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

Abstract

Disclosed are embodiments of devices for occluding the left atrial appendage (LAA) and other cavities or openings within the body. Some device embodiments may include an implant configured to be deployed within the LAA or other cavity, configured to expand or move relative to a wall portion of the LAA or other cavity, and configured to twist at least a portion of the LAA or other cavity when the implant is rotated. One or more fixation elements, staples, sutures, or other fasteners can then be implanted within the collected tissue to hold the tissue in a collected state, thereby occluding the opening of the LAA or other cavity. In some embodiments, the opening of the LAA or other cavity can be occluded by using an implant device to stretch or otherwise reshape the opening and secure the opening in an occluded state.

Description

[Technical Field]

[0001] Priority Claims and Incorporation by Reference This application is based on U.S. patent application Ser. No. 62 / 497,352, filed March 25, 2019, entitled "LEFT ATRIAL APPENDAGE DEVICE AND TECHNIQUES," U.S. patent application Ser. No. 62 / 824,948, filed March 27, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND TECHNIQUES," U.S. patent application Ser. No. 62 / 828,351, filed April 2, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND TECHNIQUES," and U.S. patent application Ser. No. 62 / 849,713, filed May 17, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME." U.S. patent application Ser. No. 62 / 853,672, filed May 28, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. patent application Ser. No. 62 / 854,162, filed May 29, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. patent application Ser. No. 62 / 866,405, filed June 25, 2019, entitled "LEFT ATRIAL APPENDAGE CLOSURE DEVICES AND METHODS OF USING SAME"; U.S. patent application Ser. No. 62 / 880,552, filed July 30, 2019, entitled "DEVICES, SYSTEMS, AND METHODS FOR CLOSING THE LEFT ATRIAL"; U.S. patent application Ser. No. 62 / 894,501, filed August 30, 2019, entitled "Devices, Systems, and Methods for Closing the Left Atrial Appendage"; U.S. patent application Ser. No. 62 / 925, filed October 23, 2019, entitled "Devices, Systems, and Methods for Closing the Left Atrial Appendage";No. 62 / 949,338, filed December 17, 2019, entitled "DEVICES, SYSTEMS, AND METHODS FOR TREATING THE LEFT ATRIAL APPENDAGE," filed on December 17, 2019, and U.S. Patent Application No. 62 / 949,338, filed December 17, 2019, entitled "DEVICES, SYSTEMS, AND METHODS FOR TREATING THE LEFT ATRIAL APPENDAGE," filed on December 155, 2019, the contents of each of which are incorporated herein by reference in their entirety as if fully set forth herein. The benefit of priority may be claimed under appropriate statutory grounds, including, but not limited to, 35 U.S.C. § 119(e). All applications filed in this application in which a foreign or domestic priority claim is identified in the Application Data Sheet are hereby incorporated herein by reference in their entirety.

[0002] SUMMARY OF THE INVENTION Embodiments of the present disclosure 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 commonly performed to prevent emboli from exiting the LAA. A typical surgical closure involves suturing the opening closed through the left atrial ostium. Other techniques include the application of an external clamp, such as the ATRICLIP, manufactured by Atricure, in which a nitinol device is used to clamp the appendage without opening the left atrium, excluding the appendage from left atrial blood circulation.

[0004] Another solution uses a plug to close the appendage from inside the left atrium. Such a plug can be constructed from a laser-cut nitinol tube expanded into a hemispherical shape. The portion exposed to the left atrium can be covered with a covering, such as a thin micron membrane made from polyethylene terephthalate. The membrane can act as a blood barrier to prevent blood flow through and between one or more struts of the plug. Typical sizes range from approximately 20 mm to 35 mm in diameter and approximately 20 mm to 40 mm in depth. The device can have anchors protruding from its outer surface intended to engage with the wall of the appendage and prevent migration after deployment. The device can be delivered via venous access to the left atrium, via the groin and transseptal access, with a guide catheter and coaxial delivery catheter placed proximal to the left atrial appendage. The appendage exclusion implant is typically located in 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-procedure sizing algorithms used to determine 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 the devices are designed to reduce. Typical medications associated with conventional LAA treatment devices include warfarin anticoagulation for 45 days (approximately 6 weeks), followed by dual antiplatelet therapy (DAPT) for 6 months post-procedure, followed by aspirin. Another procedure commonly required with conventional LAA treatment devices includes a follow-up transesophageal echocardiogram 6 weeks after the procedure. The incidence of device-related thrombus in patients undergoing LAA imaging is reported to be 7.2% per year. Summary of the Invention

[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 embodiments of devices and systems for treating the LAA that may include an implant including a contact member configured to move between a first state and a second state and a fixation element, wherein the contact member is 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 after the contact member is advanced into the LAA, the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member is 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 is configured to prevent rotation of the implant in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction.

[0007] Also disclosed herein are embodiments of devices and systems for treating the LAA that 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 such that the implant can twist at least a portion of the LAA when the implant is in the second state.

[0008] Also disclosed herein are embodiments of devices and systems for retracting a first tissue surface toward a second tissue surface, the devices 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 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 configured to rotate in at least a first direction from a first rotational position to a second rotational position, wherein rotation of the contact member in the first direction causes at least a proximal portion of the first tissue surface to twist and move toward a proximal portion of the second tissue surface, and 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 and second tissue surfaces, the second direction being opposite the first direction. Further, in any device and / or system embodiment disclosed herein, the device may be configured to occlude or close a body cavity having a first tissue surface and a second tissue surface, where the first and second tissue surfaces may be tissue surfaces within any body cavity, and / or rotation of the contact member further causes a proximal portion of the second tissue surface to twist and move toward the proximal portion of the first tissue surface.

[0009] Any embodiment of the devices and systems disclosed herein can, in further embodiments, 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 embodiment disclosed herein: 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 deployed 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 clockwise or counterclockwise; and the device is configured to contact the left atrium and / or the left atrium when the contact member is rotated to the second rotational position. or an implant configured to contract tissue of the LAA around an outer surface of a body portion of the implant, wherein a fixation element is configured to engage with the tissue contracted around 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 with an inner wall of the heart adjacent the LAA; the fixation element has a helical shape and is configured to rotate around the body portion of the implant during an 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, wherein the plurality of tissue anchors on the outer surface of the contact member are configured to engage with an inner wall surface of the LAA after the contact member is moved to the second state; the implant includes a fixation element configured to engage with tissue portions of the heart adjacent the LAA; the second rotational position is at least one-quarter of a rotation relative to the first rotational position;The second rotational position is at least half a rotation relative to the first rotational position, and / or the second rotational position is from approximately one-quarter of a rotation to one or more full rotations relative to the first rotational position.

[0010] Additionally, any of the embodiments of the devices and systems disclosed herein can, in further embodiments, 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 embodiment disclosed herein, further including a catheter selectively coupled to the contact member and applying a torque on the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being approximately 0.25 in-oz. (1.765 mN m) ~approximately 10in-oz (70.6mN·m) of torque, the threshold predetermined torque level is approximately 0.5 in-oz (3.531 mN m) ~approximately 5in-oz (35.31 mN m)and a retaining member configured to urge the fixation element toward the tissue wall of the LAA, and a retaining member configured to urge the fixation element toward the contact member, and a retaining member configured to couple the fixation element to the contact member, the retaining member comprising a threaded shaft, and the device configured such that rotation of the retaining member in a first direction moves the fixation element toward the contact member, the contact member configured to rotate in at least a first direction from a first rotational position to a second rotational position when torque is applied to the contact member, the device configured such that the contact member can be removed from the LAA after the fixation element is deployed to an operative state of the fixation element, and the device configured such that the contact member can be removed from the LAA after the fixation element is deployed to an operative state of the fixation element, and the fixation element is configured to prevent rotation of tissue of the left atrium and / or LAA contracted as a result of rotation of the contact member from the first rotational position to the second rotational 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 LAA after deployment of the device, and 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 is configured for use with a surgical robotic device or system, the surgical robotic device including one or more robotic arms; any embodiment of the device disclosed herein is configured for use with a surgical robotic device, the contact member and the fixation element are integrally formed and / or integrally formed; the device is configured to contract tissue of the left atrium and / or LAA around an outer surface of the body portion of the implant when the contact member is rotated to a second rotational position; and the fixation element is configured to compress the contracted 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.

[0011] Some embodiments of devices and systems for closing or occluding the left atrial appendage (LAA) disclosed herein can 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 being 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 is rotated from a first rotational position to a second rotational position. In any of the embodiments disclosed herein, the twisting movement or step can be achieved by a torque catheter.

[0012] Any embodiment of the devices and systems disclosed herein may, in further embodiments, include 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 activated and then 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 activated; the implant is 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 is 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 past the distal end of the outer sleeve of the catheter; the implant is substantially collapsed when the implant is in the first state, and the size of the implant can be adjusted. the implant may be deployed when in the second state such that the size can be larger when the implant is in the second state than when the implant is in the first state, and after deployment into the left atrial appendage the implant may be biased to remain in the second state, the implant may be configured to rotate 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 cork screw 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 cork screw 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, and after the implant is fully deployed,The implant may be configured to prevent rotation back to the first rotational position, the implant may be configured to rotate in a first direction from the first rotational position to a second rotational position, and after the implant is fully deployed, the implant may be configured to prevent rotation of the implant in a second direction, the second direction being opposite to the first direction.

[0013] Any of the embodiments of the devices and systems disclosed herein may, in further embodiments, include one or more of the following features or details, in any combination: the implant has a plurality of tissue anchors on an exterior surface thereof, the plurality of tissue anchors on the exterior 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; and the second rotational position is at, or approximately, one-quarter of a rotation (i.e., 90 degrees or approximately 90 degrees) relative to the first rotational position. The second rotational position can be at or about one-half of a rotation (i.e., at or about 180 degrees) relative to the first rotational position, and the second rotational position can be at or about one-quarter of a rotation (i.e., at or about 90 degrees) to one or more or about one or more full rotations (i.e., at or about 360 degrees or more) relative to the first rotational position, and the catheter can be configured to exert a torque on the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being at or about 0.25 in-oz. (1.765 mN m) Torque ~10 or approximately 10 in-oz (76.62 mN m) of torque, and / or threshold predetermined torque level is 0.5 or approximately 0.5 in-oz (3.531 mN m) Torque ~5 or approximately 5 in-oz (35.31 mN m) is the torque.

[0014] Any embodiment 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 so that the outer surface of the contact member expands against the inner wall surface of the LAA after the contact member has advanced into the LAA, wherein the catheter is configured to apply a torque on 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 is rotated until a predetermined torque level is reached, allowing the contact member to twist at least a portion of the LAA.

[0015] Any embodiment of the devices and systems disclosed herein can include an expandable implant and a catheter configured to move between a first state and a second state, the 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 has advanced into the left atrial appendage such that the outer surface of the implant expands against at least a portion of the inner wall surface of the left atrial appendage. In any embodiment of the devices for closing or occluding the LAA disclosed herein, the catheter can be configured to exert a torque on 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 embodiments, until a user determines to stop, whichever occurs first.

[0016] Also disclosed herein are devices and systems for treating the LAA, including a device configured to be inserted into and engage LAA tissue while the device is rotated to a rotated position to close blood communication between the LAA and the left atrium. In any embodiment of the device, the device may be configured to be selectively lockable in a rotated position 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 to the LAA to maintain the device in the rotated position after implantation, the device may be round, spherical, or disc-shaped when the device is in a deployed state in the LAA, the device may be expandable from a first collapsed state to a second expanded state, and / or the device may self-expand from the first collapsed state to the second expanded state.

[0017] Also disclosed herein are embodiments of methods for treating the LAA, 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 embodiment of the methods disclosed herein, rotating the tissue of the LAA to close or occlude blood communication between the LAA and the left atrium can include rotating the tissue of the LAA to close or occlude the ostium of the LAA. Furthermore, any embodiment of the methods disclosed herein can further include fixing the LAA in a rotated position to maintain the LAA in a closed or occluded state.

[0018] Any embodiment of the method for closing or occluding the LAA disclosed herein can include advancing a deployment device having an implant into the left atrial appendage, where the implant can be configured to move from a first state to a second state. In some embodiments, at least a portion of the implant can radially expand when the implant is in the second state compared to the first state. The method can 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 the 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 the inner wall surface of the left atrial appendage; rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage; and preventing the implant from rotating to the first rotational position.

[0019] Any embodiment of the method of closing or occluding the LAA disclosed herein may, in some additional embodiments, include one or more of the following steps, in any combination, and in any combination with any of the other steps, features, or other details of any other embodiment: 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 a wall portion on the interior of the LAA includes engaging the wall portion on the interior of the LAA with one or more tissue anchors located on an exterior 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 be secured 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 includes engaging the tissue wall with the anchor elements. preventing the implant from rotating back to the first rotational position includes engaging cardiac tissue 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 with an anchor element outside of the closed portion of the LAA, 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 including a plurality of tissue anchors on at least one surface thereof configured to engage an inner wall of the heart outside of the LAA; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant until the 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 at least approximately 180 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 approximately 90 degrees to approximately 360 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 approximately 90 degrees to approximately 180 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 applying a torque on the implant to rotate the implant in either direction from the first rotational position until a threshold predetermined torque level is reached, holding the implant in the second rotational position, and securing the implant in approximately the second rotational position against a tissue surface surrounding the LAA, wherein the maximum predetermined torque level is approximately 0.25 in-oz. (1.765 mN m) ~approximately 10in-oz (70.62 mN m) of torque and / or maximum specified torque level is approximately 0.5 in-oz (3.531 mN m) ~approximately 5in-oz (35.31 mN m) is the torque.

[0020] Any embodiment of the method of closing or occluding the LAA disclosed herein can, in some additional embodiments, include one or more of the following steps, in any combination, and in any combination with any other step, function, or other details of any other embodiment: the implant is self-expanding; moving the implant from the first state to the second state can include advancing the implant from the distal end of the deployment device; engaging a wall portion on the interior of the left atrial appendage can include engaging at least a portion of the wall portion on the interior of the left atrial appendage or surrounding the left atrial appendage with one or more tissue anchors positioned on an exterior surface of the implant; preventing the implant from rotating back to the first rotational position can include engaging the tissue wall on the exterior of the left atrial appendage with an anchor element, which may be rotationally fixed to the implant to prevent relative movement between the anchor element and the implant; and the implant can include: Preventing the implant from rotating back to the first rotational position can 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 can include engaging an inner 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; the anchor element may include a plurality of tissue anchors on at least one surface thereof configured to engage the inner 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 can include rotating the implant until the ostium of the LAA is substantially or completely closed or occluded or folded around the outer surface of the implant.

[0021] Any embodiment of the method of closing or occluding the LAA disclosed herein may, in any additional embodiments, include one or more of the following steps, in any combination, and in any combination with any other step, feature, or other detail of any other embodiment: rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage includes rotating the implant at least or approximately one-quarter of a rotation relative to the first rotational position (i.e., 90 degrees or approximately 90 degrees relative to the first rotational position); rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage includes rotating the implant at least or approximately one-half of a rotation (i.e., 180 degrees or approximately 180 degrees) 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 left atrial appendage includes rotating the implant at least or approximately one-quarter of a rotation (i.e., 90 degrees or approximately 90 degrees) to one or approximately one rotation (i.e., and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage includes rotating the implant from the first rotational position to either one-quarter of a rotation (i.e., at or about 90 degrees) to one-half of a rotation (i.e., at or about 180 degrees), or more than one rotation (i.e., more than 360 degrees) in either direction from the first rotational position. wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage includes exerting a torque on the implant to rotate the implant in either direction from the first rotational position until a threshold predetermined torque level is reached, and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage can include holding the implant in the second rotational position, 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 from the first rotational position to the second rotational position to twist the left atrial appendage against a tissue surface surrounding the left atrial appendage.and securing the implant in approximately a second rotational position, the maximum predetermined torque level being approximately 0.25 in-oz. (1.765 mN m) ~approximately 10in-oz (70.62 mN m) of torque and / or maximum specified torque level is approximately 0.5 in-oz (3.531 mN m) ~approximately 5in-oz (35.31 mN m) is the torque.

[0022] Some embodiments of implants for deployment within a cavity or vessel disclosed herein include an expandable body, a plurality of tissue anchors on an exterior 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 to the inner wall surface of the cavity or vessel.

[0023] Any embodiment of the devices and systems disclosed herein can include an expandable implant having a plurality of tissue anchors on its exterior surface, the 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 has been advanced into the left atrial appendage so that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage. In some embodiments, the catheter can 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.

[0024] Some embodiments of the devices and systems for closing or occluding the LAA disclosed herein can 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 after the implant has advanced into the left atrial appendage such that an outer surface of the implant moves against an inner wall surface of the inner wall of the left atrial appendage. In some embodiments, the catheter can 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.

[0025] Any embodiment of the method 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 substantially inhibit or inhibit, blood communication between the left atrial appendage and the left atrium. Any embodiment of the method disclosed herein may, in further embodiments, 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 embodiment of the method of treatment disclosed herein, wherein rotating the tissue of the left atrial appendage to close blood communication between the left atrial appendage and the left atrium further includes rotating the tissue of the left atrial appendage to close an ostium in the left atrial appendage, and / or further includes fixing the left atrial appendage in a rotated position to hold the left atrial appendage closed.

[0026] Some embodiments of the 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 some embodiments, 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 formed in a round, spherical, or disk shape when the device is in a deployed state within the left atrial appendage, the device may be expandable from a first collapsed state to a second expanded state, and / or the device may self-expand from the first collapsed state to the second expanded state.

[0027] Disclosed herein are additional embodiments of implants for treating the LAA, which are configured to elongate or stretch the opening of the LAA. In any of the embodiments of such implants disclosed herein, the implant can include a frame expandable from a collapsed state to an expanded state, the frame including a wall having an elongated shape along the entire length of the frame, at least in the expanded state, and an opening extending axially through the frame from the proximal end to the distal end of the frame, the opening being surrounded by the wall. In any of the embodiments disclosed herein, the frame can be configured to define a first width in a first direction from a first portion to a second portion across the opening of the frame that is greater than a second width in a second direction perpendicular to the first direction.

[0028] Additionally, any embodiment of an implant for treatment of the LAA disclosed herein can, in further embodiments, 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 embodiment disclosed herein: a first apex extension extending away from the proximal end of the frame at a first portion of the wall, the first apex extension may be configured to bias the proximal end of the frame into approximately alignment with an outer edge of the ostium; a first apex extension extending away from the proximal end of the frame at a first portion of the wall, the first apex extension may be configured to prevent the frame from passing completely through the ostium of the LAA; a first apex extension extending away from the proximal end of the frame at a first portion of the wall, the first apex extension configured to prevent the frame from passing completely through the ostium of the LAA; the first apex extension may be configured to overlap an outer surface of a wall portion surrounding the ostium of the LAA when the implant is in an operative position within the LAA; the second apex extension extends away from the proximal end of the frame at a second portion of the wall; the second apex extension extends away from the proximal end of the frame at a second portion of the wall; the second apex extension may be configured to bias the proximal end of the frame into approximately alignment with an outer edge of the ostium; the second apex extension extends away from the proximal end of the frame at a second portion of the wall; the second apex extension may be configured to prevent the frame from passing completely through the ostium of the LAA; and / or the second apex extension extends away from the proximal end of the frame at a second portion of the wall of the frame; the second apex extension may be configured to overlap an outer surface of a wall portion surrounding the ostium of the LAA when the implant is in an operative position within the LAA.

[0029] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein: the first width of the opening in the frame is at least approximately twice the second width of the frame, but is no more than approximately 10 times the second width of the opening in the frame when the implant is in a naturally expanded state outside of the body; the first width of the opening in the frame is between approximately 2 times and approximately 5 times the second width of the opening in the frame when the implant is in a naturally expanded state outside of the body; and the first width of the opening in the frame is between approximately 2 times and approximately 4 times the second width of the opening in the frame when the implant is in a naturally expanded state outside of the body. wherein the first width of the frame opening when the implant is in a naturally expanded state outside the body is about 3 to about 4 times the second width of the frame opening; the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a naturally expanded state outside the body is at least about 2:1; the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a naturally expanded state outside the body is about 2:1 to about 5:1; the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a naturally expanded state outside the body is about 3:1 to about 4:1; and / or the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a naturally expanded state outside the body is about 3.5:1.

[0030] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein: the first width of the frame opening is at least approximately two times the second width of the frame opening and is no more than approximately ten times the second width of the frame opening when the implant is in a deployed state in the LAA; the first width of the frame opening is between approximately two times and approximately five times the second width of the frame opening when the implant is in a deployed state in the LAA; the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a deployed state in the LAA is about 2 to about 4 times the width of the frame opening, and the ratio of the first width of the frame opening to the second width of the frame opening when the implant is in a deployed state in the LAA is at least about 2:1, and the ratio of the first width of the frame opening to the second width of the frame when the implant is in a deployed state in the LAA is about 2:1 to about 5:1, and the ratio of the first width of the frame to the second width of the frame when the implant is in a deployed state in the LAA is about 3:1 to about 4:1, and / or the ratio of the first width of the frame to the second width of the frame when the implant is in a deployed state in the LAA is about 3.5:1.

[0031] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein; wherein the implant may be configured to alter the shape of the ostium such that the first width of the ostium is at least approximately twice the second width of the ostium, but not more than approximately 10 times the second width of the ostium when the implant is in a deployed state in the LAA; wherein the implant may be configured to alter the shape of the ostium such that the first width of the ostium is between approximately two and approximately five times the second width of the ostium when the implant is in a deployed state in the LAA; wherein the implant may be configured to alter the shape of the ostium such that the first width of the ostium is between approximately two and approximately four times the second width of the ostium when the implant is in a deployed state in the LAA; The implant may be configured to alter the shape of the ostium such that, when the implant is in a deployed state in the LAA, the first width of the ostium is about 3 to about 4 times the second width of the ostium; the implant may be configured to alter the shape of the ostium such that, when the implant is in a deployed state in the LAA, the ratio of the first width of the ostium to the second width of the ostium is at least about 2:1; the implant may be configured to alter the shape of the ostium such that, when the implant is in a deployed state in the LAA, the ratio of the first width of the ostium to the second width of the ostium is about 2:1 to about 5:1; the implant may be configured to alter the shape of the ostium such that, when the implant is in a deployed state in the LAA, the ratio of the first width of the ostium to the second width of the ostium is about 3:1 to about 4:1; the implant may be configured to alter the shape of the ostium such that, when the implant is in a deployed state in the LAA, the ratio of the first width of the ostium to the second width of the ostium is about 3:1 to about 4:1;The frame may be configured to change the shape of the ostium to a 5 to 1 ratio, further comprising anchor elements configured to secure the frame to the LAA located at at least a first portion and a second portion of the frame, the frame comprising gripping features on an outer surface of the frame at least in the first and second portions of the frame configured to inhibit movement of the frame relative to a tissue surface of the ostium of the LAA, the frame comprising first and second roughened regions on the outer surface of the frame at the first and second portions, respectively, the first and second roughened regions configured to inhibit movement of the frame relative to the tissue surface of the ostium of the LAA, a cover coupled to the frame, the cover at least partially covering the opening in the frame, the cover coupled to the frame, the cover completely covering the opening in the frame, the cover comprising a mesh material, and / or the first and second ends of the frame configured to extend a first portion of the ostium of the LAA away from a second portion of the opening opposite the first portion to extend the ostium of the LAA in a first direction.

[0032] Further, in any embodiment of the implant disclosed herein, the implant can include a frame expandable from a collapsed state to an expanded state, the frame including a wall having an elongated shape along at least the entire length of the frame in the expanded state, and an opening extending axially through the frame from the proximal end to the distal end of the frame, the opening being surrounded by the wall. In some embodiments, the elongated shape can define a first width in a first direction from a first portion of the frame across the opening in the frame to a second portion of the frame when the implant is in an operable position at least twice as large as a second width in a second direction perpendicular to the first direction, and the proximal end of the frame is flared outward at least at the first portion and the second portion of the frame. In any embodiment disclosed herein, the first width can be about two to about five times larger than the second width; the first width can be about three to about five times larger than the second width; the first width can be about three to about four times larger than the second width; and / or the first and second portions of the frame can be configured to widen a first portion of the ostium of the LAA away from a second portion of the opening opposite the first portion to stretch the ostium of the LAA in a first direction.

[0033] Furthermore, any of the implant, device, and / or system embodiments disclosed herein can be adapted and / or used to treat any bodily orifice, chamber, or cavity. Any of the implant embodiments disclosed herein can include a frame expandable from a collapsed state to an expanded state, the frame including a wall continuously surrounding an opening extending through the frame, a plurality of openings extending through the wall, a first recess in a first portion of the wall, and a second recess in a second portion of the wall, wherein the first and second recesses may be configured to receive an edge of the wall of the bodily orifice when the implant is expanded against the wall of the opening, and the first and second recesses are configured to bias the edge of the bodily orifice to remain in the first and second recesses. In any of the embodiments disclosed herein, the recesses may have a curved profile. Furthermore, the first and second portions of the frame wall may be configured to extend a first portion of the opening of the opening away from a second portion of the opening opposite the first portion to extend the opening of the opening.

[0034] In any embodiment disclosed herein, the implant may include a frame expandable from a first state to a second state, the frame having a first portion movable in a first direction when the frame is expanded from the first state to the second state, a second portion connected to the first portion, the second portion movable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite to the first direction, a length in a longitudinal direction (also referred to herein as a first direction) between an end of the first portion and an end of the second end, a width in a width direction (also referred to herein as a second direction) perpendicular to the longitudinal direction, and a height in a height direction (also referred to herein as a third direction) perpendicular to the longitudinal and width directions.

