Devices, systems, and methods for treating the left atrial appendage

Abstract

A device for treating a left atrial appendage, comprising an implant having a contact member configured to engage an internal tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position to twist the left atrial appendage when the contact member engages the internal tissue surface of the left atrial appendage. Some embodiments may also include a fixation element configured to move between a first position in which the fixation element is decoupled from the contact member and a second position in which the fixation element is coupled to the contact member.

Description

[Technical Field]

[0001] Priority Claims and Incorporation by Reference This application claims the benefit under 35 U.S.C. § 119(e) of U.S. patent application Ser. No. 63 / 171,011, filed April 5, 2021, U.S. patent application Ser. No. 63 / 072,035, filed August 28, 2020, and U.S. patent application Ser. No. 63 / 049,077, filed July 7, 2020, the contents of each of which priority applications are incorporated herein by reference in their entirety for all purposes as if fully set forth herein. All applications for which foreign or domestic priority claims are identified in the Application Data Sheet filed in this application are hereby incorporated herein by reference in their entirety.

[0002] SUMMARY OF THE INVENTION Embodiments of the present disclosure relate to devices, apparatus, and methods for closing or occluding the left atrial appendage. [Background technology]

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

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

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

[0006] Disclosed herein are embodiments of methods for treating a left atrial appendage. In some embodiments, the method may include twisting the left atrial appendage and / or fixing the left atrial appendage in a twisted position. Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: twisting the left atrial appendage can include engaging a wall portion within the left atrial appendage with a contact member and rotating the contact member from a first rotational position (also referred to herein as the first position) to a second rotational position (also referred to herein as the second position) to twist the left atrial appendage; engaging the wall portion within the left atrial appendage with the contact member can include advancing a deployment device into the left atrial appendage; engaging the wall portion within the left atrial appendage can include engaging the wall portion with one or more tissue anchors within the left atrial appendage; the contact member can be a balloon, and the contact member can be an implant coupled to the deployment device. and a contact member positioned on the left atrial appendage, the implant can be self-expanding, balloon-expandable, and / or mechanically expandable, and the method further includes applying a vacuum through the contact member to engage the left atrial appendage; rotating the components of the deployment device can include rotating the contact member from a first rotational position to a second rotational position to twist the left atrial appendage; rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the contact member at least approximately 90 degrees in either direction from the first rotational position; rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the contact member at least approximately 180 degrees in either direction from the first rotational position; rotating the contact member from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the contact member from about 90 degrees to about 360 degrees in either direction from the first rotational position; and rotating the deployment device can include rotating the contact member from about 0.The method can include torquing the deployment device between a 25 in-oz torque and a 10 in-oz torque, and the method can include allowing the contact member to rotate from the second orientation to a third rotational position, which can be between the first rotational position and the second rotational position (for example, and without limitation, as a result of tissue loosening), and / or the contact member includes at least one vacuum port configured to transmit suction force from a suction source through the at least one vacuum port.

[0007] Furthermore, any embodiment of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: twisting the left atrial appendage may include rotating a portion of the left atrial appendage about an axis from a first rotational position to a second rotational position to twist the left atrial appendage; rotating a portion of the left atrial appendage about an axis from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the portion of the left atrial appendage at least about 90 degrees in either direction from the first rotational position; rotating a portion of the left atrial appendage about an axis from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the portion of the left atrial appendage at least about 180 degrees in either direction from the first rotational position; Twisting the left atrial appendage by rotating a portion of the left atrial appendage about an axis from a first rotational position to a second rotational position can include rotating the portion of the left atrial appendage in either direction from the first rotational position from about 90 degrees to about 360 degrees; twisting the left atrial appendage by rotating a portion of the left atrial appendage about an axis from the first rotational position to a second rotational position can include twisting the left atrial appendage until the ostium of the LAA is substantially or completely closed; securing the left atrial appendage in the twisted position can include engaging twisted heart tissue; engaging the twisted heart tissue can include engaging the tissue wall with an anchor element, which can include a suture; securing the left atrial appendage in the twisted position can include securing heart tissue outside the blocked portion of the left atrial appendage with the anchor element; and / or the anchor element can include multiple tissue anchors on at least one surface thereof configured to engage an interior wall of the heart outside the left atrial appendage.

[0008] Also disclosed herein are embodiments of methods for closing the left atrial appendage ostium. In some embodiments, the method may include twisting cardiac tissue to constrict the left atrial appendage ostium and / or securing the collected tissue in the collected position resulting from twisting the cardiac tissue. Any of the embodiments of the methods, devices, and systems for closing the left atrial appendage ostium disclosed herein can, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: securing the cardiac tissue in the collected position may include advancing a fixation element into the collected tissue, which may be a suture, and / or which may be a tissue anchor.

[0009] Disclosed herein are embodiments of devices and systems for treating the LAA, which may include an implant including a contact member and a fixation element, wherein the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member is configured to twist at least a portion of the LAA when the contact member rotates from the first rotational position to the second rotational position, and the fixation element is configured to prevent rotation of the implant in a second direction opposite the first direction when the fixation element is in an operable state. In some embodiments, the contact member may be configured to move between a first state and a second state, with the contact member being larger or expanded in the second state. Some embodiments of the contact member may be configured to move from the first state to the second state such that at least a portion of the contact member engages with a wall portion of the LAA when the contact member is advanced into the LAA. In any embodiment disclosed herein in which the contact member moves or expands from the first state to the second state, the contact member may move or expand from the first state to the second state in the LA or LAA. Additionally, in any embodiment, the contact member may be configured to remain fixed in state and / or size throughout the procedure, allowing the contact member to extend beyond the distal end of the delivery catheter (or the outer tube of the delivery catheter can be retracted), advanced into contact with or engage a wall portion of the LAA, and then twisted, without changing the size of the contact member and / or without expanding the contact member.

[0010] Also disclosed herein are embodiments of devices and systems for treating the LAA that may include an implant configured to move between a first state and a second state; and a catheter configured to advance the implant into the LAA when the implant is in the first state and move the implant from the first state to the second state such that an outer surface of the implant moves against an inner wall surface of the LAA after the implant is advanced into the LAA, the catheter configured to rotate the implant in a first direction from a first rotational position to a second rotational position such that the implant can twist at least a portion of the LAA when the implant is in the second state.

[0011] Also disclosed herein are embodiments of devices and systems for pulling a first tissue surface toward a second tissue surface, including a contact member configured to expand from a first state to a second state and a fixation element configured to move from the first state to the second state, wherein the contact member is configured to expand from the first state to the second state such that at least a portion of the contact member engages at least a distal portion of the first tissue surface and at least a distal portion of the second tissue surface; the contact member can be configured to rotate in at least a first direction from a first rotational position to a second rotational position, wherein rotation of the contact member in the first direction causes at least a proximal portion of the first tissue surface to twist and move toward a proximal portion of the second tissue surface; and the fixation element is configured to prevent rotation of the implant in a second direction when the fixation element is in an operable state and engaged with tissue portions adjacent to and / or including the proximal portions of the first and second tissue surfaces, the second direction being opposite the first direction. Additionally, in any device and / or system embodiment disclosed herein, the device may be configured to occlude or close a body cavity having a first tissue surface and a second tissue surface, where the first and second tissue surfaces may be tissue surfaces within any body cavity, and / or rotation of the contact member further causes a proximal portion of the second tissue surface to twist and move toward the proximal portion of the first tissue surface.

[0012] Any embodiment of the devices and systems disclosed herein can include, in additional embodiments, one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein: the implant is self-expandable such that the implant automatically expands from a first state to a second state when the restraint is detached from the implant; the contact member is self-expandable such that at least a portion of the contact member automatically expands from the first state to the second state when the restraint is detached from the contact member; the implant is substantially collapsed when the implant is in the first state and deployed when the implant is in the second state such that the size of the implant is larger when the implant is in the second state than when the implant is in the first state; the contact member is biased to remain in the second state after deployment into the LAA; the contact member is configured to rotate clockwise or counterclockwise; and the device extends the left atrium when the contact member is rotated to the second rotational position. and / or configured to contract tissue of the LAA around an outer surface of the body portion of the implant, and a fixation element configured to engage the tissue contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction, the fixation element having a plurality of tissue anchors configured to engage an inner wall of the heart adjacent the LAA, the fixation element having a helical shape and configured to rotate around the body portion of the implant during the implant procedure, the implant configured to rotate in a first direction from a first rotational position to a second rotational position, the implant configured to prevent rotation of the implant in the second direction after the implant is fully deployed, the second direction being opposite to the first direction, the contact member having a plurality of tissue anchors on its outer surface, the plurality of tissue anchors on the outer surface of the contact member configured to engage an inner wall surface of the LAA after the contact member is moved to the second state, the implant including the fixation element configured to engage tissue portions of the heart adjacent the LAA, the second rotational position being at least one-quarter of a rotation relative to the first rotational position;The second rotational position is at least half a rotation relative to the first rotational position, and / or the second rotational position is from about one-quarter of a rotation to one or more full rotations relative to the first rotational position.

[0013] Additionally, any of the embodiments of the devices and systems disclosed herein can, in additional embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein, further including a catheter selectively coupled to the contact member and applying a torque on the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being between approximately 0.25 in-oz and approximately 10 in-oz of torque, the threshold predetermined torque level being between approximately 0.25 in-oz and approximately 10 in-oz of torque,and a torque of between 5 in-oz and approximately 5 in-oz, further including a retention element configured to urge the fixation element toward the tissue wall of the LAA, further including a retention element configured to urge the fixation element toward the contact member, further including a retention element configured to couple the fixation element to the contact member, the retention element including a threaded shaft, the device configured such that rotation of the retention element in a first direction moves the fixation element toward the contact member, the contact member configured to rotate in at least a first direction from a first rotational position to a second rotational position when torque is applied to the contact member, the device configured such that the contact member can be removed from the LAA after the fixation element is deployed to an operative state of the fixation element, the device configured such that the contact member can be removed from the LAA after the fixation element is deployed to an operative state of the fixation element, and the fixation element prevents contraction of tissue of the left atrium and / or LAA as a result of rotation of the contact member from the first rotational position to the second rotational position. the device is configured to prevent rotation of the implant in the second direction, wherein only a portion of the fixation element extends into the left atrium after deployment of the device and all other portions of the device are inside the LAA after deployment of the device, and wherein only approximately 10% or less of the total length of the deployed device extends into the left atrium after deployment of the device; the device is configured to be used with a surgical robotic device or system, the surgical robotic device includes one or more robotic arms; the device of any embodiment disclosed herein is configured to be used with a surgical robotic device, the contact member and the fixation element are integrally formed and / or monolithically formed; the device is configured to contract tissue of the left atrium and / or LAA around an outer surface of the body portion of the implant when the contact member is rotated to a second rotational position, and the fixation element is configured to compress the contracted tissue around the outer surface of the body portion of the implant between the distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction.

[0014] Some embodiments of devices and systems for closing or occluding the left atrial appendage (LAA) disclosed herein can include an implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state; the implant may be configured to move from the first state to the second state such that at least a portion of the implant engages a wall portion of the left atrial appendage after advancement into the left atrial appendage; and the implant may be configured to twist at least a portion of the left atrial appendage when the implant is in the second state as the implant rotates from a first rotational position to a second rotational position. In any of the embodiments disclosed herein, the twisting movement or step can be achieved by a torque catheter.

[0015] Any embodiment of the devices and systems disclosed herein may, in additional embodiments, include one or more of the following features or details, in any combination: the implant is configured to automatically rotate from a first rotational position to a second rotational position after the implant is in the second state; the implant may be configured to be triggered or activated and then automatically rotate from the first rotational position to the second rotational position; the device has a spring coupled with the implant, the spring configured to automatically rotate the implant when the spring is released or activated; the implant is self-expandable such that the implant automatically expands from the first state to the second state when the restraint is removed from the implant; the implant is self-expandable such that at least a portion of the implant automatically expands from the first state to the second state when the implant is advanced past the distal end of the outer sleeve of the catheter; the implant is substantially collapsed when the implant is in the first state; The implant may be deployed when in the second state such that the implant may be larger in the second state than in the first state, and after deployment into the left atrial appendage, the implant may be biased to remain in the second state, the implant may be configured to rotate in a clockwise or counterclockwise direction, the implant may include a fixation element configured to engage with an interior wall of the heart outside the left atrial appendage, the implant may include a fixation element configured to engage with an interior wall of the heart outside the left atrial appendage, the fixation element has a helical shape and is configured to rotate about a body portion of the implant during the implant procedure, the implant may include a cork screw shaped fixation element configured to engage with an interior wall of the heart outside the left atrial appendage, the implant may include a fixation element having a cork screw tissue anchor for engaging the interior wall of the heart and / or LAA tissue, and the implant may include a fixation element having a plurality of tissue anchors configured to engage with an interior wall of the heart adjacent the left atrial appendage, and after the implant is fully deployed,The implant may be configured to prevent rotation back to the first rotational position, the implant may be configured to rotate in a first direction from the first rotational position to a second rotational position, and after the implant is fully deployed, the implant may be configured to prevent rotation of the implant in a second direction, the second direction being opposite to the first direction.

[0016] Any embodiment of the devices and systems disclosed herein may, in additional embodiments, include one or more of the following features or details, in any combination: the implant has a plurality of tissue anchors on an exterior surface thereof, the plurality of tissue anchors on the exterior surface of the implant configured to engage an inner wall surface of the left atrial appendage after the implant is moved to the second condition; the implant may include a fixation element configured to engage a tissue portion of the heart adjacent the left atrial appendage; the second rotational position may be at least one-quarter of a rotation, or approximately one-quarter (i.e., 90 degrees or approximately 90 degrees) relative to the first rotational position; and the second rotational position may be at least one-half of a rotation, or approximately one-half of a rotation relative to the first rotational position. The first rotational position may be at or about a quarter of a rotation (i.e., at or about 180 degrees), the second rotational position may be at or about a quarter of a rotation (i.e., at or about 90 degrees) to one or more full rotations (i.e., at or about 360 degrees or more) relative to the first rotational position, and the catheter may be configured to exert a torque on the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being from 0.25 or about 0.25 in-oz torque to 10 or about 10 in-oz torque, and / or the threshold predetermined torque level being from 0.5 or about 0.5 in-oz torque to 5 or about 5 in-oz torque.

[0017] Any embodiment of the devices and systems disclosed herein may include an implant having a contact member configured to move between a first state and a second state; and a catheter configured to advance the contact member into the LAA when the contact member is in the first state and move the contact member from the first state to the second state so that the outer surface of the contact member expands against the inner wall surface of the LAA after the contact member has advanced into the LAA, and the catheter configured to apply a torque on the contact member when rotating the contact member from the first rotational position to the second rotational position such that at least a portion of the catheter is rotated until a predetermined torque level is reached, allowing the contact member to twist at least a portion of the LAA.

[0018] Any embodiment of the devices and systems disclosed herein can include an expandable implant and a catheter configured to move between a first state and a second state, the catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and to move the implant from the first state to the second state after the implant has advanced into the left atrial appendage such that the outer surface of the implant expands against at least a portion of the inner wall surface of the left atrial appendage. In any embodiment of the devices for closing or occluding the LAA disclosed herein, the catheter can be configured to exert a torque on the implant to rotate the implant from a first rotational position to a second rotational position such that the implant can twist at least a portion of the left atrial appendage until a predetermined torque level is reached, or in some embodiments, until a user determines to stop, whichever occurs first.

[0019] Also disclosed herein are devices and systems for treating the LAA, including a device configured to be inserted into and engage LAA tissue while the device is rotated to a rotated position to close blood communication between the LAA and the left atrium. In any embodiment of the apparatus, the device may be configured to be selectively lockable in a rotated position to at least substantially maintain the device in the rotated position after implantation, the device may include a fixation element configured to engage a tissue surface adjacent to the LAA to maintain the device in the rotated position after implantation, the device may be round, spherical, or disc-shaped when the device is in a deployed state in the LAA, the device may be expandable from a first collapsed state to a second expanded state, and / or the device may self-expand from the first collapsed state to the second expanded state.

[0020] Also disclosed herein are embodiments of methods for treating the LAA, including engaging tissue of the LAA and rotating the tissue of the LAA to close or occlude blood communication between the LAA and the left atrium. In any embodiment of the methods disclosed herein, rotating the tissue of the LAA to close or occlude blood communication between the LAA and the left atrium can include rotating the tissue of the LAA to close or occlude the ostium of the LAA. Furthermore, any embodiment of the methods disclosed herein can further include fixing the LAA in a rotated position to maintain the LAA in a closed or occluded state.

[0021] Any embodiment of the method for closing or occluding the LAA disclosed herein can include advancing a deployment device having an implant into the left atrial appendage, where the implant can be configured to move from a first state to a second state. In some embodiments, at least a portion of the implant can radially expand when the implant is in the second state compared to the first state. The method can further include moving the implant from the first state to the second state within the left atrial appendage to move at least a portion of the outer wall of the implant, or one or more tissue anchors extending away from the outer surface of the implant, against at least a portion of the inner wall surface of the left atrial appendage; rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage; and preventing the implant from rotating back to the first rotational position.

[0022] Any embodiment of the method of closing or occluding the LAA disclosed herein may, in some additional embodiments, include one or more of the following steps, in any combination, and in any combination with any of the other steps, features, or other details of any other embodiment: the implant is self-expanding; moving the implant from a first state to a second state includes advancing the implant out of a distal end of a deployment device; engaging a wall portion on the interior of the LAA includes engaging the wall portion on the interior of the LAA with one or more tissue anchors located on an exterior surface of the implant; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with anchor elements to prevent relative movement between the implant and the tissue wall; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with the anchor elements, the anchor elements are secured to the implant and configured to prevent rotation between the implant and the anchor elements; and preventing the implant from rotating back to the first rotational position. and preventing the implant from rotating back to the first rotational position includes engaging cardiac tissue wall with an anchor element, the anchor element being rotationally fixed to the implant and configured to prevent the implant from rotating back to the first rotational position; preventing the implant from rotating back to the first rotational position includes engaging cardiac tissue outside the closed portion of the LAA with the anchor element, the anchor element being rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; the anchor element includes a plurality of tissue anchors on at least one surface thereof configured to engage an interior wall of the heart outside the LAA; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant until the ostium of the LAA is substantially or completely closed; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes rotating the implant at least approximately 90 degrees in either direction from the first rotational position; and rotating the implant from the first rotational position to the second rotational position to twist the LAA.rotating the implant from the first rotational position to a second rotational position to twist the LAA includes rotating the implant from the first rotational position at least approximately 180 degrees in either direction from the first rotational position; rotating the implant from the first rotational position to a second rotational position to twist the LAA includes rotating the implant from the first rotational position to approximately 90 degrees in either direction from the first rotational position to approximately 360 degrees; rotating the implant from the first rotational position to a second rotational position to twist the LAA includes rotating the implant from the first rotational position to approximately 90 degrees in either direction from the first rotational position to approximately 180 degrees; rotating the implant from the first rotational position to the second rotational position to twist the LAA includes applying a torque on the implant to rotate the implant in either direction from the first rotational position until a threshold predetermined torque level is reached, holding the implant in the second rotational position, and securing the implant in approximately the second rotational position against a tissue surface surrounding the LAA, wherein the maximum predetermined torque level is between approximately 0.25 in-oz and approximately 10 in-oz of torque and / or the maximum predetermined torque level is between approximately 0.5 in-oz and approximately 5 in-oz of torque.

[0023] Any embodiment of the method of closing or occluding the LAA disclosed herein may, in some additional embodiments, include one or more of the following steps, in any combination, and in any combination with any of the other step, function, or other details of any other embodiment: the implant is self-expanding; moving the implant from the first state to the second state can include advancing the implant from the distal end of the deployment device; engaging a wall portion on the interior of the left atrial appendage can include engaging at least a portion of the wall portion on the interior of the left atrial appendage or surrounding the left atrial appendage with one or more tissue anchors positioned on an exterior surface of the implant; preventing the implant from rotating back to the first rotational position can include engaging an exterior tissue wall of the left atrial appendage with an anchor element, the anchor element can be rotationally secured to the implant to prevent relative movement between the anchor element and the implant; and Preventing the implant from rotating back to the first rotational position can include engaging a tissue wall of the heart with an anchor element, which may be rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; preventing the implant from rotating back to the first rotational position can include engaging an interior wall of the heart outside the left atrial appendage with an anchor element, which may be rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; the anchor element can include a plurality of tissue anchors on at least one surface thereof configured to engage the interior wall of the heart outside the left atrial appendage; and / or rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the implant until the ostium of the LAA is substantially or completely closed or occluded or can fold around the outer surface of the implant.

[0024] Any embodiment of the method of closing or occluding the LAA disclosed herein may, in any additional embodiments, include one or more of the following steps, in any combination, and in any combination with any of the other steps, features, or other details of any other embodiment: rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least or approximately one-quarter of a rotation (i.e., 90 degrees or approximately 90 degrees) relative to the first rotational position; rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least or approximately one-half of a rotation (i.e., 180 degrees or approximately 180 degrees) in either direction from the first rotational position; and rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage may include rotating the implant at least or approximately one-quarter of a rotation (i.e., 90 degrees or approximately 90 degrees) to one or approximately one rotation (i.e., 360 degrees) in either direction from the first rotational position. or about 360 degrees), or more than one full rotation (i.e., greater than 360 degrees), and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage can include rotating the implant from the first rotational position in either direction from a quarter of a rotation or about a quarter of a rotation (i.e., at or about 90 degrees) to a half of a rotation or about a half of a rotation (i.e., at or about 18 ...). wherein rotating the implant to a first rotational position to twist the left atrial appendage may include exerting a torque on the implant to rotate the implant in either direction from the first rotational position until a threshold predetermined torque level is reached, rotating the implant from the first rotational position to a second rotational position to twist the left atrial appendage may include holding the implant in the second rotational position, and rotating the implant from the first rotational position to the second rotational position to twist the left atrial appendage may include fixing the implant in approximately the second rotational position against a tissue surface surrounding the left atrial appendage;The maximum predetermined torque level is between approximately 0.25 in-oz and approximately 10 in-oz of torque and / or the maximum predetermined torque level is between approximately 0.5 in-oz and approximately 5 in-oz of torque.

[0025] Some embodiments of implants for deployment within a cavity or vessel disclosed herein include an expandable body, a plurality of tissue anchors on an exterior surface of the expandable body configured to engage an inner wall surface of the cavity or vessel, and anchor elements coupled to the expandable body configured to engage a tissue surface adjacent to the inner wall surface of the cavity or vessel.

[0026] Any embodiment of the devices and systems disclosed herein can include an expandable implant having a plurality of tissue anchors on its exterior surface, the expandable implant configured to move between a first state in which the implant is substantially collapsed and a second state in which at least a portion of the implant is expanded, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and to move the implant from the first state to the second state after the implant has been advanced into the left atrial appendage such that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage. In some embodiments, the catheter can be configured to rotate the implant in a first direction from a first rotational position to a second rotational position such that the implant can twist the wall of the left atrial appendage.

[0027] Some embodiments of the devices and systems for closing or occluding the LAA disclosed herein can include an implant configured to move between a first state and a second state, and a catheter configured to advance the implant into the left atrial appendage when the implant is in the first state and move the implant from the first state to the second state after the implant has advanced into the left atrial appendage such that an outer surface of the implant moves against an inner wall surface of the inner wall of the left atrial appendage. In some embodiments, the catheter can be configured to rotate the implant in a first direction from a first rotational position to a second rotational position when the implant is in the second state such that the implant can twist at least a portion of the left atrial appendage.

[0028] Any embodiment of the method of treating the left atrial appendage disclosed herein may include engaging tissue of the left atrial appendage and rotating the tissue of the left atrial appendage to close or significantly close, or substantially inhibit or inhibit, blood communication between the left atrial appendage and the left atrium. Any embodiment of the method disclosed herein may, in additional embodiments, include one or more of the following features, components, steps, and / or details, in any combination with any of the other features, components, steps, and / or details of any other embodiment of the method of treatment disclosed herein, where rotating the tissue of the left atrial appendage to close blood communication between the left atrial appendage and the left atrium includes rotating the tissue of the left atrial appendage to close an ostium in the left atrial appendage, and / or may further include fixing the left atrial appendage in a rotated position to hold the left atrial appendage closed.

[0029] Some embodiments of the apparatus for treating the left atrial appendage disclosed herein may include a device configured to be inserted into the left atrial appendage and engage left atrial appendage tissue while the device is rotated into a rotated position to close blood communication between the left atrial appendage and the left atrium. In some embodiments, the device may be configured to be locked in a rotated position to maintain the device in the rotated position after implantation, the device may include a fixation element configured to engage a tissue surface adjacent the left atrial appendage to maintain the device in the rotated position after implantation, the device may be formed in a round, spherical, or disk shape when the device is in a deployed state within the left atrial appendage, the device may be expandable from a first collapsed state to a second expanded state, and / or the device may self-expand from the first collapsed state to the second expanded state.

[0030] Disclosed herein are embodiments of a device for treating a left atrial appendage, including an implant having a contact member and a catheter configured to advance the contact member into the left atrial appendage and move the contact member against an inner wall surface of the left atrial appendage, the catheter configured to apply a torque on the contact member when at least a portion of the catheter is rotated until a predetermined torque level is reached to rotate the contact member from a first rotational position to a second rotational position such that the contact member can twist at least a portion of the left atrial appendage. In any of the embodiments disclosed herein, the contact member can be configured to move against the inner wall surface of the left atrial appendage without changing the state or shape of the contact member and / or the contact member can be configured to be movable or expandable from a first state to a second state.

[0031] Disclosed herein are embodiments of a device for reducing an opening of a left atrial appendage, including a contact member and a fixation element, wherein the contact member is configured to engage a tissue surface of the left atrial appendage, the contact member is configured to rotate at least a portion of the left atrial appendage in a first direction from a first rotational position to a second rotational position, and reduce the opening of the left atrial appendage from a first size to a second size, and / or the fixation element is configured to engage at least a portion of tissue adjacent the opening of the left atrial appendage and prevent the opening of the left atrial appendage from expanding to the first size. In any of the embodiments disclosed herein, the contact member may be configured to engage a tissue surface on the exterior surface of the left atrial appendage. Furthermore, in any of the embodiments disclosed herein, the contact member may be configured to engage a tissue surface of the left atrial appendage without changing the state or shape of the contact member.

[0032] Any of the embodiments of the devices disclosed herein can, in additional embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein, wherein the device further includes a delivery catheter, wherein the device further includes an implant of any of the implant embodiments disclosed herein advanceable through the delivery catheter when the implant is in a first state, wherein the implant includes a first stage portion and a second stage portion each independently deployable to at least a second operable or deployed state, wherein the first stage portion is configured to be at least partially deployed before the second stage portion is deployed, wherein the first stage portion is configured to be positioned near the distal end of the LAA, and wherein the second stage portion is configured to extend beyond the distal end of the LAA when the second stage portion is in the second state. the second stage portion is configured to constrict the opening of the LAA when the second stage portion is in the second state, the second stage portion is configured to close the opening of the LAA when the second stage portion is in the second state, the second stage portion is configured to fold one or more tissue portions surrounding or adjacent the opening of the LAA when the second stage portion is in the second state, the second stage portion is configured to twist one or more portions of tissue surrounding the opening of the LAA to constrict or close the opening of the LAA when the second stage portion is in the second state, the second stage portion comprises a means for constricting or closing the opening of the LAA, the second stage portion comprises a hinge mechanism for constricting or closing the opening of the LAA and further comprises at least one of a passive actuation mechanism and an active actuation mechanism for actuating the hinge mechanism, and / or at least one of the first stage portion and the second stage portion is self-expanding.

