximal face 3060 of the frame supports recapture, the frame body 3080 supports the foam cylindrical body 3002, and anchors 3090, 3094 located on the cylinder provide resistance to embolization.

The design of device 3000 provides numerous advantages, some of which have already been described. As a further example, the frame 3040 may be designed to improve, without limitation, 1) radial stiffness/compliance of the implant--while the frame 3040 is sufficiently compliant as is to permit off-axis implantation, recapture, etc. 2) movement resistance--the frame 3040 provides high pullout strength, as described; 3) transcatheter delivery--the frame 3040 is compressed within the delivery catheter. Can be fully expanded when pushed and then delivered -- 4) Recapture -- Frame 3040 allows for recapture/removal into the delivery catheter even after deployment or implantation within the LAA and 5) Mechanical Integrity--The frame 3040 provides acute and long-term structural integrity, e.g., the ability to withstand loading into a delivery catheter, deployment from a catheter, and repeated loading/fatigue. It brings many benefits including -- The frame 3040 also includes a conformable structure that allows the foam body 3002 to compress the LAA tissue and facilitate sealing and anchoring with minimal compression (oversizing). The resulting compliance of the frame 3040, as described, provides better anchoring compared to existing solutions.

As a further example, device 3000 seals against irregularly shaped LAA entrances and necks. For example, the combination of a nitinol frame 3040 with a foam body 3002 having a coating of PTFE and a cover 3100 of ePTFE allows the device 3000 to form-fit to the anatomy while forming a smooth anti-thrombotic LA surface. Contributes to the ability to seal against regular protrusions and shapes.

As a further example, device 3000 provides controlled, secure delivery. The combined frame 3040 and foam body 3002 design facilitates delivery in a controlled manner by slowing the rate of expansion. Buffer 3026 serves as an atraumatic leading edge portion to reduce the risk of trauma when delivering the implant into the LAA. The user can recapture and redeploy the device 3000 if necessary. Attachment of a flexible tether 3240, as further described, from a delivery catheter to the device 3000 places the device 3000 in a tension-free state immediately after implantation, thereby allowing the user to release the device 3000 from the final This makes it possible to ensure proper positioning.

As a further example, device 3000 provides simplified placement. The foam-covered cylindrical design allows for off-axis deployment (e.g., up to 45 degrees) during non-critical delivery, which is designed to simplify the implantation procedure, as further described. Align the center axis of the LAA with the device 3000 (by

As a further example, device 3000 performs simple sizing. Thanks to this foam and frame design, there are two diameters (e.g., 27mm and 35mm) to seal the range of expected LAA configurations and diameters (e.g., a target LAA diameter of 16 to 33mm) Just that is enough. The conformability of the foam and frame allows a 20 mm long implant to fit within the LAA to a depth as short as 10 mm. This short landing zone requirement (LAA depth) of the Device 3000, combined with the fact that only two implant diameters are required, minimizes the need for cumbersome echo and CT sizing to minimize the need for LAA allows treatment of a wide range of anatomical structures. Implant conformability is important in facilitating easy use of a product platform that is adaptable to a variety of anatomies.

As a further example, device 3000 provides anti-thrombotic materials and designs. Removable tether leaves a smooth, metal-free surface within the LA. Antithrombotic materials (PTFE coated foam and ePTFE cover) form a smooth LA surface (no metal attachment connections), reduce anticoagulation needs, enhance antithrombotic properties, and promote endothelialization. prompt.

As a further example, device 3000 includes thin, low profile anchors 3090, 3094 around the midpoint of device 3000 to provide secure yet non-invasive anchoring.

4. Distal Buffer The foam body portion 3002 has a distal buffer 3026. Cushion 3026 may be a foam distal region of body portion 3002, such as a distal portion of sidewall 3014. Cushion 3026 may be part of foam body 3002 that extends beyond distal end 3044 of frame 3040. Cushion 3026 may extend beyond the distal end 3044 of frame 3040 in the delivery and deployed configurations. The body portion 3002 is attached to the frame 3040 in various configurations such that the body portion 3002 may be extended in some embodiments, e.g., in a delivery configuration, such that the buffer 3026 initially retracts the sheath during delivery. It may be ensured that the frame 3040 extends beyond the frame 3040.

Device 3000 may be conformable in both length and diameter due to the conformability of both foam body 3002 and frame 3040. This means that the device 3000 has only two, three or several different sizes of the device 3000, such as body portions 3002 of 27 mm and 35 mm outer diameter as described herein, and One length allows it to adapt to most patient LAA anatomy. The frame 3040 may therefore be shorter than the foam body portion 3002, such that in some embodiments about 5 mm of the foam cushion 3026 is distal to the distal-most end of the frame 3040. It is in. The distal buffer 3026 acts as an atraumatic tip during delivery of the device 3000 and is compressed after implantation, thereby allowing the device 3000 to fit appendages as short as 10 mm in depth (landing zone). It can be done. The ability to accommodate both length and diameter is due to the conformability of both the foam body 3002 and the frame 3040.

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

In some embodiments, the cushion 3026 may collapse in response to axial and/or radial compression of the device 3000. The cushion 3026 may be folded inwardly, for example radially inwardly. The fold line may be axial or approximately axial. The folds may be circumferential or approximately circumferential. The folds may be a combination of radial and circumferential or angled thereto. Folding of the buffer 3026 is discussed further herein, eg, in the "Device Compliance" section.

5. Cap & Pin FIGS. 90A-90C are proximal perspective views of frame 3040 with cap 3180. FIG. 90D is a distal perspective view of cap 3180. In some embodiments, pin 3051 is placed on a diameter of proximal hub 3050 and serves to engage a tether 3240 (e.g., a suture) of a delivery catheter, which temporarily attaches to delivery catheter 3220. Wrapped around pin 3051 for attachment, such as as further described herein with respect to FIGS. 89A-89B. As shown, the hub 3050 has a pair of opposing side openings 3053 extending through the sidewalls of the hub 3050. Cap 3180 has a corresponding pair of opposing side openings 3190 extending through sidewalls 3184 of cap 3180. When the cap 3180 is assembled with the hub 3050, the pin 3051 may be inserted through the aligned pair of openings 3053, 3182. The assembly may be further secured by welding the end of pin 3051 to hub 3050.

As shown in FIG. 90D, cap 3180 includes a proximal end 3182 and a distal end 3184. Cap 3180 includes a rounded sidewall 3186 extending from proximal end 3182 to distal end 3184. Sidewall 3186 defines a longitudinal opening 3188 through cap 3180. Side wall 3186 includes a pair of lateral openings 3190 that are positioned opposite each other. Cap 3180 includes a flange 3192 at a radially outwardly extending proximal end 3182.

Cap 3180 is formed from titanium and pin 3051 is formed from Nitinol or superelastic Nitinol. In some embodiments, the cap 3180 and/or the pin 3051 are made of other materials, such as shape memory nitinol, stainless steel, MP35N, Elgiloy, polycarbonate, polysulfone, polyetheretherketone (PEEK), or polymethyl methacrylate ( PMMA), or other materials.

Cap 3180 facilitates attachment to tether 3240. Cap 3180 and pin 3051 also reduce damage to foam body 3002 during recapture of device 3000. Cap 3180 also forms an atraumatic surface to hub 3050 of frame 3040. For example, the cap 3180 may prevent the hub 3050 from cutting through the foam body 3002 when the device 3000 is folded into the access sheath. Without the cap 3180, the sharp edges of the hub 3050 shear the foam body 3002 upon recapture of the device 3000 into the access sheath.

