Devices, systems and methods for occluding cavities within body

Abstract

To provide embodiments of a device for closing or occluding a cavity or opening within a body.SOLUTION: Some embodiments of the device can include an implant configured to be deployed within the cavity, configured to be expanded or moved against a wall portion of the cavity, and configured to twist at least a portion of the cavity when the implant is rotated. Thereafter, a securing element, staple, suture, or other fastener can be implanted in the gathered tissue to hold the tissue in the gathered state, thereby occluding the opening of the cavity. The implant can remain in the cavity or be removed.SELECTED DRAWING: Figure 2E

Description

[Technical Field]

[0001] Priority Claims and Incorporation by Reference This application claims priority to U.S. patent application Ser. No. 62 / 994,240, filed March 24, 2020, entitled DEVICES, SYSTEMS AND METHODS FOR OCCLUDING CAVITIES WITHIN THE BODY, the contents of which are incorporated herein by reference in their entirety as if fully set forth herein. The benefit of priority may be claimed under any appropriate legal basis, including, but not limited to, 35 U.S.C. § 119(e).

[0002] SUMMARY OF THE INVENTION Embodiments of the present disclosure relate to devices, apparatus, and methods for closing or occluding a cavity within a body. [Background technology]

[0003] Current methods and devices for treating wounds in remote and emergency situations are limited and have drawbacks. For example, wounds on the battlefield can be difficult and time-consuming to close. There is a need for faster and more effective wound closure devices and methods for use in emergency situations, remote locations where medical assistance is difficult to obtain, and even battlefield situations.

[0004] Mitral valve regurgitation is becoming increasingly prevalent. Mitral valve regurgitation is often due to flail leaflets, ruptured chordae, or annular dilation, often referred to as type I or type II mitral valve disease. Mitral valve repair can be performed to treat mitral valve diseases, including mitral regurgitation. In some cases, mitral valve repair surgery includes implantation of annuloplasty rings, medullary repair or plication, and possible removal of excess valve tissue so that the leaflets can coapt and close completely without regurgitation. Existing devices and methods for mitral valve repair require highly competent cardiac surgeons. Many cardiac surgeons lack this advanced training and experience with such devices or techniques, making mitral valve repair extremely difficult for many surgeons to perform.

[0005] Weight loss surgery is used to slow digestion, reduce weight, lower the risk of diabetes, and lower the risk of death in obese patients. Restrictive surgery is a form of weight loss surgery that reduces the size of the stomach. One example is the LapBand device manufactured by ReShape Lifesciences. Summary of the Invention

[0006] 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.

[0007] Some embodiments of the devices for reshaping, closing, or occluding a cavity in a body 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, near, or adjacent to the cavity 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 cavity after the implant has advanced into, near, or adjacent to the cavity; and when the implant is in the second state, the implant may be configured to twist at least a portion of the cavity, or tissue near or adjacent to the cavity, when the implant is rotated from the first rotational position to the second rotational position. In any of the embodiments disclosed herein, the twisting movement or step can be achieved by a torque catheter.

[0008] Some embodiments of the devices for reshaping, closing, or occluding a wound disclosed herein may include an implant including a contact member and a fixation element configured to move between a first state and a second state.Any embodiment of the device disclosed herein for reforming, closing, or occluding a wound may, in further embodiments, include one or more of the following features or details, in any combination: the contact member is configured to move from a first state to a second state such that at least a portion of the contact member engages a wall portion of the wound cavity after the contact member is advanced into the cavity; the contact member is configured to rotate in at least a first direction from a first rotational position (also referred to as the first position) to a second rotational position (also referred to as the second position); the contact member is configured to twist at least a portion of the wall portion of the wound cavity in the first direction and pull at least the first portion of the wall portion of the cavity toward the second portion of the wall portion of the cavity when the contact member is rotated from the first rotational position to the second rotational position; the fixation element is configured to prevent rotation of the wall portion of the wound cavity in the second direction when the fixation element is in an operable state, the second direction being opposite to the first direction; and the contact member is configured to twist at least a portion of the wall portion of the wound cavity toward the second portion of the wall portion of the cavity when the fixation element is in an operable state such that at least a portion of the wall portion of the contact member engages the wall portion of the wound cavity when the restraint is removed from the contact member. the device is self-expandable so as to automatically expand from a first state to a second state, the contact member is biased to remain in the second state after being deployed within the wound cavity, the contact member is configured to be removable from the cavity after the fixation element is implanted over the cavity, the contact member is configured to rotate clockwise or counterclockwise, the device is configured to contract tissue of the wound cavity around an outer surface of the body portion of the device when the contact member is rotated to the second rotational position, the fixation element is configured to engage tissue of the cavity contracted around the outer surface of the body portion of the device or tissue adjacent to the cavity to prevent rotation of the implant and / or tissue in the second direction, the fixation element has a plurality of tissue anchors configured to engage a portion of the tissue of the cavity contracted around the outer surface of the body portion of the device or tissue adjacent to the cavity to prevent rotation of the implant and / or tissue in the second direction, and / or the fixation element has a helical shape and is configured to rotate around the body portion of the implant during the implantation procedure.