[0033] Disclosed herein are additional embodiments of methods of treatment that include advancing a deployment device having an implant into a left atrial appendage, moving at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the exterior surface of the implant, relative to an inner wall surface of the left atrial appendage, rotating the implant from a first rotational position to a second rotational position to twist the left atrial appendage, and preventing the implant from rotating back to the first rotational position. In any embodiment, the method can include moving at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the exterior surface of the implant, relative to the inner wall surface of the left atrial appendage without changing the shape or size of the implant, and / or moving the implant from a first state to a second state, wherein at least a portion of the implant is radially expanded when the implant is in the second state compared to the first state.

[0034] Disclosed herein are additional embodiments of devices and systems for closing the LAA, which may include a clamping device having a first member and a second member and configured to move between a closed position and an open position, a first guide device configured to be advanceable within the LAA, and a second guide device advanceable within the pericardial space outside the LAA and configured to move such that an end of the second guide device is in approximate axial alignment with an end of the first guide device. In any of the embodiments disclosed herein, at least one of the first and second members of the clamping device may be substantially rigid, the clamping device may have an opening sized to allow passage of the clamping device through the LAA when the clamping device is in the open position, and / or at least one of the first and second members of the clamping device may be configured to substantially flatten and close a portion of the LAA when the clamping device is moved to the closed position. In any of the additional embodiments disclosed herein, the clamping device may include only a first member and a second member. In additional embodiments, the fastening device may further include a third member and a fourth member connected together in an end-to-end arrangement and defining an opening in the fastening device sized and configured to pass over the exterior surface of the LAA. In any additional embodiment disclosed herein, the device may further include a delivery catheter having an outer sheath and a guide lumen configured to receive and track a second guide device. Furthermore, the first member of the fastening device may be rigid, and the second member of the fastening device may include a suture.

[0035] Disclosed herein are additional embodiments of a method for closing or occluding the LAA. In any embodiment disclosed herein, the method includes advancing a first guide device into the LAA, advancing a second guide device into the pericardial space outside the LAA, approximately aligning an end of the second guide device with an end of the first guide device, advancing a delivery catheter over the second guide device, advancing a clamping device having a first member and a second member from the delivery catheter, opening the clamping device from a closed position to an open position, advancing the clamping device over the outer surface of the LAA toward a neck portion of the LAA, and / or closing the clamping device from the open position to a closed position to substantially flatten and close the neck portion of the LAA.

[0036] Any embodiment of the method for closing or occluding the LAA may, in additional embodiments, include one or more of the following features, components, steps, and / or details, in any combination with any of the other features, components, steps, and / or details of any other embodiment disclosed herein, wherein moving the clamping device from the closed position to the open position includes advancing the clamping device through a distal end of the delivery catheter such that the clamping device can automatically move to the open position; the delivery catheter has a guide lumen, the guide lumen configured to receive and track a second guide device; and the delivery catheter the delivery catheter has an outer sheath, at least one of the first and second members of the clamping device is substantially rigid, at least one of the first and second members of the clamping device has a substantially planar contact surface, the contact surface being a surface configured to contact the exterior surface of the LAA, the delivery catheter has an outer sheath, the clamping device includes at least four substantially rigid members connected together in an end-to-end arrangement and defining an opening in the clamping device sized and configured to pass over the exterior surface of the LAA, and / or the clamping device includes at least one rigid member and at least one flexible member interconnected with the at least one rigid member.

[0037] Additionally, any implant and / or device or system embodiment disclosed herein may be adapted and / or used for treating any tissue condition within the body that is desired to be occluded, restricted, or closed. For example, and without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein may include an implant including a contact member and a fixation element that may (but need not) be configured to move between a first state and a second state, wherein the contact member may be configured to move from the first state to the second state such that at least a portion of the contact member engages a wall portion of the tissue condition after the contact member is advanced into the tissue state, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, wherein the contact member may be configured to twist at least a portion of the tissue of the tissue state in the first direction when the contact member rotates from the first rotational position to the second rotational position, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue state in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or contiguous tissue surfaces, or otherwise.

[0038] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include an implant having a contact member that can (but need not) be configured to move between a first state and a second state; and a catheter configured to advance the contact member into the tissue condition when the contact member is in the first state and move the contact member from the first state to the second state such that an outer surface of the contact member engages at least one wall surface of the tissue condition after the contact member has advanced into or adjacent the tissue condition, wherein the catheter is configured to apply a torque on the contact member when rotating the contact member from the first rotational position to the second rotational position such that at least a portion of the catheter is rotated until a predetermined torque level is reached, allowing the contact member to twist at least a portion of the tissue condition. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0039] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include a method of treating a tissue condition including advancing a deployment device having an implant within or adjacent to the tissue condition, wherein the implant may (but is not required to) be configured to move from a first state to a second state such that at least a portion of the implant may be radially expanded when the implant is in the second state compared to the first state; moving the implant from the first state to the second state within the tissue condition to move at least a portion of an exterior surface of the implant, or one or more tissue anchors extending away from the outer surface of the implant, against at least one wall surface of the tissue condition; rotating the implant from a first rotational position to a second rotational position to twist the tissue condition and / or prevent the implant from rotating back to the first rotational position.

[0040] Furthermore, any implant and / or device or system embodiment disclosed herein can be adapted and / or used for the treatment of any tissue condition in the body that is desired to be occluded, remodeled, restricted, or closed. For example, and without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein can include an implant including a contact member configured to engage a wall portion of the tissue condition after the contact member is advanced into the tissue condition, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue condition in the first direction when the contact member rotates from the first rotational position to the second rotational position, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue condition in a second direction when the fixation element is in an operable state, the second direction being opposite the first direction. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0041] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include an implant having a contact member and a catheter configured to advance the contact member into the tissue condition such that the contact member engages at least one wall surface of the tissue condition after the contact member has advanced into or adjacent the tissue condition, wherein the catheter is configured to apply a torque on the contact member when rotating the contact member from a first rotational position to a second rotational position such that at least a portion of the catheter is rotated until a predetermined torque level is reached, allowing the contact member to twist at least a portion of the tissue condition. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0042] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include a method of treating a tissue condition that includes advancing a deployment device having an implant within or adjacent to the tissue condition such that at least a portion of the implant engages a wall surface of the tissue condition; rotating the implant from a first rotational position to a second rotational position to twist the tissue condition and / or preventing the implant from rotating back to the first rotational position.

[0043] Disclosed herein are embodiments of devices for treating the left atrial appendage that can include an implant that can have a contact member configured to engage an internal tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position so as to twist the left atrial appendage when the contact member engages the internal tissue surface of the left atrial appendage, and a fixation element configured to move between a first position in which the fixation element is separated from the contact member and a second position in which the fixation element is coupled to the contact member. In some embodiments, the contact member can be configured to rotate in at least a first direction from the first position to the second position when a torque is applied to the contact member.

[0044] Any embodiment of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: the contact member may be configured to rotate in at least a first direction from a first position to at least a second position, twisting the left atrial appendage and reducing the size of the ostium of the left atrial appendage from the first size to a second size when the contact member engages the internal tissue surface or the left atrial appendage; the implant may be configured to prevent the ostium of the left atrial appendage from enlarging back to the first size; the device may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to its operative state; the device may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to its operative state; the fixation element may be configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to its operative state; The implant may be configured to prevent rotation of tissue in the contracted left atrium and / or left atrial appendage, the contact member may be configured to move between a first state and a second state, the outer dimension of the contact member may be larger in the second state than in the first state, the contact member may be biased to remain in the second state after deployment into the left atrial appendage, the contact member may be configured to have a substantially fixed, unalterable size and shape, the contact member may be self-expandable such that the contact member automatically expands from the first state to the second state when the restraint is detached from the implant without user intervention, the contact member may be configured to automatically move from the first state to the second state when the restraint is detached from the contact member, the contact member may be configured to engage a wall portion of the left atrial appendage when the contact member is in the second state and advanced into the left atrial appendage, the contact member may have multiple tissue anchors on its outer surface, and / or multiple tissue anchors on or adjacent to the outer surface of the contact member are configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second state.

[0045] Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein, wherein the device may be configured to contract tissue of the left atrium and / or left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second position; the fixation element may be configured to engage the contracted tissue around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction opposite the first direction; and in the operable position, the fixation element may be configured to at least prevent the contact member from rotating back to the first position; and the fixation element may be configured to at least prevent the contact member from rotating back to the first position; and the fixation element may be configured to at least prevent the contact member from rotating back to the first position such that the fixation element surrounds the ostium of the left atrial appendage. The fixation element may be configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when implanted in a tissue surface, the second direction being opposite to the first direction; the fixation element may be configured to expand from at least a first state to a second state, the fixation element having a larger outer dimension in the second state than in the first state; the fixation element may include a plurality of arms, the fixation element may have a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts, at least an end of each of the plurality of arms of the fixation element faces generally away from the contact member when the fixation element is in the first state and faces generally toward the contact member when the fixation element is in the second state; and the fixation element includes a restraint configured to be axially movable relative to at least a portion of the fixation element from a first position in which the plurality of arms of the fixation element are restrained by the restraint to a second position in which the plurality of arms of the fixation element are not restrained by the restraint.

[0046] Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein, including a restraint configured to be axially movable relative to at least a portion of the fixation element between a first position in which multiple arms of the fixation element are constrained by the restraint and a second position in which the multiple arms of the fixation element are not constrained by the restraint, the second axial position may be closer to the first portion of the implant than the first axial position, the restraint may be configured to be axially movable relative to at least a portion of the fixation element from the second position in which the multiple arms of the fixation element are not constrained by the restraint to facilitate repositioning and / or removal of the implant, and rotating the threaded member moves the restraint from the first position to the second position. the fixation element may have a helical shape and be configured to rotate about a body portion of the implant during an implant procedure, and after deployment of the device, only a portion of the fixation element extends into the left atrium, with all other portions of the device being within the left atrial appendage after deployment of the device; the fixation element may be movable between a first state in which the fixation element is free to rotate relative to the contact member and a second state in which the fixation element is rotationally locked to the contact member; one of the fixation element and the contact member may have a recess such that the protrusion is spaced from the recess when the fixation element is in the first state and the protrusion is engaged with the recess when the fixation element is in the second state; and the other of the fixation element and the contact member may have a protrusion configured to selectively engage the recess; and further comprising a retention element configured to selectively couple the fixation element to the contact member at any of a range of selectable distances when the fixation element is in the second position, and the retention elementThe retaining element may have a threaded shaft configured to threadably engage with the contact member, the threaded shaft coupled to the retention element, the retention element being adjustable to move the retention element between at least a first position and a second position, the retention element being closer to the contact member when the retention element is in the second position compared to when the retention element is in the first position, the retention element may have a threaded member, rotation of the threaded member in a first direction moves the retention element toward the contact member and rotation of the threaded member in a second direction moves the retention element away from the contact member, the retention element may be configured to slide at least axially on the inner core component of the delivery catheter, the second position being one rotation away from the first position. the second position can be at least one-quarter of a rotation relative to the first position, and the second position can be at least one-half of a rotation relative to the first position, and the second position can be from about one-quarter of a rotation to one or more full rotations relative to the first position; and a catheter selectively coupled to the contact member and configured to apply a torque to the contact member to rotate the contact member from the first position until a threshold predetermined torque level is reached, the threshold predetermined torque level can be from about 0.25 in-oz torque to about 10 in-oz torque, and / or the threshold predetermined torque level can be from about 0.5 in-oz torque to about 5 in-oz torque, and / or no more than about 10% of the total length of the deployed device extends into the left atrium after deployment of the device.

[0047] Also disclosed herein are embodiments of methods for treating a left atrial appendage that may include advancing a deployment device having an implant into the left atrium; moving at least a portion of an outer surface of a first portion of the implant and / or one or more tissue anchors on or adjacent to the outer surface of the first portion of the implant relative to an inner wall surface of the left atrial appendage; rotating the first portion of the implant from a first position to a second position to twist the left atrial appendage from the first position to the second position; and moving the second portion of the implant from a first state in which the second portion of the implant is free to rotate relative to the first portion of the implant to a second state in which the second portion of the implant may be rotationally locked to the first portion of the implant. Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiments disclosed herein: the second portion of the implant is spaced from the first portion of the implant when the second portion of the implant is in the first state; the second portion of the implant is engageable with the first portion of the implant when the second portion of the implant is in the second state; rotating the first portion of the implant until at least a portion of the left atrial appendage contracts around the portion of the implant; rotating the first portion of the implant until an ostium of the left atrial appendage contracts around the portion of the implant; the method may engage tissue contracted as a result of the rotation of the first portion of the implant with the second portion of the implant; and / or moving the second portion of the implant from the first state to the second state causes the second portion of the implant to inhibit rotation of the left atrial appendage toward the first position of the left atrial appendage.

[0048] Also disclosed herein are embodiments of devices for treating the left atrial appendage, which may include an implant device that may include a first implant member configured to engage an internal tissue surface of a first portion of the left atrial appendage and a second implant member configured to engage an internal tissue surface of a second portion of the left atrial appendage spaced from the first portion of the left atrial appendage. In some embodiments, the device may be configured to rotate the first implant member in a first direction. In some embodiments, the device may be configured to rotate the second implant member in a second direction opposite the first direction.

[0049] Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: further including a first core member coupled to the first implant member and configured to cause rotation of the first implant member when the first core member is rotated, the first implant member being selectively releasably coupleable with the first core member so that the first implant member can remain in the left atrial appendage after the first core member is withdrawn; further including a second core member coupled to the second implant member and configured to cause rotation of the second implant member when the second core member is rotated, the second implant member being selectively releasably coupleable with the second core member so that the second implant member can remain in the left atrial appendage after the second core member is withdrawn; and / or further including a fixation element configured to operably prevent rotation of the first implant member and / or the second implant member.

[0050] Disclosed herein are embodiments of devices for treating a left atrial appendage that may include an implant device that may include a first implant member configured to engage an internal tissue surface of a first portion of the left atrial appendage and a second implant member configured to engage an internal tissue surface of a second portion of the left atrial appendage spaced from the first portion of the left atrial appendage. In some embodiments, the device may be configured to rotate the first implant member in a first direction. Further, in some embodiments, the device may be configured to also rotate the second implant member in the first direction. Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: further including a first core member coupled to the first implant member and configured to rotate the first implant member when the first core member is rotated, the first implant member being selectively releasably coupleable with the first core member so that the first implant member can remain in the left atrial appendage after the first core member is withdrawn; further including a second core member coupled to the second implant member and configured to rotate the second implant member when the second core member is rotated, the second implant member being selectively releasably coupleable with the second core member so that the second implant member can remain in the left atrial appendage after the second core member is withdrawn; and / or further including a fixation element configured to operably prevent rotation of the first implant member and / or the second implant member.

[0051] Disclosed herein are embodiments of a device for treating a left atrial appendage, which may include an implant that may include a contact member and a fixation element coupled or coupleable with the contact member, the fixation element including a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts. In some embodiments, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position and to twist at least a portion of the left atrial appendage in the first direction as the contact member rotates from the first rotational position to the second rotational position. Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein; wherein the contact member may be configured to move from at least a first state to a second state such that at least a portion of the contact member radially expands to engage an interior wall portion of the left atrial appendage; the plurality of interconnections provide connection points between adjacent struts of the plurality of struts; the plurality of struts may include a plurality of pairs of struts, each pair of struts may have two struts interconnected at a distal end of the struts; and the plurality of struts may include a first strut, a second strut, and a third strut. the second strut can be disposed between the first strut and the third strut, the second strut can be interconnected with the first strut at a distal end of the first and second struts, and the second strut can be interconnected with the third strut at a central portion of the second and third struts; the implant can further have a retention element coupled to the fixation element, the retention element configured to move the fixation element axially toward or away from the contact member or to hold the fixation element in a stationary position relative to the contact member; the fixation element can be configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixation element is in an operable state, the second direction being opposite the first direction; and the contact member can be configured to automatically expand at least a portion of the contact member from the first state to the second state when the restraint is removed from the contact member.The implant may be self-expandable, the implant may be substantially collapsible when the implant is in the first state and expanded when the implant is in the second state such that the size of the implant may be larger when the implant is in the second state than when the implant is in the first state, the contact member may be biased to remain in the second state after deployment into the left atrial appendage, the contact member may be configured to rotate in a clockwise or counterclockwise direction, the device may be configured to contract tissue of the left atrium and / or left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second rotational position, and the fixation element may be configured to fix the implant the fixation element may have a plurality of tissue anchors configured to engage contracted tissue about an outer surface of the body portion of the implant to prevent rotation of the implant in a second direction, the fixation element may have a plurality of tissue anchors configured to engage an interior wall of the heart adjacent the left atrial appendage, the fixation element may have a helical shape and may be configured to rotate about the body portion of the implant during the implant procedure, the implant may be configured to rotate in a first direction from a first rotational position to a second rotational position, and / or the implant may be configured to prevent rotation of the implant in a second direction after the implant is fully deployed, the second direction being opposite to the first direction.

[0052] Any of the embodiments of the methods, devices, and systems for treating a left atrial appendage disclosed herein may, in additional embodiments, include one or more of the following steps, features, components, and / or details, in any combination with any of the other steps, features, components, and / or details of any other embodiment disclosed herein: the contact member may have a plurality of tissue anchors on its outer surface, the plurality of tissue anchors on the outer surface of the contact member configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second state, the tissue anchors of the contact member having a proximally facing surface that is angled 5 degrees toward the proximal end of the contact member, and the tissue anchors are angled 2 degrees to 10 degrees toward the proximal end of the contact member. The implant may have a proximally-facing surface that is angled, the implant may have a fixation element configured to engage a tissue portion of the heart adjacent the left atrial appendage, the second rotational position may be at least one-quarter of a rotation relative to the first rotational position, the second rotational position may be at least one-half of a rotation relative to the first rotational position, the second rotational position may be from about one-quarter of a rotation to one or more full rotations relative to the first rotational position, and the catheter may be 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, the threshold predetermined torque level may be from about 0.25 in-oz of torque to about 10 in-oz of torque, the threshold predetermined torque level may be from about 0.The torque may be between 5 in-oz and about 5 in-oz, and may include a retention element configured to urge the fixation element toward the tissue wall of the LAA, may include a retention element configured to urge the fixation element toward the contact member, may include a retention element configured to couple the fixation element with the contact member, the retention element may have a threaded shaft, the device may be configured such that rotation of the retention element in a first direction moves the fixation element toward the contact member, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position when torque is applied to the contact member, the device may be configured such that the contact member can be detached from the left atrial appendage after the fixation element is deployed to an operative state of the fixation element, the device may be configured such that the contact member can be detached from the left atrial appendage after the fixation element is deployed to an operative state of the fixation element, and the fixation element can be configured to rotate from the first rotational position to a second rotational position. The device may be configured to prevent rotation of tissue of the left atrium and / or left atrial appendage that has contracted as a result of rotation of the contact member to the second rotational position, wherein only a portion of the fixation element extends into the left atrium after deployment of the device and all other portions of the device are inside the left atrial appendage after deployment of the device, and wherein only about 10% or less of the total length of the deployed device extends into the left atrium after deployment of the device; the device may be configured for use with a surgical robotic device or system, wherein the contact member and fixation element are integrally and / or monolithically formed, and / or the device may be configured to contract tissue of the left atrium and / or left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second rotational position, and the fixation element may be configured to compress the contracted tissue around the outer surface of the body portion of the implant between a distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction.

[0053] Some embodiments enclosed herein include a surgical robotic device, which may include one or more robotic arms and a device of any of the embodiments disclosed herein, wherein the device may be configured to be used by the surgical robotic device.

[0054] Some embodiments of the methods of treating the left atrial appendage disclosed herein may include rotating the left atrial appendage and fixing the left atrial appendage in the rotated position. Any embodiment of the method of treating, closing, or occluding an LAA may, in additional embodiments, include one or more of the following features, components, steps, and / or details in any combination with any of the other features, components, steps, and / or details of any other embodiment disclosed herein: rotating the left atrial appendage includes rotating the left atrial appendage to deform or occlude the left atrial appendage; fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a rotated position where a volume of the left atrial appendage is reduced; fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a rotated position where the left atrial appendage is deformed or occluded; rotating the left atrial appendage includes bending or twisting the left atrial appendage; fixing the left atrial appendage in a rotated position includes fixing the left atrial appendage in a position where blood communication between the left atrial appendage and the left atrium is inhibited, eliminated, or substantially eliminated; rotating the left atrial appendage includes engaging an inner wall portion of the left atrial appendage and / or an ostium of the left atrial appendage with a contact member and rotating the contact member; wherein the contact member is self-expanding, balloon-expandable, mechanically expandable, and / or a balloon; rotating the left atrial appendage includes engaging an inner wall portion of the left atrial appendage with one or more tissue anchors, one or more tissue grippers, and / or one or more other tissue retention features; rotating the left atrial appendage includes advancing the device into the left atrial appendage and rotating at least components of the device to rotate the left atrial appendage; rotating at least components of the device includes rotating at least components of the device from an initial position about 90 degrees to about 360 degrees in either direction; rotating the left atrial appendage includes rotating a portion of the left atrial appendage about an axis to twist the left atrial appendage; rotating a portion of the left atrial appendage from an initial position about one or more axes includes rotating the portion of the left atrial appendage from an initial position about 90 degrees to about 360 degrees in either direction; and rotating the portion of the left atrial appendage includes rotating the left atrial appendage until the portion of the left atrial appendage is substantially or completely closed;Rotating a portion of the left atrial appendage includes rotating the left atrial appendage until blood communication between the left atrial appendage and the left atrium is obstructed; rotating a portion of the left atrial appendage includes rotating the left atrial appendage until communication of blood or other substances between the left atrial appendage and the left atrium is eliminated or substantially eliminated; securing the left atrial appendage in the rotated position includes engaging twisted heart tissue, wherein engaging twisted heart tissue includes engaging the tissue wall with anchor or gripping elements; securing the left atrial appendage in the rotated position includes securing heart tissue outside the occluded portion of the left atrial appendage with anchor elements; securing the left atrial appendage in the rotated position includes securing tissue in the occluded portion of the left atrial appendage with anchor elements, and / or the anchor elements include a plurality of tissue grippers on at least one surface thereof configured to engage an interior wall of the heart outside the left atrial appendage.

[0055] Some embodiments of the methods for reducing the left atrial appendage ostium disclosed herein can include twisting cardiac tissue to constrict the left atrial appendage ostium and fixating the deformed or contracted tissue as a result of twisting the cardiac tissue. Any embodiment of the method for treating, closing, or occluding the LAA can, in additional embodiments, include one or more of the following features, components, steps, and / or details, in any combination with any of the other features, components, steps, and / or details of the other embodiments disclosed herein: fixating the deformed or contracted tissue includes advancing a fixation element into the deformed or contracted tissue as a result of twisting the cardiac tissue, the fixation element including a tissue anchor or tissue gripper; fixating the deformed or contracted tissue as a result of twisting the cardiac tissue includes advancing a fixation element into the deformed or contracted tissue to compress the deformed or contracted tissue; and / or fixating the deformed or contracted tissue as a result of twisting the cardiac tissue includes advancing one or more sutures or one or more staples into the deformed or contracted tissue as a result of twisting the cardiac tissue.

[0056] Some embodiments of the methods of treating a left atrial appendage system disclosed herein may include twisting the left atrial appendage system so that the volume of the left atrial appendage system is reduced and securing the left atrial appendage system in the reduced volume configuration. In some embodiments, securing the left atrial appendage in the reduced volume configuration may include occluding the left atrial appendage with an implant that is smaller in size than the size of the interior of the left atrial appendage. In some embodiments, the method of treating a left atrial appendage appendage may include unclamping and untwisting the left atrial appendage appendage. [Brief explanation of the drawings]

[0057] [Figure 1A] FIG. 1A shows a pathway through the venous system via the femoral vein and transseptal puncture into the left atrium that can be used to access the left atrial appendage (LAA).

[0058] [Figure 1B] FIG. 1B shows a cross-sectional view of the left atrium, showing the guidewire being advanced towards the LAA.

[0059] [Figure 1C] Figure 1C shows the surgeon's left view of the left atrium.

[0060] [Figure 1D] Figure 1D shows the surgeon's left view of the left atrium, showing the delivery device being advanced towards the LAA.

[0061] [Figure 1E] FIG. 1E shows an example of the device being advanced through an internal jugular vein access point toward the patient's heart.

[0062] [Figure 2A] FIG. 2A illustrates an embodiment of a treatment device having an implant device advanced through a catheter into the LAA, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0063] [Figure 2B] FIG. 2B illustrates the embodiment of the treatment device of FIG. 2A, showing the contact members expanded within the LAA.

[0064] [Figure 2C] FIG. 2C illustrates the treatment device embodiment of FIG. 2A, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0065] [Figure 2D] FIG. 2D illustrates the treatment device embodiment of FIG. 2A showing a fixation element of the implant device embodiment advancing towards a contact member of the implant device.

[0066] [Figure 2E] FIG. 2E shows the fixation elements of the treatment device of FIG. 2A engaged with the patient's tissue that has contracted as a result of torsion of the LAA.

[0067] [Figure 2F] FIG. 2F shows the implant device of FIG. 2A disengaged and removed from the catheter.

[0068] [Figure 2G] FIG. 2G shows the embodiment of the treatment device of FIG. 2A advanced into the left atrium (LA), with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0069] [Figure 2H] FIG. 2H illustrates the embodiment of the treatment device of FIG. 2A, showing the contact members expanded within the LA before advancing into the LAA.

[0070] [Figure 2I] FIG. 2I illustrates the embodiment of the treatment device of FIG. 2A, showing the contact members advanced into the LAA after they have been expanded.

[0071] [Figure 2J] FIG. 2J illustrates the treatment device embodiment of FIG. 2A, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0072] [Figure 2K] FIG. 2K shows another embodiment of a treatment device in which the implant device is advanced through a catheter into the LAA, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0073] [Figure 2L] FIG. 2L shows the embodiment of the implant device of FIG. 2K engaging with a patient's tissue that has contracted as a result of torsion of the LAA.

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

[0075] [Figure 3B] FIG. 3B illustrates an embodiment of an implant device having a cover member disposed against at least a portion of an inner surface of a portion of the implant device.

[0076] [Figure 3C] FIG. 3C shows another embodiment of an implant device having a foam material or other sealing material within a portion of the implant device.

[0077] [Figure 4] FIG. 4 shows the implant device of FIG. 2A with the contact members in a second expanded state, the retention elements in a first extended state, and the fixation elements in a second open state.

[0078] [Figure 5]5 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 5-5 of FIG.

[0079] [Figure 6] FIG. 6 shows the implant device of FIG. 2A with the contact members in the second open state, the retention elements in the second contracted state, and the fixation elements in the second open state.

[0080] [Figure 7] 7 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 7-7 of FIG.

[0081] [Figure 8A] FIG. 8A illustrates the embodiment of the implant device of FIG. 2A with the contact members advanced further distally into the LAA.

[0082] [Figure 8B] FIG. 8B illustrates the embodiment of the implant device of FIG. 2A, showing the contact member rotating to twist the LAA and contract the neck or opening of the LAA around a portion of the implant device.

[0083] [Figure 8C] FIG. 8C illustrates the embodiment of the implant device of FIG. 2A showing a fixation element of the embodiment of the implant device being advanced towards a contact member of the implant device.

[0084] [Figure 9A] FIG. 9A shows another embodiment of a treatment device in which the implant device is advanced through a catheter into the LAA, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0085] [Figure 9B] FIG. 9B illustrates the embodiment of the treatment device of FIG. 9A, showing the contact members expanded within the LAA.

[0086] [Figure 9C] FIG. 9C illustrates the treatment device embodiment of FIG. 9A, showing the contact member rotating to twist the LAA and contract the neck or opening of the LAA around a portion of the implant device.

