Devices, systems and methods for treating the left atrial appendage - Patents.com

Abstract

A system for treating a left atrial appendage including a delivery catheter and an implant having a contact member configured to engage an internal tissue surface of the left atrial appendage and rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage when the contact member engages the internal tissue surface of the left atrial appendage. Some configurations of the system include a support stand for supporting the delivery catheter during the procedure. Some configurations of the implant include a fixation element configured to engage the twisted tissue of the left atrial appendage.

Description

[Technical field]

[0001] (Incorporation by reference of priority application) This application claims priority from U.S. Provisional Patent Application No. 63 / 298,928, entitled "LEFT ATRIAL APPENDAGE DEVICE AND TECHNIQUES DEVICES, SYSTEMS, AND METHODS FOR TREATING THE LEFT ATRIAL APPENDAGE," filed on January 12, 2022, and U.S. Provisional Patent Application No. 63 / 479,171, entitled "DEVICES, SYSTEMS, AND METHODS FOR TREATING THE LEFT ATRIAL APPENDAGE," filed on January 9, 2023, the contents of each of which are incorporated by reference in their entirety for all purposes as if fully set forth herein. All applications to which a foreign or domestic priority claim is made identified in an Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57.

[0002] FIELD OF THEINVENTION The presently disclosed compositions relate to devices, apparatus and methods for closing or occluding the left atrial appendage. [Background technology]

[0003] Left atrial appendage (LAA) closure has typically been performed in high-risk patients due to the potential risk of stroke. LAA closure techniques are generally performed to prevent emboli from exiting the LAA. A typical surgical closure involves suturing the opening closed via the left atrial inlet. Other techniques include application of an external clamp, such as ATRICLIP by Atricure, which uses a Nitinol device to clamp the atrial appendage without opening the left atrium, excluding it from the left atrial blood circulation.

[0004] Other solutions have used plugs to close the atrial appendage from inside the left atrium. Such plugs may be constructed from laser cut Nitinol tubes expanded into a hemispherical shape. The portion exposed to the left atrium may be covered with a cover, such as a thin micron membrane made of polyethylene terephthalate. The membrane may act as a blood barrier to prevent flow through and between one or more struts of the plug. Typical sizes range from approximately 20mm to 35mm in diameter and approximately 20mm to 40mm in depth. The device may have anchors protruding from the outer surface of the device intended to engage the wall of the atrial appendage and prevent migration after deployment. The device may be delivered into the left atrium via venous access through the groin and transseptal crossing, with a guide catheter and a coaxial delivery catheter positioned proximal to the left atrial appendage. An implant for excluding the atrial appendage is typically positioned at the most distal portion of the delivery catheter. The device is typically positioned and deployed using fluoroscopy and echocardiography for guidance. Typical problems with conventional devices include complex pre-operative sizing algorithms used to determine the appropriate device size, implant migration, leakage around or through the implant, and / or implant fracture, all of which can exacerbate the thrombus and stroke problems that the device was designed to reduce. A typical drug regimen associated with conventional LAA treatment devices includes warfarin anticoagulation for 45 days (approximately 6 weeks), followed by dual antiplatelet therapy (DAPT) for 6 months post-operatively and then aspirin. Another procedure typically required with conventional LAA treatment devices includes a follow-up transesophageal ultrasound image 6 weeks post-operatively. The incidence of device-related thrombus in patients who have undergone LAA imaging has been reported to be 7.2% per year. Summary of the Invention [Means for solving the problem]

[0005] The systems, methods, and devices of the present disclosure each have several innovative aspects, implementations, or aspects, no single one of which is solely responsible for the desirable attributes disclosed herein.

[0006] Disclosed herein are configurations of a system for treating the left atrial appendage. In some configurations, the system may include an implant configured to be at least partially positioned within the left atrial appendage and a catheter configured to deploy the implant, with a first dial configured to move a first connector and an outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial rotates in a first direction, and a second dial configured to rotate an inner catheter member and the implant in a first rotational direction from an initial position to a second rotated position when the second dial rotates in the first direction. In some configurations, the catheter may include an outer sheath coupled to the first connector, a first dial coupled to the outer sheath, an inner catheter member configured to rotate the implant when a distal end of the inner tube is engaged to the implant, and a second dial coupled to the inner catheter member.

[0007] Any configuration of the devices, systems, and methods disclosed herein may include, in additional configurations, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other configurations disclosed herein, the system being configured to move a rotating portion of the implant from a first state to a second expanded state and move an outer surface of the rotating portion of the implant against an inner wall surface of the left atrial appendage, the system including a second inner catheter member; and a third dial coupled to the second inner catheter member; the third dial is configured to rotate the second inner catheter member and move the locking portion of the implant toward the rotating portion of the implant when the third dial is rotated in a first direction, the locking portion includes one or more arms extending away from the body portion of the implant and configured to contract around an outer surface of a portion of the implant and penetrate inwardly gathered tissue of the left atrial appendage, the locking portion includes one or more arms extending away from the body portion of the locking portion, the locking portion includes at least a second arm configured to be folded over by the one or more arms. the locking portion is configured to move from a first state to a second state in which the one or more arms are extended, such that an end of each of the one or more arms is spaced further away from a body portion of the implant when the locking portion is in the second state than when the locking portion is in the first state, the one or more arms of the locking portion being configured to extend toward a rotating portion of the implant when the locking portion is in the second state; a stop element configured to limit a range of movement of the first connector relative to the first dial to limit a range of movement of the outer sheath relative to the implant, the stop element being removable and repositionable to adjust the range of movement; a third inner catheter member and a fourth dial coupled to the third inner catheter member, the fourth dial configured to rotate the third inner catheter member and disengage the third inner catheter member from the implant to release the implant from the catheter when the fourth dial is rotated at least in a first direction;the third dial is configured to rotate the second inner catheter member and move the locking portion of the implant toward the rotating portion of the implant when the third dial is rotated in a first direction, and a fourth dial coupled to the third inner catheter member, the fourth dial is configured to rotate the third inner catheter member and disengage the third inner catheter member from the implant and release the implant from the catheter when at least the fourth dial is rotated in a first direction, the connecting element comprises a sleeve configured to selectively secure the third dial to the fourth dial such that the fourth dial cannot rotate independently relative to the third dial when the connecting element is engaged with the fourth dial and the third dial, and / or further comprises a removable locking element configured to selectively prevent the connecting element from disengaging from the third dial and the fourth dial, the locking element comprising a suture;

[0008] Additionally, any configuration of the devices, systems, and methods disclosed herein may include, in additional configurations, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other configuration disclosed herein, the other sheath comprising an inner layer and an outer layer, the outer layer being positioned over the inner layer along at least a portion of a length of the inner layer such that a distal end of the inner layer having a plurality of openings therein is not covered by the outer layer, the plurality of openings comprising a plurality of angled slits formed in the inner layer of the outer sheath, the plurality of angled slits being formed in the inner layer of the outer sheath. the inclined slit is configured to increase the flexibility of the catheter and allow passage of the contrast agent through the inclined slit, and further includes a support stand for supporting the catheter and at least one guide catheter, the support stand being configured to be positioned on a support surface, such as a bed or table, or on a patient's body, and / or the support stand for supporting the catheter having a slot therein configured to receive a protrusion of the catheter, the catheter having a locking element configured to selectively secure the catheter at a desired position along the slot when the locking element is engaged.

[0009] Also disclosed herein are configurations for a method of treating a left atrial appendage, the method may include advancing an implant into the left atrial appendage, engaging an inner wall surface of the left atrial appendage with a portion of the implant, rotating the implant in a first direction from an initial position a first predetermined angle, moving the implant in a proximal direction a first predetermined distance, and rotating the implant in the first direction a second predetermined angle.

[0010] Additionally, any configuration of the devices, systems, and methods disclosed herein may include, in additional configurations, one or more of the following features, components, and / or details in any combination with any of the other features, components, and / or details of any other configurations disclosed herein, further including moving the implant in a proximal direction a first predetermined distance after rotating the implant in the first direction a first predetermined angle; and rotating the implant in the first direction a second predetermined angle after moving the implant in the proximal direction the first predetermined distance; further including rotating the implant in the first direction the first predetermined angle simultaneously with moving the implant in the proximal direction the first predetermined distance; further including preventing the implant from rotating back to its initial position; and further including deploying a fixation element to prevent the implant from rotating back to its initial position after rotating the implant in the first direction the second predetermined angle; rotating the second predetermined angle includes rotating the implant to a final rotated position, the method further including deploying a fixation element to prevent the implant from rotating back to the initial position after rotating the implant to the final rotated position, the first predetermined angle being equal to or greater than 90 degrees, the first predetermined angle being equal to or greater than 180 degrees, the first predetermined angle being between 200 degrees and 330 degrees, the first predetermined distance being equal to or greater than 0.5 cm, and the first predetermined distance being between 0.25 cm and 1.75 cm; the second predetermined angle is greater than or equal to 15 degrees, the second predetermined angle is greater than or equal to 30 degrees, the second predetermined angle is between 30 degrees and 90 degrees, and further comprising expanding the implant from the first state to the second state prior to rotating the implant through the first predetermined angle in the first direction, wherein at least a portion of the implant is radially expanded when the implant is in the second state compared to when the implant is in the first state, and / or further comprising preventing the implant from rotating back to the first rotated position.

[0011] Disclosed herein are method configurations for treating a left atrial appendage. In some configurations, the methods may include twisting the left atrial appendage and / or fixing the left atrial appendage in a twisted position. Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein; twisting the left atrial appendage may include engaging an interior wall portion of the left atrial appendage with a contact member and rotating the contact member from a first rotational position (also referred to herein as a first position) to a second rotational position (also referred to herein as a second position) to twist the left atrial appendage; engaging the interior wall portion of the left atrial appendage with the contact member may include advancing a deployment device into the left atrial appendage; engaging the interior wall portion of the left atrial appendage may include engaging the interior wall portion of the left atrial appendage with one or more tissue anchors; the contact member may be a balloon; and the contact member is positioned on an implant coupled to the deployment device. and the implant may be self-expanding, balloon-expandable, and / or mechanically expandable, and further includes applying a vacuum through the contact member to engage the left atrial appendage, and rotating the components of the deployment device may include rotating the contact member from a first rotational position to a second rotational position to twist the left atrial appendage, rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the contact member at least approximately 90° in either direction from the first rotational position, rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the contact member at least approximately 180° in either direction from the first rotational position, rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the contact member from approximately 90° to approximately 360° in either direction from the first rotational position, and rotating the deployment device may include rotating the contact member from approximately 0.Torquing the deployment device with a torque between 25 in-oz and 10 in-oz, the method further including allowing the contact member to rotate from the second orientation to a third rotational position that can be between the first rotational position and the second rotational position (e.g., but not limited to, as a result of tissue loosening), and / or the contact member includes at least one vacuum port, the vacuum port configured to transfer suction force from a suction source through the at least one vacuum port.

[0012] Further, any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein; twisting the left atrial appendage may include rotating a portion of the left atrial appendage about an axis from a first rotational position to a second rotational position to twist the left atrial appendage; rotating a portion of the left atrial appendage about an axis from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the portion of the left atrial appendage at least approximately 90° in either direction from the first rotational position; and rotating a portion of the left atrial appendage about an axis from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the portion of the left atrial appendage at least approximately 180° in either direction from the first rotational position. , rotating a portion of the left atrial appendage about an axis from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the portion of the left atrial appendage about an axis from the first rotational position to a second rotational position to twist the left atrial appendage may include twisting the left atrial appendage until the ostium of the LAA substantially or completely closes, securing the left atrial appendage in the twisted position may include engaging the twisted heart tissue, engaging the twisted heart tissue may include engaging the tissue wall with an anchor element, the anchor element may include a suture, securing the left atrial appendage in the twisted position may include securing the heart tissue outside the obstruction of the left atrial appendage with the anchor element, and / or the anchor element may include a plurality of tissue anchors on at least one surface thereof configured to engage an interior heart wall outside the left atrial appendage.

[0013] Also disclosed herein are method configurations for closing the left atrial appendage ostium. In some configurations, the method may include twisting the cardiac tissue to contract the left atrial appendage ostium and / or securing the gathered tissue in the gathered position resulting from twisting the cardiac tissue. Any configuration of the methods, devices, and systems for closing the left atrial appendage ostium disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein, where securing the cardiac tissue in the gathered position may include advancing a fixation element into the gathered tissue, where the fixation element may be a suture, and / or the fixation element may be a tissue anchor.

[0014] Disclosed herein are configurations of devices and systems for treating the LAA that may include an implant comprising a contact member and a fixation element, the contact member configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member configured to twist at least a portion of the LAA when the contact member rotates from the first rotational position to the second rotational position, and the fixation element configured to prevent rotation of the implant in a second direction opposite the first direction when the fixation element is in an operable state. The contact member may be configured in some configurations to move between a first state and a second state, the contact member being larger or expanded in the second state. Some configurations of the contact member may be configured to move from the first state to the second state such that at least a portion of the contact member engages a wall portion of the LAA when the contact member is advanced into the LAA. In any configuration disclosed herein where the contact member moves or expands from a first state to a second state, the contact member may move or expand from a first state to a second state within the LA or LAA. Additionally, in any configuration, the contact member may be configured to remain in a fixed state and / or size throughout the procedure, where the contact member may extend beyond the distal end of the delivery catheter (or the outer tube of the delivery catheter may be withdrawn), advance to contact or engage a wall portion of the LAA, and then be twisted. This may be done without changing the size of the contact member and / or without expanding the contact member.

[0015] Also disclosed herein are device and system configurations for treating the LAA, which may include an implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the LAA when the implant is in the first state and move the implant from the first state to the second state such that an outer surface of the implant moves against an inner wall surface of the LAA after the implant is advanced into the LAA, the catheter configured to rotate the implant in a first direction from a first rotational position to a second rotational position when the implant is in the second state such that the implant can twist at least a portion of the LAA.

[0016] Also disclosed herein are device and system configurations for pulling a first tissue surface towards a second tissue surface, the devices and systems including a contact member configured to expand from a first state to a second state and a fixation element configured to move from the first state to the second state, the contact member may be configured to expand from the first state to the second state such that at least a portion of the contact member engages at least a distal portion of the first tissue surface and at least a distal portion of the second tissue surface, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, rotation of the contact member in the first direction twists and moves at least a proximal portion of the first tissue surface towards a proximal portion of the second tissue surface, the fixation element configured to prevent rotation of the implant in a second direction when the fixation element is in an operable state and engaged with tissue portions adjacent to and / or including the proximal portions of the first tissue surface and the proximal portions of the second tissue surface, the second direction being opposite to the first direction. Further, in any device and / or system configuration disclosed herein, the device and / or system may be configured to occlude or close a cavity within a body having a first tissue surface and a second tissue surface, where the first tissue surface and the second tissue surface may be tissue surfaces within any cavity within a body, and / or rotation of the contact member further twists and moves a proximal portion of the second tissue surface toward the proximal portion of the first tissue surface.

[0017] Any configuration of the devices and systems disclosed herein may include, in additional configurations, one or more of the following features, components, and / or details in any combination with any of the other features, components, and / or details of any other configurations disclosed herein, wherein the implant is self-expandable such that the implant automatically expands from a first state to a second state when the restraint is removed from the implant; the contact member is self-expandable such that at least a portion of the contact member automatically expands from the first state to the second state when the restraint is removed from the contact member; the implant is substantially collapsed when the implant is in the first state and expanded when the implant is in the second state such that the size of the implant is larger when the implant is in the second state than when the implant is in the first state; the contact member is biased to remain in the second state after deployment into the LAA; the contact member is configured to rotate in a clockwise or counterclockwise direction; and the device is configured to rotate the contact member to the second rotational position to press the left atrium and / or LAA tissue against the implant's left atrium and / or LAA tissue when the contact member is rotated to the second rotational position. the contact member is configured to contract about an outer surface of the body portion, and the fixation element is configured to engage tissue contracted about the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction, the fixation element has a plurality of tissue anchors configured to engage an inner wall of the heart adjacent the LAA, the fixation element has a helical shape and is configured to rotate about the body portion of the implant during the implantation procedure, the implant is configured to rotate in a first direction from a first rotational position to a second rotational position, the implant is configured to prevent rotation of the implant in the second direction after the implant is fully deployed, the second direction being opposite to the first direction, the contact member has a plurality of tissue anchors on its outer surface, the plurality of tissue anchors on the outer surface of the contact member are configured to engage an inner wall surface of the LAA after the contact member is moved to the second state, the implant comprises a fixation element configured to engage a tissue portion of the heart adjacent the LAA, the second rotational position is at least one quarter of a full rotation relative to the first rotational position, and the second rotational position isThe first rotational position is at least half a full rotation from the first rotational position, and / or the second rotational position is approximately one-quarter to one or more full rotations from the first rotational position.

[0018] Additionally, any of the configurations of the devices and systems disclosed herein may, in additional configurations, include one or more of the following features, components, and / or details in any combination with any of the other features, components, and / or details of any other configurations disclosed herein, further comprising a catheter selectively coupled to the contact member and configured to apply a torque to the contact member to rotate the contact member from a first rotational position until a predetermined threshold torque level is reached, the predetermined threshold torque level being between approximately 0.25 in-oz of torque and approximately 10 in-oz of torque, the predetermined threshold torque level being between approximately 0.5 in-oz of torque and approximately 5 in-oz of torque, further comprising a retaining element configured to urge the fixation element toward a tissue wall of the LAA, further comprising a retaining element configured to urge the fixation element toward the contact member, further comprising a retaining element configured to couple the fixation element to the contact member, the retaining element comprising a threaded shaft, the device configured such that rotation of the retaining element in a first direction moves the fixation element toward the contact member, the material is configured to rotate in at least a first direction from a first rotational position to a second rotational position when a torque is applied to the contact member, the device is configured to allow the contact member to be removed from the LAA after the fixation element is deployed to the fixation element's operative state, the device is configured to allow the contact member to be removed from the LAA after the fixation element is deployed to the fixation element's operative state, the fixation element is configured to prevent rotation of contracted left atrium and / or tissue of the LAA as a result of rotation of the contact member from the first rotational position to the second rotational position, only a portion of the fixation element extends into the left atrium after deployment of the device and all other portions of the device are inside the LAA after deployment of the device, and only approximately 10% or less of a total length of the deployed device extends into the left atrium after deployment of the device, and a proximal portion of the contact member is configured to urge any folds or overlapping tissue of the left atrial appendage that have formed around the contact member as a result of rotation of the contact member within the left atrial appendage to slide or move proximally away from the contact member, such thata contact member configured to rotate about an outer side of the contact member and a fixation element ...

[0019] Some configurations of devices and systems for closing or occluding the left atrial appendage (LAA) disclosed herein may include an implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state, the implant may be configured to move from the first state to the second state such that at least a portion of the implant engages a wall portion of the left atrial appendage after the implant is advanced into the left atrial appendage, and the implant may be configured to twist at least a portion of the left atrial appendage when the implant is in the second state as the implant rotates from the first rotational position to the second rotational position. In any of the configurations disclosed herein, the twisting motion or twisting step may be accomplished by a torque catheter.

[0020] Any configuration of the devices and systems disclosed herein may include, in additional configurations, one or more of the following features or details in any combination; the implant is configured to automatically rotate from a first rotational position to a second rotational position after the implant is in the second state; the implant may be configured to be triggered or actuated to thereafter automatically rotate from the first rotational position to the second rotational position; the device has a spring coupled with the implant, the spring configured to automatically rotate the implant when the spring is released or actuated; the implant may be self-expandable such that the implant automatically expands from the first state to the second state when the restraint is removed from the implant; the implant may be self-expandable such that at least a portion of the implant automatically expands from the first state to the second state when the implant is advanced beyond the distal end of the outer sleeve of the catheter; the implant is substantially collapsed when the implant is in the first state and collapsed when the implant is in the second state. the implant may be expanded when in the second state such that the implant may be larger in size than when in the first state, the implant may be biased to remain in the second state after deployment into the left atrial appendage, the implant may be configured to be rotated in a clockwise or counterclockwise direction, the implant may include a fixation element configured to engage an inner wall of the heart outside the left atrial appendage, the implant may include a fixation element configured to engage an inner wall of the heart outside the left atrial appendage, the fixation element has a helical shape and is configured to rotate about a body portion of the implant during the implantation procedure, the implant may include a helical shaped fixation element configured to engage an inner wall of the heart outside the left atrial appendage, the implant may include a fixation element having a helical tissue anchor for engaging an inner wall of the heart and / or LAA tissue, the implant may include a fixation element having a plurality of tissue anchors configured to engage an inner wall of the heart adjacent the left atrial appendage, the implant may be configured to prevent the implant from rotating back to the first rotated position after the implant is fully deployed, the implant may includeThe implant may be configured to rotate in a first direction from a first rotational position to a second rotational position, and the implant may be configured to prevent rotation of the implant in a second direction after the implant is fully deployed, the second direction being opposite the first direction.

[0021] Any configuration of the devices and systems disclosed herein may include, in additional configurations, one or more of the following features or details in any combination: the implant has a plurality of tissue anchors on an outer surface thereof, the plurality of tissue anchors on the outer surface of the implant configured to engage an inner wall surface of the left atrial appendage after the implant is moved to the second condition; the implant may include a fixation element configured to engage a tissue portion of the heart adjacent the left atrial appendage; the second rotational position may be at least or approximately one-quarter of a full rotation (i.e., 90° or approximately 90°) relative to the first rotational position; and the second rotational position may be at least or approximately one-half of a full rotation (i.e., 1 / 2 or approximately 1 / 2) relative to the first rotational position. the second rotational position may be at or about a quarter of a full rotation (i.e., at or about 90°) to one or more full rotations (i.e., at or about 360°) relative to the first rotational position, and the catheter may be configured to apply a torque to the implant to rotate the implant from the first rotational position until a predetermined threshold torque level is reached, the predetermined threshold torque level may be from 0.25 or approximately 0.25 in-oz of torque to 10 or approximately 10 in-oz of torque, and / or the predetermined threshold torque level may be from 0.5 or approximately 0.5 in-oz of torque to 5 or approximately 5 in-oz of torque.

