Devices and Systems for Treating the Left Atrial Appendage

Abstract

Embodiments of devices for closing the left atrial appendage (LAA) and other cavities or openings in the body are disclosed. Some embodiments of the device may include an implant configured to be deployed in the LAA or other cavity, configured to expand or move against 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. Thereafter, one or more fixation elements, staples, sutures, or other fasteners may be implanted in the gathered tissue to hold the tissue in a gathered state, thereby closing the opening of the LAA or other cavity. In some embodiments, the opening of the LAA or other cavity may be closed by stretching or otherwise reshaping the opening using an implant device and fixing the opening in a closed state.

Description

[0001] Cross - reference to related art

[0002] This application claims the benefit of U.S. Patent Application No. 62 / 497,352, filed on March 25, 2019, titled "LEFT ATRIAL APPENDAGE DEVICE AND TECHNIQUES"; U.S. Patent Application No. 62 / 824,948, filed on March 27, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND TECHNIQUES"; U.S. Patent Application No. 62 / 828,351, filed on April 2, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND TECHNIQUES"; U.S. Patent Application No. 62 / 849,713, filed on May 17, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. Patent Application No. 62 / 853,672, filed on May 28, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. Patent Application No. 62 / 854,162, filed on May 29, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. Patent Application No. 62 / 866,405, filed on June 25, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICE AND METHODS OF USING SAME"; U.S. Patent Application No. 62 / 880,552, filed on July 30, 2019, titled "LEFT ATRIAL APPENDAGE CLOSURE DEVICES AND METHODS"; U.S. Patent Application No. 62 / 894, filed on August 30, 2019, titled "DEVICES, SYSTEMS, AND METHODS FOR CLOSING THE LEFT ATRIAL APPENDAGE"Priority is claimed to U.S. Patent Application No. 501, filed Oct. 23, 2019, titled "Devices, Systems, and Methods for Closing the Left Atrial Appendage", U.S. Patent Application No. 62 / 925,155, filed Oct. 23, 2019, titled "Devices, Systems, and Methods for Closing the Left Atrial Appendage", and U.S. Patent Application No. 62 / 949,338, filed Dec. 17, 2019, titled "Devices, Systems, and Methods for Treating the Left Atrial Appendage", the content of each of these priority applications is hereby incorporated by reference in its entirety as if fully set forth herein. Priority benefits are claimed under appropriate legal bases, including but not limited to 35 U.S.C. § 119(e). Any and all applications for foreign or domestic priority claims identified in the application data sheet filed with this application are hereby incorporated by reference and made a part of this specification., TECHNICAL FIELD

[0003] Embodiments of the present disclosure relate to devices, apparatuses, and methods for occluding or closing the left atrial appendage. BACKGROUND ART

[0004] Due to the possible risk of stroke, left atrial appendage (LAA) occlusion is typically performed on high-risk patients. LAA occlusion techniques are generally performed to prevent emboli from leaving the LAA. Typical surgical occlusion involves occluding the opening by suturing through the left atrial inlet. Other techniques include applying an external clip, such as the ATRICLIP manufactured by Atricure, where a nitinol device is used to clamp the appendage without opening the left atrium to exclude the appendage from the left atrial blood circulation.

[0005] Other solutions use plugs to occlude the auricle from the interior of the left atrium. Such plugs can be composed of a laser-cut nitinol tube that unfolds into a hemispherical shape. The portion exposed to the left atrium can be covered with a cap, such as a micron-thin film made of polyethylene terephthalate. The film can act as a blood barrier to prevent blood from flowing through one or more support struts of the plug and flowing therebetween. The typical size range is between approximately 20 mm and 35 mm in diameter and between approximately 20 mm and 40 mm in depth. The device can have anchors extending from the outer surface of the device, which are intended to engage the auricle wall and prevent movement after deployment. The device can be delivered into the left atrium via venous access through the groin and a transseptal crossing line, where a guiding catheter and a coaxial delivery catheter are positioned proximal to the left auricle. The implant for excluding the auricle is typically located at the farthest part of the delivery catheter. The device is typically positioned and deployed using fluoroscopy and echocardiography for guidance. Typical problems with conventional devices include complex pre-operative sizing algorithms for determining the appropriate device size, migration of the implant, leakage around or within the implant, and / or breakage of the implant, all of which can exacerbate the thrombus and stroke problems that the device was originally designed to reduce. The typical drug regimen associated with conventional LAA treatment devices includes warfarin anticoagulation for 45 days (about 6 weeks), then dual antiplatelet therapy (DAPT) for six months postoperatively, and then aspirin. Another procedure typically required for conventional LAA treatment devices includes a follow-up transesophageal echocardiogram six weeks postoperatively. The incidence of device-related thrombus in patients detected by LAA imaging has been reported to be 7.2% per year. Summary of the Invention

[0006] The systems, methods, and devices of the present disclosure each have several innovative aspects, embodiments, or facets, none of which alone determines the desired attributes disclosed herein.

[0007] Embodiments of devices and systems for treating the LAA are disclosed herein, which can include an implant that includes 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 has been advanced into the LAA, the contact member is configured to rotate from a first rotational position to a second rotational position at least in a first direction, 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, wherein the second direction is opposite to the first direction.

[0008] Embodiments of devices and systems for treating the LAA are also disclosed herein. The devices and systems 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 and cause the implant to move from the first state to the second state when the implant is in the first state, such that an outer surface of the implant moves against an inner wall surface of the LAA after the implant has been advanced into the LAA, wherein the catheter is configured to cause the implant to rotate from a first rotational position to a second rotational position in a first direction such that the implant can twist at least a portion of the LAA when the implant is in the second state.

[0009] Embodiments of devices and systems for pulling a first tissue surface toward a second tissue surface are also disclosed herein. The devices and systems include a contact member configured to deploy from a first state to a second state and a fixation element configured to move from a first state to a second state, wherein the contact member can be configured to deploy from the first state to the second state such that at least a distal 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 can be configured to rotate from a first rotational position to a second rotational position at least in a first direction, wherein rotation of the contact member in the first direction twists at least a proximal portion of the first tissue surface and moves it toward a proximal portion of the second tissue surface, and wherein the fixation element is configured to prevent rotation of the implant in a second direction, opposite the first direction, when the fixation element is in an operative state and engages a tissue portion adjacent to and / or including the proximal portions of the first and second tissue surfaces. Additionally, in any device and / or system embodiment disclosed herein, the device can be configured to close or occlude a body cavity having the first and second tissue surfaces, the first and second tissue surfaces can be tissue surfaces within any body cavity, and / or wherein rotation of the contact member further twists at least a proximal portion of the second tissue surface and moves it toward a proximal portion of the first tissue surface.

[0010] In additional embodiments, any embodiment of the devices and systems disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the implant is self-deployable such that the implant automatically deploys from a first state to a second state when a restraint is removed from the implant; wherein the contact member is self-deployable such that at least a portion of the contact member automatically deploys from a first state to a second state when a restraint is removed from the contact member; wherein 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; wherein the contact member is biased to remain in the second state after being deployed into the LAA; wherein the contact member is configured to rotate in a clockwise or counterclockwise direction; wherein the device is configured to cause tissue of the left atrium and / or LAA to contract around an outer surface of a body portion of the implant when the contact member is rotated to a second rotational position, and the fixation element is configured to engage tissue that has contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction; wherein the fixation element has a plurality of tissue anchors configured to engage the inner wall of the heart adjacent the LAA; wherein the fixation element has a helical shape and is configured to rotate around the body portion of the implant during an implantation procedure; wherein the implant is configured to rotate from a first rotational position to a second rotational position in a first direction; wherein the implant is configured to prevent rotation of the implant in a second direction after the implant is fully deployed, wherein the second direction is opposite to the first direction; wherein 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 the inner wall surface of the LAA after the contact member moves to the second state; wherein the implant includes a fixation element configured to engage a portion of the heart tissue adjacent the LAA; wherein the second rotational position is at least a quarter of a full rotation relative to the first rotational position; wherein the second rotational position is at least a half of a full rotation relative to the first rotational position; and / or wherein the second rotational position is from about a quarter of a full rotation to one or more full rotations relative to the first rotational position.

[0011] In addition, in an additional embodiment, any embodiment of the devices and systems disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: further comprising a catheter selectively coupled to the contact member and configured to apply torque to the contact member to rotate the contact member from a first rotational position until a threshold predetermined torque level is reached; wherein the threshold predetermined torque level ranges from a torque of about 0.25 in-oz (inch-ounce) to a torque of about 10 in-oz; wherein the threshold predetermined torque level ranges from a torque of about 0.5 in-oz to a torque of about 5 in-oz; further comprising a retaining member configured to bias the fixation element towards the tissue wall of the LAA; further comprising a retaining member configured to bias the fixation element towards the contact member; further comprising a retaining member configured to couple the fixation element to the contact member; wherein the retaining member includes a threaded shaft; wherein the device is configured such that rotation of the retaining member in a first direction moves the fixation element towards the contact member; wherein the contact member is configured to rotate from a first rotational position to a second rotational position at least in a first direction when torque is applied to the contact member; wherein the device is configured such that the contact member can be removed from the LAA after the fixation element is deployed to the operable state of the fixation element; wherein the device is configured such that the contact member can be removed from the LAA after the fixation element is deployed to the operable state of the fixation element, and wherein the fixation element is configured to prevent rotation of the tissue of the left atrium and / or LAA that has contracted due to the rotation of the contact member from the first rotational position to the second rotational position; wherein after device deployment, only a portion of the fixation element extends into the left atrium, and after device deployment, all other portions of the device are within the LAA; wherein after device deployment, only about 10% or less of the total length of the deployed device extends into the left atrium; wherein the device is configured to be used by a surgical robotic device or system; a surgical robotic device comprising one or more robotic arms, and wherein the device of any embodiment disclosed herein is configured to be used by the surgical robotic device; wherein the contact member and the fixation element are integrally formed and / or formed as a unit; wherein the device is configured to cause the tissue of the left atrium and / or LAA to contract around the outer surface of the body portion of the implant when the contact member rotates to the second rotational position, and the fixation element is configured to compress the tissue that has contracted 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 a second direction.

[0012] Some embodiments of the devices and systems for occluding or closing the left atrial appendage (LAA) disclosed herein may include an implant configured to move between a first state and a second state and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state, wherein the implant may be configured to move from the first state to the second state such that at least a portion of the implant engages a wall portion of the left atrial appendage after the implant is advanced into the left atrial appendage, and wherein the implant may be configured to twist at least a portion of the left atrial appendage when the implant rotates from a first rotational position to a second rotational position when the implant is in the second state. In any of the embodiments disclosed herein, the twisting movement or step may be achieved by a torque catheter.

[0013] In additional embodiments, any embodiment of the devices and systems disclosed herein may include one or more of the following features or details in any combination: wherein the implant is configured to automatically rotate from a first rotational position to a second rotational position after the implant is in a second state; wherein the implant may be configured to be triggered or activated to automatically rotate from a first rotational position to a second rotational position thereafter; wherein the device has a spring coupled to the implant, the spring being configured to cause the implant to automatically rotate when the spring is released or activated; wherein the implant may be self - deployable such that the implant automatically deploys from a first state to a second state when a restraint is removed from the implant; wherein the implant may be self - deployable such that at least a portion of the implant automatically deploys from a first state to a second state as the implant is advanced past the distal end of the outer sheath of a catheter; wherein the implant is substantially collapsed when the implant is in a first state and may be deployed when the implant is in a 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; wherein the implant is biased to remain in the second state after being deployed into the left atrial appendage; wherein the implant is configured to rotate in a clockwise or counter - clockwise direction; wherein the implant may include a fixation element configured to engage the inner wall of the heart external to the left atrial appendage; wherein the implant may include a fixation element configured to engage the inner wall of the heart external to the left atrial appendage, wherein the fixation element has a helical shape and is configured to rotate around the body portion of the implant during an implantation procedure; wherein the implant may include a helical fixation element configured to engage the inner wall of the heart external to the left atrial appendage; wherein the implant may include a fixation element having a helical tissue anchor to engage the inner wall of the heart and / or LAA tissue; wherein the implant may include a fixation element having a plurality of tissue anchors configured to engage the inner wall of the heart adjacent to the left atrial appendage; wherein the implant may be configured to prevent the implant from rotating back to the first rotational position after the implant is fully deployed; wherein the implant may be configured to rotate from a first rotational position to a second rotational position in a first direction, and the implant may be configured to prevent the implant from rotating in a second direction, opposite to the first direction, after the implant is fully deployed.

[0014] In additional embodiments, any of the embodiments of the devices and systems disclosed herein may include one or more of the following features or details in any combination: wherein the implant has a plurality of tissue anchors on its outer surface; wherein the plurality of tissue anchors on the outer surface of the implant are configured to engage the inner wall surface of the left atrial appendage after the implant moves to a second state; wherein the implant may include a fixation element configured to engage a portion of the heart tissue adjacent to the left atrial appendage; wherein the second rotational position may be at least one-quarter or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees) relative to the first rotational position; wherein the second rotational position may be at least one-half or about one-half of a full rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position; wherein the second rotational position may be from one-quarter or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees) to one or more or about one or more full rotations (i.e., 360 degrees or about 360 degrees or more) relative to the first rotational position; wherein the catheter may be configured to apply torque to the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached; wherein the threshold predetermined torque level may range from a torque of 0.25 or about 0.25 in-oz to a torque of 10 or about 10 in-oz; and / or wherein the threshold predetermined torque level may range from a torque of 0.5 or about 0.5 in-oz to a torque of 5 or about 5 in-oz.

[0015] Any of the embodiments 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 and move the contact member from the first state to the second state when the contact member is in the first state such that the outer surface of the contact member unfolds against the inner wall surface of the LAA after the contact member is advanced into the LAA, wherein the catheter is configured to apply torque to the contact member as at least a portion of the catheter rotates 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 may twist at least a portion of the LAA.

[0016] Any embodiment of the devices and systems disclosed herein may include: a deployable implant configured to move between a first state and a second state; 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 such that an outer surface of the implant expands against at least a portion of an inner wall surface of the left atrial appendage after the implant is advanced into the left atrial appendage. In any embodiment of the devices for occluding or closing the LAA disclosed herein, the catheter may be configured to apply torque to the implant to rotate the implant from a first rotational position to a second rotational position such that the implant may twist at least a portion of the left atrial appendage until a predetermined torque level is reached, or in some embodiments, until the user decides to stop, whichever is earlier.

[0017] Also disclosed herein are devices and systems for treating the LAA, which include a device configured to be inserted into the LAA and to engage LAA tissue to occlude the blood communication between the LAA and the left atrium when the device is rotated to a certain rotational position. In any embodiment of the device, the device may be configured to be selectively lockable in the rotational position such that the device remains at least substantially in the rotational 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 rotational position after implantation, the device may be circular, spherical, or disc-shaped when in a deployed state in the LAA, the device may be deployed from a first collapsed state to a second deployed state, and / or the device may self-deploy from the first collapsed state to the second deployed state.

[0018] Also disclosed herein are embodiments of methods for treating the LAA, the method including engaging the tissue of the LAA and rotating the tissue of the LAA to occlude or close the blood communication between the LAA and the left atrium. In any embodiment of the method disclosed herein, rotating the tissue of the LAA to occlude or close the blood communication between the LAA and the left atrium may include rotating the tissue of the LAA to occlude or close the orifice of the LAA. Additionally, any embodiment of the method disclosed herein may further include fixing the LAA in a certain rotational position to keep the LAA in an occluded or closed state.

[0019] Any embodiment of the method of occluding or closing the LAA disclosed herein may include advancing a deployment device having an implant into the left atrial appendage, wherein the implant may be configured to move from a first state to a second state. In some embodiments, at least a portion of the implant may expand in a radial direction when the implant is in the second state as compared to the first state. The method may further include: moving the implant within the left atrial appendage from the first state to the second state such that at least a portion of an outer wall of the implant or one or more tissue anchors extending away from an outer surface of the implant move against at least a portion of an inner wall surface of the left atrial appendage; rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage; and preventing the implant from rotating back to the first rotational position.

[0020] In some additional embodiments, any embodiment of the methods for occluding or closing the LAA disclosed herein may include one or more of the following steps in any combination and in any combination with any other steps, features, or other details of any other embodiment: wherein the implant is self-expanding and wherein moving the implant from a first state to a second state includes advancing the implant beyond the distal end of a deployment device; wherein engaging a wall portion inside the LAA includes engaging a wall portion inside the LAA with one or more tissue anchors positioned on an outer surface of the implant; wherein preventing the implant from rotating back to a first rotational position includes engaging a tissue wall with an anchor element to prevent relative movement between the implant and the tissue wall; wherein preventing the implant from rotating back to a first rotational position includes engaging a tissue wall with an anchor element, and wherein the anchor element is configured to be fixed to the implant to prevent rotation between the implant and the anchor element; wherein preventing the implant from rotating back to a first rotational position includes engaging a heart tissue wall with an anchor element, wherein the anchor element is rotationally fixed relative to the implant and is configured to prevent the implant from rotating back to a first rotational position; wherein preventing the implant from rotating back to a first rotational position includes engaging heart tissue external to the occluding portion of the LAA with an anchor element, wherein the anchor element is rotationally fixed relative to the implant and is configured to prevent the implant from rotating back to a first rotational position; wherein the anchor element includes a plurality of tissue anchors on at least one of its surfaces, the plurality of tissue anchors being configured to engage the inner wall of the heart external to the LAA; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes rotating the implant until the orifice of the LAA is substantially or completely occluded; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes rotating the implant at least about 90 degrees from the first rotational position in either direction; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes rotating the implant at least about 180 degrees from the first rotational position in either direction; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes rotating the implant from about 90 degrees to about 360 degrees from the first rotational position in either direction; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes rotating the implant from about 90 degrees to about 180 degrees from the first rotational position in either direction; wherein rotating the implant from a first rotational position to a second rotational position to twist the LAA includes applying a torque to the implant to rotate the implant from the first rotational position in either direction until a threshold predetermined torque level is reached, holding the implant in the second rotational position, and fixing the implant relative to the tissue surface around the LAA in a substantially second rotational position; wherein the maximum predetermined torque level is from about 0.Torque from about 25 in-oz to about 10 in-oz; and / or wherein the maximum predetermined torque level is from about 0.5 in-oz of torque to about 5 in-oz of torque.

[0021] In some additional embodiments, any embodiment of the method of occluding or closing the LAA disclosed herein may include one or more of the following steps in any combination and in any combination with any other steps, features, or other details of any other embodiment: wherein the implant is self-expanding, and wherein moving the implant from a first state to a second state may include advancing the implant beyond the distal end of a deployment device; wherein engaging a wall portion inside the left atrial appendage may include engaging at least a portion of a wall portion inside or around the left atrial appendage with one or more tissue anchors positioned on an outer surface of the implant; wherein preventing the implant from rotating back to a first rotational position may include engaging a tissue wall outside the left atrial appendage with an anchor element; wherein the anchor element may be rotatably fixed to the implant to prevent relative movement between the anchor element and the implant; wherein preventing the implant from rotating back to a first rotational position may include engaging a tissue wall of the heart with an anchor element; wherein the anchor element may be rotatably fixed relative to the implant and is configured to prevent the implant from rotating back to a first rotational position; wherein preventing the implant from rotating back to a first rotational position may include engaging an inner wall of the heart outside the left atrial appendage with an anchor element; wherein the anchor element may be rotatably fixed relative to the implant and is configured to prevent the implant from rotating back to a first rotational position; wherein the anchor element may include a plurality of tissue anchors on at least one of its surfaces, the plurality of tissue anchors being configured to engage an inner wall of the heart outside the left atrial appendage; and / or wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant until the orifice of the LAA may be substantially or completely occluded or closed or collapsed around the outer surface of the implant.

[0022] In some additional embodiments, any embodiment of the methods for occluding or closing the LAA disclosed herein may include one or more of the following steps in any combination and in any combination with any other steps, features, or other details of any other embodiment: wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least a quarter or about a quarter of a full rotation (i.e., 90 degrees or about 90 degrees) relative to the first rotational position; wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least a half or about a half of a full rotation (i.e., 180 degrees or about 180 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 may include rotating the implant from a quarter or about a quarter of a full rotation (i.e., 90 degrees or about 90 degrees) to a full rotation or about a full rotation (i.e., 360 degrees or about 360 degrees) or to more than one full rotation (i.e., greater 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 may include rotating the implant from a quarter or about a quarter of a full rotation (i.e., 90 degrees or about 90 degrees) to a half of a full rotation or about a half of a full rotation (i.e., 180 degrees or about 180 degrees) or to more than one full rotation (i.e., greater 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 may include applying a torque to the implant to rotate the implant in either direction from the first rotational position until a threshold predetermined torque level is reached; wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include holding the implant in the second rotational position; wherein rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include fixing the implant relative to the tissue surface around the left atrial appendage at approximately the second rotational position; wherein the maximum predetermined torque level may range from a torque of about 0.25 in-oz to a torque of about 10 in-oz; and / or wherein the maximum predetermined torque level may range from a torque of about 0.5 in-oz to a torque of about 5 in-oz.

[0023] Some embodiments of the implant for deployment within a cavity or blood vessel disclosed herein include: a deployable body; a plurality of tissue anchors on an outer surface of the deployable body, the plurality of tissue anchors being configured to engage an inner wall surface of the cavity or blood vessel; and an anchor element coupled to the deployable body, the anchor element being configured to engage a tissue surface adjacent to the inner wall surface of the cavity or blood vessel.

[0024] Some embodiments of the devices and systems disclosed herein may include: a deployable implant having a plurality of tissue anchors on its outer surface, the deployable 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 deployed; 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 such that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage after the implant is advanced into the left atrial appendage. In some embodiments, the catheter may be configured to rotate the implant from a first rotational position to a second rotational position in a first direction such that the implant may twist the wall of the left atrial appendage.

[0025] Some embodiments of the devices and systems for occluding or closing the LAA disclosed herein may include: an implant configured to move between a first state and a second state; and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and to move the implant from the first state to the second state such that an outer surface of the implant moves against an inner wall surface of the left atrial appendage after the implant is advanced into the left atrial appendage. In some embodiments, the catheter may be configured to rotate the implant from a first rotational position to a second rotational position in a first direction such that the implant may twist at least a portion of the left atrial appendage when the implant is in the second state.

[0026] Any embodiment of a method for 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 occlude or substantially occlude, or inhibit or substantially inhibit, blood communication between the left atrial appendage and the left atrium. In additional embodiments, any embodiment of the methods disclosed herein may include one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment of any other treatment method disclosed herein: further including that rotating the tissue of the left atrial appendage to occlude blood communication between the left atrial appendage and the left atrium may include rotating the tissue of the left atrial appendage to occlude an orifice of the left atrial appendage, and / or further including fixing the left atrial appendage in a certain rotational position to hold the left atrial appendage in an occluded state.

[0027] Some embodiments of the devices for treating the left atrial appendage (LAA) disclosed herein may include an apparatus configured to be inserted into the LAA and engage LAA tissue to occlude blood communication between the LAA and the left atrium when the apparatus is rotated to a certain rotational position. In some embodiments, the apparatus may be configured to lock in the rotational position to maintain the apparatus in the rotational position after implantation, wherein the apparatus may include a fixation element configured to engage a tissue surface adjacent to the LAA to maintain the apparatus in the rotational position after implantation, wherein when the apparatus is in a deployed state in the LAA, the apparatus may be circular, spherical, or disc-shaped, wherein the apparatus may be deployed from a first collapsed state to a second deployed state, and / or wherein the apparatus may self-deploy from a first collapsed state to a second deployed state.

[0028] Additional embodiments of implants for treating the LAA are disclosed herein, such additional embodiments being configured to elongate the opening of the LAA or extend the opening of the LAA. In any such implant embodiments disclosed herein, the implant may include a frame deployable from a collapsed state to a deployed state, the frame including: a wall having a shape that is elongated at least along the entire length of the frame in the deployed state; and an opening extending axially through the frame from a proximal end to a distal end of the frame, the opening being surrounded by the wall. In any embodiments disclosed herein, the frame may be configured to define a first width spanning the opening from a first portion of the frame to a second portion in a first direction, the first width being greater than a second width in a second direction perpendicular to the first direction.

[0029] In addition, in additional embodiments, any embodiment of an implant for treating the LAA disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: a first apical extension that extends distally from the proximal end of the frame at a first portion of the wall, wherein the first apical extension may be configured to bias the proximal end of the frame to generally align with the outer edge of the orifice; a first apical extension that extends distally from the proximal end of the frame at a first portion of the wall, wherein the first apical extension may be configured to prevent the frame from passing completely through the orifice of the LAA; a first apical extension that extends distally from the proximal end of the frame at a first portion of the wall, wherein the first apical extension may be configured to overlap an outer surface of a wall portion around the orifice of the LAA when the implant is in an operative position within the LAA; a second apical extension that extends distally from the proximal end of the frame at a second portion of the wall; a second apical extension that extends distally from the proximal end of the frame at a second portion of the wall, wherein the second apical extension may be configured to bias the proximal end of the frame to generally align with the outer edge of the orifice; a second apical extension that extends distally from the proximal end of the frame at a second portion of the wall, wherein the second apical extension may be configured to prevent the frame from passing completely through the orifice of the LAA; and / or a second apical extension that extends distally from the proximal end of the frame at a second portion of the wall, wherein the second apical extension may be configured to overlap an outer surface of a wall portion around the orifice of the LAA when the implant is in an operative position within the LAA.

[0030] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein when the implant is in a natural deployed state in vitro, a first width of an opening of the frame is at least about twice a second width of the frame, but not more than about ten times the second width of the opening of the frame; wherein when the implant is in a natural deployed state in vitro, the first width of the opening of the frame is from about twice to about five times the second width of the opening of the frame; wherein when the implant is in a natural deployed state in vitro, the first width of the opening of the frame is from about twice to about four times the second width of the opening of the frame; wherein when the implant is in a natural deployed state in vitro, the first width of the opening of the frame is from about three times to about four times the second width of the opening of the frame; wherein when the implant is in a natural deployed state in vitro, a ratio of the first width of the opening of the frame to the second width of the opening of the frame is at least about 2 to 1; wherein when the implant is in a natural deployed state in vitro, the ratio of the first width of the opening of the frame to the second width of the opening of the frame ranges from about 2 to 1 to about 5 to 1; wherein when the implant is in a natural deployed state in vitro, the ratio of the first width of the opening of the frame to the second width of the opening of the frame ranges from about 3 to 1 to about 4 to 1; and / or wherein when the implant is in a natural deployed state in vitro, the ratio of the first width of the opening of the frame to the second width of the opening of the frame is about 3.5 to 1.

[0031] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein when the implant is in a deployed state in the LAA, a first width of an opening of the frame is at least about twice a second width of the opening of the frame, but no more than about ten times the second width of the opening of the frame; wherein when the implant is in a deployed state in the LAA, the first width of the opening of the frame is from about twice to about five times the second width of the opening of the frame; wherein when the implant is in a deployed state in the LAA, the first width of the opening of the frame is from about twice to about four times the second width of the opening of the frame; wherein when the implant is in a deployed state in the LAA, the first width of the opening of the frame is from about three times to about four times the second width of the opening of the frame; wherein when the implant is in a deployed state in the LAA, a ratio of the first width of the opening of the frame to the second width of the opening of the frame is at least about 2 to 1; wherein when the implant is in a deployed state in the LAA, a ratio of the first width of the frame to the second width of the frame is from about 2 to 1 to about 5 to 1; wherein when the implant is in a deployed state in the LAA, a ratio of the first width of the frame to the second width of the frame is from about 3 to 1 to about 4 to 1; and / or wherein when the implant is in a deployed state in the LAA, a ratio of the first width of the frame to the second width of the frame is about 3.5 to 1.