[0009] Any embodiment of the device disclosed herein for reshaping, closing, or occluding a wound may, in further embodiments, include one or more of the following features or details, in any combination: the implant is configured to rotate in a first direction from a first rotational position to a second rotational position, the implant being configured to prevent the implant from rotating 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 being configured to engage an inner wall surface of the cavity after the contact member is moved to the second state, the second rotational position being approximately one-quarter of a rotation to one or more full rotations relative to the first rotational position; and further including a retention member configured to bias the fixation element toward the contact member. and a retaining member configured to couple the fixation element to the contact member, the retaining member configured to couple the fixation element to the contact member, the retaining member having a threaded shaft, 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 to allow the contact member to be removed from the cavity after the fixation element is deployed to its operative state, the fixation element configured to prevent rotation of the implant in the second direction when the fixation element is in its operative state after the contact member is removed, only a portion of the fixation element extends out of the cavity after deployment of the device and all other portions of the device are within the cavity after deployment of the device, and / or only approximately 10% or less of the total length of the deployed device extends out of the cavity after deployment of the device.

[0010] Some embodiments of devices for reshaping, closing, or occluding a cavity disclosed herein can 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 cavity when the contact member is in the first state and move the contact member from the first state to the second state after the contact member has advanced into the cavity such that an outer surface of the contact member expands against an inner wall surface of the cavity. Any embodiment of the device disclosed herein for reforming, closing, or occluding a cavity may, in further embodiments, include one or more of the following features or details, in any combination: the catheter is 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 cavity; the contact member is configured to move from a first state to a second state such that at least a portion of the contact member engages a wall portion of the cavity after the contact member advances into the cavity; the contact member is configured to rotate in at least a first direction from the first rotational position to the second rotational position; and the contact member is configured to twist at least a portion of the wall portion of the cavity when the contact member is rotated from the first rotational position to the second rotational position. the contact member is configured to twist at least a portion of the wall portion of the cavity in a first direction and pull at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; the fixation element is configured to prevent rotation of the wall portion of the cavity in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction; 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; the contact member is biased to remain in the second state after deployment into the cavity; the contact member is configured to be removable from the cavity after the fixation element is implanted over the cavity; the contact member is configured to rotate clockwise or counterclockwise; and the device is configured to contract tissue of the cavity around an outer surface of the body portion of the device when the contact member is rotated to the second rotational position;a fixation element configured to engage tissue of the cavity contracted around the outer surface of the body portion of the device or tissue adjacent to the cavity to prevent rotation of the implant and / or tissue in a second direction, the fixation element having a plurality of tissue anchors configured to engage a portion of tissue of the cavity contracted around the outer surface of the body portion of the device or tissue adjacent to the cavity to prevent rotation of the implant and / or tissue in the second direction, and / or the fixation element having a helical shape and configured to rotate around the body portion of the implant during the implantation procedure;