[0022] Any configuration of the devices and systems disclosed herein may include an implant having a contact member configured to move between a first state and a second state; and a catheter configured to advance the contact member into the LAA when the contact member is in the first state and move the contact member from the first state to the second state such that an outer surface of the contact member expands against an inner wall surface of the LAA after the contact member is advanced into the LAA, and the catheter is configured to apply a torque to the contact member when rotating the contact member from the first rotational position to the second rotational position such that at least a portion of the catheter rotates until a predetermined torque level is reached, enabling the contact member to twist at least a portion of the LAA.

[0023] Any configuration of the devices and systems disclosed herein may include an expandable implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and to move the implant from the first state to the second state after the implant is advanced into the left atrial appendage such that an outer surface of the implant expands against at least a portion of an inner wall surface of the left atrial appendage. In any configuration of the devices for closing or occluding the LAA disclosed herein, the catheter may be configured to apply a torque to the implant to rotate the implant from a first rotational position to a second rotational position such that the implant can twist at least a portion of the left atrial appendage until a predetermined torque level is reached or, in some configurations, until a user decides to stop, whichever occurs first.

[0024] Also disclosed herein are devices and systems for treating the LAA, including a device configured to be inserted into the LAA and engage LAA tissue while the device is rotated into a rotated position to close blood communication between the LAA and the left atrium. In any configuration of the apparatus, the device may be selectively lockable in the rotated position and configured to at least substantially maintain the device in the rotated position after implantation, the device may include a fixation element configured to engage a tissue surface adjacent the LAA to maintain the device in the rotated position after implantation, the device may be round, spherical, or disk-shaped when the device is in a deployed state within the LAA, the device may be expandable from a first collapsed state to a second expanded state, and / or the device may be self-expandable from the first collapsed state to the second expanded state.

[0025] Also disclosed herein are method configurations for treating an LAA, the method including engaging tissue of the LAA and rotating the tissue of the LAA to close or occlude blood communication between the LAA and the left atrium. In any of the method configurations disclosed herein, rotating the tissue of the LAA to close or occlude blood communication between the LAA and the left atrium may include rotating the tissue of the LAA to close or occlude an ostium of the LAA. Additionally, any of the method configurations disclosed herein may further include fixing the LAA in a rotated position to maintain the LAA in a closed or occluded state.

[0026] Any configuration of the methods of closing or occluding the LAA disclosed herein may include advancing a deployment device having an implant into the left atrial appendage, the implant being configured to be moved from a first state to a second state. In some configurations, at least a portion of the implant may be radially expanded when the implant is in the second state compared to when the implant is in the first state. The method may further include moving the implant from the first state to the second state within the left atrial appendage to move at least a portion of an outer wall of the implant or one or more tissue anchors extending away from the outer surface of the implant against at least a portion of an inner wall surface of the left atrial appendage, rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage, and preventing the implant from rotating back to the first rotational position.

[0027] Any configuration of the methods of closing or occluding the LAA disclosed herein may, in some additional configurations, in any combination, and in any combination with any of the other steps, features, or other details of any other configurations, include one or more of the following steps: the implant is self-expanding; moving the implant from a first state to a second state includes advancing the implant out of a distal end of a deployment device; engaging an inner wall portion of the LAA includes engaging an inner wall portion of the LAA with one or more tissue anchors positioned on an outer surface of the implant; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with anchor elements to prevent relative movement between the implant and the tissue wall; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with anchor elements, the anchor elements configured to secure to the implant to prevent rotation between the implant and the anchor elements, and preventing the implant from rotating back to the first rotational position. the implant includes engaging a tissue wall of the heart with an anchor element, the anchor element being rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; preventing the implant from rotating back to the first rotational position includes engaging cardiac tissue outside an occluded portion of the LAA with the anchor element, the anchor element being rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position, the anchor element comprising a plurality of tissue anchors on at least one surface thereof configured to engage an interior wall of the heart outside the LAA; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant until an ostium of the LAA is substantially or completely closed; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant at least approximately 90 degrees in either direction from the first rotational position; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant from the first rotational position to the second rotational position to twist the LAA.Rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant at least approximately 180° in either direction from the first rotational position, and rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant at least approximately 90° to approximately 360° in either direction from the first rotational position, and rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant at least approximately 90° to approximately 180° in either direction from the first rotational position, and Rotating the implant to a second rotational position to twist the LAA includes applying a torque to the implant to rotate the implant in either direction from the first rotational position until a predetermined threshold torque level is reached, holding the implant in the second rotational position, and fixing the implant at approximately the second rotational position relative to a tissue surface surrounding the LAA, wherein the predetermined maximum torque level is between approximately 0.25 in-oz of torque and approximately 10 in-oz of torque, and / or the predetermined maximum torque level is between approximately 0.5 in-oz of torque and approximately 5 in-oz of torque.

[0028] Any configuration of the methods of closing or occluding the LAA disclosed herein may, in some additional configurations, in any combination, and in any combination with any of the other steps, features, or other details of any other configurations, include one or more of the following steps: the implant is self-expanding; moving the implant from the first condition to the second condition may include advancing the implant out of the distal end of the deployment device; engaging the interior wall portion of the left atrial appendage may include engaging at least a portion of the interior wall portion of the left atrial appendage or surrounding the left atrial appendage with one or more tissue anchors positioned on an outer surface of the implant; preventing the implant from rotating back to the first rotational position may include engaging an outer tissue wall of the left atrial appendage with an anchor element, the anchor element may be rotationally fixed to the implant to prevent relative movement between the anchor element and the implant; and preventing the implant from rotating back to the first rotational position. preventing the implant from rotating back to the first rotational position may include engaging a tissue wall of the heart with an anchor element, which may be rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; preventing the implant from rotating back to the first rotational position may include engaging an interior wall of the heart outside the left atrial appendage with an anchor element, which may be rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position, which may include a plurality of tissue anchors on at least one surface thereof configured to engage the interior wall of the heart outside the left atrial appendage; and / or rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the implant until the ostium of the LAA is substantially or completely closed or occluded or may be folded around an outer surface of the implant.

[0029] Any configuration of the method of closing or occluding the LAA disclosed herein may include one or more of the following steps, in any additional configurations, in any combination, and in any combination with any of the other steps, features, or other details of any other configurations: rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least or approximately one-quarter of a full rotation (i.e., 90° or approximately 90°) relative to the first rotational position; and rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage. Rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the implant at least or approximately one-half of a full rotation in either direction from the first rotational position (i.e., at or approximately 180°), and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the implant at or approximately one-quarter of a full rotation (i.e., at or approximately 90°) to a full or nearly full rotation (i.e., 360° or approximately 360°) in either direction from the first rotational position. ), or more than a full rotation (i.e., greater than 360°), and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the implant from the first rotational position from a quarter or approximately a quarter of a full rotation (i.e., at or approximately 90°) to a half or approximately a half of a full rotation (i.e., at or approximately 180°) in either direction from the first rotational position, or more than a full rotation (i.e., greater than 360°), and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage may include rotating the implant from the first rotational position from a quarter or approximately a quarter of a full rotation (i.e., at or approximately 90°) to a half or approximately a half of a full rotation (i.e., at or approximately 180°) in either direction from the first rotational position. and twisting the left atrial appendage by rotating the implant from the first rotational position to a second rotational position may include applying a torque to the implant to rotate the implant in either direction from a first rotational position until a predetermined threshold torque level is reached, and rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage may include holding the implant in the second rotational position, and rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage may include fixing the implant in approximately the second rotational position relative to a tissue surface surrounding the left atrial appendage, the predetermined maximum torque level beingThe predetermined maximum torque level may be between approximately 0.25 in-oz of torque and approximately 10 in-oz of torque, and / or the predetermined maximum torque level may be between approximately 0.5 in-oz of torque and approximately 5 in-oz of torque.

[0030] Some configurations of implants for deployment within a cavity or vessel disclosed herein include an expandable body, a number of tissue anchors on an outer surface of the expandable body configured to engage an inner wall surface of the cavity or vessel, and anchor elements coupled to the expandable body configured to engage a tissue surface adjacent the inner wall surface of the cavity or vessel.

[0031] Any configuration of the devices and systems disclosed herein may include an expandable body having a plurality of tissue anchors on an outer surface thereof, an expandable implant configured to move between a first state in which the implant is substantially collapsed and a second state in which at least a portion of the implant is expanded, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and to move the implant from the first state to the second state after the implant is advanced into the left atrial appendage such that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage. In some configurations, the catheter may be configured to rotate the implant in a first direction from a first rotational position to a second rotational position such that the implant can twist the wall of the left atrial appendage.

[0032] Some configurations of devices and systems for closing or occluding the LAA disclosed herein may include an implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and move the implant from the first state to the second state such that an outer surface of the implant moves against an inner wall surface of the left atrial appendage after the implant is advanced into the left atrial appendage. In some configurations, the catheter may be configured to rotate the implant in a first direction from a first rotational position to a second rotational position when the implant is in the second state such that the implant can twist at least a portion of the left atrial appendage.

[0033] Any of the configurations of the methods of treating the left atrial appendage disclosed herein may include engaging tissue of the left atrial appendage and rotating the tissue of the left atrial appendage to close, or significantly close, or prevent, or substantially prevent, blood communication between the left atrial appendage and the left atrium. Any of the configurations of the methods disclosed herein may, in additional configurations, include one or more of the following features, components, steps, and / or details in any combination with any of the other features, components, steps, and / or details of any other treatment method configurations disclosed herein, where rotating the tissue of the left atrial appendage to close blood communication between the left atrial appendage and the left atrium may include rotating the tissue of the left atrial appendage to close an ostium of the left atrial appendage, and / or may further include fixing the left atrial appendage in a rotated position to hold the left atrial appendage closed.

[0034] Some configurations of apparatus for treating the left atrial appendage disclosed herein may include a device configured to be inserted into the left atrial appendage and engage left atrial appendage tissue while the device is rotated into a rotated position to close blood communication between the left atrial appendage and the left atrium. In any configuration, the device may be configured to be locked in a rotated position to maintain the device in the rotated position after implantation, the device may include a fixation element configured to engage a tissue surface adjacent the left atrial appendage to maintain the device in the rotated position after implantation, the device may be round, spherical, or disk-shaped when the device is in a deployed state within the left atrial appendage, the device may be expandable from a first folded state to a second expanded state, and / or the device may be self-expandable from the first folded state to the second expanded state.

[0035] Disclosed herein are configurations of devices for treating the left atrial appendage, the devices including an implant having a contact member and a catheter configured to advance the contact member into the left atrial appendage and move the contact member against an inner wall surface of the left atrial appendage, the catheter configured to apply a torque to the contact member when rotating the contact member from a first rotational position to a second rotational position such that at least a portion of the catheter is rotated until a predetermined torque level is reached such that the contact member can twist at least a portion of the left atrial appendage. In any of the configurations disclosed herein, the contact member may be configured to move against the inner wall surface of the left atrial appendage without changing the state or shape of the contact member and / or the contact member may be configured to be movable or expandable from a first state to a second state.

[0036] Disclosed herein are configurations of devices for reducing an opening of a left atrial appendage, including a contact member and a fixation element, the contact member configured to engage a tissue surface of the left atrial appendage, the contact member configured to rotate at least a portion of the left atrial appendage in a first direction from a first rotational position to a second rotational position to reduce a size of the opening of the left atrial appendage from a first size to a second size, and / or the fixation element configured to engage at least a portion of tissue adjacent the opening of the left atrial appendage and prevent the opening of the left atrial appendage from expanding to the first size. In any of the configurations disclosed herein, the contact member may be configured to engage a tissue surface on an outer surface of the left atrial appendage. Further, in any of the configurations disclosed herein, the contact member may be configured to engage a tissue surface of the left atrial appendage without changing the state or shape of the contact member.

[0037] Any configuration of the device disclosed herein may include, in additional configurations, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other configuration disclosed herein, wherein the device further includes a delivery catheter, the device further includes an implant of any of the implant configurations disclosed herein advanceable through the delivery catheter when the implant is in a first state, the implant including a first stage portion and a second stage portion each independently deployable to at least a second operative or deployed state, the first stage portion configured to be at least partially deployed before the second stage portion is deployed, the first stage portion configured to be positioned near a distal end of the LAA, and the second stage portion configured to close an opening in the LAA when the second stage portion is in the second state. the first stage portion is configured to contract the opening of the LAA when the second stage portion is in the second state, the second stage portion is configured to fold one or more tissue portions surrounding or adjacent to the opening of the LAA when the second stage portion is in the second state, the second stage portion is configured to twist one or more tissue portions surrounding the opening of the LAA when the second stage portion is in the second state to contract or close the opening of the LAA, the second stage portion comprises a means for contracting or closing the opening of the LAA, the second stage portion comprises a hinge mechanism for contracting or closing the opening of the LAA and further comprises at least one of a passive actuation mechanism and an active actuation mechanism for actuating the hinge mechanism, and / or at least one of the first stage portion and the second stage portion is self-expanding.

[0038] Additional configurations of a method of treatment are disclosed herein, the method including advancing a deployment device having an implant into a left atrial appendage, moving at least a portion of the outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant against an inner wall surface of the left atrial appendage, rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage, and preventing the implant from rotating back to the first rotational position. In any configuration, the method may include moving at least a portion of the outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant against an inner wall surface of the left atrial appendage and / or moving the implant from a first state to a second state without changing a shape or size of the implant, wherein at least a portion of the implant is radially expanded when the implant is in the second state compared to when the implant is in the first state.

[0039] Additional configurations of devices and systems for closing the LAA are disclosed herein, which may include a clamping device having a first member and a second member and configured to move between a closed position and an open position, a first guide device configured to be advanceable into the LAA, and a second guide device configured to be advanceable into the pericardial space around the outside of the LAA and configured to be moved such that an end of the second guide device is in approximate axial alignment with an end of the first guide device. In any of the configurations disclosed herein, at least one of the first and second members of the clamping device may be substantially rigid, the clamping device may have an opening sized to allow the clamping device to pass over the LAA when the clamping device is in the open position, and / or at least one of the first and second members of the clamping device may be configured to substantially flatten and close a portion of the LAA when the clamping device is moved to the closed position. In any of the additional configurations disclosed herein, the clamping device may include only the first and second members. In additional configurations, the clamping device may further include a third member and a fourth member connected to each other in an end-to-end configuration and defining an opening in the clamping device sized and configured to pass over the outer surface of the LAA. In any additional configuration disclosed herein, the device may further include a delivery catheter having an outer sheath and a guide lumen configured to receive and follow a second guide device. Additionally, the first member of the clamping device may be rigid and the second member of the clamping device may comprise a suture.

[0040] Additional configurations of methods for closing or occluding the LAA are disclosed herein. In any of the configurations disclosed herein, the method may include advancing a first guide device into the LAA, advancing a second guide device into the pericardial space outside the LAA, substantially aligning an end of the second guide device with an end of the first guide device, advancing a delivery catheter over the second guide device, advancing a clamping device having a first member and a second member from the delivery catheter, opening the clamping device from a closed position to an open position, advancing the clamping device on the outer surface of the LAA toward a neck portion of the LAA, and / or closing the clamping device from an open position to a closed position to substantially flatten and close the neck portion of the LAA.

[0041] Any configuration of the method of closing or occluding the LAA may include, in additional configurations, one or more of the following features, components, steps, and / or details in any combination with any of any other features, components, steps, and / or details disclosed herein, where moving the clamping device from the closed position to the open position includes advancing the clamping device over a distal end of the delivery catheter such that the clamping device can automatically move to the open position, the delivery catheter having a guide lumen, the guide lumen configured to receive and follow a second guide device, the delivery catheter having an outer sheath, and the clamping device. at least one of the first and second members of the delivery catheter is substantially rigid, at least one of the first and second members of the clamping device has a substantially flat contact surface, the contact surface being a surface configured to contact an outer surface of the LAA, the delivery catheter has an outer sheath, the clamping device comprises at least four substantially rigid members connected to each other in an end-to-end configuration and sized to pass over the outer surface of the LAA and configured to define an opening in the clamping device, and / or the clamping device comprises at least one rigid member and at least one flexible member interconnected with the at least one rigid member.

[0042] Additionally, any implant and / or device or system configuration disclosed herein may be adapted and / or used to treat any tissue condition in the body where obstruction, restriction, or closure is desired. For example, without limitation, some configurations of devices and systems for treating tissue conditions disclosed herein may include an implant comprising a contact member that may (but need not be) configured to move between a first state and a second state, and a fixation element, the contact member may be configured to move from the first state to the second state such that at least a portion of the contact member engages a wall portion of the tissue condition after the contact member is advanced into the tissue condition, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue condition in a first direction when the contact member rotates from the first rotational position to the second rotational position, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue condition in a second direction when the fixation element is in an operable state, the second direction being opposite the first direction. In any configuration, the tissue condition may be a cavity, a chamber, an opening, a passageway, a break in tissue, two adjacent or adjoining tissue surfaces, or otherwise.

[0043] Additionally, some configurations of devices and systems for treating tissue conditions disclosed herein may include an implant having a contact member that may (but need not) be configured to move between a first state and a second state, and a catheter configured to advance the contact member into the tissue condition when the contact member is in the first state and move the contact member from the first state to the second state such that an outer surface of the contact member engages at least one wall surface of the tissue condition after the contact member has advanced into or adjacent the tissue condition, the catheter configured to apply a torque to the contact member when rotating the contact member from the first rotational position to the second rotational position such that at least a portion of the catheter rotates until a predetermined torque level is reached such that the contact member can twist at least a portion of the tissue condition. In any configuration, the tissue condition may be a cavity, a chamber, an opening, a passageway, a break in tissue, two adjacent or adjoining tissue surfaces, or otherwise.

[0044] Additionally, some configurations of the devices and systems for treating tissue conditions disclosed herein may include a method of treating a tissue condition comprising advancing a deployment device having an implant into or adjacent to the tissue condition, where the implant may (but need not be) configured to move from a first state to a second state, and where at least a portion of the implant may expand radially when the implant is in the second state compared to when the implant is in the first state; moving the implant from the first state to the second state within the tissue condition to move at least a portion of an outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant against at least one wall of the tissue condition; rotating the implant from a first rotational position to a second rotational position to twist the tissue condition, and / or prevent the implant from rotating back to the first rotational position.

[0045] Additionally, any of the implants and / or device or system configurations disclosed herein may be adapted and / or used to treat any tissue condition in the body where occlusion, remodeling, restriction, or closure is desired. For example, without limitation, some configurations of devices and systems for treating tissue conditions disclosed herein may include an implant comprising a contact member configured to engage a wall portion of the tissue condition after the contact member is advanced into the tissue condition, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue condition in the first direction when the contact member is rotated from the first rotational position to the second rotational position, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue condition in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction. In any configuration, the tissue condition may be a cavity, a chamber, an opening, a passageway, a break in tissue, two adjacent or adjoining tissue surfaces, or otherwise.

[0046] Additionally, some configurations of devices and systems for treating tissue conditions disclosed herein may include an implant having a contact member and a catheter configured to advance the contact member into the tissue condition such that the contact member engages at least one wall surface of the tissue condition after the contact member has been advanced into or adjacent the tissue condition, the catheter configured to apply a torque to the contact member when rotating the contact member from a first rotational position to a second rotational position such that at least a portion of the catheter rotates until a predetermined torque level is reached such that the contact member can twist at least a portion of the tissue condition. In any configuration, the tissue condition may be a cavity, a chamber, an opening, a passageway, a break in tissue, two adjacent or adjoining tissue surfaces, or otherwise.

[0047] Additionally, some configurations of the devices and systems for treating tissue conditions disclosed herein may include a method of treating a tissue condition that includes advancing a deployment device having an implant into or adjacent to the tissue condition such that at least a portion of the implant engages a wall of the tissue condition; rotating the implant from a first rotational position to a second rotational position to twist the tissue condition; and / or preventing the implant from rotating back to the first rotational position.

[0048] Disclosed herein are configurations of devices for treating a left atrial appendage, which may include an implant having a contact member configured to engage an internal tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage when the contact member is engaged with the internal tissue surface of the left atrial appendage, and a fixation element configured to move between a first position where the fixation element is separated from the contact member and a second position where the fixation element is coupled with the contact member. In some configurations, the contact member may be configured to rotate in at least a first direction from the first position to the second position when a torque is applied to the contact member.

[0049] Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein; the contact member may be configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage upon engagement of the contact member with an internal tissue surface or the left atrial appendage and cause the size of the ostium of the left atrial appendage to decrease from the first size to the second size; the implant may be configured to prevent the ostium of the left atrial appendage from enlarging back to the first size; the device may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the fixation element's operative state; the device may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the fixation element's operative state; the fixation element may be configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage upon engagement of the contact member with an internal tissue surface or the left atrial appendage and cause the size of the ostium of the left atrial appendage to decrease from the first size to the second size; The implant may be configured to prevent rotation of tissue of the atrium and / or the left atrial appendage, the contact member may be configured to move between a first state and a second state, an outer dimension of the contact member may be larger in the second state than in the first state, the contact member may be biased to remain in the second state after deployment into the left atrial appendage, the contact member may be configured to have a substantially fixed, unchanging size and shape, the contact member may be self-expandable such that the contact member automatically expands from the first state to the second state when the restraint is removed from the implant without further intervention from the user, the contact member may be configured to automatically move from the first state to the second state when the restraint is removed from the contact member, the contact member may be configured to engage a wall portion of the left atrial appendage when the contact member is in the second state and advanced into the left atrial appendage, the contact member may have a plurality of tissue anchors on its outer surface, and / or a plurality of tissue anchors on or adjacent the outer surface of the contact member configured to engage an inner wall surface of the left atrial appendage after the contact member moves to the second state.