6. Loading System FIG. 91 is a side view of one embodiment of a loading system 3200 for loading device 3000 into delivery catheter 3220. System 3200 includes a loading tool 3210. Loading tool 3210 has a conical portion 3212 with a distal opening 3213 and a cylindrical portion 3214. A delivery catheter 3220 passes through the cylindrical portion 3214 and a distal end 3222 of the delivery catheter 3220 is disposed within the cylindrical portion 3214. A pusher 3230, such as a pusher catheter, passes through the delivery catheter 3220. A tether 3240 (see FIGS. 92A-92C) is attached to device 3000 and passes through loading tool 3210, delivery catheter 3220, and pusher 3230. Tether 3240 and pusher 3230 are retracted proximally while delivery catheter 3220 and loading tool 3210 are held stationary. Device 3000 is laterally compressed by conical portion 3212 as device 3000 is pulled proximally by tether 3240 through loading tool 3210. The distal end 3232 of the pusher 3230 remains adjacent to the proximal end 3004 of the device 3000 when the device 3000 is loaded into the delivery catheter 3220. A removable tether 3240 may be fabricated from ultra high molecular weight polyethylene (UHMWPE) and is used to attach the implant to the delivery catheter. The material UHMWPE for the tether 3240 provides high strength to the device 3000 and also provides low friction that facilitates delivery of the device 3000.

In some embodiments, the conical portion 3212 of the loading tool 3210 has a beveled distal edge of approximately 45° to 75° (degrees), preferably 60°. In some embodiments, the conical portion 3212 has a distal inner diameter (ID) greater than the outer diameter (OD) of the device 3000, ideally between 15° and 25°, and in one implementation about 20°. The anchors 3090, 3094, which may have an angle A of 30° and protrude from the surface of the foam body 3002 at or about 30°, are suitably folded. The distal opening, eg, diameter or maximum width, of conical portion 3210 may be greater than the proximal opening, eg, diameter or maximum width, of conical portion 3210 that couples with cylindrical portion 3214. Cylindrical portion 3214 has an opening, e.g., diameter or maximum width, that is smaller than the distal opening of conical portion 3210 and/or the same or similar in size to the opening at the proximal end of conical portion 3210. may have.

The decreasing width of the loading tool 3210, such as a gradual taper, ensures, for example, that the frame 3040 folds evenly without crossing or excessive distortion. Angled conical portion 3212 may ensure that anchors 3090, 3094 are folded or rotated proximally rather than distally. The sidewalls of the conical portion 3212 may extend to a "total" angle A as measured between two opposing portions of the sidewalls, as shown in FIG. Angle A may be about 12° to about 35°, about 15° to about 30°, about 17° to about 25°, about 18° to about 22°, about 20°, or 20°. Angle A may be at least 10°, at least 15°, at least 20°, at least 25°, or at least 30°. Angle A may be constant along the axial length of conical portion 3212. The angle of the conical portion 3212 may be described with respect to a longitudinal geometric centroid axis defined by the conical portion 3212 and/or the cylindrical portion 3214. The side walls may extend in a direction that forms an angle with respect to such longitudinal axis and is half the value of the total angle A. Thus, this "half angle" may be at least 5°, at least 7.5°, at least 10°, at least 12.5°, or at least 15°, etc. Conical portion 3212 may have a frustoconical shape. The cross-sectional shape of the conical portion 3212 perpendicular to the longitudinal axis may be circular or nearly circular. In some embodiments, the cross-section may be rounded, non-circular, arcuate, other shapes, or combinations thereof. The cross-sectional shape of the conical portion 3212 may be constant along its axis or may vary along its axis. In some embodiments, angle A may vary along the axial length of conical portion 3212, eg, the inner surface is axially curved.

The loading tool 3210 may be smooth or generally smooth on its interior or surfaces. The inner surfaces 3211, 3215 of the conical portion 3212 and/or the cylindrical portion 3214 are smooth or generally smooth. In some embodiments, these interior surfaces 3211, 3215 or portions thereof may not be smooth. In some embodiments, these interior surfaces 3211, 3215 or portions thereof are smooth, non-smooth, rough, etched, scored, or grooved. , have varying degrees of roughness or smoothness, have other characteristics, or combinations thereof.

In one example, tool 3210 may be used by positioning a proximal end of a loading body, such as tool 3210, adjacent distal end 3222 of delivery catheter 3220. The loading body can have a sidewall defining a channel therethrough having a distal opening 3213 at the distal end that is larger than a proximal opening at the proximal end. Left atrial appendage occlusion device 3000 may be delivered proximally through the loading body, thereby radially compressing device 3000. The retraction step may include pulling tether 3240 proximally through delivery catheter 3220. The device can then be received within the distal end 3222 of the delivery catheter 3220. Device 3000 may be radially compressed within delivery catheter 3220 having an outer diameter of 15 French or less. In some embodiments, the device 3000 is radially compressed within a delivery catheter 3220 having an outer diameter of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 French or less. obtain. The proximal end of the loading tool 3210 can have an inner diameter configured to provide an interference fit with the distal end 3222 of the delivery catheter 3220. The proximal end 3210 of the loading tool, such as the cylindrical portion 3214, has an inner diameter slightly larger than the outer diameter of the delivery catheter 3220, e.g., slightly larger than 5 mm for a delivery catheter 3220 having an outer diameter of 15 French. May have. The device 3000 has a radius to a compressed width in the constrained state that is less than 50%, 40%, 30%, 20%, 10%, and/or 5% of the radial uncompressed width of the device in the unconstrained state. can be compressed in the direction. Here, the radial width may be measured perpendicular to the longitudinal axis of the device 3000, as defined by the tubular foam body 3002.

The loading tool 3210 can be formed from a material that is biocompatible, strong, transparent, and can be smoothly molded to minimize friction, such as polycarbonate. In some embodiments, the loading tool 3210 is made of hard plastic such as Delrin, UHMWPE, Ultem®, polyetherimide, acrylic, metal, stainless steel, aluminum, other materials, or combinations thereof. It may be formed from. In some embodiments, loading tool 3210 may have one or more coatings. Such coatings may be applied to reduce friction and therefore loading forces. The coating may be silicone, hydrophilic, various oils, other suitable coatings, or combinations thereof.

7. Delivery System FIG. 92A is a schematic side view of a delivery system 3201 for delivering device 3000. 92B-92C are additional drawings of system 3201. As shown in FIG. 92A, delivery system 3201 includes a delivery catheter 3220 having a distal end 3222 and a proximal end 3224. Delivery system 3201 includes a pusher 3230, such as a pusher catheter, having a distal end 3232 and a proximal end 3234. Tether 3240 includes a first end 3242 and a second end 3244. A restraining portion 3246 secures the first end 3242 and the second end 3244.

To deliver device 3000 to the LAA, an access sheath is placed across the atrial septum and into the LAA, through which a delivery catheter 3220 containing device 3000 is placed. The device 3000 is loaded into the distal end 3222 of the delivery catheter 3220 using a loading tool 3210, either at the time of manufacture or at the treatment site. To load implant device 3000, pusher 3230 and tether 3240 are pulled proximally, collapsing implant device 3000 as it enters the distal tip of delivery catheter 3220. After a loaded delivery catheter 3220 is placed through the sheath and into the LAA, a pusher 3230, such as a catheter or rod, is held axially stationary as the delivery catheter 3220 and access sheath are simultaneously retracted proximally and the implant Deploy device 3000.