[0032] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, a first width of the orifice is at least about twice a second width of the orifice, but not more than about ten times the second width of the orifice; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the first width of the orifice is about two to about five times the second width of the orifice; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the first width of the orifice is about two to about four times the second width of the orifice; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the first width of the orifice is about three to about four times the second width of the orifice; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, a ratio of the first width of the orifice to the second width of the orifice is at least about 2 to 1; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the ratio of the first width of the orifice to the second width of the orifice is about 2 to 1 to about 5 to 1; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the ratio of the first width of the orifice to the second width of the orifice is about 3 to 1 to about 4 to 1; wherein the implant may be configured to change the shape of the orifice such that when the implant is in a deployed state in the LAA, the ratio of the first width of the orifice to the second width of the orifice is about 3.5 to 1; further comprising anchoring elements located at least at a first part and a second part of the frame, the anchoring elements being configured to anchor the frame to the LAA; wherein the frame includes gripping features on an outer surface of the frame at least at the first part and the second part of the frame, the gripping features being configured to inhibit movement of the frame relative to the tissue surface of the orifice of the LAA; including a first rough area and a second rough area on the outer surface of the frame at the first part and the second part of the frame respectively, the first and second rough areas being configured to inhibit movement of the frame relative to the tissue surface of the orifice of the LAA; further comprising a cover coupled to the frame, the cover at least partially covering an opening in the frame; further comprising a cover coupled to the frame, the cover completely covering an opening in the frame; further comprising a cover coupled to the frame, the cover completely covering an opening in the frame, wherein the cover includes a mesh material; and / or wherein the first and second end portions of the frame are configured to expand a first part of the orifice of the LAA away from a second part of the orifice opposite the first part, thereby elongating the orifice of the LAA in a first direction.

[0033] In addition, in any implant embodiment disclosed herein, the implant may comprise a frame that is deployable from a collapsed state to a deployed state, the frame comprising: a wall having a shape that is elongated along the entire length of the frame at least in the deployed state; and an opening that extends axially through the frame from a proximal end to a distal end of the frame, the opening being surrounded by the wall. In some embodiments, when the implant is in an operative position, the elongated shape may define a first width that spans from a first part of the frame across the opening of the frame to a second part of the frame in a first direction, the first width being at least twice as large as a second width in a second direction orthogonal to the first direction, and the proximal end of the frame flares outwardly at least at the first part and the second part of the frame. In any embodiment disclosed herein, the first width may be about two to about five times as large as the second width, the first width may be about three to about five times as large as the second width, the first width may be about three to about four times as large as the second width, and / or the first and second parts of the frame may be configured to expand a first part of the orifice of the LAA away from a second part of the orifice opposite the first part, thereby elongating the orifice of the LAA in a first direction.

[0034] Additionally, any implant, device, and / or system embodiments disclosed herein may be adapted to and / or used for treating any opening, chamber, or cavity within the body. Any implant embodiments disclosed herein may include a frame that can be deployed from a collapsed state to a deployed state, the frame including a wall continuously surrounding an opening extending through the frame, a plurality of openings extending through the wall, and a first recess in a first portion of the wall and a second recess in a second portion of the wall, wherein the first recess and the second recess may each be configured to receive an edge of the wall of the body opening therein when the implant is deployed against the wall of the body opening, and the first and second recesses are configured to bias the edge of the body opening to remain in the first and second recesses. In any embodiments disclosed herein, the recesses may have a curved profile. Additionally, the first and second portions of the wall of the frame may be configured to expand a first portion of the orifice of the opening away from a second portion of the orifice opposite the first portion, thereby elongating the orifice of the opening.

[0035] In any embodiments disclosed herein, the implant may include: a frame that can be deployed from a first state to a second state, the frame having: a first portion that can move in a first direction when the frame is deployed from the first state to the second state; a second portion coupled to the first portion, the second portion being configured to move in a second direction when the frame is deployed 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 the first direction) between an end of the first portion and an end of the second end portion; a width in a transverse direction (also referred to herein as the second direction) perpendicular to the longitudinal direction; and a height in a height direction (also referred to herein as the third direction) perpendicular to the longitudinal direction and the transverse direction.

[0036] In additional embodiments, any implant embodiments disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiments disclosed herein: wherein the frame can be advanced through a delivery catheter when the frame is in the first state; wherein the length of the frame increases when the frame is deployed from the first state to the second state; and / or wherein the width and height of the frame remain generally constant when the frame is deployed from the first state to the second state.

[0037] The present disclosure also discloses additional embodiments of implants for treating the LAA. In any implant embodiment disclosed herein, the implant may include a frame that is deployable from a first state to a second state, the frame having: a middle portion; a first end portion coupled to the middle portion, the first end portion being deployable in a first direction when the frame is deployed from the first state to the second state; a second end portion coupled to the middle portion, the second end portion being deployable in a second direction when the frame is deployed from the first state to the second state, the second direction being opposite to the first direction; a length between the first end portion and the second end portion in a longitudinal direction; and / or a width in a transverse direction perpendicular to the longitudinal direction.

[0038] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the frame may be advanced through a delivery catheter when the frame is in a first state; wherein the length of the frame increases when the frame unfolds from the first state to the second state; and / or wherein the width of the frame remains substantially constant when the frame unfolds from the first state to the second state; wherein the implant includes a frame that can be unfolded from a first state to a second state; wherein the frame has a middle portion, a first end portion coupled to the middle portion, a second end portion coupled to the middle portion, a length in a longitudinal direction between the first end portion and the second end portion, and a width in a transverse direction perpendicular to the longitudinal direction, the first end portion being configured to unfold in a first direction when the frame unfolds from the first state to the second state, the second end portion being configured to unfold in a second direction when the frame unfolds from the first state to the second state, the second direction being opposite to the first direction; wherein the frame may be advanced through a delivery catheter when the frame is in a first state; wherein the length of the frame increases when the frame unfolds from the first state to the second state; wherein the first and second end portions of the frame are configured to expand a first portion of the orifice of the LAA away from a second portion of the orifice opposite the first portion, thereby elongating the orifice of the LAA in the longitudinal direction; further comprising a clip configured to hold two or more tissue portions of the LAA together; further comprising at least one cushion pad coupled to at least one of the first end portion and the second end portion of the frame; wherein the frame may be configured to increase in size in the longitudinal direction but not in any other direction; wherein the frame is capable of self-unfolding from the first state to the second state; wherein the second-stage portion includes an articulating mechanism for shrinking or occluding the opening of the LAA; further comprising at least one of a passive activation mechanism and an active activation mechanism to activate the articulating mechanism; wherein at least a portion of the frame may be configured to contract in the longitudinal direction, thereby reducing the length of the frame in the longitudinal direction; wherein the frame includes a wire of a certain length having a U-shape, the wire being configured to allow the cantilever near the middle portion of the frame to bend; wherein the frame includes a torsion spring wire form near the middle portion of the frame; wherein the frame includes a plurality of U-shaped cantilever segments or torsion spring forms; wherein the frame is formed of laser-cut round wire, wire tape, or sheet; and / or wherein the frame includes at least one of a polymer, a composite material, a metal, and a superelastic shape memory alloy.

[0039] In any implant embodiment disclosed herein, the implant may comprise a frame that is deployable from a first state to a second state, the frame having: a middle portion; a first end portion coupled to the middle portion, the first end portion being deployable in a first direction when the frame is deployed from the first state to the second state; a second end portion coupled to the middle portion, the second end portion being deployable in a second direction when the frame is deployed from the first state to the second state, the second direction being opposite to the first direction; a length between the first end portion and the second end portion in a longitudinal direction; and a width in a transverse direction perpendicular to the longitudinal direction. In any embodiment disclosed herein, the frame may be advanced through a delivery catheter when the frame is in the first state; the length of the frame may increase when the frame is deployed from the first state to the second state; and / or the frame may be configured to increase the size of the LAA orifice in the longitudinal direction and decrease the size of the LAA orifice in the transverse direction when the frame is deployed from the first state to the second state.

[0040] In any embodiment disclosed herein, the implant may be adapted to occlude, restrict, tighten, and / or close any blood vessel, opening, chamber, or cavity in the body and may comprise a frame that is deployable from a first state to a second state, the frame having: a middle portion comprising a proximal portion, a first portion extending distally away from the proximal portion, and a second portion extending distally away from the proximal portion; a first leg coupled to a first end of the middle portion, the first leg being deployable in a first direction when the frame is deployed from the first state to the second state; a second leg coupled to a second end of the middle portion, the second leg being deployable in a second direction when the frame is deployed from the first state to the second state, the second direction being opposite to the first direction; a length between the first end portion and the second end portion in a longitudinal direction; and a width in a transverse direction perpendicular to the longitudinal direction.

[0041] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the first leg and the second leg are integrally formed with the intermediate portion; wherein the frame is advanceable through a delivery catheter when the frame is in a first state; wherein the length of the frame increases when the frame is deployed from the first state to the second state; wherein the frame is configured to increase the size of the LAA ostium in the longitudinal direction and decrease the size of the LAA ostium in the transverse direction when the frame is deployed from the first state to the second state, thereby pulling the first wall of the LAA closer to the second wall of the LAA; wherein the first and second legs are configured to expand a first portion of the LAA ostium away from a second portion of the ostium opposite the first portion, thereby elongating the LAA ostium in the longitudinal direction; further comprising a clamp configured to hold two or more tissue portions of the LAA together; further comprising at least one cushion pad coupled to at least one of the first and second legs; wherein the frame is configured to increase in size in the longitudinal direction but not in any other direction; wherein the frame is capable of self-deploying from the first state to the second state; further comprising anchoring elements to anchor one or more walls of the LAA opening to another wall of the LAA opening; wherein the implant includes an articulating mechanism for constricting or occluding the LAA opening; further comprising at least one of a passive activation mechanism and an active activation mechanism to activate the articulating mechanism; wherein at least a portion of the frame is configured to be contractible in the longitudinal direction, thereby reducing the length of the frame in the longitudinal direction; wherein the frame includes a wire of a certain length having a U-shape, the wire being configured to allow the cantilever near the intermediate portion of the frame to bend; wherein the frame includes a torsion spring wire form near the intermediate portion of the frame; wherein the frame includes a plurality of U-shaped cantilever sections or torsion spring forms; wherein the frame is formed of laser-cut round wire, wire ribbon, or sheet; and / or wherein the frame includes at least one of a polymer, a composite material, a metal, and a superelastic shape memory alloy.

[0042] Embodiments of an apparatus for treating a left atrial appendage are disclosed. The apparatus includes 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, wherein the catheter is configured to apply torque to the contact member until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position as at least a portion of the catheter rotates, 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 deployable from a first state to a second state.

[0043] Embodiments of an apparatus for reducing the opening of a left atrial appendage are disclosed. The apparatus includes 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 from a first rotational position to a second rotational position in a first direction and reduce the size of 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 the tissue adjacent to 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 can be configured to engage a tissue surface on the outer surface of the left atrial appendage. Additionally, in any of the embodiments disclosed herein, the contact member can be configured to engage the tissue surface of the left atrial appendage without changing the state or shape of the contact member.

[0044] Additional embodiments of an implant for treating the LAA are also disclosed. In any of the embodiments disclosed herein, the implant can include a frame deployable from a first state to a second state, the frame having: an intermediate portion; a first end portion coupled to the intermediate portion, the first end portion being deployable in a first direction as the frame is deployed from the first state to the second state; a second end portion coupled to the intermediate portion, the second end portion being deployable in a second direction as the frame is deployed from the first state to the second state, the second direction being opposite to the first direction; a length between the first end portion and the second end portion in a longitudinal direction (also referred to herein as the first direction); and / or a width in a transverse direction perpendicular to the longitudinal direction.

[0045] In additional embodiments, any implant embodiment disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: a clip coupled to a proximal portion of the intermediate portion; a clip configured to hold two or more tissue portions of the LAA together; wherein the first end portion and the second end portion are integrally formed with the intermediate portion; wherein the frame is advanceable through a delivery catheter when the frame is in a first state; wherein the length of the frame increases when the frame is deployed from the first state to the second state; wherein the frame is configured to increase the size of the LAA ostium in the longitudinal direction and decrease the size of the LAA ostium in the transverse direction when the frame is deployed from the first state to the second state, thereby pulling a first wall of the LAA closer to a second wall of the LAA; wherein the clip is configured to be closable to secure a portion of the first wall to a portion of the second wall when the frame is in the second state; wherein the first and second end portions of the frame are configured to expand a first portion of the LAA ostium away from a second portion of the ostium opposite the first portion, thereby elongating the LAA ostium in the longitudinal direction; further comprising at least one cushion pad coupled to at least one of the first end portion and the second end portion of the frame; wherein the frame is configured to increase in size in the longitudinal direction but not in any other direction; wherein the frame is capable of self-deploying from the first state to the second state; further comprising a member for shrinking or occluding the opening of the LAA; wherein the implant includes a hinge mechanism for shrinking or occluding the opening of the LAA; further comprising at least one of a passive activation mechanism and an active activation mechanism to activate the hinge mechanism; further comprising a member for shrinking at least a portion of the frame in the longitudinal direction to reduce the length of the frame in the longitudinal direction; wherein the frame includes a wire of a certain length having a U-shape, the wire being configured to allow the cantilever near the intermediate portion of the frame to bend; wherein the frame includes a torsion spring wire type near the intermediate portion of the frame; wherein the frame includes a plurality of U-shaped cantilever sections or torsion spring forms; wherein the frame is formed of laser-cut round wire, wire tape, or sheet; and / or wherein the frame includes at least one of a polymer, a composite material, a metal, and a superelastic shape memory alloy.

[0046] The present disclosure also discloses additional embodiments of an occluding or closing device for the LAA. In any of the embodiments disclosed herein, the device may include a delivery catheter and an implant, the implant being advanceable through the delivery catheter when the implant is in a first state, wherein the implant has a first deployable portion and a second deployable portion, wherein the first and second deployable portions of the implant are each independently deployable to a second state, and wherein the implant is configured to occlude the opening of the LAA when the first and second deployable portions of the implant are in the second state.

[0047] In additional embodiments, any of the embodiments of the devices and systems disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiments disclosed herein: wherein the first deployable portion is the distal portion of the implant and the second deployable portion is the proximal portion of the implant; further including a removable restraint that only surrounds the proximal portion of the implant when the implant is in a pre-deployed state; wherein at least one of the first deployable portion and the second deployable portion is self-deployable; wherein the implant is configured such that the first deployable portion deploys before the second deployable portion; and / or any features, components, and / or details of any implant embodiments disclosed herein.

[0048] The present disclosure also discloses additional embodiments of an occluding or closing device for the LAA, the occluding or closing device including an implant selectively deployable from a first state to a second state and a cap coupled to the implant, wherein the implant is configured to deploy against the wall of the opening of the LAA when the implant is in the second state, wherein the size of the implant is larger in the second state than in the first state, wherein at least a portion of the cap is positioned adjacent to the outer surface of the implant and is selectively movable between at least a first state and a second state, wherein the cap is configured to have a plurality of folded portions or pleats in a portion of the cap adjacent to the outer surface of the implant when the cap is in the second state, and wherein the implant is configured to occlude the opening of the LAA when the implant is in the second state.

[0049] In additional embodiments, any embodiment of the devices disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the cap may be configured such that at least one or more of the plurality of folded portions or pleats are positioned between at least a portion of the outer surface of the implant and at least a portion of the wall of the opening of the LAA when the implant and the cap are in the second state; further comprising a pull wire coupled to the cap and configured to move the cap from the first state to the second state upon withdrawal of the pull wire; and / or wherein the implant may selectively also contract from the second state to the first state.

[0050] In additional embodiments, any embodiment of the devices disclosed herein may include one or more of the following features, components, and / or details in any combination with any other features, components, and / or details of any other embodiment disclosed herein: wherein the device further comprises a delivery catheter; wherein the device further comprises an implant of any of the implant embodiments disclosed herein, the implant being advanceable through the delivery catheter when the implant is in the first state; wherein the implant includes a first-stage portion and a second-stage portion that may each be independently deployed to at least a second operable or deployed state; wherein the first-stage portion is configured to be at least partially deployed prior to deployment of the second-stage portion; wherein the first-stage portion is configured to be positioned near the distal portion of the LAA; wherein the second-stage portion is configured to constrict the opening of the LAA when the second-stage portion is in the second state; wherein the second-stage portion is configured to occlude the opening of the LAA when the second-stage portion is in the second state; wherein the second-stage portion is configured to fold one or more tissue portions around or near the opening of the LAA when the second-stage portion is in the second state; wherein the second-stage portion is configured to twist one or more tissue portions around the opening of the LAA to constrict or occlude the opening of the LAA when the second-stage portion is in the second state; wherein the second-stage portion includes a member for constricting or occluding the opening of the LAA; wherein the second-stage portion includes a hinge mechanism for constricting or occluding the opening of the LAA; further comprising at least one of a passive activation mechanism and an active activation mechanism to activate the hinge mechanism; and / or wherein at least one of the first-stage portion and the second-stage portion is self-deployable.

[0051] Embodiments of methods for shrinking, closing, occluding, or otherwise treating the LAA (collectively referred to hereinafter as treatment methods) are disclosed. Any embodiment of such methods can be used to deploy or implant any embodiment of the implants or devices disclosed herein. Any embodiment of the methods disclosed herein can include advancing a delivery catheter coupled with an implant into the heart, advancing a distal tip of the delivery catheter near an orifice of the LAA, and / or elongating the LAA in a first direction by at least deploying the implant in the first direction such that a ratio of a size of the orifice of the LAA in the first direction to a size of the orifice of the LAA in a second direction perpendicular to the first direction is at least 2 to 1. The method can further include withdrawing the delivery catheter to position the implant within the LAA.

[0052] In additional embodiments, any embodiment of the methods disclosed herein may include one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment of the processing methods disclosed herein: elongating the LAA in the first direction by at least deploying 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 ranges from about 2:1 to about 5:1; elongating the LAA in the first direction by at least deploying 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 ranges from about 3:1 to about 4:1; elongating the LAA in the first direction by at least deploying 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 about 3.5:1; further comprising a clamp configured to hold together two or more tissue portions of the opening; further comprising at least one cushion coupled to the frame; wherein the frame may be configured to increase in size in the first direction but not increase in size in any other direction; wherein the frame is self-deployable; further comprising a catheter for implanting the implant; wherein the implant includes an articulated mechanism for constricting or occluding the opening; including at least one of a passive activation mechanism and an active activation mechanism to activate the articulated mechanism; wherein at least a portion of the frame is further configured to be contractible in the first direction, thereby reducing the length of the frame in the first direction; wherein the frame includes a wire of a certain length having a U-shape, the wire being configured to allow the cantilever near the middle portion of the frame to bend; wherein the frame includes a torsion spring wire form near the middle portion of the frame; wherein the frame includes a plurality of U-shaped cantilever sections or torsion spring forms; wherein the frame is formed of laser-cut round wire, wire tape, or sheet; and / or wherein the frame includes at least one of a polymer, a composite material, a metal, and a superelastic shape memory alloy.

[0053] Any embodiment of the methods disclosed herein may include: advancing a delivery catheter having an implant therein into the heart, advancing a distal tip of the delivery catheter near an orifice of the LAA, elongating the LAA in a first direction by causing at least a portion of the implant to deploy at least partially in the first direction, clamping a first wall portion of the LAA to a second wall portion of the LAA, and / or removing the catheter. In other embodiments, any embodiment of the methods disclosed herein may include one or more of the following features, components, steps, and / or details that may be combined arbitrarily with any other features, components, steps, and / or details of any other embodiment disclosed herein in additional embodiments: positioning the implant to achieve juxtaposition in a first direction and / or a second direction; evaluating 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; and / or retracting all or a portion of the implant and repositioning the implant.

[0054] The present disclosure provides additional embodiments of a treatment method, the treatment method comprising: 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 deployed implant at a proper implant depth and angle; deploying a proximal portion of the implant adjacent to an orifice of the LAA; and / or removing the catheter. In additional embodiments, any embodiment of the methods disclosed herein may comprise one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: evaluating a position and / or orientation of at least one of a proximal portion and a distal portion of the implant prior to removing the catheter; determining whether the position and / or orientation of the implant is desired prior to removing the catheter; constraining at least one of the proximal portion and the distal portion of the implant after at least partially deploying the distal portion of the implant; constraining at least one of the proximal portion and the distal portion of the implant after deploying the proximal portion of the implant adjacent to the orifice of the LAA; repositioning the partially deployed implant to a proper implant depth and angle; wherein the device is self-deployable; wherein deploying at least one of the proximal portion and the distal portion of the implant comprises removing a restraint from at least one of the proximal portion and the distal portion of the implant; wherein deploying at least one of the proximal portion and the distal portion of the implant comprises releasing a suture from at least one of the proximal portion and the distal portion of the implant; wherein deploying at least one of the proximal portion and the distal portion of the implant comprises removing a tension tie from at least one of the proximal portion and the distal portion of the implant; wherein deploying the proximal portion of the implant comprises activating a mechanical linkage to deploy at least one of the proximal portion and the distal portion of the implant; comprising a proximal restraint having a frame configured to selectively constrain the proximal portion of the implant in a constrained state; and / or wherein the catheter is steerable.

[0055] Additional embodiments of any of the methods disclosed herein may comprise: advancing a distal tip of a delivery catheter having an implant therein into the heart; advancing the distal tip of the delivery catheter near an orifice of the LAA; deploying a first-stage portion of the implant to at least a partially deployed state; moving the first-stage portion of the implant to a desired implant depth and angle; positioning the implant to achieve juxtaposition in a first direction and / or a second direction; activating a portion of the implant to reduce a size of an opening of the LAA adjacent to the orifice of the LAA; and / or removing the catheter.

[0056] In additional embodiments, any embodiment of the methods disclosed herein may include one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: wherein activating a portion of the implant to reduce the size of the opening of the LAA adjacent to the orifice of the LAA includes folding the tissue around the LAA opening, thereby reducing the size of the LAA opening; wherein activating a portion of the implant to reduce the size of the opening of the LAA includes folding the tissue around the LAA opening to occlude the opening of the LAA; wherein activating a portion of the implant to reduce the size of the opening of the LAA includes linearizing the opening of the LAA; wherein activating a portion of the implant to reduce the size of the opening of the LAA includes extending the opening of the LAA; twisting one or more tissue portions around the LAA opening when the second-stage portion is in the second state to contract or occlude the opening of the LAA; activating at least a portion of the implant to occlude the opening of the LAA after positioning the implant to achieve juxtaposition in the first direction and / or the second direction; activating a member for folding a portion of the tissue to fold the tissue around the LAA opening to reduce the size of the LAA opening; activating the tissue folding mechanism of the implant to fold the tissue around the LAA opening to occlude the opening of the LAA; retracting the tissue folding mechanism after evaluating the opening of the LAA and reactivating the tissue folding mechanism of the implant to fold the tissue around the LAA opening to occlude the opening of the LAA; evaluating 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; contracting the first-stage portion of the implant after evaluating the position and / or orientation 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 at least a partially expanded state; retracting all or a portion of the implant and repositioning the implant; wherein expanding the distal portion of the implant to at least a partially expanded state includes advancing the distal portion of the implant past the distal tip of the deployment catheter; and / or wherein at least the distal portion of the implant is self-expanding.

[0057] The present disclosure provides additional embodiments of a treatment method, the treatment method comprising: advancing a deployment device having an implant into the left atrial appendage; moving at least a portion of the outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant against the 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 may comprise moving at least a portion of the outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant against 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, and wherein at least a portion of the implant expands in a radial direction when the implant is in the second state as compared to the first state.

[0058] The present disclosure provides additional embodiments of devices and systems for occluding the LAA. The devices and systems may comprise: a clip device having a first member and a second member and configured to move between a closed position and an open position; a first guiding device configured to be advanced into the LAA; and a second guiding device configured to be advanced into the pericardial space outside the LAA and moved such that an end portion of the second guiding device is substantially axially aligned with an end portion of the first guiding device. In any embodiment disclosed herein, at least one of the first and second members of the clip device may be substantially rigid; the clip device may have an opening sized such that the clip device can pass over the LAA when the clip device is in the open position; and / or at least one of the first and second members of the clip device may be configured to substantially flatten and occlude a portion of the LAA when the clip device moves to the closed position. In any additional embodiment disclosed herein, the clip device may comprise only the first member and the second member. In an additional embodiment, the clip device may further comprise a third member and a fourth member connected together in an end-to-end arrangement and defining an opening in the clip device, the opening being sized and configured to pass over the outer surface of the LAA. In any additional embodiment disclosed herein, the device may further comprise a delivery catheter having an outer sheath and a guiding lumen configured to receive the second guiding device and travel over the second guiding device. Additionally, the first member of the clip device may be rigid, and the second member of the clip device may comprise sutures.

[0059] The present disclosure provides additional embodiments of methods for occluding or closing the LAA. In any of the embodiments disclosed herein, the method may comprise: advancing a first guiding device into the LAA; advancing a second guiding device into the pericardial space outside the LAA; substantially aligning an end portion of the second guiding device with an end portion of the first guiding device; advancing a delivery catheter over the second guiding device; advancing a clip device having a first member and a second member from the delivery catheter; moving the clip device from a closed position to an open position; advancing the clip device on the outer surface of the LAA toward the neck portion of the LAA; and / or substantially flattening and occluding the neck portion of the LAA by moving the clip device from the open position to the closed position.

[0060] In additional embodiments, any embodiment of the method for occluding or closing the LAA may comprise one or more of the following features, components, steps, and / or details in any combination with any other features, components, steps, and / or details of any other embodiment disclosed herein: wherein moving the clip device from the closed position to the open position includes advancing the clip device past the distal end of the delivery catheter such that the clip device automatically moves to the open position; wherein the delivery catheter has a guiding lumen configured to receive the second guiding device and travel over the second guiding device; wherein the delivery catheter has an outer sheath; wherein at least one of the first and second members of the clip device is substantially rigid; wherein at least one of the first and second members of the clip device has a substantially planar contact surface configured to contact the outer surface of the LAA; wherein the delivery catheter has an outer sheath; wherein the clip device includes at least four substantially rigid members connected together in an end-to-end arrangement and defining an opening in the clip device sized and configured to pass over the outer surface of the LAA; and / or wherein the clip device includes at least one rigid member and at least one flexible member interconnected with the at least one rigid member.

[0061] Additionally, any implant and / or device or system embodiments disclosed herein may be adapted to and / or used for treating any tissue environment in the body that is desired to be enclosed, restricted, or occluded. By way of example and not limitation, some embodiments of the devices and systems for treating tissue environments disclosed herein may include an implant that includes 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 environment after the contact member is advanced into the tissue environment, the contact member may be configured to rotate from a first rotational position to a second rotational position at least in a first direction, wherein the contact member may be configured to twist at least a portion of the tissue environment 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 environment in a second direction that is opposite the first direction when the fixation element is in an operative state. In any embodiment, the tissue environment may be a cavity, chamber, opening, passageway, tear in tissue, two adjacent or contiguous tissue surfaces, or otherwise.