[0050] Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein, where the device may be configured to contract tissue of the left atrium and / or left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second position, and the fixation element may be configured to engage the contracted tissue around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction opposite the first direction, and in the operable position, the fixation element may be configured to at least prevent the contact member from rotating back to the first position, and the fixation element may be configured to contract tissue of the left atrium and / or left atrial appendage around an outer surface of the body portion of the implant to prevent rotation of the implant in a second direction opposite the first direction when the fixation element is implanted in a tissue surface surrounding an ostium of the left atrial appendage. the second direction is opposite to the first direction, the fixation element may be configured to expand from at least a first state to a second state, an outer dimension of the fixation element may be larger in the second state than in the first state, the fixation element may include a plurality of arms, the fixation element may have a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts, at least an end of each of the plurality of arms of the fixation element faces generally away from the contact member when the fixation element is in the first state and faces generally toward the contact member when the fixation element is in the second state, and includes a restraint, the restraint configured to be axially movable relative to at least a portion of the fixation element from a first position in which the plurality of arms of the fixation element are restrained by the restraint to a second position in which the plurality of arms of the fixation element are not restrained by the restraint.

[0051] Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein, including a restraint configured to be axially movable relative to at least a portion of the fixation element between a first position in which the arms of the fixation element are constrained by the restraint and a second position in which the arms of the fixation element are not constrained by the restraint, the second axial position may be closer to the first portion of the implant than the first axial position, the restraint may be axially movable relative to at least a portion of the fixation element from the second position in which the arms of the fixation element are not constrained by the restraint to the first position in which the arms of the fixation element are constrained by the restraint to facilitate repositioning and / or removal of the implant, including a threaded member configured to move the restraint from the first position to the second position upon rotation of the threaded member. and wherein the restraint may be rotatable relative to the threaded member such that the restraint is not rotated when the threaded member is rotated; the fixation element may have a helical shape and be configured to rotate about a body portion of the implant during an implantation procedure; only a portion of the fixation element extends into the left atrium after deployment of the device and all other portions of the device are within the left atrial appendage after deployment of the device; the fixation element is movable between a first state in which the fixation element is free to rotate relative to the contact member and a second state in which the fixation element may be locked in rotation relative to the contact member; One of the element and the contact member may have a recess, and the other of the fixation element and the contact member may have a protrusion configured to selectively engage the recess, the protrusion being spaced from the recess when the fixation element is in a first state and the protrusion engaging the recess when the fixation element is in a second state, further comprising a retaining element configured to selectively couple the fixation element to the contact member at any of a range of selectable distances when the fixation element is in the second position, the retaining element may have a threaded shaft configured to threadably engage the contact member, the threaded shaft being coupled to the fixation element,The retaining element may be adjustable to move the fixation element between at least a first position and a second position, and the fixation element may be closer to the contact member when the retaining element is in the second position compared to when the retaining element is in the first position, and the retaining element may have a threaded member, and rotation of the threaded member in a first direction moves the fixation element toward the contact member and rotation of the threaded member in a second direction moves the fixation element away from the contact member, and the retaining element may be configured to slide at least axially over the inner core component of the delivery catheter, and the second position may be at least one-quarter of a full rotation relative to the first position, and the second position may be at least one-quarter of a full rotation relative to the first position. the second position may be at least one-half of a full rotation relative to the first position, and the second position may be about one-quarter to one or more full rotations relative to the first position, and a catheter selectively coupled to the contact member and configured to apply a torque to the contact member to rotate the contact member from the first position until a predetermined threshold torque level is reached, the predetermined threshold torque level may be between about 0.25 in-oz of torque and about 10 in-oz of torque, and / or the predetermined threshold torque level may be between about 0.5 in-oz of torque and about 5 in-oz of torque, and / or no more than about 10% of the total length of the deployed device extends into the left atrium following deployment of the device.

[0052] Also disclosed herein are configurations for a method of treating a left atrial appendage, the method may include advancing a deployment device having an implant into the left atrium, moving at least a portion of an outer surface of a first portion of the implant and / or one or more tissue anchors on or adjacent to the outer surface of the first portion of the implant against an inner wall surface of the left atrial appendage, rotating the first portion of the implant from a first position to a second position to twist the left atrial appendage from the first position to the second position, and moving the second portion of the implant from a first state in which the second portion of the implant is free to rotate relative to the first portion of the implant to a second state in which the second portion of the implant may be locked in rotation relative to the first portion of the implant. Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein: when the second portion of the implant is in the first state, the second portion of the implant may be spaced from the first portion of the implant; when the second portion of the implant is in the second state, the second portion of the implant engages the first portion of the implant, including rotating the first portion of the implant until at least a portion of the left atrial appendage has contracted around the portion of the implant; rotating the first portion of the implant until an ostium of the left atrial appendage has contracted around the portion of the implant; the method may engage tissue contracted as a result of the rotation of the first portion of the implant with the second portion of the implant; and / or moving the second portion of the implant from the first state to the second state causes the second portion of the implant to inhibit rotation of the left atrial appendage towards the first position of the left atrial appendage.

[0053] Also disclosed herein are device configurations for treating a left atrial appendage, including an implant device that may include a first implant member configured to engage an internal tissue surface of a first portion of the left atrial appendage and a second implant member configured to engage an internal tissue surface of a second portion of the left atrial appendage spaced from the first portion of the left atrial appendage. In some configurations, the device may be configured to rotate the first implant member in a first direction. In some configurations, the device may be configured to rotate the second implant member in a second direction opposite the first direction.

[0054] Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configuration disclosed herein, further including a first core member coupled with the first implant member and configured to rotate the first implant member upon rotation of the first core member, the first implant member configured to rotate the first implant member after the first core member is withdrawn from the left atrial appendage; The implantable stent may be selectively releasably coupled to the first core member so that it may remain within the left atrial appendage, and may further include a second core member coupled to the second implant member and configured to rotate the second implant member upon rotation of the second core member, the second implant member may be selectively releasably coupled to the second core member so that the second implant member may remain within the left atrial appendage after the second core member is withdrawn, and / or may further include a fixation element configured to prevent the first implant member and / or the second implant member from operably rotating.

[0055] Disclosed herein are configurations of devices for treating the left atrial appendage, which may include an implant device that may include a first implant member configured to engage an internal tissue surface of a first portion of the left atrial appendage and a second implant member configured to engage an internal tissue surface of a second portion of the left atrial appendage spaced from the first portion of the left atrial appendage. In some configurations, the device may be configured to rotate the first implant member in a first direction. Additionally, in some configurations, the device may be configured to also rotate the second implant member in the first direction. Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configuration disclosed herein, further including a first core member coupled with the first implant member and configured to rotate the first implant member upon rotation of the first core member, the first implant member configured to rotate the first implant member after the first core member is withdrawn from the left atrial appendage; The implantable stent may be selectively releasably coupled to the first core member so that it may remain within the left atrial appendage, and may further include a second core member coupled to the second implant member and configured to rotate the second implant member upon rotation of the second core member, the second implant member may be selectively releasably coupled to the second core member so that the second implant member may remain within the left atrial appendage after the second core member is withdrawn, and / or may further include a fixation element configured to prevent the first implant member and / or the second implant member from operably rotating.

[0056] Disclosed herein are configurations of devices for treating a left atrial appendage that may include an implant that may include a contact member and a fixation element coupled or coupleable to the contact member, the fixation element including a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts. In some configurations, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position upon rotation of the contact member from a first rotational position to a second rotational position to twist at least a portion of the left atrial appendage in a first direction. Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configurations disclosed herein; the contact member may be configured to move from at least a first state to a second state such that at least a portion of the contact member radially expands to engage an interior wall portion of the left atrial appendage; the plurality of interconnects provide connection points between adjacent struts of the plurality of struts; the plurality of struts may have a plurality of pairs of struts, each pair of struts may have two struts that are interconnected at a distal end of the struts; the plurality of struts may have a first strut, a second strut, and a third strut, and the second strut may be positioned between the first strut and the third strut; the second strut may be interconnected with the first strut at a distal end of the first and second struts, and the second strut may be interconnected with the third strut at an intermediate portion of the second and third struts; the implant may further have a retention element coupled with the fixation element, the retention element configured to move the fixation element axially toward or away from the contact member or to hold the fixation element in a stationary position relative to the contact member; the fixation element may be configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixation element is in an operative state, the second direction being opposite to the first direction; the contact member may be self-expandable such that at least a portion of the contact member automatically expands from the first state to the second state when the restraint is removed from the contact member; and the implant may be substantially collapsed when the implant is in the first state;The implant may be expanded when in the second state such that the size of the implant may be larger when the implant is in the second state than when the implant is in the first state, the contact member may be biased to remain in the second state after deployment into the left atrial appendage, the contact member may be configured to be rotated in a clockwise or counterclockwise direction, and the device may be configured to cause tissue of the left atrium and / or left atrial appendage to contract around an outer surface of the body portion of the implant as the contact member is rotated to the second rotational position, and the fixation element engages the contracted tissue around the outer surface of the body portion of the implant. and configured to prevent rotation of the implant in a second direction, the fixation element may have a plurality of tissue anchors configured to engage an interior wall of the heart adjacent the left atrial appendage, the fixation element may have a helical shape and may be configured to rotate about a body portion of the implant during the implantation procedure, the implant may be configured to rotate in a first direction from a first rotational position to a second rotational position, and / or the implant may be configured to prevent rotation of the implant in a second direction after the implant is fully deployed, the second direction being opposite to the first direction.

[0057] Any configuration of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional configurations, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other configuration disclosed herein, wherein the contact member may have a plurality of tissue anchors on an outer surface thereof, the plurality of tissue anchors on the outer surface of the contact member configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second condition, the tissue anchors of the contact member having a proximal facing surface inclined at an angle of 5° toward the proximal end of the contact member, the tissue anchors of the contact member having a proximal facing surface inclined at an angle of 2° to 10° toward the proximal end of the contact member. and the implant may have a fixation element configured to engage a tissue portion of the heart adjacent the left atrial appendage, the second rotational position may be at least one-quarter of a full rotation relative to the first rotational position, the second rotational position may be at least one-half of a full rotation relative to the first rotational position, the second rotational position may be about one-quarter to one or more full rotations relative to the first rotational position, and a catheter selectively coupled to the contact member and configured to apply a torque to the contact member to rotate the contact member from the first rotational position until a predetermined threshold torque level is reached, the predetermined threshold torque level may be between about 0.25 in-oz of torque and about 10 in-oz of torque, the predetermined threshold torque level may be between about 0.The torque may be between 5 in-oz and approximately 5 in-oz, the device may include a retaining element configured to urge the fixation element towards a tissue wall of the LAA, the device may include a retaining element configured to urge the fixation element towards the contact member, the retaining element configured to couple the fixation element with the contact member, the retaining element may have a threaded shaft, the device may be configured such that rotation of the retaining element in a first direction moves the fixation element towards the contact member, the contact member may be configured to rotate in at least the first direction from a first rotational position to a second rotational position when torque is applied to the contact member, the device may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the fixation element's operative state, the device may be configured such that the fixation element can be removed from the left atrial appendage after the fixation element is deployed to the fixation element's operative state, ... position, wherein only a portion of the fixation element extends into the left atrium after deployment of the device and all other portions of the device are inside the left atrial appendage after deployment of the device, and wherein only approximately 10% or less of the total length of the deployed device extends into the left atrium after deployment of the device, the device may be configured for use with a surgical robotic device or system, the contact member and the fixation element are integrally and / or monolithically formed, and / or the device may be configured to contract the left atrium and / or left atrial appendage tissue about an outer surface of the body portion of the implant when the contact member is rotated to the second rotational position, and the fixation element may be configured to compress the contracted tissue about the outer surface of the body portion of the implant between a distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction.

[0058] Some configurations encompassed herein include a surgical robotic device that may include one or more robotic arms and a device of any of the configurations disclosed herein, where the device may be configured for use with the surgical robotic device.

[0059] Some configurations of the methods of treating the left atrial appendage disclosed herein may include rotating the left atrial appendage and fixing the left atrial appendage in a rotated position. Any configuration of the methods of treating, closing or occluding the LAA may, in additional configurations, include one or more of the following features, components, steps and / or details, in any combination with any of the other features, components, steps and / or details disclosed herein, where rotating the left atrial appendage includes rotating the left atrial appendage to deform or occlude the left atrial appendage, fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a rotated position where the volume of the left atrial appendage is reduced, fixing the left atrial appendage in a rotated position where the volume of the left atrial appendage is reduced, and fixing the left atrial appendage in a rotated position where the volume of the left atrial appendage is reduced. Fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a rotated position in which the left atrial appendage is deformed or occluded, rotating the left atrial appendage includes bending or twisting the left atrial appendage, fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a position in which blood communication between the left atrial appendage and the left atrium is prevented, eliminated or substantially eliminated, rotating the left atrial appendage includes engaging an interior wall portion of the left atrial appendage and / or an ostium of the left atrial appendage with a contact member and rotating the contact member, the contact member being adapted to rotate the delivery catheter. a contact member that is self-expanding, balloon-expandable, mechanically expandable, and / or a balloon; rotating the left atrial appendage includes engaging an interior wall portion of the left atrial appendage with one or more tissue anchors, one or more tissue grippers, and / or one or more other tissue retention mechanisms; rotating the left atrial appendage includes advancing the device into the left atrial appendage and rotating at least one component of the device to rotate the left atrial appendage; rotating at least one component of the device includes rotating at least one component of the device from an initial position by approximately 90° to approximately 360° in either direction; rotating the left atrial appendage includes rotating a portion of the left atrial appendage about an axis to twist the left atrial appendage; rotating a portion of the left atrial appendage about one or more axes from an initial position includes rotating a portion of the left atrial appendage from an initial position by approximately 90° to approximately 360° in either direction from an initial position; rotating a portion of the left atrial appendage includes rotating a portion of the left atrial appendage aboutor completely closed; rotating a portion of the left atrial appendage includes rotating the left atrial appendage until blood communication between the left atrial appendage and the left atrium is prevented; rotating a portion of the left atrial appendage includes rotating the left atrial appendage until communication of blood or other matter between the left atrial appendage and the left atrium is eliminated or substantially eliminated; securing the left atrial appendage in the rotated position includes engaging the twisted heart tissue, and engaging the twisted heart tissue includes engaging the tissue wall with an anchor or gripping element; securing the left atrial appendage in the rotated position includes securing the heart tissue outside the occluded portion of the left atrial appendage with an anchor element; securing the left atrial appendage in the rotated position includes securing the heart tissue outside the occluded portion of the left atrial appendage with an anchor element; and / or the anchor element includes a plurality of tissue anchors on at least one surface thereof configured to engage an interior heart wall outside the left atrial appendage.

[0060] Some configurations of the methods for reducing the left atrial appendage ostium disclosed herein may include twisting heart tissue to constrict the left atrial appendage ostium and fixing the deformed or constricted tissue as a result of twisting the heart tissue. Any configuration of the method of treating, closing or occluding the LAA may include one or more of the following features, components, steps and / or details in any combination with any of any other features, components, steps and / or details disclosed herein, in additional configurations: securing the deformed or contracted tissue includes advancing a fixation element into the tissue that has been deformed or contracted as a result of twisting the cardiac tissue, the fixation element comprising a tissue anchor or tissue gripper; securing the tissue that has been deformed or contracted as a result of twisting the cardiac tissue includes advancing a fixation element into the deformed or contracted tissue to compress the deformed or contracted tissue; and / or securing the tissue that has been deformed or contracted as a result of twisting the cardiac tissue includes advancing one or more sutures or one or more staples into the tissue that has been deformed or contracted as a result of twisting the cardiac tissue.

[0061] Some configurations of the methods of treating the left atrial appendage disclosed herein may include twisting the left atrial appendage such that the volume of the left atrial appendage is reduced and fixing the left atrial appendage in the reduced volume configuration. In some configurations, fixing the left atrial appendage in the reduced volume configuration may include occluding the left atrial appendage with an implant having a size smaller than the size of the interior of the left atrial appendage. In some configurations, the methods of treating the left atrial appendage may include releasing the fixation of the left atrial appendage and untwisting it. [Brief description of the drawings]

[0062] [Figure 1A] 1 shows a pathway through the venous system via the femoral vein and a transseptal puncture into the left atrium that may be used to access the left atrial appendage (LAA). [Figure 1B] A cross-sectional view of the left atrium is shown, showing a guidewire being advanced towards the LAA. [Figure 1C] Shown is a surgeon's left-sided view of the left atrium. [Figure 1D] Shows the surgeon's left-side view of the left atrium, showing the delivery device being advanced towards the LAA. [Figure 1E] 1 shows an example of a device being advanced through an access point in the internal jugular vein toward the patient's heart. [Figure 2A] 1 illustrates a configuration of a treatment device having an implant device advanced through a catheter into the LAA, where the implant device is in a collapsed state and constrained within the outer tube of the catheter. [Figure 2B] 2B illustrates the configuration of the treatment device of FIG. 2A, showing the contact members expanded within the LAA. [Figure 2C] FIG. 2A illustrates a configuration of the treatment device in which the contact members rotate to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device. [Figure 2D] 2B illustrates the treatment device configuration of FIG. 2A with the fixation element of the implant device configuration advanced towards the contact member of the implant device. [Figure 2E] 2B shows the fixation elements of the treatment device of FIG. 2A engaged with the patient's tissue that has contracted as a result of kinking of the LAA. [Figure 2F] 2B shows the implant device of FIG. 2A disengaged and removed from the catheter. [Figure 2G] 2B shows the configuration of the treatment device of FIG. 2A advanced into the left atrium (LA), with the implant device in a collapsed state and constrained within the outer tube of the catheter. [Figure 2H] 2B illustrates the configuration of the treatment device of FIG. 2A, showing the contact members expanded within the LAA prior to advancement into the LAA. [Figure 2I] 2B illustrates the configuration of the treatment device of FIG. 2A, showing the contact member advanced into the LAA after the contact member has been expanded. [Figure 2J] FIG. 2A illustrates a configuration of the treatment device in which the contact members rotate to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device. [Figure 2K] 1 illustrates another configuration of a treatment device having an implant device advanced through a catheter into the LAA, where the implant device is in a collapsed state and constrained within the outer tube of the catheter. [Figure 2L] 2K shows the configuration of the implant device engaged with a patient's tissue that has contracted as a result of torsion of the LAA. [Figure 3A] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 3B] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 3C] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4A] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4B] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4C]1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4D] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4E] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4F] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4G] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4H] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4I] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 4J] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Diagram 5] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 6] 1 illustrates another configuration of a treatment device for closing or occluding the LAA. [Figure 7] 1 shows an experimental setup to demonstrate the construction of a treatment device for closing or occluding the LAA. [Figure 8A] 1 shows the configuration of a system for closing or occluding the LAA, including a delivery system and an implant. [Figure 8B] 8C shows some of the components of a system for closing or occluding the LAA shown in FIG. 8B. [Figure 9A] 1 shows a first isometric view of a portion of a delivery catheter configuration that may be used with any of the implant configurations disclosed herein. [Figure 9B] FIG. 9B shows a second isometric view of the delivery catheter configuration shown in FIG. 9A. [Figure 9C] FIG. 9B shows a first side view of the delivery catheter configuration shown in FIG. 9A. [Figure 9D]FIG. 9B shows a second side view of the delivery catheter configuration shown in FIG. 9A. [Figure 9E] FIG. 9B shows a plan view of the delivery catheter configuration shown in FIG. 9A. [Figure 9F] FIG. 9B shows a bottom view of the delivery catheter configuration shown in FIG. 9A. [Figure 9G] FIG. 9B shows a front view of the delivery catheter configuration shown in FIG. 9A. [Figure 9H] FIG. 9B shows a rear view of the delivery catheter configuration shown in FIG. 9A. [Figure 10A] FIG. 10B shows a side view of the configuration of the distal end of the implant and delivery catheter shown in FIG. 10A. [Figure 10B] FIG. 10B shows a plan view of the configuration of the distal end of the implant and delivery catheter shown in FIG. 10A. [Figure 10C] FIG. 10B shows an isometric view of the configuration of the distal end of the implant and delivery catheter shown in FIG. 10A. [Figure 11A] 1 shows a side view of the configuration of the distal end of the outer sheath, with an implant positioned within the outer sheath of a delivery catheter. [Figure 11B] FIG. 11B illustrates a cross-sectional view of the configuration of the distal end of the outer sheath shown in FIG. 11A, with an implant positioned within the outer sheath of a delivery catheter. [Figure 11C] 11B illustrates a side view of the configuration of the distal end of the outer sheath shown in FIG. 11A, with the implant positioned partially beyond the distal end of the outer sheath such that the fixation element is positioned within the outer sheath and the contact member is positioned beyond the distal end of the outer sheath. [Figure 11D] 11B illustrates a cross-sectional view of the configuration of the distal end of the outer sheath shown in FIG. 11A, with the implant positioned partially beyond the distal end of the outer sheath such that the fixation element is positioned within the outer sheath and the contact member is positioned beyond the distal end of the outer sheath. [Figure 11E] 11B illustrates a side view of the configuration of the distal end of the outer sheath shown in FIG. 11A with the implant positioned beyond the distal end of the outer sheath and the contact members and fixation elements in an expanded but spaced apart state. [Figure 11F] 11B illustrates a side view of the configuration of the distal end of the outer sheath shown in FIG. 11A with the implant positioned beyond the distal end of the outer sheath and the contact members and fixation elements in an expanded state and positioned adjacent to one another. [Figure 12A] 12B shows a side view of the delivery catheter configuration shown in FIG. 12A, as well as partial cross-sectional views of the distal end of the outer sheath and the implant at various stages of deployment of the implant. [Figure 12B] 12B shows a side view of the delivery catheter configuration shown in FIG. 12A, as well as partial cross-sectional views of the distal end of the outer sheath and the implant at various stages of deployment of the implant. [Figure 12C] 12B shows a side view of the delivery catheter configuration shown in FIG. 12A, as well as partial cross-sectional views of the distal end of the outer sheath and the implant at various stages of deployment of the implant. [Figure 12D] 12B shows a side view of the delivery catheter configuration shown in FIG. 12A, as well as partial cross-sectional views of the distal end of the outer sheath and the implant at various stages of deployment of the implant. [Figure 13A] 13B shows a side view of the delivery system configuration shown in FIG. 13A, as well as a side view of the outer sheath and implant at various stages of implant deployment. [Figure 13B] 13B shows a side view of the delivery system configuration shown in FIG. 13A, as well as a side view of the outer sheath and implant at various stages of implant deployment. [Figure 13C] 13B shows a side view of the delivery system configuration shown in FIG. 13A, as well as a side view of the outer sheath and implant at various stages of implant deployment. [Figure 13D] 13B shows a side view of the delivery system configuration shown in FIG. 13A, as well as a side view of the outer sheath and implant at various stages of implant deployment. [Figure 13E] 13B shows a side view of the delivery system configuration shown in FIG. 13A, as well as a side view of the outer sheath and implant at various stages of implant deployment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] Described herein are novel devices, systems, and methods for closing or occluding the left atrial appendage (LAA). Some configurations of the novel devices, systems, and methods for closing or occluding the LAA disclosed herein include percutaneous transcatheter devices aimed at reducing the risk of thromboembolism from the LAA in patients with non-valvular atrial fibrillation (NVAF), who are at increased risk of stroke and systemic embolism and for whom anticoagulant therapy is recommended.