[0035] Any embodiment of the implant disclosed herein can, in further embodiments, 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 embodiment disclosed herein, wherein when the frame is in a first state, the frame is advanceable through a delivery catheter, and when the frame is expanded from the first state to a second state, the length of the frame increases, and / or when the frame is expanded from the first state to the second state, the width and height of the frame remain generally constant.

[0036] Additional embodiments of implants for treating the LAA are also disclosed herein. In any of the implant embodiments disclosed herein, the implant may include a frame expandable from a first state to a second state, the frame including a central portion, a first end connected to the central portion, the first end expandable in a first direction when the frame is expanded from the first state to the second state, a second end connected to the central portion, the second end expandable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite to the first direction, and a longitudinal length between the first end and the second end and / or a width perpendicular to the longitudinal direction.

[0037] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein, wherein the frame is advanceable through a delivery catheter when the frame is in a first state, wherein a length of the frame increases when the frame is expanded from the first state to a second state, and / or a width of the frame remains approximately constant when the frame is expanded from the first state to the second state, the implant comprising a frame expandable from the first state to the second state, the frame having a central portion and a first end coupled to the central portion, the first end expandable in a first direction when the frame is expanded from the first state to the second state, the second end coupled to the central portion, the second end expandable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite the first direction, a longitudinal length between the first end and the second end, and a longitudinal width of the frame. and a width in a width direction perpendicular to the longitudinal direction, wherein the frame is advanceable through a delivery catheter when the frame is in a first state, and a length of the frame increases when the frame is expanded from the first state to a second state, the first and second ends of the frame are configured to spread a first portion of the ostium of the LAA away from a second portion of the ostium opposite the first portion so as to longitudinally stretch the ostium of the LAA, the frame further includes a clip configured to hold two or more portions of tissue of the LAA together, and the frame further includes at least one cushion coupled to at least one of the first end and the second end of the frame, the frame may be configured to increase in size in the longitudinal direction without increasing in size in any other direction, the frame is self-expandable from the first state to the second state, the second stage portion includes a hinge mechanism for contracting or closing the opening of the LAA, and further includes at least one of a passive activation mechanism and an active activation mechanism for actuating the hinge mechanism, and at least a portion of the frame may be configured to be longitudinally contractible to decrease the length of the frame in the longitudinal direction,The frame includes a length of wire having a U-shape configured to allow cantilever bending near a central portion of the frame, the frame includes a torsion spring wire form near a central portion of the frame, the frame includes a plurality of U-shaped cantilever sections or torsion spring forms, the frame is formed from round wire, wire strips, or laser cut sheets, and / or the frame includes at least one of a polymer, a composite, a metal, and a superelastic shape memory alloy.

[0038] In any of the implant embodiments disclosed herein, the implant can include a frame expandable from a first state to a second state, the frame having a central portion, a first end coupled to the central portion, the first end being expandable in a first direction when the frame is expanded from the first state to the second state, and a second end coupled to the central portion, the second end being expandable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite to the first direction, a longitudinal length between the first end and the second end, and a width perpendicular to the longitudinal length. In any of the embodiments disclosed herein, the frame can be advanceable through a delivery catheter when the frame is in the first state, and the length of the frame can increase when the frame is expanded from the first state to the second state, and / or the frame can be configured to increase the size of the ostium of the LAA longitudinally and decrease the size of the ostium of the LAA widthwise when the frame is expanded from the first state to the second state.

[0039] In any embodiment disclosed herein, the implant may be adapted for use in closing, restricting, constricting, and / or occluding any vessel, opening, chamber, or cavity in the body, and includes a frame expandable from a first state to a second state, the frame having a central portion including a proximal portion, a first portion extending distally from the proximal portion, and a second portion extending distally from the proximal portion; a first leg connected to a first end of the central portion, the first leg expandable in a first direction when the frame is expanded from the first state to the second state; a second leg connected to a second end of the central portion, the second leg expandable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite to the first direction; a longitudinal length between the first end and the second end; and a width in a width direction perpendicular to the longitudinal direction.

[0040] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein: the first leg and the second leg are integrally formed with the central portion; when the frame is in a first state, the frame is advanceable through a delivery catheter; when the frame is expanded from the first state to the second state, the length of the frame increases; and the frame may be configured to longitudinally increase a size of the ostium of the LAA and widthwise decrease a size of the ostium of the LAA when expanded from the first state to the second state such that the frame draws a first wall of the LAA closer to a second wall of the LAA; the first leg and the second leg are configured to spread a first portion of the ostium of the LAA away from a second portion of the ostium opposite the first portion to longitudinally stretch the ostium of the LAA; and further include a clip configured to hold two or more portions of tissue of the LAA together, wherein at least one of the first and second legs is configured to extend the first portion of the ostium of the LAA away from a second portion of the ostium opposite the first portion to longitudinally stretch the ostium of the LAA. the frame may be configured to increase in size in a longitudinal direction without increasing in size in any other direction; the frame is self-expandable from a first state to a second state and further comprises an anchor element for securing one or more walls of the LAA opening to another wall of the LAA opening; the implant comprises a hinge mechanism for contracting or closing the LAA opening and further comprises at least one of a passive activation mechanism and an active activation mechanism for actuating the hinge mechanism; at least a portion of the frame may be configured to be longitudinally contractible to decrease a length of the frame in a longitudinal direction; the frame comprises a length of wire having a U-shape configured to allow cantilever bending near a central portion of the frame; the frame comprises a torsion spring wire form near a central portion of the frame; the frame comprises a plurality of U-shaped cantilever sections or torsion spring forms; the frame is formed from a round wire, a wire strip, or a laser cut sheet; and / or the frame is made of a polymer, a composite, a metal,and superelastic shape memory alloys.

[0041] Disclosed herein are embodiments of a device for treating a left atrial appendage, 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 on the contact member when at least a portion of the catheter is rotated until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position such that the contact member can twist at least a portion of the left atrial appendage. In any of the embodiments disclosed herein, the contact member can 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 can be configured to be movable or expandable from a first state to a second state.

[0042] Disclosed herein are embodiments of a device for reducing an opening of a left atrial appendage, including a contact member and a fixation element, wherein the contact member is configured to engage a tissue surface of the left atrial appendage, the contact member is 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, and reduce the opening of the left atrial appendage from a first size to a second size, and / or the fixation element is 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 embodiments disclosed herein, the contact member may be configured to engage a tissue surface on the exterior surface of the left atrial appendage. Furthermore, in any of the embodiments 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.

[0043] Additional embodiments of implants for treating the LAA are also disclosed herein. In any embodiment disclosed herein, the implant may include a frame expandable from a first state to a second state, the frame having a central portion, a first end connected to the central portion, the first end expandable in a first direction when the frame is expanded from the first state to the second state, and a second end connected to the central portion, the second end expandable in a second direction when the frame is expanded from the first state to the second state, the second direction being opposite to the first direction, a length in a longitudinal direction (also referred to herein as a first direction) between the first end and the second end, and a width in a width direction perpendicular to the longitudinal direction.

[0044] Any implant embodiment disclosed herein can, in further embodiments, 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 embodiment disclosed herein: a clip coupled to a proximal portion of the central portion, the clip configured to hold two or more portions of tissue of the LAA together, the first end and the second end being integrally formed with the central portion; the frame being advanceable through a delivery catheter when the frame is in a first state; the frame increasing in length when the frame is expanded from the first state to the second state; the frame being configured to increase a size of the ostium of the LAA longitudinally and decrease a size of the ostium of the LAA widthwise to draw a first wall of the LAA closer to a second wall of the LAA when the frame is expanded from the first state to the second state; and the clip being configured to be closeable to secure a portion of the first wall to a portion of the second wall when the frame is in the second state. and a first and second end of the frame configured to spread a first portion of the ostium of the LAA away from a second portion of the ostium opposite the first portion to longitudinally stretch the ostium of the LAA, and further comprising at least one cushion coupled to at least one of the first and second ends of the frame, wherein the frame may be configured to increase in size longitudinally without increasing in size in any other direction, wherein the frame is self-expandable from a first state to a second state and further comprises a means for constricting or closing the opening of the LAA, wherein the implant comprises a hinge mechanism for constricting 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 further comprises a means for longitudinally contracting at least a portion of the frame to longitudinally decrease the length of the frame, wherein the frame comprises a length of wire having a U-shape configured to enable cantilever bending near a central portion of the frame, wherein the frame comprises a torsion spring wire form near a central portion of the frame,The frame includes a plurality of U-shaped cantilever sections or torsion spring configurations, the frame being formed from round wire, wire strips, or laser-cut sheets, and / or the frame comprising at least one of a polymer, a composite, a metal, and a superelastic shape memory alloy.

[0045] Also disclosed herein are additional embodiments of closure or occlusion devices for the LAA. In any embodiment disclosed herein, the device can include a delivery catheter and an implant advanceable through the delivery catheter when the implant is in a first state, the implant having a first expandable portion and a second expandable portion, the first and second expandable portions of the implant each independently expandable to a second state, and the implant configured to block an opening in the LAA when the first and second expandable portions of the implant are in the second state.

[0046] Any of the embodiments of the devices and systems disclosed herein can, in further embodiments, 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 embodiment disclosed herein, wherein the first expandable portion is a distal portion of the implant and the second expandable portion is a proximal portion of the implant, a removable restraint that surrounds only the proximal portion of the implant when the implant is in a pre-deployed state, wherein at least one of the first and second expandable portions is self-expanding, and the implant can be configured such that the first expandable portion is expanded before the second expandable portion is expanded, and / or further includes any features, components, and / or details of any implant embodiment disclosed herein.

[0047] Disclosed herein are additional embodiments of a closure or occlusion device for the LAA, including an implant selectively expandable from a first state to a second state and a cover coupled to the implant, wherein when the implant is in the second state, the implant may be configured to expand against a wall of an opening of the LAA, the size of the implant is larger in the second state than in the first state, at least a portion of the cover is positioned adjacent an outer surface of the implant and selectively movable between at least the first and second states, and when the cover is in the second state, the cover may be configured to have a plurality of folds or wrinkles in a portion of the cover adjacent the outer surface of the implant, and the implant may be configured to block the opening of the LAA when the implant is in the second state.

[0048] Any embodiment of the device disclosed herein can, in further embodiments, 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 embodiment disclosed herein; wherein the cover can be configured such that when the implant and the cover are in the second state, at least one or more of the plurality of folds or wrinkles are positioned between an outer surface of at least a portion of the implant and at least a portion of a wall of the opening of the LAA; further comprising a pull wire coupled to the cover and configured to move the cover from the first state to the second state upon retraction of the pull wire; and / or the implant is also selectively retractable from the second state to the first state.

[0049] Any of the embodiments of the devices disclosed herein can, in further embodiments, 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 embodiment disclosed herein, wherein the device further includes a delivery catheter, wherein the device further includes an implant of any of the implant embodiments disclosed herein advanceable through the delivery catheter when the implant is in a first state, wherein the implant includes a first stage portion and a second stage portion each independently deployable to at least a second operable or deployed state, wherein the first stage portion is configured to be at least partially deployed before the second stage portion is deployed, wherein the first stage portion is configured to be positioned near the distal end of the LAA, and wherein the second stage portion is configured to extend beyond the first stage portion. the second stage portion is configured to constrict the opening of the LAA when the first stage portion is in the second state, the second stage portion is configured to close 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 portions of tissue surrounding the opening of the LAA to constrict or close the opening of the LAA when the second stage portion is in the second state, the second stage portion includes a means for constricting or closing the opening of the LAA, the second stage portion includes a hinge mechanism for constricting or closing the opening of the LAA and further includes at least one of a passive activation mechanism and an active activation mechanism for actuating the hinge mechanism, and / or at least one of the first stage portion and the second stage portion is self-expanding.

[0050] Disclosed herein are embodiments of methods for constricting, occluding, closing, or otherwise treating the LAA (collectively hereinafter referred to as treatment methods). Any of these method embodiments can be used to deploy or implant any of the implant or device embodiments disclosed herein. Any of the method embodiments disclosed herein can include advancing a delivery catheter having an implant coupled thereto within the heart, advancing a distal tip of the delivery catheter near the ostium of the LAA, and / or advancing the LAA in a first direction by at least expanding the implant in the first direction such that the ratio of the size of the ostium of the LAA in the first direction to the size of the ostium of the LAA in a second direction perpendicular to the first direction is at least 2 to 1. The method can also include retrieving the delivery catheter with the implant positioned within the LAA.

[0051] Any of the method embodiments disclosed herein can, in further embodiments, 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 embodiment disclosed herein: elongating the LAA in a first direction by at least expanding the implant in a first direction such that the ratio of the size of the ostium of the LAA in the first direction to the size of the ostium of the LAA in the second direction is from about 2:1 to about 5:1; elongating the LAA in a first direction by at least expanding the implant in the first direction such that the ratio of the size of the ostium of the LAA in the first direction to the size of the ostium of the LAA in the second direction is from about 3:1 to about 4:1;the implant may include a clip configured to hold two or more portions of tissue of the opening together by expanding the implant in at least a first direction such that the ratio of the LAA to the opening is 5 to 1; the clip may further include at least one cushion coupled with the frame, the frame being configured to increase in size in the first direction without increasing in size in any other direction; the frame being self-expandable; the frame may further include a catheter for implanting the implant; the implant includes a hinge mechanism for contracting or closing the opening; and at least one of a passive activation mechanism and an active activation mechanism for activating the hinge mechanism. and wherein at least a portion of the frame is further configured to be contractible in a first direction to reduce a length of the frame in the first direction, the frame includes a length of wire having a U-shape configured to enable cantilever bending near a central portion of the frame, the frame includes a torsion spring wire form near the central portion of the frame, the frame includes a plurality of U-shaped cantilever sections or torsion spring forms, the frame is formed from round wire, wire strip, or laser cut sheet, and / or the frame comprises at least one of a polymer, a composite, a metal, and a superelastic shape memory alloy.

[0052] Any embodiment of the method disclosed herein can include advancing a delivery catheter having an implant therein into the heart, advancing a distal tip of the delivery catheter near the ostium of the LAA, stretching the LAA in a first direction by at least partially expanding at least a portion of the implant in the first direction, clipping a first wall portion of the LAA against a second wall portion of the LAA, and / or withdrawing the catheter. In other embodiments, any embodiment of the method disclosed herein can 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 embodiment disclosed herein, including positioning the implant to achieve apposition in a first direction and / or a second direction, assessing the position and / or orientation of the implant, retracting at least a portion of the implant, repositioning at least a portion of the implant relative to the LAA, and / or remodeling all or a portion of the implant and repositioning the implant.

[0053] Disclosed herein are additional embodiments of methods of treatment that include advancing a distal tip of a catheter having an implant therein into the heart, at least partially deploying a distal portion of the implant, positioning the partially expanded implant at an appropriate implant depth and angle, deploying a proximal portion of the implant adjacent the ostium of the LAA, and / or removing the catheter.Any embodiment of the method disclosed herein may, in further embodiments, 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 embodiment disclosed herein: assessing a position and / or orientation of at least one of the proximal and distal portions of the implant before removing the catheter; determining whether the position and / or orientation of the implant is desirable before removing the catheter; constraining at least one of the proximal and distal portions of the implant after at least partially positioning the distal portion of the implant; constraining at least one of the proximal and distal portions of the implant after deploying the proximal portion of the implant adjacent the ostium of the LAA; and placing the partially expanded implant in a suitable position. and repositioning the proximal portion of the implant to a depth and angle of approximately 100 mm, the device being self-expanding, wherein positioning at least one of the proximal and distal portions of the implant comprises removing a restraint from at least one of the proximal and distal portions of the implant, wherein positioning at least one of the proximal and distal portions of the implant comprises releasing a suture from at least one of the proximal and distal portions of the implant, wherein positioning at least one of the proximal and distal portions of the implant comprises removing a tension tether from at least one of the proximal and distal portions of the implant, wherein deploying the proximal portion of the implant comprises activating a mechanical linkage to expand at least one of the proximal and distal portions of the implant, and wherein the proximal restraint has a frame configured to selectively restrain the proximal portion of the implant in a restrained state, and / or the catheter is orientable.

[0054] Additional embodiments of any of the methods disclosed herein may include advancing a distal tip of a delivery catheter having an implant therein into the heart, advancing the distal tip of the delivery catheter near the ostium of the LAA, expanding a first stage portion of the implant to at least a partially expanded state, moving the first stage portion of the implant to a desired implant depth and angle, positioning the implant to achieve apposition in a first direction and / or a second direction, actuating a portion of the implant to reduce the size of the LAA opening adjacent the LAA ostium, and / or removing the catheter.

[0055] Any embodiment of the method disclosed herein can, in further embodiments, 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 embodiment disclosed herein: actuating a portion of the implant to reduce a size of the LAA ostium adjacent the ostium of the LAA comprises folding tissue surrounding the ostium of the LAA to reduce the size of the LAA ostium; actuating a portion of the implant to reduce the size of the LAA ostium comprises folding tissue surrounding the ostium of the LAA to close the ostium of the LAA; actuating a portion of the implant to reduce the size of the LAA ostium comprises straightening the ostium of the LAA; actuating a portion of the implant to reduce the size of the LAA ostium comprises stretching the ostium of the LAA; and twisting one or more portions of tissue surrounding the ostium of the LAA to constrict or close the ostium of the LAA when the second stage portion is in the second state. and after positioning the implant to achieve apposition in the first direction and / or the second direction, activating at least a portion of the implant to close the opening of the LAA; activating a means for folding a portion of the tissue to fold the tissue surrounding the ostium of the LAA to reduce the size of the ostium of the LAA; activating a tissue folding mechanism of the implant to fold the tissue surrounding the ostium of the LAA to close the ostium of the LAA; after assessing the opening of the LAA, reversing the tissue folding mechanism and reactivating the tissue folding mechanism of the implant to fold the tissue surrounding the ostium of the LAA to close the opening of the LAA; assessing the position and / or orientation of the implant, contracting at least a portion of the implant, and repositioning at least a portion of the implant relative to the LAA; after assessing the position and / or orientation of the implant, contracting a first stage portion of the implant, repositioning at least a portion of the implant relative to the LAA, and expanding the first stage portion of the implant to an at least partially expanded state; and recapturing all or a portion of the implant.and repositioning the implant, wherein expanding the distal portion of the implant to the at least partially expanded state includes advancing the distal portion of the implant beyond the distal tip of the deployment catheter, and / or at least the distal portion of the implant is self-expanding.

[0056] Disclosed herein are additional embodiments of methods of treatment that include advancing a deployment device having an implant into a left atrial appendage, moving at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the exterior surface of the implant, relative to 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 embodiment, the method can include moving at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the exterior surface of the implant, relative to the inner wall surface of the left atrial appendage without changing the shape or size of the implant, and / or moving the implant from a first state to a second state, wherein at least a portion of the implant is radially expanded when the implant is in the second state compared to the first state.

[0057] Disclosed herein are additional embodiments of devices and systems for closing the LAA, 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 within the LAA, and a second guide device advanceable within the pericardial space outside the LAA and configured to move such that an end of the second guide device is generally axially aligned with an end of the first guide device. In any of the embodiments 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 passage of the clamping device through 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 embodiments disclosed herein, the clamping device may include only a first member and a second member. In additional embodiments, the fastening device may further include a third member and a fourth member connected together in an end-to-end arrangement and defining an opening in the fastening device sized and configured to pass over the exterior surface of the LAA. In any additional embodiments disclosed herein, the device may further include a delivery catheter having an outer sheath and a guide lumen configured to receive and track a second guide device. Furthermore, the first member of the fastening device may be rigid, and the second member of the fastening device may include a suture.

[0058] Disclosed herein are additional embodiments of a method for closing or occluding the LAA. In any embodiment disclosed herein, the method includes advancing a first guide device into the LAA, advancing a second guide device into the pericardial space outside the LAA, approximately 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 over the outer surface of the LAA toward a neck portion of the LAA, and / or closing the clamping device from the open position to a closed position to substantially flatten and close the neck portion of the LAA.

[0059] Any embodiment of the method for closing or occluding the LAA may, in further embodiments, 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 embodiment disclosed herein, wherein moving the clamping device from the closed position to the open position includes advancing the clamping device through 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 track a second guide device; the delivery catheter has an outer sheath, at least one of the first and second members of the clamping device is substantially rigid, at least one of the first and second members of the clamping device has a substantially planar contact surface, the contact surface being a surface configured to contact the exterior surface of the LAA; the delivery catheter has an outer sheath, the clamping device includes at least four substantially rigid members connected together in an end-to-end arrangement and defining an opening in the clamping device sized and configured to pass over the exterior surface of the LAA; and / or the clamping device includes at least one rigid member and at least one flexible member interconnected with the at least one rigid member.

[0060] Additionally, any implant and / or device or system embodiment disclosed herein may be adapted and / or used for treating any tissue condition within the body that is desired to be occluded, restricted, or closed. For example, without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein may include an implant including a contact member and a fixation element that may (but need not) be configured to move between a first state and a second state, wherein 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 state, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, wherein when the contact member rotates from the first rotational position to the second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue state in the first direction, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue state in a second direction when the fixation element is in an operable state, the second direction being opposite the first direction. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or contiguous tissue surfaces, or otherwise.

[0061] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include an implant having a contact member that can (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, wherein the catheter is configured to apply a torque on 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 is rotated until a predetermined torque level is reached, allowing the contact member to twist at least a portion of the tissue condition. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0062] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include a method of treating a tissue condition including advancing a deployment device having an implant within or adjacent to the tissue condition, the implant may (but is not required to) be configured to move from a first state to a second state such that at least a portion of the implant may be radially expanded when the implant is in the second state compared to 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 surface 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.

[0063] Furthermore, any implant and / or device or system embodiment disclosed herein can be adapted and / or used for the treatment of any tissue condition in the body that is desired to be occluded, remodeled, restricted, or closed. For example, without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein can include an implant including 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 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 embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0064] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can 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 advanced into or adjacent the tissue condition, wherein the catheter is configured to apply a torque on 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, allowing the contact member to twist at least a portion of the tissue condition. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0065] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include a method of treating a tissue condition that includes advancing a deployment device having an implant within or adjacent to the tissue condition such that at least a portion of the implant engages a wall surface 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. [Brief explanation of the drawings]

[0066] [Figure 1] FIG. 1A shows a pathway through the venous system via the femoral vein and transseptal puncture into the left atrium that can be used to access the left atrial appendage (LAA).

[0067] FIG. 1B shows a cross-sectional view of the left atrium, showing the guidewire being advanced towards the LAA.

[0068] [Figure 2A] FIG. 2A illustrates an embodiment of a treatment system having an implant device advanced through a catheter into the LAA, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0069] [Figure 2B] FIG. 2B illustrates the embodiment of the treatment system of FIG. 2A, showing the contact members expanded within the LAA.

[0070] [Figure 2C] FIG. 2C illustrates the embodiment of the treatment system of FIG. 2A, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0071] [Figure 2D]FIG. 2D illustrates the embodiment of the treatment system of FIG. 2A showing the fixation element of the embodiment of the implant device being advanced towards the contact member of the implant device.

[0072] [Figure 2E] FIG. 2E shows the fixation element of the treatment system of FIG. 2A engaging with patient tissue surrounding the proximal portion of the contact member of the implant device.

[0073] [Figure 2F] FIG. 2F shows the implant device of FIG. 2A disengaged and removed from the catheter.

[0074] [Figure 3] FIG. 3 illustrates an embodiment of an implant device having a cover member surrounding at least a portion of the implant device.

[0075] [Figure 4] FIG. 4 shows the implant device of FIG. 2A with the contact members in a second expanded state, the retention members in a first elongated state, and the fixation elements in a second open state.

[0076] [Figure 5] 5 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 5-5 of FIG.

[0077] [Figure 6] FIG. 6 shows the implant device of FIG. 2A with the contact members in the second open state, the retention members in the second contracted state, and the fixation elements in the second open state.

[0078] [Figure 7] 7 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 7-7 of FIG.

[0079] [Figure 8]FIG. 8A illustrates the embodiment of the implant device of FIG. 2A with the contact members advanced further distally into the LAA.

[0080] FIG. 8B illustrates the embodiment of the implant device of FIG. 2A, showing the contact member rotating to twist the LAA and contract the neck or opening of the LAA around a portion of the implant device.

[0081] FIG. 8C illustrates the embodiment of the implant device of FIG. 2A showing a fixation element of the embodiment of the implant device being advanced towards a contact member of the implant device.

[0082] [Figure 9A] FIG. 9A shows another embodiment of a treatment system in which an implant device is advanced through a catheter into the LAA, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0083] [Figure 9B] FIG. 9B illustrates the embodiment of the treatment system of FIG. 9A, showing the contact members expanded within the LAA.

[0084] [Figure 9C] FIG. 9C illustrates the embodiment of the treatment system of FIG. 9A, showing the contact member being rotated to twist the LAA and contract the neck or opening of the LAA around a portion of the implant device.

[0085] [Figure 9D] FIG. 9D illustrates the embodiment of the treatment system of FIG. 9A showing the fixation element of the embodiment of the implant device being advanced towards the contact member of the implant device.

[0086] [Figure 9E] FIG. 9E shows the fixation element of the treatment system of FIG. 9A engaging with patient tissue surrounding the proximal portion of the contact member of the implant device.