Tether 3220 is placed from the proximal end of delivery catheter 3220, through opening 3221 in catheter pusher 3230, around implant tether pin 3051, and back through delivery catheter 3220. When the ends of tether 3240 (held together by restraint 3246 at the proximal end of the catheter) are pulled, device 3000 is drawn into delivery catheter 3220. After the device 3000 is properly anatomically positioned, one end of the tether 3240 is cut, the uncut end is pulled proximally, and the cut end is placed distally into the system. The entire tether 3240 can be removed from the system by sliding it into the system around pin 3051 and disengaging it from pin 3051. The distal end 3232 of the pusher 3230 and/or the distal end 3222 of the delivery catheter 3220 may be in contact with, e.g., pressed against, the proximal end of the device 3000, such as in a relative arrangement as shown in FIG. 92A. obtain. For example, the distal end 3232 of the pusher 3230 may contact the device 3000 upon retrieval of the tether 3240 and prevent its proximal movement, as further described herein. Further details of tether release are provided herein with respect to, for example, FIGS. 92B-93B.

In some embodiments, delivery system 3201 may include other features. For example, delivery catheter 3220 may include an injection lumen. The injection lumen may allow radiopaque dye to be injected distally of the device 3000 after implantation to check for leaks using fluoroscopy.

8. Tether Release System FIGS. 92B and 92C are proximal and distal perspective views of delivery system 3201. The approach to releasing the tether and other features of the system are described in this section. For clarity, some features are not shown, such as cover 3100, foam body 3002, and frame 3040.

System 3201 as shown in FIGS. 92B and 92C shows delivery catheter 3220, pusher 3230, and hub 3050 in different axial positions with respect to each other. In some embodiments, upon release, the distal end 3222 of the delivery catheter 3220 coexists with the distal end 3232 of the pusher 3230 or is otherwise near or adjacent to the distal end 3232 of the pusher 3230. You may do so. Further, distal ends 3222 and/or 3232 may contact or be adjacent to proximal end 3004 of device 3000, such as contact or be adjacent to cover 3100 and/or foam body portion 3002. In some embodiments, the pusher distal end 3232 may be disposed distal to the distal end 3222 of the delivery catheter 3220, as shown, upon release of the tether 3240.

Tether 3240 extends from the proximal end of pusher 3230, passes through opening 3221 in pusher 3230, wraps around pin 3051, and passes proximally through opening 3221 in pusher 3230, as described with respect to FIG. 92A. and may exit from the proximal end of pusher 3230. Tether 3240 may pass through cover 3100 and foam body 3002. Tether 3240 extends distally, through a first aligned path within cover 3100 and foam body 3002, around pin 3051, and through a first aligned path within cover 3100 and foam body 3002. Return proximally through 2 aligned paths. Tether 3240 may pass through an opening in inner cover 3101, for example, as described with respect to FIGS. 85D and 87D. Tether 3240 may only extend around the distal surface or some surfaces of pin 3051 as shown. Tether 3240 extends distally and wraps around pin 3051 and may extend 180° or about 180° distally with respect to the proximal extension. In some embodiments, tether 3240 may be wrapped around pin 3051 one or more times, such as two, three, or more times. In some embodiments, tether 3240 may be on a spool around pin 3051. In some embodiments, tether 3240 may be wrapped partially, completely, or multiple times around a bushing that is rotatably coupled around pin 3051.

System 3201 may facilitate removal of tether 3240 while pusher catheter 3230 is in contact with device 3000. Such contact may, for example, help avoid or reduce inadvertent displacement of the device 3000 from the LAA after implantation and anchoring. For example, upon release of tether 3240, pusher 3230 may have a position with respect to device 3000 as shown in FIG. 92A. Pusher 3230 may contact device 3000 on proximal end 3002 of the device to prevent or reduce any proximal movement of device 3000 after removal of tether 3240. For example, as tether 3240 is unwound around pin 3051, friction may occur between tether 3240 and pin 3051. The distal end of pusher 3230 may prevent this friction or other forces from moving or otherwise moving device 3000 proximally. In some embodiments, delivery catheter 3220 may also contact, abut, etc. device 3000. In some embodiments, upon release and removal of the tether, the distal ends of delivery catheter 3220 and pusher 3230 extend axially together, adjacent to each other, or as described. It's best if it's nearby. Additionally, tether 3240 may be fully withdrawn proximally from delivery catheter 3220 and/or pusher 3230 before delivery catheter 3220 and/or pusher 3230 is removed from the patient. In some embodiments, tether 3240 may be removed from the patient along with delivery catheter 3220 and/or pusher 3230, for example, while tether 3240 remains completely or partially within pusher 3230.

93A and 93B are proximal and distal perspective views, respectively, of another embodiment of a tether release system 3400. Release system 3400 includes tube 3420 and lock 3402. Tube 3420 has a proximal end 3422 and a distal end 3424. An opening 3426 extends through tube 3420. System 3400 may be used in the same manner as described with respect to system 3201, unless otherwise noted. For example, pusher 3230 and/or tube 3420 may contact device 3000 during tether removal, as described.

Lock 3402 includes a proximal end 3404 and a distal end 3406. An opening 3408 defined by sidewall 3409 extends through lock 3402 from proximal end 3404 to distal end 3406. Tube 3420 passes through opening 3408 at proximal end 3404 of lock 3402 and extends to distal end 3406 of opening 3408. The sidewall 3409 of the lock 3402 has a first groove 3410 extending longitudinally from the proximal end 3404 to the distal end 3406 and partially extending radially through the thickness of the sidewall 3409. Sidewall 3409 of lock 3402 includes a groove extending longitudinally from proximal end 3404 partially along sidewall 3409 toward distal end 3406 and partially radially through the thickness of sidewall 3409. 2 grooves 3412.

Tether 3240 includes a first end 3243 and a second end 3245. Tether 3240 extends distally from first end 3243 within opening 3426 of tube 3240 and exits through distal end 3424 of tube 3420 to cap 3180. Tether 3240 extends distally into opening 3188 of cap 3180, around pin 3051, and back proximally. The tether 3240 then extends proximally into the first groove 3410 of the lock 3402, extends around the proximal end 3404 of the lock 3402, and then distally into the second groove 3412 and extends into the first groove 3410 of the lock 3402. 2 through the groove 3412. Tether 3240 terminates at second end 3245 within knot 3247.

In use, knot 3247 may be secured by the relative position of lock 3402 and pusher catheter 3230 inside delivery catheter 3220. Knot 3247 may be prevented from advancing distally because the inner diameter of the distal end of pusher 3230 fits snugly to the outer diameter of lock 3402. Grooves 3410 and/or 3412 within lock 3402 hold tether 3240 in an orientation that prevents tether 3240 from slipping when lock 3402 is engaged within pusher 3230 (e.g., if pulled hard enough). It is possible. Pusher 3230 may be advanced distally to expose lock 3402, eg, the entire length f of lock 3402, or a portion thereof. When the proximal end of tether 3240 is pulled proximally, knot 3247 moves away from second groove 3412 and advances around proximal end 3404 of lock 3402 and away from first groove 3410. It can be advanced into the cap 3180, around the pin 3051, and then distally through the opening 3408 of the lock 3402 and removed by the pusher 3230. In some embodiments, the distal end of lock 3402 is positioned axially proximal to the distal end of tube 3420, e.g., for implantation of device 3000 in contact with tube 3420, as described above. Preventing subsequent proximal movement of device 3000.

9. Off-Axis Delivery and Deployment The device 3000 can be deployed off-axis within the LAA while forming a complete, stable, non-invasive seal. In some embodiments, the device 3000 may be deployed at an angle of at least about 15° or 25°, and in some embodiments, for example, as much as 35° or 45° with respect to the central longitudinal LAA axis; Still yields an effective seal. The LAA axis is defined here as the geometric center of the entrance to the LAA and follows the best fit geometric center of the LAA cavity.