[0011] Any embodiment of the device disclosed herein for reforming, closing, or occluding a cavity may, in further embodiments, include one or more of the following features or details, in any combination: the implant is configured to rotate in a first direction from a first rotational position to a second rotational position, the implant is configured to prevent the implant from rotating in the second direction after the implant is fully deployed, the second direction being opposite to the first direction; the contact member has a plurality of tissue anchors on its outer surface, the plurality of tissue anchors on the outer surface of the contact member configured to engage an inner wall surface of the cavity after the contact member is moved to the second state, the second rotational position being approximately one-quarter of a rotation to one or more full rotations relative to the first rotational position; and further including a retention member configured to bias the fixation element toward the contact member. and a retaining member configured to couple the fixation element to the contact member, the retaining member configured to couple the fixation element to the contact member, the retaining member having a threaded shaft, 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 to allow the contact member to be removed from the cavity after the fixation element is deployed to its operative state, the fixation element configured to prevent rotation of the implant in the second direction when the fixation element is in its operative state after the contact member is removed, only a portion of the fixation element extends out of the cavity after deployment of the device and all other portions of the device are within the cavity after deployment of the device, and / or only approximately 10% or less of the total length of the deployed device extends out of the cavity after deployment of the device.

[0012] Some embodiments of the methods for reforming, closing, or occluding a cavity disclosed herein include advancing a deployment device having an implant into the cavity, the implant being configured to move from a first state to a second state such that at least a portion of the implant is 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 cavity so as to move at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the outer surface of the implant, against an inner wall surface of the cavity; rotating the implant from a first rotational position to a second rotational position to twist the cavity and / or prevent the implant from rotating back to the first rotational position.

[0013] Any embodiment of the method disclosed herein for reforming, closing, or occluding a cavity may, in further embodiments, include one or more of the following steps, features, or details, in any combination, wherein the implant is self-expanding; moving the implant from the first state to the second state includes advancing the implant from a distal end of a deployment device; engaging a wall portion inside the cavity includes engaging the wall portion inside the cavity with one or more tissue anchors disposed on an exterior surface of the implant; preventing the implant from rotating back to the first rotated 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 rotated position includes engaging the tissue wall with the anchor elements, the anchor elements configured to be secured to the implant to prevent rotation between the implant and the anchor elements; and preventing the implant from rotating back to the first rotated position includes engaging a tissue surface adjacent the cavity with the anchor elements. the anchor element is rotatably fixed relative to the implant and configured to prevent the implant from rotating back to the first rotated position, preventing the implant from rotating back to the first rotated position comprises engaging a tissue surface adjacent the cavity outside a closed portion of the cavity with the anchor element, the anchor element is rotatably fixed relative to the implant and configured to prevent the implant from rotating back to the first rotated position, the anchor element having a plurality of tissue anchors on at least one surface thereof configured to engage tissue outside the cavity, rotating the implant from the first rotated position to the second rotated position to twist the cavity comprises rotating the implant until an opening of the cavity is substantially or completely closed, and / or the cavity is a gastric cavity, the method further comprising advancing a contact member to contact a wall of the stomach, creating an indentation in the wall of the stomach, twisting the contact member, and / or further advancing to create a secondary cavity in the wall of the stomach, and closing the secondary cavity by twisting the contact member until the opening of the secondary cavity is folded around a portion of the implant.

[0014] Any embodiment of the method disclosed herein for reforming, closing, or occluding a cavity may, in further embodiments, include one or more of the following steps, features, or details, in any combination: the cavity is an intra-costal space of the mitral valve; and the method of occluding a space within the costal space of the mitral valve, wherein rotating the implant from a first rotational position to a second rotational position to twist the cavity includes rotating the implant at least approximately 180 degrees in either direction from the first rotational position; and rotating the implant from the first rotational position to the second rotational position to twist the cavity includes rotating the implant at least approximately 90 degrees in either direction from the first rotational position. and rotating the implant 360 degrees from the first rotational position to the second rotational position to twist the cavity, 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 fixing the implant at approximately the second rotational position against the tissue surface surrounding the cavity, wherein the maximum predetermined torque level is between approximately 0.25 in. of torque and approximately 50 in. of torque, and / or the maximum predetermined torque level is between approximately 5 in. of torque and approximately 25 in. of torque.

[0015] Some embodiments of the implants for deployment within a cavity or vessel disclosed herein can include an expandable body, a plurality of tissue anchors on an exterior surface of the expandable body configured to engage an interior wall surface of the cavity or vessel, and a fixation element coupled to the expandable body configured to engage a tissue surface adjacent to the interior wall surface of the cavity or vessel.