[0062] In addition, some embodiments of the devices and systems for treating tissue environments disclosed herein may include an implant, a catheter, the implant having a contact member that may (but need not) be configured to move between a first state and a second state, the catheter being configured to advance the contact member into the tissue environment and cause the contact member to move 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 environment after the contact member is advanced into or near the tissue environment, wherein the catheter is configured to apply torque to the contact member until a predetermined torque level is reached to cause the contact member to rotate from a first rotational position to a second rotational position as at least a portion of the catheter rotates, such that the contact member may twist at least a portion of the tissue environment. In any embodiment, the tissue environment may be a cavity, chamber, opening, passageway, tear in tissue, two adjacent or contiguous tissue surfaces, or otherwise.

[0063] In addition, some embodiments of the devices and systems for treating a tissue environment disclosed herein may include a method for treating a tissue environment, which includes: advancing a deployment device having an implant into or near the tissue environment, wherein the implant may (but is not required to) be configured to move from a first state to a second state, and wherein at least a portion of the implant may expand in a radial direction when the implant is in the second state as compared to the first state; moving the implant from the first state to the second state within the tissue environment such that at least a portion of the outer surface of the implant or one or more tissue anchors extending away from the outer surface of the implant move against at least one wall surface of the tissue environment; rotating the implant from a first rotational position to a second rotational position to twist the tissue environment; and / or preventing the implant from rotating back to the first rotational position.

[0064] Additionally, any implant and / or device or system embodiments disclosed herein may be adapted and / or used to treat any tissue environment within the body that is desired to be enclosed, reshaped, restricted, or occluded. By way of example and not limitation, some embodiments of the devices and systems for treating a tissue environment disclosed herein may include an implant that includes a contact member configured to engage a wall portion of the tissue environment after the contact member is advanced into the tissue environment, the contact member may be configured to rotate from a first rotational position to a second rotational position at least in a first direction, the contact member may be configured to twist at least a portion of the tissue of the tissue environment in the first direction when the contact member rotates from the first rotational position to the second rotational position, and / or a fixing element may be configured to prevent rotation of at least a portion of the tissue of the tissue environment in a second direction when the fixing element is in an operable state, wherein the second direction is opposite to the first direction. In any embodiment, the tissue environment may be a cavity, chamber, opening, passageway, tear in tissue, two adjacent or adjoining tissue surfaces, or other aspects.

[0065] Furthermore, some embodiments of the devices and systems for treating a tissue environment disclosed herein may include an implant having a contact member and a catheter configured to advance the contact member into the tissue environment such that the contact member engages at least one wall surface of the tissue environment after the contact member is advanced into or near the tissue environment, wherein the catheter is configured to apply a torque to the contact member until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position when at least a portion of the catheter rotates, such that the contact member may twist at least a portion of the tissue environment. In any embodiment, the tissue environment may be a cavity, chamber, opening, passageway, tear in tissue, two adjacent or adjoining tissue surfaces, or other aspects.

[0066] In addition, some embodiments of the devices and systems for treating a tissue environment disclosed herein may include a method of treating a tissue environment, including: advancing a deployment device having an implant into or near the tissue environment, and wherein at least a portion of the implant engages a wall surface of the tissue environment; rotating the implant from a first rotational position to a second rotational position to twist the tissue environment; and / or preventing the implant from rotating back to the first rotational position. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] Figure 1A Shows a path through the femoral vein and septal puncture into the left atrium through the venous system, which can be used to access the left atrial appendage (LAA).

[0068] Figure 1B Shows a cross-sectional view of the left atrium, showing a guide wire being advanced towards the LAA.

[0069] Figure 2A Shows an embodiment of a treatment system having an implant device advanced through a catheter into the LAA, the implant device being in a collapsed state and constrained within the outer tube of the catheter.

[0070] Figure 2B Shows Figure 2A An embodiment of a treatment system, showing a contact member being deployed within the LAA.

[0071] Figure 2C Shows Figure 2A An embodiment of a treatment system, showing the contact member rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0072] Figure 2D Shows Figure 2A An embodiment of a treatment system, showing a fixing element of an embodiment of advancing the implant device towards the contact member of the implant device.

[0073] Figure 2E Shows Figure 2A A fixing element of a treatment system, the fixing element engaging the tissue of the patient around the proximal portion of the contact member of the implant device.

[0074] Figure 2F Shows the implant device Figure 2A detached from and removed from the catheter.

[0075] Figure 3 Shows an embodiment of an implant device having a cover member around at least a portion of the implant device.

[0076] Figure 4 Shows Figure 2AThe implant device, wherein the contact member is in a second deployed state, the retention member is in a first extended state, and the fixation element is in a second open state.

[0077] Figure 5 is taken along line 5-5 through Figure 4 the implant device shown in Figure 2A a cross-sectional view of the implant device.

[0078] Figure 6 shows Figure 2A the implant device, wherein the contact member is in a second open state, the retention member is in a second contracted state, and the fixation element is in a second open state.

[0079] Figure 7 is taken along line 7-7 through Figure 6 the implant device shown in Figure 2A a cross-sectional view of the implant device.

[0080] Figure 8A shows Figure 2A an embodiment of the implant device, showing the contact member further advanced distally into the LAA.

[0081] Figure 8B shows Figure 2A an embodiment of the implant device, showing the contact member rotated to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0082] Figure 8C shows Figure 2A an embodiment of the implant device, showing the fixation element of the embodiment of the implant device advanced toward the contact member of the implant device.

[0083] Figure 9A shows another embodiment of a treatment system having an implant device advanced through a catheter into the LAA, the implant device being in a collapsed state and constrained within the outer tube of the catheter.

[0084] Figure 9B shows Figure 9A an embodiment of the treatment system, showing the contact member deployed within the LAA.

[0085] Figure 9C shows Figure 9A an embodiment of the treatment system, showing the contact member rotated to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0086] Figure 9D shows Figure 9A an embodiment of the treatment system, showing the fixation element of the embodiment of the implant device advanced toward the contact member of the implant device.

[0087] Figure 9E Shows Figure 9A a fixed element of a processing system, the fixed element engaging with tissue of a patient around a proximal portion of a contact member of an implant device.

[0088] Figure 9F Shows Figure 9A a processing system, wherein the contact member is in a second deployed state, the holding member is in a second contracted state, and the fixed element is in a second open state.

[0089] Figure 9G is a cross-section of the processing system taken along line 9G-9G through Figure 9F as shown in Figure 9A as shown in

[0090] Figure 9H Shows Figure 9A an enlarged side view of a processing system.

[0091] Figure 9I Shows Figure 9A an exploded view of a processing system.

[0092] Figure 10 Shows another embodiment of a processing system for treating the LAA, showing the contact member of the processing system deployed within the LAA.

[0093] Figure 11 Shows an embodiment of a fixed element implanted adjacent a closed opening of the LAA.

[0094] Figure 12 Shows another embodiment of a fixed element implanted adjacent a closed opening of the LAA.

[0095] Figure 13 Shows another embodiment of a processing system having an implant device, wherein the contact member is in a second deployed state, the holding member is in a second contracted state, and the fixed element is in a second open state.

[0096] Figure 14 is a cross-section of the processing system taken along line 14-14 through Figure 13 as shown in Figure 13 as shown in

[0097] Figure 15 Shows another embodiment of an implant device, wherein the contact member is in a second deployed state, the holding member is in a second contracted state, and the fixed element is in a second open state.

[0098] Figure 16 is a cross-section of the processing system taken along line 16-16 through Figure 15 as shown in Figure 15 as shown in

[0099] Figure 17 Shows another embodiment of the processing system, where the contact member is in a second deployed state, the holding member is in a second retracted state, and the fixing element is in a second open state.

[0100] Figure 18 Side view showing another embodiment of the processing system, where the contact member is in a second deployed state, the holding member is in a second retracted state, and the fixing element is in a second open state.

[0101] Figure 19 Is taken along line 19-19 through Figure 18 The cross-sectional view of the processing system shown in Figure 18 .

[0102] Figure 20 Is Figure 18 Another side view of the processing system shown in

[0103] Figure 21 Is taken along line 21-21 through Figure 20 The cross-sectional view of the processing system shown in Figure 18 .

[0104] Figure 22A Side view showing another embodiment of the processing system, where the contact member is in a second deployed state and the holding member is in a first retracted state.

[0105] Figure 22B Side view showing the processing system of FIG. 22, where the contact member is in a second state and the holding member is in a second deployed state.

[0106] Figure 23A Isometric view showing another embodiment of the fixing element.

[0107] Figure 23B Shows Figure 23A The side view of the embodiment of the fixing element shown in

[0108] Figure 23C Isometric view showing another embodiment of the fixing element.

[0109] Figure 23D Shows Figure 23C The side view of the embodiment of the fixing element shown in

[0110] Figure 23E Isometric view showing another embodiment of the fixing element.

[0111] Figure 23F Shows Figure 23E The side view of the embodiment of the fixing element shown in

[0112] Figures 24 - 35 Shows an embodiment of a deployment method for an embodiment of the processing system shown Figure 22A in the figure.

[0113] Figure 36 Shows another embodiment of an implant device, wherein the retaining member is engaged with the tissue surface around the opening of the LAA.

[0114] Figure 37 Shows another embodiment of the processing system, wherein the tab member of the fixing element is in the first engaged state.

[0115] Figure 38 Shows Figure 37 the processing system, wherein the tab member is in the second disengaged state.

[0116] Figure 39 Shows Figure 37 the fixing element of the processing system.

[0117] Figure 40 Shows Figure 37 the processing system, wherein the fixing element is engaged with the contact member, and the tab member of the fixing element is in the first engaged state.

[0118] Figure 41 Shows Figure 37 the processing system, wherein the tab member of the fixing element has been moved to the second disengaged state by the axial advancement of the core member of the delivery system.

[0119] Figure 42 Shows Figure 37 the processing system, wherein the fixing element rotates to offset the tab member relative to the opening of the contact member and permits withdrawal of the fixing element from the contact member.

[0120] Figure 43 Shows Figure 37 the processing system, wherein the fixing element has been withdrawn from the contact member.

[0121] Figure 44A And 44B are respectively a front view and a side view of another embodiment of the processing system configured to twist and occlude or close the LAA at the orifice of the LAA.

[0122] Figure 45A And 45B are respectively a front view and a side view of the processing system of FIG. 44, showing an implant for twisting the LAA to occlude or close the LAA at the orifice.

[0123] Figure 46A And Figure 46BFront and side views of a treatment system of FIG. 44, showing the removal of the delivery device from the implant device after the LAA has been occluded.

[0124] Figures 47A - 47F Another embodiment of a treatment system for occluding or closing the LAA is shown.

[0125] Figures 48A - 48F Illustrating some stages or steps of an exemplary deployment procedure of a Figures 47A - 47F deployable implant for treating the LAA.

[0126] Figures 49A - 49G Another embodiment of a treatment system for occluding or closing the LAA is shown.

[0127] Figures 50A - 50F Illustrating some stages or steps of an exemplary deployment procedure of a Figures 49A - 49G deployable implant for treating the LAA.

[0128] Figure 51 Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0129] Figure 52 Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0130] Figure 53 Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0131] Figure 54 Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0132] Figure 55 Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0133] Figures 56A - 56B Another embodiment of a contact member that can be used with any treatment system embodiment disclosed herein is shown.

[0134] Figures 57A - 57B Another embodiment of a fixation element that can be used with any treatment system embodiment disclosed herein is shown.

[0135] Figures 58A - 58B Another embodiment of a fixation element that can be used with any treatment system embodiment disclosed herein is shown.

[0136] Figures 59A - 59B Another embodiment of a fixation element that can be used with any treatment system embodiment disclosed herein is shown.

[0137] Figures 60A - 60B Shows another embodiment of a fixing element that can be used with any processing system embodiment disclosed herein.

[0138] Figures 61A - 61B Shows another embodiment of a fixing element that can be used with any processing system embodiment disclosed herein.

[0139] Figures 62A - 62B Shows additional embodiments of contact members that can be used with any processing system embodiment disclosed herein.

[0140] Figure 63 Shows a side view of an embodiment of a contact member.

[0141] Figure 64 Shows a view of the left atrium (LA).

[0142] Figure 65 Shows the approach path of the LAA.

[0143] Figures 66A - 66D Shows an embodiment of an implant device and method for closing the LAA.

[0144] Figures 67A - 67D Shows various embodiments of an anchor member.

[0145] Figures 68A - 68F Shows another embodiment of an implant and method for closing the LAA.

[0146] Figures 69A - 69G Shows another embodiment of a device and method for closing the LAA.

[0147] Figures 70A - 70F Shows another embodiment of a device and method for closing the LAA.

[0148] Figures 71A - 71G Shows some details of some embodiments of staples that can be used with any device for closing the LAA disclosed herein.

[0149] Figures 72A - 72F Shows an embodiment of a device and method for forming staples.

[0150] Figures 73A - 73B Shows an embodiment of a device and method for closing the LAA.

[0151] Figures 74A - 74E Shows an embodiment of a device and method for closing the LAA.

[0152] Figures 75A - 75EEmbodiments showing some stages of an embodiment of a staple that can be used with any of the devices or methods disclosed herein.

[0153] Figures 76A - 76E Embodiments showing devices and methods for closing the LAA.

[0154] Figures 77A - 77C Embodiments showing devices and methods for closing the LAA.

[0155] Figures 78A - 78C Embodiments showing devices and methods for closing the LAA.

[0156] Figures 79A - 79C Embodiments showing devices and methods for closing the LAA.

[0157] Figures 80A - 80C Embodiments showing devices for treating the LAA.

[0158] Figures 81A - 81C Showing Figures 80A - 80C Embodiments of a method of using the device shown in to close the LAA.

[0159] Figures 82A - 82C Embodiments showing devices for treating the LAA.

[0160] Figures 83A - 83C Embodiments showing devices for treating the LAA.

[0161] Figures 84A - 84C Showing Figures 83A - 83C Embodiments of a method of using the device shown in to close the LAA.

[0162] Figures 85A - 85C Embodiments showing devices for treating the LAA.

[0163] Figures 86A - 86C Showing Figures 85A - 85C Embodiments of a method of using the device shown in to close the LAA.

[0164] Figures 87A - 87C Embodiments showing devices for treating the LAA.

[0165] Figures 88A - 88C Showing Figures 87A - 87C Embodiments of a method of using the device shown in to close the LAA.

[0166] Figures 89A - 89C Embodiments of a method of using another embodiment of a device to close the LAA.

[0167] Figures 90A - 90C Embodiments showing devices for treating the LAA.

[0168] Figures 91A - 91C Illustrates an embodiment of a method of using the device shown in Figures 90A - 90C to occlude the LAA.

[0169] Figures 92A - 92C Illustrates an embodiment of a method of using another embodiment of the device to occlude the LAA.

[0170] Figures 93A - 93C Illustrates an embodiment of a device for treating the LAA.

[0171] Figures 94A - 94C Illustrates using Figures 93A - 93C the device shown in

[0172] Figures 95A - 95C to occlude the LAA.

[0173] Figures 96A - 96C Illustrates using Figures 95A - 95C the device shown in

[0174] Figures 97A - 97C to occlude the LAA.

[0175] Figures 98A - 98C Illustrates an embodiment of a method of deploying Figures 95A - 95C the device shown in

[0176] Figures 99A - 99C Illustrates an embodiment of a device for treating the LAA.

[0177] Figures 100A - 100C Illustrates using Figures 99A - 99C the device shown in

[0178] Figures 101A - 101C to occlude the LAA.

[0179] Figures 102A - 102C Illustrates an embodiment of a method of deploying another embodiment of the device for treating the LAA.

[0180] Figures 103A - 103D Illustrates an embodiment of another implant device and an embodiment of a method of using such a device to treat the LAA.

[0181] Figures 104A - 104E Illustrates Figures 103A - 103D a side view of an embodiment of the implant device shown in

[0182] Figures 105A - 105EIllustrates an embodiment of another implant device and an embodiment of a method of using such a device to treat the LAA.

[0183] Figures 106A - 106D Illustrates Figures 105A - 105E A side view of an embodiment of the implant device and method of using such a device shown in

[0184] Figures 107A - 107G Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0185] Figures 108A - 108C Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0186] Figures 109A - 109C Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0187] Figures 110A - 110E Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0188] Figure 111 Illustrates another embodiment of a device for treating the LAA.

[0189] Figure 112 Illustrates another embodiment of a device for treating the LAA.

[0190] Figures 113A - 113C Illustrates an embodiment of a device for treating the LAA.

[0191] Figures 114A to 114C Illustrates an embodiment of a device for treating the LAA.

[0192] Figures 115A - 115C Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0193] Figures 116A - 116C Illustrates an embodiment of a device for treating the LAA.

[0194] Figures 117A - 117C Illustrates an embodiment of a device for treating the LAA.

[0195] Figures 118A - 118D Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0196] Figures 119A - 119D Illustrates another embodiment of a device and an embodiment of a method of using such a device to treat the LAA.

[0197] Figures 120A - 120C Illustrates an embodiment of a device for treating the LAA.

[0198] Figures 121A - 121C Shows an embodiment of an apparatus for treating the LAA.

[0199] Figure 122 Shows another embodiment of an apparatus for treating the LAA from a downward viewing perspective.

[0200] Figure 123 Shows from a side viewing angle Figure 122 an embodiment of the apparatus.

[0201] Figure 124 Shows Figure 122 a side view of an embodiment of the apparatus, showing the apparatus relative to the orifice of the LAA.

[0202] Figure 125 Shows a top view of another embodiment of an apparatus for treating the LAA.

[0203] Figure 126 Shows the total cross-sectional area of some embodiments of the apparatus disclosed herein relative to a conventional apparatus for treating the LAA.

[0204] Figure 127 Shows another embodiment of an apparatus for treating the LAA.

[0205] Figure 128 Shows another embodiment of an apparatus for treating the LAA.

[0206] Figure 129 Shows a side view of another embodiment of an apparatus for treating the LAA, showing the apparatus in an extended state.

[0207] Figure 130 Shows Figure 129 a side view of an embodiment of the apparatus shown in, showing the apparatus in a contracted state.

[0208] Figure 131 Shows Figure 129 an end view of an embodiment of the apparatus shown in, showing the apparatus in an extended state.

[0209] Figure 132 Shows Figure 129 an end view of an embodiment of the apparatus shown in, showing the apparatus in a contracted state.

[0210] Figure 133 Shows a side view of another embodiment of an apparatus for treating the LAA, showing the apparatus in an extended state.

[0211] Figure 134 Shows Figure 133Side view of an embodiment of the device shown, showing the device in a contracted state.

[0212] Figure 135 Showing Figure 133 End view of an embodiment of the device shown, showing the device in an extended state.

[0213] Figure 136 Showing Figure 133 End view of an embodiment of the device shown, showing the device in a contracted state.

[0214] Figures 137A - 137D Showing an embodiment of a device for treating the LAA.

[0215] Figures 138A - 138C Showing for implantation Figures 137A - 137D An embodiment of a method of an embodiment of the device shown.

[0216] Figures 139A - 139E Showing another embodiment of a device and an embodiment of a method of using such a device for treating the LAA.

[0217] Figures 140A - 140G Showing additional embodiments of a device for treating the LAA.

[0218] Figures 141A - 141H Showing additional embodiments of a device for treating the LAA.

[0219] Figures 142A - 142F Showing additional embodiments of a device and a method of using such a device for treating the LAA.

[0220] Figures 143A - 143E Showing another embodiment of a device and a method of using such a device for treating the LAA.

[0221] Figures 144A - 144F Showing another embodiment of a device and a method of using such a device for treating the LAA.

[0222] Figures 145A - 145D Showing another embodiment of a device and a method of using such a device for treating the LAA.

[0223] Figures 146A - 146C Showing an embodiment of a device for treating the LAA.

[0224] Figures 147A - 147B Showing the use of Figures 146A - 146C An embodiment of a method of a device.

[0225] Figures 148A - 148B Showing another embodiment of a device and a method of using such a device for treating the LAA.

[0226] Figures 149A - 149BAnother embodiment showing a device and a method of using such a device for treating the LAA.

[0227] Figures 150A - 150C Another embodiment showing a device and a method of using such a device for treating the LAA.

[0228] Figures 151A - 151B An embodiment showing a portion of a delivery device that can be used with some embodiments of the implant devices disclosed herein.

[0229] Figures 152A - 152C An embodiment showing a delivery device having a steering mechanism, an implant device, and a method of using such devices.

[0230] Figures 153A - 153B An embodiment showing a delivery device having a steering mechanism, an implant device, and a method of using such devices.

[0231] Figures 154A - 154B An embodiment showing a delivery device having a steering mechanism, an implant device, and a method of using such devices.

[0232] Figures 155A - 155B An embodiment showing a delivery device having a steering mechanism, an implant device, and a method of using such devices.

[0233] Figures 156A - 156D An embodiment showing an implant device having a sealing element for treating the LAA.

[0234] Figures 157A - 157C An embodiment showing an implant device having a cover element for treating the LAA.

[0235] Figures 158A - 158C Another embodiment showing a device and a method of using such a device for treating the LAA.

[0236] Figures 159A - 159B Another embodiment showing a device and a method of using such a device for treating the LAA.

[0237] Figures 160A - 160D Another embodiment showing a device and a method of using such a device for treating the LAA.

[0238] Figures 161A - 161C An embodiment showing a device for treating the LAA.

[0239] Figures 162A - 162C An embodiment showing a device for treating the LAA.

[0240] Figures 163A - 163D Another embodiment showing a device and a method of using such a device for treating the LAA.

[0241] Figures 164A - 164C Another embodiment showing a device and a method of using such a device for treating the LAA.

[0242] Figures 165A - 165C An embodiment showing a device for treating the LAA.

[0243] Figures 166A - 166C An embodiment showing a device for treating the LAA.

[0244] Figures 167A - 167D Another embodiment showing a device and a method of using such a device for treating the LAA.

[0245] Figures 168 - 170 An embodiment showing a processing system and an embodiment of a method for treating the LAA.

[0246] Figures 171A - 171D An embodiment showing a processing system and an embodiment of a method of using such a device for treating the LAA.

[0247] Figures 172A - 172C An embodiment showing a processing system and an embodiment of a method of using such a device for treating the LAA.

[0248] Figures 173A - 173D An additional embodiment showing a tissue anchor that can be used with any implant device or system disclosed herein.

[0249] Figure 174 An embodiment showing a device for treating the LAA.

[0250] Figures 175A - 175D An additional embodiment showing an implant device for treating the LAA.

[0251] Figures 176A - 176D An embodiment showing a processing system and an embodiment of a method of using such a device for treating the LAA.

[0252] Figure 177 The left atrium is shown.

[0253] Figures 178A - 178B An embodiment showing a processing system and an embodiment of a method of using such a device for treating the LAA.

[0254] Figures 179A - 179B An embodiment showing a processing system and an embodiment of a method of using such a device for treating the LAA.

[0255] Figures 180A - 180D An embodiment showing a device for treating the LAA.

[0256] Figures 181A - 181D An embodiment showing a device for treating the LAA.

[0257] Figures 182A - 182FEmbodiments of a processing system and a method of using such a device to process the LAA are shown.

[0258] Figures 183A - 183E Embodiments of a processing system and a method of using such a device to process the LAA are shown.

[0259] Figure 184 Is a front view of a heart showing the right ventricle, left ventricle, and LAA.

[0260] Figure 185 The heart is shown within the pericardial space beneath the patient's rib cage.

[0261] Figures 186A - 186F Embodiments of a processing system and a method of using such a device to process the LAA are shown.

[0262] Figures 187A - 187E Embodiments of a processing system and a method of using such a device to process the LAA are shown.

[0263] Figures 188A - 188E Embodiments of a processing system and a method of using such a device to process the LAA are shown. Detailed Description

[0264] Novel devices, systems, and methods for occluding or closing the LAA are described herein. Some embodiments include a method comprising: advancing a delivery system into the LAA; advancing and deploying an expandable element (which may be covered with barbs, texture, or other tissue-engaging features in some embodiments or alternatively may be smooth) into the left atrial appendage, and the expandable element may have a generally spherical or ball shape, thereby allowing the expandable element to engage the inner wall surface of the LAA distally and / or radially; applying rotation to an inner catheter component connected to the expandable element to twist the LAA to occlude and / or close the LAA at or near the orifice. By closing the LAA, some embodiments disclosed herein can effectively eliminate or significantly or almost completely eliminate the communication of blood or other substances between the left atrium and the LAA. Any deployment method disclosed herein may also include the deployment of a fixation element (also referred to herein as a locking element or an anchoring element), which is configured to inhibit or prevent the unwinding of the expandable element relative to the LAA and the LA opening tissue, thereby inhibiting or preventing the unwinding of the LAA.

[0265] The devices, systems, and methods disclosed herein can be used or adapted for other applications within or on the surface of the body of any human, animal, reptile, or other living organism. Other applications include but are not limited to occluding openings in tissues other than the LAA, closing or occluding openings, passages, and / or chambers within the heart or other organs, closing or occluding holes or other slits or openings in blood vessels and passages, and / or treating other conditions.

[0266] The clinical benefit of some embodiments is that the resulting implant, except for possible portions of the fixation features, does not make direct blood contact with the left atrial blood or blood flow. The fixation elements of any embodiment can be configured to limit the exposure of the fixation elements in the blood within the left atrium (i.e., limit the amount of the fixation element protruding into the left atrium). In some embodiments, the entire implant can be surrounded by tissue in the LAA tissue such that no or only a minimal portion (e.g., less than 10% of the surface area, or less than 40% of the surface area) of any part of the implant is exposed to the blood flow within the left atrium. This can have clinical benefits for the patient because a post-medication regimen is required. Any device used in any of the methods described herein can be advanced under any of a variety of visualization techniques such as fluoroscopic visualization, ultrasound, etc.

[0267] The implant of any embodiment disclosed herein can have a deployable atraumatic shape, where tissue-gripping features are located on the outer edge of the shape, coupled to fixation and / or ratchet features that can hold the initial or final closed position of the implant. The implant of any embodiment disclosed herein can be configured to also grip the internal tissue of the LAA with a radial force. In some embodiments, a vacuum or suction can be provided by a catheter or any of its components to pull the tissue portion of the LAA or atrium towards the implant. The implant of any embodiment disclosed herein can have an atraumatic shape, which can be spherical, dome-shaped, or include a coil of a disc shape, can have a deployed cut pattern of a stent shape, or can have any other form with rounded edges. In some embodiments, barbs (which can be tissue anchors) on the outer edge or surface of the implant can include metal hooks that grip the inner surface of the LAA, plastic anti-slip spikes, a rough texture of some material or surface feature, a coating, or an activated adhesive. Additionally, in any embodiment disclosed herein, tissue anchors can be positioned on or near the end portion of the implant to engage the end portion of the LAA. In any embodiment, the barbs can be directed such that tissue can engage in one rotational direction and disengage in the opposite rotational direction for possible repositioning, sizing, or removal from the LAA.

[0268] For any of the embodiments disclosed herein, the rotation for twisting and occluding (fully or substantially) the LAA can be as little as a quarter turn (i.e., revolution), a half turn, a full turn, up to multiple turns for deeper or longer LAAs. The fixation features or elements (also referred to herein as anchoring elements) in any of the embodiments disclosed herein can have a single arm or multiple arms, and the arms can be connected to an implant body that is positioned and rotated within the occluded or substantially occluded LAA. The fixation features or elements can also be configured to engage tissue adjacent to the orifice of the LAA. In any embodiment, the fixation element can have multiple arms or components, can have an annular ring, can have a disk, or any other suitable shaped surface anchor configured to couple untwisted tissue to the twisted implant. In some embodiments, the fixation element can also have a small diameter ring that can be configured to grip or engage tissue (adjacent to the orifice of the LAA) that contacts the central hub of the implant, or can also have a clamp that folds and clamps the implant against the side of the left atrial (LA) wall.