[0087] [Figure 9D] FIG. 9D illustrates the treatment device embodiment of FIG. 9A showing a fixation element of the implant device embodiment advancing towards a contact member of the implant device.

[0088] [Figure 9E] FIG. 9E shows the fixation elements of the treatment device of FIG. 9A engaged with the patient's tissue that has contracted as a result of torsion of the LAA.

[0089] [Figure 9F] FIG. 9F shows the treatment device of FIG. 9A with the contact members in a second expanded state, the retention elements in a second contracted state, and the fixation elements in a second open state.

[0090] [Figure 9G] FIG. 9G is a cross-sectional view of the treatment device shown in FIG. 9A taken along line 9G-9G of FIG. 9F.

[0091] [Figure 9H] FIG. 9H shows an enlarged side view of the treatment device of FIG. 9A.

[0092] [Figure 9I] FIG. 9I shows an exploded view of the treatment device of FIG. 9A.

[0093] [Figure 9J] FIG. 9J illustrates another embodiment of a treatment device for treating the LAA, showing contact members advanced into the LAA before being expanded.

[0094] [Figure 9K]FIG. 9K illustrates the embodiment of the treatment device of FIG. 9J, showing the contact members engaging the wall of the LAA.

[0095] [Figure 9L] FIG. 9L illustrates another embodiment of a treatment device for treating the LAA, showing the contact members advanced into the LAA without expansion.

[0096] [Figure 9M] FIG. 9M shows the embodiment of the treatment device of FIG. 9L with the contact members advanced into contact with the medial wall surface of the LAA.

[0097] [Figure 9N] FIG. 9N illustrates an embodiment of the treatment device of FIG. 9L in which the contact members rotate to twist the LAA, occlude the neck or opening of the LAA, and / or contract around a portion of the implant device.

[0098] [Figure 9O] FIG. 9O illustrates the treatment device embodiment of FIG. 9L, showing the fixation element of the implant device embodiment advancing towards the contact member of the implant device.

[0099] [Figure 9P] FIG. 9P shows that the fixation elements of the treatment device of FIG. 9L engaged with the patient's tissue have contracted as a result of twisting of the LAA.

[0100] [Figure 10A] FIG. 10A illustrates another embodiment of a treatment device for treating the LAA, showing the contact members of the treatment device expanded within the LAA.

[0101] [Figure 10B] FIG. 10B illustrates another embodiment of a treatment device for treating the LAA, showing a contact member of the treatment device advanced into the LAA.

[0102] [Figure 10C] FIG. 10C illustrates the embodiment of the treatment device shown in FIG. 10B with the contact members advanced into the LAA in a pre-expanded state.

[0103] [Figure 10D] FIG. 10D illustrates the embodiment of the treatment device shown in FIG. 10B, showing the contact members expanded to engage the inner surface of the tissue of the LAA.

[0104] [Figure 10E] 10E-10L show different embodiments of expandable members that can be used in conjunction with any of the treatment or implant devices disclosed herein. [Figure 10F] Same as above. [Figure 10G] Same as above. [Figure 10H] Same as above. [Figure 10I] Same as above. [Figure 10J] Same as above. [Figure 10K] Same as above. [Figure 10L] Same as above.

[0105] [Figure 11] FIG. 11 shows an embodiment of a fixation element implanted adjacent to an obstructed opening in the LAA.

[0106] [Figure 12] FIG. 12 shows another embodiment of a fixation element implanted adjacent to an obstructed opening in the LAA.

[0107] [Figure 13] FIG. 13 illustrates another embodiment of a treatment device having an implant device with the contact members in a second expanded state, the retention elements in a second contracted state, and the fixation elements in a second open state.

[0108] [Figure 14]14 is a cross-sectional view of the treatment device shown in FIG. 13 taken along line 14-14 in FIG.

[0109] [Figure 15] FIG. 15 shows another embodiment of an implant device with the contact members in a second expanded state, the retention elements in a second contracted state, and the fixation elements in a second open state.

[0110] [Figure 16] 16 is a cross-sectional view of the treatment device shown in FIG. 15 taken along line 16-16 of FIG.

[0111] [Figure 17] FIG. 17 illustrates another embodiment of a treatment device with the contact members in a second expanded state, the retention elements in a second contracted state, and the fixation elements in a second open state.

[0112] [Figure 18] FIG. 18 shows a side view of another embodiment of a treatment device with the contact members in a second expanded state, the retention elements in a second contracted state, and the fixation elements in a second open state.

[0113] [Figure 19] 19 is a cross-sectional view of the treatment device shown in FIG. 18 taken along line 19-19 of FIG.

[0114] [Figure 20] FIG. 20 is another side view of the treatment device shown in FIG.

[0115] [Figure 21] 21 is a cross-sectional view of the treatment device shown in FIG. 18 taken along line 21-21 of FIG.

[0116] [Figure 22A] FIG. 22A shows a side view of another embodiment of a treatment device with the contact members in a second expanded state and the retention elements in a first retracted state.

[0117] [Figure 22B] FIG. 22B shows a side view of the treatment device of FIG. 22 with the contact members in the second position and the retention elements in the second deployed position.

[0118] [Figure 23A] FIG. 23A shows an isometric view of another embodiment of a fixation element.

[0119] [Figure 23B] FIG. 23B shows a side view of the embodiment of the fixation element shown in FIG. 23A.

[0120] [Figure 23C] FIG. 23C shows an isometric view of another embodiment of a fixation element.

[0121] [Figure 23D] FIG. 23D shows a side view of the embodiment of the fixation element shown in FIG. 23C.

[0122] [Figure 23E] FIG. 23E shows an isometric view of another embodiment of a fixation element.

[0123] [Figure 23F] FIG. 23F shows a side view of the embodiment of the fixation element shown in FIG. 23E.

[0124] [Figure 24] 24-35 illustrate an embodiment of a deployment method for the treatment device embodiment shown in FIG. 22A. [Figure 25] Same as above. [Figure 26] Same as above. [Figure 27] Same as above. [Figure 28] Same as above. [Figure 29] Same as above. [Figure 30] Same as above. [Figure 31] Same as above. [Figure 32] Same as above. [Figure 33] Same as above. [Figure 34] Same as above. [Figure 35] Same as above.

[0125] [Figure 36] FIG. 36 shows another embodiment of an implant device in which a retention element engages the tissue surface surrounding the opening of the LAA.

[0126] [Figure 37] FIG. 37 shows another embodiment of a treatment device with the tab members of the fixation elements in a first engaged state.

[0127] [Figure 38] FIG. 38 shows the treatment device of FIG. 37 with the tab members in a second, disengaged state.

[0128] [Figure 39] FIG. 39 shows a fixation element of the treatment device of FIG.

[0129] [Figure 40] FIG. 40 shows the treatment device of FIG. 37 with the fixation element engaged with the contact member and the tab member of the fixation element in a first engaged state.

[0130] [Figure 41] FIG. 41 shows the treatment device of FIG. 37 with the tab members of the fixation elements moved to a second, disengaged state by axial advancement of the core member of the delivery system.

[0131] [Figure 42] FIG. 42 shows the treatment device of FIG. 37, where the fixation element is rotated to misalign the tab members with the openings in the contact members, allowing for withdrawal of the fixation element from the contact members.

[0132] [Figure 43]FIG. 43 shows the treatment device of FIG. 37 with the fixation elements retracted from the contact members.

[0133] [Figure 44A] 44A and 44B are front and side views, respectively, of another embodiment of a treatment device configured to twist, close or occlude the LAA at the ostium of the LAA. [Figure 44B] Same as above.

[0134] [Figure 45A] 45A and 45B are front and side views, respectively, of the treatment device of FIG. 44, showing the implant used to twist the LAA to close or occlude the LAA at the ostium.

[0135] [Figure 46A] 46A and 46B are front and side views, respectively, of the treatment device of FIG. 44, showing the delivery device being detached from the implant device after the LAA has been occluded. [Figure 46B] Same as above.

[0136] [Figure 47A] 47A-47F show another embodiment of a treatment device for closing or occluding the LAA. [Figure 47B] Same as above. [Figure 47C] Same as above. [Figure 47D] Same as above. [Figure 47E] Same as above. [Figure 47F] Same as above.

[0137] [Figure 48A] 48A-48F illustrate several stages or steps illustrating an example deployment procedure for the expandable implant of FIGS. 47A-47F for treatment of the LAA. [Figure 48B] Same as above. [Figure 48C] Same as above. [Figure 48D]Same as above. [Figure 48E] Same as above. [Figure 48F] Same as above.

[0138] [Figure 48G] 48G-48O show some example stages or steps of a treatment procedure for another treatment device. [Figure 48H] Same as above. [Figure 48I] Same as above. [Figure 48J] Same as above. [Figure 48K] Same as above. [Figure 48L] Same as above. [Figure 48M] Same as above. [Figure 48N] Same as above. [Figure 48O] Same as above.

[0139] [Figure 49A] 49A-49G show another embodiment of a treatment device for closing or occluding the LAA. [Figure 49B] Same as above. [Figure 49C] Same as above. [Figure 49D] Same as above. [Figure 49E] Same as above. [Figure 49F] Same as above. [Figure 49G] Same as above.

[0140] [Figure 50A] 50A-50F illustrate several stages or steps illustrating an example deployment procedure for the expandable implant of FIGS. 49A-49G for treatment of the LAA. [Figure 50B] Same as above. [Figure 50C] Same as above. [Figure 50D] Same as above. [Figure 50E] Same as above. [Figure 50F] Same as above.

[0141] [Figure 51] FIG. 51 shows another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein.

[0142] [Figure 52] FIG. 52 illustrates another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein.

[0143] [Figure 53] FIG. 53 illustrates another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein.

[0144] [Figure 54] FIG. 54 illustrates another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein.

[0145] [Figure 55A] FIG. 55 shows another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein.

[0146] 55A-55C show additional embodiments of implants that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 55B] Same as above. [Figure 55C] Same as above.

[0147] [Figure 56A] 56A-56B show another embodiment of a contact member that can be used with any of the treatment device embodiments disclosed herein. [Figure 56B] Same as above.

[0148] [Figure 57A] 57A-57B show another embodiment of a fixation element that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 57B] Same as above.

[0149] [Figure 58A] 58A-58B show another embodiment of a fixation element that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 58B] Same as above.

[0150] [Figure 59A] 59A-59B show another embodiment of a fixation element that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 59B] Same as above.

[0151] [Figure 60A] 60A-60B show another embodiment of a fixation element that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 60B] Same as above.

[0152] [Figure 61A] 61A-61B show another embodiment of a fixation element that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 61B] Same as above.

[0153] [Figure 62A] 62A-62B show additional embodiments of contact members that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 62B] Same as above.

[0154] [Figure 62C] 62C1-62Z show additional embodiments of contact members and / or implant devices that can be used in conjunction with any of the treatment device embodiments disclosed herein. [Figure 62D] Same as above. [Figure 62E] Same as above. [Figure 62F] Same as above. [Figure 62G] Same as above. [Figure 62H] Same as above. [Figure 62I] Same as above. [Figure 62J] Same as above. [Figure 62K] Same as above. [Figure 62L] Same as above. [Figure 62N] Same as above. [Figure 62M] Same as above. [Figure 62O] Same as above. [Figure 62P] Same as above. [Figure 62Q] Same as above. [Figure 62R] Same as above. [Figure 62S] Same as above. [Figure 62T] Same as above. [Figure 62U] Same as above. [Figure 62V] Same as above. [Figure 62W] Same as above. [Figure 62X] Same as above. [Figure 62Y] Same as above. [Figure 62Z] Same as above.

[0155] [Figure 63] FIG. 63 shows a side view of an embodiment of a contact member.

[0156] [Figure 64] FIG. 64 illustrates another embodiment of a treatment device in which a contact member rotates to twist the LAA, causing the neck or opening of the LAA to contract around a portion of the implant device.

[0157] [Figure 65] FIG. 65 illustrates the treatment device embodiment of FIG. 64 with the fixation element of the implant device embodiment advanced adjacent to the ostial tissue of the LAA or the ostium of the LAA.

[0158] [Figure 66A] FIG. 66A shows an isometric view of another embodiment of an implant device for treating the LAA, showing a contact member in a second expanded state, a fixation element in a second expanded state, and a retention element in a first rotational position where the retention element is spaced from the contact member by a first distance.

[0159] [Figure 66B] FIG. 66B shows a top view of the embodiment of the implant device shown in FIG. 66A.

[0160] [Figure 66C] FIG. 66C shows an exploded view of the embodiment of the implant device shown in FIG. 66A, illustrating the contact members in a second expanded state and the fixation elements in a second expanded or unconstrained state.

[0161] [Figure 66D] FIG. 66D shows a cross-sectional view of the embodiment of the implant device shown in FIG. 66A taken through the axial centerline of the implant device, showing the contact member in a second expanded state, the fixation element in a first, folded, or constrained state, and the retention element in a first rotational position in which the retention element is spaced from the contact member by a first distance.

[0162] [Figure 66E] Figure 66E shows a cross-sectional view of the embodiment of the implant device shown in Figure 66A taken through the axial centerline of the implant device, showing the contact member in a second expanded state, the fixation element in a second expanded or unconstrained state, and the retention element in a first rotational position in which the retention element is spaced from the contact member by a first distance.

[0163] [Figure 66F]Figure 66F shows a cross-sectional view of the embodiment of the implant device shown in Figure 66A through the axial centerline of the implant device, showing the contact member in a second expanded state, the fixation element in a second expanded, or unconstrained, state, and the retention element in a second rotational position where the retention element is separated from the contact member by a second distance, the second distance being less than the first distance when the retention element is in the first rotational position.

[0164] [Figure 67A] FIG. 67A shows an embodiment of a device that may be configured to be used as a contact member and / or fixation element in any of the embodiments of the treatment devices disclosed herein.

[0165] [Figure 67B] FIG. 67B illustrates an embodiment of a treatment device for shielding the LAA showing an implant device with contact members in a collapsed state being advanced into the LAA.

[0166] [Figure 67C] FIG. 67C illustrates the embodiment of the treatment device shown in FIG. 67B, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0167] [Figure 67D] FIG. 67D illustrates the embodiment of the treatment device shown in FIG. 67B, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0168] [Figure 67E] FIG. 67E illustrates the embodiment of the treatment device shown in FIG. 67B with the fixation element of the embodiment of the implant device advanced towards the contact member.

[0169] [Figure 67F]FIG. 67F shows the fixation elements of the treatment device shown in FIG. 67B engaged with and / or adjacent to a patient's tissue that has contracted as a result of torsion of the LAA.

[0170] [Figure 67G] FIG. 67G shows another embodiment of a treatment device for occluding the LAA showing an implant device with contact members shown in a folded state advancing into the LAA and fixation elements shown in FIG. 67A in a folded state within a delivery device.

[0171] [Figure 67H] FIG. 67H illustrates the embodiment of the treatment device shown in FIG. 67G, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0172] [Figure 67I] FIG. 67I illustrates the embodiment of the treatment device shown in FIG. 67G, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0173] [Figure 67J] FIG. 67J illustrates the embodiment of the treatment device shown in FIG. 67G with the fixation element advanced toward the contact member.

[0174] [Figure 67K] FIG. 67K illustrates the embodiment of the treatment device shown in FIG. 67G, showing the fixation elements engaged with tissue that has contracted as a result of torsion of the LAA and / or tissue adjacent to tissue that has contracted as a result of torsion of the LAA.

[0175] [Figure 67L] FIG. 67L illustrates another embodiment of a treatment device for occluding the LAA, showing a contact member in a collapsed state being advanced into the LAA, and an implant device having a fixation element in a collapsed state within a delivery device.

[0176] [Figure 67M] FIG. 67M illustrates the embodiment of the treatment device shown in FIG. 67L, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0177] [Figure 67N] FIG. 67N illustrates the embodiment of the treatment device shown in FIG. 67L, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0178] [Figure 67O] FIG. 67O illustrates the embodiment of the treatment device shown in FIG. 67L, showing the fixation element advanced towards the contact member.

[0179] [Figure 67P] FIG. 67P illustrates the embodiment of the treatment device shown in FIG. 67L, showing the fixation elements engaged with tissue that has contracted as a result of torsion of the LAA and / or tissue adjacent to tissue that has contracted as a result of torsion of the LAA.

[0180] [Figure 68A] FIG. 68A shows another embodiment of a device that may be configured to be used as a contact member and / or fixation element in any of the treatment device embodiments disclosed herein.

[0181] [Figure 68B] FIG. 68B illustrates another embodiment of a treatment device for occluding the LAA, showing a contact member in a collapsed state being advanced into the LAA.

[0182] [Figure 68C] FIG. 68C illustrates the embodiment of the treatment device shown in FIG. 68B, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0183] [Figure 68D] FIG. 68D illustrates the embodiment of the treatment device shown in FIG. 68B, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0184] [Figure 68E] FIG. 68E illustrates the embodiment of the treatment device shown in FIG. 68B with the fixation element advanced toward the contact member.

[0185] [Figure 68F] Figure 68F shows the embodiment of the treatment device shown in Figure 68B, showing the fixation element engaged with tissue that has contracted as a result of torsion of the LAA and / or tissue adjacent to tissue that has contracted as a result of torsion of the LAA.

[0186] [Figure 69A] FIG. 69A shows another embodiment of a device that may be used as a contact member and / or fixation element in any of the treatment device embodiments disclosed herein.

[0187] [Figure 69B] FIG. 69B illustrates an embodiment of a treatment device for occluding the LAA, showing an implant device with contact members in a collapsed state being advanced into the LAA.

[0188] [Figure 69C] FIG. 69C illustrates the embodiment of the treatment device shown in FIG. 69B, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0189] [Figure 69D] FIG. 69D illustrates the embodiment of the treatment device shown in FIG. 69B, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0190] [Figure 69E] FIG. 69E illustrates the embodiment of the treatment device shown in FIG. 69B with the fixation element of the embodiment of the implant device advanced towards the contact member.

[0191] [Figure 69F] FIG. 69F shows the fixation element of the treatment device shown in FIG. 69B engaging with a patient's tissue that has contracted as a result of torsion of the LAA and / or tissue adjacent to a patient's tissue that has contracted as a result of torsion of the LAA.

[0192] [Figure 70A] FIG. 70A shows another embodiment of an implant that can be used as a contact member and / or fixation element in any of the treatment device embodiments disclosed herein.

[0193] [Figure 70B] FIG. 70B illustrates an embodiment of a treatment device for occluding the LAA, showing an implant device with contact members in a collapsed state being advanced into the LAA.

[0194] [Figure 70C] FIG. 70C illustrates the embodiment of the treatment device shown in FIG. 70B, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0195] [Figure 70D] FIG. 70D illustrates the embodiment of the treatment device shown in FIG. 70B, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0196] [Figure 70E] FIG. 70E illustrates the embodiment of the treatment device shown in FIG. 70B with the fixation element of the embodiment of the implant device advanced towards the contact member.

[0197] [Figure 70F] FIG. 70F shows the fixation elements of the treatment device shown in FIG. 70B engaged with a patient's tissue that has contracted as a result of torsion of the LAA and / or tissue adjacent to a patient's tissue that has contracted as a result of torsion of the LAA.

[0198] [Figure 70G] FIG. 70G illustrates another embodiment of a treatment device for occluding the LAA, showing an implant device with contact members in a collapsed state being advanced into the LAA.

[0199] [Figure 70H] FIG. 70H illustrates the embodiment of the treatment device shown in FIG. 70B, with the contact members expanded within the LAA and engaging the inner surface of the wall portion of the LAA.

[0200] [Figure 70I] FIG. 70I illustrates the embodiment of the treatment device shown in FIG. 70B, showing the contact members rotating to twist the LAA and cause the neck or opening of the LAA to contract around a portion of the implant device.

[0201] [Figure 70J] FIG. 70J illustrates the treatment device embodiment shown in FIG. 70B with the fixation element of the implant device embodiment advanced toward the contact member.

[0202] [Figure 71K] FIG. 70K shows the fixation elements of the treatment device shown in FIG. 70B engaged with patient tissue that has contracted as a result of torsion of the LAA and / or that is adjacent to patient tissue that has contracted as a result of torsion of the LAA.

[0203] [Figure 70L] 70L-70T show another embodiment of a treatment system for treating or occluding the LAA. [Figure 70M] Same as above. [Figure 70N] Same as above. [Figure 70O] Same as above. [Figure 70P] Same as above. [Figure 70Q] Same as above. [Figure 70R] Same as above. [Figure 70S] Same as above. [Figure 70T] Same as above.

[0204] [Figure 71A] FIG. 71A illustrates another embodiment of a treatment device for treating or occluding the LAA, showing an implant device advanced past the distal end of a delivery device and toward the LAA.

[0205] [Figure 71B] FIG. 71B illustrates the embodiment of the treatment device shown in FIG. 71A, showing the implant device advanced into the LAA.

[0206] [Figure 71C] FIG. 71C illustrates the embodiment of the treatment device shown in FIG. 71A, showing the first and second implant members of the implant device rotating to twist the tissue of the LAA to occlude the ostium of the LAA.

[0207] [Figure 71D] FIG. 71D illustrates the embodiment of the treatment device shown in FIG. 71A, showing the first and second implant members of the implant device after occluding the LAA, with the first and second implant members secured together and detached from the delivery device.

[0208] [Figure 72A] FIG. 72A illustrates another embodiment of a treatment device for treating or occluding the LAA, showing an implant device having a first implant member and a second implant member positioned within the ostium of the LAA.

[0209] [Figure 72B] FIG. 72B illustrates the embodiment of the treatment device shown in FIG. 72A, showing the first and second implant members of the implant device rotating and twisting the tissue of the LAA to occlude the ostium of the LAA.

[0210] [Figure 73A] FIG. 73A illustrates another embodiment of a treatment device for treating or occluding the LAA, showing a deployment device having a suction member advanced into the LAA.

[0211] [Figure 73B] FIG. 73B illustrates the embodiment of the treatment device shown in FIG. 73A with the suction member advanced toward the distal wall of the LAA.

[0212] [Figure 73C] FIG. 73C illustrates the embodiment of the treatment device shown in FIG. 73A, showing the suction member engaging the distal wall of the LAA with suction to retract a portion of the distal portion of the wall of the LAA.

[0213] [Figure 73D] FIG. 73D shows another embodiment of a treatment device for treating or occluding the LAA, showing a suction member engaging the distal wall of the LAA and retracting a portion of the distal portion of the wall of the LAA.

[0214] [Figure 73E] FIG. 73E illustrates another embodiment of a treatment device for treating or occluding the LAA, showing the clamping members surrounding a portion of tissue that has been everted by withdrawal of the suction members.

[0215] [Figure 74] Figure 74 is a front view of the heart showing the right ventricle, left ventricle, and LAA.

[0216] [Figure 75] FIG. 75 shows the heart located within the pericardial cavity beneath the patient's rib cage.

[0217] [Figure 76A] 76A-76F show embodiments of treatment devices and methods of using such devices for treating the LAA. [Figure 76B] Same as above. [Figure 76C] Same as above. [Figure 76D] Same as above. [Figure 76E] Same as above. [Figure 76F] Same as above.

[0218] [Figure 77A] 77A-77E show embodiments of treatment devices and methods of using such devices to treat the LAA. [Figure 77B] Same as above. [Figure 77C] Same as above. [Figure 77D] Same as above. [Figure 77E] Same as above.

[0219] [Figure 78A] 78A-78E show embodiments of treatment devices and methods of using such devices to treat the LAA. [Figure 78B] Same as above. [Figure 78C] Same as above. [Figure 78D] Same as above. [Figure 78E] Same as above.

[0220] [Figure 79A] 79A-79H show another embodiment of a treatment device for occluding the LAA. [Figure 79B] Same as above. [Figure 79C] Same as above. [Figure 79D] Same as above. [Figure 79E] Same as above. [Figure 79F] Same as above. [Figure 79G] Same as above. [Figure 79H] Same as above.

[0221] [Figure 80A] 80A-80W show another embodiment of a treatment device for closing or occluding the LAA. [Figure 80B] Same as above. [Figure 80C] Same as above. [Figure 80D] Same as above. [Figure 80E] Same as above. [Figure 80F] Same as above. [Figure 80G] Same as above. [Figure 80H] Same as above. [Figure 80I] Same as above. [Figure 80J] Same as above. [Figure 80K] Same as above. [Figure 80L] Same as above. [Figure 80M] Same as above. [Figure 80N] Same as above. [Figure 80O] Same as above. [Figure 80P] Same as above. [Figure 80Q] Same as above. [Figure 80R] Same as above. [Figure 80S] Same as above. [Figure 80T] Same as above. [Figure 80U] Same as above. [Figure 80V] Same as above. [Figure 80W] Same as above.

[0222] [Figure 81A] 81A-81F are an embodiment of treatment of the LAA using the device embodiment shown in FIG. 80A. [Figure 81B] Same as above. [Figure 81C] Same as above. [Figure 81D] Same as above. [Figure 81E] Same as above. [Figure 81F] Same as above.

[0223] [Figure 82A] 82A-82E show another embodiment of a treatment device for closing or occluding the LAA. [Figure 82B] Same as above. [Figure 82C] Same as above. [Figure 82D] Same as above. [Figure 82E] Same as above.

[0224] [Figure 83A] 83A-83J show another embodiment of a treatment device for closing or occluding the LAA. [Figure 83B] Same as above. [Figure 83C] Same as above. [Figure 83D] Same as above. [Figure 83E] Same as above. [Figure 83F] Same as above. [Figure 83G] Same as above. [Figure 83H] Same as above. [Figure 83I] Same as above. [Figure 83J] Same as above.

[0225] [Figure 84A] 84A-84B show another embodiment of a retention element that can be used with any of the treatment or implant device embodiments disclosed herein. [Figure 84B] Same as above.

[0226] [Figure 85A] 85A-85I show another embodiment of a treatment device for closing or occluding the LAA. [Figure 85B] Same as above. [Figure 85C] Same as above. [Figure 85D] Same as above. [Figure 85E] Same as above. [Figure 85F] Same as above. [Figure 85G] Same as above. [Figure 85H] Same as above. [Figure 85I] Same as above.

[0227] [Figure 86A] 86A-86I show another embodiment of a treatment device for closing or occluding the LAA. [Figure 86B] Same as above. [Figure 86C] Same as above. [Figure 86D] Same as above. [Figure 86E] Same as above. [Figure 86F] Same as above. [Figure 86G] Same as above. [Figure 86H] Same as above. [Figure 86I] Same as above.

[0228] [Figure 86J] 86J-86L show another embodiment of a treatment device for closing or occluding the LAA. [Figure 86K] Same as above. [Figure 86L] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0229] Described herein are novel devices, systems, and methods for closing or occluding the LAA. Some embodiments include methods that include advancing a delivery system into the LAA, advancing and deploying an expandable element (which in some embodiments may be covered with barbs, texture, or other tissue-engaging features, or may be smooth) and having a generally spherical or spherical shape within the left atrial appendage, allowing the expandable element to distally and / or radially engage the inner wall surface of the LAA, and applying rotations to an inner catheter member connected to the expandable element to twist the LAA and close and / or occlude the LAA at or near the ostium. By occluding the LAA, some embodiments disclosed herein can effectively eliminate, or significantly or nearly completely eliminate, communication of blood or other substances between the left atrium and the LAA. Any of the deployment methods disclosed herein may also include deployment of a fixation element (also referred to herein as a locking element or anchor element) configured to inhibit or prevent unwinding of the expandable element against the LAA and LA entrance tissues, thereby inhibiting or preventing untwisting of the LAA.