[0016] Some embodiments of devices for reshaping, closing, or occluding a cavity disclosed herein may include an expandable implant having a plurality of tissue anchors on an outer surface of a portion thereof, 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 cavity when the implant is in the first state and selectively move the implant from the first state to the second state such that at least some of the plurality of tissue anchors engage an inner wall surface of the cavity after the implant is advanced into the cavity, 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 through the cavity.

[0017] Some embodiments of devices for reforming, closing, or occluding a cavity 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 cavity 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 cavity after the implant is advanced into the cavity, 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 cavity when the implant is in the second state.

[0018] Some embodiments of the methods of reforming, closing, or occluding a cavity disclosed herein include advancing a deployment device having an implant into the cavity, the implant configured to move from a first state to a second state such that at least a portion of the implant is radially larger 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 cavity to move at least a portion of the implant against a portion of an inner wall surface of the cavity; rotating the implant from a first rotational position to a second rotational position to twist the cavity and draw tissue in the cavity together; holding the drawn tissue with fixation elements to hold the tissue together; and rotating the implant or allowing the implant to rotate back toward the first rotational position while continuing to hold the drawn tissue with the fixation elements. In any embodiment, moving the implant from a first state to a second state within the cavity so as to move at least a portion of the implant relative to a portion of the inner wall surface of the cavity includes moving at least a portion of the outer wall of the implant and / or one or more tissue anchors extending away from the outer surface of the implant relative to the inner wall surface of the cavity.

[0019] Also, some embodiments of devices for drawing a first tissue surface toward a second tissue surface disclosed herein include 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 is 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, any embodiment of the device disclosed herein for pulling a first tissue surface toward a second tissue surface may, in further embodiments, include one or more of the following features or details, in any combination, wherein the device is configured to occlude or close a body cavity having a first tissue surface and a second tissue surface, the first and second tissue surfaces being tissue surfaces within any cavity within the body, and / or wherein rotation of the contact member causes a proximal portion of the second tissue surface to twist and move toward the proximal portion of the first tissue surface.

[0020] Disclosed herein are embodiments of devices and systems for treating a cavity within a body that may include an implant including a contact member configured to move between a first state and a second state and a fixation element, the contact member 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 cavity after the contact member advances into the cavity, the contact member configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member configured to twist at least a portion of the cavity when the contact member rotates from the first rotational position to the second rotational position, and the fixation element configured to prevent rotation of the implant in a second direction when the fixation element is in an operable state, the second direction being opposite to the first direction.

[0021] Also disclosed herein are embodiments of devices and systems for treating a cavity in a body 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 cavity 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 cavity after the implant is advanced into the cavity, 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 cavity when the implant is in the second state.

[0022] 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 is 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. Further, in any device and / or system embodiment disclosed herein, the device may be configured to occlude or close a body cavity having a first tissue surface and a second tissue surface, where the first and second tissue surfaces may be tissue surfaces within any body cavity, and / or rotation of the contact member further causes a proximal portion of the second tissue surface to twist and move toward the proximal portion of the first tissue surface.

[0023] Any of the embodiments of the devices and systems disclosed herein can, in further embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein: the implant is self-expandable such that the implant automatically expands from a first state to a second state when the restraint is removed from the implant; the contact members are self-expandable such that at least a portion of the contact members automatically expand from the first state to the second state when the restraint is removed from the contact members; 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 members are biased to remain in the second state after deployment into the cavities; the contact members are configured to rotate clockwise or counterclockwise; and the device expands the set of cavities when the contact members are rotated to the second rotational position. the implant is configured to contract tissue around an outer surface of the body portion of the implant, the fixation element is configured to engage tissue contracted around the outer surface of the body portion of the implant to prevent rotation of the implant in a second direction, the fixation element has a plurality of tissue anchors configured to engage an inner wall of the cavity or an adjacent space, the fixation element has a helical shape and is configured to rotate around the body portion of the implant during an implantation procedure, the implant is configured to rotate in a first direction from a first rotational position to a second rotational position, the implant is configured to prevent rotation of the implant in the second direction after the implant is fully deployed, the second direction being opposite to the first direction, the contact member has a plurality of tissue anchors on its outer surface, the plurality of tissue anchors on the outer surface of the contact member are configured to engage an inner wall surface of the cavity after the contact member is moved to the second state, the implant includes a fixation element configured to engage tissue portions outside of the cavity or an adjacent space, the second rotational position is at least one-quarter of a rotation relative to the first rotational position,The second rotational position is at least half a revolution relative to the first rotational position, and / or the second rotational position is from approximately one-quarter of a revolution to one or more full revolutions relative to the first rotational position.