[0269] In some embodiments disclosed herein, the device can be configured to limit the opening of the LAA (including the occlusive effect from the device) by reducing the cross-sectional area of the opening of the LAA by at least 95%, or by at least 90%, or by at least about 80% to about 100% compared to the cross-sectional area of the opening of the LAA prior to device implantation. Additionally, 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 orifice of the LAA is occluded and / or limited by at least 95%, or by at least 90%, or by at least 80%, or by at least about 70% to being occluded and / or limited by about 100%. Further, any of the embodiments disclosed herein can include implanting two or more implants from any of the implant embodiments disclosed herein into the LAA. By way of example and not limitation, any of the implant embodiments disclosed herein can be configured to be deployed or implanted into the LAA to improve the occlusion of an implant already implanted in the LAA, where the implant already implanted in the LAA includes any implant that meets any of the foregoing ranges that do not achieve complete occlusion. In some embodiments, one or more additional implants or devices can be implanted adjacent to, overlapping, around, or otherwise with an existing implant to improve the degree of occlusion of the LAA.

[0270] Alternatively, in any of the embodiments disclosed herein, the fixation element may be configured such that, after the contact member has been rotated to the second rotational position, only the tissue that has contracted around the outer surface of the body portion of the implant between the distal surface of the fixation element and the contact member of the left atrium and / or left atrial appendage is compressed, but not penetrated into such tissue, to prevent rotation of the implant in the second direction. By way of example and not limitation, in any of the embodiments disclosed herein, the fixation element may have a smooth non-protrusive or non-penetrating body portion, such that, for example, no tissue-penetrating features extend towards the tissue surface on the fixation element. In other embodiments, the arm (or at least the portion of the arm that extends in the axial direction when the fixation element is in the second state) or other tissue-penetrating portion of the fixation element may be shorter, such as a length of about 1 mm to about 5 mm, or a length of about 1 mm to about 3 mm, or a length of about 1 mm to about 2 mm, or any value or range of values between any of the foregoing ranges.

[0271] Figure 1A and 1B A cross-sectional view of the left atrium is shown, showing a guide wire G advanced from a catheter C towards the left atrial appendage LAA. Figure 2A An embodiment of a closure system 100 for closing or occluding an opening of the LAA is shown. In any of the embodiments disclosed herein, the closure system (including embodiments of the closure system 100) may be configured to rotate and twist the LAA such that the neck or a portion of the LAA adjacent to the LAA opening contracts and substantially or completely occludes around the outer surface of a portion of the implant device, thereby closing the opening of the LAA. In any of the embodiments of the closure system, including embodiments of the closure system 100, the system may have an implant device 102 having a contact member 104 (also referred to herein as a contact element or a deployable implant component), a fixation element or fixation element 110 (also referred to as a fixation component), and a retention member 108. The implant device 102 may be configured to be advanced into the LAA through a catheter 112. Figure 2A The embodiment of the implant device 102 shown in is shown in a collapsed state and is constrained within the outer sleeve 114 of the catheter 112. As shown, by advancing a portion or component of the catheter 112, such as but not limited to the core component 113 of the catheter 112, the implant device 102 may be advanced distally past the distal end 114a of the outer sleeve 114 outside of the catheter such that the contact member 104 of the implant device 102 may be advanced into and / or deployed within the LAA.

[0272] Alternatively, a catheter 112 having an implant device 102 therein may be advanced to a desired position within the LAA, and the outer sleeve 114 of the catheter 112 may be retracted or withdrawn while maintaining the core member 113 of the catheter 112 in a fixed axial position to hold the implant device 102 in a fixed axial position, thereby exposing and / or unconstraining the contact member 104 of the implant device 102. In any of the embodiments disclosed herein, the contact member 104 may self-expand in the radial direction such that when the constraint is removed from the contact member 104, the contact member 104 may automatically expand against the inner surface or wall of the LAA. In other embodiments, the contact member 104 may be expanded mechanically, for example, by a balloon expander, to expand against the inner surface or wall of the LAA. Figure 2B Shows contact number 104 after deployment against the inner wall of the LAA distal to the orifice or opening O of the LAA.

[0273] Alternatively, in any of the embodiments disclosed herein, the contact member may be configured to remain in a first state within the catheter during and / or after the entire procedure. By way of example and not limitation, in any of the embodiments disclosed herein, the contact member may be configured such that the contact member is deployed from the catheter and advanced to contact the tissue surface of the inner wall of the LAA, engage the tissue surface of the inner wall of the LAA, and twist the LAA when torque and / or rotation is applied to the contact member, all without changing the state of the contact member. Alternatively, in any of the embodiments disclosed herein, the contact member may be configured to be advanced into the pericardial space surrounding the outside of the LAA to engage the outer surface of the LAA and twist the LAA when torque and / or rotation is applied to the contact member.

[0274] In any of the embodiments disclosed herein that include Figure 2B the embodiment shown therein, the contact member 104 may have a plurality of arms or support rods 116, each of the plurality of arms or support rods being configured to self-expand in the radial direction when the restraint has been removed from the outer surface of the contact member 104. By way of example and not limitation, any of the embodiments of the contact member disclosed herein may have six support rods 116, or six to ten support rods, or less than six support rods to more than ten support rods.

[0275] In addition, in any embodiment, the contact member 104 may have a plurality of teeth, spikes, barbs, knobs, textures, studs, anchors, or other tissue engagement features 118 configured to penetrate into the tissue within the LAA when the contact member 104 is deployed against the tissue of the LAA and / or when the contact member 104 rotates or twists within the LAA, or other similar features configured to penetrate or engage the tissue of the LAA. Note that teeth, spikes, barbs, knobs, textures, studs, anchors, and other tissue engagement features or features configured to grip or engage tissue when torque is applied to the deployed contact member will be collectively referred to herein as tissue anchors, and the use of this term is intended to individually describe and encompass any of the foregoing features and / or describe and encompass any combination of these features.

[0276] The tissue anchors 118 may be integrally formed with, formed on, added to, or otherwise coupled to or supported by the support struts. The tissue anchors 118 may be circumferentially oriented (radially oriented as shown) so as to penetrate or engage the 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 otherwise. In some embodiments, each support strut 116 may support a plurality of tapered tissue anchors oriented in the circumferential direction, as Figure 2B shown. All of the tissue anchors may be oriented in a similar orientation relative to each support strut, such as in the circumferential direction relative to each support strut. In the illustrated embodiment, each support strut 104 has five tissue anchors 118. In this embodiment, when the contact member 104 rotates in a first direction (indicated by the arrow A1 in Figure 2C , which may be clockwise or counterclockwise), one or more or all of the support struts 116 and one or more or all of the tissue anchors 118 may engage the tissue of the LAA and cause the LAA to twist or rotate in the first direction A1. The twisting or rotation of the LAA from a first rotational position to a second rotational position in the first direction causes the opening or orifice O of the LAA to contract in the radial direction (represented or identified by the arrow A2 in Figure 2C ), such that the opening O of the LAA moves or contracts around the outer surface of the proximal portion 104a of the contact member 104. The operator may twist or rotate the contact member 104 by twisting or rotating the core member 113 of the catheter 112. The tightening or contraction of the opening O of the LAA around the outer surface of the proximal portion 104a of the contact member 104 or other portion of the implant device may cause the internal portion of the LAA to be closed or substantially closed or substantially isolated from the remainder of the chambers within the heart, thereby significantly reducing the health risks associated with an open LAA.

[0277] In some embodiments, such as the illustrated embodiment, the fixation element 110 may be constrained by the outer sleeve 114 of the catheter 112, for example, when the contact member 104 is deployed and rotated, to maintain it in a collapsed or first state to prevent the fixation element 110 from contacting tissue within the heart and potentially tearing or otherwise damaging such tissue. The 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 portion 110a of the fixation element in a fixed axial position while applying a distally-directed force to the contact member 104 to maintain the holding member in a first extended state. In any implant device embodiment disclosed herein, the fixation element (e.g., but not limited to, including the fixation element 110) may be keyed, indexed, or otherwise rotationally fixed to the contact member (e.g., but not limited to, including 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 may prevent or substantially prevent or inhibit the contact member and the LAA from rotating back towards the first rotational position.

[0278] Reference Figure 2D , where the contact member 104 has been 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 closed relative to the remainder of the heart chamber, the catheter member 115 may be advanced in the distal direction (represented by the arrow A3 shown in Figure 2D ), or the outer sleeve 114 may be retracted in the proximal direction such that the fixation element 110 may be exposed and allowed to self-expand from the first collapsed state (as shown in Figure 2C ) to a second expanded or open state (as shown in Figure 2D ). In the second state, the plurality of support bars or members 120 of the fixation element 110 may expand in a generally radial direction to open to a larger overall diameter or profile. Additionally, since each of one or more members 120 of the fixation element 110 may have an end portion 120a that extends in a generally distal axial direction (but may be slightly inwardly angled), when the fixation element 110 is advanced in the axial direction, the distal portion 120a of each of the one or more members 120 may penetrate into and / or engage with a tissue portion of the heart, as shown in Figure 2E. The portion of tissue that the one or more members 120 may penetrate or engage may include a portion of tissue that includes the left atrium and / or a portion of tissue that includes the LAA. As mentioned above, the contact member 104 may be maintained in a substantially fixed axial position using the core member 113 as the fixation element 110 is advanced distally toward the contact member 104. The retaining member 108 may then be unconstrained so that it can maintain the fixation element 110 in a second position in which the fixation element 110 engages cardiac tissue, such as Figure 2E In some embodiments, the fixing element may be biased toward a smaller size in the axial direction, for example, by a spring member or the like. For example, the retaining member 108 may be formed by laser cutting an opening in a cylindrical tube, such as a hypotube, made of an elastic material such as Nitinol. Figure 2F , the implant device 102 can be detached from the catheter 112, and the catheter 112 can be retracted and removed from the patient's body. Figure 2F As shown, when the fixation element 110 is engaged with the patient's tissue, the LAA is prevented from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fix and maintain the LAA in a substantially or completely closed or substantially or completely occluded state.

[0279] Thereafter, the retaining member 108 may be unconstrained (eg, loosened) so that it may be retracted to maintain the fixation element 110 in a second position in which the fixation element 110 engages the heart tissue, such as Figure 2E In some embodiments, the fixed retaining member 108 may be biased in the axial direction toward a smaller length or size, for example, by a spring member or the like. For example, the retaining member 108 may be formed by laser cutting an opening in a cylindrical tube, such as a hypotube, made of an elastic material such as Nitinol.

[0280] Afterwards, refer to Figure 2F , the implant device 102 can be detached from the catheter 112, and the catheter 112 can be retracted and removed from the patient's body. Figure 2F As shown in , when the fixation element 110 engages with the patient's tissue, the LAA is prevented or at least inhibited or biased from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fix and maintain the LAA in a substantially or completely closed or substantially or completely occluded state.

[0281] Any component of any implant embodiment disclosed herein may be made of nitinol or any other elastic or superelastic material, including any other shape memory material, or any mechanically deployable material such as stainless steel or others. In any embodiment disclosed herein, the contact member (e.g., contact member 104) may have a spherical, cylindrical, or other shape, such as the shape of an elongated bullet, a stent, a mushroom, or any other non-circular or non-cylindrical shape or any shape described or shown with respect to any embodiment disclosed herein. In any embodiment disclosed herein, the contact member may include a series of interconnected support struts (which may or may not form a diamond pattern on all or part of the surface of the contact member), or may be made of a series of fins or paddles forming a deployable device.

[0282] Reference Figure 3 , the fixation element of any device embodiment disclosed herein, including but not limited to fixation element 110, may have an outer size (e.g., the outer diameter of the arm 144 of the fixation element) that is significantly smaller than the outer size (e.g., outer diameter) of the contact member 104. By way of example and not limitation, the fixation element of any device embodiment disclosed herein may have an outer size that is about one-half of the outer size of the contact member 104, or about 30% to about 80% of the outer size of the contact member 104, or about 50% to about 60% of the outer size of the contact member 104. In any embodiment, the outer size of the fixation element may be similar to, substantially the same as, or even larger than the outer size of the contact member 104.

[0283] Also as Figure 3 shown, any embodiment of the implant device 102 disclosed herein may also have a cover member 121, which may provide an additional seal or barrier around the outer surface of the contact member 104 and / or other parts of the implant device 102 to provide an additional barrier to the implant device 102. In some embodiments, the cover may be located or positioned on or against the inner surface or part of the contact member of the implant. This may improve the seal or enclosure created by the implant device 102 in the LAA. In some embodiments, the cover member 121 may substantially or completely cover all of the contact members of the implant device 102.

[0284] Reference will now be made to Figures 4 - 7 describe more details regarding the implant system 100. Figure 4The contact member 104 is shown in a second deployed state, the retention member 108 (also referred to herein as a biasing member) is shown in a first extended state, and the fixation element 110 is shown in a second open state. In any of the embodiments disclosed herein, the retention member can be an axially spring-like member or other axially elastic member. In some embodiments, the contact member 104 can have a continuous and unbroken outer periphery at a proximal end 104a from which each support rod member 116 extends distally therefrom. Each support rod member 116 can be preformed into a curved shape such that when no external restraint or limitation is applied to the outer surface of the contact member 104 (e.g., when in a relaxed state), the support rod member 116 is biased to deploy to the second state. At the distal end, each support rod member 116 can but need not be coupled to the hub member 122. Refer to Figures 5 - 6 , the hub member 122 can have a plurality of sockets 123 configured to receive and limit a distal portion 116b of each support rod member 116. Additionally, each socket 123 can be configured to permit rotation of the distal portion 116b of each support rod member 116 relative to the hub member 122 such that when the contact member 104 is in the second deployed state, the distal portion 116b of the support rod member 116 can extend generally radially away from the hub member 123. The hub member 123 can be configured to permit rotation of the distal portion 116b of each support rod member 116 relative to the hub member 122 without resistance or significant resistance. The distal end of each support rod member 116 can have a tab or other feature (e.g., a T-shaped termination or other increased width) 119 that locks into, is fixed by, or otherwise engages each socket 123 to axially limit the end portion of each support rod member 116 while permitting rotation about the end portion.

[0285] In some embodiments, as in the embodiment shown in Figure 4 , the retention member 108 and the fixation element 110 can be integrally formed. By way of example and not limitation, the retention member 108 and the fixation element can be laser cut from a section of tubing material such as an elastic or shape memory material and then formed into the desired shape using conventional or suitable processes. In other embodiments, the fixation element 110 can 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 acts thereon), some embodiments of the retention member 108 can be biased to move to a second or collapsed state, such as shown in Figure 2E , 6 and 7, etc. Additionally, in a relaxed state, the retention member 110 can be in a second or open position, also as shown in Figure 2E . Additionally, refer to Figure 5 , this figure is a cross-section through Figure 4An enlarged cross-sectional view of line 5-5, the pin or transverse member 124 can be coupled to the distal end 108b of the retaining member 108, and can be configured to fit within a slot 126 formed within the distal end 113b of the core member 113. In this embodiment, the core member 113 can be advanced in the distal direction, thereby causing the contact member 104 to be advanced in the distal direction. Additionally, the core tube 128 can extend proximally from the distal end 113b of the core member 113 and be coupled to the proximal end 104a of the contact member 104. The pin 124 can extend through a pair of openings formed in the core tube 128 to secure the core tube 128 to the pin 124, and thus to the distal end 108b of the retaining member 108. Accordingly, the core tube 128 can be used to couple the contact member 104 to the retaining member 108. A pin, tab, suture, tether, protrusion, clip, recess, pawl, or other feature can be used to couple the proximal end 104a of the contact member 104 to the proximal end of the core tube 128. Note that for clarity, the core tube 128 has been omitted from some of the figures.

[0286] Additionally, in any embodiment, the system 100 can be configured such that the implant device 102 is biased or selectively fixed relative to the core member 113 in the proximal direction. By way of example and not limitation, as Figure 5 shown, some embodiments of the implant device 102 can have a suture or thread 130 that extends through the interior of the core member 113 (e.g., through the lumen of the core member 113) and surrounds the pin 124, thereby permitting the user to retract or withdraw the suture to pull the implant device 102 proximally relative to the core member 113. In this configuration, the two ends of the suture 130 can extend from the proximal end of the device 100 such that the practitioner can grasp the two ends of the suture 130 to apply a biasing force around the pin 124 to maintain the pin against the proximal end of the slot 126 formed within 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 practitioner can simply release one end of the suture and withdraw the other end of the suture until the suture no longer forms a loop and / or no longer wraps around the pin 124. After removing the biasing force or holding force from the suture 130 and / or the proximally directed force from the contact member, the core member 124 can be withdrawn relative to the implant device 102 while the contact member remains fixed within the LAA. This can be done after the contact member and the fixation element have been fully deployed or implanted into the LAA and / or the tissue adjacent to the LAA.

[0287] Furthermore, in any embodiment disclosed herein, the pin or transverse member 124 can be configured to permit a guide wire to pass through the distal portion of the implant device 102 without obstruction. By way of example and not limitation, an opening larger than the outer diameter of the guide wire can be formed in the pin 124 to permit the guide wire to pass therethrough, or the pin 124 can be formed in two parts with a space therebetween that is large enough.

[0288] ReferenceFigures 8A - 8C In any embodiment, the contact member 104 of the implant device 102 can be advanced to a desired distal location within the LAA by the surgeon, or to an appropriate location. By way of example and not limitation, as Figures 8A - 8C shown, the contact member 104 can be advanced to contact, be adjacent to, or be proximate to the distal end of the LAA prior to rotation of the contact member 104. This will permit more of the implant to be positioned within the LAA and, in some embodiments, will permit more of the LAA tissue to contract around the body portion or other portion of the implant device 102. In some embodiments, this can permit the user to rotate the contact member 104 of the implant device 102 to a greater extent and can also create less stress on the tissue of the LAA. Any implant device embodiment disclosed herein can be configured to be advanced within the LAA to any extent prior to rotation of the contact member 104, including being advanced only through the orifice of the LAA, being advanced to an intermediate portion of the LAA, or being further advanced into the LAA to contact, be adjacent to, or be proximate to the distal end of the LAA.

[0289] Figures 9A - 9I Another embodiment of a treatment system 140 for occluding or closing the LAA is shown. In any embodiment disclosed herein, any component, feature, or other detail of the treatment system 140 or the implant device 142 can have any combination of any component, feature, or other detail of any other treatment system embodiment or implant device embodiment disclosed herein with any component, feature, or other detail of the treatment system 140 or the implant device 142 disclosed below, the embodiments including but not limited to any embodiment of the treatment system 100 or the implant device 102 described above. Similarly, any component, feature, or other detail of any other treatment system embodiment or implant device embodiment disclosed herein can have any combination of any component, feature, or other detail of the treatment system 140 or the implant device 142 disclosed herein with any component, feature, or other detail of any embodiment of the treatment system 140 or the implant device 142.

[0290] In any embodiment of the occlusion system 140, including embodiments that include the 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 a deployable implant component), some fixation element or fixation elements 150 (also referred to as fixation components), and a retention member 148. Figure 9AShows contact member 144 and fixation element 150 both in a first contracted or constrained state within outer sleeve 154 of catheter 152. The implant device 142 can be advanced distally past the distal end 154a of outer sleeve 154 of catheter 152 and out of catheter 152 by advancing core member 153 of catheter 152, such that contact member 144 of implant device 142 can be deployed within the LAA at any desired depth within the LAA, including near the distal end of the LAA, the middle portion of the LAA, or, by way of example and not limitation, also by maintaining core member 153 of catheter 152 in a fixed axial position and retracting outer sleeve 154 of catheter 152 to hold implant device 142 in a fixed axial position. In any of the embodiments disclosed herein, contact member 144 can expand radially on its own such that when the constraint is removed from contact member 144, contact member 144 can automatically expand against the inner surface or wall of the LAA. In other embodiments, contact member 144 can be expanded mechanically, for example by a balloon expander, to expand against the inner surface or wall of the LAA.

[0291] In any embodiment, contact member 144 can have a plurality of arms or support struts 156, each of the plurality of arms or support struts being configured to expand radially on its own when the constraint has been removed from the outer surface of contact member 144. By way of example and not limitation, any embodiment of the contact member disclosed herein can have six support struts 156, or six to ten support struts, or less than six support struts to more than ten support struts. Additionally, in any embodiment, contact member 144 can have a plurality of tissue anchors 158 or other similar features configured to penetrate or engage the LAA tissue, which are configured to penetrate into the tissue within the LAA when contact member 144 expands against the tissue of the LAA and / or when contact member 144 rotates or twists within the LAA.

[0292] In this configuration, when contact member 144 rotates in a first direction (indicated by arrow A6 in Figure 9C which can be in a clockwise or counterclockwise direction), one or more or all of the support struts 156 and one or more or all of the tissue anchors 158 can engage the tissue of the LAA and cause the LAA to twist or rotate in the first direction A6. The twisting or rotation of the LAA from a first rotational position to a second rotational position in the first direction will cause the opening or orifice O of the LAA to move in the radial direction (in Figure 9Ccontracts on the arrow A7 (represented or identified by the arrow A7), thereby causing the opening O of the LAA to move or contract around the outer surface of the proximal portion 144a of the contact member 144. The operator can twist or rotate the contact member 144 by twisting or rotating the core member 153 of the catheter 152. The tightening or contraction of the opening O of the LAA around the outer surface of the proximal portion 144a of the contact member 144 or other parts of the implant device can cause the internal portion of the LAA to be closed or substantially closed or substantially isolated from the remaining chambers within the heart, thereby significantly reducing the health risks associated with the open LAA. In any of the embodiments disclosed herein, the implant 142 can be configured to be removed after applying the fixation element to the tissue that has been contracted by twisting the contact member, such that the only part of the implant device 142 remaining in the LAA or the heart is the fixation element 150.

[0293] The retaining member 148 can be used to couple the fixation element 150 to the contact member 144 and also allows a user (e.g., a surgeon) to move the fixation element 150 towards and away from the contact member 144. In any embodiment, the retaining member 148 can have helical threads on its outer surface. In any embodiment, the retaining member 148 can include a threaded shaft. In this configuration, the retaining member 148 can be rotated in a first direction to advance the fixation element 150 towards the contact member 144 and in a second, opposite direction to move the fixation element 150 away from the contact member 144. The retaining member 148 can be configured to engage the fixation element 150 such that when the retaining member 148 is rotated, the fixation element 150 moves in the axial direction corresponding to the rotation of the retaining member 148. By way of example and not limitation, the retaining member 148 can have an annular recess 149 near its proximal end 148a, which is configured to engage or couple with a tab or protrusion 151 of the fixation element 150. In some embodiments, the protrusion 151 can extend into the annular recess 149, thereby axially locking or engaging the fixation element 150 with the retaining member 148. The interaction of the protrusion 151 with the annular recess 149 - where the walls of the annular recess contact and push 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, both of which engage the annular recess 149. The contact member 144 can have a threaded neck portion 145 that threadedly engages the threads of the retaining member 148 such that the retaining member 148 screws into and out of the threaded neck portion 145. In this configuration, the retaining member 148 screws into and out of the contact member 144 to move the fixation element 150 relative to the contact member. As Figure 9HAs shown, the retaining member 148 is threaded almost completely into the contact member 144 and into the cavity or space 161 within the contact member 144 such that the fixing element 150 moves towards the contact member 144 to the extent that the fixing element 150 can approximately reach. When the retaining member 148 is rotated in the second direction, the retaining member 148 will move out of the space 161 within the contact member 144 and move the fixing element 150 away from the contact member 144.

[0294] Reference Figure 9H , the intermediate sleeve 155 can be advanced distally to contact and engage with the proximal portion 148a of the retaining member 148. The intermediate sleeve 155 can be configured such that when the intermediate sleeve 155 engages with the proximal portion 148a of the retaining member 148, the retaining member 148 can be rotated in the first or second direction by rotating the intermediate sleeve 155 in the first or second direction. In some embodiments, the intermediate sleeve 155 can move axially and rotate independently of other tubes or sleeves of the delivery catheter 152. By way of example, but not limitation, as Figure 9H shown, a protrusion or tab 159 on the distal portion 155b of the intermediate sleeve 155 can be selectively coupled to or advanced into a recess or depression 147 formed in the proximal portion 148a of the retaining member 148, and the recess or depression can selectively unite or couple the intermediate tube 155 with the retaining member 148.

[0295] In addition, in any embodiment, the retaining member 148 can be used to couple the implant 142 to the delivery catheter 152. By way of example, but not limitation, the core member 153 of the delivery catheter 152 can be coupled to the retaining member 148 via a threaded protrusion 165 at the distal end 153b of the core member 153, and the threaded protrusion engages in a threaded recess 167 formed in the proximal portion 148a of the retaining member 148 in a threaded manner. 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 with the distal end. In this configuration, the implant 142 can be removed from the catheter by disengaging the threaded protrusion 165 from the retaining member 148. This can be performed as follows: when the core member 153 is rotated in the second direction, the intermediate tube 155 is used to prevent the retaining member 148 from rotating, thereby withdrawing the threaded protrusion 165 from the recess 167 of the retaining member 148.

[0296] In addition, the second intermediate tube or sleeve 157 can be advanced distally to contact and engage the proximal portion 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 portion 150a of the fixation element 150, the fixation element 150 can be rotated in a first or second direction by rotating the second intermediate sleeve 157 in a first or 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. By way of example and not limitation, as Figure 9H shown, a protrusion or tab 169 on the distal portion 157b of the second intermediate sleeve 157 can selectively couple with a support bar or arm of the fixation element 150 such that the second intermediate sleeve 157 can be joined or coupled to the fixation element 150.

[0297] In addition, in some embodiments, the fixation element 150 can be joined or coupled to the contact member 144 such that the fixation element 150 and the contact member 144 rotate dependently and simultaneously. For example, in some embodiments, the fixation element 150 can have a body portion 170 having one or more tabs or protrusions 172 configured to extend into channels or recesses 173 formed in a body portion 175 of the contact member 144. One or more channels 173 can be formed in an axial orientation such that the protrusions 172 of the fixation element 150 and the fixation element 150 can move freely relative to the contact member 144 in the axial direction. However, the narrow width of the channels 173 relative to the protrusions 172 can prevent the protrusions 172 and thus the fixation element 150 from rotating relative to the contact member 144.

[0298] In this configuration, the second intermediate sleeve 155 can be coupled to the fixation element 150 and can be used to rotate the implant 142 at least in a first or second direction. By way of example and not limitation, the second intermediate sleeve 155 can be rotated to rotate the contact member 144 to twist the LAA to a desired rotational and / or torque level. Thereafter, the second intermediate sleeve 155 can be used to maintain the desired rotational position of the contact member 144 by maintaining contact between the second intermediate sleeve 155 and the fixation element 150 and maintaining the second intermediate sleeve 155 in a fixed rotational position, and thus holding the contact member 144 in a fixed rotational position while the holding member 148 rotates 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 LA / LAA that has contracted due to the twisting of the contact member 144), the implant 142 can be removed from the catheter 152 by disengaging the threaded protrusion 165 from the holding member 148 as described above, and the catheter can be removed from the LA. As Figure 9EAs shown, when the fixation element 150 is engaged with the patient's tissue, rotation of the LAA to a first rotational position, which is an untwisted or relaxed position, is prevented. In this configuration, the implant device 142 can fix and maintain the LAA in a substantially or fully closed or substantially or fully occluded state.