The ability of the device 3000 to be deployed off-axis is due in part to the cylindrical nature of the device 3000, which includes a relatively thick, compressible foam body 3002 material, a compliant frame 3040, and a foam cushion 3026. This is due to the shape. Device 3000 is stable within the LAA despite having a length less than the diameter or having L/D<1. As described, the length may be 20 mm for the device 3000 with ODs of both 27 mm and 35 mm. Therefore, having one length not only allows for greater flexibility and simplicity in the manufacturing process, but also provides stability and effectiveness of the device in use. Additionally, the axial compressibility of the buffer 3026, in combination with the axially compliant frame 3040, allows a 20 mm long device 3000 to be placed within a 10 mm deep LAA, whereas the existing LAA closure devices require a longer landing zone, or at least a landing zone equal in size to the length of the metal frame.

In some embodiments, the device 3000 can be configured to allow sufficient flow of blood even in the event of an accidental embolization, as described herein. Further, the device 3000 can be configured to allow sufficient flow of blood even if the device 3000 causes an embolism that is misaligned with the direction of blood flow. For example, device 3000 may define a longitudinal axis and the direction of blood flow may define a flow axis. The longitudinal axis of the device may be at an angle with respect to the flow axis to provide sufficient blood flow through the device 3000 even if the device 3000 embolizes and becomes lodged within the patient's circulatory system. Thus, for example, with respect to the flow of blood through the device in the event of an embolization, or its testing with water under controlled conditions, as described herein with respect to the "Proximal Cover" section. The capabilities of device 3000 may also be applied to device 3000 in such an off-axis configuration or orientation with the body's circulatory system. The device axis can be at an angle of 5 degrees, 10 degrees, 20 degrees, 30 degrees, or more with respect to the flow axis and still provide sufficient flow of blood through the device 3000.

10. Anchor/Foam Interface As described, the frame 3040 with anchors 3090, 3094 and foam body 3002 can have various geometries, such as lengths, thicknesses, etc. This section describes some specific embodiments of frame 3040, particularly anchors 3090, 3094, and foam body 3002. 94A-94C illustrate various embodiments of anchor/foam interfaces 3500 using anchor 3090 as an illustrative example. 94A-94C are side cross-sectional views of a portion of device 3000 showing one embodiment of interface 3500. In some embodiments, the outer tips of the anchors 3090, 3094, even in an unconstrained configuration, engage a portion of the outer surface 3016 of the foam body 3002, as further described herein. It may or may not extend radially beyond.

Interface 3500 includes, for example, a portion of a tubular body 3080 of frame 3040 having proximal struts 3082 and distal struts 3086, as described in further detail herein with respect to FIG. 89A. Anchors 3090 extend radially outwardly from frame 3040 in a proximal direction, such as from tubular body 3080, for example. The same or similar features and/or functionality described in this section with respect to interface 3500 with anchor 3090 may be used with other anchors, such as an anchor/foam interface with distal anchor 3094. /Can also be applied to foam interfaces. For example, frame 3080 can have a distal end at the base of anchor 3094 where distal apex 3088 is located (see, eg, FIG. 89A).

As shown in FIGS. 94A-94C, anchors 3090 extend outwardly and proximally from frame 3040, which may be from proximal apex 3084, as described herein. . Anchor 3090 has an axial length L. Length L extends from the distal base of anchor 3090 at frame 3040 to proximal tip 3091 of anchor 3090. Length L may include only straight portions of anchor 3090, for example, if the base of anchor 3090 is curved. In some embodiments, length L may include the entirety of anchor 3090, with L extending axially along anchor 3090 from tip 3091 of anchor 3090 to frame 3040. Although anchor 3090 is illustrated as having a flat end, it may also be sharp, angled, etc. Length L may extend proximally along the length of anchor 3090 to the axially most distal end, such as tip 3091. In some embodiments, the length L is 2.5 mm, about 2.5 mm, or from about 2.25 mm to about 2.75 mm. Length L may be of various other lengths, or within a range of other lengths, for example, as described in further detail with respect to anchors 3090, 3094 in the "Compliant Frame" section herein. It can be assumed that there is.

Anchor 3090 extends at angle B with respect to proximal strut 3082. In some embodiments, proximal strut 3082 as illustrated is considered a projection of proximal strut 3082 onto a vertical plane where the longitudinal axis of device 3000 and the longitudinal axis of anchor 3090 intersect. It's fine. Accordingly, angle B may be relative to such planes and/or struts 3082. For simplicity, angle B is described with respect to strut 3082. Angle B may be at or about 30°. Angle B may be at various other angles, or within a range of angles, for example, as described in more detail with respect to anchors 3090, 3094 in the "Compliant Frame" section herein. The anchor further has a radial height H. The radial height H may be the radially outermost extent of the anchor 3090, such as the proximal tip 3091 of the anchor 3090. Length L and angle B may define a radial height H of anchor 3090. Height H may be in a direction perpendicular to the longitudinal axis of device 3000 (see, eg, FIG. 87B).

Also illustrated are sidewalls 3014 of the foam body 3002. Sidewall 3014 has a thickness T. Thickness T extends radially outward from inner surface 3018 to outer surface 3016 of sidewall 3014. Thickness T may extend radially outward perpendicular to the longitudinal axis of device 3000. The thickness T may be equal to the distance from the radially outer portion of the frame 3040 to the outer surface 3016 of the side wall 3014, eg, the distance at which the inner surface 3018 of the side wall 3014 contacts the outer side of the frame struts 3082, 3086. The thickness T can be the thickness of the sidewall 3014 in an unconstrained configuration, a compressed configuration while inside the delivery catheter, or a compressed configuration after being implanted within the LAA, as further described. . The measurement of the thickness T of the sidewall 3014 may be in the same direction as the measurement of the height H of the anchor 3090. The thickness T of the sidewall 3014 may be at or about 2.5 mm. The thickness T of the sidewall 3014 may be other values or ranges of values, for example, as described in more detail in the "Compressible Foam Body" section herein.

As shown in FIG. 94A, in some embodiments, the height H of the anchor 3090 may be greater than the thickness T of the foam sidewall 3014. This difference may be equal to delta D. Device 3000 may have this configuration in an open-ended configuration, such as resting on a table top as described herein. Delta D is approximately 0.05mm to approximately 5mm, approximately 0.075mm to approximately 4mm, approximately 0.1mm to approximately 3mm, approximately 0.2mm to approximately 2mm, approximately 0.3mm to approximately 1.5mm, approximately 0.4mm to approximately 1mm, approximately 0.5mm. , or 0.5mm. In some embodiments, these exemplary values for delta D may be negative and T is greater than H. In some embodiments, delta D may be zero, as described with respect to FIG. 94B.

As shown in FIG. 94B, in some embodiments, the height H of the anchor 3090 may be the same or approximately the same as the thickness T of the foam sidewall 3014. Therefore, delta D may be zero or near zero. Device 3000 may have this configuration in an open-ended configuration, such as resting on a table top as described herein. The anchors 3090, 3094 extend through the foam body 3002 to the outer surface 3016 in the unconstrained configuration and then when loaded for delivery and/or after implantation within the LAA. may extend radially outwardly beyond. In other embodiments, the foam body 3002 is locally compressed so that the anchors extend beyond the outer surface 3016, as further described.