[0024] Additionally, any of the embodiments of the devices and systems disclosed herein can, in further embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein, further including a catheter selectively coupled to the contact member and applying a torque on the contact member to rotate the contact member from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being between approximately 0.25 in-oz and approximately 10 in-oz of torque, the threshold predetermined torque level being between approximately 0.a torque of between 5 in-oz and approximately 5 in-oz, further including a retaining member configured to urge the fixation element toward the tissue wall of the cavity, further including a retaining member configured to urge the fixation element toward the contact member, further including a retaining member configured to couple the fixation element to the contact member, the retaining member including a threaded shaft, the device configured such that rotation of the retaining member in a first direction moves the fixation element toward the contact member, the contact member configured to rotate in at least a first direction from a first rotational position to a second rotational position when torque is applied to the contact member, the device configured such that the contact member can be removed from the cavity 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 cavity after the fixation element is deployed to an operative state of the fixation element, and the fixation element prevents rotation of tissue of the cavity that has contracted as a result of rotation of the contact member from the first rotational position to the second rotational position. the contact member and the fixation element are integrally and / or integrally formed, the device is configured to contract tissue of the cavity 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 a distal surface of the fixation element and the contact member to prevent rotation of the implant in the second direction.

[0025] Some embodiments of the devices and systems for closing or occluding a cavity 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 cavity when the implant is in the first state, wherein the implant may be configured to move from the first state to the second state such that at least a portion of the implant engages a wall portion of the cavity after being advanced into the cavity, and wherein the implant may be configured to twist at least a portion of the cavity when the implant is in the second state as the implant is rotated from a first rotational position to a second rotational position. In any of the embodiments disclosed herein, the twisting movement or step can be achieved by a torque catheter.

[0026] Any embodiment of the devices and systems disclosed herein may, in further embodiments, include one or more of the following features or details, in any combination: the implant is configured to automatically rotate from a first rotational position to a second rotational position after the implant is in the second state; the implant may be configured to be triggered or activated and then automatically rotate from the first rotational position to the second rotational position; the device has a spring coupled with the implant, the spring configured to automatically rotate the implant when the spring is released or activated; the implant is self-expandable such that the implant automatically expands from the first state to the second state when the restraint is removed from the implant; the implant is self-expandable such that at least a portion of the implant automatically expands from the first state to the second state when the implant is advanced past the distal end of the outer sleeve of the catheter; the implant is substantially collapsed when the implant is in the first state; the implant may be deployed when in the second state such that it may be larger in the second state than when in the first state, and after deployment into the cavity 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 inner wall of an outer or adjacent space of the cavity; the implant may include a fixation element configured to engage with an inner wall of an outer or adjacent space of the cavity; the fixation element has a helical shape and is configured to rotate about a body portion of the implant during the implantation procedure; the implant may include a cork screw shaped fixation element configured to engage with an inner wall of an outer or adjacent space of the cavity; the implant may include a fixation element having a cork screw tissue anchor for engaging with the inner wall of the cavity and / or the inner wall of the outer or adjacent space of the cavity; the implant may include a fixation element having a plurality of tissue anchors configured to engage with an inner wall of an adjacent space and / or the inner wall of the cavity;The implant may be configured to prevent rotation of the implant back to the first rotational position after it is fully deployed, the implant may be configured to rotate from the first rotational position to a second rotational position in a first direction, and the implant may be configured to prevent rotation of the implant in a second direction after it is fully deployed, the second direction being opposite the first direction.