[0230] The devices, systems, and methods disclosed herein can be used or adapted for other uses within or on the body of any human, animal, insect, or other organism, including, but not limited to, closing openings in other tissues other than the LAA, occluding or closing openings, passages, and / or chambers in the heart or other organs, occluding or closing holes or other slits or openings in blood vessels and passages, and / or treating other conditions.

[0231] A clinical benefit of some embodiments is that the resulting implant does not come into direct blood contact with left atrial blood or flow, except for the potential fixation function. The fixation element of any embodiment can be configured to limit its exposure to blood in the left atrium (i.e., limit the amount of fixation element protruding into the left atrium). In some embodiments, the entire implant can be surrounded by LAA tissue so that no part of the implant is exposed to blood flow in the left atrium, or only a minimal portion (e.g., less than 10% of the surface area, or less than 40% of the surface area) is exposed. This can provide a clinical benefit to patients by reducing the need for post-drug regimens. Any of the devices used in any of the methods described herein can be advanced under any of a variety of visualization techniques, such as visualization under fluoroscopy, ultrasound, etc.

[0232] For any of the embodiments disclosed herein, access to the LAA can be gained by any number of suitable means or access points. For example, and without limitation, access to the LAA for some embodiments can be gained by entering the venous system via the femoral vein and transseptal puncture into the left atrium. Imaging can use both fluoroscopy and echo (TEE, ICE, or transthoracic) to image the size, location, and position of the LAA for insertion of a prosthesis or occlusion device. Figures 1A-1D show some example pathways from the access site to the LAA.

[0233] For any of the device, system, and method embodiments disclosed herein, the venous system is entered via a transseptal puncture into the femoral vein and left atrium to access the left atrial appendage (LAA). Imaging of the size, location, and position of the LAA for prosthetic entry for closure can be performed using both fluoroscopy and echocardiography (TEE, ICE, or transthoracic). Figures 1A-1D show examples of routes from the access site to the LAA. Other access sites for any of the device, system, and method embodiments disclosed herein may include access through the internal jugular (IJ) vein, as shown in Figure 1E.

[0234] Furthermore, any of the device, system, and method embodiments disclosed herein may be delivered to the LA / LAA or may include delivery to the LA / LAA via a transfemoral artery route. In some embodiments, a transfemoral artery route may include advancing a delivery device through the femoral artery, up the aorta, down the aortic valve, up the mitral valve, and into the LAA. Similarly, any of the device, system, and method embodiments disclosed herein may be delivered to the LA / LAA or may include delivery to the LA / LAA via a forearm route, including, for example, and without limitation, access through the radial artery at the wrist. This access route is also referred to as forearm access, forearm approach, or forearm angioplasty.

[0235] Any of the embodiments of the implants disclosed herein may have an expandable, atraumatic shape with tissue-grasping features located on the outer edge of the shape coupled with locking and / or latching features that can hold the implant in an initial or final closed position. Any of the embodiments of the implants disclosed herein may be configured to grip the internal tissue of the LAA with a radial force. In some embodiments, a vacuum or suction may be provided by the catheter or any component thereof to draw tissue portions of the LAA or atrium toward the implant. Any of the embodiments of the implants disclosed herein may have an atraumatic shape that is spherical, dome-shaped, or includes a disc-shaped coil of wire, may have an expanded cut pattern in the shape of a stent, or any other shape that may have rounded edges. In some embodiments, barbs on the outer edge or surface of the implant (which may be tissue anchors) may include metal hooks, plastic cleats, a rough texture of some material or surface feature, a coating, or an activated adhesive that grips the internal surface of the LAA. Additionally, in any embodiment disclosed herein, a tissue anchor can be positioned on or adjacent the end of the implant for engaging the end of the LAA. In any embodiment, the barbs can be directional to allow tissue engagement in one rotational direction and disengagement in the opposite rotational direction for possible repositioning, resizing, or removal from the LAA.

[0236] For any embodiment disclosed herein, the rotation used to twist and close or occlude (completely or substantially) the LAA can be a quarter turn (i.e., a turn), a half turn, a full turn, or up to multiple turns for deeper or longer LAAs. The fixation feature or element (also referred to herein as an anchor element) in any embodiment disclosed herein can have a single arm or multiple arms that can be connected to an implant body that is positioned and rotated within a closed or substantially closed LAA. The fixation feature or element can be configured to engage tissue adjacent the ostium of the LAA. In any embodiment, the fixation element can have multiple arms or members, an annular ring, a disk, or any other suitable shape of surface anchor configured to connect non-twisted tissue to a twisted implant. In some embodiments, the fixation element can have a small diameter ring that can be configured to secure or engage tissue that contacts the implant's central hub (adjacent the ostium of the LAA) and can also have a clip that folds over and fastens the implant to the side of the left atrium (LA) wall.

[0237] In some embodiments disclosed herein, the device can be configured to restrict the opening of the LAA (including any occlusive effects from the device) by reducing the cross-sectional area of ​​the LAA ostium by at least 95%, or at least 90%, or at least approximately 80% to approximately 100% compared to the cross-sectional area of ​​the LAA ostium before the device was implanted. Furthermore, in some embodiments, the method can include rotating the implant from a first rotational position to a second rotational position to twist the LAA until the ostium of the LAA is at least 95% blocked and / or restricted, or at least 90% blocked and / or restricted, or at least 80% blocked and / or restricted, or approximately 70% to approximately 100% blocked and / or restricted. Furthermore, any embodiment disclosed herein can include implantation of two or more implants of any of the implant embodiments disclosed herein in the LAA. For example, and without limitation, any of the implant embodiments disclosed herein may be configured to be deployed or implanted in the LAA to improve occlusion of an implant already implanted in the LAA, including any implant that fits within any of the aforementioned ranges of less than total occlusion. In some embodiments, one or more additional implants or devices may be implanted adjacent to, above, around, or otherwise to improve the level of occlusion of the LAA.

[0238] Alternatively, in any embodiment disclosed herein, the fixation element may be configured to simply compress contracted left atrial and / or left atrial appendage tissue around the outer surface of the implant's body portion between the distal surface of the fixation element and the contact member to prevent rotation of the implant after rotation in the second direction, i.e., the contact member, to the second rotational position without penetrating the tissue. For example, and without limitation, in any embodiment disclosed herein, the fixation element may have a smooth body portion that is non-obstructive or non-penetrating, e.g., such that the fixation element does not have any tissue-penetrating features thereon that extend toward the tissue surface. In other embodiments, the arms (or at least the portions of the arms that extend axially when the fixation element is in the second state) or other tissue-penetrating portions of the fixation element may be shorter, such as from about 1 mm to about 5 mm in length, or from about 1 mm to about 3 mm in length, or from about 1 mm to about 2 mm in length, or any value or range of values ​​between any of the aforementioned ranges.

[0239] 1A and 1B show cross-sectional views of the left atrium and show a guidewire G advancing from a catheter C toward the left atrial appendage LAA. FIG. 2A shows one embodiment of a treatment device 100 (also referred to herein as an occlusion device) for occluding or closing the opening of the LAA.

[0240] In any embodiment disclosed herein, rotating the contact member, implant device, and / or left atrial appendage can include rotating the contact member, implant device, and / or left atrial appendage about a longitudinal axis of the contact member and / or implant device. In some embodiments, the axis of rotation can be an axis extending through the ostium of the LAA toward the inner wall of the LAA, or can be an axis defined by an insertion path of the implant into the LAA. In some embodiments, the insertion path can be through the ostium of the LAA to the distal wall of the LAA. In some embodiments, the axis of rotation can be an axis extending through the ostium of the LAA toward the inner wall of the LAA, and the LAA and / or implant rotate about the axis. In some embodiments, the axis of rotation can be an axis extending through the ostium of the LAA toward the inner wall of the LAA, and the LAA and / or implant rotate about the axis, twisting the LAA.

[0241] In any embodiment disclosed herein, the treatment device (including the embodiment of treatment device 100) can be configured to rotate and twist the LAA to contract a portion of the LAA adjacent the opening of the LAA and substantially or completely close around the exterior surface of a portion of the implant device, thereby occluding the opening of the LAA. In any embodiment of the treatment device, including the embodiment of treatment device 100, the system can include an implant device 102 having a contact member 104 (also referred to as a contact element, a first portion of the implant, or an expandable implant member in any embodiment disclosed herein), a fixation member or fixation element 110 (also referred to as a fixation member or a second portion of the implant in any embodiment herein), and a retention element 108 (also referred to as a retention member). The implant device 102 can be configured to be advanced into the LAA through a catheter 112. The embodiment of implant device 102 shown in FIG. 2A is shown in a collapsed state and is constrained within an outer sleeve 114 of the catheter 112. As shown, the implant device 102 can be advanced distally out of the catheter 112 through the distal end 114a of the outer sleeve 114 by advancing a portion or member of the catheter, such as (but not limited to) the core member 113 of the catheter 112, so that the contact member 104 of the implant device 102 can be advanced into and / or deployed within the LAA.

[0242] Alternatively, the catheter 112 with the implant device 102 therein can be advanced to a desired location within the LAA, and the outer sleeve 114 of the catheter 112 can be retracted or withdrawn to expose and / or unconstrain the contact members 104 of the implant device 102 while maintaining the core member 113 of the catheter 112 in a fixed axial position, thereby holding the implant device 102 in a fixed axial position. In any embodiment disclosed herein, the contact members 104 can be radially self-expanding such that when a constraint is removed from the contact members 104, the contact members 104 can automatically expand against the inner surface or wall of the LAA. In other embodiments, the contact members 104 can be mechanically expandable, such as by a balloon expander, to expand against the inner surface or wall of the LAA. FIG. 2B shows the contact members 104 after they have been expanded against the inner wall of the LAA distal to the ostium or opening O of the LAA.

[0243] Alternatively, in any embodiment disclosed herein, the contact member may be configured to remain in a first state within the catheter during and / or after the entire treatment procedure. For example, and without limitation, in any embodiment disclosed herein, the contact member may be configured so that the contact member is deployed from the catheter, advances into contact with the tissue surface of the inner wall of the LAA, engages with the tissue surface of the inner wall of the LAA, and twists the LAA when torque and / or rotation is applied to the contact member, all without changing the state of the contact member. Alternatively, in any embodiment disclosed herein, the contact member may be advanced into the pericardial space around the outside of the LAA, engages with the outer surface of the LAA, and twists the LAA when torque and / or rotation is applied to the contact member.

[0244] 2B, the contact member 104 may have multiple arms or struts 116, each configured to self-expand radially when a restraint is removed from the exterior surface of the contact member 104. For example, without limitation, any embodiment of a contact member disclosed herein may have six struts 116, or six to ten struts, or fewer than six to more than ten struts.

[0245] Additionally, in any embodiment, the contact members 104 may have a plurality of teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue engagement features 118 configured to penetrate tissue within the LAA when the contact members 104 are expanded against the tissue of the LAA and / or when the contact members 104 are rotated or twisted within the LAA, or other similar features configured to penetrate or engage tissue of the LAA. Note that teeth, cleats, barbs, nubs, texture, studs, anchors, and other tissue engagement features, or features configured to grip or engage tissue when torque is applied to the expanded contact members, are collectively referred to herein as tissue anchors. Use of this term is intended to describe and include the aforementioned features individually and / or any combination of these features.

[0246] The tissue anchors 118 may be formed integrally with, on, added to, or otherwise coupled to or supported by the struts. The tissue anchors 118 may face circumferentially (or radially, as shown) to penetrate or engage tissue at an angle perpendicular to the tissue surface of the LAA, at an angle relative to a line tangent to the outer surface of the contact member 104, or at other angles. In some embodiments, each strut 116 may support multiple tapered tissue anchors facing circumferentially, as shown in FIG. 2B. All of the tissue anchors may face a similar orientation relative to each strut, such as circumferentially relative to each strut. In the illustrated embodiment, each strut 104 has five tissue anchors 118. In this embodiment, when the contact member 104 is rotated in a first direction (indicated by arrow A1 in FIG. 2C , which can be clockwise or counterclockwise), one or more or all of the struts 116 and one or more or all of the tissue anchors 118 can engage tissue of the LAA and twist or rotate the LAA in the first direction A1, resulting in radial contraction of the opening or ostium O of the LAA such that the opening O of the LAA moves or contracts about the outer surface of the proximal portion 104 a of the contact member 104 (represented or identified by arrow A2 in FIG. 2C ). An operator can twist or rotate the contact member 104 by twisting or rotating the core member 113 of the catheter 112. Tightening or constriction of the opening O of the LAA around the outer surface of the proximal portion 104a of the contact member 104 or other portions of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior portion of the LAA from the remaining chambers within the heart, thereby substantially reducing the health risks associated with an open LAA.

[0247] In some embodiments, as in the illustrated example, the fixation element 110 may be maintained in a collapsed or first state by being constrained by an outer sleeve 114 of the catheter 112 while the contact members 104 unfold and rotate to prevent the fixation element 110 from contacting tissue within the heart and potentially lacerating or damaging such tissue. An intermediate sleeve or tube 115 may be coupled to the fixation element 110 and may be used to manipulate and control the position and / or orientation of the fixation element 110, including holding the proximal end 110a of the fixation element in a fixed axial position while a distally directed force is exerted on the contact member 104 to maintain the fixation element in the first, extended state. In any of the implant device embodiments disclosed herein, the fixation element (including, for example, and without limitation, the fixation element 110) may be keyed, indexed, or otherwise rotationally fixed to the contact member (including, for example, and without limitation, the contact member 104) such that the fixation element cannot rotate relative to the contact member and the contact member cannot rotate relative to the fixation element. In this configuration, the fixation element can prevent or substantially prevent or inhibit the contact member and LAA from rotating back to the first rotated position.

[0248] 2D , with the contact member 104 rotated to a second rotational position and maintained in the second rotational position such that the opening O of the LAA remains constricted around the proximal portion 104a of the contact member 104 or other portion of the implant device and the LAA is generally occluded from the remainder of the heart chamber, the catheter tube member 115 can then be advanced distally (represented by arrow A3 as shown in FIG. 2D ) or the outer sleeve 114 can be retracted proximally to expose the fixation element 110 so that it can self-expand from the first, collapsed state (shown in FIG. 2C ) to a second, expanded, or open state (shown in FIG. 2D ). In the second state, the multiple struts or members 120 of the fixation element 110 can expand generally radially to open to a larger overall diameter or profile. Additionally, each of the one or more members 120 of the fixation element 110 may have an end 120a that extends generally distally axially (but may be angled slightly inward) as the fixation element 110 advances axially, such that the distal portion 120a of each of the one or more members 120 can penetrate and / or engage a tissue portion of the heart, as shown in FIG. 2E . The tissue portion that the one or more members 120 can penetrate or engage may include a portion of the tissue comprising the left atrium and / or a portion of the tissue comprising the LAA. As described above, the contact member 104 may be held in a generally fixed axial position using the core member 113 while the fixation element 110 is advanced distally toward the contact member 104. The retention element 108 may then be unconstrained to maintain the fixation element 110 in a second rotational position in which the fixation element 110 engages the tissue of the heart, as shown in FIG. 2E . In some embodiments, the fixation element may be biased axially toward a smaller size, such as with a spring member or the like. For example, the retention element 108 may be formed by a laser cut opening in a cylindrical tube, such as a hypotube, made of a resilient material such as Nitinol. Thereafter, with reference to FIG. 2F, the implant device 102 may be disengaged from the catheter 112, and the catheter 112 may be retracted and removed from the patient's body.When the fixation element 110 engages the patient's tissue, as shown in FIG. 2F, the LAA can be prevented from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fixate and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0249] 2F, the implant device 102 may then be disengaged from the catheter 112, and the catheter 112 may be retracted and removed from the patient's body. When the fixation element 110 engages the patient's tissue, as shown in FIG. 2F, the LAA is prevented, or at least inhibited or biased, from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fixate and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0250] In any embodiment of the methods and devices disclosed herein, including but not limited to any of the methods for treating the LAA, the contact member can be partially or fully expanded in the left atrium (LA) before being advanced into the LAA. For example, and without limitation, FIG. 2G shows the embodiment of the treatment device 100 of FIG. 2A advanced into the left atrium (LA), with the implant device 102 in a collapsed state and constrained within the outer tube of the catheter. FIG. 2H shows the contact member 104 partially or fully expanded (or partially or fully moved to a second state) within the LA before being advanced into the LAA. As shown in FIG. 2I, the contact member 104 and other components of the treatment device 100 can be advanced into the LAA when the contact member is in the expanded state or the second state, or when the contact member is partially expanded or between the first and second states. As shown in FIG. 2J, the contact member can be rotated to twist the LAA, causing the neck or opening of the LAA to contract around a portion of the implant device, as described above. Other steps for completing treatment can be as described above and in other methods disclosed herein. As mentioned above, it should be noted that any of the embodiments of the treatment devices disclosed herein can be configured so that the contact member can be partially or completely expanded within the LA before advancing the contact member into the LAA. Similarly, in any of the embodiments of the methods disclosed herein (for example, and without limitation, embodiments for treating and / or occluding the LAA), the contact member can be partially or completely expanded within the LA before advancing the contact member into the LAA. In certain embodiments, the contact member is not further expanded once positioned within the LAA, and in certain embodiments, the contact member can be further expanded or contracted once positioned within the LAA. In certain embodiments, the contact member can be contracted within the LA before entering the LAA and then remain in a contracted position within the LAA, or can be further expanded or contracted once positioned within the LAA.

[0251] As described above, the contact member is rotated to twist the LAA so as to contract the neck or portion of the LAA adjacent the opening of the LAA and substantially or completely close around the exterior surface of a portion of the implant device, thereby occluding the opening of the LAA. In the illustrated embodiment, the contact member 104 can rotate about its longitudinal axis to cause twisting of the LAA. In certain embodiments, the longitudinal axis about which the contact member rotates can correspond to or be closely aligned with the insertion axis of the fixation element 110 as it advances toward the contact member 104. Additionally, any of the method and device embodiments disclosed herein can be configured such that the implant or contact member can advance from the delivery catheter and engage the wall of the LAA without the implant or contact member fully or partially expanding, changing size, changing shape, or moving toward or towards a second state. For example, in some embodiments, the implant or contact member can be configured to engage the LAA without the implant or contact member fully or partially expanding, changing size, changing shape, or moving toward or towards a second state, and to rotate upon rotation of the implant or contact member.

[0252] FIG. 2K shows another embodiment of a treatment device 100′ having an implant device 102′ advanced through a catheter into the LAA, with the implant device 102′ in a collapsed state and constrained within the outer tube 114 of the catheter. FIG. 2L shows the embodiment of the implant device 102′ of FIG. 2K engaged with patient tissue that has contracted as a result of torsion of the LAA. In any embodiment, the implant device 102′ can have a contact member 104′, a fixation element 110′, and a retention element 108′ extending between the contact member 104′ and the fixation element 110′. In some embodiments, the implant device 102′ can be inverted compared to the implant device 102 described above.

[0253] In some embodiments, the contact member 104' can be configured to treat the LAA similarly to any other embodiment of a contact member disclosed herein. For example, and without limitation, the contact member 104' can be configured, like other embodiments of a contact member disclosed herein, to engage tissue portions within the LAA and twist the LAA to inwardly constrict a portion of the tissue of the LAA. In the illustrated embodiment, the contact member 104' can have the same or similar structure, functionality, components, and / or other details as any of the embodiments of a fixation element disclosed herein, such as, but not limited to, the embodiments of the fixation element 110 disclosed herein, while being configured to engage tissue within the LAA and twist the LAA to constrict and / or occlude the ostium of the LAA.

[0254] Additionally, in some embodiments, fixation element 110' can be configured to treat the LAA in the same manner as any other embodiment of a fixation element disclosed herein. For example, and without limitation, fixation element 110' can be configured to engage contracted tissue resulting from twisting of the LAA to prevent untwisting of the contracted tissue and / or inhibit dilation of the constricted opening of the LAA. In the illustrated embodiment, fixation element 110' can have the same or similar structure and functionality as any of the contact member embodiments disclosed herein, for example, and without limitation, the contact member 104 embodiments disclosed herein.

[0255] In other embodiments, implant device 110' may have a contact member similar to any of the embodiments of contact member 104 disclosed herein, or any of the other embodiments of contact members disclosed herein (excluding the embodiments of contact member 104') along with the embodiments of fixation element 110' disclosed herein, or a fixation element having the same or similar structure as any of the other embodiments of contact members disclosed herein (excluding the embodiments of contact member 104'). Alternatively, in other embodiments, implant device 110' may have a contact member 104' disclosed herein, or a fixation element similar to any of the other fixation elements shown herein, such as any of the embodiments of fixation element 110 disclosed herein.

[0256] Components of any of the implant embodiments disclosed herein may be made from any other elastic or superelastic material, including nitinol or any other shape-memory material, or stainless steel or any other mechanically expandable material. In any of the embodiments disclosed herein, the contact member (such as contact member 104) may have a spherical, cylindrical, or other shape, such as an elongated bullet, a stent, a mushroom, or other non-circular or non-cylindrical shape, or any of the shapes described or shown with respect to any of the embodiments disclosed herein. In any of the embodiments disclosed herein, the contact member may include a series of interconnected struts (which can, but are not required to, form a diamond-shaped pattern across all or a portion of the surface of the contact member) or may be made from a series of ribs or paddles that form an expandable device.

[0257] 3A , the fixation elements of any device embodiment disclosed herein, including but not limited to fixation element 110, may have an outer size (e.g., outer diameter of arms 117 of fixation element 110) that is significantly smaller than the outer size (e.g., outer diameter) of contact member 104. For example, and without limitation, the fixation elements of any device embodiment disclosed herein may have an outer size that is approximately half the outer size of contact member 104, or approximately 30% to approximately 80% of the outer size of contact member 104, or approximately 50% to approximately 60% of the outer size of contact member 104. In any embodiment, the outer size of the fixation element may be similar to, approximately the same as, or larger than the outer size of contact member 104.

[0258] As also shown in FIG. 3A , any of the embodiments of the implant device 102 or contact members disclosed herein can have a cover member 121 that can provide an additional seal or barrier around the exterior surface of the contact member 104 and / or other portions of the implant device 102 that provide an additional barrier to the implant device 102. In some embodiments, the cover may be positioned on or over an interior surface or portion of the implant's contact member, as shown in FIG. 3B , with the cover member 121′ bonded to the interior surface of the contact member 104. This can improve the seal or occlusion that the implant device 102 creates within the LAA. In some embodiments, the cover member 121 or 121′ can cover substantially or completely all of the implant device's contact member 104.

[0259] In any embodiment disclosed herein, the cover member 121 or 121′ may be coupled to the contact member 104 using one or more loops 105 (which may be made from sutures or suture material) that pass around each of the arms or struts of the contact member 104 and are coupled to the cover member 121 or 121′. In some embodiments, the cover member 121 or 121′ may be coupled to the contact member 104 using adhesive, loops of cover material, or any other suitable fasteners, connectors, or other methods.

[0260] 3C , any embodiment disclosed herein may be configured to have a foam material or other sealing material 129 within the contact member 104. For example, and without limitation, the sealing material 129 may self-expand upon actuation by a surgeon or other user, or upon expansion of the contact member 104, or upon another actuation or deployment step occurring, such as when the fixation element 110 advances toward the contact member 104. In other embodiments, the sealing material 129 may be in a compressed state when the contact member 104 is in a first or collapsed state and may expand to an expanded state when the contact member 104 is unconstrained. In some embodiments, the sealing material 129 may self-expand or expand upon actuation from the surgeon, causing the contact member 104 to expand to a second or expanded state. In other embodiments, for example, the contact member 104 may be configured to remain a similar or same size and shape throughout and / or after the procedure, and the sealing material 129 may be fully expanded within the contact member 104 prior to deployment of the contact member 104.

[0261] Further details regarding the implant system 100 are described with reference to FIGS. 4-7. FIG. 4 illustrates the contact member 104 in a second expanded state, the retention element 108 (also referred to herein as a biasing member) in a first elongated state, and the fixation element 110 in a second open state. In any embodiment disclosed herein, the retention element can be an axial spring-like member or other axially resilient member. In some embodiments, the contact member 104 can have a continuous, uninterrupted circumference at the proximal end 104a from which each of the strut members 116 extends distally. Each of the strut members 116 can be preformed into a curved shape such that when no external restraint or constraint is applied to the outer surface of the contact member 104 (e.g., in a relaxed state), the strut member 116 is biased to expand to the second state. At the distal end, each of the strut members 116 can be coupled to a hub member 122, although this is not required. 5-6, the hub member 122 may have a plurality of receptacles 123 configured to receive and restrain the distal end portions 116b of each of the strut members 116. Additionally, each of the receptacles 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 such that the distal end portions 116b of the strut members 116 may extend generally radially away from the hub member 123 when the contact members 104 are in the second expanded state. The hub member 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 without resistance or significant resistance. The distal end of each of the strut members 116 may have a tab or other feature (such as a T-shaped termination or other width increase) 119 that locks into, secures, or otherwise engages with, each of the receptacles 123 so as to axially restrain each end of the strut member 116 while rotating about the end.

[0262] In some embodiments, the retention element 108 and the fixation element 110 may be integrally formed, such as in the embodiment illustrated in FIG. 4. For example, and without limitation, the retention element 108 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape using a conventional or suitable process. In other embodiments, the fixation element 110 may be formed separately and coupled to the proximal end 108a of the retention element 108. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention element 108 may be biased to move to a second or folded state, as shown, for example, in FIGS. 2E, 6, and 7. Furthermore, in the relaxed state, the retention element 110 may be in a second, or open, position, as also shown in FIG. 2E. Further, with reference to FIG. 5, which is an enlarged cross-sectional view taken along line 5-5 of FIG. 4, a pin or cross member 124 may be coupled to the distal end 108b of the retention element 108 and may be configured to fit within a slot 126 formed in the distal end 113b of the core member 113. In this embodiment, the core member 113 may be advanced distally, resulting in the contact member 104 advancing distally. Furthermore, a core tube 128 may extend proximally from the distal end 113b of the core member 113 and couple to the proximal end 104a of the contact member 104. The pin 124 may extend through a pair of openings formed in the core tube 128 to secure the core tube 128 to the pin 124, and therefore to the distal end 108b of the retention element 108. Thus, the core tube 128 may be used to couple the contact member 104 to the retention element 108. Pins, tabs, sutures, ties, protrusions, clips, indentations, detents, or other features may be used to couple the proximal end 104a of the contact member 104 with the proximal end of the core tube 128. Note that the core tube 128 is omitted from some of the figures for clarity.

[0263] Additionally, in any embodiment, the system 100 may be configured such that the implant device 102 is biased or selectively secured proximally relative to the core member 113. For example, and without limitation, as shown in FIG. 5 , some embodiments of the implant device 102 may have a suture or thread 130 that extends through the interior of the core member 113 (such as through a lumen of the core member 113) and loops around the pin 124, thereby allowing a user to retract or withdraw the suture to pull the implant device 102 proximally relative to the core member 113. In this configuration, both ends of the suture 130 may extend from the proximal end of the device 100 such that a practitioner can grasp both ends of the suture 130 and exert a biasing force around the pin 124 to maintain the pin against the proximal end of the slot 126 formed in the distal end 113b of the core member 113. When the implant device 102 is ready to be released from the core member 113, the 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 is no longer wrapped around the pin 124. After removing the biasing or retaining force from the suture 130 and / or removing the proximally directed force from the contact members, the core member 124 can be withdrawn relative to the implant device 102 while the contact members remain stationary within the LAA. This may occur after the contact members and fixation elements are fully deployed or implanted in the LAA and / or tissue adjacent to the LAA.

[0264] Additionally, in any embodiment disclosed herein, the pin or cross member 124 may be configured to allow a guidewire to pass unobstructed through the distal end of the implant device 102. For example, without limitation, an opening larger than the outer diameter of the guidewire may be formed in the pin 124 to allow the guidewire to pass therethrough, or the pin 124 may be formed in two sections with a sufficiently large space between them.