[0087] [Figure 9F] FIG. 9F shows the treatment system of FIG. 9A with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0088] [Figure 9G] FIG. 9G is a cross-sectional view of the treatment system shown in FIG. 9A taken along line 9G-9G of FIG. 9F.

[0089] [Figure 9H] FIG. 9H shows an enlarged side view of the treatment system of FIG. 9A.

[0090] [Figure 9I] FIG. 9I shows an exploded view of the treatment system of FIG. 9A.

[0091] [Figure 10] FIG. 10 illustrates another embodiment of a treatment system for treating the LAA, showing the contact members of the treatment system expanded within the LAA.

[0092] [Figure 11] FIG. 11 shows an embodiment of a fixation element implanted adjacent to an obstructed opening in the LAA.

[0093] [Figure 12] FIG. 12 shows another embodiment of a fixation element implanted adjacent to an obstructed opening in the LAA.

[0094] [Figure 13] FIG. 13 illustrates another embodiment of a treatment system having an implant device with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0095] [Figure 14] 14 is a cross-sectional view of the treatment system shown in FIG. 13 taken along line 14-14 in FIG.

[0096] [Figure 15] FIG. 15 shows another embodiment of an implant device with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0097] [Figure 16] 16 is a cross-sectional view of the treatment system shown in FIG. 15 taken along line 16-16 in FIG.

[0098] [Figure 17] FIG. 17 illustrates another embodiment of a treatment system in which the contact members are in a second expanded state, the retention members are in a second contracted state, and the fixation elements are in a second open state.

[0099] [Figure 18] FIG. 18 shows a side view of another embodiment of a treatment system with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0100] [Figure 19] 19 is a cross-sectional view of the treatment system shown in FIG. 18 taken along line 19-19 of FIG.

[0101] [Figure 20] FIG. 20 is another side view of the treatment system shown in FIG.

[0102] [Figure 21] 21 is a cross-sectional view of the treatment system shown in FIG. 18 taken along line 21-21 of FIG.

[0103] [Figure 22] FIG. 22A shows a side view of another embodiment of a treatment system with the contact members in a second expanded state and the retention members in a first retracted state.

[0104] FIG. 22B shows a side view of the treatment system of FIG. 22 with the contact members in a second position and the retention members in a second deployed position.

[0105] [Figure 23] FIG. 23A shows an isometric view of another embodiment of a fixation element.

[0106] FIG. 23B shows a side view of the embodiment of the fixation element shown in FIG. 23A.

[0107] FIG. 23C shows an isometric view of another embodiment of a fixation element.

[0108] FIG. 23D shows a side view of the embodiment of the fixation element shown in FIG. 23C.

[0109] FIG. 23E shows an isometric view of another embodiment of a fixation element.

[0110] FIG. 23F shows a side view of the embodiment of the fixation element shown in FIG. 23E.

[0111] [Figure 24] 24-35 illustrate an embodiment of a deployment method for the embodiment of the treatment system shown in FIG. 22A. [Figure 25] Same as above. [Figure 26] Same as above. [Figure 27] Same as above. [Figure 28] Same as above. [Figure 29] Same as above. [Figure 30] Same as above. [Figure 31] Same as above. [Figure 32] Same as above. [Figure 33] Same as above. [Figure 34] Same as above. [Figure 35] Same as above.

[0112] [Figure 36]FIG. 36 shows another embodiment of an implant device in which a retention member engages the tissue surface surrounding the opening of the LAA.

[0113] [Figure 37] FIG. 37 illustrates another embodiment of a treatment system with the tab members of the fixation elements in a first engaged state.

[0114] [Figure 38] FIG. 38 shows the treatment system of FIG. 37 with the tab members in a second, disengaged state.

[0115] [Figure 39] FIG. 39 shows a fixation element of the treatment system of FIG.

[0116] [Figure 40] FIG. 40 shows the treatment system of FIG. 37 with the fixation element engaged with the contact member and the tab member of the fixation element in a first engaged state.

[0117] [Figure 41] FIG. 41 shows the treatment system of FIG. 37 with the tab members of the fixation elements moved to a second, disengaged state by axial advancement of the core member of the delivery system.

[0118] [Figure 42] FIG. 42 shows the treatment system of FIG. 37 where the fixation element is rotated to misalign the tab members with respect to the openings in the contact members, allowing for withdrawal of the fixation element from the contact members.

[0119] [Figure 43] FIG. 43 shows the treatment system of FIG. 37 with the fixation element retracted from the contact member.

[0120] [Figure 44] 44A and 44B are front and side views, respectively, of another embodiment of a treatment system configured to twist closed or occlude the LAA at the ostium of the LAA.

[0121] [Figure 45] 45A and 45B are side views of the treatment system of FIG. 44, respectively, showing the implant used to twist the LAA to close or occlude the LAA at the ostium.

[0122] [Figure 46] 46A and 46B are side views of the treatment system of FIG. 44, respectively, showing the delivery device being removed from the implant device after the LAA has been occluded.

[0123] [Figure 47] 47A-47F illustrate another embodiment of a treatment system for closing or occluding the LAA.

[0124] [Figure 48] 48A-48F illustrate several stages or steps illustrating an example deployment procedure for the expandable implant of FIGS. 47A-47F for treatment of the LAA.

[0125] [Figure 49] 49A-49G illustrate another embodiment of a treatment system for closing or occluding the LAA.

[0126] [Figure 50] 50A-50F illustrate several stages or steps illustrating an example deployment procedure for the expandable implant of FIGS. 49A-49G for treatment of the LAA.

[0127] [Figure 51] FIG. 51 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0128] [Figure 52] FIG. 52 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0129] [Figure 53] FIG. 53 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0130] [Figure 54] FIG. 54 illustrates another embodiment of a contact member that may be used with any of the treatment system embodiments disclosed herein.

[0131] [Figure 55] FIG. 55 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0132] [Figure 56] 56A-56B illustrate another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0133] [Figure 57] 57A-57B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0134] [Figure 58] 58A-58B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0135] [Figure 59] 59A-59B show another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0136] [Figure 60] 60A-60B show another embodiment of a fixation element that may be used with any of the treatment system embodiments disclosed herein.

[0137] [Figure 61] 61A-61B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0138] [Figure 62] 62A-62B illustrate additional embodiments of contact members that can be used with any of the treatment system embodiments disclosed herein.

[0139] [Figure 63] FIG. 63 shows a side view of an embodiment of a contact member.

[0140] [Figure 64] Figure 64 shows a diagram of the left atrium (LA).

[0141] [Figure 65] Figure 65 shows the access route to the LAA.

[0142] [Figure 66] 66A-66D illustrate an embodiment of an implant device and method for occluding the LAA.

[0143] [Figure 67] 67A-67D show various embodiments of anchor members.

[0144] [Figure 68] 68A-68F show another embodiment of an implant and method for occluding the LAA.

[0145] [Figure 69] 69A-69G show another embodiment of a device and method for occluding the LAA.

[0146] [Figure 70] 70A-70F show another embodiment of a device and method for occluding the LAA.

[0147] [Figure 71] 71A-71G show some details of some embodiments of staples that can be used in conjunction with any of the devices disclosed herein to occlude the LAA.

[0148] [Figure 72] 72A-72F show an embodiment of a device and method for forming staples.

[0149] [Figure 73] 73A-73B show an embodiment of a device and method for occluding the LAA.

[0150] [Figure 74] 74A-74E show an embodiment of a device and method for occluding the LAA.

[0151] [Figure 75] 75A-75E show embodiments of several stages for forming staple embodiments that can be used with any of the devices or methods disclosed herein.

[0152] [Figure 76] 76A-76E show an embodiment of a device and method for occluding the LAA.

[0153] [Figure 77] 77A-77C show an embodiment of a device and method for occluding the LAA.

[0154] [Figure 78] 78A-78C show an embodiment of a device and method for occluding the LAA.

[0155] [Figure 79] 79A-79C show an embodiment of a device and method for occluding the LAA.

[0156] [Figure 80] 80A-80C show an embodiment of a device for treating the LAA.

[0157] [Figure 81] 81A-81C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 80A-80C.

[0158] [Figure 82] 82A-82C show an embodiment of a device for treating the LAA.

[0159] [Figure 83] 83A-83C show an embodiment of a device for treating the LAA.

[0160] [Figure 84] 84A-84C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 83A-83C.

[0161] [Figure 85] 85A-85C show an embodiment of a device for treating the LAA.

[0162] [Figure 86] 86A-86C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 85A-85C.

[0163] [Figure 87] 87A-87C show an embodiment of a device for treating the LAA.

[0164] [Figure 88] 88A-88C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 87A-87C.

[0165] [Figure 89]89A-89C show an embodiment of a method of using another embodiment of a device for occluding the LAA.

[0166] [Figure 90] 90A-90C show an embodiment of a device for treating the LAA.

[0167] [Figure 91] 91A-91C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 90A-90C.

[0168] [Figure 92] 92A-92C show an embodiment of a method of using another embodiment of a device for occluding the LAA.

[0169] [Figure 93] 93A-93C show an embodiment of a device for treating the LAA.

[0170] [Figure 94] 94A-94C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 93A-93C.

[0171] [Figure 95] 95A-95C show an embodiment of a device for treating the LAA.

[0172] [Figure 96] 96A-96C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 95A-95C.

[0173] [Figure 97] 97A-97C show an embodiment of a method of using another embodiment of a device for occluding the LAA.

[0174] [Figure 98]98A-98C illustrate an embodiment of a method for deploying the embodiment of the device shown in FIGS. 95A-95C.

[0175] [Figure 99] 99A-99C show an embodiment of a device for treating the LAA.

[0176] [Figure 100] 100A-100C illustrate an embodiment of a method for occluding the LAA using the device shown in FIGS. 99A-99C.

[0177] [Figure 101] 101A-101C show an embodiment of a method of using another embodiment of a device for occluding the LAA.

[0178] [Figure 102] 102A-102C show an embodiment of a method for deploying another embodiment of a device for treating the LAA.

[0179] [Figure 103] 103A-103D show another implant device embodiment and method embodiment of using such a device to treat the LAA.

[0180] [Figure 104] 104A-104E show side views of an embodiment of an implant device and method of using such a device shown in FIGS. 103A-103D.

[0181] [Figure 105] 105A-105E show another implant device embodiment and method of using such a device to treat the LAA.

[0182] [Figure 106]106A-106D show side views of an embodiment of an implant device and a method of using such a device as shown in FIGS. 105A-105E.

[0183] [Figure 107] 107A-107G show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0184] [Figure 108] 108A-108C show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0185] [Figure 109] 109A-109C show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0186] [Figure 110] 110A-110E show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0187] [Figure 111] FIG. 111 shows another embodiment of a device for treating the LAA.

[0188] [Figure 112] FIG. 112 shows another embodiment of a device for treating the LAA.

[0189] [Figure 113] 113A-113C show an embodiment of a device for treating the LAA.

[0190] [Figure 114] 114A-114C show an embodiment of a device for treating the LAA.

[0191] [Figure 115] 115A-115C show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0192] [Figure 116] 116A-116C show an embodiment of a device for treating the LAA.

[0193] [Figure 117] 117A-117C show an embodiment of a device for treating the LAA.

[0194] [Figure 118] 118A-118D show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0195] [Figure 119] 119A-119D show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0196] [Figure 120] 120A-120C show an embodiment of a device for treating the LAA.

[0197] [Figure 121] 121A-121C show an embodiment of a device for treating the LAA.

[0198] [Figure 122] FIG. 122 shows another embodiment of a device for treating the LAA from a downward perspective.

[0199] [Figure 123] FIG. 123 shows the embodiment of the device of FIG. 122 from a side view.

[0200] [Figure 124] FIG. 124 shows a side view of the embodiment of the device of FIG. 122, showing the device relative to the ostium of the LAA.

[0201] [Figure 125] FIG. 125 shows a top view of another embodiment of a device for treating the LAA.

[0202] [Figure 126] FIG. 126 shows the total cross-sectional area of ​​several embodiments of the devices disclosed herein compared to conventional devices for treating the LAA.

[0203] [Figure 127] FIG. 127 shows another embodiment of a device for treating the LAA.

[0204] [Figure 128] FIG. 128 shows another embodiment of a device for treating the LAA.

[0205] [Figure 129] FIG. 129 shows a side view of another embodiment of a device for treating the LAA, showing the device in an extended state.

[0206] [Figure 130] FIG. 130 shows a side view of the embodiment of the device shown in FIG. 129, showing the device in a contracted state.

[0207] [Figure 131] FIG. 131 shows an end view of the embodiment of the device shown in FIG. 129, showing the device in an extended state.

[0208] [Figure 132] FIG. 132 shows an end view of the embodiment of the device shown in FIG. 129, showing the device in a contracted state.

[0209] [Figure 133] FIG. 133 shows a side view of another embodiment of a device for treating the LAA, showing the device in an extended state.

[0210] [Figure 134] FIG. 134 shows a side view of the embodiment of the device shown in FIG. 133, showing the device in a contracted state.

[0211] [Figure 135] FIG. 135 shows an end view of the embodiment of the device shown in FIG. 133, showing the device in an extended state.

[0212] [Figure 136] FIG. 136 shows an end view of the embodiment of the device shown in FIG. 133, showing the device in a contracted state.

[0213] [Figure 137] 137A-137D show an embodiment of a device for treating the LAA.

[0214] [Figure 138] 138A-138C illustrate an embodiment of a method of implanting the embodiment of the device shown in FIGS. 137A-137D.

[0215] [Figure 139] 139A-139E show another embodiment of a device for treating the LAA and an embodiment of a method of using such a device.

[0216] [Figure 140] 140A-140G show additional embodiments of devices for treating the LAA.

[0217] [Figure 141] 141A-141H show additional embodiments of devices for treating the LAA.

[0218] [Figure 142] 142A-142F show additional embodiments of devices and methods of using such devices for treating the LAA.

[0219] [Figure 143] 143A-143E show another embodiment of a device for treating the LAA and a method of using such a device.

[0220] [Figure 144] 144A-144F show another embodiment of a device for treating the LAA and a method of using such a device.

[0221] [Figure 145] 145A-145D show another embodiment of a device for treating the LAA and a method of using such a device.

[0222] [Figure 146] 146A-146C show an embodiment of a device for treating the LAA.

[0223] [Figure 147] 147A-147B illustrate an embodiment of a method of using the device of FIGS. 146A-146C.

[0224] [Figure 148] 148A-148B show another embodiment of a device for treating the LAA and a method of using such a device.

[0225] [Figure 149] 149A-149B show another embodiment of a device for treating the LAA and a method of using such a device.

[0226] [Figure 150]150A-150C show another embodiment of a device for treating the LAA and a method of using such a device.

[0227] [Figure 151] 151A-151B show embodiments of portions of a delivery device that may be used with some embodiments of the implant devices disclosed herein.

[0228] [Figure 152] 152A-152C show an embodiment of a delivery device having a steering mechanism and an implant device, as well as a method of using such a device.

[0229] [Figure 153] 153A-153B show an embodiment of a delivery device having a steering mechanism and an implant device, as well as a method of using such a device.

[0230] [Fig. 154] 154A-154B show an embodiment of a delivery device having a steering mechanism and an implant device, as well as a method of using such a device.

[0231] [Figure 155] 155A-155B show an embodiment of a delivery device having a steering mechanism and an implant device and a method of using such a device.

[0232] [Figure 156] 156A-156D show an embodiment of an implant device having a sealing element for treating the LAA.

[0233] [Figure 157] 157A-157C show an embodiment of an implant device having a cover element for treating the LAA.

[0234] [Figure 158] 158A-158C show another embodiment of a device for treating the LAA and a method of using such a device.

[0235] [Figure 159] 159A-159B show another embodiment of a device for treating the LAA and a method of using such a device.

[0236] [Figure 160] 160A-160D show another embodiment of a device for treating the LAA and a method of using such a device.

[0237] [Figure 161] 161A-161C show an embodiment of a device for treating the LAA.

[0238] [Figure 162] 162A-162C show an embodiment of a device for treating the LAA.

[0239] [Figure 163] 163A-163D show another embodiment of a device for treating the LAA and a method of using such a device.

[0240] [Fig. 164] 164A-164C show another embodiment of a device for treating the LAA and a method of using such a device.

[0241] [Figure 165] 165A-165C show an embodiment of a device for treating the LAA.

[0242] [Figure 166] 166A-166C show an embodiment of a device for treating the LAA.

[0243] [Figure 167] 167A-167D show another embodiment of a device for treating the LAA and a method of using such a device.

[0244] [Figure 168] 168-170 illustrate embodiments of treatment systems and methods for treating the LAA. [Figure 169] Same as above. [Figure 170] Same as above.

[0245] [Figure 171] 171A-171D illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0246] [Fig. 172] 172A-172C illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0247] [Figure 173] 173A-173D show additional embodiments of tissue anchors that can be used in conjunction with any of the implant devices or systems disclosed herein.

[0248] [Fig. 174] FIG. 174 shows an embodiment of a device for treating the LAA.

[0249] [Figure 175] 175A-175D show additional embodiments of implant devices for treating the LAA.

[0250] [Figure 176] 176A-176D illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0251] [Figure 177] Figure 177 shows the left atrium.

[0252] [Figure 178] 178A-178B illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0253] [Figure 179] 179A-179B illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0254] [Figure 180] 180A-180D show an embodiment of a device for treating the LAA.

[0255] [Figure 181] 181A-181D show an embodiment of a device for treating the LAA.

[0256] [Figure 182-1] 182A-182F illustrate an embodiment of a treatment system and method for treating the LAA using such a device. [Figure 182-2] Same as above. [Figure 182-3] Same as above.

[0257] [Figure 183] 183A-183E illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0258] [Figure 184] Figure 184 is a front view of the heart showing the right ventricle, left ventricle, and LAA.

[0259] [Figure 185] FIG. 185 shows the heart located within the pericardial cavity beneath the patient's rib cage.

[0260] [Figure 186] 186A-186F illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0261] [Figure 187] 187A-187E illustrate an embodiment of a treatment system and method for treating the LAA using such a device.

[0262] [Figure 188] 188A-188E illustrate an embodiment of a treatment system and method for treating the LAA using such a device. DETAILED DESCRIPTION OF THE INVENTION

[0263] Described herein are novel devices, systems, and methods for closing or occluding the LAA. Some embodiments include methods that include advancing a delivery system into the LAA, advancing and deploying an expandable element (which in some embodiments may be covered with barbs, texture, or other tissue-engaging features, or may be smooth) and having a generally spherical or spherical shape within the left atrial appendage, allowing the expandable element to distally and / or radially engage the inner wall surface of the LAA, and applying rotations 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 embodiments disclosed herein can effectively eliminate, or significantly or nearly completely eliminate, communication of blood or other substances between the left atrium and the LAA. Any of the deployment methods disclosed herein may also include deployment of a fixation element (also referred to herein as a locking element or anchor element) configured to inhibit or prevent unwinding of the expandable element against the LAA and LA ostial tissue, thereby inhibiting or preventing untwisting of the LAA.

[0264] The devices, systems, and methods disclosed herein can be used or adapted for other uses within or on the body of any human, animal, insect, 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.

[0265] A clinical benefit of some embodiments is that the resulting implant does not come into direct blood contact with left atrial blood or flow, except for the portion potentially responsible for fixation. The fixation element of any embodiment can be configured to limit its exposure to blood in the left atrium (i.e., limit the amount of fixation element protruding into the left atrium). In some embodiments, the entire implant can be surrounded by LAA tissue so that no portion of the implant is exposed to 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 patients by reducing the need for post-drug regimens. 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 visualization under fluoroscopy, ultrasound, etc.

[0266] Any of the embodiments of the implants disclosed herein may have an expandable, atraumatic shape with tissue-grasping features located on the outer edge of the shape coupled with securing and / or latching features that can hold the implant in an initial or final closed position. Any of the embodiments of the implants disclosed herein may be configured to grip the internal tissue of the LAA with a radial force. In some embodiments, 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. Any of the embodiments of the implants disclosed herein may have an atraumatic shape that is spherical, dome-shaped, or includes a disc-shaped coil of wire, may have an expanded cut pattern in the shape of a stent, or any other shape that may have rounded edges. In some embodiments, barbs on the outer edge or surface of the implant (which may be tissue anchors) may include metal hooks, plastic cleats, a rough texture of some material or surface feature, a coating, or an activated adhesive that grips the internal surface of the LAA. Additionally, in any embodiment disclosed herein, a tissue anchor can be positioned on or adjacent the end of the implant for engaging the end of the LAA. In any embodiment, the barbs can be oriented to allow tissue engagement in one rotational direction and disengagement in the opposite rotational direction for possible repositioning, resizing, or removal from the LAA.

[0267] For any embodiment disclosed herein, the rotation used to twist and close or occlude (completely or substantially) the LAA can be a quarter turn (i.e., a rotation), a half turn, a full turn, or up to multiple turns for deeper or longer LAAs. The fixation feature or element (also referred to herein as an anchor element) in any embodiment 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 feature or element can be configured to engage tissue adjacent the ostium of the LAA. In any embodiment, the fixation element can have multiple arms or members, an annular ring, a disk, or any other suitable shape of surface anchor configured to connect non-twisted tissue to a twisted implant. In some embodiments, the fixation element can have a small diameter ring that can be configured to secure or engage tissue that contacts the implant's central hub (adjacent the ostium of the LAA) and can also have a clip that folds over and fastens the implant to the side of the left atrium (LA) wall.

[0268] In some embodiments disclosed herein, the device can be configured to restrict the opening of the LAA (including any occlusive effects from the device) by reducing the cross-sectional area of ​​the LAA ostium by at least 95%, or at least 90%, or at least approximately 80% to approximately 100% compared to the cross-sectional area of ​​the LAA ostium before the device is implanted. Furthermore, in some embodiments, the method can 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 approximately 70% to approximately 100% blocked and / or restricted. Furthermore, any embodiment disclosed herein can include implantation of two or more implants of any of the implant embodiments disclosed herein in the LAA. For example, without limitation, any of the implant embodiments disclosed herein may be configured to be deployed or implanted in the LAA to improve occlusion of an implant already implanted in the LAA, including any implant that fits within any of the aforementioned ranges of less than total occlusion. In some embodiments, one or more additional implants or devices may be implanted adjacent to, above, around, or otherwise to improve the level of occlusion of the LAA.

[0269] Alternatively, in any embodiment 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 implant's body portion between the distal surface of the fixation element and the contact member to prevent rotation of the implant after the contact member is rotated in the second direction, i.e., to the second rotational position, without penetrating the tissue. For example, without limitation, in any embodiment disclosed herein, the fixation element may have a smooth body portion that is non-obstructive or non-penetrating, e.g., such that the fixation element does not have any tissue-penetrating features thereon that extend toward the tissue surface. In other embodiments, the arms (or at least the portions of the arms that extend 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.

[0270] 1A and 1B show cross-sectional views of the left atrium and show a guidewire G advancing from a catheter C toward the left atrial appendage (LAA). FIG. 2A shows an embodiment of an occlusion system 100 for occluding or closing the opening of the LAA. In any embodiment disclosed herein, the occlusion system (including the embodiment of occlusion system 100) can be configured to rotate and twist the LAA to constrict a neck or portion of the LAA adjacent the opening and substantially or completely close it around the exterior surface of a portion of the implant device, thereby occluding the opening of the LAA. In any embodiment of an occlusion system, including the embodiment of occlusion system 100, the system can have an implant device 102 having a contact member 104 (also referred to herein as a contact element or an expandable implant member), a fixation element or fixation element 110 (also referred to as a fixation member), and a retention member 108. The implant device 102 can be configured to be advanced into the LAA through a catheter 112. 2A is shown in a collapsed state and is constrained within an outer sleeve 114 of a catheter 112. As shown, the implant device 102 can be advanced distally out of the catheter 112 through a 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 can be advanced and / or deployed within the LAA.

[0271] Alternatively, the catheter 112 with the implant device 102 therein can be advanced to a desired location within the LAA, and the outer sleeve 114 of the catheter 112 can be retracted or withdrawn to expose and / or unconstrain the contact member 104 of the implant device 102 while maintaining the core member 113 of the catheter 112 in a fixed axial position, thereby holding the implant device 102 in a fixed axial position. In any embodiment disclosed herein, the contact member 104 can be radially self-expanding such that when a constraint is removed from the contact member 104, the contact member 104 can automatically expand against the inner surface or wall of the LAA. In other embodiments, the contact member 104 can 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 member 104 after it has been expanded against the inner wall of the LAA distal to the ostium or opening O of the LAA.

[0272] Alternatively, in any embodiment disclosed herein, the contact member may be configured to remain in a first state within the catheter during and / or after the entire treatment procedure. For example, without limitation, in any embodiment disclosed herein, the contact member may be configured to be deployed from the catheter, advanced into contact with the tissue surface of the medial wall of the LAA, engage with the tissue surface of the medial wall of the LAA, and twist the LAA when torque and / or rotation is applied to the contact member, all without changing the state of the contact member. Alternatively, in any embodiment disclosed herein, the contact member may be configured to be advanced into the pericardial space around the outside of the LAA, engage with the outer surface of the LAA, and twist the LAA when torque and / or rotation is applied to the contact member.

[0273] 2B, the contact member 104 may have multiple arms or struts 116, each configured to radially self-expand when a restraint is removed from the exterior surface of the contact member 104. For example, without limitation, any embodiment of a contact member disclosed herein may have six struts 116, or six to ten struts, or fewer than six to more than ten struts.