[0299] In addition, in any embodiment, the device can be configured such that after the fixation element 150 is sufficiently engaged with the tissue to hold the tissue in an occluded or closed state as shown, for example, Figures 11 - 12 the contact member 144 can be removed from the patient's LAA after the fixation element 177 and the fixation element 150 are the only components remaining in the body after a complete implantation procedure. In this configuration, the implant can have a plug or cap (such as a cap 178 coupled to the fixation member 177) that can cover the opening through which the contact member (such as the contact member 180 or the contact member 144) is withdrawn from the implant, or can otherwise be configured to plug or cover the opening through which the contact member 144 is withdrawn from the implant. By way of example and not limitation, in a configuration where the contact member 144 remains in the LAA after the fixation element 150 is implanted, a cap member such as the cap member 121 can be coupled to the fixation element 150 to substantially cover any opening in the implant, or can be coupled to the contact member 144 to cover the contact member 144 inside the LAA.

[0300] Additionally, in some embodiments, the contact member 144 may have a continuous and unbroken outer perimeter at the proximal end 144a from which each support strut member 156 extends distally away therefrom. Each support strut member 156 may be preformed in a curved shape such that when no external restraint or limitation is applied to the outer surface of the contact member 144 (e.g., when in a relaxed state), the support strut members 156 are biased to deploy to a second state. At the distal end, each support strut member 156 may or may not be coupled to the hub member 162. Similar to the hub member 122 described above, the hub member 162 may have a plurality of sockets (not shown) configured to receive and limit the distal portions 156b of each support strut member 156. Additionally, each socket 163 may be configured to permit rotation of the distal portion 156b of each support strut member 156 relative to the hub member 162 such that when the contact member 144 is in the second deployed state, the distal portions 156b of the support strut members 156 may extend generally radially away from the hub member 163. The hub member 163 may be configured to permit rotation of the distal portion 156b of each support strut member 156 relative to the hub member 162 without resistance or significant resistance. In any embodiment, the distal end of each support strut member 156 may have a tab or other feature (e.g., a T-shaped termination or other increased width) (not shown) that locks into, is fixed by, or otherwise engages each socket 163 to axially limit the end portion of each support strut member 156 while allowing rotation about the end portion.

[0301] Additionally, as described above, in any of the embodiments disclosed herein, the implant device may be configured such that the contact member may be removed from the patient's LAA after the fixation element engages tissue to hold the ostium of the LAA in a occluded state. For example, referring to Figure 10 , in any of the embodiments disclosed herein, the contact member may be an expandable balloon, such as the expandable balloon 184. The balloon may have a smooth outer surface or may have dimples, protrusions, a rough texture, tissue anchors, or otherwise engage the inner surface of the LAA. In some embodiments, the balloon may be a typical expandable balloon, such as those used in angioplasty procedures, and may be sized and configured for use in the LAA. In these configurations, after the LAA has been rotated and / or twisted to a desired degree and the fixation element has been implanted to maintain the opening of the LAA sufficiently occluded or constricted, the balloon may be deflated and removed from the LAA, leaving only the fixation element to maintain the LAA in a closed state, as shown in the non-limiting example of Figures 11 - 12 .

[0302] Figure 13Another embodiment of a treatment system 200 is shown with an implant device 202 wherein the contact member 204 of the implant device 202 is in a second, expanded state, the retention member 208 is in a second, retracted state, and the fixation element 210 is in a second, open state. Figure 14 It passes through Figure 13 The line 14-14 is intercepted Figure 13 , a cross-sectional view of an embodiment of a processing system 200 shown in . In any embodiments disclosed herein, any component, feature, or other detail of the processing system 200 or implant device 202 may have any component, feature, or other detail of any other processing system embodiment or implant device embodiment disclosed herein in any combination with any component, feature, or detail of the processing system 200 or implant device 202 disclosed below, including but not limited to any embodiment of the processing system 100 or implant device 102 described above. Similarly, any component, feature, or other detail of any other processing system embodiment or implant device embodiment disclosed herein may have any component, feature, or other detail of any embodiment of the processing system 200 or implant device 202 disclosed herein in any combination with any component, feature, or detail of the processing system and / or implant device.

[0303] refer to Figures 13 - 14 In some embodiments, the contact member 204 can have an annular proximal portion 204a, wherein all arms or support rods 230 (six shown) of the contact member 204 extend distally away from the proximal portion 204a. The support rods 230 can have any form of tissue anchor 232 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0304] In addition, in some embodiments, the contact member 204 may have an annular distal portion 204b, wherein all arms or support rods 230 may be coupled to the annular distal portion 204b. The contact member 204 may have a bulbous shape, a cylindrical shape with a curved distal portion, an elongated spherical shape, or other shapes. In some embodiments, the contact member 204 may be laser cut from a hypotube, or may be formed from different components and welded, brazed or otherwise coupled together. Each support rod component 230 may be prefabricated into a curved shape (which may have a spherical or bulbous shape), and is formed so that when no external constraints or restrictions are applied to the outer surface of the contact member 204, the support rod component 230 is biased to expand to the second state.

[0305] In some embodiments, such as the illustrated embodiments, the retention member 208 and the fixation element 210 may be integrally formed. By way of example and not limitation, the retention member 208 and the fixation element may be laser cut from a tube of material of an elastic or shape memory material such as nitinol and then formed into a 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 to a second or collapsed state, and the fixation element 210 may be in a second or open state.

[0306] Additionally, with reference Figure 14 , a pin or transverse member 268 may be coupled to the distal end 208b of the retention member 208 and may be configured to mate within a slot 270 formed within the distal end 218b of the core member 218. In this embodiment, the core member 218 may be advanced in the distal direction, thereby causing the contact member 204 to be advanced in the distal direction. Additionally, the core tube 274 may extend proximally from the distal end 218b of the core member 218 and be coupled to the proximal end 204a of the contact member 204. The pin 268 may extend through a pair of openings formed within the core tube 274 to secure the core tube 274 to the pin 268 and thus 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, tether, protrusion, clip, recess, pawl, or other feature may be used to couple the proximal end 204a of the contact member 204 to the proximal end of the core tube 274.

[0307] Additionally, in any embodiment, the system 200 may be configured such that the implant device 202 is biased in the proximal direction relative to the core member 218. By way of example and not limitation, as Figure 14 illustrated, some embodiments of the implant device 202 may have a suture or thread 280 that extends through the interior of the core member 218 (e.g., through the lumen of the core member 218) and loops around the pin 268, thereby permitting the user to retract or withdraw the suture to pull the implant device 202 proximally relative to the core member 218. In this configuration, the ends of the suture 280 may extend from the proximal end of the device 200 such that a practitioner may grasp the ends of the suture 280 to apply 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 practitioner may simply release one end of the suture and withdraw the other end of the suture until the suture no longer forms a loop or winds around the pin 268. After removing the biasing force from the suture 280, the core member 268 may be withdrawn relative to the implant device 202. This may be done after the contact member and its fixation element are fully deployed.

[0308] Figure 15Another embodiment of the implant device 302 is shown, wherein the contact member 304 is in a second expanded state, the retaining member 308 is in a second retracted 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 processing system 300 or the implant device 302 may have any component, feature, or other detail of any other processing system or implant device embodiment disclosed herein in any combination with any component, feature, or detail of the processing system 300 or the implant device 302 disclosed below, including but not limited to any embodiment of the processing system 100, 200 or the implant device 102, 202 described above. Similarly, any component, feature, or other detail of any other processing system embodiment or implant device embodiment disclosed herein may have any component, feature, or other detail of any embodiment of the processing system 300 or the implant device 302 disclosed herein in any combination with any component, feature, or detail of the processing system and / or implant device.

[0309] In any embodiments, the length of the retention member (including the retention member 308) and / or the distance between the fixation element and the contact member can be adjusted or changed to be different than shown and described, for example, to accommodate different anatomical sizes and characteristics of the LA and / or LAA or to accommodate different amounts or thicknesses of collapsed or torquing LAA tissue. For example, but not 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 collapsed state (e.g., in the second state), or can be approximately one-half the length of the contact member when the retention member is in the second state, or between one-quarter and one-half the length of the contact member when the retention member is in the second state, or otherwise.

[0310] In some embodiments, the contact member 304 may have an annular proximal portion 304a, wherein all arms or support rods 330 (six are shown) of the contact member 304 extend distally away from the proximal portion 304a. In addition, in some embodiments, the contact member 304 may have an annular distal portion 304b, wherein all arms or support rods 330 may be coupled to the annular distal portion 304b. In some embodiments, the contact member 304 may be laser cut from a hypotube, or may be formed from different components and welded, brazed or otherwise coupled together. Each support rod component 330 may be prefabricated into a curved shape (which may have a rounded shape or a bulbous shape), and is formed so that when no external constraints or restrictions are applied to the outer surface of the contact member 304, the support rod component 330 is biased to expand to the second state. The support rod 330 may have any form of tissue anchor 332 on the support rod or have any form of tissue anchor attached to the support rod, such as any one of the tissue anchors 118 described above.

[0311] In some embodiments, the contact member 304, the retaining member 308 and the fixing element 310 may be integrally formed, such as cut from a section of hypotube, or produced in other ways. For example, but not limited to, the retaining member 308 and the fixing element may be laser cut from a section of tubular material, such as an elastic or shape memory material, and then formed into a desired shape. In other embodiments, the contact member 304, the retaining member 308 and / or the fixing element 310 may be formed separately and welded, brazed or otherwise combined together to form a single integral component. Because in some embodiments, the distance between the contact member 304 and the fixing element 310 may be large, such as, but not limited to, greater than the length of the contact member when the contact member is in the second expanded state, the contact member 304 may be further advanced distally into the LAA and then rotated, thereby twisting the opening of the LAA so that the opening of the LAA shrinks around the outer surface of the retaining member. The larger length of the retaining member 310 can also accommodate a greater degree of twisting or rotation or a greater number of rotations or twists of the LAA before the fixing element engages.

[0312] An intermediate sleeve or tube (not shown) may be coupled to the fixation element 310 and may be used to manipulate and control the position and / or orientation of the fixation element 310, including maintaining the proximal portion 310a of the fixation element in a fixed axial position while applying a distally directed force to the contact member 304 to maintain the retaining member 310 in the first extended state. Additionally, a core member (not shown) may engage the distal portion 304b of the contact member 304b to allow a distally directed force to be applied to the contact member 304. Pins, tabs, sutures, ties, extensions, clips, recesses, detents, or other features may be used to selectively (i.e., reversibly) couple the contact member 304 to the core member.

[0313] After a reversal of the desired degree of LAA performance, the fixation element 310 can be moved to a second deployed state by, for example, advancing the fixation element 310 beyond the distal end of the delivery catheter and allowing the fixation element to deploy to a second state of the fixation element. Thereafter, while maintaining the contact member 304 in a desired axial and rotational position (e.g., a second rotational position), the fixation element 310 can be advanced into tissue that has been contracted around the outer surface of the implant, thereby fixing the tissue in a twisted and / or contracted state. In some embodiments, this can be accomplished or performed by simply holding the contact member in the 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. When deployment is complete, the user can disengage the core member from the contact member 304 such that the core member can be withdrawn. As in other embodiments, the implant device 304 can be selectively biased or fixed in the proximal direction relative to the delivery catheter, for example, by a suture or filament 380 that extends through the interior of the catheter and loops around a pin, tab, or other feature of the implant device, and released by disengaging or removing the suture or other retention means.

[0314] Figure 17 Another embodiment of the implant device 402 is shown, where the contact member 404 is in a second deployed state, the retention member 408 is in a second contracted state (or in at least a partially contracted or retracted state), and the fixation element 410 is in a second open state. Any embodiment of the processing system 400 or the implant device 402 can have any combination of any components, features, or details of any other processing system or implant device embodiment disclosed herein with any components, features, or other details of the processing system 400 or the implant device 402 disclosed herein, including but not limited to any embodiment of the processing systems 100, 200, 300 or the implant devices 102, 202, 302 described above. Similarly, any components, features, or other details of any other processing system or implant device embodiment disclosed herein can have any combination of any components, features, or details of any embodiment of the processing system 400 or the implant device 402 disclosed herein with any components, features, or other details of any other processing system or implant device embodiment disclosed herein.

[0315] The contact member 404 may have an annular proximal portion 404a and a distal portion 404b having a plurality of openings or loops 480. A support rod or link 430 of the contact member 404 may form a reticulated pattern, thereby forming a contact member having a curved, bulbous, elongated bulbous, spherical, or other shape. The support rod 430 may have a plurality of tissue anchors or protrusions 432 coupled to the support rod or link 430 at a plurality of locations around the contact member 404, such as any of the tissue anchors 118 described above. In any one of the embodiments disclosed herein, the tissue anchor 432 may or may not be integrally formed with the support rod 430. The support rod or link 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.

[0316] Additionally referring Figure 17 , by way of example and not limitation, a pin or transverse member 468 may be coupled to the implant device 402 at the distal end 408b of the retention member 408 or between the retention member 410 and the contact member 404. The pin 468 may be configured to engage an end portion of the core member 418 of the catheter or a feature formed within the distal portion of the core member of the catheter to selectively couple the implant device 402 to the core member of the catheter, as is the case with other embodiments disclosed herein.

[0317] 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 surrounds or otherwise engages the pin 468, thereby allowing a user to retract or withdraw the suture to pull the implant device 402 proximally 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 be done after the implant and its fixation elements are fully deployed.

[0318] In some embodiments, the contact member 404, the retention member 408, and / or the fixation element 410 may be integrally formed, such as by laser cutting from a single piece of hypotube, or otherwise produced. By way of example and not limitation, the retention member 408 and the fixation element may be laser cut from a single piece of tubing material, such as an elastic or shape memory material, and then formed into the desired shape. In other embodiments, the contact member 404, the retention member 408, and / or the fixation element 410 may be formed separately and welded, brazed, or otherwise joined together to form a single integral assembly. In some embodiments, because the distance between the contact member 404 and the fixation element 410 may be large, the contact member 404 may be further advanced distally into the LAA and then rotated, thereby twisting the opening of the LAA such that the opening of the LAA contracts around the outer surface of the retention member. The greater length of the retention member 410 may also accommodate a greater number of rotations or twists of the LAA before the fixation element engages.

[0319] An intermediate sleeve or tube (not shown) may be coupled to the fixation element 410 and may be used to manipulate and control the position and / or orientation of the fixation element 410, including holding the proximal portion 410a of the fixation element in a fixed axial position while applying a distally-directed force to the contact member 404 to maintain the holding member 410 in a first extended state. Deployment of the device 402 may include any combination of steps described with respect to any other embodiment disclosed herein.

[0320] Figures 18 - 21 Another embodiment of a treatment system 500 with an implant device 502 is shown, where the contact member 504 is in a second deployed state, the holding member 508 is in a second contracted state, and the fixation element 510 is in a second open state. Any embodiment of the treatment system 500 or the implant device 502 may have any combination of components, features, or details of any other treatment system or implant device embodiment disclosed herein with any components, features, or details of the treatment system 500 or the implant device 502 disclosed herein, the embodiments including but not limited to any embodiment of the treatment systems 100, 200, 300, 400 or the implant devices 102, 202, 302, 402 described above. Similarly, any combination of components, features, or details of any other treatment system or implant device embodiment disclosed herein may have any combination of components, features, or details of any embodiment of the treatment system 500 or the implant device 502 disclosed herein with any components, features, or details of any other treatment system or implant device embodiment disclosed herein.

[0321] The contact member 504 may have a plurality of support rods or links 530 at a plurality of locations around the contact member 504, and a plurality of tissue anchors 532 may be provided on the plurality of support rods or links, such as any of the tissue anchors 118 described above. As in any one of the embodiments disclosed herein, the tissue anchors 532 may or may not be formed integrally with the support rods 530. The contact member 504 may have a generally spherical or bulbous shape, or the shape of any other embodiment disclosed herein.

[0322] Similar to other embodiments described above, any embodiment of the processing system 500 may have a suture or thread 580 that extends through the interior of the core member 518 (e.g., through the lumen of the core member 518) and surrounds the pin 568 or other retention member coupled to the contact member 504, thereby allowing the user to retract or withdraw the suture 580 to pull the contact member 504 proximally relative to the fixation element 510 and keep the implant 502 engaged with the delivery catheter. In this configuration, both ends of the suture 580 may extend from the proximal end of the device 500 such that the practitioner can grasp both ends of the suture 580 to apply a proximally directed force around the pin 568 to pull the contact member 504 toward the fixation element 510 and keep the pin 568 positioned within the slot 570 of the core member 518. Additionally, the size of the slot 574 formed in the cylindrical body portion 572 of the fixation element 510 may be set such that the cylindrical body portion 572 of the fixation element 510 can axially move relative to the pin 568 in the proximal and distal directions between the proximal end 574a of the slot 574 and the distal end 574b of the slot 574. Thus, the pin 568 and the suture 580 can be used to bias or force the implant 502 to remain in contact with the catheter (e.g., in contact with the core member 518 or the slot 570 formed in the core member), and allow the user to move the fixation element 510 from a first position to a second engagement position (as Figures 18 - 21 shown).

[0323] In some embodiments, if the contact member 504 is maintained in a fixed position using the catheter or the core member 518, the user can move the fixation element 510 from the first position to the second position by pulling back or withdrawing the suture 580 (again, while the contact member 504 is held in a fixed position within the LAA) and advancing the outer tube 576 of the delivery catheter in the distal direction to push the fixation element 576 distally. This will be done after the desired degree of torsion of the LAA has been achieved by twisting or turning the core member 518 or other parts of the catheter. Referring Figure 19 , in some embodiments, this may cause the fixation element 510 and the body portion 572 of the fixation element to advance distally relative to the contact member 504, thereby forcing the fixation element into the tissue of the LAA or LA to hold the tissue in a occluded or constricted position.

[0324] Additionally, any embodiment of the device can be configured such that when the fixation element 510 is advanced to a second position where the fixation element 510 engages tissue and holds the LAA in a closed or occluded position, a retention member can be used to prevent the fixation element from moving away from the second position toward the first position, thereby maintaining the position of the fixation element and maintaining the occlusion in the LAA. By way of example and not limitation, one or more tabs 582 formed on or coupled to the body portion 584 of the contact member 504 can be biased to deflect into or engage corresponding recesses or openings 586 among a plurality of recesses or openings 586, thereby preventing or inhibiting the fixation element 510 from moving back toward the first position relative to the contact member 504. The tab 582 (which can be any other type of retention feature, such as a ball and detent, or a cable tie-type retention feature, or other feature) can be configured such that the fixation element 510 can move freely from a first deployed position to a second collapsed position, and is configured to selectively prevent or inhibit movement from the second position to the first position, thereby substantially fixing the fixation element in the second position. Additionally, in any embodiment disclosed herein, one or more sutures, wires, pins, or other components or fasteners can be used - by way of example and not limitation, sutures including slipknots that can be tightened during deployment - to hold the fixation element and the contact member together. The sutures can then be trimmed to a certain length during final deployment to hold the fixation element and the contact member together to maintain the LAA in an occluded or constricted state. Thereafter, the suture 580 can be removed, and the remaining components of the deployment device can be withdrawn from the patient's body, leaving the implant 502 in place.

[0325] In some embodiments, the implant device 502 can be configured such that a ratchet or retention mechanism formed by the engagement of the tab 582 and the opening 586 is reversible or releasable, such that the fixation element can move from the second position to the first position or toward the first position, to, for example, disengage the fixation element from the tissue for repositioning, re-twisting the LAA, or other operations. For example, some embodiments of the implant device 502 can be configured such that the fixation element (and thus one or more tabs 582) is rotated or twisted relative to the body portion 584 of the contact member 504 such that the tab 582 disengages from the opening 586. Additionally, in some embodiments, the tab can be located on the body portion 584 of the contact member 504, and the opening can be formed in the body portion of the fixation element 510. Further, the tab can be formed in two directions such that the fixation element can ratchet or be selectively fixable in two axial movement directions. Additionally, in any embodiment disclosed herein, the tab can be formed and configured such that the tab can move from a fixed position or state to a non-fixed (or sliding) state. Examples of these embodiments will be described below.

[0326] Figure 22AAnother embodiment of a processing system 600 with an implant device 602 is shown, where the contact member 604 is in a second deployed state and the fixation element 610 is in a first retracted or pre-deployed state. FIG. 23 shows an embodiment of the implant device 602 where the fixation element 610 has moved to a second deployed or locked state. Figures 24 - 35 An embodiment of a deployment method for an embodiment of the processing system 600 shown in FIGS. 22-23 is shown. Any embodiment of the processing system 600 or the implant device 602 may have any components, features, or other details of any other implant device embodiment disclosed herein in any combination with any components, features, or details of the processing system 600 or the implant device 602 disclosed below, where any other implant device embodiment includes, but is not limited to, any embodiment of the implant devices 100, 200, 300, 400, 500 described above. Similarly, any components, features, or other details of any other processing system or implant device embodiment disclosed herein may have any components, features, or other details of any embodiment of the processing system 600 or the implant device 602 disclosed herein in any combination with any components, features, or details of the processing system or implant device embodiment disclosed herein.

[0327] Reference Figures 22A - 22B , the fixation element 610 may have a body portion 611, which may have a curved or helical (or coiled) shape that extends from a proximal portion 610a of the fixation element 610 to a distal portion 610b of the fixation element 610, and may have a sharp distal tip 612 at the distal portion 610b of the fixation element 610, which may engage (or in some embodiments, at least partially penetrate) the tissue of the LA and / or LAA after the contact member 604 is rotated to the second position, thereby fixing the tissue and occluding or closing the LAA opening around the implant device, such as the LAA opening around the body portion 614 that is integral with or coupled to the contact member 604 or other parts of the implant device.

[0328] 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 inner core member of the catheter and / or the body portion 614 of the implant, such that the body portion 611 of the fixation element 610 winds or coils (in a helical shape or otherwise) around the inner core member of the catheter and / or the body portion 614, and / or may rotate around the inner core member and / or the body portion.

[0329] Figures 23A - 23BAnother embodiment of the fixation element 610 that can be implemented in conjunction with any of the implant or delivery system embodiments and / or processing methods disclosed herein is shown. In any embodiment, the cross-section of the body portion 611 can be circular, square (as shown), oval, or have any other desired shape. In any embodiment, the body portion 611 can have 2 to 15 or more coils (i.e., complete revolutions), or 3 to 10 coils, or 4 to 6 coils, and can terminate at the distal portion 610b of the fixation element 610 with a sharp point, blunt end, one or more tissue anchors or barbs, or otherwise. Additionally, any embodiment of the fixation element disclosed herein can have tissue anchors or barbs (not shown) along the length of the body portion 611, or in embodiments having two or more body portions as described below, along the lengths of the multiple body portions 611, to engage the tissue and prevent or inhibit the fixation member 610 from exiting the tissue after the fixation element 610 is advanced into such tissue. The proximal portion 610a of the fixation element 610 can have a flange 617, an opening 619, and / or other features configured to connect the fixation element 610 to other parts of the implant 602.

[0330] Additionally, in any of the embodiments disclosed herein, the fixation element 610 can also have a rotational or axial lock feature that can fix the fixation element in a desired rotational position and / or desired axial position, and / or inhibit reverse rotation of the fixation element. The rotational or axial locking can be selectively reversible such that the user can return the fixation element to a freely movable state as needed. By way of example and not limitation, referring to Figures 23C - 23D , any embodiment of the fixation element disclosed herein can have one or more tissue anchors or barbs 621 or multiple tissue anchors or barbs extending away from the proximal end 610a of the fixation element 610, which can improve the grip of the fixation element in the target tissue, and / or prevent or inhibit the fixation member 610 from exiting the tissue after the fixation element 610 is advanced into such tissue. In any embodiment, the tissue anchors or barbs 621 can be axially oriented, radially oriented, or at an angle relative to the axial direction of the fixation element 610. The tissue anchors or barbs 621 can be angled or otherwise configured to easily enter the tissue and have a vertical surface or other features configured to engage and / or lock with the tissue to prevent reverse rotation of the fixation element 610.

[0331] Furthermore, referring to Figures 23E - 23F , any embodiment of the fixation element disclosed herein can have two or more body portions 611 extending away from the proximal end 610a of the fixation element. Figures 23E - 23FThe embodiment of the fixation element 610 shown in has a first body portion 611a and a second body portion 611b, both of which are helical in shape, have the same or similar spacing, and both extend the full length of the fixation element 610. In other embodiments, one of the body portions 611 may have a different length (e.g., shorter) than the other body portion 611. In addition, in any embodiments disclosed herein, one or more body portions 611 may have a spacing that changes (increases or decreases) along its length from the proximal portion to the distal portion of the fixation element. The body portion 611 having a spacing that decreases along the length of the fixation element (so that the spacing increases along the length of the body portion) can cause the tissue between the coils to compress more near the proximal portion of the fixation element than near the distal portion of the fixation element. In some embodiments, this can increase the retention force of the fixation element in the tissue. The first body portion 611a may have a distal portion 612a, and the second body portion 611b may have a distal portion 612b.

[0332] As mentioned, in some embodiments, the fixation element 610 can have two or more curved or helical (or spiral) shaped body portions 611, each of which can 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 embodiments disclosed herein, a fixation element having a helical shape (e.g., Figures 22A - 22B ) can have two helical body portions 611 that can each be configured to penetrate and engage tissue that has contracted around a portion of the implant. In any embodiments including single helical and double helical fixation element embodiments, the body portion or portions 611 can be long enough to engage the contact member, or shorter and only engage all or a proximal portion of the LA wall / LAA tissue, such as about 1 mm to about 2 mm of LA wall / LAA tissue, or about 2 mm to about 5 mm or more of LA wall / LAA tissue.

[0333] Additionally, in any embodiments, one or more body portions 611 can 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 otherwise. For example, and not limitation, in any embodiments, one or more body portions 611 can 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 portion 610b of the fixation element 610. As the fixation element 610 is advanced into the LA wall / LAA tissue, the conical shape can cause the tissue to be broadly gathered and gathered together (i.e., radially inward).

[0334] refer toFigure 22B The fixation element 610 (which can be any fixation element embodiment or any combination having any features of the fixation element embodiments disclosed herein) is rotatable (e.g., in a helical manner) and advanceable such that it penetrates and / or passes through the tissue of the LA and / or LAA that has been gathered and / or constricted around the body portion 614 or other portions 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 the tissue of the LA and / or LAA while generally maintaining the LAA fixed in a second rotational position by holding the contact member 604 in a fixed position. In any embodiment, a sleeve or other component of the catheter or delivery system can be coupled to the fixation element (including but not limited to the fixation element 610) to enable a user to move the fixation element between a first state and a second state (which should be understood to also include moving 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 can be configured to perform these operations independent of any other movement or operation of the catheter such that, for example, the fixation element can be axially advanced toward the contact member while the contact member is held in a fixed position by the catheter.

[0335] The fixation element 610 can thereby hold the tissue of the LA and / or LAA such that the tissue of the LA and / or LAA is maintained in a constricted state around the implant device to occlude the LAA. Additionally, in some embodiments, as shown, the fixation element 610 can be configured to also pass through one or more openings 620 that can be formed or created in the contact member 604 when the contact member 604 is in a second deployed state, thereby further securing the fixation element 610 to the contact member 604 and preventing or inhibiting rotation of the contact member 604 toward the first position. In any embodiment, the fixation element 610 and / or the contact member 604 can have one or more teeth, studs, barbs, knobs, textures, posts, anchors, or other tissue-engaging features or anchor components around the outer surface of the fixation element 610 to prevent or inhibit detachment of the fixation element 610 from the tissue of the LA and / or LAA when in the second state. Further, in any embodiment, the fixation element can be biased to the second position by a biasing member (not shown) such as an axial elastic member or using one or more sutures, threads, ratchets, tabs, and openings, or other securing features. However, in some embodiments, engaging the fixation element 610 within the tissue of the LA and / or LAA can be sufficient to secure the fixation element 610 in the second position and maintain the LAA in an occluded state.