[0265] 8A-8C , in any embodiment, the contact member 104 of the implant device 102 can be advanced into the LAA as desired or appropriate by the surgeon. For example, and without limitation, as shown in FIGS. 8A-8C , the contact member 104 can be advanced to contact, adjacent to, or near the distal end of the LAA before the contact member 104 is rotated. This positions more of the implant within the LAA and, in some embodiments, allows more tissue of the LAA to contract around the body portion or other portion of the implant device 102. This, in some embodiments, allows the user to rotate the contact member 104 of the implant device 102 to a greater extent and can also result in less stress on the tissue of the LAA. Any implant device embodiment disclosed herein can be configured to advance to any extent within the LAA, including through the ostium of the LAA, into a central portion of the LAA, and further into the LAA so as to contact, adjacent to, or near the distal end of the LAA before the contact member 104 is rotated.

[0266] 9A-9I illustrate another embodiment of a treatment device 140 (also referred to herein as a treatment system) for closing or occluding the LAA. In any embodiment disclosed herein, any component, feature, or other detail of the treatment device 140 or implant device 142 shown in FIGS. 9A-9I can have any of the components, features, or other details of any other treatment device embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment device 100 or implant device 102 embodiments described above, in any combination with any of the components, features, or details of the treatment device 140 or implant device 142 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment device embodiment or implant device embodiment disclosed herein can have any of the components, features, or other details of any treatment device and / or implant device embodiment disclosed herein, in any combination with any of the treatment device and / or implant device components, features, or details.

[0267] In any embodiment of treatment device 140, including the embodiment of treatment device 140, the system can include an implant device 142 having a contact member 144 (also referred to herein as a contact element or an expandable implant member), a fixation element 150 (also referred to as a fixation member), and a retention element 148. FIG. 9A shows both contact member 144 and fixation element 150 in a first, contracted, or restrained state within an outer sleeve 154 of a catheter 152. The implant device 142 can be advanced distally out of the catheter 152 by advancing the core member 153 of the catheter 152, past the distal end 154a of the outer sleeve 154, such that the contact member 144 of the implant device 142 can be deployed within the LAA at any desired depth within the LAA, including, for example, and without limitation, near or in contact with the distal wall of the LAA, the central portion of the LAA, or elsewhere, by maintaining the core member 153 of the catheter 152 in a fixed axial position and retracting the outer sleeve 154 of the catheter 152. In any embodiment disclosed herein, the contact member 144 can be radially self-expanding such that when a restraint is released from the contact member 144, the contact member 144 can automatically expand against the inner surface or wall of the LAA. In other embodiments, the contact member 144 can be mechanically expandable, such as by a balloon expander, to expand against the inner surface or wall of the LAA.

[0268] In any embodiment, the contact member 144 can have multiple arms or struts 156, each configured to radially self-expand when a restraint is removed from the exterior surface of the contact member 144. For example, without limitation, any embodiment of a contact member disclosed herein can have six struts 156, or six to ten struts, or fewer than six to more than ten struts. Additionally, in any embodiment, the contact member 144 can have multiple tissue anchors 158 or other similar features configured to penetrate or engage tissue of the LAA when the contact member 144 is expanded against the tissue of the LAA and / or when the contact member 144 is rotated or twisted within the LAA.

[0269] In this configuration, when the contact member 144 is rotated in a first direction (indicated by arrow A6 in FIG. 9C , which can be clockwise or counterclockwise), one or more or all of the struts 156 and one or more or all of the tissue anchors 158 can engage tissue of the LAA, twisting the LAA or rotating the LAA in the first direction A6. Twisting or rotating the LAA in the first direction from the first rotational position to the second rotational position results in the opening or ostium O of the LAA constricting radially (identified by arrow A7 in FIG. 9C ) such that the opening O of the LAA is translated or constricted about the exterior surface of the implant device 142. An operator can twist or rotate the contact member 144 by twisting or rotating the core member 153 of the catheter 152. Tightening or constriction of the opening O of the LAA around the outer surface of the proximal portion 144a of the contact member 144 or other portions of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior portion of the LAA from the remaining chambers in the heart, thereby substantially reducing the health risks associated with an open LAA. In any embodiment disclosed herein, the implant 142 can be configured to be removed such that the only portion of the implant device 142 remaining in the LAA or heart is the fixation element 150 after the fixation element has been applied to the tissue constricted by twisting of the contact member.

[0270] The retaining element 148 is used to couple the fixation element 150 to the contact member 144 and allows a user (such as a surgeon) to move the fixation element 150 toward and away from the contact member 144. In any embodiment, the retaining element 148 may have a helical thread on its outer surface. In any embodiment, the retaining element 148 may include a threaded shaft. In this configuration, the retaining element 148 may be rotated in a first direction to advance the fixation element 150 toward the contact member 144 and rotated in a second, opposite direction to move the fixation element 150 away from the contact member 144. The retaining element 148 may be configured to engage the fixation element 150 such that as the retaining element 148 rotates, the fixation element 150 moves in an axial direction corresponding to the rotation of the retaining element 148. For example, and without limitation, the retaining element 148 can have an annular recess 149 near its proximal end 148 a configured to engage or mate with a tab or protrusion 151 on the fixation element 150. In some embodiments, the protrusion 151 can extend into the annular recess 149 to axially lock or engage the fixation element 150 with the retaining element 148. The interaction of the protrusion 151 and the annular recess 149, where the walls of the annular recess contact and press against the protrusion 151, causes the retaining element 148 to move the fixation element 150 when the retaining element 148 is rotated. In some embodiments, as in the illustrated embodiment, the fixation element 150 can have two tabs 151 that both engage with the annular recess 149. The contact member 144 can have a threaded neck portion 145 that threadably mates with the threads of the retaining element 148 such that the retaining element 148 threads into and out of the threaded neck portion 145. In this configuration, the retaining element 148 threads into and out of the contact member 144, moving the locking element 150 relative to the contact member. As shown in FIG. 9H , the retaining element 148 is threaded almost fully into the contact member 144 and into a cavity or space 161 within the contact member 144, such that the locking element 150 moves as far as possible toward the contact member 144. When the retaining element 148 is rotated in a second direction, the retaining element 148 moves out of the space 161 within the contact member 144, moving the locking element 150 away from the contact member 144.

[0271] 9H, intermediate sleeve 155 can be advanced distally into contact with and engagement with proximal end 148a of retaining element 148. Intermediate sleeve 155 can be configured such that when intermediate sleeve 155 engages with proximal end 148a of retaining element 148, rotating intermediate sleeve 155 in a first or second direction can rotate retaining element 148 in a first or second direction. In some embodiments, intermediate sleeve 155 can move axially and rotate independently of other tubes or sleeves of catheter 152. For example, and without limitation, as shown in FIG. 9H, protrusions or tabs 159 on distal end 155b of intermediate sleeve 155 can selectively mate with or be advanced into recesses or indentations 147 formed in proximal end 148a of retaining element 148, allowing intermediate tube 155 to be selectively keyed or indexed with retaining element 148.

[0272] Additionally, in any embodiment, the implant 142 can be coupled to the delivery catheter 152 using a retention element 148. For example, and without limitation, the core member 153 of the delivery catheter 152 can be coupled to the retention element 148 via a threaded protrusion 165 at the distal end 153b of the core member 153 that threadably mates with a threaded recess 167 formed in the proximal end 148a of the retention element 148. The threaded protrusion 165 can be formed separately from and coupled to the distal end of the core member 153, or can be integrally formed. In this configuration, the implant 142 can be removed from the catheter by disengaging the threaded protrusion 165 from the retention element 148. This can be accomplished by using the intermediate tube 155 to prevent rotation of the retention element 148 while the core member 153 is rotated in a second direction to withdraw the threaded protrusion 165 from the recess 167 of the retention element 148.

[0273] Additionally, the second intermediate tube or sleeve 157 can be advanced distally into contact and engagement with the proximal end 150a of the fixation element 150. The second intermediate sleeve 157 can be configured such that when the second intermediate sleeve 157 engages the proximal end 150a of the fixation element 150, rotating the second intermediate sleeve 157 in a first direction or a second direction allows the fixation element 150 to rotate in a first direction or a second direction. In some embodiments, the second intermediate sleeve 157 can move axially and rotate independently of the other tubes or sleeves of the catheter 152. For example, and without limitation, as shown in FIG. 9H , protrusions or tabs 169 on the distal end 157b of the second intermediate sleeve 157 can selectively couple with posts or arms of the fixation element 150 such that the second intermediate sleeve 157 can be keyed or indexed to the fixation element 150.

[0274] Additionally, in some embodiments, the fixation element 150 may be keyed or indexed to the contact member 144 such that the fixation element 150 and the contact member 144 rotate simultaneously, dependent on one another. For example, in some embodiments, the fixation element 150 may have a body portion 170 with one or more tabs or protrusions 172 configured to extend into a channel or recess 173 formed in a body portion 175 of the contact member 144. The one or more channels 173 may be formed axially such that the protrusions 172 of the fixation element 150 and the fixation element 150 can move freely axially relative to the contact member 144. However, the narrow width of the channel 173 relative to the protrusions 172 may prevent the protrusions 172, and therefore the fixation element 150, from rotating relative to the contact member 144.

[0275] In this configuration, the second intermediate sleeve 155 may be coupled with the fixation element 150 and can be used to at least rotate the implant 142 in a first direction or a second direction. For example, and without limitation, the second intermediate sleeve 155 can be rotated to rotate the contact member 144 and twist the LAA to a desired rotational and / or torque level. The second intermediate sleeve 155 can then be used to maintain a desired position (e.g., a rotational position) of the contact member 144 by contacting the fixation element 150 and maintaining the second intermediate sleeve 155 in a fixed rotational position, thus holding the contact member 144 in a fixed rotational position while the retention element 148 is rotated in a first direction to advance the fixation element 150 toward the contact member 144. Once the fixation element 150 is in the desired axial position (e.g., engaged with the tissue of the contracted LA / LAA as a result of twisting of the contact member 144), the implant 142 can be removed from the catheter 152 by disengaging the threaded protrusion 165 from the retention element 148 as described above, and the catheter can be removed from the LA. When the fixation element 150 engages the patient's tissue, as shown in FIG. 9E, the LAA is prevented from rotating to a first rotated position, which is an untwisted or relaxed position. In this configuration, the implant device 142 can fix and maintain the LAA in a substantially or completely occluded or substantially or completely closed state.

[0276] Additionally, in any embodiment, the device may be configured such that contact member 144 can be removed from the patient's LAA after fixation element 150 has sufficiently engaged with tissue to hold the tissue closed or occluded, as shown, for example, in FIGS. 11-12 , but fixation element 177 and fixation element 150 are the only components remaining in the body after the implant procedure is complete. In this configuration, the implant may have a plug or cover (such as cover 178 coupled to fixation member 177) that can cover an opening in the implant through which a contact member (such as contact member 180 or contact member 144) is withdrawn, or may be configured to plug or cover an opening in the implant through which contact member 144 is withdrawn. For example, and without limitation, a cover member, such as cover member 121, may be coupled to fixation element 150 in a configuration in which contact member 144 remains in the LAA after fixation element 150 is implanted, substantially covering any opening in the implant or coupling to contact member 144 within the LAA.

[0277] Additionally, in some embodiments, the contact members 144 may have a continuous, uninterrupted circumference at the proximal end 144a, from which each of the strut members 156 extends distally. Each of the strut members 156 may be pre-formed into a curved shape such that when no external restraint or constraint is applied to the exterior surface of the contact members 144 (e.g., when in a relaxed state), the strut members 156 are biased to expand to a second state. At the distal end, each of the strut members 156 may be coupled to a hub member 162, although this is not required. Similar to the hub member 122 described above, the hub member 162 may have multiple receptacles (not shown) configured to receive and restrain the distal ends 156b of each of the strut members 156. Additionally, each of the receptacles 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 such that the distal end 156b of the strut member 156 can extend generally radially away from the hub member 163 when the contact member 144 is in the second, expanded state. The hub member 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 without resistance or significant resistance. In any embodiment, the distal end of each of the strut members 156 may have a tab or other feature (such as a T-shaped termination or other width increase) (not shown) that locks into, thereby securing, or otherwise engages with, the respective receptacle 163 to axially restrain the respective end of the strut member 156 while rotating about the end.

[0278] In any embodiment of the devices and methods disclosed herein, the fixation element can be configured such that the arms or struts of the fixation element extend proximally when the fixation element is in the first or collapsed state. In some embodiments, the fixation element can be in the first or collapsed state within a restraint, within a delivery catheter, and / or only the struts of the fixation element are restrained or secured in the collapsed position with a retaining element that slides or moves axially over the struts. Figures 9J-9K show another embodiment of a treatment device 140'. In any embodiment disclosed herein, any component, feature, or other detail of treatment device 140' or implant device 142' can have any of the components, features, or other details of any other treatment device embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment device 140 or implant device 142, or treatment device 100 or implant device 102 embodiments, in any combination with any of the components, features, or details of treatment device 140' or implant device 142' disclosed below. Similarly, any component, feature, or other detail of any of the other therapeutic device embodiments or implant device embodiments disclosed herein may have any of the components, features, or other details of any of the therapeutic device 140' or implant device 142' embodiments disclosed herein in any combination with any of the therapeutic device and / or implant device components, features, or details.

[0279] 9J-9K, some embodiments of the delivery device 140' may include a fixation element 150' having one or more struts or arms that can extend proximally when the fixation element is in a first or collapsed state. In some embodiments, the arms may reverse direction when the arms are expanded or extended to a second state, such that the distal ends of the arms extend toward the contact member 144', as shown in FIG. 9K. For example, in some embodiments, the outer sleeve 154' of the treatment device 140' may be retracted to expose and / or unconstrain the fixation element 150'. Once the constraint is removed from the fixation element 150', the arms of the fixation element 150' may be deployed or rotated distally, e.g., toward the contact member 144'. The fixation element 150' may then be advanced distally such that at least a distal point or portion of the arms of the fixation element 150' penetrates the tissue of the LAA and / or LA that has contracted as a result of torsion of the LAA. The fixation element 150' may be held or biased in a second rotational position, where the fixation element 150' engages the tissue of the heart as shown in FIG. 9E.

[0280] 9L-9P illustrate another embodiment of a treatment device 140'' for treating the LAA. In any embodiment disclosed herein, any component, feature, or other detail of treatment device 140'' or its implant device 142'' can have any of the components, features, or other details of any other treatment device embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment device 140 or implant device 142, or treatment device 100 or implant device 102 embodiments described above, in any combination with any of the components, features, or details of treatment device 140'' or implant device 142'' disclosed below. Similarly, any component, feature, or other detail of any of the other treatment device embodiment or implant device embodiment disclosed herein can have any of the components, features, or other details of any treatment device and / or implant device embodiment disclosed herein.

[0281] In any embodiment of the devices and methods disclosed herein, the contact member 144'' may be non-expandable or otherwise configured not to expand or change size or shape throughout the treatment procedure. For example, and without limitation, the contact member 144'' can remain the same or similar size and / or shape or maintain the same or similar size and / or shape throughout the treatment procedure. In this configuration, the contact member 144'' can have the same or similar size and / or shape when the contact member 144'' is positioned within the delivery catheter 152 (as shown in FIG. 9L ), as well as when the contact member 144'' extends through the distal end of the delivery catheter 152 and engages a tissue surface anywhere within the LAA (as shown in FIG. 9M ). Further, in any embodiment, the contact member 144'' can have the same or similar size and / or shape when the contact member 144'' is rotated to the second rotational position or when the LAA is twisted to the second rotational position (shown in FIG. 9N) and when the contact member 144'' is rotated to the second rotational position or when the LAA is twisted to the second rotational position (shown in FIGS. 9O and 9P).

[0282] Additionally, as described above, in any embodiment disclosed herein, the implant device may be configured to allow the contact member to be removed from the patient's LAA after the fixation element engages tissue to hold the ostium of the LAA closed. For example, with reference to FIG. 10A , in any embodiment disclosed herein, the contact member may be a dilatation balloon, such as dilatation balloon 184. The balloon may have a smooth exterior surface or may have dimples, protrusions, a rough texture, tissue anchors, or other features to engage the interior surface of the LAA. In some embodiments, the balloon may be a typical dilatation balloon, such as a balloon used in angioplasty procedures, and may be sized and configured for use in the LAA. With reference to FIG. 10A , the distal end of the dilatation balloon may have an atraumatic surface to reduce the risk of injury to the LAA or other tissue. In any embodiment of the implant device or contact member disclosed herein, the contact member may be configured to have an atraumatic distal tip, such as a distal tip made from or covered by a rubber material or other soft or atraumatic material.

[0283] Additionally, any embodiment of a balloon or implant member disclosed herein may have any of the features, components, shapes, sizes, or other details of any of the expansion members shown in FIGS. 10E-10L, and any of the treatment device embodiments disclosed herein may use any of the expansion member embodiments disclosed in FIGS. 10E-10L in place of or in combination with the contact members of such treatment device embodiments. Additionally, any of the expansion members shown in FIGS. 10E-10L may have an atraumatic distal tip. For example, and without limitation, the expansion members shown in FIGS. 10E-10L may extend to the distal end of the device such that the distal portions of the expansion members shown in FIGS. 10E-10L are atraumatic. Additionally, in any of the embodiments disclosed herein, the expansion members and / or contact members may include conformable or adjustable balloons that allow the surgeon or user to adjust the diameter of the balloon based on inflation pressure, thereby customizing the size of the contact members at the point of use to achieve optimal closure in various LAA shapes and sizes.

[0284] Referring to the figures, some dilation members may have points, protrusions, linear ridges, wire mesh structures, wire frame structures, channels, and other features to improve engagement of the dilation member with the tissue of the LAA. In any of these configurations, after the LAA has been rotated and / or torqued to a desired extent and the fixation element has been implanted to hold the opening of the LAA sufficiently closed or constricted, the balloon can be deflated and removed from the LAA, leaving only the fixation element to maintain the LAA in an occluded state, as shown in the non-limiting examples of Figures 11-12.

[0285] FIG. 10B illustrates another embodiment of a treatment device 140''' for treating the LAA, showing a contact member 144''' of the treatment device 140''' advanced into the LAA. FIG. 10C illustrates the contact member 144''' advanced into the LAA in a pre-expanded state. However, in other embodiments, the contact member 144''' can be expanded within the LA and advanced into the LAA in the expanded state. FIG. 10D illustrates the contact member 144''' expanded to engage the interior surface of tissue of the LAA.

[0286] In some embodiments, as with other embodiments disclosed herein, contact member 144''' can be configured to be mechanically expandable, such as, for example, and without limitation, using an expandable or inflatable balloon. Additionally, any embodiment of treatment device 140''' and / or contact member 144''' can have any of the features, components, or details of any other treatment device or contact member embodiment disclosed herein, instead of or in combination with any of the features, components, or other details of the treatment device 140''' and / or contact member 144''' embodiments disclosed herein. Similarly, any of the other embodiments of treatment devices and / or contact members disclosed herein can have any of the features, components, or details of treatment device 140''' and / or contact member 144''' disclosed herein, including mechanical or balloon-expandable contact members.

[0287] In some embodiments, the contact members 144''' can expand into a generally spherical or elongated spherical shape. In other embodiments, the contact members 144''' can expand into a generally cylindrical shape, a stent-like shape, or any other suitable or desired shape, including one that conforms to the shape of the interior of the LAA.

[0288] For example, and without limitation, any embodiment of contact member 144''' may have multiple struts or arms having multiple tissue anchors or barbs thereon configured to engage tissue of the LAA. In other embodiments, contact member 144''' may be barbless and / or may have any other desired shape, such as any of the shapes of any other contact member or implant embodiment disclosed herein.

[0289] 10B-10D, contact member 144'" or any other contact member disclosed herein may have an inflatable or expandable balloon 185 within the interior space of contact member 144'", which balloon is selectively actuatable to expand contact member 144'" so that contact member 144'" can expand against the interior surface of the LAA. Any embodiment of treatment device 140 may be configured so that contact member 144'" can be expanded to any desired size and / or shape. In some embodiments, a surgeon or other user of treatment device 140'" can control the level of inflation of balloon 185 within contact member 144'" by controlled inflation and / or deflation of balloon 185 so that contact member 144'" can expand to any size. For example, and without limitation, balloon 185 and contact member 144'" may be partially expanded for smaller LAA anatomies or more fully expanded for larger LAA anatomies. In some embodiments, any of the balloons or expandable members disclosed herein can have an outer diameter or size that can range from 4 mm (or about 4 mm) or less to 16 mm (or about 16 mm) or more in the contracted or first state, or from 4 mm (or about 4 mm) to 10 mm (or about 10 mm) in the contracted or first state, and / or from 10 mm (or about 10 mm) or less to 40 mm (or about 40 mm) or more in the expanded or second state, or from 15 mm (or about 15 mm) to about 35 mm (or about 35 mm) in the expanded or second state.

[0290] In any embodiment, the balloon 185 can be detached from the contact member 144'" after a desired level of expansion of the contact member 144'" is reached by deflating and retracting the balloon 185 through the axial opening in the contact member 144'". In other embodiments, the treatment device 140'" can be configured to allow the balloon 185 to remain in the contact member 144'" even after the procedure is terminated and the LAA is occluded. The balloon 185 can remain within the contact member 144'" in an inflated, deflated, or partially inflated state.

[0291] 13 shows another embodiment of a treatment device 200 having an implant device 202 with a contact member 204 in a second expanded state, a retention element 208 in a second contracted state, and a fixation element 210 in a second open state. FIG. 14 is a cross-sectional view of the embodiment of treatment device 200 shown in FIG. 13 taken along line 14-14 in FIG. 13. In any embodiment disclosed herein, any component, feature, or other detail of treatment device 200 or implant device 202 may have any of the components, features, or other details of any other treatment device embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment device 100 or implant device 102 embodiments described above, in any combination with any of the following treatment device 200 or implant device 202 components, features, or details. Similarly, any component, feature, or other detail of any of the other therapeutic device embodiments or implant device embodiments disclosed herein can have any of the component, feature, or other detail of any of the therapeutic device 200 or implant device 202 embodiments disclosed herein, in any combination with any of the therapeutic device and / or implant device components, features, or details.

[0292] 13-14, in some embodiments, contact member 204 may have an annular proximal end 204a, and all (six are shown) of the arms or struts 230 of contact member 204 extend distally away from proximal end 204a. The struts 230 may have any form of tissue anchor 232 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0293] Additionally, in some embodiments, the contact members 204 may have an annular distal end 204b, and all of the arms or struts 230 may be coupled to the annular distal end 204b. The contact members 204 may have a bulbous shape, a cylindrical shape with a curved distal portion, an elongated spherical shape, or other. In some embodiments, the contact members 204 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise coupled together. Each of the strut members 230 may be pre-formed into a curved shape (which may have a spherical or bulbous shape) and may be formed such that the strut members 230 are biased to expand to the second state when no external restraint or constraint is applied to the exterior surface of the contact members 204.

[0294] In some embodiments, such as the illustrated embodiment, the retention element 208 and the fixation element 210 may be integrally formed. For example, and without limitation, the retention element 208 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material such as Nitinol, and then formed into the desired shape. In other embodiments, the fixation element 210 may be coupled to the proximal end 208a of the retention element 208. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention element 208 may be biased to move, for example, to a second state, or a folded state, and the fixation element 210 may be in the second state, or an open state.

[0295] 14 , a pin or cross member 268 may be coupled to the distal end 208b of the retention element 208 and may be configured to fit within a slot 270 formed in the distal end 218b of the core member 218. In this embodiment, the core member 218 may be advanced distally, thereby advancing the contact member 204 distally. Furthermore, a core tube 274 may extend proximally from the distal end 218b of the core member 218 and couple to the proximal end 204a of the contact member 204. The pin 268 may extend through a pair of openings formed in the core tube 274 to secure the core tube 274 to the pin 268 and, therefore, to the distal end 208b of the retention element 208. Thus, the core tube 274 may be used to couple the contact member 204 to the retention element 208. Pins, tabs, sutures, ties, protrusions, clips, indentations, detents, or other features may be used to couple the proximal end 204 a of the contact member 204 to the proximal end of the core tube 274 .

[0296] Further, in any embodiment, the system 200 may be configured such that the implant device 202 is biased proximally relative to the core member 218. For example, and without limitation, as shown in FIG. 14 , some embodiments of the implant device 202 may have a suture or thread 280 that extends through the interior of the core member 218 (such as through a lumen of the core member 218) and loops around the pin 268, thereby allowing a user to retract or withdraw the suture to proximally retract the implant device 202 relative to the core member 218. In this configuration, both ends of the suture 280 may extend from the proximal end of the device 200 such that a practitioner can grasp both ends of the suture 280 and exert a biasing force around the pin 268 to maintain the pin against the proximal end of the slot 270. When the implant device 202 is ready to be released from the core member 218, the 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 or is wrapped around the pin 268. After removing the biasing force from the suture 280, the core member 268 can be withdrawn relative to the implant device 202. This may occur after the contact members and their fixation elements are fully deployed.

[0297] 15 shows another embodiment of implant device 302 in which contact member 304 is in a second expanded state, retention element 308 is in a second contracted state, and fixation element 310 is in a second open state. In any embodiment disclosed herein, any component, feature, or other detail of treatment device 300 or implant device 302 can have any of the components, features, or other details of any other treatment device or implant device embodiment disclosed herein, including, but not limited to, any of the treatment device 100, 200 or implant device 102, 202 embodiments described above, in any combination with any of the treatment device and / or implant device components, features, or details. Similarly, any component, feature, or other detail of any other treatment device or implant device embodiment disclosed herein can have any of the components, features, or other details of any treatment device or implant device embodiment disclosed herein, in any combination with any of the treatment device and / or implant device components, features, or details.

[0298] In any embodiment, the length of the retention elements (including retention element 308) and / or the distance between the fixation element and the contact members can be adjusted or varied beyond that shown and described, e.g., to accommodate different anatomical sizes and characteristics of the LA and / or LAA, or to accommodate different amounts or thicknesses of collected or twisted LAA tissue. For example, without limitation, in some embodiments, the length of the retention element or the distance between the fixation element and the contact members can be approximately the same as the length of the contact members when the retention elements are in a relaxed or folded state (e.g., the second state), or approximately half the length of the contact members when the retention elements are in the second state, between one-quarter and one-half the length of the contact members when the retention elements are in the second state, or the like.

[0299] In some embodiments, the contact member 304 may have an annular proximal end 304a, and all of the arms or struts 330 (six shown) of the contact member 304 extend distally from the proximal end 304a. Further, in some embodiments, the contact member 304 may have an annular distal end 304b, and all of the arms or struts 330 may be coupled to the annular distal end 304b. In some embodiments, the contact member 304 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise coupled together. Each of the strut members 330 may be pre-formed into a curved shape (which may have a rounded or bulbous shape) and may be formed such that the strut members 330 are biased to expand to a second state when no external restraint or constraint is applied to the exterior surface of the contact member 304. The struts 330 may have any form of tissue anchor 332 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0300] In some embodiments, the contact members 304, retention elements 308, and fixation elements 310 can be cut or otherwise integrally formed from a single length of hypotubing. For example, and without limitation, the retention elements 308 and fixation elements can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact members 304, retention elements 308, and / or fixation elements 310 can be formed separately and welded, brazed, or otherwise joined together to form a single, unitary component. In some embodiments, the distance between the contact members 304 and the fixation elements 310 can be greater, for example, and without limitation, greater than the length of the contact members when the contact members are in the second, expanded state, so that the contact members 304 can be advanced further distally into the LAA and then rotated to twist the opening of the LAA and constrict the opening of the LAA around the outer surface of the retention element. A greater length of the retention element 310 may accommodate a greater degree of twisting or rotation of the LAA, or a greater number of twists or rotations, before the fixation element engages.