[0274] Additionally, in any embodiment, the contact members 104 may have a plurality of teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue engagement features 118 configured to penetrate tissue within the LAA when the contact members 104 are expanded against the 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. Note that teeth, cleats, barbs, nubs, texture, studs, anchors, and other tissue engagement features, or features configured to grip or engage tissue when torque is applied to the expanded contact members, are collectively referred to herein as tissue anchors. Use of this term is intended to describe and include the aforementioned features individually and / or any combination of these features.

[0275] The tissue anchors 118 may be formed integrally with, on, added to, or otherwise coupled to or supported by the struts. The tissue anchors 118 may face circumferentially (or may face radially, as shown) to penetrate or engage tissue at an orthogonal angle to the tissue surface of the LAA, at an angle relative to a line tangent to the outer surface of the contact member 104, or at other angles. In some embodiments, each strut 116 may support multiple tapered tissue anchors that face circumferentially, as shown in FIG. 2B, all of which may face a similar orientation relative to each strut, such as circumferentially relative to each strut. In the illustrated embodiment, each strut 104 has five tissue anchors 118. In this embodiment, when the contact member 104 is rotated in a first direction (indicated by arrow A1 in FIG. 2C , which can be clockwise or counterclockwise), 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, causing the LAA to twist or rotate in the first direction A1. Twisting or rotation of the LAA in the first direction from the first rotational position to the second rotational position results in the opening or ostium O of the LAA contracting radially (represented or identified by arrow A2 in FIG. 2C ) such that the ostium O of the LAA moves or contracts around the outer surface of the proximal portion 104a of the contact member 104. An operator can twist or rotate the contact member 104 by twisting or rotating the core member 113 of the catheter 112. Tightening or constriction of the opening O of the LAA around the outer surface of the proximal portion 104a of the contact member 104 or other portions of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior portion of the LAA from the remaining chambers in the heart, thereby substantially reducing the health risks associated with an open LAA.

[0276] In some embodiments, as in the illustrated example, the fixation element 110 may be maintained in a collapsed or first state by being constrained by an outer sleeve 114 of the catheter 112 while the contact member 104 is deployed and rotated to prevent the fixation element 110 from contacting tissue within the heart and potentially lacerating or damaging such tissue. An intermediate sleeve or tube 115 may be coupled to the fixation element 110 and may be used to manipulate and control the position and / or orientation of the fixation element 110, including holding the proximal end 110a of the fixation element in a fixed axial position while a distally directed force is exerted on the contact member 104 to maintain the retention member in the first, extended state. In any of the implant device embodiments disclosed herein, the fixation element (e.g., including but not limited to, the fixation element 110) may be keyed, indexed, or otherwise rotationally secured to the contact member (e.g., including but not limited to, the 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 LAA from rotating back toward the first rotated position.

[0277] 2D , with the contact member 104 rotated to a second rotational position and maintained in the 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 can then be advanced distally (represented by arrow A3 as shown in FIG. 2D ) or the outer sleeve 114 can be retracted proximally to expose the fixation element 110 so that it can 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 can expand generally radially to open to a larger overall diameter or profile. Additionally, each of the one or more members 120 of the fixation element 110 may have an end 120a that extends generally distally axially (but may be angled slightly inward) as the fixation element 110 advances axially, such that the distal portion 120a of each of the one or more members 120 can 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 can penetrate or engage may include a portion of the tissue comprising the left atrium and / or a portion of the tissue comprising the LAA. As described above, the contact member 104 may be held in a generally fixed axial position using the core member 113 while the fixation element 110 is advanced distally toward the contact member 104. The retention member 108 may then be unconstrained to maintain the fixation element 110 in a second position in which it engages the heart tissue, as shown in FIG. 2E . In some embodiments, the fixation element may be biased axially toward a smaller size, such as with a spring member or the like. For example, the retention member 108 may be formed by a laser cut opening in a cylindrical tube, such as a hypotube, made of a resilient material such as Nitinol. Thereafter, with reference 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.When the fixation element 110 engages the patient's tissue, as shown in FIG. 2F, the LAA is prevented from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fixate and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0278] The retention member 108 may then be unconstrained (e.g., released) to allow it to retract to maintain the fixation element 110 in a second position in engagement with cardiac tissue, as shown in FIG. 2E. In some embodiments, the fixed retention member 108 may be axially biased toward a smaller size length or size, such as with a spring member or the like. For example, the retention member 108 may be formed by a laser-cut opening in a cylindrical tube, such as a hypotube, made of a resilient material such as Nitinol.

[0279] 2F, the implant device 102 may then be disengaged from the catheter 112, and the catheter 112 may be retracted and removed from the patient's body. When the fixation element 110 engages the patient's tissue, as shown in FIG. 2F, the LAA is prevented, or at least inhibited or biased, from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fixate and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0280] Components of any of the implant embodiments disclosed herein may be made from any other elastic or superelastic material, including nitinol or any other shape-memory material, or stainless steel or any other mechanically expandable material. In any embodiment disclosed herein, the contact member (such as contact member 104) may have a spherical, cylindrical, or other shape, such as an elongated bullet, a stent, a mushroom, or other non-circular or non-cylindrical shape, or any of the shapes described or shown with respect to any of the embodiments disclosed herein. In any embodiment disclosed herein, the contact member may include a series of interconnected struts (which can, but are not required to, form a diamond-shaped pattern across all or a portion of the surface of the contact member) or may be made from a series of ribs or paddles that form an expandable device.

[0281] 3 , the fixation elements of any device embodiment disclosed herein, including but not limited to fixation element 110, may have an outer size (e.g., outer diameter of fixation element arms 144) that is significantly smaller than the outer size (e.g., outer diameter) of contact member 104. For example, without limitation, the fixation elements of any device embodiment disclosed herein may have an outer size that is approximately half the outer size of contact member 104, or approximately 30% to approximately 80% of the outer size of contact member 104, or approximately 50% to approximately 60% of the outer size of contact member 104. In any embodiment, the outer size of the fixation element may be similar to, approximately the same as, or larger than the outer size of contact member 104.

[0282] 3 , any embodiment of the implant device 102 disclosed herein may also have a cover member 121 that can provide an additional seal or barrier around the exterior surface of the contact member 104 and other portions of the implant device 102, providing an additional barrier for the implant device 102. In some embodiments, the cover may be positioned or disposed on or against an interior surface or portion of the implant's contact member, which can improve the seal or occlusion that the implant device 102 creates within the LAA. In some embodiments, the cover member 121 can cover substantially or completely all of the implant device's contact member 102.

[0283] Further details regarding the implant system 100 are described with reference to FIGS. 4-7. FIG. 4 illustrates the contact member 104 in a second expanded state, the retention member 108 (also referred to herein as a biasing member) in a first elongated state, and the fixation element 110 in a second open state. In any embodiment disclosed herein, the retention member can be an axial spring-like member or other axially resilient member. In some embodiments, the contact member 104 can have a continuous, uninterrupted circumference at the proximal end 104a from which each of the strut members 116 extends distally. Each of the strut members 116 can be preformed into a curved shape such that when no external restraint or constraint is applied to the outer surface of the contact member 104 (e.g., in a relaxed state), the strut member 116 is biased to expand to the second state. At the distal end, each of the strut members 116 can be coupled to a hub member 122, although this is not required. 5-6, the hub member 122 may have a plurality of receptacles 123 configured to receive and restrain the distal end portions 116b of each of the strut members 116. Additionally, each of the receptacles 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 such that the distal end portions 116b of the strut members 116 may extend generally radially away from the hub member 123 when the contact members 104 are in the second expanded state. The hub member 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 without resistance or significant resistance. The distal end of each of the strut members 116 may have a tab or other feature (such as a T-shaped termination or other width increase) 119 that locks into, secures, or otherwise engages with, each of the receptacles 123 so as to axially restrain each end of the strut member 116 while rotating about the end.

[0284] In some embodiments, such as the embodiment illustrated in FIG. 4, the retention member 108 and the fixation element 110 may be integrally formed. For example, without limitation, the retention member 108 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape using a conventional or suitable process. In other embodiments, the fixation element 110 may be formed separately and coupled to the proximal end 108a of the retention member 108. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention member 108 may be biased to move to a second or folded state, as shown, for example, in FIGS. 2E, 6, and 7. Furthermore, in the relaxed state, the retention member 110 may be in a second, or open, position, as also shown in FIG. 2E. Further, with reference to FIG. 5, which is an enlarged cross-sectional view taken along line 5-5 of FIG. 4, a pin or cross member 124 may be coupled to the distal end 108b of the retention member 108 and may be configured to fit within a slot 126 formed in the distal end 113b of the core member 113. In this embodiment, the core member 113 may be advanced distally, resulting in the contact member 104 advancing distally. Furthermore, a core tube 128 may extend proximally from the distal end 113b of the core member 113 and couple to the proximal end 104a of the contact member 104. The pin 124 may extend through a pair of openings formed in the core tube 128 to secure the core tube 128 to the pin 124, and therefore to the distal end 108b of the retention member 108. Thus, the core tube 128 may be used to couple the contact member 104 to the retention member 108. A pin, tab, suture, tie, protrusion, clip, indentation, detent, or other feature may be used to couple the proximal end 104a of the contact member 104 with the proximal end of the core tube 128. Note that the core tube 128 is omitted from some of the figures for clarity.

[0285] Additionally, in any embodiment, the system 100 may be configured such that the implant device 102 is biased or selectively secured proximally relative to the core member 113. For example, without limitation, as shown in FIG. 5 , some embodiments of the implant device 102 may have a suture or thread 130 that extends through the interior of the core member 113 (such as through a lumen of the core member 113) and loops around the pin 124, thereby allowing a user to retract or retrieve the suture and withdraw the implant device 102 proximally relative to the core member 113. In this configuration, both ends of the suture 130 may extend from the proximal end of the device 100 such that a physician can grasp both ends of the suture 130 and exert a biasing force around the pin 124 to maintain the pin against the proximal end of the slot 126 formed in the distal end 113b of the core member 113. When the implant device 102 is ready to be released from the core member 113, the physician can simply release one end of the suture and retract the other end of the suture until the suture no longer forms a loop and / or is no longer wrapped around the pin 124. After removing the biasing or retaining force from the suture 130 and / or removing the proximally directed force from the contact members, the core member 124 can be retracted relative to the implant device 102 while the contact members remain stationary within the LAA. This may occur after the contact members and fixation elements are fully deployed or implanted in the LAA and / or tissue adjacent to the LAA.

[0286] Additionally, in any embodiment disclosed herein, the pin or cross member 124 may be configured to allow a guidewire to pass unobstructed through the distal end of the implant device 102. For example, without limitation, an opening larger than the outer diameter of the guidewire may be formed in the pin 124 to allow the guidewire to pass therethrough, or the pin 124 may be formed in two sections with a sufficiently large space between them.

[0287] 8A-8C , in any embodiment, the contact member 104 of the implant device 102 can be advanced into the LAA as desired or appropriate by the surgeon. For example, without limitation, as shown in FIGS. 8A-8C , the contact member 104 can be advanced to contact, adjacent to, or near the distal end of the LAA before the contact member 104 is rotated. This positions more of the implant within the LAA and, in some embodiments, allows more tissue of the LAA to contract around the body portion or other portion of the implant device 102. This, in some embodiments, allows the user to rotate the contact member 104 of the implant device 102 to a greater extent and can also result in less stress on the tissue of the LAA. Any implant device embodiment disclosed herein can be configured to advance to any extent within the LAA, including through the ostium of the LAA, into a central portion of the LAA, and further into the LAA so as to contact, adjacent to, or near the distal end of the LAA before the contact member 104 is rotated.

[0288] 9A-9I illustrate another embodiment of a treatment system 140 for closing or occluding the LAA. In any embodiment disclosed herein, any component, feature, or other detail of the treatment system 140 or implant device 142 may have any of the components, features, or other details of any other treatment system embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100 or implant device 102 embodiments described above, in any combination with any of the following treatment system 140 or implant device 142 components, features, or details. Similarly, any component, feature, or other detail of any other treatment system embodiment or implant device embodiment disclosed herein may have any of the components, features, or other details of any of the treatment system and / or implant device embodiments disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0289] In any embodiment of occlusion system 140, including those of occlusion system 140, the system can have an implant device 142 having a contact member 144 (also referred to herein as a contact element or an expandable implant member), a fixation element or fixation element 150 (also referred to as a fixation member), and a retention member 148. FIG. 9A shows both contact member 144 and fixation element 150 in a first, contracted, or restrained state within an outer sleeve 154 of a catheter 152. The implant device 142 can be advanced distally out of the catheter 152 by advancing the core member 153 of the catheter 152, past the distal end 154 a of the outer sleeve 154, such that the contact member 144 of the implant device 142 can be deployed within the LAA at any desired depth within the LAA, including, for example, without limitation, near the distal end of the LAA, the central portion of the LAA, or elsewhere, by maintaining the core member 153 of the catheter 152 in a fixed axial position and retracting the outer sleeve 154 of the catheter 152. In any embodiment disclosed herein, the contact member 144 can be radially self-expanding such that when a restraint is removed from the contact member 144, the contact member 144 can automatically expand against the inner surface or wall of the LAA. In other embodiments, the contact member 144 can be mechanically expandable, such as by a balloon expander, to expand against the inner surface or wall of the LAA.

[0290] In any embodiment, the contact member 144 can have multiple arms or struts 156, each configured to radially self-expand when a restraint is removed from the exterior surface of the contact member 144. For example, without limitation, any embodiment of a contact member disclosed herein can have six struts 156, or six to ten struts, or fewer than six to more than ten struts. Additionally, in any embodiment, the contact member 144 can have multiple tissue anchors 158 or other similar features configured to penetrate or engage tissue of the LAA when the contact member 144 is expanded against the tissue of the LAA and / or when the contact member 144 is rotated or twisted within the LAA.

[0291] In this configuration, when the contact member 144 is rotated in a first direction (indicated by arrow A6 in FIG. 9C , which can be clockwise or counterclockwise), one or more or all of the struts 156 and one or more or all of the tissue anchors 158 engage tissue of the LAA, causing the LAA to twist or rotate in the first direction A6. Twisting or rotating the LAA in the first direction from the first rotational position to the second rotational position results in the opening or ostium O of the LAA being radially constricted (represented or identified by arrow A7 in FIG. 9C ) so that the opening O of the LAA is translated or constricted about the outer surface of the proximal portion 144a of the contact member 144. An operator can twist or rotate the contact member 144 by twisting or rotating the core member 153 of the catheter 152. Tightening or constriction of the opening O of the LAA around the outer surface of the proximal portion 144a of the contact member 144 or other portions of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior portion of the LAA from the remaining chambers in the heart, thereby substantially reducing the health risks associated with an open LAA. In any embodiment disclosed herein, the implant 142 can be configured to be removed such that after the fixation element is applied to the tissue constricted by twisting of the contact member, the only portion of the implant device 142 remaining in the LAA or heart is the fixation element 150.

[0292] The retention member 148 is used to couple the fixation element 150 to the contact member 144 and allows a user (such as a surgeon) to move the fixation element 150 toward and away from the contact member 144. In any embodiment, the retention member 148 may have a helical thread on its outer surface. In any embodiment, the retention member 148 may include a threaded shaft. In this configuration, the retention member 148 may be rotated in a first direction to advance the fixation element 150 toward the contact member 144 and rotated in a second, opposite direction to move the fixation element 150 away from the contact member 144. The retention member 148 may be configured to engage the fixation element 150 such that, as the retention member 148 rotates, the fixation element 150 moves in an axial direction corresponding to the rotation of the retention member 148. For example, without limitation, the retaining member 148 can have an annular recess 149 near its proximal end 148 a configured to engage or couple with a tab or protrusion 151 on the fixation element 150. In some embodiments, the protrusion 151 can extend into the annular recess 149 to axially lock or engage the fixation element 150 with the retaining member 148. The interaction of the protrusion 151 and the annular recess 149, where the walls of the annular recess contact and press against the protrusion 151, causes the retaining member 148 to move the fixation element 150 when the retaining member 148 is rotated. In some embodiments, as in the illustrated embodiment, the fixation element 150 can have two tabs 151 that both engage with the annular recess 149. The contact member 144 can have a threaded neck portion 145 that threadingly engages with the threads of the retaining member 148 such that the retaining member 148 threadably engages in and out of the threaded neck portion 145. In this configuration, the retaining member 148 threads into and out of the contact member 144, moving the fixation element 150 relative to the contact member. As shown in FIG. 9H , the retaining member 148 is threaded almost fully into the contact member 144 and into a cavity or space 161 within the contact member 144, such that the fixation element 150 moves as far as possible toward the contact member 144. When the retaining member 148 is rotated in a second direction, the retaining member 148 moves out of the space 161 within the contact member 144, moving the fixation element 150 away from the contact member 144.

[0293] Referring to FIG. 9H , intermediate sleeve 155 can be advanced distally into contact with and engagement with proximal end 148a of retention member 148. Intermediate sleeve 155 can be configured such that when intermediate sleeve 155 engages proximal end 148a of retention member 148, rotating intermediate sleeve 155 in a first or second direction can rotate retention member 148 in a first or second direction. In some embodiments, intermediate sleeve 155 can move axially and rotate independently of other tubes or sleeves of catheter 152. For example, and without limitation, as shown in FIG. 9H , protrusions or tabs 159 on distal end 155b of intermediate sleeve 155 can selectively mate with or be advanced into recesses or indentations 147 formed in proximal end 148a of retention member 148, allowing intermediate tube 155 to be selectively keyed or indexed with retention member 148.

[0294] Additionally, in any embodiment, the implant 142 can be coupled to the delivery catheter 152 using a retention member 148. For example, without limitation, the core member 153 of the delivery catheter 152 can be coupled to the retention member 148 via a threaded protrusion 165 at the distal end 153b of the core member 153 that threadingly engages a threaded recess 167 formed in the proximal end 148a of the retention member 148. The threaded protrusion 165 can be formed separately from and coupled to the distal end of the core member 153, or can be integrally formed. In this configuration, the implant 142 can be removed from the catheter by disengaging the threaded protrusion 165 from the retention member 148. This can be accomplished by using the intermediate tube 155 to prevent rotation of the retention member 148 while the core member 153 is rotated in a second direction to retrieve the threaded protrusion 165 from the recess 167 of the retention member 148.

[0295] Additionally, the second intermediate tube or sleeve 157 can be advanced distally into contact and engagement with the proximal end 150a of the fixation element 150. The second intermediate sleeve 157 can be configured such that when the second intermediate sleeve 157 engages the proximal end 150a of the fixation element 150, rotating the second intermediate sleeve 157 in a first direction or a second direction can cause the fixation element 150 to rotate in a first direction or a second direction. In some embodiments, the second intermediate sleeve 157 can move axially and rotate independently of the other tubes or sleeves of the catheter 152. For example, and without limitation, as shown in FIG. 9H , protrusions or tabs 169 on the distal end 157b of the second intermediate sleeve 157 can selectively couple with posts or arms of the fixation element 150 such that the second intermediate sleeve 157 can be keyed or indexed to the fixation element 150.

[0296] Additionally, in some embodiments, the fixation element 150 may be keyed or indexed to the contact member 144 such that the fixation element 150 and the contact member 144 rotate simultaneously, dependent on one another. For example, in some embodiments, the fixation element 150 may have a body portion 170 with one or more tabs or protrusions 172 configured to extend into a channel or recess 173 formed in a body portion 175 of the contact member 144. The one or more channels 173 may be formed axially such that the protrusions 172 of the fixation element 150 and the fixation element 150 can move freely axially relative to the contact member 144. However, the narrow width of the channel 173 relative to the protrusions 172 may prevent the protrusions 172, and therefore the fixation element 150, from rotating relative to the contact member 144.

[0297] In this configuration, the second intermediate sleeve 155 may be coupled with the fixation element 150 and can be used to at least rotate the implant 142 in a first direction or a second direction. For example, without limitation, the second intermediate sleeve 155 can be rotated to rotate the contact member 144 and twist the LAA to a desired rotational and / or torque level. The second intermediate sleeve 155 can then be used to maintain the desired rotational position of the contact member 144 by contacting the fixation element 150 and maintaining the second intermediate sleeve 155 in a fixed rotational position, thus holding the contact member 144 in a fixed rotational position while the retention member 148 is rotated in a first direction to advance the fixation element 150 toward the contact member 144. Once the fixation element 150 is in the desired axial position (e.g., engaged with the tissue of the contracted LA / LAA as a result of twisting of the contact member 144), the implant 142 can be removed from the catheter 152, and the catheter can be removed from the LA, by disengaging the threaded protrusion 165 from the retention member 148 as described above. When the fixation element 150 engages the patient's tissue, as shown in FIG. 9E, the LAA is prevented from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 142 can fixate and maintain the LAA in a substantially or completely occluded state, or in a substantially or completely closed state.

[0298] Additionally, in any embodiment, the device may be configured to allow contact member 144 to be removed from the patient's LAA after fixation element 150 has sufficiently engaged with tissue to hold the tissue closed or occluded, as shown, for example, in FIGS. 11-12 , with fixation element 177 and fixation element 150 being the only components remaining in the body after the implant procedure is complete. In this configuration, the implant may have a plug or cover (such as cover 178 coupled to fixation member 177) that can cover an opening in the implant through which a contact member (such as contact member 180 or contact member 144) is withdrawn, or may be configured to plug or cover an opening in the implant through which contact member 144 is withdrawn. For example, but not limited to, a cover member, such as cover member 121, may be coupled to fixation element 150 in a configuration in which contact member 144 remains in the LAA after fixation element 150 is implanted, substantially covering any opening in the implant or coupling with contact member 144 within the LAA.

[0299] Additionally, in some embodiments, the contact members 144 may have a continuous, uninterrupted circumference at the proximal end 144a, from which each of the strut members 156 extends distally. Each of the strut members 156 may be preformed into a curved shape such that when no external restraint or constraint is applied to the outer surface of the contact members 144 (e.g., when in a relaxed state), the strut members 156 are biased to expand to a second state. At the distal end, each of the strut members 156 may be coupled to a hub member 162, although this is not required. Similar to the hub member 122 described above, the hub member 162 may have multiple receptacles (not shown) configured to receive and restrain the distal ends 156b of each of the strut members 156. Additionally, each of the receptacles 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 such that the distal end 156b of the strut member 156 can extend generally radially away from the hub member 163 when the contact member 144 is in the second, expanded state. The hub member 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 without resistance or significant resistance. In any embodiment, the distal end of each of the strut members 156 may have a tab or other feature (such as a T-shaped termination or other width increase) (not shown) that locks into, thereby securing, or otherwise engages with, the respective receptacle 163 to axially restrain the respective end of the strut member 156 while allowing rotation about the end.

[0300] Additionally, as described above, in any of the embodiments disclosed herein, the implant device can be configured to allow the contact member to be removed from the patient's LAA after the fixation element has engaged tissue to hold the ostium of the LAA closed. For example, with reference to FIG. 10 , in any of the embodiments disclosed herein, the contact member can be a dilatation balloon, such as dilatation balloon 184. The balloon can have a smooth exterior surface or can have dimples, protrusions, a rough texture, tissue anchors, or other features to engage the interior surface of the LAA. In some embodiments, the balloon can be a typical dilatation balloon, such as those used in angioplasty procedures, and can be sized and configured for use in the LAA. In these configurations, after the LAA has been rotated and / or torqued to the desired extent and the fixation element has been implanted to hold the ostium of the LAA sufficiently closed or constricted, the balloon can be deflated and removed from the LAA, leaving only the fixation element to maintain the LAA occluded, as shown in the non-limiting examples of FIGS. 11-12 .

[0301] 13 illustrates another embodiment of a treatment system 200 having an implant device 202 with the contact member 204 in a second expanded state, the retention member 208 in a second contracted state, and the fixation element 210 in a second open state. FIG. 14 is a cross-sectional view of the embodiment of treatment system 200 shown in FIG. 13 taken along line 14-14 in FIG. 13. In any embodiment disclosed herein, any component, feature, or other detail of treatment system 200 or implant device 202 may have any of the components, features, or other details of any other treatment system embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100 or implant device 102 embodiments described above, in any combination with any of the following treatment system 200 or implant device 202 components, features, or details. Similarly, any component, feature, or other detail of any of the other treatment system embodiments or implant device embodiments disclosed herein can have any of the components, features, or other details of any embodiment of treatment system 200 or implant device 202 disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0302] 13-14, in some embodiments, contact member 204 may have an annular proximal end 204a, and all (six are shown) of the arms or struts 230 of contact member 204 extend distally away from proximal end 204a. The struts 230 may have any form of tissue anchor 232 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0303] Additionally, in some embodiments, the contact members 204 may have an annular distal end 204b, and all of the arms or struts 230 may be coupled to the annular distal end 204b. The contact members 204 may have a bulbous shape, a cylindrical shape with a curved distal portion, an elongated spherical shape, or other. In some embodiments, the contact members 204 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise joined together. Each of the strut members 230 may be pre-formed into a curved shape (which may have a spherical or bulbous shape) and may be formed such that the strut members 230 are biased to expand to the second state when no external restraint or constraint is applied to the exterior surface of the contact members 204.

[0304] In some embodiments, such as the illustrated embodiment, the retention member 208 and the fixation element 210 may be integrally formed. For example, without limitation, the retention member 208 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material such as Nitinol, and then formed into the desired shape. In other embodiments, the fixation element 210 may be coupled to the proximal end 208a of the retention member 208. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention member 208 may be biased to move, for example, to a second state, or a collapsed state, and the fixation element 210 may be in the second state, or an open state.