[0027] Any embodiment of the devices and systems disclosed herein may, in further embodiments, include one or more of the following features or details, in any combination: the implant 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 cavity after the implant is moved to the second state; the implant may include a fixation element configured to engage a tissue portion of an area outside or adjacent to the cavity; the second rotational position may be at or about a quarter of a rotation (i.e., 90 degrees or about 90 degrees) relative to the first rotational position; and the second rotational position may be at or about half of a rotation (i.e., 1 / 2 of a rotation) relative to the first rotational position. , or approximately 180 degrees), and the second rotational position can be from at or approximately a quarter of a rotation (i.e., at or approximately 90 degrees) to one or more full rotations or approximately one or more full rotations (i.e., at or approximately 360 degrees) relative to the first rotational position, and the catheter can be configured to exert a torque on the implant to rotate the implant from the first rotational position until a threshold predetermined torque level is reached, the threshold predetermined torque level being from at or approximately 0.25 in-oz of torque to 10 or approximately 10 in-oz of torque, and / or the threshold predetermined torque level being from 0.5 or approximately 0.5 in-oz of torque to 5 or approximately 5 in-oz of torque.

[0028] 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 cavity when the contact member is in the first state and move the contact member from the first state to the second state such that an outer surface of the contact member expands against an inner wall surface of the cavity after the contact member has advanced into the cavity, 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 cavity.

[0029] 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 cavity 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 cavity such that an outer surface of the implant expands against at least a portion of an inner wall surface of the cavity. In any embodiment of the device for closing or occluding a cavity 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 cavity until a predetermined torque level is reached, or in some embodiments, until a user determines to stop, whichever occurs first.

[0030] Also disclosed herein are devices and systems for treating a cavity, including a device configured to be inserted into the cavity and engage cavity tissue while the device is rotated to a rotated position to close blood communication between the cavity and an adjacent space. In any embodiment of the device, the device may be configured to be selectively lockable in a rotated position to at least substantially maintain the device in the rotated position after implantation, the device may include a fixation element configured to engage a tissue surface adjacent the cavity 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 cavity, 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.

[0031] Disclosed herein are embodiments of methods for treating a cavity, including engaging tissue of the cavity and rotating the tissue of the cavity to close or occlude blood communication between the cavity and a space adjacent to or outside the cavity. In any embodiment of the methods disclosed herein, rotating the tissue of the cavity to close or occlude blood communication between the cavity and a space adjacent to or outside the cavity can include rotating the tissue of the cavity to close or occlude an opening (also called an ostium) of the cavity. Additionally, any embodiment of the methods disclosed herein can further include fixing the cavity in a rotated position to maintain the cavity in a closed or occluded state.

[0032] Any embodiment of the method of closing or occluding a cavity disclosed herein can include advancing a deployment device having an implant into the cavity, 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 cavity 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, relative to at least a portion of the inner wall surface of the cavity; rotating the implant from the first rotational position to a second rotational position to twist the cavity; and preventing the implant from rotating to the first rotational position.

[0033] Any embodiment of the method of closing or occluding a cavity 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 the first state to the second state includes advancing the implant out of the distal end of the deployment device; engaging a wall portion on the interior of the cavity includes engaging the wall portion on the interior of the cavity with one or more tissue anchors located on an exterior surface of the implant; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with anchor elements to prevent relative movement between the implant and the tissue wall; preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with anchor elements, the anchor elements configured to be secured to the implant to prevent rotation between the implant and the anchor elements; and preventing the implant from rotating back to the first rotational position includes engaging the tissue wall with the anchor elements. preventing the implant from rotating back to the first rotational position comprises engaging tissue outside the closed portion of the cavity 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; preventing the implant from rotating back to the first rotational position comprises engaging tissue outside the closed portion of the cavity 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 comprises a plurality of tissue anchors on at least one surface thereof configured to engage with an inner wall of the outer or adjacent space of the cavity and / or tissue of the cavity; rotating the implant from the first rotational position to the second rotational position to twist the cavity comprises rotating the implant until the opening of the cavity is substantially or completely closed; rotating the implant from the first rotational position to the second rotational position to twist the cavity comprises rotating the implant at least approximately 90 degrees in either direction from the first rotational position;Rotating the implant from the first rotational position to the second rotational position to twist the cavity includes rotating at least approximately 180 degrees in either direction from the first rotational position; rotating the implant from the first rotational position to the second rotational position to twist the cavity includes rotating the implant from approximately 90 degrees to approximately 360 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 cavity includes rotating the implant from approximately 90 degrees to approximately 180 degrees in either direction from the first rotational position. wherein rotating the implant from the first rotational position to the second rotational position to twist the cavity 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 at about the second rotational position against a tissue surface surrounding the cavity, wherein the maximum predetermined torque level is between about 0.25 in-oz and about 10 in-oz of torque and / or the maximum predetermined torque level is between about 0.5 in-oz and about 5 in-oz of torque.