[0301] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 310 and can be used to manipulate and control the position and / or orientation of the fixation element 310, including holding the proximal end 310a of the fixation element in a fixed axial position while a distally directed force is exerted on the contact member 304 to maintain the retention element 310 in a first extended state. Additionally, a core member (not shown) can engage the distal end 304b of the contact member 304b to allow a distally directed force to be exerted on the contact member 304. Pins, tabs, sutures, ties, protrusions, clips, indentations, detents, or other features can be used to selectively (i.e., reversibly) couple the contact member 304 to the core member.

[0302] After the desired degree of twisting of the LAA has been achieved, the fixation element 310 can be moved to a second expanded state, for example, by advancing the fixation element 310 out of the distal end of the delivery catheter tube, expanding the fixation element to its second state. Thereafter, while maintaining the contact members 304 in a desired axial and rotational position (e.g., the second rotational position), the fixation element 310 can be advanced into the contracted tissue around the outer surface of the implant to secure the tissue in its twisted and / or contracted state. In some embodiments, this can be achieved or implemented by simply holding the contact members in a desired position and allowing the retention element 308 to retract to its retracted or relaxed state, thereby advancing the fixation element 310 into the tissue. Once deployment is complete, the user can disengage the core member from the contact members 304 so that the core member can be withdrawn. As with other embodiments, the implant device 304 may be selectively biased or secured proximally relative to the delivery catheter, such as with a suture or thread 380 that extends through the inside of the catheter and loops around a pin, tab, or other feature of the implant device, and is released by disengaging or removing the suture or other retaining device.

[0303] 17 illustrates another embodiment of an implant device 402 in which the contact members 404 are in a second expanded state, the retention element 408 is in a second contracted state (or at least partially contracted or retracted state), and the fixation element 410 is in a second open state. Any embodiment of the treatment device 400 or implant device 402 can have any of the components, features, or other details of any other treatment device or implant device embodiment disclosed herein, including, but not limited to, any of the treatment device 100, 200, 300 or implant device 102, 202, 302 embodiments described above, in any combination with any of the components, features, or details of the treatment device 400 or implant device 402 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment device or implant device embodiments disclosed herein can have any of the components, features, or other details of any treatment device 400 or implant device 402 embodiments disclosed herein, in any combination with any of the components, features, or details of the treatment device or implant device embodiments disclosed herein.

[0304] The contact member 404 may have an annular proximal end 404a and a distal portion 404b with multiple openings or rings 480. The struts or links 430 of the contact member 404 may form a mesh pattern to form a curved, bulbous, elongated bulbous, spherical, or other shaped contact member. The struts 430 may have multiple tissue anchors or protrusions 432 coupled to the struts or links 430 at multiple locations around the contact member 404, such as any of the tissue anchors 118 described above. As with any of the embodiments disclosed herein, the tissue anchors 432 may be, but are not required to be, integrally formed with the struts 430. The struts or links 430 may form a generally diamond-shaped pattern around the surface of the contact member. The contact member 404 may have a generally spherical or bulbous shape.

[0305] 17, a pin or cross member 468 may be coupled to the implant device 402, for example, and without limitation, at the distal end 408b of the retaining element 408 or between the retaining element 410 and the contact member 404. The pin 468 may be configured to engage an end of the catheter core member 418 or a feature formed within the distal end of the catheter core member to selectively couple the implant device 402 to the catheter core member, similar to other embodiments disclosed herein.

[0306] Additionally, similar to other embodiments of the systems disclosed above, some embodiments of the implant device 402 may have a suture or thread 480 that loops around or otherwise engages the pin 468, thereby allowing a user to retract or withdraw the suture to proximally withdraw the implant device 402 relative to the core member 418. After removing the biasing force from the suture 480, the core member 468 may be withdrawn relative to the implant device 402. This may occur after the implant and its fixation elements are fully deployed.

[0307] In some embodiments, the contact member 404, retention element 408, and / or fixation element 410 can be laser cut or otherwise integrally formed from a single length of hypotubing. For example, and without limitation, the retention element 408 and fixation element can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact member 404, retention element 408, and / or fixation element 410 can be formed separately and welded, brazed, or otherwise joined together to form a single, unitary component. In some embodiments, the distance between the contact member 404 and the fixation element 410 can be large so that the contact member 404 can be advanced further distally into the LAA and then rotated, twisting the opening of the LAA and constricting the opening of the LAA around the outer surface of the retention element. A longer length of the retention element 410 can accommodate a greater number of rotations or twists of the LAA before the fixation element engages.

[0308] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 410 and can be used to manipulate and control the position and / or orientation of the fixation element 410, including holding the proximal end 410a of the fixation element in a fixed axial position, while a distally directed force is exerted on the contact member 404 to maintain the retention element 410 in the first extended state. Deployment of the device 402 can include any combination of the steps described with respect to any of the other embodiments disclosed herein.

[0309] 18-21 show another embodiment of treatment device 500 having implant device 502 with contact member 504 in a second expanded state, retention element 508 in a second contracted state, and fixation element 510 in a second open state. Any embodiment of treatment device 500 or implant device 502 may have any of the components, features, or other details of any other treatment device or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment device 100, 200, 300, 400 or implant device 102, 202, 302, 402 embodiments, in any combination with any of the components, features, or details of treatment device 500 or implant device 502 disclosed herein. Similarly, any component, feature, or other detail of any of the other therapeutic device or implant device embodiments disclosed herein can have any of the component, feature, or other detail of any of the therapeutic device 500 or implant device 502 embodiments disclosed herein in any combination with any of the component, feature, or detail of the therapeutic device or implant device embodiments disclosed herein.

[0310] The contact member 504 can have multiple struts or links 530 that can have multiple tissue anchors 532 thereon, such as any of the tissue anchors 118 described above, at multiple locations around the contact member 504. As with any of the embodiments disclosed herein, the tissue anchors 532 can be, but need not be, integrally formed with the struts 530. The contact member 504 can have a generally spherical or bulbous shape, or the shape of any of the other embodiments disclosed herein.

[0311] Similar to the other embodiments described above, any embodiment of the treatment device 500 may have a suture or thread 580 extending through the interior of the core member 518 (such as through a lumen of the core member 518) and looping around the pin 568 or other retention element coupled with the contact member 504, thereby allowing a user to retract or withdraw the suture 580 to pull the contact member 504 proximally relative to the fixation element 510 and engage the implant 502 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 and exert a proximally directed force around the pin 568 to pull the contact member 504 toward the fixation element 510, with the pin 568 positioned within the slot 570 in the core member 518. Additionally, the slot 574 formed in the cylindrical body portion 572 of the fixation element 510 can be sized to allow the cylindrical body portion 572 of the fixation element 510 to move axially in the proximal and distal directions relative to the pin 568 between the proximal end 574 a of the slot 574 and the distal end 574 b of the slot 574. Thus, the pin 568 and suture 580 bias or urge the implant 502 into contact with the catheter (e.g., into contact with the core member 518 or the slot 570 formed in the core member) and allow a user to move the fixation element 510 from the first rotational position to the second engaged position (shown in FIGS. 18-21 ).

[0312] In some embodiments, when the contact members 504 are maintained in a fixed position using the catheter or core member 518, the user can move the fixation element 510 from the first rotational position to the second rotational position by pulling back or withdrawing the suture 580 (while the contact members 504 are held in a fixed position within the LAA) and by distally advancing the outer tube 576 of the delivery catheter to push the fixation element 576 distally. This occurs after the desired level of twisting of the LAA has been achieved by twisting or torquing the core member 518 or other portions of the catheter. Referring to FIG. 19 , in some embodiments, this can advance the fixation element 510 and body portion 572 of the fixation element distally relative to the contact members 504, thereby forcing the fixation element into the tissue of the LAA or LA to hold the tissue in a closed or contracted position.

[0313] Additionally, any embodiment of the device can be configured to use a retention element to prevent the fixation element from moving away from the second rotational position toward the first rotational position when the fixation element 510 is advanced to the second rotational position and engages tissue to retain the LAA in an occluded or closed position, thereby maintaining the position of the fixation element and maintaining occlusion of the LAA. For example, and without limitation, one or more tabs 582 formed on or coupled with the body portion 584 of the contact member 504 can be biased into or into engagement with each of the plurality of recesses or openings 586 to prevent or inhibit the fixation element 510 from moving back toward the first rotational position relative to the contact member 504. The tab 582 (which may be any other type of fixation feature, such as a ball and detent, or a zip-tie type fixation feature, or otherwise) can be configured to allow the fixation element 510 to move freely from the first expanded position to the second collapsed position and selectively prevent or inhibit movement from the second rotated position to the first rotated position, thereby essentially locking the fixation element in the second rotated position. Additionally, in any embodiment disclosed herein, the fixation element and contact members can be held together using one or more sutures, wires, pins, or other components or fasteners, including, for example and without limitation, sutures having slip knots that can be tightened during deployment. The sutures can then be trimmed to length during final deployment to hold the fixation element and contact members together and maintain the LAA in a closed or contracted state. The sutures 580 may then be removed, and the remaining components of the deployment device can be withdrawn from the patient's body, leaving the implant 502 in place.

[0314] In some embodiments, the implant device 502 may be configured such that the ratchet or retention mechanism formed by the engagement of the tabs 582 and the openings 586 is reversible or removable, such that the fixation element can be moved from a second rotational position to or toward a first rotational position to disengage the fixation element from tissue, for example, to retwist or otherwise reposition the LAA. For example, some embodiments of the implant device 502 may be configured to rotate or twist the fixation element (and thus the tab(s) 582) relative to the body portion 584 of the contact member 504 such that the tabs 582 disengage the openings 586. Further, in some embodiments, the tabs may be positioned on the body portion 584 of the contact member 504, and the openings may be formed in the body portion of the fixation element 510. Furthermore, the tabs may be formed in both directions such that the fixation element can ratchet or selectively lock in both axial directions of movement. Additionally, in any of the embodiments disclosed herein, the tabs may be shaped and configured such that they are movable from a locked position or state to an unlocked (or sliding) state. Examples of these embodiments are described below.

[0315] FIG. 22A illustrates another embodiment of a treatment device 600 having an implant device 602 with contact members 604 in a second expanded state and a fixation element 610 in a first retracted or pre-deployed state. FIG. 23 illustrates an embodiment of an implant device 602 with fixation element 610 moved to a second deployed or locked state. FIGS. 24-35 illustrate an embodiment of a method of deployment of the embodiment of treatment device 600 illustrated in FIGS. 22-23. Any embodiment of treatment device 600 or implant device 602 can have any of the components, features, or other details of any other implant device embodiment disclosed herein, including, but not limited to, any of the above-described embodiments of implant devices 100, 200, 300, 400, and 500, in any combination with any of the components, features, or details of treatment device 600 or implant device 602 disclosed below. Similarly, any component, feature, or other detail of any of the other therapeutic device or implant device embodiments disclosed herein can have any of the component, feature, or other detail of any of the therapeutic device 600 or implant device 602 embodiments disclosed herein, in any combination with any of the component, feature, or detail of the therapeutic device or implant device embodiments disclosed herein.

[0316] 22A-22B, the fixation element 610 may have a body portion 611 that may have a curved or helical (or corkscrew) shape that may extend from the proximal end 610a of the fixation element 610 to the distal end 610b of the fixation element 610, and may have a pointed distal tip 612 at the distal tip 610b of the fixation element 610 that may engage (or, in some embodiments, at least partially penetrate) tissue of the LA and / or LAA after the contact member 604 is rotated to the second rotational position, thereby anchoring the tissue and closing or occluding the opening of the LAA around the implant device, for example, around the body portion 614 that is integral with or coupled to the contact member 604 or other portions of the implant device.

[0317] The fixation element 610 may define an axial opening 615 therethrough. In some embodiments, the opening 615 may be larger than the distal portion of the catheter's inner core member and / or the implant's body portion 614, such that the body portion 611 of the fixation element 610 wraps around or curves (helically or otherwise) and / or is rotatable around the catheter's inner core member and / or the implant's body portion 614.

[0318] 23A-23B illustrate another embodiment of a fixation element 610 that can be used with any of the implant or delivery system embodiments and / or treatment methods disclosed herein. In any embodiment, the cross-section of the body portion 611 can be circular, square (as shown), oval, or any other desired shape. In any embodiment, the body portion 611 can have 2-15 or more coils (i.e., full rotations), or 3-10 coils, or 4-6 coils, and can terminate at the distal end 610b of the fixation element 610 with a sharp point, a blunt tip, one or more tissue anchors or barbs, or otherwise. Additionally, any of the fixation element embodiments disclosed herein, in embodiments having two or more body portions as described below, can have tissue anchors or barbs (not shown) along the length or length of the body portion 611 to engage tissue and prevent or inhibit retraction of the fixation element 610 from the tissue after the fixation element 610 is advanced into such tissue. The proximal end 610 a of the fixation element 610 may have a flange 617 , an opening 619 , and / or other features configured to connect the fixation element 610 to other portions of the implant 602 .

[0319] Additionally, in any embodiment disclosed herein, the fixation element 610 may also have a rotational or axial locking feature that can secure the fixation element in a desired rotational and / or axial position and / or inhibit counter-rotation of the fixation element. The rotational or axial lock may be selectively reversible, allowing the user to return the fixation element to a freely movable state as desired. For example, and without limitation, with reference to FIGS. 23C-23D , any embodiment of the fixation element disclosed herein may have one or more tissue anchors or barbs 621 extending away from the proximal end 610 a of the fixation element 610 to improve the fixation element's grip on the target tissue and / or prevent or inhibit the fixation element 610 from retracting out of the tissue after the fixation element 610 has been advanced into such tissue. In any embodiment, the tissue anchors or barbs 621 may face axially, radially, or at an angle relative to the axial direction of the fixation element 610. The tissue anchors or barbs 621 may be angled or otherwise configured to easily penetrate tissue, have vertical faces or otherwise be configured to engage and / or lock with tissue to prevent counter-rotation of the fixation element 610.

[0320] Further, with reference to FIGS. 23E-23F, any embodiment of a fixation element disclosed herein can have two or more, or multiple, body portions 611 extending away from the proximal end 610a of the fixation element. The embodiment of the fixation element 610 shown in FIGS. 23E-23F has a first body portion 611a and a second body portion 611b, both of which are helical in shape, have the same or similar pitch, and can extend the entire length of the fixation element 610. In other embodiments, one of the body portions 611 can have a different length (e.g., shorter) than the other body portion 611. Furthermore, in any embodiment disclosed herein, one or more body portions 611 can have a pitch that varies (increases or decreases) along its length from the proximal to the distal portion of the fixation element. A body portion 611 having a pitch that decreases along the length of the fixation element (such that the spacing increases along the length of the body portions) can result in the tissue between the coils being more compressed near the proximal end of the fixation element than near the distal end of the fixation element. In some embodiments, this may increase the retention force of the fixation element within tissue. First body portion 611a may have a distal end 612a, and second body portion 611b may have a distal end 612b.

[0321] As mentioned above, in some embodiments, the fixation element 610 may have two or more curved or helical (or corkscrew)-shaped body portions 611, each of which may have a pointed distal tip that can engage (or, in some embodiments, at least partially penetrate) tissue of the LA and / or LAA after the contact member is rotated to the second rotational position. In any embodiment disclosed herein, a fixation element having a helical shape (such as the embodiment of fixation element 610 shown in FIGS. 22A-22B) may have two helical-shaped body portions 611, each of which may be configured to penetrate and engage tissue contracted around a portion of the implant. In any embodiment, including single and double helical fixation element embodiments, the body portion or portions 611 may be long enough to engage the contact member, or may be shorter and engage all or only a proximal portion of the LA wall / LAA tissue, such as approximately 1 mm to approximately 2 mm of the LA wall / LAA tissue, or approximately 2 mm to approximately 5 mm or more of the LA wall / LAA tissue.

[0322] Additionally, in any embodiment, the one or more body portions 611 may define a cylindrical shape along the length of the fixation member 610, as shown, a conical shape along the length of the fixation member 610, or the like. For example, and without limitation, in any embodiment, the one or more body portions 611 may define a conical shape that increases along the length of the fixation member 610 such that the opening 615 is larger at the distal end 610b of the fixation element 610. The conical shape may result in the fixation element 610 widely gathering and packing tissue (i.e., radially inward) as it advances into the LA wall / LAA tissue.

[0323] 22B, the fixation element 610 (which may be any of the fixation element embodiments or may have any combination of the features of any of the fixation element embodiments disclosed herein) may be rotated (such as in a corkscrew fashion) and advanced to penetrate and / or pass through tissue of the LA and / or LAA collected and / or constrained around the body portion 614, or portion thereof, of the implant device 602. In this configuration, the fixation element 610 is configured to be rotatable relative to the contact member 604 such that the fixation element 610 can rotate and pass through tissue of the LA and / or LAA while holding the contact member 604 in a stationary position generally fixes the LAA in a second rotated position. In any embodiment, a sleeve or other component of the catheter or delivery system engages a fixation element (including, but not limited to, fixation element 610) to allow a user to move the fixation element from a second state to a first state (which should be interpreted to include movement from the second state to the first state), rotate the fixation element in either direction, move the fixation element between a first and a second rotated position, and / or otherwise manipulate the fixation element. In some embodiments, the catheter or delivery system may be configured to perform these actions independently of any other movement or movement of the catheter, such as, for example, allowing the fixation element to be advanced axially toward the contact member while the contact member is held in a fixed position by the catheter.

[0324] The fixation element 610 can thereby hold tissue of the LA and / or LAA to hold the tissue of the LA and / or LAA in a constrained state around the implant device and occlude the LAA. Additionally, in some embodiments, as shown, the fixation element 610 can also be configured to pass through one or more openings 620 that can be formed in or result in the contact member 604 when the contact member 604 is in the second expanded state, thereby further securing the fixation element 610 to the contact member 604 and preventing or inhibiting the contact member 604 from rotating toward the first rotated position. In any embodiment, the fixation element 610 and / or contact member 604 can have one or more teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue-engaging features or anchor members about an exterior surface of the fixation element 610 to prevent or inhibit the fixation element 610 from disengaging from the tissue of the LA and / or LAA when in the second state. Additionally, in any embodiment, the fixation element may be biased into the second rotational position by a biasing member (not shown), such as an axially resilient member, or using one or more sutures, wires, ratchets, tabs and openings, or other fixation features. However, in some embodiments, engagement of the fixation element 610 with tissue of the LA and / or LAA may be sufficient to secure the fixation element 610 in the second rotational position and maintain the LAA in an occluded state.

[0325] Embodiments of deployment sequences will now be described with reference to Figures 24-35. Figures 24-27 show the contact member 604 being advanced into the LAA. With reference to Figure 27, the contact member 604 can be advanced to any desired depth, including to the end of the LAA. In some embodiments, the contact member 610 can be advanced to a desired position relative to the LAA and then expanded to a second state to contact an interior surface or tissue of the LAA. The contact member 604 can then be rotated in a first direction (represented by arrow A3 in Figures 28-29, which can be either clockwise or counterclockwise) toward a second rotated position to twist the LAA in the first direction toward the second state, as also shown by arrow A3 in Figures 28-29. As will be described, as shown in Figures 28-29, the twisting can cause the ostium of the LAA to contract around a portion of the body of the implant device 602 to occlude the LAA from the LA.

[0326] 30-31 , while maintaining the contact member 604 in the second rotational position and / or maintaining the tissue of the LA and / or LAA in an occluded or contracted state and the LAA in a twisted position, the fixation element 610 can be advanced distally (as shown by arrow A4 in FIGS. 30-31 ) toward the tissue of the LA and / or LAA contracted about the body of the implant device. Before the distal end of the fixation element 610 reaches the tissue of the LA and / or LAA, the fixation element 610 can be rotated in a first direction (such as the rotational direction shown by arrow A5 in FIGS. 32-33 ) while the fixation element 610 is advanced distally such that the fixation element 610 penetrates and / or engages the tissue of the LA and / or LAA contracted about the body portion of the implant device 602. In some embodiments, the fixation element 610 can be advanced to completely penetrate the tissue of the LA and / or LAA, as shown in FIGS. 34-35 . In some embodiments, the fixation element 610 can be configured to engage and / or only partially penetrate tissue of the LA and / or LAA. The implant device 602 can then be released from the delivery catheter, which can be withdrawn from the patient's heart, leaving the LAA in an occluded position, as shown in FIGS. 34-35.

[0327] 36 illustrates another embodiment of an implant device 650 having a different embodiment of a fixation element 652 that can be used in conjunction with any of the embodiments of the implant device disclosed herein. As shown in FIG. 36, the fixation element 650 can have a back member 654 coupled to the proximal end 652a of the fixation element 652 that can provide an additional seal against the tissue of the LA and / or LAA when the fixation element is in the second or deployed position.

[0328] 37-38 show another embodiment of a treatment device 700 having an implant device 702 with contact members 704 in a second expanded state and fixation element 710 in a second open state. Any embodiment of treatment device 700 or implant device 702 may have any of the components, features, or other details of any other treatment device or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment device 100, 200, 300, 400, 500, 600 or implant device 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or details of treatment device 700 or implant device 702 disclosed below. Similarly, any component, feature, or other detail of any of the other therapeutic device or implant device embodiments disclosed herein can have any of the component, feature, or other detail of any of the therapeutic device 700 or implant device 702 embodiments disclosed herein, in any combination with any of the component, feature, or detail of the therapeutic device or implant device embodiments disclosed herein.

[0329] In any embodiment, the contact member 704 may have a body portion 706, which may, but need not, have a cylindrical shape. An opening or recess 708 may be formed in the body portion 706 as part of a retaining element to hold the fixation element 710 in a desired axial position relative to or locked to the coupling member 704. The fixation element 710 may also have a body portion 712, which may, but need not, have a cylindrical shape. In some embodiments, the body portion 712 may extend into the body portion 706 of the contact member 704 even when the fixation element 710 is in the first retracted state. The body portion 706 may have an opening 708 extending therethrough and sized and configured to selectively receive the body portion 712 of the fixation element 710. The body portion 712 may have an opening 722 extending therethrough and sized and configured to selectively receive the core member 720 of the delivery catheter of the treatment device 700.

[0330] 39, the fixation element 710 may have a deflectable tab member 714 that is movable or can be moved from a first engaged position (as shown in FIG. 37) to a second disengaged position (as shown in FIG. 38). The tab member 714 may be configured to rotate about a pin that may be coupled with the tab member 714 and the body portion 712, or may be configured to rotate about a thin strip of material (referred to herein as material strip 715) used to form the body portion 712 and / or tab member 714. For example, and without limitation, the body portion 712, the tab member 714, and one or more material strips 715 (two shown) may be integrally formed. Additionally, in some embodiments, one or more arms 711 (four shown) of the fixation element 710 may also be integrally formed with other features of the fixation element 710. In some embodiments, the tab 714 may be biased toward a first engaged position (as shown in FIGS. 37 and 39 ), but is physically deflectable or rotatable toward a second disengaged position (as shown in FIG. 38 ) by advancing a core member 720 or other component through an opening 722 extending through the body portion 712 of the fixation element 710. For example, and without limitation, as shown in FIG. 38 , the core member 720 may be advanced distally through the opening 722 of the fixation element 710 to deflect or rotate the tab member 714, thereby moving the tab member 714 from the first engaged position to the second disengaged position.

[0331] When the tab member 714 is in the engaged position, the tab member 714 can engage with an opening 708 formed in the body portion 706 of the contact member to axially lock or couple the fixation element 710 with the contact member 704, for example, after the contact member has twisted the LAA into a closed or occluded position or condition, as described above. However, in some embodiments, if a user desires to disengage or separate the fixation element 710 from the contact member 704, the user can accomplish this by moving the tab member 714 to a second disengaged position, for example, and without limitation, as described above, thereby disengaging the tab member 714 from the opening 708. The user can then axially retract the fixation element 710.

[0332] 40-43 illustrate another embodiment of implant device 732. Any embodiment of implant device 732 can have any of the components, features, or details of any other therapeutic or implant device embodiment disclosed herein, including, but not limited to, any of the above-described therapeutic devices 100, 200, 300, 400, 500, 600, 700, or implant devices 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or other details of implant device 732 disclosed below. Similarly, any component, feature, or other detail of any other therapeutic or implant device embodiment disclosed herein can have any of the components, features, or other details of any of the therapeutic or implant device embodiments disclosed herein, in any combination with any of the components, features, or other details of therapeutic or implant device embodiments disclosed herein.

[0333] As shown in FIG. 40 , the deflectable tab member 744 of the implant device 732 engages with the opening 738 of the contact member 734, thereby engaging the fixation element 740 with the contact member 734. In any embodiment, the deflectable tab member 744 is movable or can be moved from the first engaged position (shown in FIG. 40 ) to the second disengaged position (shown in FIG. 41 ) by distally advancing the fixation element 710 such that the body portion 739 of the contact member 734 changes and moves the tab member 744 to the second disengaged position, as shown in FIG. 41 . Thereafter, the fixation element 740 can be rotated in either direction (e.g., by 90 degrees) to a position where the tab member 744 is not aligned with, and therefore cannot be engaged with, the opening 738, as shown in FIG. 42 . Body portion 739 of contact member 734 can hold tab member 744 in the second, disengaged position while fixation element 740 is withdrawn or disengaged from the contact member, as shown in FIG.

[0334] Figures 44A and 44B are front and side views, respectively, of another embodiment of a treatment device 750 configured to twist closed or occlude the LAA at the ostium of the LAA. Figures 45A and 45B are front and side views, respectively, of the treatment device 750 of Figure 44, showing an implant used to twist the LAA to close or occlude the LAA at the ostium. The LA or LAA material contracted around the LAA ostium, or implant device, can then be clipped or locked in the contracted state, similar to any embodiment disclosed herein and using any fixation feature or component disclosed herein. Figures 46A and 46B are front and side views, respectively, of the treatment device of Figure 44, showing the delivery device being removed from the implant device after the LAA has been occluded.

[0335] In some embodiments, the steps of deploying and implanting can include, in any combination, and in any combination with any other steps, (a) inserting the catheter and implant device through the ostium of the LAA; (b) rotating the contact members or other engaging components of the implant to twist the LAA and fold at least the ostium of the LAA onto itself, thereby closing or occluding the ostium of the LAA; (c) clipping, holding, or securing the LA and / or LAA tissue in an occluded or closed state; and / or (d) releasing and withdrawing the delivery catheter from the implant. As shown, the treatment device twists the LAA closed at the ostium and clips and holds its position, essentially closing the LAA. In some embodiments, the steps of deploying and implanting include inserting the catheter centered at the ostium of the LAA; rotating the paddles of the implant to twist the LAA and self-fold the LAA; clipping and holding its position against the atrial wall; and releasing the delivery catheter from the implant.

[0336] 47A-47F illustrate another embodiment of a treatment device 1100 for closing or occluding the LAA, including an embodiment of a delivery device 1101 and an embodiment of an expandable implant or implant 1102 for the left atrial appendage, particularly showing the implant 1102 in several exemplary stages of expansion and deployment. The implant 1102 can have a body portion 1104 with a plurality of expandable struts or arms 1106. The body portion 1104 can expand, in some embodiments, to an approximately spherical or elongated spherical shape. The struts 1106 can each have a plurality of barbs or tissue anchors 1108 thereon (which can be or include any of the tissue anchors disclosed herein). Any of the embodiments of the implants disclosed herein can have a laser-cut nitinol body portion that is self-expanding and covered with micro-barbs.