[0305] 14 , a pin or cross member 268 may be coupled to the distal end 208b of the retention member 208 and may be configured to fit within a slot 270 formed in the distal end 218b of the core member 218. In this embodiment, the core member 218 may be advanced distally, thereby advancing the contact member 204 distally. Furthermore, a core tube 274 may extend proximally from the distal end 218b of the core member 218 and couple with the proximal end 204a of the contact member 204. The pin 268 may extend through a pair of openings formed in the core tube 274 to secure the core tube 274 to the pin 268 and, therefore, to the distal end 208b of the retention member 208. Thus, the core tube 274 may be used to couple the contact member 204 to the retention member 208. A pin, tab, suture, tie, protrusion, clip, indentation, detent, or other feature may be used to connect the proximal end 204 a of the contact member 204 with the proximal end of the core tube 274 .

[0306] Additionally, in any embodiment, the system 200 may be configured such that the implant device 202 is biased proximally relative to the core member 218. For example, without limitation, as shown in FIG. 14 , some embodiments of the implant device 202 may have a suture or thread 280 that extends through the interior of the core member 218 (such as through a lumen of the core member 218) and loops around the pin 268, thereby allowing a user to retract or retrieve the suture and withdraw the implant device 202 proximally relative to the core member 218. In this configuration, both ends of the suture 280 may extend from the proximal end of the device 200 such that a physician can grasp both ends of the suture 280 and exert a biasing force around the pin 268 to maintain the pin against the proximal end of the slot 270. When the implant device 202 is ready to be released from the core member 218, the physician can simply release one end of the suture and withdraw the other end of the suture until it no longer forms a loop or is wrapped around the pin 268. After removing the biasing force from the suture 280, the core member 268 can be withdrawn relative to the implant device 202. This may occur after the contact members and their fixation elements are fully deployed.

[0307] 15 illustrates another embodiment of an implant device 302 in which the contact members 304 are in a second expanded state, the retention members 308 are in a second contracted state, and the fixation element 310 is in a second open state. In any embodiment disclosed herein, any component, feature, or other detail of the treatment system 300 or implant device 302 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100, 200 or implant device 102, 202 embodiments described above, in any combination with any of the treatment system and / or implant device components, features, or details. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein may have any of the components, features, or other details of any of the treatment system and / or implant device embodiments disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0308] In any embodiment, the length of the retention member (including retention member 308) and / or the distance between the fixation element and the contact member can be adjusted or varied beyond that shown and described, e.g., to accommodate different anatomical sizes and characteristics of the LA and / or LAA, or to accommodate different amounts or thicknesses of collected or twisted LAA tissue. For example, without limitation, in some embodiments, the length of the retention member or the distance between the fixation element and the contact member can be approximately the same as the length of the contact member when the retention member is in a relaxed or folded state (e.g., the second state), or approximately half the length of the contact member when the retention member is in the second state, between one-quarter and one-half the length of the contact member when the retention member is in the second state, or the like.

[0309] In some embodiments, the contact member 304 may have an annular proximal end 304a, and all (six are shown) of the arms or struts 330 of the contact member 304 extend distally from the proximal end 304a. Further, in some embodiments, the contact member 304 may have an annular distal end 304b, and all of the arms or struts 330 may be coupled to the annular distal end 304b. In some embodiments, the contact member 304 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise joined together. Each of the strut members 330 may be pre-formed into a curved shape (which may have a rounded or bulbous shape) and may be formed such that the strut members 330 are biased to expand to a second state when no external restraint or constraint is applied to the exterior surface of the contact member 304. The struts 330 may have any form of tissue anchor 332 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0310] In some embodiments, the contact members 304, retention members 308, and fixation elements 310 can be cut or otherwise integrally formed from a single length of hypotubing. For example, without limitation, the retention members 308 and fixation elements can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact members 304, retention members 308, and / or fixation elements 310 can be formed separately and welded, brazed, or otherwise joined together to form a single, unitary component. In some embodiments, the distance between the contact members 304 and the fixation elements 310 can be greater. For example, without limitation, the distance between the contact members 304 and the fixation elements 310 can be greater than the length of the contact members when the contact members are in the second, expanded state so that the contact members 304 can be advanced further distally into the LAA and then rotated to twist the opening of the LAA and constrict the opening of the LAA around the outer surface of the retention members. A longer length of the retention member 310 may accommodate a greater degree of twisting or rotation of the LAA, or a greater number of twists or rotations, before the fixation elements engage.

[0311] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 310 and can be used to manipulate and control the position and / or orientation of the fixation element 310, including holding the proximal end 310a of the fixation element in a fixed axial position while a distally directed force is exerted on the contact member 304 to maintain the retention member 310 in a first extended state. Additionally, a core member (not shown) can engage the distal end 304b of the contact member 304b to allow a distally directed force to be exerted on the contact member 304. Pins, tabs, sutures, ties, protrusions, clips, indentations, detents, or other features can be used to selectively (i.e., reversibly) couple the contact member 304 to the core member.

[0312] After the desired degree of twisting of the LAA has been achieved, the fixation element 310 can be moved to a second expanded state, for example, by advancing the fixation element 310 out of the distal end of the delivery catheter tube, expanding the fixation element to its second state. Thereafter, while maintaining the contact members 304 in a desired axial and rotational position (e.g., the second rotational position), the fixation element 310 can be advanced into the contracted tissue around the outer surface of the implant to secure the tissue in its twisted and / or contracted state. In some embodiments, this can be achieved or implemented by simply holding the contact members in a desired position and allowing the retention member 308 to retract to its retracted or relaxed state, thereby advancing the fixation element 310 into the tissue. Once deployment is complete, the user can disengage the core member from the contact members 304 so that the core member can be retrieved. As with other embodiments, the implant device 304 may be selectively biased or secured proximally relative to the delivery catheter, such as with a suture or thread 380 that extends through the inside of the catheter and loops around a pin, tab, or other feature of the implant device, and is released by disengaging or removing the suture or other retaining device.

[0313] 17 illustrates another embodiment of an implant device 402 in which the contact members 404 are in a second expanded state, the retention members 408 are in a second contracted state (or at least partially contracted or retracted state), and the fixation element 410 is in a second open state. Any embodiment of the treatment system 400 or implant device 402 can have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100, 200, 300 or implant device 102, 202, 302 embodiments described above, in any combination with any of the components, features, or details of the treatment system 400 or implant device 402 described below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any of the components, features, or other details of any of the treatment system 400 or implant device 402 embodiments disclosed herein, in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0314] The contact member 404 may have an annular proximal end 404a and a distal portion 404b with multiple openings or rings 480. The struts or links 430 of the contact member 404 may form a mesh pattern to form a curved, bulbous, elongated bulbous, spherical, or other shaped contact member. The struts 430 may have multiple tissue anchors or protrusions 432 coupled to the struts or links 430 at multiple locations around the contact member 404, such as any of the tissue anchors 118 described above. As with any of the embodiments disclosed herein, the tissue anchors 432 may be, but are not required to be, integrally formed with the struts 430. The struts or links 430 may form a generally diamond-shaped pattern around the surface of the contact member. The contact member 404 may have a generally spherical or bulbous shape.

[0315] 17 , a pin or cross member 468 may be coupled to the implant device 402, for example, but not limited to, at the distal end 408b of the retaining member 408 or between the retaining member 410 and the contact member 404. The pin 468 may be configured to engage an end of the catheter core member 418 or a feature formed within the distal end of the catheter core member to selectively couple the implant device 402 to the catheter core member, similar to other embodiments disclosed herein.

[0316] Additionally, similar to other embodiments of the systems disclosed above, some embodiments of the implant device 402 may have a suture or thread 480 that loops around or otherwise engages the pin 468, thereby allowing a user to retract or retrieve the suture to proximally withdraw the implant device 402 relative to the core member 418. After removing the biasing force from the suture 480, the core member 468 may be withdrawn relative to the implant device 402. This may occur after the implant and its fixation elements are fully deployed.

[0317] In some embodiments, the contact member 404, retention member 408, and / or fixation element 410 can be laser cut or otherwise integrally formed from a single length of hypotubing. For example, without limitation, the retention member 408 and fixation element can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact member 404, retention member 408, and / or fixation element 410 can be formed separately and welded, brazed, or otherwise joined together to form a single, unitary component. In some embodiments, the distance between the contact member 404 and the fixation element 410 can be large so that the contact member 404 can be advanced further distally into the LAA and then rotated, twisting the opening of the LAA and constricting the opening of the LAA around the outer surface of the retention member. A longer length of the retention member 410 can accommodate a greater number of rotations or twists of the LAA before the fixation element engages.

[0318] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 410 and can be used to manipulate and control the position and / or orientation of the fixation element 410, including holding the proximal end 410a of the fixation element in a fixed axial position, while a distally directed force is exerted on the contact member 404 to maintain the retention member 410 in the first extended state. Deployment of the device 402 can include any combination of the steps described with respect to any of the other embodiments disclosed herein.

[0319] 18-21 show another embodiment of a treatment system 500 having an implant device 502 with a contact member 504 in a second expanded state, a retention member 508 in a second contracted state, and a fixation element 510 in a second open state. Any embodiment of the treatment system 500 or implant device 502 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described embodiments of the treatment system 100, 200, 300, 400 or implant device 102, 202, 302, 402, in any combination with any of the components, features, or details of the treatment system 500 or implant device 502 disclosed herein. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any component, feature, or other detail of any embodiment of treatment system 500 or implant device 502 disclosed herein in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0320] The contact member 504 can have multiple struts or links 530 that can have multiple tissue anchors 532 thereon, such as any of the tissue anchors 118 described above, at multiple locations around the contact member 504. As with any of the embodiments disclosed herein, the tissue anchors 532 can be, but need not be, integrally formed with the struts 530. The contact member 504 can have a generally spherical or bulbous shape, or the shape of any of the other embodiments disclosed herein.

[0321] Similar to the other embodiments described above, any embodiment of the treatment system 500 can have a suture or thread 580 extending through the interior of the core member 518 (such as through a lumen of the core member 518) and looping around the pin 568 or other retention member coupled with the contact member 504, thereby allowing a user to retract or retrieve the suture 580 and pull the contact member 504 proximally relative to the fixation element 510 to engage the implant 502 with the delivery catheter. In this configuration, both ends of the suture 580 can extend from the proximal end of the device 500 such that a physician can grasp both ends of the suture 580 and exert a proximally directed force around the pin 568 to pull the contact member 504 toward the fixation element 510, with the pin 568 positioned within the slot 570 of the core member 518. Additionally, the slot 574 formed in the cylindrical body portion 572 of the fixation element 510 can be sized to allow the cylindrical body portion 572 of the fixation element 510 to move axially in the proximal and distal directions relative to the pin 568 between the proximal end 574 a of the slot 574 and the distal end 574 b of the slot 574. Thus, the pin 568 and suture 580 bias or urge the implant 502 into contact with the catheter (e.g., into contact with the core member 518 or the slot 570 formed in the core member) and allow a user to move the fixation element 510 from the first position to the second, engaged position (shown in FIGS. 18-21 ).

[0322] In some embodiments, when the contact members 504 are maintained in a fixed position using the catheter or core member 518, the user can move the fixation element 510 from the first position to the second position by pulling back or retrieving the suture 580 (while the contact members 504 are held in a fixed position within the LAA) and by distally advancing the outer tube 576 of the delivery catheter to push the fixation element 576 distally. This occurs after the desired level of twisting of the LAA has been achieved by twisting or torquing the core member 518 or other portions of the catheter. Referring to FIG. 19 , in some embodiments, this allows the fixation element 510 and body portion 572 of the fixation element to be advanced distally relative to the contact members 504, thereby forcing the fixation element into the tissue of the LAA or LA to hold the tissue in a closed or contracted position.

[0323] Additionally, any embodiment of the device can be configured to use a retention member to prevent the fixation element 510 from moving away from the second position toward the first position when the fixation element 510 is advanced to the second position and engages tissue to retain the LAA in an occluded or closed position, thereby maintaining the position of the fixation element and maintaining occlusion of the LAA. For example, without limitation, one or more tabs 582 formed on or coupled with the body portion 584 of the contact member 504 can be biased into or into engagement with each of the plurality of recesses or openings 586 to prevent or inhibit the fixation element 510 from moving back toward the first position relative to the contact member 504. The tabs 582 (which may be any other type of fixation feature, such as a ball and detent, or a zip-tie type fixation feature, or otherwise) can be configured to allow the fixation element 510 to move freely from the first, expanded position to the second, collapsed position and selectively prevent or inhibit movement from the first position to the second position, thereby essentially locking the fixation element in the second position. Furthermore, in any embodiment disclosed herein, the fixation element and contact members can be held together using one or more sutures, wires, pins, or other components or fasteners, including, for example, but not limited to, sutures with slip knots that can be tightened during deployment. The sutures can then be trimmed to length during final deployment to hold the fixation element and contact members together and maintain the LAA in a closed or contracted state. The sutures 580 may then be removed, and the remaining components of the deployment device can be withdrawn from the patient's body, leaving the implant 502 in place.

[0324] In some embodiments, the implant device 502 may be configured such that the ratchet or retention mechanism formed by the engagement of the tabs 582 and the openings 586 is reversible or removable, such that the fixation element can be moved from a second position to or toward a first position to disengage the fixation element from tissue, for example, to re-twist or otherwise reposition the LAA. For example, some embodiments of the implant device 502 may be configured to rotate or twist the fixation element (and thus the tab(s) 582) relative to the body portion 584 of the contact member 504 such that the tabs 582 disengage the openings 586. Further, in some embodiments, the tabs may be positioned on the body portion 584 of the contact member 504, and the openings may be formed in the body portion of the fixation element 510. Furthermore, the tabs may be formed in both directions such that the fixation element can ratchet or be selectively locked in both axial directions of movement. Additionally, in any of the embodiments disclosed herein, the tabs may be shaped and configured such that they are movable from a locked position or state to an unlocked (or sliding) state. Examples of these embodiments are described below.

[0325] FIG. 22A illustrates another embodiment of a treatment system 600 having an implant device 602 with the contact members 604 in a second, expanded state and the fixation element 610 in a first, retracted, or pre-deployed state. FIG. 23 illustrates an embodiment of an implant device 602 with the fixation element 610 moved to a second, deployed, or locked state. FIGS. 24-35 illustrate an embodiment of a method of deployment of the embodiment of the treatment system 600 illustrated in FIGS. 22-23. Any embodiment of the treatment system 600 or implant device 602 can have any of the components, features, or other details of any other implant device embodiment disclosed herein, including, but not limited to, any of the embodiments of implant devices 100, 200, 300, 400, and 500 described above, in any combination with any of the components, features, or details of the treatment system 600 or implant device 602 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any component, feature, or other detail of any embodiment of treatment system 600 or implant device 602 disclosed herein in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0326] 22A-22B, the fixation element 610 may have a body portion 611 that may have a curved or helical (or corkscrew) shape that may extend from the proximal end 610a of the fixation element 610 to the distal end 610b of the fixation element 610, and may have a pointed distal tip 612 at the distal end 610b of the fixation element 610 that may engage with (or, in some embodiments, at least partially penetrate) tissue of the LA and / or LAA after the contact member 604 is rotated to a second position, thereby securing the tissue and closing or occluding the opening of the LAA around the implant device, for example, around the body portion 614 that is integral with or coupled to the contact member 604 or other portions of the implant device.

[0327] The fixation element 610 may define an axial opening 615 therethrough. In some embodiments, the opening 615 may be larger than the distal portion of the catheter's inner core member and / or the implant's body portion 614, such that the fixation element 610's body portion 611 wraps around or curves (helically or otherwise) and / or is rotatable around the catheter's inner core member and / or the implant's body portion 614.

[0328] 23A-23B illustrate another embodiment of a fixation element 610 that can be used with any of the implant or delivery system embodiments and / or treatment methods disclosed herein. In any embodiment, the cross-section of the body portion 611 can be circular, square (as shown), oval, or any other desired shape. In any embodiment, the body portion 611 can have 2-15 or more coils (i.e., full rotations), or 3-10 coils, or 4-6 coils, and can terminate at the distal end 610b of the fixation element 610 with a sharp point, a blunt tip, one or more tissue anchors or barbs, or otherwise. Additionally, any of the fixation element embodiments disclosed herein, in embodiments having two or more body portions as described below, can have tissue anchors or barbs (not shown) along the length or length of the body portion 611 to engage tissue and prevent or inhibit retraction of the fixation element 610 from the tissue after the fixation element 610 is advanced into such tissue. The proximal end 610 a of the fixation element 610 may have a flange 617 , an opening 619 , and / or other features configured to connect the fixation element 610 to other portions of the implant 602 .

[0329] Additionally, in any embodiment disclosed herein, the fixation element 610 may also have a rotational or axial locking feature that can secure the fixation element in a desired rotational and / or axial position and / or inhibit reversal of the fixation element. The rotational or axial lock may be selectively reversible, allowing the user to return the fixation element to a freely movable state as desired. For example, without limitation, with reference to FIGS. 23C-23D , any embodiment of the fixation element disclosed herein may have one or more tissue anchors or barbs 621 extending away from the proximal end 610 a of the fixation element 610 to improve the fixation element's grip on the target tissue and / or prevent or inhibit the fixation element 610 from retracting out of the tissue after the fixation element 610 has been advanced into such tissue. In any embodiment, the tissue anchors or barbs 621 may face axially, radially, or at an angle relative to the axial direction of the fixation element 610. The tissue anchors or barbs 621 may be angled or otherwise configured to easily penetrate tissue, have vertical faces or otherwise be configured to engage and / or lock with tissue to prevent counter-rotation of the fixation element 610.

[0330] Further, with reference to FIGS. 23E-23F, any embodiment of a fixation element disclosed herein can have two or more, or multiple, body portions 611 extending away from the proximal end 610a of the fixation element. The embodiment of the fixation element 610 shown in FIGS. 23E-23F has a first body portion 611a and a second body portion 611b, both of which are helical in shape, have the same or similar pitch, and can extend the entire length of the fixation element 610. In other embodiments, one of the body portions 611 can have a different length (e.g., shorter) than the other body portion 611. Furthermore, in any embodiment disclosed herein, one or more body portions 611 can have a pitch that varies (increases or decreases) along its length from the proximal to the distal portion of the fixation element. A body portion 611 having a pitch that decreases along the length of the fixation element (such that the spacing increases along the length of the body portions) can result in the tissue between the coils being more compressed near the proximal end of the fixation element than near the distal end of the fixation element. In some embodiments, this may increase the retention force of the fixation element within tissue. First body portion 611a may have a distal end 612a, and second body portion 611b may have a distal end 612b.

[0331] As mentioned above, in some embodiments, the fixation element 610 may have two or more curved or helical (or corkscrew)-shaped body portions 611, each of which may have a pointed distal tip that can engage (or, in some embodiments, at least partially penetrate) tissue of the LA and / or LAA after the contact member is rotated to the second position. In any embodiment disclosed herein, a fixation element having a helical shape (such as the embodiment of fixation element 610 shown in FIGS. 22A-22B) may have two helical-shaped body portions 611, each of which may be configured to penetrate and engage tissue that has contracted around a portion of the implant. In any embodiment, including single and double helical fixation element embodiments, the body portion or portions 611 may be long enough to engage the contact member, or may be shorter and engage all or only a proximal portion of the LA wall / LAA tissue, such as approximately 1 mm to approximately 2 mm of the LA wall / LAA tissue, or approximately 2 mm to approximately 5 mm or more of the LA wall / LAA tissue.

[0332] Additionally, in any embodiment, the one or more body portions 611 may define a cylindrical shape along the length of the fixation member 610, as shown, a conical shape along the length of the fixation member 610, or the like. For example, without limitation, in any embodiment, the one or more body portions 611 may define a conical shape that increases along the length of the fixation member 610 such that the opening 615 is larger at the distal end 610b of the fixation element 610. The conical shape may result in the fixation element 610 widely gathering and packing tissue (i.e., radially inward) as it advances into the LA wall / LAA tissue.

[0333] 22B, the fixation element 610 (which may be any of the fixation element embodiments or may have any combination of the features of any of the fixation element embodiments disclosed herein) may be rotated (such as in a corkscrew fashion) and advanced to penetrate and / or pass through tissue of the LA and / or LAA collected and / or constrained around the body portion 614, or portion thereof, of the implant device 602. In this configuration, the fixation element 610 is configured to be rotatable relative to the contact member 604 such that the fixation element 610 can rotate and pass through tissue of the LA and / or LAA while holding the contact member 604 in a stationary position generally fixes the LAA in a second rotated position. In any embodiment, a sleeve or other component of the catheter or delivery system engages a fixation element (including, but not limited to, fixation element 610) to allow a user to move the fixation element from a second state to a first state (which should be interpreted as including movement from the second state to the first state), rotate the fixation element in either direction, move the fixation element between a first position and a second position, and / or otherwise manipulate the fixation element. In some embodiments, the catheter or delivery system may be configured to perform these actions independently of any other movement or movement of the catheter, such as, for example, allowing the fixation element to be advanced axially toward the contact member while the contact member is held in a fixed position by the catheter.

[0334] The fixation element 610 can thereby hold tissue of the LA and / or LAA to hold the tissue of the LA and / or LAA in a constrained state around the implant device and occlude the LAA. Additionally, in some embodiments, as shown, the fixation element 610 can also be configured to pass through one or more openings 620 that can be formed in or resultantly formed in the contact member 604 when the contact member 604 is in the second expanded state, thereby further securing the fixation element 610 to the contact member 604 and preventing or inhibiting the contact member 604 from rotating toward the first position. In any embodiment, the fixation element 610 and / or contact member 604 can have one or more teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue-engaging features or anchor members about an exterior surface of the fixation element 610 to prevent or inhibit the fixation element 610 from disengaging from the tissue of the LA and / or LAA when in the second state. Additionally, in any embodiment, the fixation element may be biased to the second position by a biasing member (not shown), such as an axially resilient member, or using one or more sutures, wires, ratchets, tabs and openings, or other fixation features. However, in some embodiments, engagement of the fixation element 610 with tissue of the LA and / or LAA may be sufficient to secure the fixation element 610 in the second position and maintain the LAA in an occluded state.

[0335] Embodiments of deployment sequences will now be described with reference to Figures 24-35. Figures 24-27 show the contact member 604 being advanced into the LAA. With reference to Figure 27, the contact member 604 can be advanced to any desired depth, including to the end of the LAA. In some embodiments, the contact member 610 can be advanced to a desired position relative to the LAA and then expanded to a second state to contact an interior surface or tissue of the LAA. The contact member 604 can then be rotated in a first direction (represented by arrow A3 in Figures 28-29, which can be either clockwise or counterclockwise) toward a second position to twist the LAA in the first direction toward the second state, as also shown by arrow A3 in Figures 28-29. As will be described, as shown in Figures 28-29, twisting can cause the ostium of the LAA to contract around a portion of the body of the implant device 602 to occlude the LAA from the LA.

[0336] 30-31 , while maintaining the contact member 604 in the second rotational position and / or maintaining the tissue of the LA and / or LAA in an occluded or contracted state and the LAA in a twisted position, the fixation element 610 can be advanced distally (as shown by arrow A4 in FIGS. 30-31 ) toward the tissue of the LA and / or LAA contracted about the body of the implant device. Before the distal end of the fixation element 610 reaches the tissue of the LA and / or LAA, the fixation element 610 can be rotated in a first direction (such as the rotational direction shown by arrow A5 in FIGS. 32-33 ) while the fixation element 610 is advanced distally such that the fixation element 610 penetrates and / or engages the tissue of the LA and / or LAA contracted about the body portion of the implant device 602. In some embodiments, the fixation element 610 can be advanced to completely penetrate the tissue of the LA and / or LAA, as shown in FIGS. 34-35 . In some embodiments, the fixation element 610 can be configured to engage and / or only partially penetrate tissue of the LA and / or LAA. The implant device 602 can then be released from the delivery catheter, which can be withdrawn from the patient's heart, leaving the LAA in an occluded position, as shown in FIGS. 34-35.

[0337] 36 illustrates another embodiment of an implant device 650 having a different embodiment of a fixation element 652 that can be used in conjunction with any of the embodiments of the implant device disclosed herein. As shown in FIG. 36, the fixation element 650 can have a back member 654 coupled to the proximal end 652a of the fixation element 652 that can provide an additional seal against the tissue of the LA and / or LAA when the fixation element is in the second or deployed position.

[0338] 37-38 show another embodiment of a treatment system 700 having an implant device 702 with the contact members 704 in a second expanded state and the fixation elements 710 in a second open state. Any embodiment of treatment system 700 or implant device 702 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment system 100, 200, 300, 400, 500, 600 or implant device 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or details of treatment system 700 or implant device 702 disclosed below; similarly, a component, feature, or other detail of any other treatment system or implant device embodiment disclosed herein may have any of the components, features, or other details of any of the treatment system or implant device embodiments disclosed herein, in any combination with any of the components, features, or details of treatment system or implant device embodiments disclosed herein.