[0064] Some configurations include a method that includes advancing a delivery system into the LAA, advancing and deploying an expandable element (which in some configurations may be covered with barbs, textures, or other tissue-engaging features or may be smooth) that may have a generally spherical or spherical shape within the left atrial appendage, allowing the expandable element to distally and / or radially engage an inner wall surface of the LAA, and applying a rotation to an inner catheter member connected to the expandable element to twist the LAA and close and / or occlude the LAA at or near the ostium. By occluding the LAA, some configurations disclosed herein can effectively eliminate, or significantly or nearly completely eliminate, communication of blood or other material between the left atrium and the LAA. Any of the methods of deployment disclosed herein may also include deployment of a fixation element (also referred to herein as a locking element or anchor element) that is configured to inhibit or prevent unwinding of the expandable element against the LAA and LA ostium tissue, thereby inhibiting or preventing untwisting of the LAA.

[0065] The devices, systems, and methods disclosed herein may be used or adapted for other applications in or on the body of any human, animal, reptile, or other organism, including, but not limited to, closing openings in other tissues other than the LAA, occluding or closing openings, passages, and / or chambers in the heart or other organs, occluding or closing holes or other slits or openings in blood vessels and passages, and / or treating other conditions.

[0066] A clinical advantage of some configurations is that the resulting implant does not have direct blood contact with the blood or flow of the left atrium, except for possible portions of the fixation mechanism. The fixation elements of any configuration can be configured to limit the exposure of the fixation elements to the blood in the left atrium (i.e., limit the amount of fixation elements that protrude into the left atrium). In some embodiments, the entire implant can be surrounded by tissue of the LAA tissue such that no portion of the implant is exposed to the blood flow in the left atrium, or only a minimal portion (e.g., less than 10% of the surface area, or less than 40% of the surface area) is exposed. This can provide a clinical benefit to the patient as post-drug regimens are required. Any of the devices used in any of the methods described herein can be advanced under any of a variety of visualization techniques, such as fluoroscopic visualization, ultrasound, etc.

[0067] For any of the configurations disclosed herein, access to the LAA can be obtained by any number of suitable means or access points. For example, but not by way of limitation, access to the LAA for some configurations can be obtained by entering through the venous system via the femoral vein and transseptal puncture into the left atrium. Imaging can use both fluoroscopy and echo (TEE, ICE, or transthoracic) to image the size, location, and position of the LAA for insertion of a prosthesis or occlusion device. Figures 1A-1D show some example pathways from the access site to the LAA.

[0068] Access to the left atrial appendage (LAA) for any of the configurations of the devices, systems, and methods disclosed herein can be gained by entering through the venous system via a transseptal puncture into the femoral vein and the left atrium. Imaging of the size, location, and position of the LAA for occlusion can be done using both fluoroscopy and echo (TEE, ICE, or transthoracic). Figures 1A-1D show this example of a path from the access site to the LAA. Other access sites for any of the configurations of the devices, systems, and methods disclosed herein can include access through the internal jugular (IJ) vein, as shown in Figure 1E.

[0069] Additionally, any of the device, system, and method configurations disclosed herein may be delivered to the LA / LAA or may include delivery to the LA / LAA via a transfemoral artery route. In some configurations, the transfemoral artery route may include advancing a delivery device through the femoral artery, up the aorta, down the aortic valve, up the mitral valve, and into the LAA. Similarly, any of the device, system, and method configurations disclosed herein may be delivered to the LA / LAA or may include delivery to the LA / LAA via a transradial artery route, which may include, for example, but not limited to, access through the radial artery at the wrist. This access route is also referred to as transradial access, transradial approach, or transradial angioplasty.

[0070] Implants of any configuration disclosed herein may have an expandable atraumatic shape with tissue gripping features located on the outer edge of the shape coupled to a locking and / or ratcheting mechanism that can hold the implant in an initial or final closed position. Implants of any configuration disclosed herein may be configured to grip the internal tissue of the LAA with radial forces as well. In some configurations, a vacuum or suction may be provided by the catheter or any component thereof to draw tissue portions of the LAA or atrium toward the implant. Implants of any configuration disclosed herein may have an atraumatic shape that may be spherical, dome-shaped, or may comprise a coil of wire in a disk shape, may have an expanded cut pattern in a stent shape, or any other that may have rounded edges. In some configurations, barbs (which may be tissue anchors) on the outer edge or outer surface of the implant may include metal hooks, plastic cleats, rough texture of some material or surface features, coatings or activated adhesives that grip the inner surface of the LAA. Additionally, in any of the configurations disclosed herein, tissue anchors may be positioned at or adjacent the ends of the implant to engage the ends of the LAA. In any configuration, the barbs may be directional to allow for tissue engagement in one rotational direction and disengagement in the opposite rotational direction, allowing for repositioning, resizing, or removal from the LAA.

[0071] For any configuration disclosed herein, the rotation used to twist and close or occlude (completely or substantially) the LAA can be as little as a quarter turn (i.e., a rotary motion), a half turn, a full turn, or even multiple turns for deeper or longer LAA. The fixation feature or element (also referred to herein as an anchor element) in any configuration disclosed herein can have a single arm or multiple arms that can be connected to an implant body that is positioned and rotated within a closed or substantially closed LAA. The fixation mechanism or element can also be configured to engage tissue adjacent the ostium of the LAA. In any configuration, the fixation element can have multiple arms or members, can have an annular ring, can have a disk, or any other suitable shape of surface anchor configured to couple untwisted tissue to a twisted implant. In some configurations, the fixation element can also have a small diameter ring that can be configured to secure or engage tissue that contacts the central hub of the implant (adjacent the ostium of the LAA), or can have a clip that folds the implant and clips to the side of the wall of the left atrium (LA).

[0072] In some configurations disclosed herein, the device may be configured to restrict the opening of the LAA (including the blocking effect from the device) by reducing the cross-sectional area of ​​the LAA ostium by at least 95%, or at least 90%, or at least about 80% to about 100% compared to the cross-sectional area of ​​the LAA ostium before the device is implanted. Furthermore, in some configurations, the method may include rotating the implant from a first rotational position to a second rotational position to twist the LAA until the ostium of the LAA is at least 95% blocked and / or restricted, or at least 90% blocked and / or restricted, or at least 80% blocked and / or restricted, or about 70% to about 100% blocked and / or restricted. Additionally, any configuration disclosed herein may include implanting two or more implants of any of the implant configurations disclosed herein into the LAA. For example, without limitation, any of the implant configurations disclosed herein may be configured to be deployed within or implanted in the LAA to improve occlusion of an implant already implanted in the LAA, such as any implant that falls within any of the aforementioned ranges short of complete occlusion. In some configurations, one or more additional implants or devices may be implanted adjacent to, on, around, or otherwise with the existing implant to improve the level of occlusion of the LAA.

[0073] Alternatively, in any configuration disclosed herein, the fixation element may be configured to simply compress contracted left atrial and / or left atrial appendage tissue around the outer surface of the body portion of the implant between the distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction, i.e., not to penetrate such tissue after the contact member is rotated to the second rotational position. For example, without limitation, in any configuration disclosed herein, the fixation element may have a smooth, non-protruding, or non-penetrating body portion, such that the fixation element does not have a tissue-penetrating feature thereon that extends toward the tissue surface. In other configurations, the arms (or at least the portion of the arms that extends axially when the fixation element is in the second state) or other tissue-penetrating portions of the fixation element may be shorter, such as from about 1 mm to about 5 mm in length, or from about 1 mm to about 3 mm in length, or from about 1 mm to about 2 mm in length, or any value or range of values ​​between any of the aforementioned ranges.

[0074] 1A and 1B show a cross-sectional view of the left atrium and show a guidewire G advancing from a catheter C towards the left atrial appendage LAA. Figure 2A shows a configuration of a treatment device 100 (also referred to herein as an occlusion device) for occluding or closing the ostium of the LAA.

[0075] In any configuration disclosed herein, rotating the contact member, implant device, and / or left atrial appendage may include rotating the contact member, implant device, and / or left atrial appendage about a longitudinal axis of the contact member and / or implant device. In some configurations, the axis of rotation may be an axis extending through the ostium of the LAA toward the inner wall of the LAA, or is an axis defined by an insertion path of the implant into the LAA. In some configurations, the insertion path may be through the ostium of the LAA to the distal wall of the LAA. In some configurations, the axis of rotation may be an axis extending through the ostium of the LAA toward the inner wall of the LAA, and the LAA and / or implant rotate about the axis. In some configurations, the axis of rotation may be an axis extending through the ostium of the LAA toward the inner wall of the LAA, and the LAA and / or implant rotate about the axis to twist the LAA.

[0076] In any configuration disclosed herein, the treatment device (such as that of treatment device 100) may be configured to rotate and twist the LAA to contract a neck or portion of the LAA adjacent the opening of the LAA and substantially or completely close around an outer surface of a portion of the implant device, thereby occluding the opening of the LAA. In any configuration of the treatment device, such as that of treatment device 100, the system may include an implant device 102 having a contact member 104 (also referred to as a contact element, a first portion of the implant, or an expandable implant member in any configuration disclosed herein), a fixation member or fixation element 110 (also referred to as a second portion of the implant in any configuration herein), and a retention element 108 (also referred to as a retention member). The implant device 102 may be configured to be advanced through a catheter 112 into the LAA. The implant device 102 configuration shown in FIG. 2A is shown in a folded state and constrained within an outer sleeve 114 of the catheter 112. As shown, the implant device 102 may be advanced distally out of the catheter 112 beyond the distal end 114a of the outer sleeve 114 by advancing a portion or member of the catheter, such as, but not limited to, the core member 113 of the catheter 112, so that the contact member 104 of the implant device 102 may be advanced into and / or deployed within the LAA.

[0077] Alternatively, the catheter 112 with the implant device 102 therein may be advanced to a desired location within the LAA, and the outer sleeve 114 of the catheter 112 may be backed off or retracted to expose and / or unconstrain the contact members 104 of the implant device 102 while holding the implant device 102 in a stationary axial position by maintaining the core member 113 of the catheter 112 in a stationary axial position. In any configuration disclosed herein, the contact members 104 may be radially self-expanding such that when the constraint is removed from the contact members 104, the contact members 104 may automatically expand against the inner surface or wall of the LAA. In other configurations, the contact members 104 may be mechanically expandable, such as by a balloon expander, to expand against the inner surface or wall of the LAA. FIG. 2B shows the contact members 104 after expansion against the inner wall of the LAA distal to the ostium or opening O of the LAA.

[0078] Alternatively, in any of the configurations disclosed herein, the contact member may be configured to remain in a first state within the catheter during and / or after the treatment procedure. For example, without limitation, in any of the configurations disclosed herein, the contact member may be configured to be deployed from the catheter and advanced into contact with a tissue surface of the inner wall of the LAA, engage the tissue surface of the inner wall of the LAA, and twist the LAA when torque and / or rotation is applied to the contact member, without any change in state of the contact member. Alternatively, in any of the configurations disclosed herein, the contact member may be advanced into the pericardial space around the outside of the LAA, engage the outer surface of the LAA, and twist the LAA when torque and / or rotation is applied to the contact member.

[0079] 2B, the contact member 104 may have multiple arms or struts 116, each configured to self-expand radially when a constraint is removed from the outer surface of the contact member 104. For example, without limitation, any of the configurations of the contact members disclosed herein may have six struts 116, or between six and ten struts, or between less than six and more than ten struts.

[0080] Additionally, in any configuration, the contact members 104 may have a number of teeth, cleats, barbs, nubs, textures, studs, anchors, or other tissue engagement features 118 configured to penetrate tissue within the LAA when the contact members 104 are expanded against tissue of the LAA and / or when the contact members 104 are rotated or twisted within the LAA, or other similar features configured to penetrate or engage tissue of the LAA. It should be noted that the teeth, cleats, barbs, nubs, textures, studs, anchors, and other tissue engagement features, or features configured to grip or engage tissue when a torque is applied to the expanded contact members, are collectively referred to herein as tissue anchors, and use of this term is meant to describe and include any of the aforementioned features individually and / or any combination of these features.

[0081] The tissue anchors 118 may be integrally formed with the posts, formed on the posts, added to the posts, or otherwise coupled to or supported by the posts. The tissue anchors 118 may face circumferentially (or radially, as shown) to penetrate or engage tissue, at an angle perpendicular to the tissue surface of the LAA, at an angle relative to a line that is tangent to the outer surface of the contact member 104, or otherwise. In some configurations, each strut 116 may support multiple tapered tissue anchors that face circumferentially, as shown in FIG. 2B. All of the tissue anchors may face in a similar orientation relative to each of the struts, such as circumferentially relative to each strut. In the configuration shown, each strut 104 has five tissue anchors 118. In this configuration, when the contact member 104 is rotated in a first direction (indicated by arrow A1 in FIG. 2C, which may be a clockwise or counterclockwise direction), one or more or all of the struts 116 and one or more or all of the tissue anchors 118 engage tissue of the LAA and rotate the LAA in a first direction. The LAA may be twisted or rotated in a direction A1 from the first rotational position to the second rotational position. Twisting or rotating the LAA in a first direction from a first rotational position to a second rotational position causes the opening or ostium O of the LAA to contract in a radial direction (represented or identified by arrow A2 in FIG. 2C ) to move or contract the opening O of the LAA around the outer surface of the proximal portion 104a of the contact member 104. The surgeon may twist or rotate the contact member 104 by twisting or rotating the core member 113 of the catheter 112. The tightening or contraction of the opening O of the LAA around the outer surface of the proximal portion 104a of the contact member 104 or other portion of the implant device may result in an internal obstruction, or substantial obstruction, or substantial closure of the LAA from the remaining chambers in the heart, thereby substantially reducing the health risks associated with an open LAA.

[0082] In some configurations, such as the configuration shown, the fixation element 110 can be maintained in the folded or first state, such as by being constrained by an outer sleeve 114 of the catheter 112 while the contact members 104 are deployed and rotated to prevent the fixation element 110 from contacting and potentially lacerating or otherwise damaging tissue within the heart. An intermediate sleeve or tube 115 can be coupled to the fixation element 110 and used to manipulate and control the position and / or orientation of the fixation element 110, such as holding the proximal end 110a of the fixation element in a fixed axial position while a distal force is applied to the contact members 104 to maintain the retention element in the first expanded state. In any of the implant device configurations disclosed herein, the fixation element (such as, for example, but not limited to, fixation element 110) may be fixed, indexed, or otherwise rotationally fixed to a contact member (such as, for example, but not limited to, contact member 104) such that the fixation element cannot rotate relative to the contact member and the contact member cannot rotate relative to the fixation element. In this configuration, the fixation element can prevent, or substantially prevent, or inhibit the contact member and the LAA from rotating back toward the first rotational position.

[0083] 2D, with the contact member 104 rotated to and maintained in a second rotational position such that the opening O of the LAA remains constricted around the proximal portion 104a of the contact member 104 or other portion of the implant device and the LAA is generally occluded from the remainder of the heart chamber, the catheter tube member 115 may then be advanced distally (represented by arrow A3 shown in FIG. 2D) or the outer sleeve 114 may be retracted proximally such that the fixation element 110 is exposed and allowed to self-expand from the first collapsed state (shown in FIG. 2C) to a second expanded or open state (shown in FIG. 2D). In the second state, the multiple struts or members 120 of the fixation element 110 may expand in a generally radial direction to open to a larger overall diameter or profile. In addition, each of the one or more members 120 of the fixation element 110 may have an end 120a that extends generally in a distal axial direction (but may be angled slightly inward) so that as the fixation element 110 advances axially, the distal portion 120a of each of the one or more members 120 may penetrate and / or engage a tissue portion of the heart, as shown in FIG. 2E. The tissue portion that the one or more members 120 may penetrate or engage may include a portion of tissue that includes the left atrium and / or a portion of tissue that includes the LAA. As described above, the contact member 104 may be held in a generally stationary axial position using the core member 113 while the fixation element 110 is advanced distally toward the contact member 104. The retention element 108 may then be released to maintain the fixation element 110 in a second rotational position in which the fixation element 110 is engaged with the tissue of the heart, as shown in FIG. 2E. In some configurations, the fixation element may be axially biased toward the smaller size with a spring member or the like. For example, the retention element 108 may be formed by laser cutting an opening in a cylindrical tube, such as a hypotube, made of a resilient material, such as Nitinol. Then, referring to FIG. 2F, the implant device 102 may be disengaged from the catheter 112, and the catheter 112 may be retracted and removed from the patient's body.2F, with the fixation element 110 engaged with the patient's tissue, the LAA can be prevented from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fix and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0084] Thereafter, with reference to Figure 2F, the implant device 102 may be disengaged from the catheter 112, which may be retracted and removed from the patient's body. With the fixation element 110 engaged with the patient's tissue, as shown in Figure 2F, the LAA is prevented, or at least inhibited or biased, from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 may fix and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0085] It should be noted that in any configuration of the methods and devices disclosed herein, including but not limited to any of the methods of treating the LAA, the contact member may be partially or fully expanded within the left atrium (LA) before being advanced into the LAA. For example, and without limitation, FIG. 2G illustrates a configuration of the treatment device 100 of FIG. 2A advanced into the left atrium (LA), with the implant device 102 in a collapsed state and constrained within an outer tube of a catheter. FIG. 2H illustrates the contact member 104 partially or fully expanded (or moved to a second state partially or fully) within the LA before being advanced into the LAA. As illustrated in FIG. 2I, the contact member 104 and other components of the treatment device 100 may be advanced into the LAA when the contact member is in an expanded state, i.e., a second state, or when the contact member is partially expanded or between a first state and a second state. As shown in FIG. 2J, the contact member may be rotated to twist the LAA and contract the neck or opening of the LAA around a portion of the implant device, as described above. Other steps to complete the treatment may be as described above and in other methods disclosed herein. As described above, it is noted that any of the treatment device configurations disclosed herein may be configured such that the contact member may be partially or fully expanded within the LA before the contact member is advanced into the LAA. Similarly, in any of the method configurations disclosed herein (such as, but not limited to, configurations for treating and / or occluding the LAA), the contact member may be partially or fully expanded within the LA before the contact member is advanced into the LAA. In certain configurations, the contact member is not further expanded once positioned within the LAA, and in certain configurations, the contact member may be further expanded or contracted once positioned within the LAA. In certain configurations, the contact member may be contracted within the LA prior to entering the LAA and then may remain in a contracted position within the LAA or may be further expanded or contracted once positioned within the LAA.

[0086] As described above, the contact members can rotate and twist the LAA to cause the neck of the LAA adjacent the opening of the LAA or a portion of the LAA to contract and substantially or completely close around an outer surface of a portion of the implant device, thereby occluding the opening of the LAA. In the illustrated configuration, the contact members 104 can be rotated about their longitudinal axis to cause twisting of the LAA. In certain configurations, the longitudinal axis about which the contact members are rotated can correspond to or be closely aligned with the insertion axis of the fixation element 110 as it is advanced toward the contact members 104. Additionally, any of the method and device configurations disclosed herein can be configured such that the implant or contact members can be advanced from the delivery catheter and engage the wall of the LAA without the implant or contact members fully or partially expanding, changing size, changing shape, or moving to or toward a second state. For example, in some configurations, the implant or contact member can be configured to engage the LAA and rotate the LAA upon rotation of the implant or contact member without the implant or contact member fully or partially expanding, changing size, changing shape, or moving to or toward a second state.