[0337] The barbs 1108 may be configured to engage tissue during torsional translation or movement of the body portion 1104 relative to the inner wall of the LAA after the body portion 1104 is expanded from the first state to the second state, where the struts 1106 and barbs 1108 can engage or contact tissue on the inner wall of the LAA. Additionally, any embodiment of the implant 1102 can have one or more anchor elements 1112 configured to engage tissue adjacent to or surrounding the LAA to prevent the implant 1102 from rotating back to the first rotational position after the implant 1102 is rotated to the second rotational position within the LAA. In any embodiment, the anchor element 1112 can include two arms or members, each capable of engaging a tissue surface and each having multiple barbs thereon, configured to prevent the implant from rotating back to the first rotational position. 48A-48E illustrate several stages or steps illustrating the deployment procedure for the expandable implant 1102 of FIGS. 47A-47F as the implant 1102 is deployed within the LAA.

[0338] Any of the embodiments of the treatment systems or implant devices disclosed herein can be configured to maintain the LAA in an occluded state using one or more sutures, or multiple sutures. For example, and without limitation, any of the embodiments disclosed herein can be configured such that after the LAA has twisted and the ostium of the LAA has been constricted or occluded, one or more sutures, or multiple sutures, are advanced into the tissue of the ostium of the LAA and / or adjacent to the ostium of the LAA to secure the tissue in a twisted, constricted, and / or occluded state, or to prevent the ostium of the LAA from expanding after the sutures are implanted.

[0339] 48G-48O show example stages or steps of a treatment procedure for another embodiment of a treatment device 1101′, which can have any of the components, features, or details of any other embodiment disclosed herein. The treatment device 1101′ can have an expandable implant 1102′ that can be used to engage tissue of the LAA and twist the LAA upon rotation of the LAA, as shown in FIGS. 48L-48O, and a suturing device 1103′ configured to implant one or more sutures 1104′ in the tissue of the LAA ostium and / or tissue adjacent to the ostium to inhibit dilation of the ostium. For example, and without limitation, one or more suture loops can be applied to the tissue of the LAA ostium and / or tissue adjacent to the LAA ostium in a circular or crossed, such as crisscrossed, fashion to provide a secure closure. In any embodiment, the sutures may be implanted using a circular purse-string technique, a cross-stitch technique, an intermittent or continuous suture technique, a vertical or horizontal mattress technique, a vertical or horizontal suture technique, or any other suitable technique, or any combination of techniques.

[0340] Thus, in some embodiments disclosed herein, the fixation element may include one or more sutures. A portion of the implant 1102' may then be detached from the treatment device 1101' and left in the LAA, or the entire implant 1102' may be removed before the sutures are pulled tight and attached, for example and without limitation. The sutures of any embodiment disclosed herein may be of any suitable material, including nylon, polyester, PTFE, stainless steel, PVDF, polypropylene, and / or any other biocompatible and suitable material.

[0341] 49A-49G illustrate an embodiment of an implant 1202 that can be used to close or substantially close the LAA. In some embodiments, the implant 1202 can be formed by laser cutting a tube of elastic material, such as nitinol. The implant 1202 and any other implant embodiments disclosed herein can be self-expanding or mechanically expandable, such as using balloon expansion techniques. Furthermore, any embodiment of the implant 1202 can have any of the same features, components, or details of any other implant embodiment disclosed herein in place of, or in combination with, any of the features, components, or details of the embodiments of the implant 1202 disclosed herein. In some embodiments, the implant 1202 has a contact member 1204 that can be covered with multiple microbarbs or other tissue anchors 1208 and can have a fixation element 1212 (also referred to herein as an anchor element) that can include a single foldable clip anchor. The fixation element 1212 can be configured to lock the implant 1202 in a fixed, rotated position after the implant has rotated the LAA to the desired level of twisting and closure or occlusion.

[0342] 50A-50F show several illustrative stages of an embodiment of a deployment procedure for the expandable implant 1202 of FIGS. 49A-49G as the implant 1202 is deployed within the LAA. In any embodiment, the implant 1202 can be advanced into the LAA, expanded, and then rotated from a first rotational position to a second rotational position to twist the LAA and cause the ostium and / or other tissue of the LAA to contract or occlude around a portion of the implant 1202. The implants disclosed herein, or any implant, can be configured to rotate clockwise (and rotate clockwise and / or counterclockwise during any procedure disclosed herein) to twist closed or substantially close the ostium of the LAA or to contract the ostium of the LAA around a portion of the implant 1202. After the desired level of occlusion is reached, the fixation element 1212 can be rotated or folded (for example, and without limitation, about an axis or hinge 1214) laterally of the LAA so that it is approximately perpendicular to the axial centerline of the implant and forced to engage tissue adjacent the LAA adjacent the ostium of the LAA to prevent unwinding of the implant and the LAA ostium. The body portion of the fixation element 1212 can also have tissue anchors 1216 formed thereon or coupled or integrally therewith that can engage, penetrate, and / or grasp contracted LA and / or LAA tissue as a result of twisting of the LAA. In any embodiment disclosed herein, the fixation element 1212 can be configured to be biased and / or securable to a second, locked state (as shown in FIG. 49G or FIG. 50F ) using a spring, shape memory material, suture, tie, or other component. The delivery device can be detached from the implant after deployment of the fixation element 1212 and removed from the patient's body, as shown in FIG. 50F .

[0343] 51, 52, and 53 show additional embodiments of implant devices 1220, 1222, and 1224 (note that implant devices are also referred to herein as implants) that can be used in conjunction with any of the therapeutic device or procedure embodiments disclosed herein to treat the LAA. The implant device 1220 shown in FIG. 51 can have ribbons or struts made of nitinol or any other suitable material configured to expand into an approximately spherical or elongated spherical shape and can be covered with small barbs or cleats (or other tissue anchors). The tissue anchors can be oriented in one or both circumferential directions. The implant device shown in FIG. 52 can have a stent-like body made of nitinol or any other suitable material that is self-expanding or balloon-expandable into an approximately spherical or elongated spherical shape. The body of the implant can be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors). 53 may be made from stainless steel, nitinol, or any other suitable material and may have a woven wire body that may be configured to expand into an approximately spherical or elongated spherical shape. The body of the implant device 1224 may be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors).

[0344] 54 illustrates another embodiment of an implant device 1230 that is (or can be) expanded into an approximately spherical or elongated spherical shape. For example, and without limitation, the implant device 1230 can be configured with an inflatable balloon covering to expand the implant device 1230 into contact with the tissue of the LAA when the implant device 1230 is in a desired position within the LAA. The implant body 1230 is covered with small barbs or cleats or other tissue anchors.

[0345] FIG. 55 illustrates another embodiment of an implant device 1232 that can be used in conjunction with any of the embodiments of the treatment devices disclosed herein. In some embodiments, the implant device 1232 can have a helical-shaped body when in a second expanded state that can be used to exert at least a torque and torsional effect on the LAA. The implant device 1232 can be made from nitinol and can be covered with or have a plurality of small barbs, cleats, or other tissue anchors. The implant device 1232 can be self-expanding when in the second state and can have a half-dome shape. In some embodiments, the implant device 1232 can have a rounded end 1234 that can be approximately the same size as the internal lumen of the delivery system or can be smaller or larger and expandable.

[0346] FIG. 55A illustrates another embodiment of a treatment device having an implant device 1235 that can be used in conjunction with any of the treatment device embodiments disclosed herein. In some embodiments, the implant device 1235 can have a contact member 1236 that can have a generally cylindrical structure and can have multiple wires, struts, or braids that can be laser cut, braided, or woven from hypotubes using any other suitable technique known in the art. In some embodiments, the contact member 1236 can be shaped or formed like an expandable stent. The contact member 1236 can be mechanically expandable or self-expandable. As with any embodiment disclosed herein, the contact member 1236 has multiple tissue barbs or anchors thereon that are configured to engage tissue within the LAA. As with any other implant embodiment disclosed herein, the implant 1235 can be configured to twist the LAA when the implant is rotated after the implant is advanced into engagement with the LAA.

[0347] Additionally, any embodiment of the implant device 1235 may have an expandable member 1237 (such as a bladder or balloon) therein that is selectively expandable to cause expansion of the contact member 1236. In some embodiments, the expandable member 1237 may be sealable and detachable from the delivery device such that the expandable member can remain in the LAA after the treatment procedure is completed to occlude the LAA. In other embodiments, a treatment system having the implant device 1235 may be configured such that the implant device is removed either before or after the ostium of the LAA is secured in an occluded state.

[0348] In other embodiments, any of the embodiments of the implant device disclosed herein may have a contact member having a spherical shape. For example, and without limitation, any of the embodiments of the implant device disclosed herein may have a generally spherically shaped contact member 1238, as shown in FIG. 55B. The contact member 1238 may be fabricated from laser-cut hypotube, formed to the desired shape and size, formed from one or more wires, or formed using any other suitable technique known in the art. As with any of the embodiments disclosed herein, the contact member 1238 may be closed at both ends or open at one or more of the ends, formed from nitinol, stainless steel, or any other suitable material, and may be self-expanding, mechanically expandable, e.g., balloon-expandable, or otherwise formed. The contact member 1237 may have multiple tissue barbs or anchors thereon configured to engage tissue within the LAA.

[0349] In other embodiments, any of the embodiments of the implant device disclosed herein may have a contact member having a generally spherical shape. For example, and without limitation, any of the embodiments of the implant device disclosed herein may have a generally spherically shaped contact member 1239, as shown in FIG. 55C. The contact member 1239 may be open on its distal end, may be made from laser-cut hypotube and formed to the desired shape and size, may be formed from one or more wires, or may be formed using any other suitable technique known in the art. As with any of the embodiments disclosed herein, the contact member 1238 may be formed from nitinol, stainless steel, or any other suitable material, and may be self-expanding, mechanically expandable, e.g., balloon-expandable, or otherwise. The contact member 1239 may have multiple tissue barbs or anchors thereon configured to engage tissue within the LAA.

[0350] 56A-56B show an embodiment of a treatment device 1240 having an implant device 1242 generally contained within a catheter body 1244 of the treatment device 1240 in FIG. 56A , with at least a contact member 1246 of the implant device 1242 in a second, expanded state in FIG. 56B . The contact member 1246 can have multiple barbs or anchor members around its outer surface and can be configured to expand into an approximately spherical or elongated spherical shape. The contact member 1246 can be self-expanding or mechanically expandable and can have a half-dome shape with a rounded distal end 1248. In some embodiments, the rounded end 1248 can be approximately the same size as the internal lumen of the delivery system, or can be smaller or larger and expandable.

[0351] 57-61 show additional different embodiments of anchor or fixation elements that can be used in conjunction with any of the other components of the implant device embodiments disclosed herein. Figure 57A shows an embodiment of a dual-arm fixation element. Figure 57B shows the dual-arm fixation element of Figure 57A being advanced around the body portion of the implant device and into the tissue of the LA and / or LAA adjacent the ostium of the contracted LAA.

[0352] FIG. 58A shows an embodiment of a single folding clip anchor or fixation element. FIG. 58B shows the single-arm fixation element of FIG. 58A rotated or clipped against tissue of the LA and / or LAA adjacent the ostium of the LAA constricted around the body portion of the implant device. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. FIG. 59A shows an embodiment of a disc anchor or fixation element. FIG. 59B shows the disc fixation element of FIG. 59A advanced toward tissue of the LA and / or LAA adjacent the ostium of the LAA constricted around the body portion of the implant device so that one or more tissue anchors of the fixation element of FIG. 59A can engage and / or penetrate tissue of the LA and / or LAA adjacent the ostium of the LAA.

[0353] FIG. 60A shows an embodiment of a fixation element having a single folding clip anchor or helical or screw-type tissue anchor that can be used to engage and / or penetrate tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device. FIG. 60B shows the single folding clip anchor or fixation element of FIG. 60A rotated or clipped against tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device. In any embodiment, the fixation element can be biased to remain in a fixed or locked position. FIG. 61A shows a dual-arm fixation element having two helical or screw-type tissue anchors. FIG. 61B shows the dual-arm fixation element of FIG. 61A rotated against tissue of the LA and / or LAA adjacent to the ostium of the contracted LAA around the body portion of the implant device so that the tissue anchors on the arms can engage and / or penetrate the tissue. Both arms of the fixation element of FIGS. 61A-61B can be folded toward the body portion or axial centerline of the fixation element and can be configured to automatically deploy when extended past the distal end of the delivery catheter.

[0354] 62A-62B show side and end views of different embodiments of contact members that can be deployed within the LAA to engage tissue of the LAA such that the LAA twists when torque is applied to the contact member. FIGS. 62A-62B show contact member embodiments having a cylindrical or disc-shaped body portion, a spherically shaped body portion, a cone-shaped body portion, and a semi-spherical and / or hemispherical-shaped body portion configured to better engage or bond with LAA tissue. Any of the contact member embodiments shown in FIGS. 62A-62B can have multiple barbs, micro-barbs, or other tissue anchors on their exterior surface. Additionally, any of the contact member embodiments shown in FIGS. 62A-62B can have an exterior surface uniformly covered with barbs, micro-barbs, or other tissue anchors. Additionally, any of the body portion embodiments disclosed herein, including but not limited to the hemispherically shaped body portion shown in FIGS. 62A-62B, can have a flattened region on a portion thereof to allow for a lower profile.

[0355] Figures 62C1-62Z show additional embodiments of contact members and / or implant devices that can be used with any of the treatment device embodiments disclosed herein. Furthermore, any contact member embodiment disclosed herein can have any of the features, components, or other details of any of the other contact member embodiments and / or implant device embodiments disclosed herein, including, but not limited to, tissue barbs, covers, and other features, in combination with any of the components, features, and details disclosed for these embodiments below. Furthermore, any of these devices shown in any of Figures 62C1-62Z can be configured to be removed from the LAA or to remain indefinitely in the LAA. Any of the contact member and / or implant device embodiments shown in Figures 62C1-62Z can be configured to be expanded to grip the LAA to twist an occluded or blocked LAA. Some embodiments of the contact members and / or implant devices shown in Figures 62C1-62Z may be configured to fold, further reducing (e.g., to zero) the remaining portion of the closed LAA pouch after the fixation element engages tissue of the LAA and / or surrounds the LAA and / or contact member.

[0356] Figures 62C1-62C3 show an embodiment of a contact member having a tube, stretcher, and runner extending through its center. The contact member shown in Figures 62C1-62C3 can be radially expanded by advancing the runner axially along the tube, thereby extending the stretcher outward so that the arms or ribs can expand outward, for example, against tissue in the LAA. The contact member may be selectively locked in an expanded state and / or folded if desired. This contact member hinge can reduce the overall profile of the contact member for small passage delivery. As with any contact member embodiment, the contact member shown in Figures 62C1-62C3 can have one or more tissue barbs on its exterior surface, such as the ends of the ribs, as represented by the rectangular-shaped objects at the ends of the ribs.

[0357] The contact member device shown in FIG. 62D can have multiple hinges and multiple struts to improve collapsibility and therefore reduce the profile of the contact member when it is in the collapsed state. In some embodiments, the contact member shown in FIG. 62D can be open at one end and closed at both ends, such as with a spherical or elongated shaped member. The device in FIG. 62E can be open at one end and closed or sealed at the second end. The contact member shown in FIG. 62D can have a cover configured to provide a seal at the opening of the LAA in the deployed or operable state. The contact member shown in FIG. 62F can be reversible so that the arms of the device can extend in either direction. The cover can be coupled to the arms of the device. The arms can be flexible and unconstrained at their distal ends, or they can be constrained at their distal ends.

[0358] The contact members in Figures 62G1-62G2 are shown extending from the distal end of the delivery catheter. The contact members can have multiple struts or arms, e.g., 15-20 struts or arms, extending radially around the device. The arms can have a larger distal diameter or size compared to the diameter or size of the device at or near the proximal end of the device. The device can have one or more tissue barbs or anchors with spike-like shapes extending outward from each of the struts. Some embodiments of the contact members in Figures 62G1-62G2 can also be used to secure the LAA in a twisted state or configuration. In some embodiments, a user can position the contact member and rotate it to reduce the profile or size of the contact member so that the struts and / or tissue anchors on the outer surface of the contact member that engage the tissue of the LAA can cause the LAA to fold. Thus, the contact members shown in Figures 62G1-62G2 can secure one or more folds in the tissue in this configuration. The user advances the contact member axially to expand it to a second state, engaging the arms of the contact member with tissue of the LAA, rotates the contact member to retract the tissue of the LAA, and axially retracts the contact member to retract it, thereby securing the LAA with the contact member when it is in a radially closed position. The contact member can then be decoupled from the delivery device in some embodiments. In some embodiments, this can be accomplished using a helical rib design.

[0359] Figures 62H1-62O show additional embodiments of contact members that can be used with any of the treatment devices disclosed herein. Some embodiments of contact members, including the contact member embodiments shown in Figures 62N and 62O, can be configured to expand by shortening the axial length of the inner shaft, wire, suture, or other component of the contact member so that the outer structure of the contact member expands outward, shortening the length of the outer structure. These contact members can be collapsed by increasing the length of the outer structure.

[0360] Figures 62H1 and 62H2 show another embodiment of a contact member that can have a helical spring shape with a closed end. The contact member shown in Figure 62H can be attached to the distal portion of the LAA. When the contact member is deployed and released, it can rotate and wind up the LAA. The coil at its distal tip can thread into the tissue of the LAA, securing the contact member and the LAA in a twisted or wound state. Other embodiments of the contact member can have tissue anchors, gripping mechanisms, and / or one or more clip mechanisms. To prevent the wire from rotating relative to the LAA, in some embodiments, the wire can have a square cross-section that passes through a keyway or square lumen that forces a twist into the coil tip and the LAA, as shown in Figure 62H2.

[0361] Figures 62P and 62Q show two different embodiments of contact members having fixed sizes and profiles: the contact member shown in Figure 62P may have a single smooth or blunt blade or plate, and the contact member shown in Figure 62Q may have a pair of smooth or blunt blades or plates that extend axially and can engage tissue surfaces on the interior of the LAA.

[0362] The contact member embodiments of FIGS. 62R1-62R2, shown expanded in FIGS. 62R3 and 62R4, can have one or more struts configured to provide visual feedback to the surgeon when the contact member contacts tissue in the LAA, in some embodiments, approximately how much force is being applied to the visual indicator and therefore the contact member. The visual indicator is configured to deflect and deform to provide such a visual indication. Some embodiments of the visual indicator are configured to deform before the struts or arms of the contact member do so. This is the concept of having a visual indicator of tissue contact. Additionally, the contact members shown in FIGS. 62R1-62R4 can have rounded arms configured to provide a softer visual indicator. The visual indicator can be a softer, flexible rib that is radiopaque. When the surgeon sees the flexibility indicator move, this can then indicate to the surgeon that the remainder of the relatively stiff, non-deformable contact member is in contact with tissue. The surgeon can then apply a rotation to the contact member to twist the contact member. The illustrated example shows an indicator rib (shown in darker blue) that, in some embodiments, can be advanced further anteriorly than the grasping rib. When the indicator rib can be deformed proximally, it indicates that the device is touching the LAA. The surgeon can then apply a rotation to the contact member to twist it.

[0363] The contact members shown in FIGS. 62S1 and 62S2 can have a low profile in a first state, for example, for delivery or retraction. The contact members can be self-expanding or mechanically actuable, for example, and without limitation, by axially shortening the contact member, such as by a screw drive, to cause the ribs or arms of the contact member to expand outward. The coil orientation can be designed for maximum grip. For example, for a CCW grip orientation, the left-handed coil engages and expands further when rotational resistance is encountered. Any embodiment of the contact members disclosed herein can be designed for maximum grip. For example, for a CCW grip orientation, the left-handed coil engages and expands further when rotational resistance is encountered.

[0364] The contact member embodiment shown in Figures 62U-62X can be advanced using a proximal pusher to form a hoop within the LAA. When the proximal pusher is under tension, the hoop members align with the small profile. One axial member can be relatively rigid, while the other member is more flexible to accommodate tissue. After twisting and securing the LAA, the hoop can be removed and remain within the LAA, or in other designs, the contact member can be removed through the center of the reduced LAA ostium.

[0365] Some embodiments of the contact members disclosed herein can have a ribbon or pigtail shape configured to aid in engaging tissue within the LAA. In some embodiments, the device can have one or more contact members (i.e., one or more ribbons or elements) to help engage the implant with tissue. In some embodiments, the tip of the pigtail can face proximally.

[0366] Figure 63 shows a side view of an embodiment of a contact member expanded against the tissue surface of the LAA after torque has been applied to the contact member causing contraction of the tissue of the LA / LAA around a portion of the body of the implant device. Figure 63 also shows a tissue anchor of the implant device advanced into the tissue of the LA / LAA to secure the LAA in a second rotational position.

[0367] Additionally, any of the implant embodiments disclosed herein may have a drug coating, fabric, or other at least substantially impermeable covering (such as, but not limited to, cover member 121 or cover member 121′ described above, and similar thereto), a sealing element (such as, but not limited to, sealing material 129 described above), electrical contacts to eliminate conduction of electrical signals that cause Afib, or other features to improve implant performance. Some implant embodiments may be delivered percutaneously via a catheter and a separable element between the implant element and the delivery system, which would allow for permanent separation and thus permanent implantation of the implant. Furthermore, in any of the embodiments disclosed herein, the implant may be delivered without the use of a catheter, for example, surgically or otherwise.

[0368] Some embodiments include a device for closing or occluding the LAA, the device having an expandable implant configured to move between a first state in which the implant is substantially collapsed and a second state in which the implant is expanded, and a catheter configured to advance the implant into the left atrial appendage. When the implant is in the first state, the implant may be advanced into the LAA such that the implant moves from the first state to the second state such that at least some of the plurality of tissue anchors engage an inner wall surface of the left atrial appendage after the implant has been advanced into the left atrial appendage. Any embodiment of the implant or insert may have multiple tissue anchors on its exterior surface.

[0369] Additionally, the catheter can be configured to rotate the implant in a first direction from a first rotational position to a second rotational position so that the implant can twist the wall of the left atrial appendage. As described above, the catheter can rotate the implant from as little as a quarter turn to more than a full turn. In any embodiment, the delivery device (which in any embodiment disclosed herein may be a catheter, or any other suitable deployment or surgical device or system) can be configured to allow the user to rotate the implant as many times as necessary or desired to close, occlude, or collapse the LAA on the implant itself, or about the exterior surface of the implant.

[0370] Any embodiment of the implant is self-expandable so that the implant automatically expands when a restraint is removed from the implant, such as when the implant automatically expands when advanced through the distal end of the outer sleeve of the catheter. The implant can be biased to remain in the expanded state after deployment into the left atrial appendage.

[0371] Additionally, any embodiment of the implant or system disclosed herein may be configured such that the implant can engage or automatically engage with tissue or tissue surfaces when rotated or pivoted in one (or first) direction. Any embodiment of the implant disclosed herein may also be configured to disengage any tissue it engages when pivoted in a second direction (the second direction being opposite the first direction). In this embodiment, a user can engage tissue or wall surfaces of the LAA by rotating the implant in a first direction and disengage (if necessary for any reason, including, but not limited to, repositioning the implant) by rotating the implant in a second direction, the second direction being opposite the first direction.

[0372] In any embodiment, as described above, the implant can be configured to prevent the contact member from rotating back to the first rotational position after the contact member is fully deployed. For example, as described above, any embodiment of the implant can have a fixation element or anchor element that can be configured to engage tissue surrounding the LAA, such as tissue on the interior wall of the heart outside the left atrial appendage. Some embodiments of the implant can have a fixation element with multiple tissue anchors configured to engage the interior wall of the heart adjacent the left atrial appendage.

[0373] For example, and without limitation, the implant of any of the device, apparatus, and method embodiments disclosed herein may include a fixation element configured to engage the interior wall of the heart adjacent to or outside the left atrial appendage. The fixation element may have one or more arms and / or tissue anchors configured to engage the interior wall of the heart adjacent the left atrial appendage, or may be configured to be sutured to or otherwise coupled to the interior wall of the heart adjacent the left atrial appendage. In any embodiment, the implant may be configured to prevent or inhibit counter-rotation of the contact member or other portion of the implant to a first rotational position after the contact member or other portion of the implant is fully deployed. In any embodiment, the implant may be configured to rotate or allow rotation of the contact member in a first direction from a first rotational position to a second rotational position, and to prevent or inhibit rotation of the implant in a second direction after the contact member or other portion of the implant is fully deployed, the second direction being opposite the first direction.

[0374] Any embodiment disclosed herein may include an implant for deployment within a cavity or vessel having an expandable body (which may, but need not, have any of the functionality or characteristics of a contact member), a plurality of tissue anchors on an exterior surface of the expandable body configured to engage an inner wall surface of the cavity or vessel, and an anchor element coupled to the expandable body configured to engage a tissue surface adjacent the inner wall surface of the cavity or vessel.

[0375] Several embodiments of methods for closing or occluding the LAA using any of the embodiments of the implants disclosed herein are now described. The method or procedure can include advancing a deployment device having an implant with an expandable member or contact member into a patient's left atrium; moving or deploying a portion of the implant from a first state to a second state within the left atrial appendage, such that the expandable member or contact member is substantially collapsed in the first state and deployed in the second state; engaging an inner wall portion of the left atrial appendage with the expandable member or contact member (which may, but need not, have one or more tissue anchors on its outer surface); rotating the expandable member or contact member from the first rotational position to the second rotational position to twist the wall portion on the inside of the left atrial appendage; and preventing the expandable member or contact member from rotating back to the first rotational position. Any portion of the implant, including, but not limited to, the expandable member or contact member, can be self-expanding, and moving the expandable member or contact member from the first state to the second state can include advancing the expandable member or contact member out of the distal end of the deployment device.

[0376] Furthermore, in any embodiment disclosed herein, engaging the inner wall portion of the left atrial appendage can include engaging the inner wall portion of the left atrial appendage with one or more tissue anchors positioned on an exterior surface of the expandable or contact member or other portion of the implant. Furthermore, preventing the implant from rotating back to the first rotational position can include engaging a tissue wall exterior to the left atrial appendage with an anchor or fixation element. In some embodiments, the anchor or fixation element can be rotationally fixed to the expandable or contact member and / or other portion of the implant to prevent relative movement between the anchor element and the expandable or contact member and / or other portion of the implant. Preventing the expandable or contact member and / or other portion of the implant from rotating back to the first rotational position can include engaging a tissue wall of the heart with an anchor or fixation element, such that the anchor element can be rotationally fixed relative to the implant and configured to prevent the expandable or contact member and / or other portion of the implant from rotating back to the first rotational position, or engaging an interior wall of the heart exterior to the left atrial appendage with the anchor or fixation element. In any embodiment, the anchor element or fixation element can include a plurality of tissue anchors on at least one surface thereof, the tissue anchors configured to engage the interior wall of the heart outside the left atrial appendage.

[0377] In any embodiment disclosed herein, the implant may be configured to automatically rotate from a first rotational position to a second rotational position after the contact member and / or other portions of the implant are in the second state, or may be activated to self-rotate at any desired time. For example, and without limitation, the implant may have a spring or other torsion member configured to rotate the contact member and / or other portions of the implant or other portions of the body of the implant upon release or activation of the spring, or may be configured to be pre-twisted or pre-coiled when the implant or the contact member and / or other portions of the implant are in the first state. Self-rotation or self-twisting can occur, for example, after the contact member and / or other portions of the implant are secured to the wall portion surrounding the LAA and after a portion of the implant engages at least a portion of the interior wall surface of the LAA, such that rotation or twisting of a portion of the implant can cause twisting of the LAA, thereby closing or occluding the ostium of the LAA.