As shown in FIG. 94C, device 3000 may include one or more attachments, such as sutures, eg, attachment 3001, described in further detail herein with respect to FIG. 87D. A fitting 3001 may connect the foam body 3002 to the frame 3040. As shown, the fitting 3001 extends out through the sidewall 3014, around the outer surface 3016, back through the sidewall 3014, and around the frame 3040, such as around the proximal strut 3082. can extend to The fixture 3001 may locally compress the sidewall 3014 as shown. Sidewall 3014 may have a local radial thickness R. The thickness R may be smaller than the thickness T. The thickness R may be the minimum value of the thickness of the foam body portion 3002. Thickness T may be adjacent to or otherwise arranged around the thickness R arrangement. The sidewall 3014 may increase in thickness from a configuration of thickness R toward a peripheral thickness T. The increase may be gradual or sudden.

Local compression of sidewall 3014 may allow anchor 3090 to extend proximally outwardly beyond outer surface 3016 of foam body 3002. As shown, the fitting 3001 extends through the thickness of the sidewall 3014 such that the proximal tip 3091 of the anchor 3090 extends for a length L at an angle B beyond the outer surface 3016 of the foam body 3002. can be locally compressed. Fitting 3001 can be positioned proximally to anchor 3090 as shown, or distally to anchor 3090, adjacent to the base of anchor 3090, and further proximally from the base of anchor 3090. / may be placed in other positions, such as distally. Fitting 3090 is positioned and configured to allow localized compression of sidewall 3014 such that tip 3091 of anchor 3090 is placed directly radially inwardly of tip 3091 of anchor 3090. It is possible to extend beyond the exterior surface 3016 of the body. In some embodiments, the fitting 3001 may be placed directly radially inward of the tip 3091 of the anchor 3090 (eg, directly “under” the tip 3091 of the anchor 3090 in the orientation shown). In some embodiments, there may be multiple fittings 3001 distributed axially along the frame 3040, all attached to a single piece of foam body portion 3002 around a particular one of the anchors 3090. Contributes to local compression.

Foam sidewall 3014 may be compressed to the configuration shown in FIG. 94C in an unconstrained configuration. The foam sidewall 3014 can be compressed to the configuration shown in FIG. 94C in a constrained configuration, for example, within the delivery catheter or after deployment from the delivery catheter. The foam sidewall 3014 may be compressed from the configuration shown or described with respect to FIG. 94A or FIG. 94B to the configuration shown in FIG. 94C. Thus, in FIG. 94C, height H may be equal to or approximately equal to thickness T, or height H may be greater or less than thickness T. In some embodiments, in the unconstrained configuration, length L is at or about 2.5 mm, angle B is at or about 30°, and thickness T is at or about 2.5 mm. It is 2.5mm.

Anchor length design may be based on a balance between longer lengths that provide flexibility for easy removal and shorter lengths that avoid penetrating the LAA wall. Anchors 3090, 3094 may be flexible and capable of bending distally due to their length. Therefore, anchors 3090, 3094 are less likely to tear tissue when repositioned and are therefore less invasive. Anchors 3090, 3094 may be longer than other tissue-engaging features of existing solutions for LAA occlusion. In some embodiments of the device 3000, the anchors 3090, 3094 are designed to have sufficient length to effectively secure to the LAA wall. The thickness of the foam 3002 and corresponding sidewalls 3014 allows the anchors 3090, 3094 to have a longer length. The advantage of lengthening the anchors 3090, 3094 is to increase their flexibility and cause less damage to tissue upon removal and repositioning. However, anchors 3090, 3094 over a certain length may penetrate the LAA wall, which is undesirable. The foam body 3002 and its thickness help preserve the advantageous longer length of the anchors 3090, 3094 while mitigating the risk of the anchors 3090, 3094 penetrating the LAA wall. For example, the foam sidewalls 3014 between the struts of the frame 3040 and the tips 3091 of the anchors 3090, 3094 limit the distance that the anchors 3090, 3094 penetrate, thereby making the anchors 3090, 3094 longer and therefore less Allows flexible anchors 3090, 3094.

For example, with a foam sidewall 3014 thickness of 2.5 mm, the anchors 3090, 3094 may have an axial length of 2.5 mm and an angle between 30 and 40 degrees from the strut, or between 25 and 45 degrees. It may be formed by In some embodiments, as described, when the frame 3040 is initially placed within the foam body 3002 and the anchors 3090, 3094 penetrate the foam sidewall 3014, the tips of the anchors 3090, 3094 Section 3091 does not necessarily extend through the foam because anchors 3090, 3094 may be too short in the radial direction. In some embodiments, the frame 3040 has an outer diameter of about 24 mm, and the foam body 3002, such as a foam cup shape, has a sidewall 3014 with an inner diameter of about 22 mm. Therefore, there may be an interference fit in which the frame 3040 bulges into the foam sidewall 3014. For the length and angle of the anchors 3090, 3094, the tips 3091 of the anchors 3090, 3094 are approximately 27 mm in diameter, which corresponds to just reaching the outer surface 3016 of the sidewall 3014. As described, this assembly may be attached by suturing the foam body 3002 and frame 3040 (and in some arrangements, the cover 3100) together at each anchor/frame interface location. This causes a localized foam body 3002 depression in the corresponding anchor 3090, 3094, thus exposing the length of the anchor 3090, 3094 to the outer surface 3016. The exposed length of the anchors 3090, 3094 may be a portion of the total length of the anchors 3090, 3094. Additionally, the length of the anchors 3090, 3094 and the radial height of the foam sidewall 3014 surrounding the anchors 3090, 3094 may be adjusted to expose a desired length of the anchors 3090, 3094.

In some embodiments, the tip 3091 may be exposed beyond the foam body 3002 when the foam is compressed, but the tip 3091 may be exposed below the outer surface 3016 when the foam is uncompacted. may be positioned within the foam. Thus, in the uncompacted state of the foam, the tip 3091 cannot be positioned radially outwardly with respect to the outer surface 3016, whereas in the compressed state of the foam, the tip 3091 can may be positioned radially outwardly with respect to. Therefore, the tip 3091 may not be exposed with "H" less than "T" in the uncompressed configuration, and the tip 3091 may be exposed with "H" greater than "T" in the compressed configuration. .

11. Device Compliance The device 3000 can conform to the geometry of the LAA. The device 3000 is designed to be compliant such that it can conform to the LAA and reduce or minimize remodeling of the LAA. For example, device 3000 may be implanted within an LAA, and after a period of time, the entrance or opening of the LAA may have the same or similar profile as before device 3000 was implanted. Furthermore, device 3000 can exhibit such properties while conforming to extreme non-circular shapes both at the opening of the LAA and within the LAA. A single size of device 3000 may be used for all or a wide range of patients with different geometries due to compliance and other benefits.

FIG. 95A is a schematic diagram illustrating one embodiment of the outline of the inlet section 110. The drawings shown may, for example, view the LAA in a plane perpendicular to the geometrically centered axis at the entrance. The geometry of the inlet portion 110 may vary widely, as described herein, for example with respect to FIG. 1. As shown in FIG. 95A, the inlet section can be approximated as an oval or ellipsoid with a relatively short minor axis A1 and a relatively long major axis A2. Although the inlet section 110 is shown to be generally symmetrical about the axes A1, A2, the inlet section 110 may have asymmetries, other local grooves, discontinuities, etc. good. Accordingly, the illustrated schematic diagram of the inlet portion 110 is for exemplary purposes only to illustrate the enhanced compliance capabilities of the device 3000. In some embodiments, the minor axis A1 may refer to the maximum width of the inlet portion 110 in a first direction, and the major axis A2 may refer to the maximum width in a second direction. The first direction may be perpendicular to the second direction.