[0087] FIG. 2K illustrates another configuration of the treatment device 100' with the implant device 102' advanced through a catheter into the LAA, where the implant device 102' is in a collapsed state and constrained within the outer tube 114 of the catheter. FIG. 2L illustrates a configuration of the implant device 102' of FIG. 2K engaged with the patient's tissue that has contracted as a result of the LAA being twisted. In any configuration, the implant device 102' may have a contact member 104', a fixation element 110', and a retention element 108' extending between the contact member 104' and the fixation element 110'. In some configurations, the implant device 102' may be inverted as compared to the implant device 102 described above.

[0088] In some configurations, the contact member 104' may be configured to treat the LAA similar to any other configuration of contact members disclosed herein. For example, but not limited to, the contact member 104' may be configured to engage tissue portions within the LAA and twist the LAA to contract a portion of the tissue of the LAA inwardly similar to other configurations of contact members disclosed herein. In the illustrated configuration, the contact member 104' may have the same or similar structure, function, components, and / or other details as any of the fixation element configurations disclosed herein, such as, but not limited to, the fixation element 110 configuration disclosed herein, but is configured to engage tissue within the LAA and twist the LAA to contract and / or occlude the ostium of the LAA.

[0089] Additionally, in some configurations, the fixation element 110' may be configured to treat the LAA similarly to any other configuration of fixation elements disclosed herein. For example, but not limited to, the fixation element 110' may be configured to engage contracted tissue resulting from twisting the LAA to prevent the contracted tissue from untwisting and / or to prevent the constricted opening of the LAA from expanding. In the illustrated configuration, the fixation element 110' may have the same or similar structure and function as any of the contact member configurations disclosed herein, such as, but not limited to, the contact member 104 configurations disclosed herein.

[0090] In other configurations, implant device 110' may have a fixation element 110' configuration as disclosed herein along with a contact member similar to the contact member 104 configuration as disclosed herein or other configurations of contact members as disclosed herein (except for the configuration of contact member 104'), or a fixation element having the same or similar structure as any other configuration of contact members as disclosed herein (except for the configuration of contact member 104'). Alternatively, in other configurations, implant device 110' may have a contact member 104' as disclosed herein and a fixation element similar to any of the other fixation elements shown herein, such as any of the fixation element 110 configurations as disclosed herein.

[0091] Any of the components of any of the implant configurations disclosed herein may be made from any other elastic or superelastic material, such as Nitinol, or any other shape memory material, or any mechanically expandable material, such as stainless steel. In any of the configurations disclosed herein, the contact members (such as contact member 104) may have other shapes, such as spherical, cylindrical, or elongated bullet, stent, mushroom, or other non-circular or non-cylindrical shapes, or any of the shapes described or illustrated with respect to any of the configurations disclosed herein. In any of the configurations disclosed herein, the contact members may comprise a series of interconnected struts (which can, but need not, form a diamond-shaped pattern over all or a portion of the surface of the contact members) or may be made from a series of ribs or paddles that form an expandable device.

[0092] 3A-3C show another configuration of a treatment device 6100 having an implant 6102 having a contact member 6104, a retention element 6108, and a fixation element 6110. In any configuration disclosed herein, the implant device 6102 may have any of the components, features, or other details of any other treatment or implant device configuration disclosed herein, including, but not limited to, any of the treatment devices or systems 100, 140, 4000, 6000, or other configurations of implant devices 102, 104, 4002, 6002 described herein, in any combination with any of the components, features, or details of the implant device 6102 shown in FIGS. Similarly, any component, feature, or other detail of any of the other therapeutic device configurations or implant device configurations disclosed herein may have any of the components, features, or other details of any configuration of implant device 6102 disclosed herein in any combination with any of the components, features, or details of the other configurations of therapeutic devices and / or implant devices disclosed herein.

[0093] 3A-3C, any configuration of the contact member 6104 disclosed herein may have multiple tissue anchors or teeth 6118 (also referred to as nubs) or other similar features configured to penetrate or engage tissue of the LAA. The tissue anchors 6118 may be configured to penetrate tissue within the LAA when the contact member 4004 is expanded against tissue of the LAA and / or when the contact member 4004 is rotated or twisted within the LAA. The tissue anchors 6118 may be positioned on one side of the post 6106 of the contact member 6104, for example, to face the intended direction of rotation of the contact member 6104. In other configurations, the tissue anchors 6118 may be positioned on both sides of the post 6106 of the contact member.

[0094] In any configuration disclosed herein, the tissue anchors or teeth 6118 of the contact members may be asymmetric or otherwise formed at an angle (such as angle A shown in FIG. 3C). In some configurations, as shown, the tissue anchors 6118 may be oriented toward the proximal end 6104a of the contact members 6104 at angle A. In this configuration, in some configurations, the tissue anchors may be angled toward the ostium. For example, without limitation, the anchors may have a proximal surface that is angled back toward the proximal end of the contact members by angle A of at or about 5°, or from at or about 2° to 15° or about 15° or more, or from at or about 5° to 10° or about 10°, or any value within the aforementioned range, or less than and greater than any value within the aforementioned range. In some configurations, the tissue anchor can be angled toward the proximal end of the contact member to improve engagement (e.g., grip) of the tissue anchor with tissue of the LAA as the retaining and / or fixation elements are pulled toward the contact member, which can be pulled toward the ostium of the LAA. In other configurations, the tissue anchor 6118 can have a distal surface that can be angled toward the distal end 6104b of the contact member 6104, or can have a mixture of tissue anchors with proximal surfaces angled toward the proximal end of the contact member, tissue anchors with distal surfaces angled toward the distal end of the contact member, and / or symmetrically shaped tissue anchors.

[0095] In some configurations, the length of any of the tissue anchors disclosed herein (such as, but not limited to, tissue anchor 6118) measured along the centerline of the tissue anchor from the base of the tissue anchor to the distal tip of the tissue anchor may be 0.6 mm or approximately 0.6 mm. In some configurations, the length of the tissue anchor may be 0.5 mm, or between 0.4 mm (or approximately 0.4 mm, or less than 0.4 mm) and 0.8 mm (or approximately 0.8 mm, or greater than 0.8 mm), or between 0.5 mm (or approximately 0.5 mm) and 0.7 mm (or approximately 0.7 mm), or any value or range of values ​​within any of the foregoing ranges.

[0096] 3A-3C, in some configurations, the tissue anchors 6118 may be positioned along the length of the struts 6108 of the contact members 6104 from the proximal end 6104a of the contact members 6104 to the distal end 6104b of the contact members 6104, or near or adjacent the proximal end 6104a of the contact members 6104 to a point adjacent or near the distal end 6104b of the contact members 6104. In some configurations, the tissue anchors 6118 may be positioned along at least 80% of the length of the struts 6108 of the contact members 6104, or along 60% (or approximately 60%, or less than 60%) to 100% (or approximately 100%) of the length of the struts 6108 of the contact members 6104, or any value or range of values ​​within the aforementioned ranges.

[0097] The fixation element 6110 shown in FIGS. 3A-3C is shown in an expanded state (e.g., a second state) and spaced apart from the contact member 6104, which is also in an expanded, second state. In some configurations of the implant 6102, similar to the implant 6002 described above, the fixation element 6110 may be axially secured to the retention element 6108. Some configurations of the retention element 6108 may have a threaded shaft that may be positioned within a body portion of the fixation element 6110. The threaded shaft 6109 may be allowed to rotate freely within the body portion 6111 of the fixation element 6110. The threaded shaft 6109 may also be threadedly engaged with the contact member 6104. In this configuration, the fixation element 6110 may be axially advanced toward the contact member 6104 by rotating the threaded shaft 6109 in a first direction. Rotating the threaded shaft 6109 in a second direction opposite the first direction can cause the fixation element 6110 to be axially retracted or moved away from the contact member 6104. With reference to FIG. 3C, the fixation element 6110 can have a bend radius or radius of curvature (represented by R in FIG. 3C) near the base of the post of the fixation element 6110 that can be 1.0 mm (or approximately 1.0 mm), or between 0.8 mm (or approximately 0.8 mm, or less than 0.8 mm) and 1.0 mm (or approximately 1.0 mm, or more than 1.0 mm), or between 0.6 mm (or approximately 0.6 mm, or less than 0.6 mm) and 1.4 mm (or approximately 1.4 mm, or more than 1.4 mm), or any value or range of values ​​within the aforementioned ranges. In any configuration disclosed herein, the fixation element (such as fixation element 6110) may have a total outer diameter (represented by D in FIG. 3C ) of 13 mm (or about 13 mm), or 10 mm (or approximately 10 mm, or less than 10 mm) to 20 mm (or approximately 20 mm, or more than 20 mm), or 12 mm (or approximately 12 mm) to 17 mm (or approximately 17 mm), or any value or range of values ​​within the aforementioned ranges.

[0098] 3C, in some configurations, the spaces 6112 between the posts (also referred to herein as arms) of the fixation element 6110 may be configured to reduce stress within the posts and allow for better stress and / or strain distribution along the length of the base of the posts of the fixation element 6110. By increasing the length of the spaces between the posts of the fixation element 6110, the posts are able to flex or contract more at the base of the posts, optimizing the stress and / or strain distribution therein along the length of the base of the posts.

[0099] In some configurations, the retaining element 6108 can have a head 6130 coupled (e.g., integrally formed) with the threaded shaft 6109, and the head 6130 can be configured to mate with an end of an intermediate member of a catheter (not shown), such that a rotation or torque applied to the intermediate member can apply an equal rotation or torque to the head 6130 of the retaining element 6108 and the threaded shaft 6109. In some configurations, the retaining element 6108 can be axially coupled to a body portion 6111 of the fixation element 6110 such that the retaining element 6108 and the fixation element 6110 move together in either axial direction. For example, and not limiting, in some configurations, the retaining element 6108 may have a first retainer 6135 that may be coupled (e.g., welded, press-fit, or otherwise attached) to the distal end 6109b of the threaded shaft 6109, and a second retainer 6136 that may be positioned within a slot 6138 formed in the body portion 6111 of the fixation element 6110 and axially constrained therein.

[0100] The first retainer 6135 can prevent proximal axial movement of the threaded shaft 6109 relative to the body portion 6111 of the fixation element 6110 (i.e., in a proximal direction away from the contact member 6104). The second retainer 6136 can have an axial opening therethrough that is smaller than the outer diameter of the threaded portion of the threaded shaft 6108 such that the second retainer 6136 can prevent distal axial movement of the threaded shaft 6109 relative to the body portion 6111 of the fixation element 6110 (e.g., in a distal direction toward the contact member 6104). In this configuration, any axial movement of the retaining element 6108 causes simultaneous and equal axial movement of the fixation element 6110. The proximal end of the contact member 6104 can have a collar member 6170. In some configurations, the collar member 6170 can be used to restrain the post 6140 to the contact member 6104 such that the post 6140 cannot be disengaged from the contact member 6104.

[0101] 4A-4J show another configuration of a treatment system 6300 having an implant 6302 configuration having a contact member 6304, a retention element 6308, and a fixation element 6310. In any configuration disclosed herein, the treatment system 6300 and / or implant device 6302 may have any of the components, features, or other details of any other treatment device configuration or implant device configuration disclosed herein, including, but not limited to, any of the treatment devices 100, 140, 4000, 6000, 6100, and / or other configurations of implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and / or implant device 6302 shown in FIGS. Similarly, any component, feature, or other detail of any of the other therapeutic device configurations or implant device configurations disclosed herein may have any of the components, features, or other details of any configuration of therapeutic device 6300 and / or implant device 6302 disclosed herein in any combination with any of the components, features, or details of the other configurations of therapeutic devices and / or implant devices disclosed herein.

[0102] Figure 4A shows an isometric view of the implant device 6302 with the expanded (e.g., second state) fixation element 6310 spaced apart from the contact member 6304, which is also in the expanded, second state. Figure 4B shows a side view of the implant device 6302 and the expanded fixation element 6310 spaced apart from the implant device 6302. Figure 4C shows an end view of the implant device 6302.

[0103] 4A-4J, in some configurations of the implant 6302, the fixation element 6310 may be axially coupled or secured to the retention element 6308. Some configurations of the retention element 6308 may have a threaded shaft 6309 that may be positioned within a body portion 6311 of the fixation element 6310 in an operable state. The body portion 6311 may have a cylindrical shape with an axially extending opening therethrough that may be sized and configured to receive the threaded shaft 6309 therein. In some configurations, the threaded shaft 6309 may be allowed to rotate freely in either direction within the body portion 6311 of the fixation element 6310. The threaded shaft 6309 may also be threadedly engaged with the contact member 6304. In this configuration, by rotating the threaded shaft 6309 in a first direction, the fixing element 6310 can be advanced axially toward the contact member 6304, and by rotating the threaded shaft 6309 in a second, opposite direction, the fixing element 6310 can be moved axially away from the contact member 6304.

[0104] FIG. 4F is a cross-sectional view of the configuration of the implant 6302 shown in FIG. 4A, showing the fixation element 6310 advanced to a position adjacent the contact member 6304. FIG. 4G is an exploded cross-sectional view of the configuration of the implant 6302 shown in FIG. 4A. FIG. 4J is a side view of the configuration of the implant shown in FIG. 4A, also showing the fixation element 6310 advanced to a position adjacent the contact member 6304. However, some configurations of the implant may be configured to allow the fixation element 6310 to be advanced to a position adjacent the contact member 6304, such that the distal end of the fixation element 6310 extends beyond the proximal end of the contact member 6304, as shown in FIG. 4J. However, in some configurations, when implanted in the body, some tissue of the LA and / or LAA may be positioned between the fixation element 6310 and the contact member 6304, which may limit the range of movement of the fixation element 6310 relative to the contact member 6304. As described above, the fixation element 6310 can be axially retracted or moved away from the contact member 6304 by rotating the threaded shaft 6309 in a second direction opposite the first direction. Figures 4E and 4H show the fixation element 6310 advanced to a position spaced from the contact member 6304. In some configurations, the first direction can be, without limitation, clockwise.

[0105] In some configurations, the fixation element 6310 can have a number of arms or struts 6316 extending away from a proximal end 6311a of the body portion 6311 of the fixation element 6310. In some configurations, each of the plurality of struts 6316 can initially bend radially outward at its proximal end 6316a and can each have a distal end 6316b that can be closer to the contact member 6304 than the proximal end 6316a of the strut 6316 in a second, or expanded, state of the fixation element 6310. Each of the struts 6316 can have an intermediate portion 6316c that can angle outward and forward toward the contact member in the second, or expanded, state. In some configurations, the intermediate portion 6316c may be inclined forward at an angle of 45° (or approximately 45°) relative to the axial or longitudinal axis of the body portion 6311 of the fixation element 6310, or at an angle of 35° (or approximately 35°, or less than 35°) to 60° (or approximately 60°, or more than 60°) relative to the axial or longitudinal axis of the body portion 6311.

[0106] 4J , in some configurations, as the fixation element 6310 advances distally (e.g., as the fixation element 6310 moves into a position adjacent the contact member 6304), at least the distal ends 6316b of some of the plurality of struts 6316 may overlap the contact member 6304. For example, without limitation, in any configuration of the implant disclosed herein, at least the distal ends 6316b of some of the plurality of struts 6316 may overlap the proximal end of the contact member by 1 mm, approximately 1 mm, or less than 1 mm, or 2 mm or approximately 2 mm, or 2 mm or approximately 2 mm, or less than 1 mm or less than 1 mm to 3 mm or more than 3 mm. As another non-limiting example, in any configuration of the implant disclosed herein, at least the distal ends 6316b of some of the plurality of struts 6316 may overlap the proximal end of the contact member such that at least or approximately 20%, or at least or approximately 40%, or at least or approximately 50%, or approximately 50%, or approximately 20% to 50%, or approximately 50% of the total length of at least the distal ends 6316b of some of the plurality of struts 6316 in the deployed state may extend beyond the proximal end of the contact member. In some configurations, the implant may be configured such that the arms or struts of the fixation element may extend into the spaces or voids between the arms or struts of the contact member as the fixation element is advanced toward the contact member.

[0107] In any configuration of the fixation element 6310 disclosed herein, each of the struts 6316 may have one or more interconnections 6320 with an adjacent strut 6316, or multiple struts 6316, along the length of each of the struts 6316. For example, and without limitation, with reference to FIG. 4C, each of the struts 6316 may have a first interconnection 6320 at an end 6316b of each of the struts 6316, the first interconnection 6320 being an interconnection between the distal ends 6316b of two adjacent struts 6316. Additionally, in some configurations, each of the struts 6316 may have a second interconnection 6322 at an intermediate portion 6316c of each of the struts 6316, the second interconnection 6322 being an interconnection between the intermediate portions 6316c of two adjacent struts 6316. In this configuration, each of the struts 6316 of the fixation element 6310 can have a first interconnection and a second interconnection along its length with adjacent struts 6316. Additionally, any configuration of fixation element 6310 can have one or more interconnections 6323 at the proximal end 6316a of the strut 6316, or at the proximal ends 6316a of multiple struts 6316.

[0108] The interconnects 6320, 6322, 6323 may provide additional stiffness and strength to the overall fixation element 6310. Additionally, in some configurations, each of the interconnects 6320, 6322, 6323 may also provide an additional fixation point for each of the struts 6316 to the fixation element 6310, such that if a strut is crushed or broken, the first interconnect 6320 and / or the second interconnect 6322 may couple or secure the broken or crushed strut 6316 to the fixation element 6310 and prevent the broken or crushed strut 6316 from coming loose and migrating into the patient's heart or bloodstream. Additionally, in some configurations, each of the struts 6316 may have a sharpened distal end 6316b, and in some configurations the distal end 6316b may have two struts that are coupled to each other at the distal end 6316b of the strut. In some configurations, the distal end 6316b may have a sharp tip designed to penetrate tissue. In some configurations, the distal end 6316b may have a tip configured to grasp or engage tissue without penetrating the tissue. Additionally, in some configurations, the distal end 6316b of each of the posts may have a beveled or angled surface 6329 that can aid in the penetration of the distal end 6316b into tissue.

[0109] In some configurations, the first interconnect 6320 and / or the second interconnect 6322 may increase the stiffness of the fixation element 6310, at least torsionally. In some configurations, with a more torsionally stiff configuration having interconnects, the struts 6316 may be made with a thinner cross-sectional size, which in some configurations may improve tissue ingrowth into the fixation element 6310 and / or reduce the weight of the fixation element 6310. In some configurations, without limitation, the cross-sectional area or size of the struts 6316 may be the same or approximately the same as a 2-0 suture.

[0110] Similarly, any configuration of the contact members 6304 disclosed herein may have one or more interconnections between adjacent struts 6318 or between multiple struts 6318 along the length of each of the struts 6318. For example, without limitation, with reference to FIG. 4C, each of the struts 6318 may have a first interconnection at or adjacent to each end 6318b of the strut 6318, the first interconnection being an interconnection between the distal ends 6318b of two adjacent struts 6318. Additionally, in some configurations, each of the struts 6318 may have a second interconnection at a middle portion 6318c of each of the struts 6318, the second interconnection being an interconnection between the middle portions 6318c of the two adjacent struts 6318. In this configuration, each of the struts 6318 of the contact members 6304 can have a first interconnection and a second interconnection along its length with adjacent struts 6318. Additionally, any configuration of the contact members 6304 can have one or more interconnections at the proximal end 6318a of the strut 6318 or at the proximal ends 6318a of multiple struts 6318.

[0111] The interconnects may provide additional stiffness and strength to the overall fixation element 6304. Additionally, in some configurations, each of the interconnects may also provide an additional fixation point for each of the struts 6318 to the contact member 6304, such that if a strut fractures or breaks, the first interconnect, the second interconnect, and / or an interconnect that may be at a proximal end of the contact member 6304 may couple or secure the broken or fractured strut 6318 to the contact member 6304 and prevent the broken or fractured strut 6318 from coming loose and migrating into the patient's heart or bloodstream.

[0112] In some configurations, the retaining element 6308 may have a head 6330 coupled to a threaded shaft 6309, which is configured to couple with an end of an intermediate member of a catheter (such as end 8098b of the catheter shown in FIG. 96C), such that a rotation or torque applied to the intermediate member may apply an equal rotation or torque to the head 6330 of the retaining element 6308 and the threaded shaft 6309. In some configurations, the retaining element 6308 may be axially coupled to a body portion 6311 of the fixation element 6310 such that the retaining element 6308 and the fixation element 6310 move together in either axial direction. For example, without limitation, in some configurations, the threaded shaft 6309 of the retaining element 6308 may threadably mate with a threaded drive element 6331, which may have a threaded opening 6332 extending axially therethrough, which may be configured to receive the threaded shaft 6309 therethrough. As will be described, the drive element 6331 can be configured to be supported by other components of the implant 6302 to prevent the drive element 6331 from rotating. Additionally, some configurations of the implant 6302 can be configured to allow the drive element 6331 to move axially along the length of the body portion 6311 of the fixation element 6310 as the threaded shaft 6309 rotates. In this configuration, the drive element 6331 can be advanced axially in either direction by rotating the threaded shaft 6309.

[0113] A retainer cap 6333 can be used to couple the drive element 6331 to the proximal end 6304a of the contact member 6304. In some configurations, the retainer cap 6333 can be coupled (e.g., welded, press-fit, or otherwise attached) to the drive element 6331 with a portion of the proximal end 6304a of the contact member 6304 captured or fixed between the drive element 6331 and the retainer cap 6333. For example, without limitation, the drive element 6331 can be positioned within an opening 6339 in the proximal end 6304a of the contact member 6304, distal to an annular ring of the proximal end 6304a of the contact member 6304, and the retainer cap 6333 can be coupled to the drive element 6331 with the proximal end 6304a of the contact member 6304 captured between the drive element 6331 and the retainer cap 6333. In some configurations, the drive element 6331 may have a post or tab 6334 that extends into the slot 6312 of the body portion 6311 of the fixation element 6310 to block (e.g., prevent) the drive element 6331 from rotating when the threaded shaft 6309 rotates into the drive element 6331. Additionally, in some configurations, the tab 6334 may engage a recess 6337 formed in the retainer cap 6333 to provide an overlap between the drive element 6331 and the retainer cap 6333, thereby improving the connection between the drive element 6331 and the retainer cap 6333.