[0336] Regarding Figures 24 - 35 an embodiment of the deployment sequence will now be described. Figures 24 - 27 The contact member 604 is shown being advanced into the LAA. ReferringFigure 27 , the contact member 604 can be advanced to any desired depth within the LAA, including advancement to the end portion. In some embodiments, the contact member 610 can be advanced relative to the LAA to a desired position and then deployed to a second state so as to contact the inner surface or tissue of the LAA. Thereafter, the contact member 604 can be rotated in a first direction (represented by the arrow A3 in Figures 28 - 29 , which can be in a clockwise or counterclockwise direction) toward a second position, thereby also twisting the LAA in the first direction as indicated by the arrow A3 in Figures 28 - 29 . As described, the twisting can cause the orifice of the LAA to contract around a portion of the body of the implant device 602, thereby closing the LAA and isolating it from the LA, as shown in Figures 28 - 29 .

[0337] Thereafter, referring to Figures 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 a closed or contracted state and maintaining the LAA in a twisted position, the fixation element 610 can be advanced distally (as indicated by the arrow A4 in Figures 30 - 31 ) toward the tissue of the LA and / or LAA that has contracted around 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 (e.g., the direction of rotation indicated by the arrow A5 shown in Figures 32 - 33 ) while advancing the fixation element 610 distally so that the fixation element 610 penetrates and / or engages the tissue of the LA and / or LAA that has contracted around the body portion of the implant device 602. In some embodiments, the fixation element 610 can be advanced so as to completely penetrate the tissue of the LA and / or LAA, as shown in Figures 34 - 35 . In some embodiments, the fixation element 610 can be configured to engage and / or only partially penetrate into the tissue of the LA and / or LAA. Thereafter, the implant device 602 can be released from the delivery catheter, and the delivery catheter can be withdrawn from the patient's heart, as shown in Figures 34 - 35 , thereby maintaining the LAA in a closed position.

[0338] Figure 36 Shows another embodiment of an implant device 650 having a different embodiment of a fixation element 652 that can be used with any of the embodiments of the implant devices disclosed herein. As shown in Figure 36 , the fixation element 650 can have a backing member 654 coupled to the proximal end 652a of the fixation element 652, which can provide an additional seal against the tissue of the LA and / or LAA when the fixation element is in a second or deployed position.

[0339] Figures 37 - 38Another embodiment of a processing system 700 with an implant device 702 is shown, where the contact member 704 is in a second deployed state and the fixation element 710 is in a second open state. Any embodiment of the processing system 700 or the implant device 702 may have any combination of any components, features, or details of any other processing system or implant device embodiment disclosed herein with any components, features, or details of the processing system 700 or the implant device 702 disclosed herein, including but not limited to any embodiment of the processing systems 100, 200, 300, 400, 500, 600 or the implant devices 102, 202, 302, 402, 502, 602 described above. Similarly, any components, features, or other details of any other processing system or implant device embodiment disclosed herein may have any combination of any components, features, or details of any embodiment of the processing system 700 or the implant device 702 disclosed herein with any components, features, or details of the processing system or implant device embodiment disclosed herein.

[0340] In any embodiment, the contact member 704 may have a body portion 706, which may or may not have a cylindrical shape. An opening or recess 708 may be formed in the body portion 706 as part of a retaining element to hold the fixation element 710 in a desired axial position relative to the coupling member 704 or to lock the fixation element to the coupling member. The fixation element 710 may also have a body portion 712, which may or may not have a cylindrical shape. In some embodiments, even when the fixation element 710 is in a first retracted state, the body portion 712 may extend into the body portion 706 of the contact member 704. The body portion 706 may have an opening 708 extending therethrough, which is 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, which is sized and configured to selectively receive the core member 720 of the delivery catheter of the processing system 700.

[0341] Additionally, referring to Figure 39 , the fixation element 710 may have a deflectable tab member 714, which may be moved or moved from a first engaged position (as shown in Figure 37 ) to a second disengaged position (as shown in Figure 38as shown). The tab member 714 can be configured to rotate about a pin that can be coupled to the tab member 714 and the body portion 712, or can be configured to rotate about a thin strip of material (referred to herein as the material strip 715) that forms the body portion 712 and / or the tab member 714. By way of example and not limitation, the body portion 712, the tab member 714, and one or more material strips 715 (two are shown) can be integrally formed. Additionally, in some embodiments, one or more arms 711 (four are shown) of the fixation element 710 can also be integrally formed with other features of the fixation element 710. In some embodiments, the tab 714 can be biased toward a first engagement position (as Figure 37 and 39 shown), but can be physically deflected or rotated toward a second disengagement position (as Figure 38 shown) by advancing the core member 720 or other component through an opening 722 that extends through the body portion 712 of the fixation element 710. By way of example and not limitation, as Figure 38 shown, the core member 720 can 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 engagement position to the second disengagement position.

[0342] When the tab member 714 is in the engagement position, the tab member 714 can engage an opening 708 formed in the body portion 706 of the contact member to axially lock or couple the fixation element 710 to the contact member 704, for example, after the contact member has twisted the LAA into the occluded or closed position or state as described above. However, in some embodiments, if the user desires to disengage or decouple the fixation element 710 from the contact member 704, the user can do so by moving the tab member 714 to, by way of example and not limitation, the second disengagement position as described above to disengage the tab member 714 from the opening 708. Thereafter, the user can axially withdraw the fixation element 710.

[0343] Figures 40 - 43Another embodiment of the implant device 732 is shown. Any embodiment of the implant device 732 may have any combination of any components, features, or details of any other processing system or implant device embodiment disclosed herein with any components, features, or details of the implant device 732, where any other processing system or implant device embodiment includes, but is not limited to, any embodiment of the processing systems 100, 200, 300, 400, 500, 600, 700 or implant devices 102, 202, 302, 402, 502, 602 described above. Similarly, any components, features, or other details of any other processing system or implant device embodiment disclosed herein may have any combination of any components, features, or details of any embodiment of the implant device 732 with any components, features, or details of the processing system or implant device embodiment disclosed herein.

[0344] As Figure 40 shown, the deflectable tab member 744 of the implant device 732 engages 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 may be moved or displaced from a first engaged position (as Figure 40 shown) to a second disengaged position (as Figure 41 shown) by advancing the fixation element 710 distally, such that the body portion 739 of the contact member 734 deflects the tab member 744 and moves it to the second disengaged position, as Figure 41 shown. Thereafter, the fixation element 740 may be rotated in either direction (e.g., 90 degrees) to a position where the tab member 744 is not aligned with and thus does not engage the opening 738, as Figure 42 shown. As Figure 43 shown, the body portion 739 of the contact member 734 may hold the tab member 744 in the second disengaged position while the fixation element 740 withdraws or disengages from the contact member.

[0345] Figure 44A and 44B are a front view and a side view, respectively, of another embodiment of a processing system 750 configured to twist and occlude or close the ostium of the LAA. Figure 45A and 45B are a front view and a side view, respectively, of the processing system 750 of FIG. 44, showing an implant for twisting the LAA to occlude or close the LAA at the ostium. Then, as in any embodiment disclosed herein and using any fixation features or components disclosed herein, the LAA ostium or a portion of the substance of the LA or LAA that has been contracted around the implant device may be clamped or locked in the contracted state. Figure 46A and Figure 46BFront and side views of the treatment system of FIG. 44, respectively, showing the removal of the delivery device from the implant device after the LAA has been occluded.

[0346] In some embodiments, the steps of deployment and implantation, in any combination or in any combination with any other steps, may include: (a) inserting a catheter and an implant device through the orifice of the LAA; (b) rotating the contact member or other engagement assembly of the implant to twist the LAA; at least causing the orifice of the LAA to collapse on its own, thereby occluding or closing the orifice of the LAA; (c) clamping, holding, or fixing the LA and / or LAA tissue in a closed or occluded state; and / or (d) releasing and withdrawing the delivery catheter from the implant. As shown, the treatment system twists and occludes the LAA at the orifice and then clamps and holds this position, thereby effectively occluding the LAA. In some embodiments, the steps of deployment and implantation may include: inserting the catheter into the middle of the LAA orifice, rotating the blades of the implant to twist the LAA and cause the LAA to collapse on its own, clamping and holding the position to the atrial wall, and releasing the delivery catheter from the implant.

[0347] Figures 47A - 47F Another embodiment of a treatment system 1100 for occluding or closing the LAA is shown, the treatment system having an embodiment of a delivery device 1101 for the left atrial appendage and an embodiment of a deployable implant or implant 1102. Specifically, the implant 1102 is shown in a plurality of illustrative deployment and deployment stages. The implant 1102 may have a body portion 1104 having a plurality of deployable support rods or arms 1106. In some embodiments, the body portion 1104 may be deployed to a substantially spherical shape or an elongated spherical shape. Each of the support rods 1106 may have a plurality of barbs or tissue anchors 1108 thereon (which may be or may include any tissue anchor disclosed herein). Any embodiment of the implant disclosed herein may have a laser-cut self-expanding nitinol body portion, and the body portion is covered with microbarbs.

[0348] The barb 1108 can be configured to engage tissue when the body portion 1104 twists or moves relative to the inner wall of the LAA after the body portion 1104 unfolds from a first state to a second state, wherein in the second state, the support strut 1106 and the barb 1108 can engage or contact tissue on the inner wall of the LAA. Additionally, any embodiment of the implant 1102 can have one or more anchoring elements 1112 that are configured to engage tissue adjacent to or surrounding the LAA to prevent the implant 1102 from rotating back to a first rotational position after the implant 1102 has been rotated within the LAA to a second rotational position. In any embodiment, the anchoring element 1112 can include two arms or components that can each engage a tissue surface and can each have a plurality of barbs on the arms or components, and the arms or components are configured to prevent the implant from rotating back to the first rotational position. Figures 48A - 48E Illustrating when implant 1102 is deployed into the LAA Figures 47A - 47F Some phases or steps of an illustrative deployment procedure of the deployable implant 1102.

[0349] Figures 49A - 49G Illustrating an embodiment of an implant 1202 that can be used to occlude or substantially occlude the LAA. In some embodiments, the implant 1202 can be formed by laser cutting a tube of an elastic material such as nitinol. The implant 1202 and any other implant embodiments disclosed herein can be self-deployable or mechanically deployable, such as using balloon dilation techniques. Additionally, any embodiment of the implant 1202 can have any same features, components, or details of any other implant embodiments disclosed herein that replace or combine with any features, components, or other 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 a plurality of micro barbs or other tissue anchors 1208, and a fixation element 1212 (also referred to herein as an anchoring element) that can include a single folded clamping anchor. The fixation element 1212 can be configured to lock the implant 1202 in a fixed rotational position after the implant has rotated the LAA to a desired degree of torsion and occlusion or closure.

[0350] Figures 50A - 50F Illustrating when implant 1202 is deployed into the LAA Figures 49A - 49GSome illustrative phases of an embodiment of a deployment procedure for an expandable implant 1202. 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, thereby twisting the LAA and causing the orifice of the LAA and / or other tissue to contract or close around a portion of the implant 1202. The implants disclosed herein or any implant can be configured to rotate clockwise (and can rotate clockwise and / or counterclockwise during any procedure disclosed herein) to twist and occlude or substantially occlude the orifice of the LAA or cause the orifice of the LAA to contract around a portion of the implant 1202. After achieving the desired degree of closure, the fixation element 1212 can be rotated or folded (e.g., but not limited to, about an axis or hinge 1214) to the side of the LAA, thereby being generally perpendicular to the axial centerline of the implant and being forced into engagement with tissue adjacent to the LAA near the LAA orifice to prevent unwinding of the implant and the LAA orifice. The body portion of the fixation element 1212 can also have tissue anchors 1216, which are formed on, coupled to, or integral with the body portion, and the tissue anchors can engage, penetrate, and / or grip the LA and / or the tissue of the LAA that has contracted due to the twisting of the LAA. In any embodiment disclosed herein, the fixation element 1212 can be configured to bias towards (e.g., Figure 49G or Figure 50F as shown in) a second locked state and / or can be fixed in the second locked state. As Figure 50F shown, after deploying the fixation element 1212, the delivery device can be disconnected from the implant and removed from the patient.

[0351] Figure 51 、 52 and 53 show additional embodiments of implant devices 1220, 1222, and 1224 (note that implant devices are also referred to as implants herein), which can be used with any embodiment of the processing system, delivery device, or procedure disclosed herein to treat the LAA. Figure 51 The implant device 1220 shown in Figure 52 can have a strip or support rod made of nitinol or any other suitable material, which is configured to expand into a generally spherical or elongated spherical shape and can be covered with small barbs or spikes (or other tissue anchors). The tissue anchors can point in one or both circumferential directions. Figure 53The implant device 1224 shown in [Fig. 0] may have a braided wire body that may be made of nitinol or any other suitable material and configured to deploy into a generally spherical or elongated spherical shape. The body of the implant device 1224 may be uniformly or otherwise covered with small barbs or spurs (or other tissue anchors).

[0352] Figure 54 Another embodiment of an implant device 1230 is shown that may be deployed (or deployed) into a generally spherical or elongated spherical shape. By way of example and not limitation, the implant device 1230 may be configured to cover an inflatable balloon that may be inflated to deploy 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 spurs or other tissue anchors.

[0353] Figure 55 Another embodiment of an implant device 1232 is shown that may be used with any of the processing system embodiments disclosed herein. In some embodiments, the implant device 1232 may have a helical body at least when in a second deployed state that is available for applying torque and torsional effects to the LAA. The implant device 1232 may be made of nitinol and may be covered with or have a plurality of small barbs, spurs, or other tissue anchors. The implant device 1232 may be self-deploying and may have a semi-dome shape when in the second state. In some embodiments, the implant device 1232 may have a rounded end 1234 that may be generally the same size as the lumen of the delivery system, or may be smaller, or larger and deployable.

[0354] Figures 56A - 56B An embodiment of a processing system 1240 having an implant device 1242 is shown, where in Figure 56A the implant device 1242 is primarily housed within the catheter body 1244 of the processing system 1240, and in Figure 56B at least the contact member 1246 of the implant device 1242 is in a second deployed state. The contact member 1246 may have a plurality of barbs or anchor members around its outer surface and may be configured to deploy into a generally spherical or elongated spherical shape. The contact member 1246 may be self-deploying or mechanically deployable and may have a semi-dome shape with a rounded distal portion 1248. In some embodiments, the rounded end portion 1248 may be generally the same size as the lumen of the delivery system, or may be smaller, or larger and deployable.

[0355] Figs. 57 - 61 show additional different embodiments of an anchoring or fixation element that may be used with any of the other components of the implant device embodiments disclosed herein. Figure 57A An embodiment of a two-armed fixation element is shown. Figure 57B ShownFigure 57A The double - arm fixation element is advanced into the tissue of the LA and / or LAA adjacent to the LAA orifice, which has contracted around the body portion of the implant device.

[0356] Figure 58A An embodiment showing a single - fold clamping anchor or fixation element is presented. Figure 58B An embodiment showing a single - arm fixation element that rotates against or clamps against the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device is presented. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. Figure 58A An embodiment showing a disk anchor or fixation element is presented. Figure 59A An embodiment showing a disk fixation element that is advanced towards the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device is presented, such that Figure 59B one or more tissue anchors of the fixation element can engage with and / or penetrate into the tissue of the LA and / or LAA adjacent to the LAA orifice. Figure 59A such that Figure 59A one or more tissue anchors of the fixation element can engage with and / or penetrate into the tissue of the LA and / or LAA adjacent to the LAA orifice.

[0357] Figure 60A An embodiment showing a single - fold clamping anchor or fixation element having helical or screw - type tissue anchors that can be used to engage with and / or penetrate into the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device is presented. Figure 60B An embodiment showing a single - fold clamping anchor or fixation element that rotates against or clamps against the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device is presented. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. Figure 60A An embodiment showing a single - fold clamping anchor or fixation element having helical or screw - type tissue anchors that can be used to engage with and / or penetrate into the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device is presented. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. Figure 61A An embodiment showing a double - arm fixation element having two helical or screw - type tissue anchors is presented. Figure 61B An embodiment showing Figure 61A the double - arm fixation element rotates against the tissue of the LA and / or LAA adjacent to the LAA orifice that has contracted around the body portion of the implant device, such that the tissue anchors on the arms can engage with and / or penetrate into the tissue. Figures 61A - 61B The two arms of the fixation element can collapse towards the body portion or the axial centerline of the fixation element and can be configured to automatically deploy when extending through the distal end of the delivery catheter.

[0358] Figures 62A - 62B Side and end views of different embodiments of a contact member are presented, which can be deployed in the LAA to engage the tissue of the LAA, such that the LAA twists when torque is applied to the contact member. Figures 62A - 62BAn embodiment of a contact member is shown having a cylindrical or thick disk-shaped body portion, a spherical body portion, a conical body portion, and a hemispherical and / or semi-spherical body portion configured to better engage or couple to LAA tissue. Figures 62A - 62B Any embodiment of the contact member shown in Figures 62A - 62B may have a plurality of barbs, micro-barbs, or other tissue anchors on its outer surface. Additionally, Figures 62A - 62B any embodiment of the contact member shown in Figures 62A - 62B may have an outer surface uniformly covered with barbs, micro-barbs, or other tissue anchors. Further, any embodiment of the body portion disclosed herein, including but not limited to Figures 62A - 62B the hemispherical body portion shown in Figures 62A - 62B , may have a flat area on a portion thereof to allow for a lower profile. Figure 63 A side view of an embodiment of a contact member is shown deployed against the tissue surface of the LAA after torque is applied to the contact member causing the tissue of the LA / LAA to contract around a portion of the body of the implant device. Figure 63 Also shown is a tissue anchor of an implant device advanced into the tissue of the LA / LAA to secure the LAA in a second position.

[0359] Additionally, any embodiment of the implant disclosed herein may have a drug coating, a fabric, or other at least substantially impermeable covering (non-limiting examples and similar to the cover member 121 described above), electrical contacts for eliminating the conduction of electrical signals that cause Afib, or other features for improving the performance of the implant. Some embodiments of the implant may be delivered transseptally via a catheter and a disconnectable element between the implant element and the delivery system, the disconnectable element allowing for permanent disconnection and thus permanent implantation of the implant. Additionally, in any embodiment disclosed herein, the implant may be delivered, for example, surgically or otherwise without the use of a catheter.

[0360] Some embodiments include a device for occluding or closing the LAA having: a deployable implant configured to move between a first state in which the implant is substantially collapsed and a second state in which the implant is deployed; 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 and the implant is moved from the first state to the second state such that at least some of a plurality of tissue anchors engage the 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 a plurality of tissue anchors on its outer surface.

[0361] Additionally, the catheter may be configured to rotate the implant from a first rotational position to a second rotational position in a first direction such that the implant may twist the wall of the left atrial appendage. As mentioned above, the catheter may rotate the implant as little as a quarter turn to more than one turn. In any embodiment, the delivery device (which may be a catheter or any other suitable deployment or surgical device or system in any embodiment disclosed herein) may be configured such that the user may rotate the implant multiple times as necessary or as desired to occlude, close, or collapse the LAA itself or the outer surface around the implant.

[0362] Any embodiment of the implant may be self - deployable such that when the constraint is removed from the implant, the implant automatically deploys, e.g., when the implant is advanced past the distal end of the catheter sheath, the implant automatically deploys. After deployment into the left atrial appendage, the implant may be biased to remain in the deployed state.

[0363] Additionally, any embodiment of the implant or system disclosed herein may be configured such that when rotated or turned in one (or first) direction, the implant may engage or automatically engage tissue or a tissue surface. The implant of any embodiment disclosed herein may also be configured to disengage from any tissue engaged by the implant when turned in a second direction (the second direction being opposite the first direction). In this embodiment, the user may engage the tissue or wall surface of the LAA by rotating the implant in the first direction and disengage (if needed for any reason, including but not limited to repositioning the implant) by rotating the implant in the second direction, the second direction being opposite the first direction.

[0364] In any embodiment, as has been described, the implant may 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 may have a fixation element or an anchoring element that may be configured to engage tissue around the LAA, such as tissue of the inner wall of the heart outside the left atrial appendage. Some embodiments of the implant may have a fixation element having a plurality of tissue anchors configured to engage the inner wall of the heart adjacent to the left atrial appendage.

[0365] By way of example and not limitation, an implant of any of the apparatus, devices, and method embodiments disclosed herein may include a fixation element configured to engage an inner wall of the heart external to or near the left atrial appendage. The fixation element may have one or more arms and / or tissue anchors configured to engage an inner wall of the heart adjacent to the left atrial appendage, or may be configured to suture to or otherwise couple with an inner wall of the heart adjacent to the left atrial appendage. In any embodiment, the implant may be configured to prevent or inhibit the contact member or other portions of the implant from rotating back to a first rotational position after full deployment of the contact member or other portions of the implant. In any embodiment, the implant may be configured to allow the contact member to rotate from a first rotational position to a second rotational position in a first direction and to prevent or inhibit rotation of the implant in a second direction opposite the first direction after full deployment of the contact member or other portions of the implant or the implant.

[0366] Any embodiment disclosed herein may include an implant for deployment within a cavity or blood vessel, the implant having: a deployable body (which may or may not have any features or characteristics of the contact member); a plurality of tissue anchors on an outer surface of the deployable body, the plurality of tissue anchors configured to engage an inner wall surface of the cavity or blood vessel; and an anchor element coupled to the deployable body, the anchor element configured to engage a tissue surface near an inner wall surface of the cavity or blood vessel.

[0367] Some embodiments of a method of occluding or closing the LAA using any of the implants disclosed herein will now be described. The method or procedure may include: advancing a deployment device having an implant with a deployable member or contact member into the left atrium of a patient; moving or deploying a portion of the implant within the left atrial appendage from a first state to a second state, wherein the deployable member or contact member is substantially collapsed in the first state and deployed in the second state; engaging a wall portion within the left atrial appendage with the deployable member or contact member (which may or may not have one or more tissue anchors on an outer surface thereof); rotating the deployable member or contact member from a first rotational position to a second rotational position to twist a wall portion within the left atrial appendage; and preventing the deployable member or contact member from rotating back to the first rotational position. Any portion of the implant, including but not limited to the deployable member or contact member, may be self-deploying, wherein moving the deployable member or contact member from the first state to the second state includes ejecting the deployable member or contact member from a distal end of the deployment device.

[0368] Additionally, in any embodiment disclosed herein, the wall portion engaging the interior of the left atrial appendage may include engaging the wall portion interior of the left atrial appendage by one or more tissue anchors positioned on an outer surface of the deployable member or contact member or other portion of the implant. Further, preventing the implant from rotating back to the first rotational position may include engaging a tissue wall exterior to the left atrial appendage by an anchor element or fixation element. In some embodiments, the anchor element or fixation element may be rotatably fixed to the deployable member or contact member and / or other portions of the implant to prevent relative movement between the anchor element and the deployable member or contact member and / or other portions of the implant. Preventing the deployable member or contact member and / or other portions of the implant from rotating back to the first rotational position may include: engaging a tissue wall of the heart with the anchor element or fixation element, wherein the anchor element is rotatably fixed relative to the implant and is configured to prevent the deployable member or contact member and / or other portions 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 by the anchor element or fixation element. In any embodiment, the anchor element or fixation element may include a plurality of tissue anchors on at least one of its surfaces, the tissue anchors being configured to engage an inner wall of the heart exterior to the left atrial appendage.

[0369] 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 a second state, or may be activated at any desired time to rotate itself. By way of example and not limitation, the implant may have a spring or other torsional member configured to rotate the contact member and / or other portions of the implant or other portions of the implant body when the spring is released or activated, or may be configured to be pre-wound or pre-twisted when the implant or contact member and / or other portions of the implant are in a first state. The self-rotation or self-twisting may be completed, for example, after the contact member and / or other portions of the implant are fixed to a wall portion around 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 causes twisting of the LAA, thereby occluding or substantially occluding the orifice of the LAA.

[0370] Accordingly, in any embodiment, the implant may be configured to automatically rotate or self-rotate from a first rotational position to a second rotational position after release of the constraint holding the implant in the first rotational position, or after triggering or actuating a rotational mechanism that may be a spring or other torsional member. In some embodiments, the shaft extending through the implant may be configured to wind or rotate relative to a fixed portion or base of the implant, or may have a spring around the shaft such that rotation of the shaft relative to the fixed portion or base of the implant due to torsion in the shaft or in the spring around at least a portion of the shaft may cause twisting of the LAA.

[0371] In other embodiments, the implant may have a shaft or body portion extending from a base, where the shaft may be rotatable (manually, via a catheter, or self-rotating) from a first rotational position relative to the base to a second rotational position, and where a ratchet mechanism or other fixation mechanism may be used to fix the shaft or body portion relative to the base in the second rotational position. The base may be configured to engage and fix to the heart wall or tissue around the LAA before the shaft or body portion engages an inner wall portion of the LAA and before the shaft or body portion rotates to the second position.

[0372] Additionally, in any of the devices, implant devices, methods, or other embodiments disclosed herein, the second rotational position may be at least one-eighth or about one-eighth of a full rotation (i.e., 45 degrees or about 45 degrees), one-quarter or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees), or at least one-half or about one-half of a full rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position, or where the second rotational position may be from one-eighth or about one-eighth of a full rotation (i.e., 45 degrees or about 45 degrees) to one-half or about one-half of a full rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position. In any of the devices, implant devices, methods, or other embodiments disclosed herein, the second rotational position may be from one-quarter or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees) to one or more or about one or more full rotations (i.e., 360 degrees or about 360 degrees or more), or from one-quarter or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees) to two, three, or more full rotations or about one or more full rotations (i.e., 360 degrees or about 360 degrees or more) relative to the first rotational position, one-eighth or about one-eighth of a full rotation (i.e., 45 degrees or about 45 degrees) to one, two, three, or more full rotations or about one or more full rotations (i.e., 360 degrees or about 360 degrees or more) relative to the first rotational position, or any value or range of values within any of the foregoing ranges. In any of the embodiments disclosed herein, the torsional movement or step may be achieved via a torque catheter.

[0373] Furthermore, in any of the device, implant device, or method embodiments disclosed herein, the catheter may be configured to apply torque to the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached, or until the user decides to stop rotating, whichever is earlier. In some embodiments, the threshold predetermined torque level may be from a torque of 0.25 in-oz or about 0.25 in-oz to a torque of 10 in-oz or about 10 in-oz, or from a torque of 0.5 in-oz or about 0.5 in-oz to a torque of 5 in-oz or about 5 in-oz.

[0374] In any of the embodiments disclosed herein, non - limitingly, the outer diameter or size of the contact member when in the first or collapsed state can range from about 3 mm to about 8 mm (about 9 Fr to about 24 Fr), or from about 4 mm to about 6 mm, or any value or range of values between any of the foregoing ranges, and / or the length (of the arm or strut member) can range from about 20 mm to about 60 mm, or from about 30 mm to about 50 mm, or any value or range of values between any of the foregoing ranges. Additionally, in any of the embodiments disclosed herein, non - limitingly, the outer diameter or size of the contact member when in the second or deployed state can range from about 6 mm to about 14 mm (about 18 Fr to about 42 Fr), or any value or range of values between any of the foregoing ranges, or from about 9 mm to about 11 mm, or any value or range of values between any of the foregoing ranges, and / or the length (of the arm or strut member) can range from about 10 mm to about 40 mm, or from about 20 mm to about 30 mm, or any value or range of values between any of the foregoing ranges.