The lengths of the axes A1, A2 may have different values or ranges of values. Minor axis A1 may be about 5 mm to about 30 mm, about 7.5 mm to about 20 mm, about 10 mm to about 17.5 mm, about 12 mm to about 15 mm, about 14 mm, or 14 mm. The major axis A2 may be about 10 mm to about 40 mm, about 15 mm to about 37 mm, about 20 mm to about 35 mm, about 22 mm to about 32 mm, about 25 mm to about 30 mm, about 27 mm, or 27 mm.

FIG. 95B shows entrance section 110 from the same perspective with device 3000 implanted within the LAA. Cover 3100 is visible, showing proximal surface 3102 having proximal opening 3122. Other covers as described herein, such as cover 3150, may be included. The inlet section 110 with the device 3000 may have the same or similar shape and size as the inlet section shown in FIG. 95A without the device 3000. Other portions of the LAA may also have the same shape and size before and after implantation of device 3000. Thus, the device 3000 may conform to the shape of the LAA, such as the inlet portion 110. Device 3000 may conform to an anatomical shape due to the configuration of foam body 3002 and frame 3040 as described herein. Device 3000 may exhibit sufficient compliance to assume an anatomical shape to provide sufficient occlusion function without remodeling or any other form of deformation of the shape of the LAA, such as entrance portion 110.

The LAA may retain the same or similar original size and shape as the LAA immediately after implantation of the device 3000 and for a period of time thereafter. In some embodiments, the anatomical geometry, e.g., size and shape, of the LAA is longer than 24 hours, longer than 7 days, longer than 30 days, longer than 6 months, longer than 1 year, longer than 5 years, or longer is the same or nearly the same after implantation of device 3000 after a period of . Test structures having approximately the same geometry, stiffness, etc. may be fabricated to ensure that long-term changes in the structure due to device 3000 are minimal. The construct, which has an opening with a short axis of approximately 14 mm and a long axis of approximately 27 mm, where stiffness is typically present in a patient's normal LAA entrance, was constructed after implanting the device 3000 over the aforementioned period of time. may have the same or similar size and shape. Device 3000 may permit the same or similar shape along the length of the LAA, eg, distal to entrance portion 110, during these time periods, as further described.

In one example of use, the device 3000 may be configured to be inserted into a non-cylindrical opening in a test body having a non-cylindrical profile. The specimen may have a rigidity such that the specimen does not deform in response to device 3000 being implanted therein. The specimen may be formed from rigid plastic, metal, and the like. The opening and contour may have a size and shape substantially similar to a natural left atrial appendage. The device 3000 may radially expand within the non-cylindrical opening and conform to the non-cylindrical contour, which may be at least at the opening of the specimen. Device 3000 may conform to the aperture, with no visible gap between device 3000 and the aperture. There may be one or more radial gaps of no more than 5, 4, 3, 2, and/or 1 millimeter each at their widest point. Such a gap may be measured radially or perpendicular to a longitudinal axis passing through the geometric center of the specimen opening. The gap may be measured between the outer surface of the device 3000 and the inner surface of the aperture of the specimen. The gap may be measured at the maximum spacing between the device 3000 and the specimen. 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 use case, the device 3000 is inserted into a non-cylindrical opening in a specimen having a size and radial stiffness substantially similar to that of the natural left atrial appendage, and is expanded radially within the non-cylindrical opening. and may be configured to assume a non-cylindrical profile at the opening of the specimen 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 device 3000 in a radially constrained configuration. Device 3000 may have the configuration shown after being implanted within the LAA, eg, after the period described above. Device 3000 is shown having a proximal end 3004 having a width D1 and a distal end 3004 having a width D2. Widths D1, D2 may be diameters or the maximum width of each end of device 3000. Width D1 is larger than width D2. In some embodiments, width D1 may be less than width D2. In some embodiments, width D1 may be equal to or approximately equal to width D2. In some embodiments, width D2 may be about 15% of width D1. Width D2 is 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 of width D1. , 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. In some embodiments, the width D2 is at other locations along the device 3000 instead of or in addition to the distal end of the device 3000, e.g., proximal to, adjacent to, or It may be located in a portion close to it, in an intermediate portion of the device 3000, or the like. In some embodiments, the entire device 3000 or a substantial portion of the device 3000 may have a width D2. For example, the entire device may have a width D2 when constrained within a delivery catheter, such as described herein in the "Loading System" section.

FIG. 96B shows a side view of the device 3000 in an axially constrained configuration with respect to an axially unconstrained configuration. Device 3000 has an axial length L1 in the unconstrained state and an axial length L2 in the constrained state. Each configuration has a length L1, L2 between the proximal end 3004 and the distal end 3006 of the device 3000. Device 3000 may have the illustrated configuration with length L2 after being implanted within the LAA, eg, after the period described above. Length L2 is shorter than length L1. Length L2 is 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. In some embodiments, length L2 may be equal to or approximately equal to length L1.

In some embodiments, the buffer 3026 may allow the distal end 3006 of the device to be extremely short. In some embodiments, the cushion 3026 may be folded inward to accommodate radial and/or axial constraints of the device 3000. The cushion 3026 may be folded radially inwardly and/or proximally inwardly. Additionally, the compliant frame 3040 within the foam body 3002 can be further shortened axially beyond the length of the cushion 3026. Frame 3040 may be folded radially and/or axially inward.

Additionally, the cylindrical shape of the device 3000 facilitates sealing the LAA even though the anatomy of the LAA has an atypical geometry. The cylindrical shape ensures that the anchor is placed at the widest point of the device 3000. Tubular body portion 3080 provides a cylindrical base for anchors 3090, 3094, as described herein, such that the anchors are located at the radially outermost portion of device 3000. It is possible. Such a cylindrical shape of the device along its longitudinal axis helps the device 3000 perform the necessary sealing function, even in the constrained configuration shown in FIGS. 96A and 96B. In some embodiments, the device 3000 may be constrained both axially and radially, for example, both of these variations are shown in FIGS. 96A and 96B. The compliance of the device 3000 along with the cylindrical shape can ensure superior sealing performance compared to typical LAA occlusion devices currently available.

FIG. 97 is a side view of one embodiment of a laser cut tube frame 3040 shown in a flat configuration. Frame 3040 may have various dimensions, such as those shown in inches. The dimensions are just one embodiment; some or all dimensions may be different in other embodiments. Hub 3050 is located at the proximal end with aperture 3053. Struts 3061 extend distally from hub 3050 and have a curved (when assembled) proximal portion 3062, a straight portion 3064, and an outwardly curved (when assembled) portion 3066. Strut 3061 connects to proximal strut 3082 at proximal apex 3084. Proximal anchor 3090 extends proximally from intermediate apex 3087. Distal struts 3086 extend from apex 3087 to form distal apex 3088 from which distal anchor 3094 extends proximally. Frame 3040 may have approximately the same dimensions as shown, or may have different dimensions. The illustrated frame 3040 may be used with a device 3000 having a width of 27 mm or about 27 mm.

Device 3000, as described herein, provides many advantages over existing solutions to LAA occlusion. An important advantage is that the device is highly compliant while providing excellent resistance to embolism. This inherent feature of being highly compliant yet able to be properly fixed is counterintuitive. Compared to existing solutions, the device 3000 is much more conformable and can therefore assume the oval shape of the LAA inlet section as described, while providing excellent provides resistance to movement and, in some embodiments, has a bench test pull-out force of greater than 0.8 pounds (lbs).