[0114] The first retainer 6335 may be coupled (e.g., welded, press fit, or otherwise attached) to the distal end 6309b of the threaded shaft 6309, and the second retainer 6336 may be used to capture the distal end 6311b of the body portion 6311 of the fixation element 6310 between the first retainer 6335 and the second retainer 6336. The second retainer 6336 may have a post or tab 6341 that extends into the slot 6312 of the body portion 6311 of the fixation element 6310 to prevent the second retainer 6336 from moving distally relative to the distal end 6311b of the body portion 6311. This can be achieved by sizing the opening 6342 axially through the second retainer 6336 slightly larger compared to the cylindrical end 6343 at the distal end 6309b of the threaded shaft 6309, and making the opening 6342 smaller than the threaded portion 6344 of the threaded shaft 6309 such that the threaded portion 6344 of the threaded shaft 6309 cannot extend through the opening 6342 in the second retainer 6336. In this configuration, the second retainer 6336 is positioned around the cylindrical end 6343 at the distal end 6309b of the threaded shaft 6309, the distal end 6311b of the body portion 6311 of the fixation element 6310 is positioned between the first retainer 6335 and the second retainer 6336, the first retainer 6335 is non-removably coupled to the cylindrical end 6343 of the threaded shaft 6309, and the threaded shaft 6309 can be non-removably coupled to the fixation element 6310.

[0115] As described above, the first retainer 6335 can prevent proximal axial movement of the threaded shaft 6309 relative to the body portion 6311 of the fixation element 6310 (i.e., in the proximal direction away from the contact member 6304). The second retainer 6336 can have an axial opening 6342 therethrough that is smaller than the outer diameter of the threaded portion of the threaded shaft 6308 such that the second retainer 6336 can prevent distal axial movement of the threaded shaft 6309 relative to the body portion 6311 of the fixation element 6310 (i.e., in the distal direction toward the contact member 6304). The outer diameter or flange 6351 of the first retainer 6335 can be larger than the diameter of the opening 6313 at the distal end 6311b of the body portion 6311 of the fixation element 6310 to prevent the first retainer 6335, which is coupled to the end 6309b of the threaded shaft 6309, from passing through the opening 6313. In this configuration, any axial movement of the retaining element 6308 (e.g., caused by rotation of the threaded shaft 6309) will cause simultaneous and equal axial movement of the fixation element 6310 relative to the contact member 6304.

[0116] In this configuration, when the threaded shaft 6309 rotates in a first direction, the drive element 6331 can move axially in a first direction (e.g., distal axial) relative to the fixation element 6310, and thus when the threaded shaft 6309 rotates in a second direction opposite the first direction, the drive element 6331 can move axially in a second direction opposite the first direction (e.g., proximal axial) relative to the fixation element 6310. As described above, the drive element 6331 can be coupled with the proximal end 6304a of the contact member 6304 such that when the drive element 6331 moves axially relative to the fixation element 6310, the fixation element 6310 can simultaneously and equally move axially relative to the contact member 6304. In this configuration, the fixation element 6310 can be moved toward or away from the contact member 6304 by rotating the head portion 6330 of the threaded shaft 6309 of the retention element 6308.

[0117] 4G, some configurations of the contact member 6304 may have a hub 6350 at the distal end 6304b of the contact member 6304 that may be coupled to the distal end 6318b of the post 6318. The hub 6350 may be coupled to the distal end 6318b of the post 6318 to axially secure the hub 6350 with the distal end 6318b of the post 6318. The hub 6350 may be configured to allow the distal end 6318b of the post 6318 to rotate relative to the hub 6350. In some configurations, the hub 6350 may include a first retaining element 6354 and a second retaining element 6356. The first and second retaining elements 6354 and 6356 may have openings 6353 and 6357 respectively extending axially therethrough for passage of a guidewire or other instrument and may be configured to capture the distal ends 6318b of the post 6318 in an assembled state. For example, and without limitation, the first retaining element 6354 may have an annular recess therein that may be sized and configured to receive the distal ends 6318b of the post 6318 therein, and the second retaining element 6356 may have a slot 6358 formed therein that extends radially and is sized and configured to allow a thin or narrow portion of the distal ends 6318b of the post 6318 to pass therethrough, but not a wider portion of the most distal end of the distal ends 6318b of the post 6318 to pass therethrough. In other words, the slot 6358 can be configured to engage with a tab or other T-shaped feature 6366 formed on the distal end 6318b of the post 6318 to allow the distal end 6318b to rotate relative to the hub 6350. The second retaining element 6356 can also have a slot or recess configured to engage with a tab formed on the first retaining element 6354 to provide a more secure coupling between the first retaining element 6354 and the second retaining element 6356.

[0118] In this configuration, as the threaded shaft 6309 is rotated in a first direction, the fixation element 6310 can be advanced toward the contact member 6304 to engage and / or compress any tissue that has contracted or closed as a result of twisting of the contact member 6304 or the LAA and / or any tissue adjacent to tissue that has contracted or closed as a result of twisting of the contact member 6304 or the LAA. The distal tips 6316b of the arms 6316 of the fixation element 6310 can penetrate the compressed tissue or otherwise inhibit (e.g., without limitation, prevent) the contracted tissue from opening back up or expanding around the body of the implant 6302.

[0119] In some configurations, as described above, the proximal end 6304a of the contact member 6304 and the distal end 6304b of the contact member 6304 can be formed by struts. In some configurations, for example, but not limited to, the proximal portion of the contact member 6304 or any contact member disclosed herein can be configured to urge any folds or overlapping tissue of the LAA that form around the contact member 6304 as a result of twisting of the contact member 6304 to slide or move proximally away from the contact member 6304 such that only a minimal amount, if any, of folds or overlapping tissue forms around the outside of the contact member 6304. For example, without limitation, in some configurations, the proximal end 6304a of the contact member 6304, or any struts thereof, may be angled at or about 85° relative to the longitudinal axis of the contact member 6304, or at or about 90° relative to the longitudinal axis of the contact member 6304, or at or about 80° to or about 100° relative to the longitudinal axis of the contact member 6304 (see angle A88 shown in FIG. 4B). In any configuration, the proximal end 6304a of the contact member 6304, or any struts thereof, and / or the distal end 6304b of the contact member 6304, or any struts thereof, may be angled at or about 30° or less, or at an angle at or about 10° to or about 30° or less, perpendicular to the longitudinal axis or longitudinal centerline of the contact member 6304. Further, in any configuration, an intermediate portion of the contact member 6304 and / or any struts thereof may be approximately parallel to the longitudinal centerline axis of the contact member 6304, or may be within 30° or approximately 30° or less of parallel to the longitudinal axis of the contact member 6304, or within 10° or approximately 10°-30° or approximately 30° or less.

[0120] Thus, in some configurations, the contact member 6304 may be configured to urge the fold or overlapping tissue to occur around the outside of the proximal end 6304a of the contact member 6304 and / or the body portion 6311 of the retention element 6308 after at least a threshold degree of rotation of the contact member 6304 relative to the LAA (e.g., after at or about 90° rotation of the contact member 6304, or after at or about 70° to at or about 110° rotation of the contact member 6304). In some configurations, this may be accomplished by using a contact member 6304 having a lateral width or diameter at or adjacent the end of the LAA that is equal to or slightly smaller than the inner size or diameter of the LAA. For example, and not by way of limitation, in any configuration of the implant disclosed herein, the contact member can have an outer size or diameter that is 80% or approximately 80%, or at least 80% of the inner size or diameter of the LAA at or adjacent to the end of the LAA, or 70% or approximately 70%-100%, or approximately 100%, or greater than 100% of the inner size or diameter of the LAA at or adjacent to the end of the LAA, or 80% or approximately 80%-90%, or approximately 90% of the inner size or diameter of the LAA at or adjacent to the end of the LAA.

[0121] Additionally, in any configuration of the contact members disclosed herein, the length of the contact members along the outer surface of the contact members can be significantly less than the width or diameter of the outer surface of the contact members. Having a shorter length may, in some configurations, allow the body of the implant (e.g., but not limited to, the body portion of the retention element) to have a greater length over which tissue of the LAA can contract and occlude or substantially occlude the LAA. In some configurations, for example, but not limited to, the length of the contact members along the outer surface of the contact members (e.g., but not limited to, represented by length L in FIGS. 4B, 5, and 6) can be 50%, or approximately 50%, or less than 50% of the width or diameter of the outer surface of the contact members (e.g., but not limited to, represented by width W in FIGS. 4B, 5, and 6), or 40%, or approximately 40%-60%, or approximately 60% of the width or diameter of the outer surface of the contact members.

[0122] In some configurations, the width or diameter of the outer surface of the contact member (e.g., without limitation, represented by width W in FIGS. 4B, 5, and 6) can be greater than the width or diameter of the outer surface of the fixation element (e.g., without limitation, represented by width Wse in FIGS. 4B, 5, and 6). For example, without limitation, in some configurations, the width or diameter W of the outer surface of the contact member can be 50% or about 50% to 100% or about 100% greater than the width or diameter Wse of the outer surface of the fixation element.

[0123] In any configuration disclosed herein, the width or diameter W of the outer surface of the contact member may be at or about 12 mm (0.47 inches), or at or about 16 mm (0.63 inches), or from 10 mm (0.39 inches), about 10 mm (0.39 inches), or less than 10 mm (0.39 inches) to 18 mm (0.71 inches), about 18 mm (0.71 inches), or more than 18 mm (0.71 inches), or any value or range of values ​​within the aforementioned ranges. In any configuration disclosed herein, the width or diameter Wse of the outer surface of the fixation element may be at or approximately 13 mm (0.51 inches), or may be from 10 mm (0.39 inches), approximately 10 mm (0.39 inches), or less than 10 mm (0.39 inches) to 16 mm (0.63 inches), approximately 16 mm (0.63 inches), or more than 16 mm (0.63 inches), or any value or range of values ​​within the aforementioned ranges.

[0124] FIG. 5 shows a contact member configuration (which may be that of the contact member 6360 disclosed above) having a lateral width or diameter that is slightly smaller (e.g., 10% or approximately 10% smaller) than the inner size or diameter of the LAA at or adjacent the end of the LAA, and a length along the outer surface of the contact member that is significantly smaller than the width or diameter of the outer surface of the contact member. FIG. 4 shows tissue of the LAA gathered around the body portion 6362 of the implant after the implant has been rotated approximately 360°. The simulated LAA has multiple folds 6366 around the body portion 6362 of the implant, while the simulated LAA tissue around the contact member 6364 has far fewer, if any, folds. In this configuration, folds can begin to form in the LAA tissue before the contact member is rotated 180°, or in a similarly sized and configured configuration.

[0125] In any configuration disclosed herein, the implant may be configured such that rotating the contact member 90° or approximately 90°, or 60° or approximately 60° to 100° or approximately 100°, or 70° or approximately 70° to 90° or approximately 90° from a first or initial position of the contact member causes the contact member to contact and rotate at least an end of the tissue of the left atrial appendage (in some configurations, for example, but not limited to, without forming any or multiple overlaps or folds in the tissue of the left atrial appendage around the contact member), and such that rotating the contact member 90° or approximately 90° to 180° or approximately 180°, or between 60° or approximately 60° and 100° or approximately 100° to 160° or approximately 160° and 200° or approximately 200° causes the tissue of the left atrial appendage to twist around the implant at least between the contact member and the fixation element. In some configurations, the implant can be configured such that rotating the contact member greater than or approximately greater than 180°, or between or approximately 160° and or approximately 200°, causes the tissue of the left atrial appendage to continue to twist and contract around the implant, primarily between the contact member and the fixation element.

[0126] With some configurations of the implants disclosed herein, and in some procedures, as the tissue is wrapped around the ball, it may form one or more spiral patterns of tissue that may present one or more potential leak channels. This potential "fold" of tissue is shown in FIG. 91, as described above. In some configurations or procedures, the spiral patterns may present leak channels after the wrapped tissue is folded axially, which may cause the tissue to slacken around the outer surface of the implant. These leak channels (if present) and the angle of the leak channels relative to the axis of the contact members and delivery catheter may be further compressed and reduced, respectively, by axial motion that changes the angle of the channels closer to perpendicular to the longitudinal axis of the contact members and delivery catheter, and / or further rotation of the contact members to further clamp the tissue around the outer surface of the implant. Further rotation may cause the tissue to form a tighter seal around the implant device. Non-limiting exemplary configurations of steps that may be taken to achieve tighter compression of the tissue and reduction in the angle of the folds relative to the longitudinal axis include at least the following steps:

[0127] In any configuration of the treatment or delivery methods disclosed herein, the procedure may include all or any of the following steps in combination with any of the other steps or procedures disclosed herein: After advancing the contact member axially to a desired location within the LAA, the contact member may be rotated in a first direction by a first predetermined angle. In some configurations, this may be done by rotating a second dial 8084 on the handle of the delivery catheter. In any configurations disclosed herein, the first predetermined angle may be equal to or greater than 180 degrees, or may be equal to or greater than 180 degrees, or may be 270 degrees, approximately 270 degrees, 200 degrees or less to 330 degrees or more than 330 degrees, 230 degrees to 300 degrees, 250 degrees to 290 degrees, or any value or range of values ​​within any of the foregoing ranges. The user may then retract (e.g., pull back) the contact member 6304 proximally by a first predetermined distance. In some configurations, the predetermined distance may be 0.5 cm or more, or may be 1 cm, approximately 1 cm, between 0.25 cm and 1.75 cm, between 0.5 cm and 1.5 cm, between 0.75 cm and 1.25 cm, or any value or range of values ​​within any of the foregoing ranges.

[0128] After retracting the contact member as described above, the contact member can then be rotated in the first direction by a second predetermined angle. For example, but not limited to, the second predetermined angle can be 15 degrees or more, or 30 degrees or more, or can be 65 degrees, approximately 65 degrees, 30 degrees or less to 90 degrees or more, 45 degrees to 150 degrees, 30 degrees to 120 degrees, 30 degrees to 90 degrees, or any value or range of values ​​within any of the foregoing ranges. The fixation element can then be deployed and advanced toward the contact member.

[0129] Alternatively, in some configurations, after rotating the contact member a second predetermined angle in the first direction, but before deploying the fixation elements, the user can retract (e.g., pull back) the contact member proximally a second predetermined distance. For example, without limitation, the second predetermined distance can be 1 cm, approximately 1 cm, 0.25 cm to 1.75 cm, 0.5 cm to 1.5 cm, 0.75 cm to 1.25 cm, or any value or range of values ​​within any of the foregoing ranges. In some configurations, the fixation elements can then be deployed and advanced toward the contact member.

[0130] Alternatively, after the contact member is retracted the second predetermined distance and before the fixation element is deployed, the contact member can then be rotated in the first direction a third predetermined angle. For example, without limitation, the third predetermined angle can be 30 degrees, approximately 30 degrees, 15 degrees or less to 60 degrees or more than 60 degrees, 15 degrees to 100 degrees, 15 degrees to 60 degrees, 15 degrees to 45 degrees, or any value or range of values ​​within any of the foregoing ranges. The fixation element can then be deployed and advanced toward the contact member.

[0131] Delivery Systems and Methods of Using the Delivery Systems: FIG. 8A illustrates a system 8000 configuration for closing or occluding the LAA, including a delivery system 8002 configuration and an implant 8004 configuration. FIG. 8B illustrates a delivery system 8002 configuration shown in FIG. 8A, including additional components for injecting saline, contrast, and the like. In any configuration of the system 8000 disclosed herein, the implant 8004 may be the same as or have any combination of features of any other configuration of the implants disclosed herein, such as, but not limited to, implants 6102, 6302. For reference, the implant 6302 configuration is shown in FIG. 8A. As shown in FIGS. 8A and 8B, the delivery system 8002 may include a catheter device 8010 and a support stand 8012. The delivery system 8002 may include a guide catheter 8014 and a dilator. In some configurations, the guide catheter may optionally include a steerable sheath and the delivery system 8002 may optionally include a steering device 8016 having a steering knob 8020 for steering the steerable sheath. In other configurations, the delivery system may include a non-steerable guide catheter.

[0132] 9A-9H show some of the configurations of the delivery catheter 8002 that may be used with any of the configurations of the implants disclosed herein. FIGS. 10A-10C show side views of the configurations of the implant 6304 and the distal end of the delivery catheter 8002 with the outer sheath 8040 partially retracted and the contact members 6304 and fixation elements 6310 in their respective expanded states. With reference to FIG. 8A, the support stand 8012 may be positioned on a support surface such as a bed or table, or may be positioned on the patient's body. In some configurations, the support stand 8012 may have a low slip surface at its bottom or may be positioned on a low slip material or surface such as a low slip mat. As discussed later, the support stand 8012 may be used to removably support the delivery catheter 8010 (also referred to herein as a surgical catheter). Some configurations of the support stand 8012 may include a base 8030, a first support 8032 having a slot 8033 therein, and a second support 8034 coupled with a first locking element 8038. Some configurations of the support stand 8012 may have a scale used to measure the distance traveled by the delivery catheter 8002 along the slot 8033 or to provide a user of the system with a reference for determining such distance traveled. The scale may provide millimeter and / or centimeter markings. For example, but not by way of limitation, this may assist the user in determining the distance traveled by the implant relative to the user's anatomy during a procedure. In some configurations, the delivery catheter 8010 may have a clamping element 8041 having a tab or protrusion 8043 that is sized and configured to extend from the clamping element 8041 and extend into the slot 8033 to help maintain alignment of the delivery catheter 8010 relative to the first support 8032.

[0133] The second support 8034 may be configured to support the guide catheter and dilator, and the first locking element 8038 may be selectively adjusted or tightened to secure the guide sheath of the guide catheter in a desired axial and / or rotational position after the guide sheath is advanced to the target location using the steering device 8016. Using standard percutaneous techniques, a guidewire (e.g., a 0.035 in guidewire) and introducer (e.g., a 6-8 Fr introducer) may be advanced into the patient's vasculature (e.g., the femoral vein, the contralateral femoral artery, or the radial artery), and the guidewire and dilator may be advanced into the left atrium. Any recognized or suitable transseptal procedure may be performed to achieve transseptal access.

[0134] The steerable guide catheter 8014 may be advanced over the guidewire and supported by or coupled to the second support 8034. In some configurations, the metal tube of the guide catheter 8014 may be secured to the second support 8034. A second locking element 8039 may be used to secure the guide catheter 8014 in a desired position relative to the guide catheter 8014 and the support stand 8012. Upon removal of the dilator, the distal end of the outer sheath 8040 of the delivery catheter 8010 may be inserted into the guide sheath and advanced to the target location. FIG. 8 shows this system after the outer sheath 8040 of the delivery catheter 8010 has been advanced into the guide catheter 8014. Angiography or other suitable imaging techniques may be performed at any step of the process for baseline purposes and for visualization during the procedure.

[0135] The outer sheath 8040 of the delivery catheter 8010 can be axially advanced and retracted relative to the guide sheath 8015 by sliding the delivery catheter 8010 distally and proximally, respectively, along the slot 8033 in the first support 8032 of the support stand 8012. The outer sheath 8040 of the delivery catheter 8010 can be advanced past the distal end of the guide sheath 8015 by translating the delivery catheter 8010 distally toward the guide catheter 8014. FIG. 8 shows the implant 8004 after it has advanced past the distal end 8040b of the outer sheath 8040. As described, by retracting the outer sheath 8040 proximally relative to the implant 6302, the contact members 6304 and / or fixation elements 6310 of the implant 6302 can self-expand depending on the distance the outer sheath 8040 has been retracted relative to the implant 6302. The outer sheath 8040 can be advanced or retracted by rotating a first dial 8060 of the delivery catheter 8010 in either a first direction (e.g., clockwise) or a second direction (e.g., counterclockwise), respectively. Alternatively, in any configuration, the contact member 6304 and / or fixation element 6310 of the implant 6302 can be advanced past the distal end 8040b of the outer sheath 8040 by advancing the implant 6302 distally relative to the outer sheath 8040. FIG. 8 shows both the contact member 6302 and fixation element 6304 advanced past the distal end 8040b of the outer sheath 8040 and in an expanded state.

[0136] For reference, Figure 12A shows the delivery system 8002 and implant 6302 with a solid black shading of the outer sheath 8040 and a first dial 8060 that is rotationally coupled to the outer sheath 8040. In some configurations, the delivery system 8002 can be configured such that rotation of the first dial 8060 in a first direction (e.g., clockwise) can thread a threaded connector 8080, which can be coupled to the outer sheath 8040, into a threaded opening in the first dial 8060 (e.g., moving the threaded connector 8080 from a first position shown in Figure 13A to a second position shown in Figure 13B), thereby moving the outer sheath 8040 in a proximal direction. Similarly, the delivery system 8002 can be configured such that rotation of the first dial 8060 in a second direction (e.g., counterclockwise) can disengage the threaded connector 8080, which can be coupled to the outer sheath 8040, from an opening in the first dial 8060, thereby moving the outer sheath 8040 in a distal direction. This movement of the outer sheath 8040 can move a distal end 8040b of the outer sheath 8040 relative to the implant 6302 to unconstrain the implant 6302.