[0375] In any of the embodiments disclosed herein, non - limitingly, the outer diameter or size of the fixation element when in the first or collapsed state can range from about 3 mm to about 8 mm (about 9 Fr to about 24 Fr), or any value or range of values between any of the foregoing ranges, or from about 4 mm to about 6 mm, and / or the length can range from about 4 mm to about 12 mm, or from about 6 mm to about 8 mm, or any value or range of values between any of the foregoing ranges. Additionally, in any of the embodiments disclosed herein, non - limitingly, the outer diameter or size of the fixation element when in the second or deployed state can range from about 6 mm to about 18 mm (about 18 Fr to about 54 Fr), or from about 9 mm to about 15 mm, or any value or range of values between any of the foregoing ranges, and / or the length (of the arm or strut member) can range from about 4 mm to about 8 mm, or from about 4 mm to about 6 mm, or any value or range of values between any of the foregoing ranges. Further, any of the embodiments of the fixation element disclosed herein can have a tissue - engaging tip or portion (i.e., a portion configured to penetrate or engage tissue), and the length of the tissue - engaging tip or portion ranges from about 0.2 mm to about 2 mm, or from about 0.5 mm to about 1 mm, or is any value or range of values between any of the foregoing ranges.

[0376] Compared to the conventional devices described above, some embodiments of the occlusion devices disclosed herein can be configured to more closely mimic surgical - type occlusion, where the LAA is not occluded but rather sealed off and the device is limitedly exposed in the left atrium.

[0377] Access to the LAA can be obtained by passing through the femoral vein and through a septal perforation into the venous system and into the left atrium. Imaging can be used with fluoroscopy and echo (TEE, ICE, or transthoracic), the size, orientation, and position of the LAA to enable entry of the prosthesis for occlusion. Figures 1, 64, and 65 illustrate at least a portion of the path from the access site to the LAA.

[0378] Some embodiments of the implant devices disclosed herein have two anchors that can be placed in the lateral ends of the LAA orifice and an oval mesh cover that can be attached to the two anchors. For any of the embodiments disclosed herein, the steps of deployment and implantation can include: inserting a catheter expander into the lateral ends of the LAA orifice; positioning the anchors; deploying the mesh cover along the extended catheter to the anchors; and / or attaching the mesh cover to the anchors.

[0379] In some embodiments, the mesh cover can be configured to maintain the extended position of the anchors and cover the orifice of the LAA. Embodiments of the implant device 1600 of this design are shown in Figures 66A - 66D and Figures 68A - 68F In some embodiments, the lateral anchors 1601 of the implant device 1600 can have a larger backing that can encapsulate the atrial wall between this backing and the mesh 1602 attached later. Figures 67A - 67D Additional embodiments of the anchors 1610, 1612, 1614, and 1616 are shown in. Alternatively, the anchors can be connected and separated via a hinged mechanism, so there is no need for the mesh cover to provide this structural separation.

[0380] Figures 69A - 69G Another embodiment of the device 1620 and the method for deploying the implant 1622 is shown, where one end comes out first and is anchored, and then the other end comes out. Some embodiments of this method and the device 1620 have the following characteristics, including but not limited to: (1) there can be more space to support the mesh by staggering the second anchoring catheter behind the mesh in the delivery system, and (2) the placement of the lateral anchors may be more precise when positioning one lateral anchor at a time. Another option would be to lock the anchors in place through barbs, barbs, or spiral mechanisms, thereby further strengthening the attachment of the anchors to the atrial wall at the lateral ends of the LAA orifice.

[0381] Figures 70A - 70FAnother embodiment showing the device 1640 and a method of deploying such a device may include deploying a plurality of staples, backing staples, clamps, or other fasteners 1644 (collectively referred to herein as staples) in a sequential manner after changing the shape of the LAA orifice to a narrow oval. Some embodiments may include a series of customized staples 1644 that may be placed all the way along the LAA orifice after the shape of the LAA orifice is changed to a narrow oval. These staples 1644 may have a backing thereon, which may provide a reaction force to the traumatic end of the staple to divide the tissue and pull the top and bottom of the atrial wall together, thereby sealing the LAA orifice in a lateral manner. The backing may also provide a large sealing area inside the LAA, which is not achievable with conventional staples. As mentioned, Figures 70A - 70F Shows the deployment of backing staples 1644 in a sequential manner after changing the shape of the LAA orifice to a narrow oval. When the staples are engaged and closed, these staples further bring the two ends of the tissue together, thereby sealing the LAA orifice.

[0382] In any of the embodiments disclosed herein, any combination of the following steps may be used to deploy the implant: inserting a catheter expander into the lateral end of the LAA orifice; applying one or more staples at one end (or both sides) of the extended LAA; removing the catheter expander from the LAA orifice (or only one side); reinserting the catheter expander into the LAA orifice, placing it between the last backing staple and the distal end; applying a backing staple at one end of the extended LAA; and / or repeating any one or all of the last three steps until the LAA orifice is closed or sealed.

[0383] Figures 71A - 71G Shows some details of some embodiments of the staple 1644 (which may be a backing staple). Any embodiment of the backing feature of the staple 1644 may be of any shape and does not necessarily need to be made of metal or the same material as the staple. Figures 71A - 71G And 72A - 72F show additional details of the device 1648 that gives the backing staple 1644 a "z - bend" to further bring the two ends of the atrial wall together. Figures 72A - 72F Also shows an embodiment of a catheter mechanism device and a method of forming this "z - bend" on the staple body, which will shorten the distance between the two tines of the staple.

[0384] Another embodiment of the implant device and method may include a series of sutures or staples along the LAA orifice after the shape of the LAA orifice has been changed to a narrow oval, thereby sealing the LAA orifice in a lateral manner. Figures 73A - 73BAn example of an apparatus 1650 and method for achieving this is shown. The deployment and implantation steps may include: inserting a catheter expander 1652 into the lateral end of the LAA orifice; applying sutures (or staples) 1654 along the inner edge of the expander (on one or both sides); removing the catheter expander from the LAA orifice; reinserting the catheter expander into the LAA orifice, between the positions where the last suture was placed; applying sutures along the inner edge of the expander; and / or repeating the last three steps until the LAA orifice is closed or occluded.

[0385] Another embodiment of an implantation apparatus 1660 and method may include a series of sutures or staples 1644 along the LAA orifice before the shape of the LAA orifice is changed to a narrow oval shape. After tensioning, the placement and connection of the sutures change the shape to a narrow oval shape, thereby occluding the LAA orifice in a lateral manner. Figures 74A - 74E An embodiment of an apparatus and method for achieving this is shown. Some embodiments of the deployment and implantation method of such an apparatus may include: inserting a catheter expander into the middle of the LAA orifice and expanding it from top to bottom; applying sutures (or staples) along the edge of the expander (on one or both sides); removing the catheter expander from the LAA orifice; reinserting the catheter expander into the LAA orifice, between the position where the last suture was placed and the lateral end; applying sutures along the inner edge of the expander; and / or repeating the last three steps until the LAA orifice is closed or occluded.

[0386] Any embodiment of the implantation apparatus and / or method disclosed herein may include a series of implant staples along the LAA orifice after the shape of the LAA orifice has been changed to a narrow oval shape, thereby occluding the LAA orifice in a lateral manner. Figures 75A - 75E An embodiment showing some stages of the formation of a staple 1670 (which may have any features, shapes, or other details of any other staple embodiments disclosed herein), from left to right: the staple will leave the catheter, open and be ready for tissue engagement, be applied and anchored to the atrial wall tissue, and z-bend to bring the tissue ends together. Above Figures 72A - 72F An embodiment of a method for forming a z-bend is shown. In any embodiment disclosed herein, the deployment and implantation steps may include (refer to Figures 76A - 76E ): inserting a catheter into the middle of the LAA; extending the catheter with an attached folded staple; unfolding (opening) the staple; advancing the staple into the tissue; folding or z-bending the staple to shorten and bring the tissue together; and / or repeating the last four steps until the LAA orifice is closed or occluded. Any embodiment of the staple or delivery device disclosed herein may be used in combination with other delivery devices or implant embodiments to anchor or occlude other LAA covers or closure devices.

[0387] Another embodiment of the implant device includes a compression spring that, when inserted into the LAA orifice, changes the shape of the LAA orifice to a narrow oval, thereby occluding the LAA orifice in a lateral manner. Figures 77A - 77C Illustrates the compressed state of spring 1680 and subsequent deployment phases. Figures 78A - 78C Illustrates the deployment phase for this design. In some embodiments, the steps of deployment and implantation may include: inserting a catheter into the middle of the LAA orifice; releasing the tension on the cable that restricts the compressed state of the spring; guiding the ends of the spring into the lateral ends of the LAA orifice; and / or releasing the delivery catheter from the implant.

[0388] Figures 79A - 79C Illustrates the same embodiment of the spring device 1680 described above, but covered with a mesh or graft material 1682 that will promote ingrowth of tissue and ultimately occlude / seal the LAA. In some embodiments, the spring device 1680 may be made of metal or plastic and may be formed from wire, tape, or sheet. Embodiments of the spring device 1680 may also incorporate some telescoping or sliding features internally to guide its deployment trajectory and ensure its straightness.

[0389] Another embodiment of the implant device is an articulated or flexible member 1690 that is collapsible to fit inside a delivery catheter. During implant delivery, some embodiments of deploying the implant 1690 include withdrawing the delivery catheter sheath, which allows the implant 1690 to partially articulate open or bend open when it becomes unconstrained by the sheath. Then, the ends of the implant 1690 can be guided into each end (upper and lower) of the LAA, and each end of the implant 1690 can be held in place by friction elements or forces in any manner that allows the device to stabilize within the LAA during continued deployment. Full deployment of the implant 1690 will cause the LAA orifice to extend from an open orifice to a narrower orifice, which can be pulled down to seal around the implant. This reduction in the height of the LAA effectively (substantially or completely) occludes or closes the opening of the LAA to isolate it from the LA. In any of the embodiments disclosed herein, the terms closure or occlusion are also used herein to mean occlude, substantially occlude, and / or close. Occluding the edges of the LAA will now eliminate the flow between the left atrium and the LAA and occlude the flow in either direction, and prevent potential thrombus migration into the circulatory system.

[0390] In some embodiments, the steps of deployment and implantation may include: inserting a catheter into the middle of the LAA orifice; allowing the articulated implant to deploy (by spring assistance or by screw, wire, or hydraulic actuation); guiding the ends of the implant into the lateral ends of the LAA orifice; fully opening the implant and locking its position; and / or releasing the delivery catheter from the implant. The articulated or flexible implant 1690 may have various shapes, from Figures 87A - 87C, the extremely fine wires shown in 88A - 88C and 89A - 89C when made of wires with diameters that can range from 0.020" to diameters that can range from 0.060", to Figures 80A - 80C and the coarser rectangular shapes shown in 81A - 81C that can range from 0.060" to can range from 0.25", to Figures 82A - 82C the oval or "football" shapes shown in 83A - 83C, 84A - 84C, 85A - 85C and 86A - 86C where the middle can be thicker than the ends.

[0391] The mechanism for opening the implant 1690 after deployment can be passive or active. A passive mechanism will bias the implant 1690 to an always - open or normally deployed state and will be implemented by things such as Figures 84A - 84C the torsion springs shown in. Other spring - like methods will also achieve similar results, such as the implant itself having spring - like properties where the implant biases itself to an always - open state. The implant can also be actively deployed into place by screw - type mechanisms, pull - wire and lock mechanisms, hydraulic actuators or other mechanisms.

[0392] Articulated or flexible implants can also have features at the lateral ends to locate and engage the LAA orifice for placement and secure engagement of the implant, thus contributing to deployment accuracy and long - term migration resistance. Examples of these engagement features are shown in Figures 85A - 85C below, where the "finger and thumb" feature holds the lateral edges of the LAA orifice during deployment, as shown in Figures 86A - 86C shown. In Figures 95A - 95C , 96A - 96C and 97A - 97C show another embodiment of an implant 1750 having gripping or engaging features on the edge of the implant, where textures, serrations or teeth are used to engage the LAA lateral edge.

[0393] Another implant embodiment has a flexible or spring - like component that can be folded to fit inside a delivery catheter. Figures 87A - 87C and 88A - 88C show another embodiment where the implant 1760 can be composed of a torsion spring with shaped ends, where during implant delivery, the ends of the implant 1760 can be guided into each end (upper and lower) of the LAA, and each end of the implant 1760 can be held in place by friction elements, specific shapes or forces in any way that will allow the device to stabilize within the LAA during continued deployment. Full deployment of some embodiments of the devices disclosed herein can cause the LAA orifice to extend from an open hole to a slit in the hole, this reduction in the height of the LAA effectively seals the opening of the LAA and isolates it from the LA. The gripping features at the ends of any implant embodiments disclosed herein can be formed by the torsion spring wire itself, or can be added to features such as pads, gripping plates or other features that provide sufficient engagement with the tissue.

[0394] Figures 89A - 89C Shows the same torsion spring implant 1760, but with a cap 1762 that includes a sealing material covering all or a portion of the implant 1760 to seal any remaining unsealed space in the LAA orifice after implantation and linearization. Figures 90A - 90C Figures 91A - 91C and 92A - 92C show similar designs of implant 1770, where implant 1770 does not have a spring in all of its embodiments. Implant 1770 can be configured to achieve a locked straight position by stopping in a super - extended state.

[0395] Figures 93A - 93C and Figures 94A - 94C Shows an embodiment of implant 1780 that has a hinge mechanism similar to that of implant 1770, but with added anchoring features or barbs to prevent the lateral atrial wall tissue from relaxing and drifting posteriorly and superior - inferiorly over time, which could cause leakage. Figures 95A - 95C Figures 96A - 96C, 97A - 97C, and 98A - 98C show implant 1790, which has a similar hinge mechanism but with a 4 - bar mechanism that holds an anchoring pad or gripping pad at the distal end parallel to the catheter, thus potentially enabling better gripping and easier engagement.

[0396] Another embodiment of the implant device is a multi - articulated or multi - strut flexible component that can be collapsed to fit inside a delivery catheter. During implant delivery, the multi - articulated mechanism can be deployed within the LAA orifice to linearly unfold and extend the LAA orifice, thereby closing the superior atrial wall to the inferior atrial wall. The deployment and implantation steps can include: inserting the catheter into the middle of the LAA orifice; allowing the deployment of the multi - articulated implant (driven by screws, wire pulls, or hydraulic actuation); guiding the ends of the implant to the lateral ends of the LAA orifice; fully opening the implant and locking its position; and / or releasing the delivery catheter from the implant. Figures 99A - 99C Figures 100A - 100C and 101A - 101C show additional embodiments of implant 1800 having a multi - articulated collapsing or folding mechanism. Figures 102A - 102C Shows an additional embodiment of implant 1810 having a multi - articulated collapsing or folding mechanism. There are many options for this type of mechanism. Figures 101A - 101C Shows implant 1800 having a mesh or graft cap 1802 to assist tissue ingrowth into the atrium.

[0397] Another embodiment of implant 1820 has a conical mesh 1822 with anti - slip spikes or barbs at the perimeter of implant 1820. Two embodiments are shown, one having a circular shape and the other having an elongated shape. Figures 103A - 103DFigures 104A - 104E illustrate a circular variant of the implant 1820, wherein the deployment and implantation steps may include: inserting a catheter into the middle of the LAA orifice; allowing the deployment of the conical circular webbed barbed implant 1820; guiding the implant 1820 to fully cover the LAA orifice; applying forward pressure to the implant 1820 to engage the peripheral barbs 1824 and invert the implant 1820; and releasing the delivery catheter from the implant 1820. This implant may anchor or couple the LAA orifice and / or the tissue around the LAA orifice to the atrial wall just outside the radius of the LAA orifice via anti-slip spikes or barbs 1824 at the periphery of the implant 1820. The anchors 1824, deployed and positioned in its conical shape to cover the LAA orifice, dig into the atrial wall with a radially outward movement as the cone shape of the implant flattens and then finally slightly inverts as it is advanced. After inversion, the delivery system may be removed from the implant 1820. A feature of some embodiments of this design is that it does not depend on a certain depth of the LAA, as no part of the delivery catheter or implant ever enters the LAA. Even if not all of the anchors engage, this design locks itself in place.

[0398] Figures 105A - 105E Figures 106A - 106D illustrate an elongate variant, wherein the steps of an embodiment of the deployment and implantation may include: inserting a catheter into the middle of the LAA orifice; allowing the deployment or opening of the elongate webbed barbed implant 1830; guiding the implant 1830 to fully cover the LAA orifice from two sides (while the top and bottom will not be covered); applying forward pressure to the implant 1830 to engage the peripheral barbs, widen and narrow the LAA orifice, and finally invert the implant 1830; and / or releasing the delivery catheter from the implant 1830. This implant may anchor or couple to the atrial wall just outside the lateral radius of the LAA orifice via anti-slip spikes or barbs 1834 at the ends of the implant 1830. The anchors 1834, deployed and positioned in its folded shape to cover the LAA orifice, dig into the atrial wall with a laterally outward movement as the implant flattens and then finally inverts, thereby narrowing the LAA orifice as it widens. After inversion, the delivery system may be removed from the implant 1830. A characteristic of some embodiments of the implants disclosed herein is that the implants do not depend on a certain depth of the LAA, as no part of the delivery catheter or implant ever enters the LAA. Some embodiments of the implant are also configured to lock themselves in place, even if not all of the anchors engage. This elongate embodiment may also have a smaller surface area of exposed material compared to the circular embodiment.

[0399] Another embodiment of the implant device 1840 uses a radial reduction method to occlude the LAA ostium. In this design, a number of lumens are mounted to a balloon, a deployable mesh, or other structure for guiding needles, anchors, or barbs 1842 through sutures attached to the perimeter of the LAA ostium on the atrial wall. Once deployed in place, the anchors 1842 are advanced through the lumens into the atrial wall around the LAA ostium. The balloon can be deflated and the sutures crimped or tightened under tension, pulling the LAA ostium into an occluded state. A small plug of material may be left to seal any remaining space. Figures 107A - 107G An embodiment showing the device 1840 and at least some of the steps for deploying the device 1840. The steps of deployment and implantation may include: inserting a catheter into the middle of the LAA ostium and positioning it at an appropriate depth; deploying the balloon 1844 (which can also be a deployable mesh or other structure); advancing each anchor 1842 attached to a suture 1846 through the lumen around the balloon into the atrial wall around the LAA ostium; deflating the balloon 1844 and pulling the suture under tension to occlude the LAA ostium, and crimping or tying the suture 1846 to maintain the reduced diameter position (a plug may be inserted to seal any remaining portion of the LAA ostium if necessary); and / or disengaging the delivery catheter from the implant 1840.

[0400] Another embodiment of the implant device uses a radial reduction method to occlude the LAA ostium from inside the LAA. Figures 108A - 108C Figures 109A - 109C, 110A - 110E, 111, 112, 113A - 113C, and 114A - 114C show additional embodiments of devices for treating the LAA. The embodiments of the devices shown in the foregoing figures may be configured to grasp the atrial wall through anchors or barbs around the LAA ostium and then pull the anchors or barbs downward (or inward) through a mechanism located inside the LAA. This mechanism can be activated through an attached delivery system that can be undocked and removed from the implant once locked in the closed position.

[0401] Figures 108A - 108C An embodiment showing the device 1860 and some of the steps of a method for deploying the anchors 1862 and other parts of the device 1860, which can be achieved through a balloon or spring, a mechanical actuator, or other deployer. In other embodiments, the anchors 1862 can be self - deploying. Figures 110A - 110C Some steps of an embodiment showing the device 1860. Figures 109A - 109C Another embodiment showing the device 1868 that can be used to treat the LAA. Figure 111 、 112113A - 113C respectively illustrate additional embodiments of devices 1870, 1880, and 1890, which have reduced barb portions that allow for several devices to occlude the LAA orifice. In this way, if, for example, two, three, four, or more of these devices are used in a row, each pulling the atrial wall from top to bottom for occlusion, lateral occlusion can be achieved. The resulting occlusion will be a lateral occlusion of the LAA. Figures 114A - 114C Illustrate additional embodiments of implant 1900, which has more barbs to provide more anchoring points between the implant and tissue. One or more of implants 1900 can be used to close the LAA.

[0402] An additional embodiment of implant 1910 uses a method to laterally expand the LAA orifice and then clamp or grip it closed, thus closing the atrial wall from top to bottom and isolating it from the interior of the LA. Figures 115A - 115C 116A - 116C and 117A - 117C illustrate some embodiments of device 1910. One feature on some embodiments of implant device 1910 (or on the delivery catheter) that is visible in the figures is an extension or lateral bar. This is rounded bar 1912, which is connected to each lateral end of device 1910 and expands the LAA orifice when advanced into the LAA, thereby also narrowing the LAA orifice. Once the articulated clamp or barbs press against the atrial wall just above the LAA orifice, the gripper is closed or clamped shut. When the gripper is closed, the gripper engages the atrial wall above and below the LAA and pulls the atrial wall together, and locks a portion of the atrial wall in occlusion.

[0403] The deployment and implantation steps for some embodiments of the implant devices disclosed herein may include: inserting a catheter into the middle of the LAA orifice; advancing the implant until the gripping jaws contact the atrial wall and the extension bar has expanded the LAA orifice; actuating the closure of the jaws, which can be actuated by a pull wire or other mechanism (or can be spring - driven to a normally - closed state where the jaws remain open before deployment and simply release after deployment); locking the jaws in the closed state; and / or releasing the delivery catheter from the implant.

[0404] Another embodiment of implant device 1920 includes folding or kinking the LAA at the orifice and then clamping and holding this position, thereby effectively occluding the LAA. Figures 118A - 118D Illustrate a variant of the sequence of steps to achieve this. In some embodiments, the deployment and implantation steps may include: inserting a catheter into the middle of the LAA orifice; bending a portion of implant 1920 in a first direction (which can be upward as shown in the figures); clamping and holding the bent portion of implant 1920 to the position of the atrial wall (additional anchoring can be used to anchor the implant to the lower atrial wall); and / or releasing the delivery catheter from implant 1920.

[0405] As Figures 119A - 119D shown in and 120A - 120C, another embodiment of the implant device 1930 uses a plug - type occluder that is not circular and does not reshape the LAA into a circle. Instead, the implant can be oval or narrow, where its length (represented by L in Figures 120A - 120C ) can be made greater than the width or height of the implant (represented by W in Figures 120A - 120C ) by intentionally manipulating the shape of the LAA using the implant device 1930. Figures 119A - 119D The implant 1930 shown in and 120A - 120C can have a metal stent covered with a mesh or graft material. The implant 1930 can be self - expanding, balloon - expandable, mechanically expandable, or other forms, and can have a shape that is biased to be wider (L) than its height (W). In any of the embodiments disclosed herein, the steps of deployment and implantation can include: inserting a catheter into the middle of the LAA orifice; positioning the depth of the implant and deploying it; after deployment, allowing the implant to reshape the LAA anatomy into an oval shape where the LAA orifice is wider than its height; implanting or applying a radial force and / or anti - slip spikes or anchors to hold the implant in place; and / or releasing the delivery catheter from the implant.

[0406] Any embodiment of the implant (such as the implant 1950 shown in Figures 121A - 121C ) can also be a hybrid of a self - expanding LAA closure plug 1952 and a lateral deployment device 1954. The implant 1950 can first be deployed in a circular shape and then reshaped into an oval shape by the deployment device, which can be biased (e.g., but not limited to, spring - biased) to the deployment position or can be an actuated mechanism.

[0407] Figure 122 And 123 are a top view and a side view, respectively, of another embodiment of an implant 2000 for treating or occluding an opening such as, but not limited to, the LAA. The implant 2000 can have a frame 2002 that can be expanded from a collapsed state to an expanded state. Figure 122 Shows the expanded state of the frame 2002. The frame can be self - expanding, mechanically expandable using a balloon, or other forms. The frame can be made of one or more wires or strips. In some embodiments, the frame 2002 can be laser - cut from an extruded tube, a flat sheet, or other materials. If laser - cut from a flat sheet, the ends of the frame can be welded, brazed, or otherwise permanently joined together to form a continuous wall 2003 of the frame 2002.

[0408] The frame may have a plurality of components 2004 interconnected to form the frame 2002. The components 2004 may have a plurality of openings 2006 between the components 2004 of the frame 2002. A plurality of apexes 2010 may be formed between some adjacent components 2004. In some embodiments, the apexes 2010 may facilitate bending of the components 2004 during deployment from a collapsed or first state to an expanded or second state, the expanded second state being shown in Figure 123 As shown. In any of the embodiments disclosed herein, the components 2004 and the apexes 2010 may form a zigzag pattern.

[0409] Referring Figures 122 - 123 to, the implant 2000 may have an elongated shape. In some embodiments, the implant 2000 may have an elongated shape along the entire length of the implant 2000. The term length is intended to refer to the axial direction of the implant, as identified by arrow AL in Figure 123 As shown. The frame 2002 may have an opening 2014 that extends axially from the proximal end 2002a of the frame 2002 through the frame to the distal end 2002b. The opening 2014 may be continuously surrounded by a wall 2003 formed by the frame 2002.

[0410] Referring Figure 122 to, in any of the embodiments disclosed herein, the frame 2002 may be sized and configured such that the opening 2014 defines a first width or dimension W1 that spans the opening 2014 of the frame 2002 from a first portion 2020 to a second portion 2022 in a first direction (indicated by arrow A1), the first width or dimension being greater than a second width or dimension W2 of the opening 2014 in a second direction (indicated by arrow A2) perpendicular to the first direction A1 when the implant 2000 is in a deployed in situ state in the LAA or when the implant 2000 is in a natural expanded state in vitro. In any embodiment in which the implant is self-expanding, the natural expanded state in vitro may be an unconstrained shape. The first direction and the second direction (A1, A2) may be perpendicular to the direction AL or the axial direction shown in Figure 123 As shown. In some embodiments, by way of non-limiting example, the first width may optionally be defined as the innermost portion of the first portion 2020 in the region configured to engage or contact the orifice, whether or not the frame 2002 has a first recess 2032, to the innermost portion of the second portion 2022 in the region configured to engage or contact the orifice, whether or not the frame 2002 has a second recess 2034.

[0411] In any of the embodiments disclosed herein, when the implant 2000 or any other implant embodiment or implementation disclosed herein is in a relaxed state, a natural deployment state (i.e., deployed in vitro without external force from the LAA acting on the implant), and / or a mechanical deployment state, the first width W1 of the opening 2014 can be about 3.5 times the second width W2 of the opening 2014 in some embodiments, or at least about twice the second width W2 of the opening 2014 (i.e., the first width W1 of the opening 2014 can be twice the second width W2 of the opening 2014, or in some embodiments, about twice to about eight times the second width W2 of the opening 2014, or in some embodiments, twice to about four times the second width W2 of the opening 2014, or about three times to about four times the second width W2 of the opening 2014, or any value to any value within these ranges).

[0412] In any of the embodiments disclosed herein, when the implant 2000 or any other implant embodiment or implementation disclosed herein is in a relaxed state, a natural deployment state, and / or a mechanical deployment state, before or after one or more additional clamps, staples, sutures, or other additional occlusion devices - if present - are deployed to further occlude the orifice of the LAA, the implant 2000 can define a ratio of the first width W1 of the opening 2014 to the second width W2 of the opening 2014, the ratio being about 3.5:1, or at least about 2:1, or in some embodiments from about 2:1 to about 8:1, or in some embodiments from about 3:1 to about 4:1, or any value to any value within these ranges. For example, in some embodiments, after the implant has been fully deployed to any one of the above ratios or ratio ranges, such additional clamps, staples, sutures, or other additional occlusion devices can be implanted into the patient to further occlude or completely occlude the orifice of the LAA. In some embodiments, as stated above, the implant can be deployed to any one of the above ratios or ratio ranges, and then no additional occlusion devices are implanted.