Various modifications to the implementations described in this disclosure will be readily apparent to those skilled in the art, and the general principles defined herein may depart from the spirit or scope of this disclosure. It can also be applied to other implementations without any restrictions. Accordingly, this disclosure is not intended to be limited to the implementations set forth herein, but rather to the broadest scope consistent with the claims and principles and novel features disclosed herein. A range should be given. The word "example" is used exclusively herein to mean "serving 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 explicitly stated.

Certain features that are described herein in the context of separate implementations can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although features are described above as working in some combination, and may even be initially claimed as such, one or more features from the claimed combination may in some cases be A claimed combination that may be deleted from a subcombination may be directed to a subcombination or a variation of a subcombination.

Similarly, although acts are shown in the drawings in a particular order, such acts do not need to be performed in the particular order or sequence shown to achieve desired results, or It is understood that not all illustrated operations may need to be performed. Additionally, other implementations are within the scope of the claims. In some cases, the acts recited in the claims may be performed in a different order and still achieve desired results.

Those skilled in the art will generally understand that the language used herein should be interpreted as "open-ended" language (e.g., the phrase "including" should be interpreted as "including, but not limited to"). It is generally intended that the phrase "have" should be construed as "having at least" and the phrase "including" should be construed as "including, but not limited to," etc.). You will understand that Additionally, those skilled in the art will appreciate that if a particular number of claim enumerations are intended to be introduced, such intent will be expressly stated in the claims, and in the absence of such enumerations: It will be understood that no such intention exists. For example, as an aid to understanding, the appended claims may include the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, even if such a phrase were used in the original English text, the introduction of a claim enumeration with the indefinite article ``a'' or ``an'' would mean that even if the claim was defined by the introductory phrase ``one or more'' or ``at least in embodiments where a particular claim containing such an introduced claim enumeration contains only one such enumeration, even if it includes an indefinite article such as "one" and "a" or "an". should not be construed as meaning limited (e.g., "a" and/or "an" are typically interpreted to mean "at least one" or "one or more"); The same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a particular number of introduced claim recitations are explicitly recited, those skilled in the art will understand that such recitation typically means at least the number recited. (e.g., a plain enumeration "two enumerations" with no other modifiers typically means at least two enumerations, or two or more enumerations). ). Further, when a conventional phrase similar to "at least one of A, B, and C, etc." is used, such construction generally does not reflect what a person skilled in the art would understand this conventional phrase. (e.g., "a system with at least one of A, B, and C" means, but is not limited to, "a system with at least one of A, B, and C") , A and C together, B and C together, and/or A, B, and C together, etc.). When a conventional phrase similar to "at least one of A, B, or C, etc." is used, such construction generally means that one of ordinary skill in the art would understand this conventional phrase. is intended (e.g., "a system with at least one of A, B, or C" means, but is not limited to, "a system that has at least one of A, B, or C") and C together, B and C together, and/or A, B, and C together, etc.). Additionally, those skilled in the art will appreciate that virtually any disjunctive word and/or phrase indicating two or more alternative words, whether in the description, claims, or drawings, is It will be understood that the term is to be understood as including the possibility of including one or more of the words, or both. For example, the phrase "A or B" is understood to include the possibilities "A" or "B" or "A and B."

1 Delivery sheath
5 Delivery catheter
10 devices
15 Open cell foam body
17 slots
20 skins
25 Central lumen
30 finial
100 heart
101 Internal locking system
102 Left atrial appendage (LAA)
104 Left atrium (LA)
106 Left ventricle
110 Entrance
111 Center hub, center tube
120 Tissue Anchor
121 Tissue Engaging Segment
122 Support segment
125 Proximal region
130 Distal region
135 Hinge area
140 Unlocking system
145 ring
147 Pull rod
200 LAA
201 L.A.
202 L.A.
204 Occlusion devices or plugs, implants, foam plugs
206 layers, proximal cap, sealing layer, outer covering
208 Foam plug
210 Radiopaque Thread
212 Central lumen
214 Aisle
216 Distal Crimp
300 foam plug
302 Thread
304 Crimp
400 plug
401 Flexible Anchor
404 wire
406 LAA
408 screw wire
410 Central lumen
500 tubes
502 screw
504 LAA wall
506 Epicardial surface
600 foam plug
602 Left atrial plane
604 ePTFE material, layer
606 Tubular Crimp
608 inner tube
610 LAA side
612 Inner layer
614 Outer layer
616 first end
618 Second end
700 attachment points
800 rim
802 Guide Catheter
804 LAA entrance section
900 guide catheter
901 V-shaped tip
902 guide wire
904 LAA
1000 anchors
1002 guide wire
1003 Central lumen
1006 Balloon
1020 Devices, Implants, LAA Occlusion Devices
1022 Proximal (atrial) end
1026 Internal cavity
1028 Expandable Tubular Wall, Tissue Scaffold, Proximal Chamfer
1029 Distal extension
1030 Tissue scaffold, tubular wall, laser cut tube, outer tube
1031 Annular chamfer
1032 Internal support structure, internal frame, integral unit frame, frame corrugation, stent stent cage
1034 Corrugated stent, corrugated support cage
1038 Strut
1040 apex, foam plug, plug, foam cylinder plug, inner tube, foam cup plug
1041 Proximal vertex
1042 distal apex
1044 Reentry or Recapture Strut
1045 laser cutting tube
1046 central hub
1048 Small hole
1050 aperture
1060 crown shape wavy cage stent
1064' proximal surface
1080 Proximal spoke surface, integral front spoke surface
1100 Guide catheter, barb or anchor,
1101 Wave V-shaped tip
1102 Radiopaque Marker
1103 Two-wave V-shaped tip
1104 LAA
1108 Guidewire
1200 Guide Catheter
1201 LAA
1202 Pusher
1203 Proximal part
1204 Foam Plug
1210 guide wire
1300 Guide Catheter
1301 pull wire
1302 Deployable Anchor
1304 Hollow constraint element, tube
1306 Hinge
1308 slots
1400 Guide Catheter
1401 Lock wire
1402 Guide
1404 Foam plug, plug
1405 Deployable Anchor
1408 Distal Balloon
1412 Shaft
1500 guide
1502 Sheath, sheath cover
1504 Locking loop
1506 Deployable Anchor
1508 Guidewire Balloon
1514 Adhesive
1600 Foam, foam body
1601 External Deployable Anchor
1602 Metal stents, stents
1603 Delivery Sheath
1603 Anchor
1604 External Deployable Anchor
1604' Proximal surface
1606 hole
1608 Proximal vertex
1610 Distal Apex
1612 Zigzag Strut
1700 foam plug
1701 Rod
1702 wire
1703 wire
1704 Cavity
1705 mount
1706 Proximal end
1707 Lasso
1708 tapered cone
1709 Anchor
1711 End
1800 Spring-Like Implant Wire
1801 Anchor
1802 foam
1803 mount
1804 rod
1807 cap
1902 Distal Crimp Element
2000 plugs, barbs, laser cutting double barbs
2002 Center tube, Nitinol tube
2004 Covering, crimping part
2010 Constraint Barb, Barb
2020 Dynamic Barbs, Integrated Wave Barbs, Hinged Barbs
2100 plug
2102 Guide Catheter
2104 tube
2106 plug
2202 Foam material, foam plug
2204 Guide Catheter
2206 Plunger
2210 Disc shape
2220 cylinder
2300 Implant
2302 Barb
2304 plug
2310 Anchor
2320 foam
2350 Implant
2360 Noninvasive Foam Tip Cushion
2370 Implants, devices, and foams
2371 Barb/Anchor, Barb
2372 Corrugated Stent
2374 Foam
2375 Suture
2380 Metal stent-like frame
2381 Distal Static Barb
2382 Proximal “deceleration bump”
2384 Foam “cup”
2385 Additional materials
2390 corrugated or zigzag or other stents
2391 Loop, loop anchor
2400 Retrieval suture
2402 Proximal Cap
2404 Guide Catheter
2500 foam plug
2502 Distal Screw Lead
2504 Catheter System
2506 Catheter System, Guide
2508 Bird Nest
2510 Catheter System, Pusher
2600 foam plug
2602 Anchor
2604 Barbed Lead
3000 devices, LAA occlusion devices
3001 Mounting hardware
3002 Foam body part
3003 Internal lumen
3004 Proximal end
3005 Ablation Element
3006 Distal end
3007 pressure sensor
3008 Proximal surface
3009 Electric wire
3010 Exterior
3011 Electronic elements
3012 Inside
3013 Signal
3014 Side wall
3015 Second wire
3016 Exterior
3017 Drug storage tank
3018 Inside
3019 Conduit
3020 Distal free end
3021 Drug Exit Port
3022 Distal surface
3023 Marker, Distal Marker, Platinum Iridium (PtIr) Radiopaque (RO) Tubular Marker, Proximal and/or Distal Marker
3023A Proximal Marker
3023B marker
3024 Distal opening
3025 Electrical Pacing Element
3026 Buffer, Distal Buffer
3027 Electric wire
3028 Cavity
3029 pace generator
3030 Multilayered section
3031 Electric wire
3032 External surface
3033 battery
3035 Over-the-Wire Balloon Catheter
3037 Guidewire
3039 Balloon
3040 Deployable Compliant Frame, Frame, Structural Frame
3041 Circumferential ablation element
3042 Proximal end
3043 Balloon
3044 Distal end
3047 Over-the-Wire Circumferential Ablation Spiral Wire
3050 hub, proximal hub
3051 pin, implant tether pin
3053 Hole, side opening
3060 Proximal surface
3061 Strut, Recapture or Reentry Strut
3062 Inner curved part
3064 Straight section, straight section in the middle
3066 Outer curved part
3080 Tubular body
3082 Strut, Proximal Strut
3084 Proximal Vertex
3086 Strut, distal strut
3087 intermediate vertex
3088 Distal Apex
3090 Proximal Anchor
3091 Proximal tip
3094 Distal Anchor
3100 Cover, Proximal Cover, Outer Cover, Proximal Face, ePTFE Cover
3101 Inner cover
3102 Proximal surface
3103 Opening
3104 Outer edge
3106 External surface, external vertex
3106A area
3120 opening
3122 Proximal opening
3124 Side opening
3150 cover
3151 Proximal Cover
3152 Proximal surface
3153 Proximal Cover
3154 Outer edge
3156 outer vertex
3170 opening
3171 Opening
3172 Proximal opening
3173 Large opening
3174 Side opening
3175 Smaller opening
3177 window
3180 cap
3182 Opening, proximal end
3184 Sidewall, distal end
3186 Round side wall
3188 Longitudinal opening
3190 Side opening, lateral opening
3192 Flange
3200 loading system
3201 Delivery System
3210 Cone, loading tool
3212 Conical part
3213 Distal opening
3214 Cylindrical part
3220 Delivery Catheter, Tether
3221 opening
3222 Distal end
3224 Proximal end
3230 pusher
3232 Distal end
3234 Proximal end
3240 Tether, Tube
3242 End, first end
3243 First end
3244 End, second end
3245 Second end
3246 Restraint Department
3247 knot
3300 cover
3302 Proximal surface
3304 Outer edge
3306 outer vertex
3320 opening
3322 Proximal opening
3323 Step opening
3324 Side opening
3400 tether release system
3402 lock
3404 Proximal end
3406 Distal end
3408 opening
3409 Side wall
3410 First groove
3412 Second groove
3420 tube
3422 Proximal end
3424 Distal end
3426 opening
3500 Anchor/Foam Interface