[0378] Thus, in any embodiment, the implant can be configured to automatically or self-rotate from the first rotational position to the second rotational position upon release of a restraint holding the implant in the first rotational position, or upon triggering or actuation of a rotation mechanism, which can be a spring or other torsion member. In some embodiments, the shaft extending through the implant can be configured to be wound or rotated relative to the fixed portion or base of the implant, or can have a spring around the shaft, such that rotation of the shaft relative to the fixed portion or base of the implant can result in torsion of the LAA as a result of torsional release of the shaft or a spring surrounding at least a portion of the shaft.

[0379] In other embodiments, the implant may have a shaft or body portion extending from a base, the shaft being rotatable (manually, by catheter, or self-rotating) relative to the base from a first rotational position to a second rotational position, and a ratchet or other locking mechanism may be used to lock the shaft or body portion in the second rotational position relative to the base. The base may be configured to engage and lock into the wall or tissue of the heart surrounding the LAA before the shaft or body portion engages with an inner wall portion of the LAA and before the shaft or body portion is rotated to the second rotational position.

[0380] Further, in any apparatus, implant device, method, or other embodiment disclosed herein, the second rotational position can be at or about one-eighth of a full rotation (i.e., 45 degrees or about 45 degrees) relative to the first rotational position, at or about one-quarter of a full rotation (i.e., 90 degrees or about 90 degrees) relative to the first rotational position, or at or about one-half of a full rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position, or the second rotational position can be from at or about one-eighth of a full rotation (i.e., 45 degrees or about 45 degrees) to at or about one-half of a full rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position. In any apparatus, implant device, method, or other embodiment disclosed herein, the second rotational position can be from at or about one-quarter of a rotation (i.e., at or about 90 degrees) to one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or from at or about one-quarter of a rotation (i.e., at or about 90 degrees) to two, three, or more full rotations, or about one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or from at or about one-eighth of a rotation (i.e., at or about 45 degrees) to one, two, three, or more full rotations, or about one or more full rotations (i.e., at or about 360 degrees) relative to the first rotational position, or any value or range of values ​​within any of the foregoing ranges. In any of the embodiments disclosed herein, the torsional movement or step may be achieved by a torque catheter.

[0381] Further, in embodiments of any apparatus, implant device, or method disclosed herein, the catheter may be configured to exert a torque on the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached or until the user determines to stop rotation, whichever comes first. In some embodiments, the threshold predetermined torque level may be between 0.25 in-oz torque or approximately 0.25 in-oz torque and 10 in-oz torque or approximately 10 in-oz torque, or between 0.5 in-oz torque or approximately 0.5 in-oz torque and 5 in-oz torque or approximately 5 in-oz torque.

[0382] In any embodiment disclosed herein, the contact members, when in the first or folded state, can have an outer diameter or size of approximately 3 mm to approximately 8 mm (approximately 9 Fr to approximately 24 Fr), or approximately 4 mm to approximately 6 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or can have a length (of the arm or strut member) of approximately 20 mm to approximately 60 mm, or approximately 30 mm to approximately 50 mm, or any value or range of values ​​between any of the aforementioned ranges. Additionally, in any embodiment disclosed herein, without limitation, the contact members, when in the second or expanded state, can have an outer diameter or size of approximately 6 mm to approximately 14 mm (approximately 18 Fr to approximately 42 Fr), or any value or range of values ​​between any of the aforementioned ranges, or approximately 9 mm to approximately 11 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or can have a length (of the arm or strut member) of approximately 10 mm to approximately 40 mm, or approximately 20 mm to approximately 30 mm, or any value or range of values ​​between any of the aforementioned ranges.

[0383] In any embodiment disclosed herein, without limitation, the fixation element, when in the first or collapsed state, can have an outer diameter or size of approximately 3 mm to approximately 8 mm (approximately 9 Fr to approximately 24 Fr), or any value or range of values ​​between any of the aforementioned ranges, or approximately 4 mm to approximately 6 mm, and / or a length of approximately 4 mm to approximately 12 mm, or approximately 6 mm to approximately 8 mm, or any value or range of values ​​between any of the aforementioned ranges. Furthermore, in any embodiment disclosed herein, without limitation, the fixation element, when in the second or expanded state, can have an outer diameter or size of approximately 6 mm to approximately 18 mm (approximately 18 Fr to approximately 54 Fr), or approximately 9 mm to approximately 15 mm, or any value or range of values ​​between any of the aforementioned ranges, and / or a length (of the arm or strut member) of approximately 4 mm to approximately 8 mm, or approximately 4 mm to approximately 6 mm, or any value or range of values ​​between any of the aforementioned ranges. Additionally, any embodiment of the fixation elements disclosed herein may have a tissue-engaging tip or portion (i.e., the portion configured to penetrate or engage tissue) having a length of approximately 0.2 mm to approximately 2 mm, or approximately 0.5 mm to approximately 1 mm, or any value or range of values ​​between any of the aforementioned ranges.

[0384] Some embodiments of the closure devices disclosed herein can be configured to more closely mimic a surgical-type closure compared to the conventional devices described above, in which the LAA is unplugged but closed, with limited exposure of the device within the left atrium.

[0385] 64 shows another embodiment of a treatment device 1300 having an implant device 1302 with contact members 1304 in a second expanded state within the LAA and a fixation element 1310 in a first contracted state. A retention element 1308 (also referred to herein as a retention element) is used to retain the fixation element 1310 in a desired axial position relative to the contact members 1304 and is shown in the first expanded state in FIG. 64. Any embodiment of treatment device 1300 or implant device 1302 can have any of the components, features, or other details of any other treatment device or implant device embodiment disclosed herein, including, but not limited to, treatment devices 100, 200, 300, 400, 500, or any of the embodiments of implant devices 102, 202, 302, 402, 502 described above, in any combination with any of the components, features, or details of treatment device 1300 or implant device 1302 disclosed herein. Similarly, any component, feature, or other detail of any of the other therapeutic device or implant device embodiments disclosed herein can have any of the component, feature, or other detail of any of the therapeutic device 1300 or implant device 1302 embodiments disclosed herein in any combination with the component, feature, or detail of the therapeutic device or implant device embodiments disclosed herein.

[0386] The contact member 1304 can have multiple posts or links 1306 that can have multiple tissue anchors 1307 at multiple locations around the posts 1306 of the contact member 1304. In some embodiments, the tissue anchors 1307 can be the same as or similar to any of the tissue anchors 118 described above. As with any of the embodiments disclosed herein, the tissue anchors 1307 can be, but are not required to be, integrally formed with the posts 1306. The contact member 1304 can have a generally spherical or bulbous shape, or the shape of any of the other embodiments of contact members disclosed herein.

[0387] Similar to other embodiments described above, including embodiments of treatment device 500, any embodiment of treatment device 1300 can have a suture or thread (not shown) extending through the inside of the catheter body and / or a portion of implant 1302 (such as through a lumen extending through the catheter) and looped around a pin or other fixation element (not shown) on implant 1302, allowing a user to retract or withdraw the suture to pull contact member 1304 proximally relative to fixation element 1310, keep implant 1302 engaged with the delivery catheter, and / or use contact member 1304 to twist the LAA and then advance fixation element 1310 toward contact member 1304. In some embodiments, the pin or other fixation element can be coupled to contact member 1304 or to a portion of implant 1302 (such as a shaft or body portion) that is coupled to contact member 1304. In some embodiments, in this configuration, both ends of the suture can extend from the proximal end of the device 1300 such that a practitioner can grasp both ends of the suture and apply a proximal force around the pin or other fixation element to pull the contact member 1304 toward the fixation element 1310 and / or advance the fixation element 1310 toward the contact member 1304 after using the contact member 1304 to twist the LAA.

[0388] In other embodiments, the fixation element 1310 can be advanced toward the contact member 1304 using a portion of the catheter 1302, such as, for example and without limitation, a tube or sleeve (such as, but not limited to, the second intermediate tube 157 of any of the treatment device 140 embodiments described above) that can contact and engage the proximal end of the fixation element 1310 and advance distally. The catheter tube or sleeve can be configured to be rotatable to adjust the rotational position of the fixation element and / or maintain the fixation element 1310 in a fixed rotational position relative to the anatomy and / or advance the fixation element 1310 toward the contact member 1304 and into the tissue surrounding the implant 1302 after the LAA has twisted. In any embodiment disclosed herein, the implant 1302 can be configured to be removed such that the only portion of the implant device 1302 remaining in the LAA or heart is the fixation element 1310 after the fixation element 1310 has been applied to the tissue contracted by twisting of the contact member 1304.

[0389] In any embodiment disclosed herein, the implant 1302 can have a first tube or body portion 1312 coupled to the contact member 1304 and a second tube or body portion 1314 coupled to the fixation element 1310. In any embodiment disclosed herein, the first tube or body portion 1312 is slidable (telescopically or otherwise) relative to the second tube or body portion 1314 so that the distance between the contact member 1304 and the fixation element 1310 can be adjusted by a surgeon or other user of the treatment device 1300. In some embodiments, the first tube 1312 and / or the second tube 1314 can be configured to be indexed relative to one another such that the tubes are rotationally fixed to one another, for example, using the slot and pin arrangement of any of the embodiments of the treatment device 500 described above. In other embodiments, the first and / or second tubes 1312, 1314 may be configured to be rotatable relative to one another such that the angular orientation or position of the fixation element 1310 is adjustable relative to the contact member 1304 (or vice versa) and / or such that the fixation element 1310 can be held in a stationary position or orientation as the contact member 1302 and LAA are rotated by a surgeon or other user of the treatment device 1300.

[0390] In this configuration, when the contact member 1304 is rotated in a first direction (which may be clockwise or counterclockwise, as indicated by arrow A8 in FIG. 64 ), one or more or all of the struts 1306 and one or more or all of the tissue anchors 1307, if present, may engage tissue of the LAA, twisting the LAA or rotating the LAA in the first direction A8. Twisting or rotating the LAA in the first direction from the first rotational position to the second rotational position may cause the opening or ostium O of the LAA to contract radially (represented or identified by arrow A9 in FIG. 64 ) such that the opening O of the LAA moves or contracts about the exterior surface of the first tube or body portion 1312 or about the proximal portion of the contact member 1304. An operator can twist or rotate the contact member 1304 by twisting or rotating a portion of the catheter device coupled to the contact member 1304 or coupled to the first body portion or tube 1312 of the implant device 1302. Tightening or constricting the opening O of the LAA around the exterior surface of the first tube or body portion 1312, or around the proximal portion of the contact member 1304 or other portion of the implant device, can result in occlusion, or substantial occlusion, substantially closing off the interior portion of the LAA from the LA, thereby significantly reducing the health risks associated with an open LAA.

[0391] Note that, as shown in FIG. 64 , any embodiment of the treatment device disclosed herein can be configured such that the fixation element is held in a first or folded state when the contact member is rotated, thus allowing the LAA to twist and tissue at or adjacent to the ostium of the LAA to contract around the implant. This can reduce the risk of the fixation element tearing or damaging tissue within the heart during the twisting portion of the procedure. Thereafter, once the contact member and LAA are in the desired rotational position, the fixation element can be unconstrained or otherwise moved from the first, folded position to the second, expanded position. This can be accomplished in some embodiments by removing the restraint surrounding the fixation element (e.g., without limitation, by retracting the sleeve, outer sleeve, or other component of the catheter) after the contact member and LAA are in the desired rotational position, as shown in FIGS. 64-65 .

[0392] In some embodiments, the user can move the fixation element 1310 from a first axial position toward the contact member 1304 to a second axial position by pulling back or withdrawing the suture (again, while the contact member 1304 is held in a fixed position within the LAA, as described above). This is done after a desired level of twisting of the LAA has been achieved by torquing or twisting the contact member 1304. Referring to FIG. 65 , this, in some embodiments, allows the fixation element 1310 and second tube or body portion 1314 to advance distally relative to the contact member 1304 and first tube or body portion 1312, thereby forcing the fixation element into the tissue of the LAA or LA and holding the tissue in a closed, twisted, or contracted state.

[0393] Additionally, any embodiment of the device can be configured such that when the fixation element 1310 is advanced to the second rotational position, it engages tissue to hold the LAA in an occluded or closed position, and the retention element can be used to prevent the fixation element from moving away from the second rotational position toward the first rotational position (or away from the contact member 1304). In any embodiment disclosed herein, the retention element can be used to bias or retain the fixation element in a desired axial position relative to the contact member to fixate or bias tissue at and adjacent the ostium of the LAA to remain in the contracted or occluded state.

[0394] For example, and without limitation, some embodiments of the implant 1302 may have a ratchet mechanism configured to bias or secure the fixation element to remain in any of several desired axial positions relative to the contact member. In some embodiments, similar to, for example, the treatment device 500 disclosed herein, the first and / or second tube or body portion 1312, 1314 may have one or more tabs or other deflectable or deformable features (collectively referred to herein as tabs) configured to reversibly or irreversibly engage (i.e., removably or non-removably) with one or more recesses or openings (such as multiple openings aligned along a portion of the length of the first or second tube or body portion) formed in the first and / or second tube or body portion 1312, 1314. For example, and without limitation, one or more tabs or other deformable or deflectable features may be formed on or coupled to the first tube or body portion 1312 that are engageable with multiple openings or recesses formed in the second tube or body portion 1314. In some embodiments, the tabs can extend radially inward in the relaxed state. In this configuration, one or more tabs or other deflectable or deformable features can be configured to engage one or more recesses or openings to prevent movement of a portion of the implant (such as, for example, and without limitation, the second tube or body portion) toward and away from the contact member.

[0395] In this manner, the tabs (which may be other types of locking features, such as a ball and detent, a zip-tie type locking feature, or other deflectable or deformable feature) can be configured to allow the locking element 1310 to move freely from the first expanded position to the second collapsed position and to selectively prevent or inhibit movement from the second rotated position to the first rotated position, thereby substantially locking the locking element in the second rotated position. Further, in any embodiment disclosed herein, the treatment device 1300 can be configured such that the retention element is reversible or removable, or otherwise, allowing a surgeon or other user to release the retention element and move it away from the contact member for removal or repositioning of the implant device.

[0396] In some embodiments, the implant device 1302, including embodiments of the retention element having one or more tabs engageable with one or more recesses or openings, can be configured such that the ratchet or retention element is deflectable or deformable such that a surgeon or other user can disengage the one or more tabs from the one or more recesses or openings to move the fixation element from a second rotational position to or toward a first rotational position, e.g., to reposition the fixation element, retwist the LAA, or ot...

Claims

1. 1. A device for treating a left atrial appendage, comprising: a contact member configured to engage an internal tissue surface of the left atrial appendage and configured to rotate in at least a first direction from a first position to at least a second position so as to twist the left atrial appendage when the contact member is engaged with the internal tissue surface of the left atrial appendage; A device comprising an implant including a fixation element configured to move between a first position in which the fixation element is decoupled from the contact member and a second position in which the fixation element is coupled to the contact member.

2. The device of claim 1 , wherein the contact member is configured to rotate in at least the first direction from the first position to the second position when a torque is applied to the contact member.

3. 3. The device of claim 1, wherein the contact member is configured to rotate in at least the first direction from a first position to at least a second position to twist the left atrial appendage and reduce the size of the ostium of the left atrial appendage from a first size to a second size when the contact member engages an internal tissue surface or the left atrial appendage.

4. The device of claim 3 , wherein the implant is configured to inhibit the ostium of the left atrial appendage from enlarging back to the first size.

5. The device of any one of claims 1 to 4, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to its operative state.

6. 6. The device of claim 1, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the operable state of the fixation element, and the fixation element is configured to prevent rotation of contracted left atrium and / or tissue of the left atrial appendage as a result of the rotation of the contact member from the first position to the second position.

7. 7. The device of claim 1, wherein the contact member is configured to move between a first state and a second state, and wherein an outer dimension of the contact member is greater in the second state than in the first state.

8. The device of claim 7 , wherein the contact member is biased to remain in the second state after deployment into the left atrial appendage.

9. The device of any preceding claim, wherein the contact members are configured to have a fixed and unalterable size and shape.

10. 10. The device of any of claims 1-9, wherein the contact member is self-expandable such that the contact member automatically expands from the first state to the second state when a restraint is removed from the implant without further intervention from a user.

11. 11. The device of claim 1, wherein the contact member is configured to automatically move from the first state to the second state when a restraint is released from the contact member, and wherein the contact member is configured to engage a wall portion of the left atrial appendage when the contact member is in the second state and advanced into the left atrial appendage.

12. The device of any preceding claim, wherein the contact member has a plurality of tissue anchors on its outer surface.

13. 13. The device of claim 12, wherein the plurality of tissue anchors on or adjacent the outer surface of the contact member are configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second state.

14. The device of any one of claims 1 to 13, wherein the device is configured to cause tissue of the left atrium and / or the left atrial appendage to contract around the outer surface of the body portion of the implant when the contact member is rotated to the second position.

15. 15. The device of claim 14, wherein the fixation element is configured to engage the tissue contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction opposite the first direction.

16. A device according to any preceding claim, wherein in the operable position the fixing element is configured to at least inhibit the contact member from rotating back to the first position.

17. 17. The device of any one of claims 1 to 16, wherein the fixation element is configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixation element is embedded in a tissue surface surrounding an ostium of the left atrial appendage, the second direction being opposite to the first direction.

18. 18. The device of any preceding claim, wherein the fixation element is configured to at least expand from a first state to a second state, and wherein an outer dimension of the fixation element is greater in the second state than in the first state.

19. The device of any preceding claim, wherein the fixation element comprises a plurality of arms.

20. The device of any preceding claim, wherein the fixation element comprises a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts.

21. 21. The device of claim 1, wherein at least an end of each of the plurality of arms of the fixation element faces generally away from the contact member when the fixation element is in the first state and faces generally towards the contact member when the fixation element is in the second state.

22. 22. The device of any of claims 1 to 21, comprising a restraint configured to be axially movable relative to at least a portion of the fixation element from a first position in which the multiple arms of the fixation element are restrained by the restraint, to a second position in which the multiple arms of the fixation element are not restrained by the restraint.

23. 23. The device of any of claims 1-22, including a restraint configured to be axially movable relative to at least a portion of the fixation element between a first position in which the arms of the fixation element are restrained by a restraint and a second position in which the arms of the fixation element are not restrained by the restraint, the second axial position being closer to the first portion of the implant than the first axial position.

24. 24. The device of claim 23, wherein the restraint is configured to be axially movable relative to at least a portion of the fixation element from the second position in which the arms of the fixation element are not restrained by the restraint to the first position in which the arms of the fixation element are restrained by the restraint to facilitate repositioning and / or removal of the implant.

25. 25. The device of claim 23 or 24, comprising a threaded member configured to move the restraint from the first position to the second position by rotating the threaded member.

26. 26. The method of any one of claims 23 to 25, wherein the restraint is rotatable relative to the threaded member such that when the threaded member is rotated, the restraint is not forced to rotate.

27. The device of any preceding claim, wherein the fixation element has a helical shape and is configured to rotate around a body portion of the implant during the implantation procedure.

28. 28. The device of any of claims 1 to 27, wherein only a portion of the fixation element extends into the left atrium after deployment of the device, and all other portions of the device are internal to the left atrial appendage after deployment of the device.

29. 29. A device as claimed in any preceding claim, wherein the fixing element is movable between a first state in which the fixing element is free to rotate relative to the contact member and a second state in which the fixing element is rotationally locked to the contact member.

30. 30. The device of claim 29, wherein one of the fixation element and the contact member has the recess and the other of the fixation element and the contact member has the protrusion, such that the protrusion is spaced from the recess when the fixation element is in the first state and the protrusion engages with the recess when the fixation element is in the second state.

31. 31. The device of any preceding claim, further comprising a retaining element configured to selectively couple the fixation element to the contact member at any of a range of selectable distances when the fixation element is in the second position.

32. 32. The device of claim 31, wherein the retaining element includes a threaded shaft configured to threadably engage the contact member with the threaded shaft coupled to the fixation element.

33. 33. A device as described in any one of claims 31 to 32, wherein the retaining element is adjustable to move the fixing element between at least a first position and a second position, and wherein the fixing element is closer to the contact member when the retaining element is in the second position compared to when the retaining element is in the first position.

34. 34. The device of claim 33, wherein the retaining element comprises a threaded member, wherein rotation of the threaded member in a first direction moves the fixation element toward the contact member and rotation of the threaded member in a second direction moves the fixation element away from the contact member.

35. The device of any preceding claim, wherein the retention element is configured to slide at least axially over the inner core component of the delivery catheter.

36. A device according to any preceding claim, wherein the second position is at least a quarter of a revolution relative to the first position.

37. A device according to any preceding claim, wherein the second position is at least half a revolution relative to the first position.

38. A device according to any preceding claim, wherein the second position is from one-quarter of a revolution to one or more revolutions relative to the first position.

39. 39. The device of any of claims 1-38, comprising a catheter selectively coupled to the contact member and configured to apply a torque on the contact member to rotate the contact member from the first position until a threshold predetermined torque level is reached.

40. 40. The device of claim 39, wherein the threshold predetermined torque level is between 1.765 mN·m and 70.62 mN·m of torque.

41. 40. The device of claim 39, wherein the threshold predetermined torque level is between 3.531 mN·m and 35.31 mN·m of torque.

42. The device of any preceding claim, wherein no more than 10% of the total length of the deployed device extends into the left atrium after deployment of the device.

43. 1. A device for treating a left atrial appendage, comprising: A contact member; an implant including a fixation element coupled or coupleable with the contact member, the fixation element including a plurality of struts and a plurality of interconnections between adjacent struts of the plurality of struts; The device is configured such that the contact member rotates in at least a first direction from a first rotational position to a second rotational position 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.

44. 44. The device of claim 43, wherein the contact member is configured to move from at least a first condition to a second condition such that at least a portion of the contact member radially expands to engage a wall portion within the left atrial appendage.

45. 45. A device according to any one of claims 43 to 44, wherein the plurality of interconnects provide connection points between adjacent struts of the plurality of struts.

46. 46. ​​The device of any one of claims 43 to 45, wherein the plurality of struts comprises a plurality of pairs of struts, each pair of struts comprising two struts interconnected at a distal end of the strut.

47. the plurality of struts includes a first strut, a second strut, and a third strut; the second support pillar is located between the first support pillar and the third support pillar; the second strut is interconnected with the first strut at a distal end of the first and second struts; 47. The device of any one of claims 43 to 46, wherein the second strut is interconnected with the third strut at a central portion of the second and third struts.

48. 48. The device of any one of claims 43 to 47, wherein the implant further comprises a retention element coupled to the fixation element, the retention element configured to move the fixation element axially towards or away from the contact member or to hold the fixation element in a stationary position relative to the contact member.

49. 49. The device of any one of claims 43 to 48, wherein the fixation element is configured to prevent rotation of at least a portion of the left atrial appendage in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction.

50. 50. The device of any one of claims 43-49, wherein the contact member is self-expandable such that at least a portion of the contact member automatically expands from the first state to the second state when a restraint is removed from the contact member.

51. 51. The device of any one of claims 43 to 50, wherein the implant is collapsed when the implant is in the first state and expanded when the implant is in the second state such that the size of the implant is greater when the implant is in the second state than when the implant is in the first state.

52. The device of any one of claims 43 to 51, wherein the contact member is biased to remain in the second state after deployment into the left atrial appendage.

53. A device according to any one of claims 43 to 52, wherein the contact member is configured to rotate in a clockwise or counterclockwise direction.

54. 54. The device of any one of claims 43 to 53, wherein the device is configured to contract tissue of the left atrium and / or the left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second rotational position, and the fixation element is configured to engage the tissue contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in the second direction.

55. The device of any one of claims 43 to 54, wherein the fixation element comprises a plurality of tissue anchors configured to engage an interior wall of the heart adjacent the left atrial appendage.

56. 56. The device of any one of claims 43 to 55, wherein the fixation element has a helical shape and is configured to rotate about a body portion of the implant during the implantation procedure.

57. the implant is configured to rotate in a first direction from the first rotational position to the second rotational position; 57. The device of any one of claims 43 to 56, wherein the implant is configured to prevent rotation of the implant in a second direction after the implant is deployed, the second direction being opposite to the first direction.

58. The device of any one of claims 43 to 57, wherein the contact member has a plurality of tissue anchors on its outer surface.

59. 53. The device of claim 52, wherein the plurality of tissue anchors on the outer surface of the contact member are configured to engage an inner wall surface of the left atrial appendage after the contact member is moved to the second state.

60. 60. The device of any one of claims 43 to 59, wherein the implant includes a fixation element configured to engage a tissue portion of the heart adjacent the left atrial appendage.

61. 61. A device according to any one of claims 43 to 60, wherein the second rotational position is at least a quarter of a rotation relative to the first rotational position.

62. 62. A device according to any one of claims 43 to 61, wherein the second rotational position is at least half a rotation relative to the first rotational position.

63. 63. A device according to any one of claims 43 to 62, wherein the second rotational position is from one-quarter of a rotation to one or more rotations relative to the first rotational position.

64. 64. The device of any one of claims 43 to 63, comprising a catheter selectively coupled to the contact member and configured to apply a torque on the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached.

65. 65. The device of claim 64, wherein the threshold predetermined torque level is between 1.765 mN·m and 70.62 mN·m of torque.

66. 65. The device of claim 64, wherein the threshold predetermined torque level is between 3.531 mN·m and 35.31 mN·m of torque.

67. 67. The device of any one of claims 43 to 66, comprising a retention element configured to bias the fixation element toward a tissue wall of the LAA.

68. 68. The device of any one of claims 43 to 67, comprising a retaining element configured to bias the fixation element towards the contact member.

69. 69. The device of any one of claims 43 to 68, comprising a retaining element configured to couple the fixation element with the contact member.

70. 70. The device of claim 69, wherein the retaining element comprises a threaded shaft.

71. 71. The device of claim 70, wherein the device is configured such that rotation of the retaining element in a first direction moves the fixation element toward the contact member.

72. 72. A device according to any one of claims 43 to 71, wherein the contact member is configured to rotate in at least a first direction from a first rotational position to a second rotational position when a torque is applied to the contact member.

73. The device of any one of claims 43 to 72, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the operable state of the fixation element.

74. 74. The device of any one of claims 43 to 73, wherein the device is configured such that the contact member can be removed from the left atrial appendage after the fixation element is deployed to the operable state of the fixation element, and the fixation element is configured to prevent rotation of contracted left atrium and / or tissue of the left atrial appendage as a result of the rotation of the contact member from the first rotational position to the second rotational position.

75. 75. The device of any one of claims 43 to 74, wherein only a portion of the fixation element extends into the left atrium after deployment of the device, and all other portions of the device are internal to the left atrial appendage after deployment of the device.

76. 76. The device of any one of claims 43 to 75, wherein no more than 10% of the total length of the deployed device extends into the left atrium after deployment of the device.

77. The device of any one of claims 43 to 76, wherein the device is configured for use with a surgical robotic device or system.

78. 10. A surgical robotic device comprising: one or more robotic arms; and a device according to any one of claims 43 to 77, wherein the device according to any one of claims 43 to 77 is configured for use by the surgical robotic device.

79. A device according to any one of claims 43 to 78, wherein the contact member and the fixation element are integrally and / or monolithically formed.

80. 80. The device of any one of claims 43 to 79, wherein the device is configured to contract tissue of the left atrium and / or the left atrial appendage around an outer surface of the body portion of the implant when the contact member is rotated to the second rotational position, and the fixation element is configured to compress the contracted tissue around the outer surface of the body portion of the implant between the distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction.

81. The device of any preceding claim, wherein the tissue anchor of the contact member has a proximally facing surface angled at 5 degrees toward the proximal end of the contact member.

82. 81. The device of any preceding claim, wherein the tissue anchor of the contact member has a proximally-facing surface that is angled toward the proximal end of the contact member at an angle of between 2 degrees and 10 degrees.

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