[0339] In any embodiment, the contact member 704 may have a body portion 706, which may, but need not, have a cylindrical shape. An opening or recess 708 may be formed in the body portion 706 as part of a retention element to hold the fixation element 710 in a desired axial position relative to or locked to the coupling member 704. The fixation element 710 may also have a body portion 712, which may, but need not, have a cylindrical shape. In some embodiments, the body portion 712 may extend into the body portion 706 of the contact member 704 even when the fixation element 710 is in the first retracted state. The body portion 706 may have an opening 708 extending therethrough and sized and configured to selectively receive the body portion 712 of the fixation element 710. The body portion 712 may have an opening 722 extending therethrough and sized and configured to selectively receive a core member 720 of a delivery catheter of the treatment system 700.

[0340] 39, the fixation element 710 may have a deflectable tab member 714 that is movable or can be moved from a first engaged position (as shown in FIG. 37) to a second disengaged position (as shown in FIG. 38). The tab member 714 may be configured to rotate about a pin that may be coupled with the tab member 714 and the body portion 712, or may be configured to rotate about a thin strip of material (referred to herein as material strip 715) used to form the body portion 712 and / or tab member 714. For example, without limitation, the body portion 712, the tab member 714, and one or more material strips 715 (two shown) may be integrally formed. Furthermore, in some embodiments, one or more arms 711 (four shown) of the fixation element 710 may also be integrally formed with other features of the fixation element 710. In some embodiments, the tab 714 may be biased toward a first engaged position (as shown in FIGS. 37 and 39 ), but is physically deflectable or rotatable toward a second disengaged position (as shown in FIG. 38 ) by advancing a core member 720 or other component through an opening 722 extending through the body portion 712 of the fixation element 710. For example, without limitation, as shown in FIG. 38 , the core member 720 may be advanced distally through the opening 722 of the fixation element 710 to deflect or rotate the tab member 714, thereby moving the tab member 714 from the first engaged position to the second disengaged position.

[0341] When the tab member 714 is in the engaged position, the tab member 714 can engage with an opening 708 formed in the body portion 706 of the contact member to axially lock or couple the fixation element 710 with the contact member 704, for example, after the contact member has twisted the LAA into a closed or occluded position or condition, as described above. However, in some embodiments, if a user desires to disengage or separate the fixation element 710 from the contact member 704, the user can accomplish this by moving the tab member 714 to, for example, as described above and without limitation, a second disengaged position, thereby disengaging the tab member 714 from the opening 708. The user can then axially withdraw the fixation element 710.

[0342] 40-43 illustrate another embodiment of an implant device 732. Any embodiment of the implant device 732 can have any of the components, features, or details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment systems 100, 200, 300, 400, 500, 600, 700, or implant devices 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or other details of the implant device 732 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any of the components, features, or other details of any of the implant device 732 embodiments disclosed herein, in any combination with any of the components, features, or other details of the treatment system or implant device embodiments disclosed herein.

[0343] As shown in FIG. 40 , the deflectable tab member 744 of the implant device 732 engages with the opening 738 of the contact member 734, thereby engaging the fixation element 740 with the contact member 734. In any embodiment, the deflectable tab member 744 is movable or can be moved from the first engaged position (shown in FIG. 40 ) to the second disengaged position (shown in FIG. 41 ) by distally advancing the fixation element 710 such that the body portion 739 of the contact member 734 changes and moves the tab member 744 to the second disengaged position, as shown in FIG. 41 . Thereafter, the fixation element 740 can be rotated in either direction (e.g., by 90 degrees) to a position where the tab member 744 is not aligned with, and therefore cannot be engaged with, the opening 738, as shown in FIG. 42 . The body portion 739 of the contact member 734 can hold the tab member 744 in the second, disengaged position while the securing element 740 is pulled away or disengaged from the contact member, as shown in FIG.

[0344] Figures 44A and 44B are front and side views, respectively, of another embodiment of a treatment system 750 configured to twist and close or occlude the LAA at the ostium of the LAA. Figures 45A and 45B are front and side views, respectively, of the treatment system 750 of Figure 44, showing an implant used to twist the LAA to close or occlude the LAA at the ostium. The LA or LAA material that has contracted around the LAA ostium or implant device can then be clipped or locked in the contracted state, similar to any embodiment disclosed herein and using any fixation feature or component disclosed herein. Figures 46A and 46B are side views, respectively, of the treatment system of Figure 44, showing the delivery device being removed from the implant device after the LAA has been occluded.

[0345] In some embodiments, the steps of deploying and implanting can include, in any combination, and in any combination with any other steps, (a) inserting the catheter and implant device through the ostium of the LAA; (b) rotating the contact members or other engaging components of the implant to twist the LAA and fold at least the ostium of the LAA back on itself, thereby closing or occluding the ostium of the LAA; (c) clipping, holding, or securing the LA and / or LAA tissue in an occluded or closed state; and / or (d) releasing and retrieving the delivery catheter from the implant. As shown, the treatment system twists the LAA closed at the ostium and clips and holds it in place, essentially closing the LAA. In some embodiments, the steps of deploying and implanting include inserting the catheter centered at the ostium of the LAA; rotating the paddles of the implant to twist the LAA and cause it to self-fold; clipping and holding it in place against the atrial wall; and releasing the delivery catheter from the implant.

[0346] 47A-47F illustrate another embodiment of a treatment system 1100 for closing or occluding the LAA, including an embodiment of a delivery device 1101 and an embodiment of an expandable implant or implant 1102 for the left atrial appendage, particularly showing the implant 1102 in several exemplary stages of expansion and deployment. The implant 1102 can have a body portion 1104 with a plurality of expandable struts or arms 1106. The body portion 1104 can expand, in some embodiments, to an approximately spherical or elongated spherical shape. The struts 1106 can each have a plurality of barbs or tissue anchors 1108 thereon (which can be or include any of the tissue anchors disclosed herein). Any of the embodiments of the implants disclosed herein can have a laser-cut nitinol body portion that is self-expanding and covered with micro-barbs.

[0347] The barbs 1108 may be configured to engage tissue upon torsional translation or movement of the body portion 1104 relative to the medial wall of the LAA after the body portion 1104 is expanded from the first state to the second state, where the struts 1106 and barbs 1108 can engage or contact tissue on the interior wall of the LAA. Additionally, any embodiment of the implant 1102 can have one or more anchor elements 1112 configured to engage tissue adjacent to or surrounding the LAA to prevent the implant 1102 from rotating back to the first rotated position after the implant 1102 is rotated to the second rotated position within the LAA. In any embodiment, the anchor element 1112 can include two arms or members, each capable of engaging a tissue surface and each having multiple barbs thereon, configured to prevent the implant from rotating back to the first rotated position. 48A-48E illustrate several stages or steps illustrating the deployment procedure for the expandable implant 1102 of FIGS. 47A-47F as the implant 1102 is deployed within the LAA.

[0348] 49A-49G illustrate an embodiment of an implant 1202 that can be used to close or substantially close the LAA. In some embodiments, the implant 1202 can be formed by laser cutting a tube of a resilient material such as nitinol. The implant 1202 and any other implant embodiments disclosed herein can be self-expanding or mechanically expandable, such as using balloon expansion techniques. Furthermore, any embodiment of the implant 1202 can have any of the same features, components, or details of any other implant embodiment disclosed herein, instead of, or in combination with, any of the features, components, or details of the embodiments of the implant 1202 disclosed herein. In some embodiments, the implant 1202 can have a contact member 1204 that can be covered with multiple microbarbs or other tissue anchors 1208 and a fixation element 1212 (also referred to herein as an anchor element) that can include a single folding clip anchor. The fixation element 1212 can be configured to lock the implant 1202 in a fixed, rotated position after the implant has rotated the LAA to the desired level of twisting and closure or occlusion.

[0349] 50A-50F show several illustrative stages of an embodiment of a deployment procedure for the expandable implant 1202 of FIGS. 49A-49G as the implant 1202 is deployed within the LAA. In any embodiment, the implant 1202 can be advanced into the LAA, expanded, and then rotated from a first rotational position to a second rotational position to twist the LAA and cause the ostium and / or other tissue of the LAA to contract or occlude around a portion of the implant 1202. The implants disclosed herein, or any implant, can be configured to rotate clockwise (and rotate clockwise and / or counterclockwise during any procedure disclosed herein) to twist closed or substantially close the ostium of the LAA or to contract the ostium of the LAA around a portion of the implant 1202. After the desired level of occlusion is reached, the fixation element 1212 can be rotated or folded (e.g., without limitation, about an axis or hinge 1214) laterally of the LAA so that it is approximately perpendicular to the axial centerline of the implant and forced to engage tissue adjacent to the LAA adjacent the ostium of the LAA to prevent unwinding of the implant and the LAA ostium. The body portion of the fixation element 1212 can also have tissue anchors 1216 formed thereon or coupled or integrally therewith that can engage, penetrate, and / or grasp contracted LA and / or LAA tissue as a result of twisting of the LAA. In any embodiment disclosed herein, the fixation element 1212 can be configured to be biased and / or securable to a second, locked state (as shown in FIG. 49G or FIG. 50F ) using a spring, shape memory material, suture, tie, or other component. The delivery device can be detached from the implant after deployment of the fixation element 1212 and removed from the patient's body, as shown in FIG. 50F .

[0350] 51, 52, and 53 illustrate additional embodiments of implant devices 1220, 1222, and 1224 (note that implant devices are also referred to herein as implants) that can be used in conjunction with any of the treatment system, delivery device, or procedure embodiments disclosed herein to treat the LAA. The implant device 1220 shown in FIG. 51 can have ribbons or struts made from nitinol or any other suitable material that are configured to expand into an approximately spherical or elongated spherical shape and can be covered with small barbs or cleats (or other tissue anchors). The tissue anchors can point in one or both circumferential directions. The implant device shown in FIG. 52 can have a stent-like body made from nitinol or any other suitable material that is self-expanding or balloon-expandable into an approximately spherical or elongated spherical shape. The body of the implant can be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors). 53 may be made from nitinol or any other suitable material and may have a woven wire body that may be configured to expand into an approximately spherical or elongated spherical shape. The body of the implant device 1224 may be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors).

[0351] 54 illustrates another embodiment of an implant device 1230 that is (or can be) expanded into an approximately spherical or elongated spherical shape. For example, without limitation, the implant device 1230 can be configured with an inflatable balloon covering that expands the implant device 1230 into contact with the tissue of the LAA when the implant device 1230 is in a desired position within the LAA. The implant body 1230 is covered with small barbs or cleats or other tissue anchors.

[0352] FIG. 55 illustrates another embodiment of an implant device 1232 that can be used with any of the treatment system embodiments disclosed herein. In some embodiments, the implant device 1232 can have a helical-shaped body when in a second expanded state that can be used to exert at least a torque and torsional effect on the LAA. The implant device 1232 can be made from nitinol and can be covered with or have a plurality of small barbs, cleats, or other tissue anchors. The implant device 1232 can be self-expanding when in the second state and can have a half-dome shape. In some embodiments, the implant device 1232 can have a rounded end 1234 that can be approximately the same size as the internal lumen of the delivery system or can be smaller or larger and expandable.

[0353] 56A-56B illustrate an embodiment of a treatment system 1240 having an implant device 1242 generally contained within a catheter body 1244 of the treatment system 1240 in FIG. 56A , with at least a contact member 1246 of the implant device 1242 in a second, expanded state in FIG. 56B . The contact member 1246 can have multiple barbs or anchor members around its outer surface and can be configured to expand into an approximately spherical or elongated spherical shape. The contact member 1246 can be self-expanding or mechanically expandable and can have a half-dome shape with a rounded distal end 1248. In some embodiments, the rounded end 1248 can be approximately the same size as the internal lumen of the delivery system, or can be smaller or larger and expandable.

[0354] 57-61 show additional different embodiments of fixation or anchor elements that may be used with any of the other components of the implant device embodiments disclosed herein. Fig. 57A shows an embodiment of a dual-arm fixation element. Fig. 57B shows the dual-arm fixation element of Fig. 57A being advanced around the body portion of the implant device into the tissue of the LA and / or LAA adjacent the ostium of the contracted LAA.

[0355] FIG. 58A shows an embodiment of a single folded clip anchor or fixation element. FIG. 58B shows the single-arm fixation element of FIG. 58A rotated or clipped against tissue of the LA and / or LAA adjacent the ostium of the LAA constricted around the body portion of the implant device. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. FIG. 59A shows an embodiment of a disc anchor or fixation element. FIG. 59B shows the disc fixation element of FIG. 59A advanced toward tissue of the LA and / or LAA adjacent the ostium of the LAA constricted around the body portion of the implant device so that one or more tissue anchors of the fixation element of FIG. 59A can engage and / or penetrate tissue of the LA and / or LAA adjacent the ostium of the LAA.

[0356] FIG. 60A shows an embodiment of a fixation element having a single folded clip anchor or helical or screw-type tissue anchor that can be used to engage and / or penetrate tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device. FIG. 60B shows the single folded clip anchor or fixation element of FIG. 60A rotated or clipped against tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. FIG. 61A shows a dual-arm fixation element having two helical or screw-type tissue anchors. FIG. 61B shows the dual-arm fixation element of FIG. 61A rotated against tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device so that the tissue anchors on the arms can engage and / or penetrate the tissue. Both arms of the fixation element of FIGS. 61A-61B can be folded toward the body portion or axial centerline of the fixation element and can be configured to automatically deploy when extended past the distal end of the delivery catheter.

[0357] 62A-62B show side and end views of different embodiments of contact members that can be deployed within the LAA to engage tissue of the LAA such that the LAA twists when torque is applied to the contact member. FIGS. 62A-62B show contact member embodiments having a cylindrical or disc-shaped body portion, a spherical body portion, a conical body portion, and a semi-spherical and / or hemispherical body portion configured to better engage or bond with LAA tissue. Any of the contact member embodiments shown in FIGS. 62A-62B can have multiple barbs, micro-barbs, or other tissue anchors on their exterior surface. Additionally, any of the contact member embodiments shown in FIGS. 62A-62B can have an exterior surface uniformly covered with barbs, micro-barbs, or other tissue anchors. Additionally, any of the body portion embodiments disclosed herein, including but not limited to the hemispherical body portion shown in FIGS. 62A-62B, can have a flat region on a portion thereof to allow for a lower profile. 63 shows a side view of an embodiment of a contact member expanded against the tissue surface of the LAA after torque has been applied to the contact member causing contraction of the tissue of the LA / LAA around a portion of the body of the implant device. FIG. 63 also shows a tissue anchor of the implant device advanced into the tissue of the LA / LAA to secure the LAA in a second position.

[0358] Additionally, any embodiment of the implant disclosed herein may have a drug coating, a fabric or other at least substantially impermeable covering (similar to, but not limited to, the cover member 121 described above), electrical contacts to eliminate conduction of the electrical signals that cause Afib, or other features to improve the performance of the implant. Some embodiments of the implant may be delivered percutaneously via a catheter and a detachable element between the implant element and the delivery system, which would allow for permanent separation and thus permanent implantation of the implant. Furthermore, in any embodiment disclosed herein, the implant may be delivered without the use of a catheter, for example, surgically or otherwise.

[0359] Some embodiments include a device for closing or occluding the LAA, the device having an expandable implant configured to move between a first state in which the implant is substantially collapsed and a second state in which 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, the implant may be advanced into the LAA such that the implant moves from the first state to the second state such that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage after the implant has been advanced into the left atrial appendage. Any embodiment of the implant or insert may have multiple tissue anchors on its exterior surface.

[0360] Additionally, the catheter can be configured to rotate the implant in a first direction from a first rotational position to a second rotational position so that the implant can twist the wall of the left atrial appendage. As described above, the catheter can rotate the implant from as little as a quarter turn to more than a full turn. In any embodiment, the delivery device (which in any embodiment disclosed herein may be a catheter, or any other suitable deployment or surgical device or system) can be configured to allow the user to rotate the implant as many times as necessary or desired to close, occlude, or collapse the LAA on the implant itself, or around the exterior surface of the implant.

[0361] Any embodiment of the implant is self-expandable so that the implant automatically expands when a restraint is removed from the implant, such as when the implant automatically expands when advanced through the distal end of the outer sleeve of the catheter. The implant can be biased to remain in the expanded state after deployment into the left atrial appendage.

[0362] Additionally, any embodiment of the implant or system disclosed herein may be configured such that the implant can engage or automatically engage with tissue or tissue surfaces when rotated or pivoted in one (or first) direction. Any embodiment of the implant disclosed herein may also be configured to disengage any tissue it engages when pivoted in a second direction (the second direction being opposite the first direction). In this embodiment, a user can engage tissue or wall surfaces of the LAA by rotating the implant in a first direction and disengage (if necessary for any reason, including, but not limited to, repositioning the implant) by rotating the implant in a second direction, the second direction being opposite the first direction.

[0363] In any embodiment, as described above, the implant can be configured to prevent the contact member from rotating back to the first rotational position after the contact member is fully deployed. For example, as described above, any embodiment of the implant can have a fixation element or anchor element that can be configured to engage tissue surrounding the LAA, such as tissue on the inner wall of the heart outside the left atrial appendage. Some embodiments of the implant can have a fixation element with multiple tissue anchors configured to engage the inner wall of the heart adjacent the left atrial appendage.

[0364] For example, without limitation, the implant of any of the device, apparatus, and method embodiments disclosed herein may include a fixation element configured to engage the inner wall of the heart adjacent to or outside the left atrial appendage. The fixation element may have one or more arms and / or tissue anchors configured to engage the inner wall of the heart adjacent the left atrial appendage, or may be configured to be sutured to or otherwise coupled to the inner wall of the heart adjacent the left atrial appendage. In any embodiment, the implant may be configured to prevent or inhibit reverse rotation of the contact member or other portion of the implant to a first rotational position after the contact member or other portion of the implant is fully deployed. In any embodiment, the implant may be configured to rotate or allow rotation of the contact member in a first direction from a first rotational position to a second rotational position, and to prevent or inhibit rotation of the implant in a second direction after the contact member or other portion of the implant is fully deployed, the second direction being opposite the first direction.

[0365] Any embodiment disclosed herein may include an implant for deployment within a cavity or vessel having an expandable body (which may, but need not, have any of the functionality or characteristics of a contact member), a plurality of tissue anchors on an exterior surface of the expandable body configured to engage an inner wall surface of the cavity or vessel, and an anchor element coupled to the expandable body configured to engage a tissue surface adjacent the inner wall surface of the cavity or vessel.

[0366] Several embodiments of methods for closing or occluding the LAA using any of the embodiments of the implants disclosed herein are now described. The method or procedure can include advancing a deployment device having an implant with an expandable member or contact member into a patient's left atrium; moving or deploying a portion of the implant from a first state to a second state within the left atrial appendage, such that the expandable member or contact member is substantially collapsed in the first state and deployed in the second state; engaging an inner wall portion of the left atrial appendage with the expandable member or contact member (which may, but need not, have one or more tissue anchors on its outer surface); rotating the expandable member or contact member from the first rotational position to the second rotational position to twist the wall portion on the inside of the left atrial appendage; and preventing the expandable member or contact member from rotating back to the first rotational position. Any portion of the implant, including, but not limited to, the expandable member or contact member, can be self-expanding, and moving the expandable member or contact member from the first state to the second state can include advancing the expandable member or contact member out of the distal end of the deployment device.

[0367] Furthermore, in any embodiment disclosed herein, engaging the inner wall portion of the left atrial appendage can include engaging the inner wall portion of the left atrial appendage with one or more tissue anchors positioned on an exterior surface of the expandable member or contact member or other portion of the implant. Furthermore, preventing the implant from rotating back to the first rotational position can include engaging a tissue wall exterior to the left atrial appendage with an anchor or fixation element. In some embodiments, the anchor or fixation element can be rotationally fixed to the expandable member or contact member and / or other portion of the implant to prevent relative movement between the anchor element and the expandable member or contact member and / or other portion of the implant. Preventing the expandable member or contact member and / or other portion of the implant from rotating back to the first rotational position can include engaging a tissue wall of the heart with an anchor or fixation element, such that the anchor element can be rotationally fixed relative to the implant and configured to prevent the expandable member or contact member and / or other portion of the implant from rotating back to the first rotational position, or engaging an inner wall of the heart exterior to the left atrial appendage with the anchor or fixation element. In any embodiment, the anchor element or fixation element can include a plurality of tissue anchors on at least one surface thereof, the tissue anchors configured to engage the inner wall of the heart outside the left atrial appendage.

[0368] In any embodiment disclosed herein, the implant may be configured to automatically rotate from a first rotational position to a second rotational position after the contact member and / or other portions of the implant are in the second state, or may be activated to self-rotate at any desired time. For example, without limitation, the implant may have a spring or other torsion member configured to rotate the contact member and / or other portions of the implant or other portions of the body of the implant upon release or activation of the spring, or may be configured to pre-twist or pre-coil when the implant or the contact member and / or other portions of the implant are in the first state. Self-rotation or self-twisting can occur, for example, after the contact member and / or other portions of the implant are secured to the wall portion surrounding the LAA and after a portion of the implant engages at least a portion of the inner wall surface of the LAA, such that rotation or twisting of a portion of the implant can cause twisting of the LAA, thereby closing or occluding the ostium of the LAA.

[0369] Thus, in any embodiment, the implant can be configured to automatically or self-rotate from the first rotational position to the second rotational position upon release of a restraint holding the implant in the first rotational position or upon triggering or actuation of a rotation mechanism, which can be a spring or other torsion member. In some embodiments, the shaft extending through the implant can be configured to be wound or rotated relative to the fixed portion or base of the implant or can have a spring around the shaft, such that rotation of the shaft relative to the fixed portion or base of the implant can result in torsion of the LAA as a result of torsional release of the shaft or a spring surrounding at least a portion of the shaft.

[0370] In other embodiments, the implant may have a shaft or body portion extending from a base, the shaft being rotatable (manually, by catheter, or self-rotating) relative to the base from a first rotational position to a second rotational position, and a ratchet or other locking mechanism may be used to lock the shaft or body portion in the second rotational position relative to the base. The base may be configured to engage and lock into the heart wall or tissue surrounding the LAA before the shaft or body portion engages with an inner wall portion of the LAA and before the shaft or body portion is rotated to the second position.

[0371] Further, in any apparatus, implant device, method, or other embodiment disclosed herein, the second rotational position can be at least or approximately one-eighth of a full rotation (i.e., 45 degrees or approximately 45 degrees) relative to the first rotational position, at or approximately one-quarter of a full rotation (i.e., 90 degrees or approximately 90 degrees) relative to the first rotational position, or at least or approximately one-half of a full rotation (i.e., 180 degrees or approximately 180 degrees) relative to the first rotational position, or the second rotational position can be from at or approximately one-eighth of a full rotation (i.e., 45 degrees or approximately 45 degrees) to at or approximately one-half of a full rotation (i.e., 180 degrees or approximately 180 degrees) relative to the first rotational position. In any apparatus, implant device, method, or other embodiment disclosed herein, the second rotational position can be from at or about one-quarter of a rotation (i.e., at or about 90 degrees) to one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or from at or about one-quarter of a rotation (i.e., at or about 90 degrees) to two, three, or more full rotations, or about one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or from at or about one-eighth of a rotation (i.e., at or about 45 degrees) to one, two, three, or more full rotations, or about one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or any value or range of values ​​within any of the foregoing ranges. In any embodiment disclosed herein, the torsional movement or step can be achieved by a torque catheter.

[0372] Further, in embodiments of any apparatus, implant device, or method disclosed herein, the catheter may be configured to exert a torque on the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached or until the user determines to stop rotation, whichever comes first. In some embodiments, the threshold predetermined torque level may be between 0.25 in-oz torque or approximately 0.25 in-oz torque and 10 in-oz torque or approximately 10 in-oz torque, or between 0.5 in-oz torque or approximately 0.5 in-oz torque and 5 in-oz torque or approximately 5 in-oz torque.

[0373] In any embodiment disclosed herein, the contact members, when in the first or folded state, can have an outer diameter or size of approximately 3 mm to approximately 8 mm (approximately 9 Fr to approximately 24 Fr), or approximately 4 mm to approximately 6 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or can have a length (of the arm or strut member) of approximately 20 mm to approximately 60 mm, or approximately 30 mm to approximately 50 mm, or any value or range of values ​​between any of the aforementioned ranges. Additionally, in any embodiment disclosed herein, without limitation, the contact members, when in the second or expanded state, can have an outer diameter or size of approximately 6 mm to approximately 14 mm (approximately 18 Fr to approximately 42 Fr), or any value or range of values ​​between any of the aforementioned ranges, or approximately 9 mm to approximately 11 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or can have a length (of the arm or strut member) of approximately 10 mm to approximately 40 mm, or approximately 20 mm to approximately 30 mm, or any value or range of values ​​between any of the aforementioned ranges.

[0374] In any embodiment disclosed herein, without limitation, the fixation element, when in the first or collapsed state, can have an outer diameter or size of approximately 3 mm to approximately 8 mm (approximately 9 Fr to approximately 24 Fr), or any value or range of values ​​between any of the aforementioned ranges, or approximately 4 mm to approximately 6 mm, and / or a length of approximately 4 mm to approximately 12 mm, or approximately 6 mm to approximately 8 mm, or any value or range of values ​​between any of the aforementioned ranges. Furthermore, in any embodiment disclosed herein, without limitation, the fixation element, when in the second or expanded state, can have an outer diameter or size of approximately 6 mm to approximately 18 mm (approximately 18 Fr to approximately 54 Fr), or approximately 9 mm to approximately 15 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or a length (of the arm or strut member) of approximately 4 mm to approximately 8 mm, or approximately 4 mm to approximately 6 mm, or any value or range of values ​​between any of the aforementioned ranges. Additionally, any embodiment of the fixation elements disclosed herein may have a tissue-engaging tip or portion (i.e., the portion configured to penetrate or engage tissue) having a length of approximately 0.2 mm to approximately 2 mm, or approximately 0.5 mm to approximately 1 mm, or any value or range of values ​​between any of the aforementioned ranges.