[0137] In any configuration disclosed herein, the delivery system 8002 may be configured to selectively limit the amount of rotation of the first dial 8060 relative to the threaded connector 8080. This may be done to discourage (e.g., prevent) a user from inadvertently releasing the fixation element 6310 from the outer sheath 8040 before the user is ready. For example, without limitation, some configurations of the delivery system 8002 may have a stop element (e.g., a clip) 8083 that may be removably coupled to the threaded connector 8080 at any desired location of the threaded connector 8080. The stop element 8083 may be coupled with the threaded connector 8080 in a position such that, when the stop element 8083 abuts the distal end of the first dial 8060, the first dial 8060 is blocked (e.g., prevented) from further rotating in a direction that would cause the threaded connector 8080 to thread into the first dial 8060, thereby preventing further retraction of the outer sheath 8040 until the clip is moved distally, or, more generally, removed from the outer sheath 8040. In some configurations, the stop element 8083 positioned as shown in FIG. 9A may abut the distal end of the first dial 8060 when the outer sheath 8040 is positioned as shown in FIG. 11D (with the fixation element 6310 positioned completely or nearly completely within the outer sheath 8040). The stop element 8083 can be removed from the threaded connector 8080 to allow continued rotation of the first dial 8060 in a direction causing further retraction of the outer sheath 8040, as shown in FIG. 13C.

[0138] 12B shows the delivery system 8002 and implant 6302, with the inner catheter 8086 (also referred to herein as a first inner catheter or inner catheter member) having one or more fins 8088 (also referred to herein as an inner tube) at a distal end 8086b of the inner catheter 8086, and a second dial 8084 rotationally coupled to the inner catheter 8086, shown in solid black shading. Axial translation in a first direction and / or rotation of the second dial 8084 (along with the entire handle of the delivery system 8002) in a first direction causes an equivalent axial translation and / or rotation, respectively, of the inner catheter 8086, which in turn causes an equivalent axial translation and / or rotation, respectively, of the implant 6302 when the implant 6302 is engaged with the inner catheter 8086. In some configurations, the inner catheter 8086 can have one or more or multiple fins 8088 extending radially at the distal end 8086 of the inner catheter 8086. The fins 8088 can be configured to fit between the posts 6316 of the fixation element 6310, at least when the fixation element 6310 is in a restrained position within the outer sheath 8040. In this configuration, a user can rotate the contact members and / or the fixation element by rotating the second dial 8084 and thus the inner catheter 8086.

[0139] In some configurations, the delivery system 8002 may have a goniometer 8090 configured to rotate with the second dial 8084 such that the user can measure or track the angle of rotation of the second dial 8084. This can provide the user with visual feedback of the angle the implant has generally rotated during the procedure. In some configurations, the goniometer 8090 can be configured to be adjustably or selectively rotatable relative to the second dial 8084. For example, without limitation, in some configurations, the user can disengage a coupling mechanism that selectively rotationally couples the goniometer 8090 to the second dial 8084 such that the user can rotate the goniometer 8090 relative to the second dial 8084 and reset the goniometer 8090 to zero marks, for example, relative to an indicator on the delivery system 8002. In some configurations, the coupling mechanism may be a ball and one or more detents, or multiple balls and detents, and may be configured to bias the goniometer 8090 to be rotationally coupled with the second dial 8084, but may be overcome by applying a threshold torque to the goniometer 8090 relative to the second dial 8084. The goniometer 8090 may have graduations at 45 degrees, or 30 degrees, or 15 degrees. An optional ball and detent mechanism may be configured to have detents every 45 degrees, or 30 degrees, or 15 degrees, that may be sized and configured to receive balls, such that a user can selectively rotate the goniometer 8090 relative to the second dial 8084 and then recouple the goniometer 8090 to the second dial 8084 at such increments (e.g., at 45 degrees, or 30 degrees, or 15 degrees). Other selective rotational coupling mechanisms may be used to bias or selectively rotationally couple the goniometer 8090 relative to the second dial 8084.

[0140] 12C, after the contact members have been rotated and / or translated as desired such that the LAA and / or LA tissue contracts around the implant, the user can then advance the fixation element 6310 toward the contact members 6304 by rotating the coupling element 8096 (also referred to herein as a sleeve) of the delivery system 8002. The sleeve 8096 can be rotationally coupled or otherwise secured to a third dial 8097 (not shown in FIG. 12C) having one or more splines, teeth, and / or other engagement mechanisms and a fourth dial 8102 when the sleeve 8096 is in a first position (as shown in FIG. 12C). The third dial 8097 can be axially rotationally coupled to a second inner catheter 8098 (also referred to herein as a second inner catheter member) positioned inside the inner catheter 8086. Sleeve 8096 and second inner catheter 8098 are shown in solid black shading in FIG. 12C for reference.

[0141] The distal end 8098b of the second inner catheter 8098 may be rotationally coupled with the head 6330, which is coupled with the threaded shaft 6309 of the retaining element 6308 when the distal end 8098b of the second inner catheter 8098 is engaged with the head 6330, such that when the sleeve 8096 is in a first position, rotation of the sleeve 8096 causes simultaneous and equal rotation of the third dial 8097 and the second inner catheter 8098 to rotate the retaining element 6308. In this condition, rotation of the sleeve 8096 in a first direction can rotate the retaining element 6308 in a first direction and move the fixation element 6310 towards the contact member 6304 (e.g., to a position as shown in FIG. 13E), and rotation of the sleeve 8096 in a second, opposite direction can rotate the retaining element 6308 in a second direction and move the fixation element 6310 away from the contact member 6304. By rotating the sleeve 8096 in a first direction, the user can advance the fixation element 6310 toward the tissue of the LAA and / or LA that has been contracted by rotation of the contact member 6304, forcing the tissue of the LAA and / or LA into a closed or occluded state.

[0142] Some configurations of the delivery device 8002 may have a fourth dial 8102 that may be used to release the implant from the delivery catheter 8002, as shown in FIG. 13E. The fourth dial 8102 may be positioned at a proximal end of a handle portion of the delivery catheter 8002 and may be coupled to an inner core 8106 (also referred to herein as a third inner catheter member) positioned inside the second inner catheter 8098. The fourth dial 8102 and the inner core 8106 are shown in solid black shading in FIG. 12D for reference. The inner core 8106 may have a threaded end 8108 having male threads that may be threadedly engaged with a threaded opening 6315 having female threads. The threaded end 8108 may be used to selectively couple the inner core 8106 to a retaining element 6308. The threaded portion 8108 may be removed from the retaining element 6308 by rotating the threaded portion 8108 in a first direction (e.g., counterclockwise) relative to the retaining element 6308, thereby disengaging the threaded portion 8108 from the retaining element 6308. In some configurations, the retaining element 6308 may be held in a fixed rotational position along with the inner catheter 8086, for example, while turning the fourth dial 8102 to remove the inner core 8106 from the retaining element 6308. Thus, in some configurations, when the user is ready to release the implant from the delivery catheter, the user can disengage the threaded portion 8108 from the retaining element 6308 and then axially retract the entire 8002 while the implant remains in a deployed position within the LAA / LA.

[0143] 12D, in some configurations, the sleeve 8096 can be selectively axially coupled to the fourth dial 8102. When axially coupled to the fourth dial 8102, the sleeve 8096 can prevent independent rotation of the fourth dial 8102 relative to other components of the delivery system 8002, including, but not limited to, the third dial 8097. In some configurations, the sleeve 8096 can be rotationally coupled to the fourth dial 8102 using one or more splines, teeth, and / or other engagement features when the sleeve 8096 is in a first position (as shown in FIG. 12C), e.g., when the sleeve 8096 overlaps the fourth dial 8102 sufficiently to engage complementary splines, teeth, and / or other engagement features of the sleeve 8096 and the fourth dial 8102. Once the sleeve 8096 is slid into an axial position (e.g., to a second position as shown in FIG. 12D ) such that the splines, teeth, and / or other engagement features of the sleeve 8096 do not engage with complementary splines, teeth, and / or other engagement features of the fourth dial 8102, the fourth dial 8102 can then be rotated in a first direction to remove the threaded portion 8108 from the retaining element 6308, as described above.

[0144] In some configurations, the sleeve 8096 can be selectively blocked (e.g., selectively prevented) from moving axially from a first position of the sleeve 8096 to a second position of the sleeve 8096. For example, without limitation, a removable locking element 8110 can be used to selectively block the sleeve 8096 from moving axially from the first position to the second position. In some configurations, the removable locking element 8110 can be a suture passing through one, two, or more openings in the sleeve 8096 that are aligned with one, two, or more openings 8112 in the fourth dial 8102 that are aligned with one, two, or more openings 8112 in the sleeve 8096 when the sleeve 8096 is in the first position, as shown in FIG. 8B. In this state, the removable locking element 8110 prevents axial movement of the sleeve 8096 relative to the fourth dial 8102. In this state, the sleeve 8096 is coupled with the fourth dial 8102, and thus the delivery system 8002 can prevent the user from inadvertently releasing the implant from the delivery catheter. In some configurations, the user can remove the removable locking element 8110, move the sleeve 8096 to the second position of the sleeve 8096, and then rotate the fourth dial 8102 to release the implant. For example, without limitation, if the removable locking element 8110 is a suture, the user can cut and pull the suture out of the delivery device 8002, move the sleeve 8096 axially to the second position, and then rotate the fourth dial 8102 to release the implant from the delivery system 8002.

[0145] 11A-11D show configurations of the distal end of the outer sheath 8040. In any configuration of the system, the outer sheath 8040 may be used to constrain an implant including contact members and fixation elements. Additionally, in any configuration disclosed herein, the contact members and fixation elements may be self-expanding such that the contact members and fixation elements, respectively, may expand from a first state to a second enlarged or expanded state when the contact members and / or fixation elements are advanced beyond the distal end of the outer sheath. To ensure that in an initial configuration of some configurations of the system 8000, the arms or struts of the fixation elements can expand and that distal and portions of the struts of the fixation elements are not within tissue that has contracted or folded around the implant or outer sheath, the fixation elements may be configured in the system such that the distal ends of the arms or struts point proximally when the fixation elements are constrained within the outer sheath in the initial configuration. Any configuration of the implant may be configured such that after the contact members and fixation elements are expanded to a second expanded state, the contact members and / or fixation elements may be collapsed or returned to a folded state within the outer sheath by distally advancing the outer sheath. In this configuration, distally advancing the outer sheath may collapse the fixation elements such that the distal ends of the posts or arms of the fixation elements point in a distal direction. Further advancement of the outer sheath may also move the distal end of the outer sheath against the contact members, causing the contact members to collapse to an initial folded state within the outer sheath. This may be useful for recapturing the implant or for repositioning the contact members and / or fixation elements.

[0146] In some configurations, the distal end of the outer sheath 8040 may have a distal portion 8070 with multiple openings 8072 therein. In some configurations, the openings 8072 may be laser ablated at the distal portion 8070. In some configurations, the openings 8072 may be 0.001 inches wide, or approximately 0.001 inches wide. The openings 8072 may be configured to allow fluid (e.g., contrast agent) to flow therethrough when a pressure differential between the inside of the outer sheath and the outside of the outer sheath reaches a predetermined value, i.e., threshold. Additionally, the openings 8072 may be positioned to allow a user to determine the location of tissue of the LAA and / or LA that has been contracted by the implant 6302. For example, and not by way of limitation, when the implant is rotated and tissue of the LAA and / or LA wraps around a portion of the implant, it may be useful for the user to determine the location of the wrapped tissue, or the location of the end of the tissue on the implant. The tissue may be difficult or impossible to see under fluoroscopy. In this situation, contrast agent may be advanced through the outer sheath 8040 and through the opening 8072 when the opening 8072 is not covered with tissue. If tissue covers the opening 8072, the tissue may block or prevent the passage of fluid (e.g., contrast agent) through the opening 8072. Thus, when contrast agent flows through the opening 8072, the opening 8072 through which the contrast agent flows is not covered with tissue. In some configurations, the opening 8072 may be used in this manner to generally determine the location of the tissue relative to the distal end 8040b of the outer sheath 8040, and may be configured to be visible under fluoroscopy. Radiopaque bands, coatings, markers, etc. may be used to provide visibility under fluoroscopy.

[0147] In some configurations, the fixation element 6310 may also be configured to be visible under fluoroscopy and therefore viewable by a user. Thus, a user may use the openings 8072 to determine the position of the contracted tissue surrounding the outer sheath 8040 relative to the fixation element 6310 to determine whether the fixation element 6310 can be expanded and deployed. When the implant is axially positioned as shown in FIG. 11D, if the distal end 6316b of each of the struts 6316 of the fixation element 6310 is distal to the contracted tissue surrounding the outer sheath 8040 (e.g., such that the distal end 8086b of the inner catheter 8086 is positioned adjacent to or within a predetermined distance from the distal end 8040b of the outer sheath 8040), the fixation element 6310 is not in an optimal position to retract and deploy the outer sheath 8040. The user may release and re-engage the LAA or otherwise adjust the position of the implant relative to the contracted tissue to ensure that when the implant is axially positioned as shown in FIG. 11D, at least the distal end 6316b of each of the posts 6316 of the fixation element 6310 is distal to the contracted tissue surrounding the outer sheath 8040.

[0148] In some configurations, the openings 8072 can be a plurality of circumferentially extending slits that extend circumferentially around the distal portion 8070. For example, without limitation, each of the slits can have a length that is 10% or approximately 10% of the circumference of the distal portion 8070, or 10%, approximately 10%, or less than 10% to 50%, approximately 50%, or more than 50%, or 15%, or approximately 15% to 40%, or approximately 40%, or 15%, or approximately 15% to 20%, or approximately 20%, or any value or range of values ​​within any of the foregoing ranges. In some configurations, the distal portion 8070 can have spaces 8073 between each of the openings 8072 in the circumferential direction. In some configurations, the spaces 8073 between each of the openings 8072 can form a spiral or angled pattern on the distal portion 8070.

[0149] In any configuration disclosed herein, any of the tubes, catheters, or sheaths (including, but not limited to, the outer sheath 8040, the inner catheter 8086, and the second inner catheter 8098, which are described in more detail below) may be made of metal, which may be stainless steel. In any configuration, the tubes, catheters, or sheaths may be laser cut, which may improve the flexibility of the tubes, catheters, or sheaths. Some configurations of the outer sheath 8040 may include a laser cut stainless steel tube and a polymer (e.g., Pebax) jacket covering at least a portion of it. For example, and not by way of limitation, for the outer sheath 8040, the polymer jacket may extend from the proximal end of the outer sheath 8040 to the proximal end of the distal portion 8070 such that it does not cover the opening 8072 of the distal portion 8070. In some configurations, the openings 8072 may extend along the entire length or nearly the entire length of the metal layer of the outer sheath 8040, and the polymer jacket may extend from the proximal end of the outer sheath 8040 to the proximal end of the distal portion 8070 so as not to cover the openings 8072 in the distal portion 8070. In some configurations, the distal end of the jacket may be heat fused into a metal tube. To this end, a band or portion without openings may be formed that may be aligned with the distal end of the jacket so that the jacket does not flow through the openings 8072.

[0150] In any configuration of the system 8000, the size, pattern, and angular orientation of the openings can vary along the length of the metal tube to provide for varying flexibility of the tube, catheter, or sheath. For example, the angle of the spaces 8073 between the openings 8072 relative to the longitudinal centerline axis of the sheath can be greater at the distal end of the sheath to provide greater flexibility at that distal end. The proximal end of the sheath can be designed to be more rigid, such as by angling the spaces between the openings at a lower angle relative to the longitudinal axis of the sheath, and an intermediate rigid portion can extend between the proximal and distal portions.

[0151] In some configurations, the delivery catheter 8010 may have one or more biasing elements (e.g., one or more springs) to bias some of the components of the delivery catheter 8010 to move relative to one another or to apply a force to one or more of the components of the delivery catheter 8010. For example, without limitation, in some configurations, one or more springs may be used to pull the fourth dial 8102 and the inner core 8106 proximally relative to the second inner catheter 8098. This may bias the second inner catheter 8098 to contact and remain engaged with the retention element 6308 and / or the screw head 6330 of the retention element 6308. Additionally, in some configurations, one or more springs may be used to pull the fourth dial 8102, the inner core 8106, and / or the second inner catheter 8098 proximally relative to the inner catheter 8088. This allows the inner catheter 8088 to be biased into contact and remain engaged with the fixation element 6310.

[0152] In some configurations, one or more or all of the components of the implant device and / or delivery device may be provided in a sterile condition. For example, without limitation, one or more or all of the components of the implant device and / or delivery device may be provided in a sterile container or pouch, which may be double-pouched. In some configurations, some of the components of the delivery system may be provided non-sterile and may be intended to be positioned and used on the non-sterile side of a sterile barrier in an operating room.

[0153] Although specific configurations of the present invention have been described, these configurations are presented for illustrative purposes only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications can be made to the systems and methods described herein without departing from the inventive spirit of the present disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as are within the scope and spirit of the present disclosure. Accordingly, the scope of the present invention is defined solely by reference to the appended claims.

[0154] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, configuration, or embodiment are applicable to any other aspect, configuration, or embodiment described in this section or elsewhere in this specification, unless inconsistent. All of the features disclosed in this specification (including any accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing configurations. Protection extends to any novel, or any novel combination of features disclosed in this specification (including any accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process so disclosed.

[0155] Moreover, certain features described in the present disclosure in the context of separate implementations may also be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, although some features may be described above as functioning in a particular combination, one or more features from a claimed combination may in some cases be excluded from the combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0156] Furthermore, although operations may be shown in the figures or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order to achieve desirable results, nor need all operations be performed. Other operations not described or illustrated can be incorporated into the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Furthermore, in other implementations, operations may be rearranged or reordered. Those skilled in the art will appreciate that in some configurations, the actual steps illustrated and / or performed in the disclosed processes may differ from the steps shown in the figures. Depending on the configuration, some of the steps described above may be removed and other steps may be added. Furthermore, the features and attributes of the specific configurations disclosed above may be combined in different ways to form additional configurations, all of which fall within the scope of the present disclosure. Also, the separation of various systems in the above implementations should not be understood as requiring such separation in all implementations, and it should be understood that the components and systems described may generally be integrated together in a single product or packaged in multiple products.

[0157] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not necessarily all such advantages may be realized in any particular configuration. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or carried out in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.

[0158] Conditional language such as "can," "could," "may," or "might," unless otherwise specified or understood otherwise within the context in which it is used, is intended to generally convey that certain configurations include certain features, elements, and / or steps, while other configurations do not include certain features, elements, and / or steps. Thus, such conditional language is not intended to generally imply that features, elements, and / or steps are required in any way for one or more configurations, or that one or more configurations necessarily include logic for determining whether those features, elements, and / or steps are included in or performed in any particular configuration, with or without user input or prompting.

[0159] Unless otherwise noted, conjunctive language such as the phrase "at least one of X, Y, and Z" is understood in the context as it is commonly used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that at least one of X, at least one of Y, and at least one of Z must be present in a particular configuration.

[0160] As used herein, degree language, such as the terms "approximately," "about," "generally," and "substantially," refers to a value, amount, or characteristic that is close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within 10%, within 5%, within 1%, within 0.1%, and within 0.01% of the stated amount. As another example, in certain configurations, the terms "approximately parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from strict parallelism by 15°, 10°, 5°, 3°, 1°, or 0.1° or less. The ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof, as well as any specific values ​​within those ranges. Words such as "up to," "at least," "greater than," "less than," "between," and the like include the recited numbers. Numbers and values ​​used herein preceded by terms such as "about" or "approximately" include the recited numbers. For example, "approximately 7 mm" includes "7 mm," and numbers and ranges preceded by terms such as "about" or "approximately" should be interpreted as disclosing the numbers and ranges with or without such terms before the numbers or values, and thus, the present application supports the claims of the numbers, values, and ranges disclosed in this specification and / or claims with or without terms such as "about" or "approximately" before such numbers, values, or ranges, for example, "approximately 2 times to approximately 5 times" also includes the disclosure of the range "2 times to 5 times." The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred configurations in this section or elsewhere herein, but may be defined by the claims as presented in this section or elsewhere herein, or as presented in the future. The language of the claims should be interpreted broadly based on the language used in the claims and not limited to the examples described in this specification or during prosecution of the application, and the examples should be interpreted as non-exclusive.

[0161] [Embodiment] (1) A system for treating a left atrial appendage, comprising: an implant configured to be positioned at least partially within the left atrial appendage; A catheter configured to deploy the implant, the catheter comprising: an outer sheath coupled to the first connector; a first dial coupled to the outer sheath; an inner catheter member configured to rotate the implant when a distal end of the inner tube is engaged with the implant; a second dial coupled to the inner catheter member; the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction; and a catheter, wherein the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction. (2) The system of embodiment 1, wherein the system is configured to move a rotating portion of the implant from a first state to a second expanded state and move an outer surface of the rotating portion of the implant against an inner wall surface of the left atrial appendage. (3) A system according to any one of embodiments 1 to 2, comprising a second inner catheter member and a third dial coupled to the second inner catheter member, the third dial being configured to rotate the second inner catheter member and move the engaging portion of the implant toward the rotating portion of the implant when the third dial is rotated in a first direction. (4) The system of embodiment 3, wherein the engaging portion comprises one or more arms extending away from a body portion of the implant and configured to contract around an outer surface of a portion of the implant and penetrate the inwardly gathered tissue of the left atrial appendage. (5) The system of embodiment 3, wherein the engaging portion has one or more arms extending away from a main body portion of the engaging portion, and the engaging portion is configured to move from at least a first state in which the one or more arms are folded to a second state in which the one or more arms are expanded, such that an end of each of the one or more arms is spaced further away from the main body portion of the implant when the engaging portion is in the second state than when the engaging portion is in the first state.