[0413] In any of the embodiments disclosed herein, when the implant 2000 or any other implant embodiment or implementation disclosed herein is in an in - situ deployed state in the LAA, the first width W1 of the opening 2014 can be about 3.5 times the second width W2 of the opening 2014 in some embodiments, or at least about twice the second width W2 of the opening 2014 (i.e., the first width W1 of the opening 2014 can be twice the second width W2 of the opening 2014), or in some embodiments from about twice to about eight times, or from about twice to about six times, or from about twice to about four times, or about three times to about four times the second width W2 of the opening 2014, or any value to any value within these ranges.

[0414] In any of the embodiments disclosed herein, when the implant 2000 is in a deployed in situ state in the LAA, the implant 2000 can define a ratio of a first width W1 of the opening 2014 to a second width W2 of the opening 2014, the ratio being about 3.5:1, or in some embodiments at least about 2:1, or in some embodiments from about 2:1 to about 8:1, from about 2:1 to about 6:1, or from about 3:1 to about 4:1, or any value to any value within these ranges.

[0415] In some embodiments, the implant 2000 and any other implant embodiments or implementations disclosed herein can be configured such that deploying the implant 2000 in the orifice of the LAA can increase the first width of the orifice (in the same direction as the first width W1 of the implant 2000) by at least about 40% (i.e., compared to the first width of the orifice before deploying and expanding the implant, thereby increasing the first width of the orifice by at least about 40%), or by about 65% or more, or by up to about 100%. Additionally, in some embodiments, with no change in the first width of the orifice or in combination with any of the above percentage increases in the first width of the orifice, deploying the implant 2000 in the orifice of the LAA can decrease the second width of the orifice (in the same direction as the second width W2 of the implant 2000) by at least about 50% (i.e., thereby halving the second width of the orifice), in some embodiments by about 25% to about 100%, or by about 40% to about 85%, or by about 40% to about 75%.

[0416] In any of the embodiments disclosed herein, the implant 2000 or any other implant embodiments or implementations disclosed herein can be configured such that when the implant 2000 is in a deployed in situ state in the LAA, deploying the implant 2000 in the orifice of the LAA can change the first width of the orifice (in the same direction as the first width W1 of the implant 2000) and the second width of the orifice (in the same direction as the second width W2 of the implant 2000) such that the orifice of the LAA defines a ratio of the first width of the orifice to the second width of the orifice (after deploying and expanding the implant 2000 or any other implant embodiments or implementations disclosed herein), the ratio being about 3.5:1, or at least about 2:1, or in some embodiments from about 2:1 to about 8:1, or in some embodiments from about 3:1 to about 4:1, or any value to any value within these ranges.

[0417] Any embodiment of the frame 2002 of the implant 2000 may flare outwardly at least at the first part and the second part 2022 of the frame 2002 at the proximal end 2002a of the frame 2002 to achieve better fixation to the tissue around the LAA and / or more accurate positioning during deployment. By way of example and not limitation, the frame 2002 may have a first tip extension 2024 extending away from the proximal end 2002a of the frame 2002 at the first part 2020 or the wall 2003 of the frame 2002. The first tip extension 2024 and / or the second tip extension 2026 may be configured in some embodiments to bias the proximal end 2002a of the frame 2002 to be generally aligned with the outer edge or surface E of the orifice (as Figure 124 shown). In some embodiments, the first tip extension 2024 may extend away from the proximal end 2002a of the frame 2002 at the first part 2024 of the wall, wherein the first tip extension 2024 is configured to prevent the frame from passing completely through the orifice O of the LAA (as Figure 124 shown). This may be achieved by overlapping a portion of the outer surface of the orifice O with at least one of the first tip extension 2024 and the second tip extension 2026.

[0418] Some embodiments of the implant 2000 may have a first tip extension 2024 extending away from the proximal end 2002a of the frame 2002 at the first part 2020 of the wall 2003. When the implant 2000 is in an operative position within the LAA, the first tip extension 2024 may be configured to overlap the outer surface E of the wall portion W around the orifice O of the LAA, a non-limiting example of which is shown in Figure 124 shown. Additionally, in some embodiments, the implant 2000 may have a second tip extension 2026 extending away from the proximal end 2002a of the frame 2002 at the second part 2022 of the wall 2003 of the frame 2002. In some embodiments, when the implant 2000 is in an operative position within the LAA, the second tip extension 2026 may be configured to bias the proximal end 2002a of the frame 2002 to be generally aligned with the outer edge E of the orifice O, configured to prevent the frame 2002 from passing completely through the orifice O of the LAA, and / or configured to overlap the outer surface of the wall 2003 portion of the orifice O of the LAA.

[0419] In this configuration, the first and / or second apical extensions may assist during the implantation procedure by providing a limit to the depth to which the implant may be advanced into the LAA. For example, a surgeon may advance a catheter into or near the LAA and expose the implant 2000 in some embodiments by advancing the implant 2000 relative to an outer sheath on the catheter or by retracting the outer sheath to expose the implant 2000. The implant 2000 may be moved to an appropriate position within the LAA and then deployed to a second deployed state. When the implant 2000 is deployed to the deployed state, the first portion 2024 and the second portion 2026 may apply a force to the LAA such that the LAA is elongated in a first direction A1. In some embodiments, the implant 2000 may be configured to expand a first portion of the orifice O of the LAA away from a second portion 2022 of the orifice O opposite the first portion, thereby elongating the orifice O of the LAA in the first direction. For example, a first portion 2020 and a second portion 2022 of the wall of the frame 2002 may be configured to expand a first portion of the orifice O of the LAA away from a second portion of the orifice O opposite the first portion, thereby elongating the orifice O of the LAA in the first direction. This may cause the walls of the LAA orifice between the first portion and the second portion to move towards each other, thereby substantially occluding the orifice or forming a better seal of the orifice and isolating it from the implant periphery or surface such as the wall 2003 of the implant 2000. This can be a particularly effective method for forming a better seal around the implant for an irregularly shaped or non-smooth orifice.

[0420] During deployment, the depth of the implant relative to the orifice may be adjusted by moving the implant distally and proximally. The first apical extension 2024 and / or the second apical extension 2026 may engage the outer surface E of the tissue surrounding the orifice O and prevent or inhibit further distal advancement of the implant 2000 into the LAA, thereby ensuring the proper depth of the implant during the deployment procedure.

[0421] Reference Figures 123 - 124 , some embodiments of the frame 2002 may also have 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 opening or orifice of the LAA therein when the implant 2000 is deployed against the wall of the opening of the LAA. In some embodiments, the first recess 2032 and the second recess 2034 may be sized, shaped, and / or otherwise configured to bias the edge of the orifice opening or other tissue surface to remain in contact with the first recess 2032 and the second recess 2034. In some embodiments, the first recess 2032 and the second recess 2034 may have a curved profile. The first recess 2032 and the second recess 2034 may assist in fixing the implant to the orifice or body tissue.

[0422] Some embodiments of the implant 2000 may have a first recess 2032 in combination with the first tip extension 2024 and / or a second recess 2034 in combination with the second tip extension 2026. The first recess 2032 and / or the second recess 2034 at the first end portion 2020 and / or the second end portion 2022 may bias the implant 2000 to remain in a generally fixed position relative to the wall of the orifice, and / or may assist in the proper alignment of the implant 2000 relative to the orifice during the implantation procedure, which may be the orifice of the LAA. Additionally, any embodiment of the implant 2000 may be configured to have a saddle-shaped or convex shape (such that when viewed from one side as in Figure 124 ), the first end portion 2020 and the second end portion 2022 are higher than the middle portion of the implant 2000, or otherwise conformable such that when the implant 2000 is deployed in the LAA, the implant 2000 may have a curved profile that substantially matches the curved profile of the heart wall surrounding the LAA.

[0423] Any embodiment of the implant 2000 may, in some embodiments, have an anchor for anchoring or fixing the frame 2002 to the LAA, the anchor being located at least at the first portion and the second portion 2022 of the frame 2002. By way of example and not limitation, barbs, surface roughness, gripping members or gripping features or other surface features or fixing features may be added to the frame or the implant to fix the implant to the LAA, including but not limited to adding such features to the first portion 2020 and the second portion 2022. The frame 2002 may be configured such that a first rough area and a second rough area are formed thereon or are respectively on the outer surfaces of the first portion 2020 and the second portion 2022 of the frame 2002, the first rough area and the second rough area being configured to inhibit movement of the frame 2002 relative to the tissue surface of the orifice O of the LAA.

[0424] Reference Figure 125 , any embodiment of the implant 2000 may have a cover 2050 coupled to the frame 2002. The cover 2050 may at least partially cover the opening 2014 in the frame 2002. In some embodiments, the cover 2050 may completely or substantially completely cover the opening 2014 in the frame 2002. The cover 2050 may be made of any suitable material configured to block or inhibit the flow of blood, thrombus or other objects or substances through the orifice of the LAA. The cover 2050 may be made of a mesh material, a graft material or other materials.

[0425] Due to the elongated shape of the implant 2000, some embodiments of the implant 2000 may have a certain total cross-sectional area, the total cross-sectional area being, for example Figure 126The size and shape of the device 2060 shown, etc., are designed to occlude an orifice of a similar size in the LAA, and are approximately 70% smaller in cross-sectional area than some types of conventional occlusion devices, and, for example, Figure 126 The size and shape of the device 2062 shown, etc., are designed to occlude an orifice of a similar size in the LAA, and are approximately 50% smaller than other types of conventional occlusion devices. For example, some embodiments of the implant 2000 have an elongated shape, and its total cross-sectional area is approximately 50% to about 70% smaller, or about 50% to at least about 80% smaller, than an implant device designed to occlude an orifice of a similar size in the LAA and having a circular shape. Additionally, some embodiments of the implant 2000 or any other implant disclosed herein may have an elongated shape, and its total cross-sectional area is approximately 50% to about 70% smaller, or about 50% to at least about 80% smaller, than the cross-sectional area of the LAA orifice prior to implantation.

[0426] Such a reduction in size can significantly improve the patient's repair time, which indicates the time during which the patient may need to take anticoagulant medications, and taking anticoagulant medications is associated with risks. Since the cross-sectional area of the implant opening and / or the distance from the wall of the LAA to the central region of the implant is reduced, the longest distance that tissue cells must migrate from atrial tissue to the lid of the implant is shortened, which should shorten the repair time and reduce the time of using anticoagulant medications.

[0427] Some embodiments of the elongated implant disclosed herein can shorten the time during which a patient needs to take anticoagulant medications for safe repair after an LAA implantation procedure, which can shorten the total repair time after device implantation. In some embodiments, this can be achieved by shortening the distance that cells need to migrate from atrial wall tissue to cover the opening of the implant (which can be covered by a lid). For the LAA, an implant with a circular opening may result in the maximum migration distance, where the diameter is the distance that such cells must migrate. If the opening is elongated such that portions of the wall move to a position where they are closer together, the cell migration distance is reduced and thus the repair time can be reduced. A similar example of this difference in repair time can be found when comparing a 1-inch long (narrow) wound on the skin to a 1-inch diameter incision. Since both the surface area and the maximum distance from healthy tissue to healthy tissue are reduced, shortening the distance that cells need to travel to repair the wound, the 1-inch long wound will heal faster than the 1-inch diameter incision.

[0428] Any embodiment of the implant and / or delivery system disclosed herein may be configured to be partially or fully self-expanding, balloon-expandable, or otherwise mechanically expandable using any known or later-developed expansion device, including but not limited to balloon expansion devices commonly used for implants, stents, stent grafts, angioplasty devices, or other devices, or any expansion device disclosed herein. Similarly, any embodiment of the implant and / or delivery system disclosed herein may be configured to be partially or fully self-lengthening, balloon-lengthenable, or otherwise mechanically lengthenable, and may be configured to use, but not limited to, balloon expansion devices commonly used for implants, stents, stent grafts, angioplasty devices, or any expansion device or other means disclosed herein for partial self-lengthening and partial balloon or mechanical lengthening. By way of example and not limitation, some implant embodiments may be configured to self-expand and / or self-lengthen to an intermediate size or shape and then balloon-expand or otherwise mechanically expand and / or lengthen to a final size or shape. Similarly, in several embodiments, any such balloon or mechanical expansion device and / or such devices disclosed herein may be used to lengthen or complete the LAA orifice beyond the lengthening, if any, caused by the self-expansion and / or self-lengthening of the implant.

[0429] Figure 127 FIG. shows a non-limiting example of an expansion device 2100 that may be used to expand and / or lengthen an implant 2102, which may have any features, components, or other details of any embodiment disclosed herein. The expansion device 2100 may have an expandable member 2104 (which may be an expandable balloon in some embodiments) and an expansion lumen 2106 in fluid communication with the expandable member 2104. Any embodiment of the expandable member 2104 may have an elongated shape and / or be otherwise configured to cause the implant 2102 to expand to have an expanded and / or elongated shape, through which expansion fluid (such as air) may be delivered to the expandable member 2104. In some embodiments, the expandable member may comprise a plurality of individual or interconnected expandable members coupled together. By way of example and not limitation, Figure 128Shown is deployment device 2120, which can be used to deploy and / or elongate implant 2102, which can have any features, components, or other details of any of the embodiments disclosed herein, and the deployment device can have a deployable member 2124 that can include a plurality of individually deployable elements. The deployable member 2124 can have any number or size of deployable elements, and in some embodiments, the deployable elements can be coupled together in a desired arrangement or orientation. As shown, the deployable member 2124 can have a first deployable element 2126 positioned in a central portion of the deployable member 2124, a second deployable element 2128 adjacent to and / or coupled to one side of the first deployable element 2126, a third deployable element 2128 adjacent to and / or coupled to a second opposite side of the first deployable element 2126, a fourth deployable element 2130, and a fifth deployable element 2131.

[0430] The second deployable element 2128 and the third deployable element 2129 can have similar sizes to each other and a size smaller than that of the first deployable element 2126 in some embodiments. In some embodiments, the fourth deployable element 2130 and the fifth deployable element 2131 can have similar sizes to each other and a size smaller than that of the second deployable element 2128 and the third deployable element 2129. In some embodiments, any of the deployable elements 2126, 2128, 2129, 2130, and 2131 can have a spherical shape.

[0431] Non-limitingly, any embodiment of the deployment device 2100 or 2120 can be configured to deploy 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 about 3.5:1, or at least about 2:1, or in some embodiments from about 2:1 to about 8:1, or in some embodiments from about 3:1 to about 4:1, or any value to any value within these ranges, before or after one or more additional clamps, staples, sutures, or other additional occluding devices, if present, are deployed to further occlude the orifice of the LAA. For example, in some embodiments, after the implant has been fully deployed to any one of the above ratios or ratio ranges, such additional clamps, staples, sutures, or other additional occluding devices can be implanted into the patient to further occlude or fully occlude the orifice of the LAA. In some embodiments, as stated above, the implant can be deployed to any one of the above ratios or ratio ranges, and no additional occluding devices are implanted thereafter.

[0432] Figure 129 and 130 A side view of another embodiment of system 2200 is shown, andFigure 131 and 132 shows an end view of said another embodiment, the system having an implant 2202 and a delivery device 2204, the delivery device having a movable core 2206 (which can be a cannula, wire or other thing) that can be used to treat the LAA. In some embodiments, the implant 2202 can include one or more wires formed as a wire mesh or braid, and the wire mesh or braid can be moved between a first undeployed state (as shown in Figure 129 ) and a second deployed state (as shown in Figure 130 ) by reducing the length of the implant 2202 from a first length L1 (as shown in Figure 129 ) to a second length L2 (as shown in Figure 130 ). In the second deployed state, the implant 2202 can have any size, shape, components (including but not limited to a cap) and / or other details of any other implant embodiment disclosed herein, including but not limited to being configured to be deployable to any elongation ratio for any implant described herein. Similarly, by increasing the length of the implant 2202 from the second length L2 to the first length L1, the implant 2202 can be moved from the second deployed state to the first undeployed state.

[0433] The delivery device 2204 can have a distal support element 2210 that is releasably coupled to the distal portion 2202a of the implant 2202 and a proximal support element 2212 that is releasably coupled to the proximal portion 2202b of the implant 2202. The distal support element 2210 can be coupled to the distal end of the core 2206. The proximal support element 2212 can be slidable relative to the core 2206 and, in some embodiments, can be supported by the distal end of a tube 2216, and when the core 2206 is retracted proximally or advanced distally relative to the tube 2216, the distal end of the tube can keep the proximal support element 2212 in a fixed position relative to the distal support element 2210. In this configuration, when the core 2206 is retracted, the distal support element 2210 will move toward the proximal support element 2212, and the implant will deploy from a first state (as shown in Figure 129 ) to a second state (as shown in Figure 130 ). Thus, the implant 2202 can be advanced into ...

Claims

1. An implant device for treating the left atrial appendage, comprising: a contact member configured to move between a first state and a second state; and a fixing 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 left atrial appendage after the contact member has been advanced into the left atrial appendage; the contact member is configured to rotate from a first rotational position to a second rotational position at least in a first direction; the contact member is configured to twist at least a portion of the left atrial appendage in the first direction when the contact member rotates from the first rotational position to the second rotational position, and the fixing element is configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixing element is in an operable state, wherein the second direction is opposite to the first direction.

2. The device according to claim 1, characterized in that, The implant device is self - deployable such that the implant device automatically deploys from the first state to the second state when the restraint is removed from the implant device.

3. The device according to claim 1, characterized in that, The contact member is self - deployable such that at least a portion of the contact member automatically deploys from the first state to the second state when the restraint is removed from the contact member.

4. The device according to claim 1, characterized in that, The implant device is substantially collapsed when the implant device is in the first state and deployed when the implant device is in the second state, such that the size of the implant device is larger when the implant device is in the second state than when the implant device is in the first state.

5. The device according to claim 1, characterized in that, The contact member is biased to remain in the second state after being deployed into the left atrial appendage.

6. The device according to claim 1, characterized in that, The contact member is configured to rotate in a clockwise or counter - clockwise direction.

7. The device according to 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 a main body portion of the implant device when the contact member rotates to the second rotational position, and the fixing element is configured to engage the tissue that has contracted around the outer surface of the main body portion of the implant device to prevent rotation of the implant device in the second direction.

8. The device according to claim 1, characterized in that, The fixing element has a plurality of tissue anchors configured to engage the inner wall of the heart adjacent to the left atrial appendage.

9. The device according to claim 1, wherein The fixing element has a helical shape and is configured to rotate around a main body portion of the implant device during an implantation procedure.

10. The device according to claim 1, wherein: the implant device is configured to rotate from the first rotational position to the second rotational position in the first direction; and the implant device is configured to prevent rotation of the implant device in the second direction after the implant device is fully deployed.

11. The device according to claim 1, characterized in that, The contact member has a plurality of tissue anchors on its outer surface.

12. The device according to claim 11, characterized in that, 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 moves to the second state.

13. The device according to claim 1, characterized in that, The fixing element is configured to engage a portion of the heart tissue adjacent to the left atrial appendage.

14. The device according to claim 1, characterized in that, The second rotational position is at least a quarter of a full rotation relative to the first rotational position.

15. The device according to claim 1, characterized in that, The second rotational position is at least a half of a full rotation relative to the first rotational position.

16. The device according to claim 1, characterized in that, The second rotational position is from a quarter of a full rotation to one or more full rotations relative to the first rotational position.

17. The device according to claim 1, characterized in that, Comprising a catheter, the catheter being selectively coupled to the contact member and configured to apply a torque to the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached.

18. The device according to claim 17, characterized in that, The threshold predetermined torque level ranges from a torque of 0.25 in-oz to a torque of 10 in-oz.

19. The device according to claim 17, characterized in that, The threshold predetermined torque level ranges from a torque of 0.5 in-oz to a torque of 5 in-oz.

20. The device according to claim 1, characterized in that Comprising a retaining member, the retaining member being configured to bias the fixing element towards the tissue wall of the left atrial appendage.

21. The device according to claim 1, wherein Comprising a retaining member, the retaining member being configured to bias the fixing element towards the contact member.

22. The device according to claim 1, characterized in that, Comprising a retaining member, the retaining member being configured to couple the fixing element to the contact member.

23. The device according to claim 22, characterized in that, The retaining member includes a threaded shaft.

24. The device according to claim 22, characterized in that, The device is configured such that rotation of the retaining member in a first direction moves the fixing element towards the contact member.

25. The device according to claim 1, characterized in that, The contact member is configured to rotate from the first rotational position to the second rotational position at least in the first direction when a torque is applied to the contact member.

26. The device according to claim 1, characterized in that The device is configured such that the contact member can be removed from the left atrial appendage after the fixing element has been deployed to the operable state of the fixing element.

27. The device according to claim 1, characterized in that, The device is configured such that the contact member can be removed from the left atrial appendage after the fixing element has been deployed to the operable state of the fixing element, and wherein the fixing element is configured to prevent rotation of the tissue of the left atrium and / or the left atrial appendage that has contracted due to rotation of the contact member from the first rotational position to the second rotational position.

28. The device according to claim 1, characterized in that, After deployment of the device, only a portion of the fixing element extends into the left atrium, and after deployment of the device, all other parts of the device are inside the left atrial appendage.

29. The device according to claim 1, characterized in that, After deployment of the device, only 10% or less of the total length of the deployed device extends into the left atrium.

30. The device according to claim 1, characterized in that, The device is configured to be used by a surgical robot device or system.

31. A surgical robot device, characterized in that, Comprising one or more robotic arms and the device according to any one of the preceding claims, wherein the device according to any one of the preceding claims is configured to be used by the surgical robot device.

32. The device according to claim 31, characterized in that, The contact member and the fixing element are integrally formed and / or formed as a single unit.

33. The device according to claim 31, characterized in that, The device is configured to cause the tissue of the left atrium and / or the left atrial appendage to contract around the outer surface of the main body portion of the implant device when the contact member rotates to the second rotational position, and the fixing element is configured to compress the tissue that has contracted around the outer surface of the main body portion of the implant device between the distal surface of the fixing element and the contact member to prevent rotation of the implant device in the second direction.

34. A device for treating the left atrial appendage, comprising: An implant having a contact member configured to move between a first state and a second state; A catheter configured to advance the contact member into the left atrial appendage and move the contact member from the first state to the second state when the contact member is in the first state, such that an outer surface of the contact member expands against an inner wall surface of the left atrial appendage after the contact member is advanced into the left atrial appendage; Characterized in that: The catheter is configured to apply a torque to the contact member until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position in a first direction when at least a portion of the catheter rotates, such that the contact member can twist at least a portion of the left atrial appendage; and The implant includes a fixing element configured to prevent at least a portion of the left atrial appendage from rotating in a second direction when the fixing element is in an operable state, wherein the second direction is opposite to the first direction.

35. A device for occluding or closing the left atrial appendage, comprising: A deployable implant having a plurality of tissue anchors on an outer surface of a portion thereof, the deployable implant being 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 deployed; A catheter configured to advance the implant into the left atrial appendage and selectively move the implant from the first state to the second state when the implant is in the first 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 is advanced into the left atrial appendage; Characterized in that: The catheter is configured to rotate the implant from a first rotational position to a second rotational position in a first direction, such that the implant can twist the left atrial appendage; and The implant includes a fixing element configured to prevent at least a portion of the left atrial appendage from rotating in a second direction when the fixing element is in an operable state, wherein the second direction is opposite to the first direction.

36. A device for occluding or closing the left atrial appendage, comprising: An implant configured to move between a first state and a second state; A catheter configured to advance the implant into the left atrial appendage and move the implant from the first state to the second state when the implant is in the first state, such that an outer surface of the implant moves against an inner wall surface of the left atrial appendage after the implant is advanced into the left atrial appendage; Characterized in that: The catheter is configured to rotate the implant from a first rotational position to a second rotational position in a first direction, such that the implant can twist at least a portion of the left atrial appendage when the implant is in the second state; and The implant includes a fixation element configured to prevent at least a portion of the left atrial appendage from rotating in a second direction when the fixation element is in an operative state, wherein the second direction is opposite to the first direction.

37. A device for pulling a first tissue surface towards a second tissue surface in a left atrial appendage, comprising: a contact member configured to deploy from a first state to a second state; a fixation element configured to move from a first state to a second state; and a catheter configured to advance the contact member into the left atrial appendage and move the contact member from the first state to the second state when the contact member is in the first state, such that an outer surface of the contact member deploys against an inner wall surface of the left atrial appendage after the contact member is advanced into the left atrial appendage; wherein: the contact member is configured to deploy 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 is configured to rotate from a first rotational position to a second rotational position at least in a first direction; rotation of the contact member in the first direction twists at least a proximal portion of the first tissue surface and moves it towards a proximal portion of the second tissue surface; the catheter is configured to apply torque to the contact member until a predetermined torque level is reached to rotate the contact member from the first rotational position to the second rotational position at least in the first direction when at least a portion of the catheter rotates, such that the contact member can twist at least a portion of the left atrial appendage in the first direction; and the fixation element is configured to prevent rotation of the contact member in a second direction when the fixation element is in an operative state and engages a tissue portion adjacent to and / or including the proximal portions of the first and second tissue surfaces, wherein the second direction is opposite to the first direction.

38. The device according to claim 37, wherein, The device is configured to close or occlude a cavity within the body having the first and second tissue surfaces.

39. The device according to claim 38, characterized in that, The first and second tissue surfaces are tissue surfaces within a cavity in the body.

40. The device according to any one of claims 37 to 39, characterized in that, Rotation of the contact member further twists at least a proximal portion of the second tissue surface and moves it towards a proximal portion of the first tissue surface.

41. A device for treating a left atrial appendage, comprising: an implant having a contact member and a fixation element; 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; wherein: the catheter is configured to apply torque to the contact member until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position in a first direction when at least a portion of the catheter rotates, such that the contact member can twist at least a portion of the left atrial appendage; and The fixing element is configured to prevent at least a portion of the left atrial appendage from rotating in a second direction when the fixing element is in an operable state, wherein the second direction is opposite to the first direction.

42. The apparatus according to claim 41, wherein, The contact member is configured to move against the inner wall surface of the left atrial appendage without changing the state or shape of the contact member.

43. The device according to claim 41, characterized in that, The contact member is configured to be movable or deployable from a first state to a second state.

44. A device for closing an opening of a left atrial appendage, comprising: a contact member; a fixing element; and a catheter configured to advance the contact member into the left atrial appendage and move the contact member against the inner wall surface of the left atrial appendage; wherein: The contact member is configured to engage the tissue surface of the left atrial appendage; The contact member is configured to rotate at least a portion of the left atrial appendage from a first rotational position to a second rotational position in a first direction and reduce the size of the opening of the left atrial appendage from a first size to a second size; The fixing element is configured to engage at least a portion of the tissue adjacent to the opening of the left atrial appendage and prevent the opening of the left atrial appendage from expanding to the first size; and The catheter is configured to apply a torque to the contact member until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position in the first direction when at least a portion of the catheter rotates, such that the contact member can twist at least a portion of the left atrial appendage.

45. The device according to claim 44, characterized in that, The contact member is configured to engage the tissue surface on the outer surface of the left atrial appendage.

46. The device according to claim 44, characterized in that, The contact member is configured to engage the tissue surface of the left atrial appendage without changing the state or shape of the contact member.

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