[0375] Some embodiments of the closure devices disclosed herein can be configured to more closely mimic a surgical-type closure compared to the conventional devices described above, in which the LAA is unplugged but closed, with limited exposure of the device within the left atrium.

[0376] Access to the long-arterial artery (LAA) can be gained by entering 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 prosthetic entry for closure can use both fluoroscopy and echocardiography (TEE, ICE, or transthoracic). Figures 1, 64, and 65 show at least a portion of the pathway from the access site to the LAA.

[0377] Some embodiments of the implant device disclosed herein have two anchors that can be placed at the lateral end of the ostium of the LAA and an oval mesh cover that can be attached to the two anchors. The deployment and implantation steps for any of the embodiments disclosed herein can include inserting a catheter spreader into the lateral end of the ostium of the LAA, positioning the anchors in place, and deploying and / or attaching the mesh cover to the anchors along with the dilatation catheter.

[0378] In some embodiments, the mesh cover can be configured to maintain the anchor in an extended position and cover the ostium of the LAA. An embodiment of an implant device 1600 of this design is shown in Figures 66A-66D and 68A-68F. The lateral anchor 1601 of the implant device 1600 can, in some embodiments, have a larger backing that can encapsulate the chamber wall between the backing and the later-attached mesh 1602. Additional embodiments of anchors 1610, 1612, 1614, and 1616 are shown in Figures 67A-67D. Alternatively, the anchors can connect and disconnect via a hinge-type mechanism, thus eliminating the need for a mesh cover to provide that structural separation.

[0379] 69A-69G show another embodiment of a device 1620 and a method for placing an implant 1622 that anchors one end out first and the other end out before the other. Some embodiments of this method and device 1620 have features, including but not limited to: (1) by shifting the second anchor catheter behind it in the delivery system, there may be more space to move the mesh back, and (2) there may be more precision in the placement of the lateral anchors when they are positioned one at a time. Another option is to lock the anchors in place with a barb, spear, or corkscrew-type mechanism to further secure their attachment to the chamber wall at the lateral end of the LAA ostium.

[0380] 70A-70F illustrate another embodiment of a device 1640 and a method of deployment of such a device, which can include sequentially deploying multiple staples, backing staples, clips, or other fasteners 1644 (collectively referred to herein as staples) after modifying the shape of the LAA ostium to a narrow oval. Some embodiments can include a series of custom staples 1644 that can be positioned all along the ostium of the LAA after the shape of the LAA ostium has been modified to a narrow oval. These staples 1644 can have a backing on the staple that can provide a reaction force against the traumatic ends of the staple to pierce the tissue, draw the top and bottom of the chamber walls together, and laterally close the LAA ostium. The backing can also provide a large sealing area within the LAA that is not possible with conventional staples. As mentioned, FIGS. 70A-70F illustrate the deployment of the backing staples 1644 in a sequential manner after modifying the shape of the LAA ostium to a narrow oval. When the staples are engaged and closed, they further join the two ends of the tissue and close the ostium of the LAA.

[0381] In any embodiment disclosed herein, the implant may be deployed using any combination of the following steps: inserting a catheter spreader into the lateral end of the ostium of the LAA, applying one or more staples to one end (or both ends) of the stretched LAA, removing the catheter spreader from the ostium (or only one side) of the LAA, reinserting the catheter spreader into the ostium of the LAA between the last backing staple and the distal end, applying a backing staple to one end of the stretched LAA, and / or repeating any or all of the last three steps until the ostium of the LAA is occluded or closed.

[0382] Figures 71A-71G show some details of some embodiments of staples 1644 (which may be backing staples). Any embodiment of the staple 1644 backing feature may be any shape and does not necessarily have to be made of metal or the same material as the staples. Figures 71A-71G and 72A-72F show additional details of a device 1648 that places a "z-bend" in the backing staple 1644 to further bring the two ends of the chamber walls together. Figures 72A-72F also show embodiments of a catheter mechanism device and method that creates this "z-bend" on the staple body, which will shorten the distance between the two prongs of the staple.

[0383] Another embodiment of the implant device and method may include a series of sutures or staples along the ostium of the LAA after the shape has been modified to a narrow oval, laterally closing the LAA ostium. Figures 73A-73B show an example of a device 1650 and a method for achieving this. The deployment and implantation steps include inserting a catheter spreader 1652 into the lateral end of the LAA ostium, applying stitches (or staples) 1654 along the medial edge of the spreader (on one or both sides), removing the catheter spreader from the LAA ostium, reinserting the catheter spreader into the LAA ostium between the last placed stitches, applying stitches along the medial edge of the spreader, and / or repeating the last three steps until the LAA ostium is occluded or closed.

[0384] Another embodiment of the implant device 1660 and method may include a series of sutures or staples 1644 along the ostium of the LAA before the shape is modified to a narrow oval, with the placement and connection of the sutures changing shape to a narrow oval after tensioning, laterally closing the LAA ostium. Figures 74A-74E show device and method embodiments for achieving this. Some embodiments of deployment and implantation methods for such a device include inserting a catheter spreader into the center of the LAA ostium and spreading it from top to bottom, applying stitches (or staples) along the edges (on one or both sides) of the spreader, removing the catheter spreader from the LAA ostium, reinserting the catheter spreader into the LAA ostium between the last placed stitch and the lateral end, applying stitches along the medial edge of the spreader, and / or repeating the last three steps until the LAA ostium is occluded or closed.

[0385] Any embodiment of the implant device and / or method disclosed herein may include implanting a series of staples along the ostium of the LAA after the shape has been modified to a narrow oval, thereby laterally closing the ostium of the LAA. Figures 75A-75E show an embodiment of several stages of forming a staple 1670 (which may have any of the features, shapes, or other details of other staple embodiments disclosed herein) from left to right as it exits the catheter, is opened and prepared for tissue engagement, is applied and secured to the chamber wall tissue, and is z-bent to draw the tissue ends together. Figures 72A-72F above show one embodiment of a method of forming a z-bend. In any embodiment disclosed herein, the deployment and implantation steps can include (see FIGS. 76A-76E ) inserting a catheter into the middle of the LAA, extending the catheter with the folded staples attached, unfolding (opening) the staples, advancing the staples into the tissue, folding or Z-bending the staples to shorten and gather the tissue, and / or repeating the last four steps until the ostium of the LAA is occluded or closed. Any of the staple or delivery device embodiments disclosed herein can be used in conjunction with other delivery device or implant embodiments to secure or close other LAA covering or occlusion devices.

[0386] Another embodiment of the implant device includes a compression spring that, upon insertion into the ostium of the LAA, modifies its shape to a narrow oval, laterally closing the LAA ostium. Figures 77A-77C show the compressed state of spring 1680 and the next stage of expansion. Figures 78A-78C show the stages of deployment for this design. In some embodiments, the deployment and implantation steps can include inserting a catheter into the middle of the LAA ostium, releasing tension on the cables that constrain the spring's compressed state, guiding the ends of the spring to the lateral ends of the LAA ostium, and / or releasing the delivery catheter from the implant.

[0387] 79A-79C show the same embodiment of spring device 1680 described above, but covered with a mesh or graft material 1682 that promotes tissue ingrowth and eventual closure / sealing of the LAA. Spring device 1680, in some embodiments, may be made from metal or plastic and may be formed from wire, strip, or sheet. Embodiments of spring device 1680 may also incorporate some telescoping or sliding mechanisms therein to guide its expansion trajectory and ensure its straightness.

[0388] Another embodiment of the implant device is a hinged or flexible member 1690 that can be folded to fit within a delivery catheter. During implant delivery, some embodiments of deploying the implant 1690 include retracting the delivery catheter sheath, allowing the implant 1690 to partially hinge or bend open once it is no longer constrained by the sheath. The ends of the implant 1690 may then be guided into each end (superior and inferior) of the LAA, and each end of the implant 1690 may be held in place with any manner of frictional element or force that allows for stabilization of the device within the LAA as deployment continues. Full deployment of the implant 1690 results in the stretching of the ostium of the LAA from an open orifice to a narrower orifice that can be pulled down to seal around the implant. This reduction in the height of the LAA effectively (substantially or completely) closes or occludes the opening of the LAA. In any embodiment disclosed herein, the terms closing or closed are also used herein to mean closing, substantially closing, and / or occluding. Closing the edges of the LAA eliminates flow between the left atrium and the LAA, closing off flow in either direction and stopping potential thrombus migration into the circulatory system.

[0389] In some embodiments, the deployment and implantation steps may include inserting the catheter into the middle of the LAA ostium, allowing the hinged implant to expand (spring-assisted or driven by a screw, pull cable, or hydraulic actuation), guiding the end of the implant to the lateral end of the LAA ostium, fully opening the implant and locking it in position, and / or releasing the delivery catheter from the implant. The hinged or flexible implant 1690 can have a variety of shapes from very narrow wires that can be 0.020 inches to 0.060 inches in diameter, as shown in Figures 87A-87C, 88A-88C, and 89A-89C, to thicker rectangular shapes that can be 0.060 inches to perhaps 0.25 inches, as shown in Figures 80A-80C and 81A-81C, to oval or "football" shapes that are thicker in the middle than at the ends, as shown in Figures 82A-82C, 83A-83C, 84A-84C, 85A-85C, 86A-86C.

[0390] The mechanism for opening the implant 1690 during deployment can be passive or active. A passive mechanism biases the implant 1690 toward a normally open or normally expanded state and is accomplished by a torsion spring, such as that shown in FIGS. 84A-84C. Other spring-like methods would also achieve similar results, such as the implant itself having spring-like properties that bias it toward a normally open state. The implant can also be actively expanded into place using a screw-type mechanism, a pull wire and locking mechanism, a hydraulic actuator, or others.

[0391] Hinged or flexible implants may also have features on the lateral ends that position and engage the ostium of the LAA for implant placement and secure engagement, aiding in deployment accuracy and long-term migration resistance. Examples of these engagement features are shown in Figures 85A-85C, where "fingers" and "thumb" features cup the lateral edges of the LAA ostium during deployment, as shown in Figures 86A-86C. Another embodiment of an implant 1750 with gripping or engagement features on the edges of the implant is shown in Figures 95A-95C, 96A-96C, and 97A-97C, and uses texture, serrations, or teeth to engage the lateral edges of the LAA.

[0392] Another implant embodiment has a flexible or spring-like member that can be folded to fit within the delivery catheter. Figures 87A-87C and 88A-88C show another embodiment in which the implant 1760 can be constructed from a torsion spring with formed ends. During implant delivery, the ends of the implant 1760 can be guided to each end (superior and inferior) of the LAA, and each end of the implant 1760 can be held in place with any manner of friction, specific shape, or force that allows stability of the device within the LAA as deployment continues. Fully deploying a portion of a device embodiment disclosed herein can result in stretching of the LAA ostium from an open orifice to a narrow slit, effectively closing off the opening of the LAA from the LA as the height of the LAA decreases. Gripping features at either end of the implant embodiments disclosed herein can be formed from the torsion spring wire itself or can be added on top of pads, gripping plates, or other features that provide appropriate engagement with tissue.

[0393] 89A-89C show the same torsion spring implant 1760, but with a cover 1762 comprising a sealing material that covers all or a portion of the implant 1760 to seal any remaining non-enclosed space in the ostium of the LAA after implantation and linearization. 90A-90C, 91A-91C, and 92A-92C show a similar design of implant 1770, which does not have a spring in all its embodiments. Implant 1770 can be configured to achieve a locked-out linear position through a stop in a hyper-extended state.

[0394] 93A-93C and 94A-94C show an embodiment of implant 1780 having a hinge mechanism similar to that of implant 1770, but with the addition of anchoring mechanisms or barbs to prevent laterally migrated chamber wall tissue from drifting up or down from relaxation, which can cause leakage over time. FIGS. 95A-95C, 96A-96C, 97A-97C, and 98A-98C show implant 1790 having a similar hinge mechanism, but achieved with a four-bar mechanism that has features that maintain anchoring or gripping pads at the distal lateral ends parallel to the catheter for better grip and easier engagement.

[0395] Another embodiment of the implant device is a multi-hinge or multi-strut flexible member that can be folded to fit within a delivery catheter. During implant delivery, the multi-hinge mechanism can expand within the ostium of the LAA, linearly dilating and stretching the LAA ostium and closing the upper chamber wall against the lower chamber wall. The deployment and implantation steps can include inserting a catheter into the middle of the LAA ostium, allowing the deployment of the multi-hinge implant (driven by a screw, pull cable, or hydraulic actuation), guiding the end of the implant to the lateral end of the LAA ostium, fully opening the implant and locking its position, and / or releasing the delivery catheter from the implant. Figures 99A-99C, 100A-100C, and 101A-101C show additional embodiments of an implant 1800 having a multi-hinge folding or collapsing mechanism. 102A-102C show additional embodiments of an implant 1810 having a multi-hinge folding or tucking mechanism. There are numerous options for this type of mechanism. 101A-101C show an implant 1800 having a mesh or graft covering 1802 to aid in tissue ingrowth into the chamber.

[0396] Another embodiment of the implant 1820 has a conical mesh 1822 with cleats or barbs around the periphery of the implant 1820. Two embodiments are shown, one having a circular shape and the other having an elongated shape. Figures 103A-103D and 104A-104E show a circular version of the implant 1820, where the deployment and implantation steps include inserting a catheter into the middle of the ostium of the LAA, allowing the expansion of the conical circular mesh barbed implant 1820, guiding the implant 1820 to completely cover the ostium of the LAA, applying forward pressure to the implant 1820 to engage the surrounding barbs 1824 and invert the implant 1820, and releasing the delivery catheter from the implant 1820. This implant can anchor or bind the tissue of the LAA ostium and / or surround the LAA ostium via cleats or barbs 1824 around the implant 1820 and the chamber wall just outside the radius of the LAA ostium. It deploys its conical shape, positioned to cover the LAA ostium, and as it advances, the anchors 1824 embed themselves into the chamber wall with a radial outward motion as the implant's conical shape flattens and eventually everts slightly. Once everted, the delivery system can be removed from the implant 1820. One feature of some embodiments of this design is that it is not dependent on a specific depth of the LAA, as no part of the delivery catheter or implant ever enters the LAA. It will also be locked into place even if not all of the anchors are engaged.

[0397] 105A-105E and 106A-106D show an elongated variant in which the steps of a deployment and implantation embodiment include inserting a catheter into the center of the LAA ostium, allowing the elongated mesh barbed implant 1830 to expand or unfold, guiding the implant 1830 to completely cover the LAA ostium from two lateral sides (the top and bottom are still uncovered), applying forward pressure to the implant 1830 against both engaging peripheral barbs, stretching the LAA ostium wider and narrower, and finally inverting the implant 1830 and / or releasing the delivery catheter from the implant 1830. The implant can be anchored or coupled to the chamber wall just outside the outer radius of the LAA ostium via cleats or barbs 1834 at the ends of the implant 1830. Deployed in its folded configuration, it is positioned over the ostium of the LAA. When advanced, the anchors 1834 embed themselves in the chamber wall with a lateral outward movement, stretching the LAA ostium and narrowing it as the implant flattens, finally everting. Once everted, the delivery system can be removed from the implant 1830. One feature of some embodiments of the implants disclosed herein is that they are not dependent on a specific depth of the LAA, as no portion of the delivery catheter or implant ever enters the LAA. Some embodiments of the implant are also configured to lock themselves into place even if not all anchors are engaged. This elongated embodiment can also leave less exposed material surface area than circular embodiments.

[0398] Another embodiment of the implant device 1840 uses a radial reduction method to close the LAA ostium. In this design, several lumens are attached to a balloon, expandable mesh, or other structure that guides needles, anchors, or barbs 1842, with sutures attached around the LAA ostium on the chamber wall. Once expanded into position, the anchors 1842 are advanced through the tube into the chamber wall around the LAA ostium. The balloon may be deflated, and the suture lines crimped or tied off under tension, drawing the LAA ostium closed. A small plug of material may be left behind to block the remaining space. Figures 107A-107G show an embodiment of the device 1840 and at least some steps for its deployment. The deployment and implantation steps can include inserting the catheter into the center of the LAA ostium and positioning it to the appropriate depth, expanding the balloon 1844 (which may be an expandable mesh or other structure), advancing anchors 1842, each attached to a suture 1846, through a lumen around the balloon and into the chamber wall surrounding the LAA ostium, deflating the balloon 1844, pulling the sutures under tension to close the LAA ostium and crimping or tying the sutures 1846 to hold them in the reduced diameter position (a plug can be inserted, if desired, to close the remainder of the LAA ostium), and / or releasing the delivery catheter from the implant 1840.

[0399] Another embodiment of the implant device uses a radial reduction method to close the LAA ostium from within the LAA. Figures 108A-108C, 109A-109C, 110A-110E, 111, 112, 113A-113C, and 114A-114C show additional embodiments of devices for treatment of the LAA. The device embodiments shown in the foregoing figures can be configured to grasp the chamber walls with anchors or barbs around the ostium of the LAA and then pull them down (or inward) through a mechanism located inside the LAA. This mechanism can be activated by an attached delivery system, which, once locked in the closed position, can be detached and removed from the implant.

[0400] Figures 108A-108C illustrate an embodiment of device 1860 and several steps of a method for expanding anchor 1862 and other portions of device 1860, which may be achieved by a balloon, or a spring, mechanical actuator, or other expander. In other embodiments, anchor 1862 may be self-expanding. Figures 110A-110C illustrate several steps of an embodiment of device 1860. Figures 109A-109C illustrate another embodiment of device 1868 that can be used to treat the LAA. Figures 111, 112, and 113A-113C illustrate additional embodiments of devices 1870, 1880, and 1890, respectively, with reduced cleat sections that allow several devices to close the ostium of the LAA. In this manner, for example, two, three, four, or more of these devices can be used in a row, each pulling the chamber wall from top to bottom or closed, to achieve lateral closure of the LAA. The resulting closure is a lateral closure of the LAA. 114A-114C show additional embodiments of implants 1900 having more cleats so that the implant has more anchor points with tissue. One or more implants 1900 can be used to occlude the LAA.

[0401] Additional embodiments of the implant 1910 use a method of enlarging the LAA ostium laterally and then pinching or clasping it closed, closing the chamber wall from the inside of the LA from top to bottom. Figures 115A-115C, 116A-116C, and 117A-117C illustrate several embodiments of the device 1910. One feature on some embodiments of the implant device 1910 (or which may be on a delivery catheter) is the stretch or lateral cover seen in the figures. This is a rounded bar 1912 connected to each lateral end of the device 1910 that enlarges the LAA ostium, thereby narrowing it, as it advances into the LAA. The clip occludes or closes when the hinged jaws or cleats press against the chamber wall immediately above the LAA ostium. When the clip closes, it engages and pulls the upper and lower chamber walls of the LAA, locking and closing a portion of the chamber wall.

[0402] The steps for deploying and implanting some embodiments of the implant devices disclosed herein may include inserting a catheter into the center of the ostium of the LAA, advancing the implant until the clip jaws contact the chamber wall and the extended bar stretches the ostium of the LAA, actuating the closure of the jaws, which may be actuated by a pull wire or other mechanism (which may also be spring-activated to a normally closed state that remains open before deployment and is simply released after deployment), locking the jaws in the closed state, and / or releasing the delivery catheter from the implant.

[0403] Another embodiment of the implant device 1920 involves folding or kinking the LAA at the ostium and clipping it to hold it in place, effectively closing the LAA. Figures 118A-118D show one variation of a series of steps to accomplish this. In some embodiments, the deployment and implantation steps include inserting a catheter into the middle of the ostium of the LAA, bending a portion of the implant 1920 in a first direction (which may be upward as shown), clipping the bent portion of the implant 1920 to hold it in place against the chamber wall (using an additional anchor to secure the implant to the lower chamber wall), and / or releasing the delivery catheter from the implant 1920.

[0404] As shown in FIGS. 119A-119D and 120A-120C, another embodiment of an implant device 1930 uses a plug-type closure, but is not circular and does not reshape the LAA into a circle. Instead, the implant can be oval or narrow, with its length (represented by L in FIGS. 120A-120C) being greater than its width or height (represented by W in FIGS. 120A-120C) through deliberate manipulation of the shape of the LAA with the implant device 1930. The implant 1930 shown in FIGS. 119A-119D and 120A-120C can have a metal scaffold covered with a mesh or graft material. The implant 1930 can be self-expanding, balloon-, or mechanically expandable, or otherwise, and can have a biased shape such that its width (L) is greater than its height (W). In any embodiment disclosed herein, the steps of deploying and implanting may include inserting a catheter into the center of the LAA ostium, positioning and deploying the implant depth, allowing the implant to reshape the LAA anatomy into an oval shape once deployed, with the LAA ostium being wider than it is tall, implanting or applying radial force and / or cleats or anchors to hold the implant in place, and / or releasing the delivery catheter from the implant.

[0405] Any embodiment of the implant (such as implant 1950 shown in FIGS. 121A-121C) may also be a hybrid of a self-expanding LAA occlusion plug 1952 with a lateral expansion device 1954. The implant 1950 may initially deploy in a circular shape and then be biased to an expanded position (for example, but not limited to, being spring-loaded) or reshaped to an oval shape through an expansion device, which may be an actuation mechanism.

[0406] 122 and 123 are top and side views, respectively, of another embodiment of an implant 2000 for treating or closing an opening, such as, but not limited to, the LAA. The implant 2000 can have a frame 2002 that is expandable from a collapsed state to an expanded state. FIG. 122 shows the expanded state of the frame 2002. The frame may be self-expanding, mechanically expandable using a balloon, or otherwise. The frame can be made from one or more wires or ribbons. In some embodiments, the frame 2002 can be laser cut from an extruded tube, a flat sheet, or other. If laser cut from a flat sheet, the ends of the frame can be welded, brazed, or otherwise permanently joined to form a continuous wall 2003 of the frame 2002.

[0407] The frame can interconnect multiple members 2004 to form the frame 2002. The members 2004 can have multiple openings 2006 between the members 2004 of the frame 2002. Multiple vertices 2010 can be formed between portions of adjacent members 2004. In some embodiments, the vertices 2010 can facilitate bending of the members 2004 during expansion from a contracted or first state to an expanded or second state, the expanded second state being shown in FIG. 123. In any embodiment disclosed herein, the members 2004 and vertices 2010 can form a zigzag pattern.

[0408] 122-123, implant 2000 can have an elongated shape. In some embodiments, implant 2000 can have an elongated shape along the entire length of implant 2000. The term "length" is meant to refer to the axial direction of the implant, as identified by arrow AL in FIG. 123. Frame 2002 can have an opening 2014 extending axially through the frame from proximal end 2002a to distal end 2002b of frame 2002. Opening 2014 can be continuously surrounded by wall 2003 formed by frame 2002.

[0409] 122 , in any embodiment disclosed herein, the frame 2002 can be sized and configured such that the opening 2014 defines a first width or dimension W1 in a first direction (indicated by arrow A1) from a first portion 2020 across the opening 2014 of the frame 2002 to a second portion 2022 that is perpendicular to the first direction A1 and is greater than a second width or dimension W2 of the opening 2014 in a second direction (indicated by arrow A2) when the implant 2000 is in a deployed state in situ in the LAA or when the implant 2000 is in a naturally expanded state outside the body. In any embodiment in which the implant is self-expanding, the naturally expanded state outside the body can be an unconstrained shape. The first and second directions (A1, A2) can be perpendicular to the direction AL or axial direction shown in FIG. 123 . In some embodiments, without limitation, the first width can be optionally defined from the innermost portion of the first portion 2020 in the area configured to engage or contact the opening, regardless of whether the frame 2002 has the first recess 2032, to the innermost portion of the second portion 2022 in the area configured to engage or contact the stoma, regardless of whether the frame 2002 has the second recess 2034.

[0410] In any embodiment disclosed herein, when implant 2000 or any other implant embodiment or embodiments disclosed herein is in a relaxed state, a naturally expanded state (i.e., expanded outside the body without external forces acting on the implant from the LAA), and / or a mechanically expanded state, the first width W1 of opening 2014 can be, in some embodiments, approximately 3.5 times the second width W2 of opening 2014, or at least approximately two times the second width W2 of opening 2014 (i.e., the first width W1 of opening 2014 can be twice the second width W2 of opening 2014), or in some embodiments, between approximately two and approximately eight times the second width W2 of opening 2014, or in some embodiments, between two and approximately four times the second width W2 of opening 2014, or between approximately three and approximately four times the second width W2 of opening 2014, or any value within these ranges.

[0411] In any embodiment disclosed herein, when implant 2000 or any other implant embodiment or embodiments disclosed herein are in a relaxed, naturally expanded, and / or mechanically expanded state, implant 2000 can define a ratio of the first width W1 of opening 2014 to the second width W2 of opening 2014 of approximately 3.5:1, or at least approximately 2:1, or in some embodiments, between approximately 2:1 and approximately 8:1, or in some embodiments, between approximately 3:1 and approximately 4:1, or any value within these ranges, either before or after one or more additional clips, staples, sutures, or other additional closure devices, if any, are deployed to further close the ostium of the LAA. For example, in some embodiments, such additional clips, staples, sutures, or other additional closure devices can be implanted in the patient after the implant is fully expanded to any of the above-mentioned ratios or ranges of ratios to further or completely close the ostium of the LAA. In some embodiments, as described above, the implant can be expanded to any of the above-mentioned ratios or ranges of ratios without any additional closure devices being subsequently implanted.