[0034] Any embodiment of the method of closing or occluding a cavity disclosed herein may, in some additional embodiments, include one or more of the following steps, in any combination, and in any combination with any other step, function, or other detail 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 cavity can include engaging at least a portion of the wall portion on the interior of the cavity or surrounding the cavity with one or more tissue anchors positioned on an exterior surface of the implant; preventing the implant from rotating back to the first rotational position can include engaging the tissue wall with an anchor element outside the cavity, the anchor element may be rotationally fixed to the implant to prevent relative movement between the anchor element and the implant; preventing the implant from rotating back to the first rotational position can include engaging a tissue wall of the cavity and / or a space outside or adjacent the cavity with an anchor element, which may be rotationally fixed relative to the implant and configured to prevent the implant from rotating back to the first rotational position; preventing the implant from rotating back to the first rotational position can include engaging an inner wall of the space outside the cavity with the 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 an inner wall of the space outside or adjacent the cavity; and / or rotating the implant from the first rotational position to the second rotational position to twist the cavity can include rotating the implant until the opening of the cavity is substantially or completely closed or occluded or folded around the outer surface of the implant.

[0035] Any embodiment of the method of closing or occluding a cavity disclosed herein may, in any additional embodiment, include one or more of the following steps, in any combination, and in any combination with any other step, feature, or other detail of any other embodiment: rotating the implant from a first rotational position to a second rotational position to twist the cavity includes 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 the second rotational position to twist the cavity includes rotating the implant at least or approximately one-half of a rotation (i.e., 180 degrees or approximately 180 degrees) in either direction from the first rotational position; and rotating the implant from the first rotational position to the second rotational position to twist the cavity includes rotating the implant from one-quarter of a rotation (i.e., 90 degrees or approximately 90 degrees) to one or approximately one rotation (i.e., 360 degrees or approximately 360 degrees), or more than one rotation. (i.e., more than 360 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 cavity includes rotating the implant from the first rotational position at or about a quarter of a turn (i.e., at or about 90 degrees) to at or about half of a turn (i.e., at or about 180 degrees), or more than a full turn (i.e., more than 360 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 cavity. twisting the cavity can include exerting a torque on the implant to rotate the implant in either direction from a 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 cavity can include holding the implant in the second rotational position, and rotating the implant from the first rotational position to the second rotational position to twist the cavity can include fixing the implant in approximately the second rotational position relative to a tissue surface surrounding the cavity, the maximum predetermined torque level being approximately 0.25 in-oz to approximately 10 in-oz of torque and / or a maximum predetermined torque level of approximately 0.5 in-oz to approximately 5 in-oz of torque.

[0036] 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.

[0037] Any embodiment of the devices and systems disclosed herein can include an expandable implant having a plurality of tissue anchors on an exterior surface thereof, 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 cavity 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 cavity such that at least a portion of the plurality of tissue anchors engage an inner wall surface of the cavity. 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 cavity.

[0038] Some embodiments of the devices and systems for closing or occluding a cavity 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 cavity 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 cavity such that an outer surface of the implant moves against an inner wall surface of an inner wall of the cavity. 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 through at least a portion of the cavity.

[0039] Any embodiment of the method of treating a cavity disclosed herein can include engaging tissue of the cavity and rotating the tissue of the cavity to close, significantly close, inhibit, or substantially inhibit blood communication between the cavity and a space adjacent to or outside the cavity. Any embodiment of the method disclosed herein can, in further embodiments, include one or more of the following features, components, steps, and / or details, in any combination with any of the other features, components, steps, and / or details of any other treatment method embodiment disclosed herein, further including rotating the tissue of the cavity to close blood communication between the cavity and a space adjacent to or outside the cavity to rotate the tissue of the cavity to close an opening of the cavity, and / or further including fixing the cavity in a rotated position to hold the cavity closed.