[0162] (6) The system of embodiment 5, wherein the one or more arms of the locking portion are configured to extend toward the rotating portion of the implant when the locking portion is in the second state. (7) A system described in any of embodiments 1 to 6, further comprising a stop element configured to limit a range of movement of the first connector relative to the first dial to limit a range of movement of the outer sheath relative to the implant, the stop element being removable and repositionable to adjust the range of movement. (8) The system of any one of embodiments 1 to 7, comprising a third inner catheter member and a fourth dial coupled to the third inner catheter member, the fourth dial configured to rotate the third inner catheter member and disengage the third inner catheter member from the implant when the fourth dial is rotated at least in a first direction, thereby releasing the implant from the catheter. (9) A second inner catheter member and a third dial coupled to the second inner catheter member, the third dial configured to rotate the second inner catheter member and move the locking portion of the implant toward a rotating portion of the implant when the third dial rotates in a first direction; a third inner catheter member and a fourth dial coupled to the third inner catheter member, the fourth dial configured to rotate the third inner catheter member and disengage the third inner catheter member from the implant to release the implant from the catheter, at least when the fourth dial rotates in a first direction; A system as described in any of embodiments 1 to 8, comprising: a coupling element comprising a sleeve configured to selectively lock the third dial with the fourth dial when the coupling element is engaged with the fourth dial and the third dial such that the fourth dial cannot rotate independently relative to the third dial. (10) The system of claim 9, further comprising a removable locking element configured to selectively prevent the connecting element from disengaging from the third dial and the fourth dial, the locking element comprising a suture.

[0163] (11) The system of any one of embodiments 1 to 10, wherein the other sheath comprises an inner layer and an outer layer, the outer layer being positioned over the inner layer along at least a portion of the length of the inner layer such that a distal end of the inner layer having a plurality of openings therein is not covered by the outer layer. (12) The system of embodiment 11, wherein the plurality of openings comprises a plurality of angled slits formed in the inner layer of the outer sheath, the plurality of angled slits configured to increase flexibility of the outer sheath and allow passage of contrast agent therethrough. (13) A system described in any of embodiments 1 to 12, comprising a support stand for supporting the catheter and at least one guide catheter, the support stand being configured to be positioned on a support surface, such as a bed or table, or on a patient's body. (14) The system of embodiment 13, wherein the support stand for supporting the catheter has a slot therein configured to receive a protrusion of the catheter, and the catheter has a locking element configured to selectively secure the catheter at a desired position along the slot when the locking element is engaged. (15) A method for treating a left atrial appendage, comprising: advancing an implant into the left atrial appendage; engaging an interior wall surface of the left atrial appendage with a portion of the implant; rotating the implant from an initial position in a first direction through a first predetermined angle; moving the implant proximally a first predetermined distance; and rotating the implant in the first orientation a second predetermined angle.

[0164] (16) The method of embodiment 15, comprising: after rotating the implant in the first direction by the first predetermined angle, moving the implant in the proximal direction by the first predetermined distance; and after moving the implant in the proximal direction by the first predetermined distance, rotating the implant in the first direction by the second predetermined angle. (17) The method of embodiment 15, comprising simultaneously moving the implant in the proximal direction the first predetermined distance and rotating the implant in the first direction the first predetermined angle. (18) The method according to any one of embodiments 15 to 17, further comprising preventing the implant from rotating back to its initial position. (19) The method of any of embodiments 15 to 18, comprising deploying a fixation element to prevent the implant from rotating back to the initial position after rotating the implant through the second predetermined angle in the first direction. (20) The method according to any of embodiments 15 to 19, wherein rotating the implant in the first direction by the second predetermined angle includes rotating the implant to a final rotational position, the method further including deploying a fixation element to prevent the implant from rotating back to the initial position after rotating the implant to the final rotational position.

[0165] (21) The method according to any one of embodiments 15 to 20, wherein the first predetermined angle is 90 degrees or greater. (22) The method according to any one of embodiments 15 to 20, wherein the first predetermined angle is 180 degrees or more. (23) The method according to any one of embodiments 15 to 20, wherein the first predetermined angle is between 200 degrees and 330 degrees. (24) The method according to any one of embodiments 15 to 23, wherein the first predetermined distance is 0.5 cm or more. (25) The method according to any one of embodiments 15 to 23, wherein the first predetermined distance is between 0.25 cm and 1.75 cm.

[0166] (26) The method according to any one of embodiments 15 to 25, wherein the second predetermined angle is 15 degrees or more. (27) The method according to any one of embodiments 15 to 25, wherein the second predetermined angle is 30 degrees or more. (28) The method according to any one of embodiments 15 to 25, wherein the second predetermined angle is between 30 degrees and 90 degrees. (29) The method of any of embodiments 15 to 25, further comprising expanding the implant from a first state to a second state before rotating the implant through the first predetermined angle in the first direction, wherein at least a portion of the implant is radially expanded when the implant is in the second state compared to when the implant is in the first state. (30) The method of any one of embodiments 15 to 29, comprising preventing the implant from rotating back to the first rotational position.

[0167] (31) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; the contact member is configured to engage an interior tissue surface of the left atrial appendage and is configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, having been twisted to at least the second position, from untwisting and returning to the first position of the left atrial appendage; The implant is configured such that rotating the contact member 90° or approximately 90° from the first position causes the contact member to contact and rotate at least an end of the tissue of the left atrial appendage, and such that rotating the contact member 90° or approximately 90° to 180° or approximately 180° causes the tissue of the left atrial appendage to twist and contract around the implant, at least between the contact member and the fixation element. (32) The device of embodiment 31, wherein the implant is configured such that rotating the contact member greater than or approximately greater than 180° causes the tissue of the left atrial appendage to continue to twist and contract around the implant primarily between the contact member and the fixation element. (33) The device of any of embodiments 31 to 32, wherein the implant is configured such that rotating the contact member 90° or approximately 90° from the first position causes the contact member to contact and rotate at least an end of the tissue of the left atrial appendage without forming any overlap or fold in the tissue of the left atrial appendage around the contact member. (34) A device described in any of embodiments 31 to 33, wherein an outer width or diameter of the fixation element at an outer point of the fixation element is smaller than the width of the outer surface of the contact member when the contact member and the fixation element are in an expanded, operable state. (35) The device of any of embodiments 31 to 34, wherein the width of the outer surface of the contact member is at least 90% or at least approximately 90% of the inner size or diameter of the LAA at or adjacent the end of the LAA when the contact member is in an expanded, operable state.

[0168] (36) A device described in any one of embodiments 31 to 35, wherein the length of the outer surface of the contact member is less than or approximately less than 50% of the width of the outer surface of the contact member when the contact member is in an expanded, operable state. (37) The device of any of embodiments 31 to 36, wherein the length of the outer surface of the contact member is 30% or approximately 30% to 60% or approximately 60% of the width of the outer surface of the contact member when the contact member is in an expanded, operable state. (38) The device described in any one of embodiments 31 to 37, wherein the contact member is configured to rotate in at least the first direction from the first position to the second position when a torque is applied to the contact member. (39) A device described in any of embodiments 31 to 38, wherein the contact member is configured to rotate in at least the first direction from a first position to at least a second position to twist the left atrial appendage when the contact member engages an internal tissue surface or the left atrial appendage and reduce the size of the ostium of the left atrial appendage from a first size to a second size. (40) The device of any one of embodiments 31 to 39, wherein the implant is configured to prevent the ostium of the left atrial appendage from enlarging back to the first size.

[0169] (41) The device described in any one of embodiments 31 to 40, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the operable state of the fixation element. (42) A device described in any of embodiments 31 to 41, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the operable state of the fixation element, and the fixation element is configured to prevent rotation of the contracted tissue of the left atrium and / or the left atrial appendage as a result of the rotation of the contact member from the first position to the second position. (43) A device described in any one of embodiments 31 to 42, wherein the contact member is configured to move between a first state and a second state, and an outer dimension of the contact member is larger in the second state than in the first state. (44) The device of embodiment 40, wherein the contact member is biased to remain in the second state after deployment into the left atrial appendage. (45) The device described in any one of embodiments 31 to 44, wherein the contact member is configured to have a substantially fixed, unchanging size and shape.

[0170] (46) A device described in any of embodiments 31 to 45, wherein the contact member is self-expandable such that the contact member automatically expands from the first state to the second state when a restraint is removed from the implant without further intervention from a user. (47) A device described in any of embodiments 31 to 46, wherein the contact member is configured to automatically move from the first state to the second state when a restraint is released from the contact member, and the contact member is configured to engage a wall portion of the left atrial appendage when the contact member is in the second state and advances into the left atrial appendage. (48) A device described in any one of embodiments 31 to 47, wherein the contact member has a plurality of tissue anchors on its outer surface. (49) The device of embodiment 48, wherein the plurality of tissue anchors on or adjacent to the outer surface of the contact member are configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second state. (50) A device described in any of embodiments 31 to 49, wherein the device is configured to contract tissue of the left atrium and / or the left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second position.

[0171] (51) The device of embodiment 50, wherein the fixation element is configured to engage the tissue contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction opposite to the first direction. (52) A device described in any one of embodiments 31 to 51, wherein in the operable position, the fixing element is configured to at least prevent the contact member from rotating back to the first position. (53) A device described in any of embodiments 31 to 52, wherein the fixation element is configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixation element is implanted in a tissue surface surrounding an ostium of the left atrial appendage, the second direction being opposite to the first direction. (54) A device described in any one of embodiments 31 to 53, wherein the fixation element is configured to at least expand from a first state to a second state, and an outer dimension of the fixation element is larger in the second state than in the first state. (55) A device described in any one of embodiments 31 to 54, wherein the fixation element has multiple arms.

[0172] (56) A device described in any one of embodiments 31 to 55, wherein the fixation element comprises a plurality of posts and a plurality of interconnections between adjacent posts of the plurality of posts. (57) A device described in any of embodiments 31 to 55, wherein at least an end of each of the multiple arms of the fixing element faces generally away from the contact member when the fixing element is in the first state and faces generally toward the contact member when the fixing element is in the second state. (58) A device described in any one of embodiments 31 to 57, comprising a restraint configured to be axially movable relative to at least a portion of the fixation element from a first position in which the multiple arms of the fixation element are restrained by the restraint to a second position in which the multiple arms of the fixation element are not restrained by the restraint. (59) A device as described in any of embodiments 31 to 58, comprising a restraint configured to be axially movable relative to at least a portion of the fixation element between a first position in which the arms of the fixation element are restrained by the restraint and a second position in which the arms of the fixation element are not restrained by the restraint, the second axial position being closer to the first portion of the implant than the first axial position. (60) The device of embodiment 59, wherein the restraint is configured to be axially movable relative to at least a portion of the fixation element from the second position in which the arms of the fixation element are not restrained by the restraint to the first position in which the arms of the fixation element are restrained by the restraint to facilitate repositioning and / or removal of the implant.

[0173] (61) The device of embodiment 59 or 60, further comprising a threaded member configured to move the restraint from the first position to the second position upon rotation of the threaded member. (62) The device of any one of embodiments 59 to 61, wherein the restraint is rotatable relative to the threaded member such that the restraint is not rotated when the threaded member is rotated. (63) The device described in any one of embodiments 31 to 62, wherein the fixation element has a helical shape and is configured to rotate around a body portion of the implant during the implantation procedure. (64) A device described in any of embodiments 31 to 63, wherein only a portion of the fixation element extends into the left atrium after deployment of the device, and all other portions of the device are within the left atrial appendage after deployment of the device. (65) A device described in any one of embodiments 31 to 64, wherein the fixing element is movable between a first state in which the fixing element can freely rotate relative to the contact member and a second state in which the fixing element is locked against rotation relative to the contact member.

[0174] (66) The device of embodiment 65, wherein one of the fixing element and the contact member has a recess and the other of the fixing element and the contact member has a protrusion configured to selectively engage with the recess, wherein when the fixing element is in the first state, the protrusion is spaced from the recess and when the fixing element is in the second state, the protrusion engages with the recess. (67) The device described in any one of embodiments 31 to 66, further comprising a retaining element configured to selectively couple the fixing element to the contact member at any one of a range of selectable distances when the fixing element is in the second position. (68) The device of embodiment 67, wherein the retaining element comprises a threaded shaft configured to threadably engage with the contact member, the threaded shaft being coupled to the fixing element. (69) A device described in any of embodiments 67 to 68, wherein the retaining element is adjustable to move the fixing element between at least a first position and a second position, and the fixing element is closer to the contact member when the retaining element is in the second position compared to when the retaining element is in the first position. (70) The device of embodiment 69, wherein the retaining element comprises a threaded member, and rotation of the threaded member in a first direction moves the fixing element toward the contact member and rotation of the threaded member in a second direction moves the fixing element away from the contact member.

[0175] (71) The device described in any one of embodiments 31 to 70, wherein the second position is at least one-quarter of a complete rotation relative to the first position. (72) The device described in any one of embodiments 31 to 71, wherein the second position is at least half a full rotation relative to the first position. (73) The device described in any one of embodiments 31 to 72, wherein the second position is approximately one-quarter to one or more full rotations relative to the first position. (74) The device described in any one of embodiments 31 to 73, comprising a catheter selectively coupled to the contact member and configured to apply a torque to the contact member until a predetermined threshold torque level is reached, thereby rotating the contact member from the first position. (75) The device of embodiment 74, wherein the predetermined threshold torque level is between approximately 0.0018 N·m (0.25 in-oz) of torque and approximately 0.0706 N·m (10 in-oz) of torque.

[0176] (76) The device of embodiment 74, wherein the predetermined threshold torque level is between approximately 0.0035 N·m (0.5 in-oz) of torque and approximately 0.0353 N·m (5 in-oz) of torque. (77) The device of any one of embodiments 31 to 76, wherein no more than approximately 10% of the total length of the deployed device extends into the left atrium after deployment of the device. (78) A device described in any of embodiments 31 to 77, wherein the proximal portion of the contact member is configured to urge any folds or overlapping tissue of the left atrial appendage that form around the contact member as a result of the rotation of the contact member within the left atrial appendage to slide or move proximally away from the contact member, such that only a minimal amount, if any, of folds or overlapping tissue forms around the outer periphery of the contact member. (79) The device of any one of embodiments 31 to 78, wherein the fixing element is rotationally fixed to the contact member such that rotation of the contact member causes equal and simultaneous rotation of the fixing element. (80) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; a contact member configured to engage an interior tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage to close or occlude the left atrial appendage from blood communication with the left atrium; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, once closed to blood communication, from reopening from the first position of the left atrial appendage; A device, wherein a length of the outer surface of the contact member is less than or approximately less than 60% of a width of the outer surface of the contact member when the contact member is in an expanded, operable state.

[0177] (81) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; a contact member configured to engage an interior tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, having been twisted to at least the second position, from untwisting and returning to the first position of the left atrial appendage; A device wherein the width of the outer surface of the contact member is at least 80% or approximately 80% of the inner size or diameter of the LAA at or adjacent to the end of the LAA when the contact member is in an expanded, operable state. (82) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; a contact member configured to engage an interior tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, having been twisted to at least the second position, from untwisting and returning to the first position of the left atrial appendage; The device, wherein the contact member is configured to urge the tissue of the left atrial appendage twisted into the second position to form a plurality of folds in such tissue when the contact member is in the second position, and to urge the tissue not to form folds around the contact member. (83) A method for treating a left atrial appendage, comprising: advancing a deployment device having an implant into the left atrium; moving at least a portion of an outer surface of a contact member of the implant and / or one or more tissue anchors on or adjacent to the outer surface of the contact member of the implant against an inner wall surface of the left atrial appendage; rotating the first portion of the implant from a first position to a second position that is between 80 degrees and 100 degrees from the first position to rotate at least an end of the left atrial appendage; continuing to rotate the first portion of the implant from the first position through 160 degrees to 200 degrees to wrap the left atrial appendage around at least a portion of the implant proximal to the contact member; and engaging the tissue of the left atrial appendage with a fixation element to prevent the tissue of the left atrial appendage from unwinding wrapped around the implant. (84) The method of embodiment 83, further comprising continuing to rotate the first portion of the implant through more than 160 degrees to 200 degrees to continue wrapping the left atrial appendage and contracting around at least a portion of the implant proximal to the contact member. (85) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; a contact member configured to engage an interior tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage to close or occlude the left atrial appendage from blood communication with the left atrium; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, closed to blood communication as a result of twisting the left atrial appendage from the first position to at least the second position, from reopening to the first position of the left atrial appendage; A device, wherein a length of the outer surface of the contact member is less than or approximately less than 60% of a width of the outer surface of the contact member when the contact member is in an expanded, operable state.

[0178] (86) A device for treating a left atrial appendage, comprising: An implant, a contact member configured to move between a first state and a second state; an implant comprising a fixation element; at least a portion of the contact members are radially larger when the implant is in the second condition compared to when the implant is in the first condition; a contact member configured to engage an interior tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage from the first position to at least a second position when the contact member is engaged with the interior tissue surface of the left atrial appendage to close or occlude the left atrial appendage from blood communication with the left atrium; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, having been twisted to at least the second position, from untwisting and returning to the first position of the left atrial appendage; the fixation element is configured to engage tissue of the left atrium and / or the left atrial appendage to prevent the left atrial appendage, closed to blood communication as a result of twisting the left atrial appendage from the first position to at least the second position, from reopening to the first position of the left atrial appendage; A device, wherein a length of the outer surface of the contact member is less than or approximately less than 60% of a width of the outer surface of the contact member when the contact member is in an expanded, operable state. (87) A method of treating a left atrial appendage substantially as herein described or shown in the accompanying drawings. (88) A device configured for treating a left atrial appendage substantially as herein described or shown in the accompanying drawings.

Claims

1. 1. A system for treating a left atrial appendage, comprising: an implant configured to be positioned at least partially within the left atrial appendage; A catheter configured to deploy the implant, the catheter comprising: an outer sheath coupled to the first connector; a first dial coupled to the outer sheath; an inner catheter member configured to rotate the implant when the distal end of the inner tube is engaged with the implant; a second dial coupled to the inner catheter member; the first dial is configured to axially move the first connector and the outer sheath in a first axial direction from an initial axial position to a second axial position when the first dial is rotated in a first direction; a catheter, wherein the second dial is configured to rotate the inner catheter member and the implant in a first rotational direction from an initial position to a second rotational position when the second dial is rotated in a first direction.

2. 10. The system of claim 1, wherein the system is configured to move a rotating portion of the implant from a first state to a second expanded state and move an outer surface of the rotating portion of the implant against an inner wall surface of the left atrial appendage.

3. 3. The system of claim 1, further comprising: a second inner catheter member; and a third dial coupled to the second inner catheter member, the third dial configured to rotate the second inner catheter member and move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction.

4. 4. The system of claim 3, wherein the anchor comprises one or more arms extending away from a body portion of the implant and configured to contract around an outer surface of a portion of the implant and penetrate the inwardly gathered tissue of the left atrial appendage.

5. 4. The system of claim 3, wherein the locking portion comprises one or more arms extending away from the body portion of the locking portion, and the locking portion is configured to move from at least a first state in which the one or more arms are collapsed to a second state in which the one or more arms are expanded, such that an end of each of the one or more arms is spaced further away from the body portion of the implant when the locking portion is in the second state than when the locking portion is in the first state.

6. 6. The system of claim 5, wherein the one or more arms of the lock are configured to extend toward the rotating portion of the implant when the lock is in the second state.

7. 2. The system of claim 1, further comprising a stop element configured to limit a range of movement of the first connector relative to the first dial to limit a range of movement of the outer sheath relative to the implant, the stop element being removable and repositionable to adjust the range of movement.

8. 10. The system of claim 1, comprising a third inner catheter member and a fourth dial coupled to the third inner catheter member, the fourth dial configured, upon rotation of at least the fourth dial in a first direction, to rotate the third inner catheter member and disengage the third inner catheter member from the implant, thereby releasing the implant from the catheter.

9. a second inner catheter member and a third dial coupled to the second inner catheter member, the third dial configured to rotate the second inner catheter member and move a locking portion of the implant toward a rotating portion of the implant when the third dial is rotated in a first direction; a third inner catheter member and a fourth dial coupled to the third inner catheter member, the fourth dial configured to rotate the third inner catheter member and disengage the third inner catheter member from the implant, releasing the implant from the catheter, when the fourth dial is rotated in at least a first direction; 2. The system of claim 1, comprising: a coupling element comprising a sleeve configured to selectively secure the third dial to the fourth dial when the coupling element is engaged with the fourth dial and the third dial such that the fourth dial cannot rotate independently relative to the third dial.

10. 10. The system of claim 9, further comprising a removable locking element configured to selectively prevent the connecting element from disengaging from the third dial and the fourth dial, the locking element comprising a suture.

11. 2. The system of claim 1, wherein the other sheath comprises an inner layer and an outer layer, the outer layer positioned over the inner layer along at least a portion of its length such that a distal end of the inner layer having a plurality of openings therein is not covered by the outer layer.

12. 12. The system of claim 11, wherein the plurality of openings comprises a plurality of angled slits formed in the inner layer of the outer sheath, the plurality of angled slits configured to increase flexibility of the outer sheath and allow passage of contrast agent therethrough.

13. 10. The system of claim 1, comprising a support stand for supporting the catheter and at least one guide catheter, the support stand configured to be positioned on a support surface such as a bed or table or on a patient's body.

14. 14. The system of claim 13, wherein the support stand for supporting the catheter includes a slot therein configured to receive a protrusion of the catheter, the catheter having a locking element configured to selectively secure the catheter in a desired position along the slot when the locking element is engaged.

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