Claims (20)

A left atrial appendage occlusion device,
a foam body having a tubular sidewall having a radially uncompacted thickness;
an expandable support coupled to the body;
at least one anchor coupled to the support and penetrating the sidewall when the foam of the sidewall is compressed, the anchor having a radial height less than or equal to the radially uncompacted thickness of the sidewall; and at least one anchor having a left atrial appendage occlusion device. The left atrial appendage occlusion device of claim 1, wherein the device defines a central axis and the at least one anchor is angled with respect to the central axis. 3. The left atrial appendage occlusion of claim 2, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least 20 degrees with respect to a proximally extending portion of the central axis of the device. device. 4. The left atrial appendage occlusion device of claim 3, wherein the angle is at least 30 degrees. The left atrial appendage occlusion device of claim 1, wherein the at least one anchor penetrates a radially compressed portion of the sidewall having a radial thickness that is less than the radially uncompressed thickness. 6. The left atrial appendage occlusion device of claim 5, further comprising a fitting that connects the support to the sidewall and radially compresses the sidewall at the radially compressed portion. A left atrial appendage occlusion device,
A tube comprising at least one first portion having a first radial thickness and at least one second portion having a second radial thickness less than said first radial thickness. a foam body having a shaped sidewall;
an expandable support coupled to the body;
at least one anchor coupled to the support and at least partially penetrating the at least one second portion of the sidewall. 8. The left atrial appendage occlusion device of claim 7, wherein the device defines a central axis and the at least one anchor is angled with respect to the central axis. 9. The left atrial appendage occlusion of claim 8, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least 20 degrees with respect to a portion of the central axis that extends proximally of the device. device. 10. The left atrial appendage occlusion device of claim 9, wherein the angle is at least 30 degrees. The at least one anchor is attached to the at least one second portion of the side wall 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 side wall. 9. The left atrial appendage occlusion device of claim 8, which penetrates the left atrial appendage occlusion device. 9. The left atrial appendage occlusion device of claim 8, wherein the at least one anchor has an axial length equal to the first radial thickness. 8. The left atrial appendage of claim 7, wherein the support comprises a tubular frame portion configured to expand radially outwardly to compress the sidewall against the wall of the left atrial appendage after implantation of the device. Occlusion device. 8. The left atrial appendage occlusion device of claim 7, further comprising a proximal cover covering at least a portion of a proximal surface of the foam body. A left atrial appendage occlusion device,
Compression comprising at least one first portion having a first radial thickness and at least one second portion having a second radial thickness less than said first radial thickness. a tubular foam body having possible sidewalls;
an expandable support coupled to the main body;
The device includes:
Inserting into a non-cylindrical opening of a rigid test body having a non-cylindrical outer shape;
radially expanding within the non-cylindrical opening;
a left atrial appendage occlusion device configured to conform to the non-cylindrical contour at least at the opening of the test body. 16. The left atrial appendage occlusion device of claim 15, wherein the compressible sidewall extends between proximal and distal ends and defines a central cavity. 17. The left atrial appendage occlusion device of claim 16, wherein the expandable support is configured to compress the sidewall against an inner surface of the test body. 16. The left atrial appendage occlusion device of claim 15, wherein the device leaves no radial gap between the device and the test body having a maximum radial dimension greater than 5 millimeters after conforming to a non-cylindrical contour. . 19. The left atrial appendage occlusion device of claim 18, wherein the device leaves no radial gap between the device and the test body having a maximum radial dimension greater than 3 millimeters after conforming to a non-cylindrical contour. . 16. The left atrial appendage occlusion device of claim 15, further comprising at least one anchor coupled to the frame and extending at least partially within the tubular foam body.