[0412] In any embodiment disclosed herein, when implant 2000 or any other implant embodiment or implementation disclosed herein is in a deployed, in situ state in the LAA, the first width W1 of opening 2014, in some embodiments, can be approximately 3.5 times the second width W2 of opening 2014, or at least approximately two times the second width W2 of opening 2014 (i.e., first width W1 of opening 2014 can be twice the second width W2 of opening 2014), or in some embodiments, can be between approximately 2 times and approximately 8 times the second width W2 of opening 2014, or between approximately 2 times and approximately 6 times, or between approximately 2 times and approximately 4 times, or between approximately 3 times and approximately 4 times, or any value within these ranges.

[0413] In any embodiment disclosed herein, when implant 2000 is in a deployed state in situ in the LAA, implant 2000 can define a ratio of a first width W1 of opening 2014 to a second width W2 of opening 2014 of approximately 3.5:1, or in some embodiments at least approximately 2:1, or in some embodiments between approximately 2:1 and approximately 8:1, between approximately 2:1 and approximately 6:1, or between approximately 3:1 and approximately 4:1, or any value within these ranges.

[0414] In some embodiments, implant 2000, and any other implant embodiments or implementations disclosed herein, can be configured such that deploying implant 2000 in an ostium of the LAA can increase (in the same direction as the first width W1 of implant 2000) the first width of the ostium by at least approximately 40% (i.e., so as to increase the first width of the ostium by at least approximately 40% compared to the first width of the ostium before the implant is deployed and expanded), or by approximately 65% ​​or more, or up to approximately 100%. Furthermore, in some embodiments, deploying implant 2000 in an ostium of the LAA can decrease the second width of the ostium by at least approximately 50% (i.e., so as to cut the second width of the ostium in half), and in some embodiments, by between approximately 25% and approximately 100%, or between approximately 40% and approximately 85%, or between approximately 40% and approximately 75% (in the same direction as the second width W2 of implant 2000), without changing the first width of the ostium, or in combination with any of the aforementioned percentage increases in the first width of the ostium.

[0415] In any embodiment disclosed herein, implant 2000, or any other implant embodiment or implementation disclosed herein, can be configured such that when implant 2000 is in a deployed state in situ in the LAA, deployment of implant 2000 into the ostium of the LAA can change the ostium first width (in the same direction as the first width W1 of implant 2000) and the ostium second width (in the same direction as the second width W2 of implant 2000) such that the ostium of the LAA (after deployment and expansion of implant 2000 or any other implant embodiment or implementation disclosed herein) defines a ratio of the ostium first width to the ostium second width of approximately 3.5:1, or at least approximately 2:1, or in some embodiments between approximately 2:1 and approximately 8:1, or in some embodiments between approximately 3:1 and approximately 4:1, or any value within these ranges.

[0416] Any embodiment of the frame 2002 of the implant 2000 can be flared outward at at least a first portion 2022 and a second portion 2026 of the frame 2002 at the proximal end 2002a of the frame 2002 to allow for better fixation to the tissue surrounding the LAA and / or greater positioning accuracy during deployment. For example, without limitation, the frame 2002 can have a first apex extension 2024 extending away from the proximal end 2002a of the frame 2002 at the first portion 2020 of the frame 2002 or wall 2003. The first apex extension 2024 and / or the second apex extension 2026, in some embodiments, can be configured to bias the proximal end 2002a of the frame 2002 into approximate alignment with the outer edge or surface E of the ostium (shown in FIG. 124 ). In some embodiments, the first apex extension 2024 may extend away from the proximal end 2002a of the frame 2002 at a first portion 2024 of the wall, the first apex extension 2024 being configured to prevent the frame from passing completely through the ostium O of the LAA (shown in FIG. 124 ). This can be achieved by overlapping a portion of the exterior surface of the ostium O with at least one of the first apex extension 2024 and the second apex extension 2026.

[0417] Some embodiments of the implant 2000 can have a first apex extension 2024 that extends away from the proximal end 2002a of the frame 2002 at a first portion 2020 of the wall 2003. The first apex extension 2024 can be configured to overlap an exterior surface E of the wall portion W that surrounds the ostium O of the LAA when the implant 2000 is in an operative position within the LAA, a non-limiting example of which is shown in FIG. 124. Additionally, in some embodiments, the implant 2000 can have a second apex extension 2026 that extends away from the proximal end 2002a of the frame 2002 at a second portion 2022 of the wall 2003 of the frame 2002. In some embodiments, the second apex extension 2026 may be configured to bias the proximal end 2002a of the frame 2002 into approximate alignment with the outer edge E of the ostium O to prevent the frame 2002 from passing completely through the ostium O of the LAA, and / or may be configured to overlap the outer surface of the portion of the wall 2003 that surrounds the ostium O of the LAA when the implant 2000 is in an operable position within the LAA.

[0418] In this configuration, the first apex extension and / or second apex extension can aid during the implantation procedure by providing a limit to the depth within the LAA to which the implant can be advanced. For example, a surgeon can advance a catheter into or adjacent to the LAA and, in some embodiments, expose the implant 2000 by advancing the implant 2000 relative to an outer sheath on the catheter or by withdrawing the outer sheath to expose the implant 2000. The implant 2000 can be moved into position within the LAA and then expanded to a second expanded state. While the implant 2000 is expanded to the expanded state, the first portion 2024 and the second portion 2026 can exert a force on the LAA, stretching the LAA in a first direction A1. In some embodiments, the implant 2000 can be configured to spread a first portion of the ear O of the LAA away from a second portion 2022 of the ostium O opposite the first portion to stretch the ostium O of the LAA in a first direction. For example, first portion 2020 and second portion 2022 of frame 2002 can be configured to stretch the ostium O of the LAA in a first direction, widening a first portion of the ostium O of the LAA away from a second portion of the ostium O opposite the first portion. This causes the walls of the LAA ostium between the first and second portions to move relative to one another to substantially close the ostium against the periphery or exterior surface of the implant, such as wall 2003 of implant 2000, or to create a better seal of the ostium. This can be a particularly effective way of forming a better seal around an implant for irregularly shaped or non-smooth ostia.

[0419] During deployment, the depth of the implant relative to the ostium can be adjusted by moving the implant distally and proximally. The first apex extension 2024 and / or the second apex extension 2026 can engage the outer surface E of the tissue surrounding the ostium O and prevent or inhibit the implant 2000 from advancing further distally into the LAA, thereby ensuring proper depth of the implant during the deployment procedure.

[0420] 123-124 , some embodiments of the frame 2002 may also include a first recess 2032 in the first portion 2020 of the frame 2002 and a second recess 2034 in the second portion 2022 of the frame 2002. The first recess 2032 and the second recess 2034 may each be configured to receive an edge E of the wall of the LAA opening or ostium therein when the implant 2000 is expanded against the wall of the LAA opening. In some embodiments, the first recess 2032 and the second recess 2034 may be sized, shaped, and / or otherwise configured to urge the edge E of the opening of the ostium or other tissue surface to remain in contact with the first recess 2032 and the second recess 2034. The first and second recesses 2032, 2034 may, in some embodiments, have a curved profile. The first and second recesses 2032, 2034 may assist in securing the implant to the ostium or body tissue.

[0421] Some embodiments of the implant 2000 can have a first recess 2032 combined with the first apical extension 2024 and / or a second recess 2034 combined with the second apical extension 2026. The first and / or second recesses 2032, 2034 at the first end 2020 and / or second end 2022 can bias the implant 2000 to remain in a generally fixed position relative to the ostial wall and / or aid in proper alignment of the implant 2000 with respect to the ostium during the implantation procedure, which can be the ostium of the LAA. Additionally, any embodiment of the implant 2000 can be configured to have a saddle or convex shape (when viewed from the side, as in FIG. 124 , the first end 2020 and second end 2022 are higher than a central portion of the implant 2000) or to be otherwise conformable. Thus, when implant 2000 is deployed in the LAA, implant 2000 can have a curved contour that substantially matches the curved contour of the heart wall surrounding the LAA.

[0422] Any embodiment of the implant 2000, in some embodiments, has anchors for anchoring or securing the frame 2002 to the LAA located on at least the first and second portions 2022 of the frame 2002. For example, but not limited to, barbs, surface roughness, grip or grasping features, or other surface features or securing functions can be added to the frame or implant to secure the implant to the LAA, including, but not limited to, adding such features to the first and second portions 2020, 2022. The frame 2002 may be configured such that first and second roughened regions are formed on or on the exterior surfaces of the first and second portions 2020, 2022 of the frame 2002, respectively, the first and second roughened regions being configured to inhibit movement of the frame 2002 relative to the tissue surface of the ostium O of the LAA.

[0423] 125 , any embodiment of implant 2000 can have a cover 2050 coupled with frame 2002. Cover 2050 can at least partially cover opening 2014 in frame 2002. In some embodiments, cover 2050 can completely or substantially completely cover opening 2014 in frame 2002. Cover 2050 can be made from any suitable material configured to block or inhibit the flow of blood, clots, or other objects or substances through the ostium of the LAA. Cover 2050 can be made from a mesh material, a graft material, or the like.

[0424] Due to the elongated shape of implant 2000, some embodiments of implant 2000 can have a total cross-sectional area that is approximately 70% smaller than the cross-sectional area of ​​some types of conventional closure devices designed to close similarly sized ostia in the LAA, such as a device of the size and shape of device 2060 shown in FIG. 126, and approximately 50% smaller than other types of conventional closure devices designed to close similarly sized ostia in the LAA, such as a device of the size and shape of device 2062 shown in FIG. 126. For example, some embodiments of implant 2000 have an elongated shape that has a total cross-sectional area that is approximately 50% to approximately 70%, or approximately 50% to at least approximately 80% less than an implant device having a circular shape designed to close a similarly sized ostium in the LAA. Furthermore, some embodiments of implant 2000, or any other implant disclosed herein, can have an elongated shape that has a total cross-sectional area that is approximately 50% to approximately 70%, or approximately 50% to at least approximately 80% less than the cross-sectional area of ​​the ostium of the LAA prior to implantation.

[0425] Such a reduction in size can provide significant improvements to patients in terms of healing time, which determines the amount of time they need to receive anticoagulant medication with its associated risks. As the cross-sectional area of ​​the implant opening and / or the distance from the LAA wall to the implant's central region decreases, the longest distance tissue cells must travel from the aortic tissue to the implant's covering decreases, which reduces healing time and reduces the anticoagulant time.

[0426] Some embodiments of the elongated implants disclosed herein can reduce overall healing time after device implantation, potentially reducing the amount of time a patient needs to receive anticoagulants for safe healing after an LAA implantation procedure. In some embodiments, this can be achieved by reducing the distance cells need to travel from the chamber wall tissue to cover the implant opening (which may be covered by a cover). Implants with circular openings can result in the greatest migration distance for the LAA, with the diameter being the distance these cells must travel. When the opening is elongated, the migration distance of cells is reduced, as sections of the wall migrate closer to each other, resulting in reduced healing time. An analogous example of this difference in healing time can be found in comparing a one-inch long (narrow) cut to a one-inch diameter wound in the skin. A one-inch long cut heals faster than a one-inch diameter wound because both the surface area and the maximum distance from healthy tissue to healthy tissue are reduced, reducing the distance cells need to travel for wound healing.

[0427] Any embodiment of the implants and / or delivery systems disclosed herein may be configured to be partially or fully self-expanding, balloon-expandable, or mechanically expandable using any known or later-developed expansion device, including, but not limited to, a balloon expansion device typically used with implants, stents, stent-grafts, angioplasty devices, or any of the expansion devices disclosed herein. Similarly, any embodiment of the implants and / or delivery systems disclosed herein may be configured to be partially or fully self-expanding, balloon-expandable, or otherwise mechanically expandable, including, but not limited to, a balloon expansion device typically used with implants, stents, stent-grafts, angioplasty devices, or any of the expansion devices disclosed herein. For example, but not limited to, some implant embodiments may be configured to self-expand and / or self-expand to an intermediate size or shape and then balloon- or otherwise mechanically expand and / or expand to a final size or shape. Similarly, any such balloon or mechanical expansion device and / or such devices disclosed herein may, in some embodiments, be used to extend or complete the elongation of the ostium of the LAA beyond the elongation that results from the self-expansion and / or self-elongation of the implant, if present.

[0428] 127 shows a non-limiting example of an expansion device 2100 that can be used to expand and / or stretch an implant 2102, which can have any of the features, components, or other details of any of the embodiments disclosed herein. The expansion device 2100 can have an expandable member 2104 (which in some embodiments can be an expandable balloon) and an expansion lumen 2106 in fluid communication with the expandable member 2104. Any embodiment of the expandable member 2104 can have an elongated shape and / or can otherwise be configured to expand the implant 2102 to have an elongated shape that can communicate an inflation fluid (such as air) therethrough to the expandable member 2104. In some embodiments, the expandable member can include multiple separate or interconnected expandable members coupled together. 128 illustrates an expansion device 2120 that can be used to expand and / or stretch an implant 2102, which may have any of the features, components, or other details of any of the embodiments disclosed herein and may have an expandable member 2124 that can include multiple individual expandable elements. The expandable member 2124, in some embodiments, may have any number or size of expandable elements that can be coupled together in a desired arrangement or orientation. As shown, the expandable member 2124 may have a first expandable element 2126 located in a central portion of the expandable member 2124, a second expandable element 2128 adjacent to and / or coupled to one side of the first expandable element 2126, a third expandable element 2128 adjacent to and / or coupled to a second, opposite side of the first expandable element 2126, a fourth expandable element 2130, and a fifth expandable element 2131.

[0429] The second and third expandable elements 2128, 2129, in some embodiments, can have similar sizes to each other and smaller than the first expandable element 2126. The fourth and fifth expandable elements 2130, 2131, in some embodiments, can have similar sizes to each other and smaller than the second and third expandable elements 2128, 2129. In some embodiments, any of the expandable elements 2126, 2128, 2129, 2130, and 2131 can have a spherical shape.

[0430] Without limitation, any embodiment of expansion device 2100 or 2120 can be configured to expand and elongate the implant to have any of the elongation ratios described herein for any of the implants described herein, including a first width to second width ratio of approximately 3.5:1, or a first width to second width ratio of at least approximately 2:1, or in some embodiments, a first width to second width ratio of approximately 2:1 to approximately 8:1, or in some embodiments, a first width to second width ratio of approximately 3:1 to approximately 4:1, or any value within these ranges, either before or after one or more additional clips, staples, sutures, or other additional closure devices, if any, are deployed to further close the ostium of the LAA. For example, in some embodiments, such additional clips, staples, sutures, or other additional closure devices can be implanted in the patient after the implant has been fully expanded to any of the above-mentioned ratios or ranges of ratios to further or completely close the ostium of the LAA. In some embodiments, as described above, the implant can be expanded to any of the above-mentioned ratios or ranges of ratios without any additional closure devices being subsequently implanted.

[0431] 129 and 130 illustrate side views, and FIGS. 131 and 132 show end views, of another embodiment of a system 2200 having an implant 2202 and a delivery device 2204 having a movable core 2206 (which may be a cannula, wire, or other) that can be used to treat the LAA. The implant 2202, in some embodiments, includes one or more wires formed into a wire mesh or woven fabric that can be moved from a first, unexpanded state (shown in FIG. 129 ) and a second, expanded state (shown in FIG. 130 ) by decreasing the length of the implant 2202 from a first length L1 (shown in FIG. 129 ) to a second length L2 (shown in FIG. 130 ). In the second, expanded state, the implant 2202 can have any of the size, shape, components (including, but not limited to, a cover), and / or other details of any of the other implant embodiments disclosed herein, including, but not limited to, being configured to be expandable to any of the elongation ratios described herein for any of the implants described herein. Similarly, the implant 2202 can be moved from the second expanded state to the first unexpanded state by increasing the length of the implant 2202 from the second length L2 to the first length L1.

[0432] The delivery device 2204 may have a distal support element 2210 that is removably coupled to the distal end 2202a of the implant 2202 and a proximal support element 2212 that is removably coupled to the proximal end 2202b of the implant 2202. The distal support element 2210 may be coupled to the distal end of the core 2206. The proximal support element 2212 may be slidable relative to the core 2206 and, in some embodiments, may be supported by the distal end of the tube 2216, which can hold the proximal support element 2212 in a fixed position relative to the distal support element 2210 as the core 2206 is proximally withdrawn or distally advanced relative to the tube 2216, respectively. In this configuration, when the core 2206 is withdrawn, the distal support element 2210 moves toward the proximal support element 2212 and the implant is expanded from a first state (shown in FIG. 129 ) to a second state (shown in FIG. 130 ). Thus, the implant 2202 can be advanced into the LAA in a first state and then expanded to a second expanded state by withdrawing the core 2206, thereby expanding the implant 2202 against the ostial walls of the LAA. The implant 2202 may then be removed from the proximal and distal support elements 2212, 2210, and the delivery device 2204 may be withdrawn, leaving the implant 2202 positioned within the LAA in the second expanded state.

[0433] 133 and 134 illustrate side views, and FIGS. 135 and 136 show end views, of another embodiment of a system 2240 having an implant 2242 and a delivery device 2244 having a movable core 2246 (which may include a cannula or wire pair, or the like) that can be used to treat the LAA. The implant 2242, in some embodiments, includes one or more wires formed into a wire mesh or woven fabric that can be moved from a first, unexpanded state (shown in FIG. 133 ) and a second, expanded state (shown in FIG. 134 ) by decreasing the length of the implant 2242 from a first length L1 (shown in FIG. 133 ) to a second length L2 (shown in FIG. 134 ). In the second, expanded state, the implant 2242 can have any of the size, shape, components (including, but not limited to, a cover), and / or other details of any of the other implant embodiments disclosed herein, including, but not limited to, being configured to be expandable to any of the elongation ratios described herein for any of the implants described herein. Similarly, the implant 2242 can be moved from the second expanded state to the first unexpanded state by increasing the length of the implant 2242 from the second length L2 to the first length L1.

[0434] The delivery device 2244 may have a pair of distal support elements 2250 removably coupled to the distal end 2242a of the implant 2242 and a pair of proximal support elements 2252 removably coupled to the proximal end 2242b of the implant 2242. The distal support elements 2250 may be coupled to the distal ends of each wire of the core 2246. The proximal support elements 2252 may be slidable relative to the wires of the core 2246. The delivery device 2244 may be configured such that the proximal support elements 2252 may be held in a fixed position relative to the distal support elements 2250 when the core 2246 is proximally retracted or distally advanced relative to the proximal support elements 2252, respectively, or in another embodiment, when the wires of the core 2246 spread apart from one another from a first state (shown in FIG. 133 ) to a second state (shown in FIG. 134 ).

[0435] In this configuration, as the wires of the core 2246 are retracted and / or expanded, the distal support elements 2250 move toward the proximal support elements 2252 and the implant is expanded from a first state (shown in FIG. 133 ) to a second state (shown in FIG. 134 ). Thus, the implant 2242 is advanced into the LAA in a first state and then expanded to a second expanded state by retracting the wires of the core 2246 and / or expanding within the wires of the core, causing the implant 2242 to expand against the walls of the ostium of the LAA. The implant 2242 can then be removed from the proximal and distal support elements 2252, 2250 and the delivery device 2244 can be retracted, leaving the implant 2242 positioned within the LAA in the second expanded state.

[0436] Another embodiment of implant device 2300 features a wireform or laser-cut shape that can straighten and / or stretch the LAA ostium upon deployment. This allows for the first and second portions of the LAA ostium to be brought together, which may be opposite sides or portions of the ostium, e.g., the superior and inferior portions. When the implant is deployed, the first stage shape may be circular, which can aid in depth and angular positioning, and the second stage shape expands laterally to engage and stretch the lateral end of the LAA ostium (shown in FIGS. 137A-137D and 138A-138C). Any embodiment of the devices disclosed herein (including device 2300) may be configured for deployment in a multi-stage or multi-step manner. For example, in some embodiments, when the implant is deployed in the first stage, the first stage shape (i.e., the shape of the implant after the user completes the first stage of deployment) can optionally be circular. When in its first stage shape and size, the implant can be positioned depth and angle relative to the LAA. During a second stage of implant deployment, the implant can be expanded in first and second generally opposite directions (which can be lateral to the user's frame of reference) to engage first and second portions (which can optionally be lateral ends) of the ostium of the LAA and stretch the LAA in the first and second directions.

[0437] In any embodiment disclosed herein, the deployment and implantation steps can include one or more of the following: advancing a delivery catheter into the proximal LAA near the ostium of the LAA, deploying the implant to a Stage 1 state (wherein a first stage portion of the implant can optionally comprise a generally circular or spherical shape), moving or positioning the implant in a partially deployed form to an appropriate implant depth and angle, positioning and deploying the implant to a Stage 2 state to achieve apposition in a first direction and / or a second direction (which can optionally be lateral), assessing the position and / or orientation of the implant, and if the position and / or orientation is not desired, recapturing all or part of the implant and repeating Stage 1 or Stage 2 of deployment until the implant is in a desired position and / or orientation, and / or detaching and removing the delivery catheter.

[0438] In any embodiment disclosed herein, the implant and delivery catheter (such as implant and delivery catheter 2310 shown in FIGS. 139A-139E) may have some means of retaining the implant in the delivery catheter and controlling the expansion of the implant from an initial stage (stage 1) to a final stage (stage 2). One embodiment of the system may have a suture or tether that can restrain the proximal portion of the implant to control the full expansion and lateral apposition of the implant into the ostium of the lateral LAA (shown in FIGS. 139A-139E). This tether may also be configured to allow for retrieval, complete implant retrieval and removal, or redeployment.

[0439] Any embodiment or version of the implants disclosed herein (including implants 2320, 2322, 2324, 2326, 2328, 2330, and 2332 shown in FIGS. 140A, 140B, 140C, 140D, 140E, 140F,...

Claims

1. 1. A device for treating a left atrial appendage, comprising: a contact member configured to move between a first condition and a second condition; and a fixation element, the contact member is configured to move from the first condition to the second condition such that at least a portion of the contact member engages a wall portion of the left atrial appendage after the contact member is advanced into the left atrial appendage; the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position; the contact member is configured to twist at least a portion of the left atrial appendage in the first direction when the contact member is rotated from the first rotational position to the second rotational position; 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 in an operable state, the second direction being opposite the first direction; The device, wherein the second rotational position is at least one quarter of a rotation relative to the first rotational position.

2. 10. The device of claim 1, wherein the contact member is self-expandable such that at least a portion of the contact member automatically expands from the first condition to the second condition when a restraint is removed from the contact member.

3. 2. The device of claim 1, wherein the contact members are substantially folded when the contact members are in the first state and expanded when the contact members are in the second state such that a size of the contact members is larger when the contact members are in the second state than when the contact members are in the first state.

4. The device of claim 1 , wherein the contact member is biased to remain in the second condition after deployment into the left atrial appendage.

5. The device of claim 1 , wherein the contact member is configured to twist at least a portion of the left atrial appendage when the contact member is rotated in a clockwise or counterclockwise direction.

6. 2. The device of claim 1, wherein the device is configured to cause tissue of the left atrium and / or the left atrial appendage to contract around 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 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 the second direction.

7. The device of claim 1 , wherein the fixation element comprises a plurality of tissue anchors configured to engage an inner wall of the heart adjacent the left atrial appendage.

8. The device of claim 1 , wherein the contact member has a plurality of tissue anchors on an exterior surface thereof.

9. The device of claim 8 , wherein the plurality of tissue anchors on 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.

10. A device for treating a left atrial appendage, comprising: a contact member configured to move between a first condition and a second condition; and a fixation element, the contact member is configured to move from the first condition to the second condition such that at least a portion of the contact member engages a wall portion of the left atrial appendage after the contact member is advanced into the left atrial appendage; the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position; the contact member is configured to twist at least a portion of the left atrial appendage in the first direction when the contact member is rotated from the first rotational position to the second rotational position; 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 in an operable state, the second direction being opposite the first direction; A device comprising: a catheter selectively coupled to the contact member and configured to apply a torque on the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached.

11. 11. The device of claim 10, wherein the threshold predetermined torque level is between 1.765 mN·m and 70.62 mN·m of torque.

12. A device for treating a left atrial appendage, comprising: a contact member configured to move between a first condition and a second condition; and a fixation element, the contact member is configured to move from the first condition to the second condition such that at least a portion of the contact member engages a wall portion of the left atrial appendage after the contact member is advanced into the left atrial appendage; the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position; the contact member is configured to twist at least a portion of the left atrial appendage in the first direction when the contact member is rotated from the first rotational position to the second rotational position; 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 in an operable state, the second direction being opposite the first direction; The device includes a retention member configured to bias the fixation element toward the contact member.

13. The device of claim 12 , wherein the retention member comprises a threaded shaft.

14. A device for treating a left atrial appendage, comprising: a contact member configured to move between a first condition and a second condition; and a fixation element, the contact member is configured to move from the first condition to the second condition such that at least a portion of the contact member engages a wall portion of the left atrial appendage after the contact member is advanced into the left atrial appendage; the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position; the contact member is configured to twist at least a portion of the left atrial appendage in the first direction when the contact member is rotated from the first rotational position to the second rotational position; 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 in an operable state, the second direction being opposite the first direction; 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 rotational position, and the fixation element is configured to compress the contracted tissue around 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.

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