[0040] Some embodiments of the apparatus for treating a cavity disclosed herein may include a device configured to be inserted into the cavity and engage cavity tissue while the device is rotated to a rotated position to close blood communication between the cavity and a space adjacent to or outside the cavity. 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 cavity 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 cavity, the device is expandable from a first collapsed state to a second expanded state, and / or the device is capable of self-expanding from the first collapsed state to the second expanded state.

[0040] Disclosed herein are embodiments of a device for treating a cavity, including an implant having a contact member and a catheter configured to advance the contact member into the cavity and move the contact member relative to an inner wall surface of the cavity, wherein the catheter is 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 cavity. In any of the embodiments disclosed herein, the contact member can be configured to move relative to the inner wall surface of the cavity 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.

[0041] Disclosed herein are embodiments of a device for reducing an opening of a cavity, including a contact member and a fixation element, wherein the contact member is configured to engage a tissue surface of the cavity, the contact member is configured to rotate at least a portion of the cavity in a first direction from a first rotational position to a second rotational position, reducing the opening of the cavity 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 cavity and prevent the opening of the cavity from expanding to the first size. In any embodiment disclosed herein, the contact member can be configured to engage a tissue surface on an exterior surface of the cavity. Furthermore, in any embodiment disclosed herein, the contact member can be configured to engage the tissue surface of the cavity without changing the state or shape of the contact member.

[0042] Also disclosed herein are additional embodiments of closure or occlusion devices for cavities. In any embodiment disclosed herein, the device can include a delivery catheter and an implant advanceable through the delivery catheter when the implant is in a first state, the implant having a first expandable portion and a second expandable portion, the first and second expandable portions of the implant each independently expandable to a second state, and the implant configured to block an opening of the cavity when the first and second expandable portions of the implant are in the second state.

[0043] Any of the embodiments of the devices and systems disclosed herein can, in further embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein: the first expandable portion is a distal portion of the implant, the second expandable portion is a proximal portion of the implant, a removable restraint that surrounds only the proximal portion of the implant when the implant is in a pre-deployed state, at least one of the first and second expandable portions is self-expanding, the implant can be configured such that the first expandable portion is expanded before the second expandable portion is expanded, and / or further include any of the features, components, and / or details of any implant embodiment disclosed herein.

[0044] Disclosed herein are additional embodiments of a closure or occlusion device for a cavity, including an implant selectively expandable from a first state to a second state and a cover coupled to the implant, wherein when the implant is in the second state, the implant may be configured to expand against a wall of the opening of the cavity, the size of the implant is larger when in the second state than when in the first state, at least a portion of the cover is positioned adjacent an exterior surface of the implant and selectively movable between at least the first and second states, and when the cover is in the second state, the cover may be configured to have a plurality of folds or wrinkles in a portion of the cover adjacent the exterior surface of the implant, and the implant may be configured to block the opening of the cavity when the implant is in the second state.

[0045] Any embodiment of the device disclosed herein can, in further embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein; wherein the cover can be configured such that when the implant and the cover are in the second state, at least one or more of the plurality of folds or wrinkles are positioned between an exterior surface of at least a portion of the implant and at least a portion of a wall of the opening of the cavity; further comprising a pull wire coupled with the cover and configured to move the cover from the first state to the second state upon withdrawal of the pull wire; and / or the implant is also selectively retractable from the second state to the first state.

[0046] Any of the embodiments of the device disclosed herein can, in further embodiments, include one or more of the following features, components, and / or details, in any combination with any of the other features, components, and / or details of any other embodiment disclosed herein, wherein the 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, and wherein the first stage portion is configured to be positioned near a distal end of the cavity, and wherein the second stage portion is configured to extend beyond the second stage portion. the second stage portion is configured to constrict the cavity opening when the second stage portion is in the second state, the second stage portion is configured to close the cavity opening 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 cavity opening 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 cavity opening to constrict or close the cavity opening when the second stage portion is in the second state, the second stage portion includes a means for constricting or closing the cavity opening, the second stage portion includes a hinge mechanism for constricting or closing the cavity opening, and further includes 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.

[0047] Disclosed herein are embodiments of methods for contracting, occluding, closing, or otherwise treating a cavity (collectively hereinafter referred to as treatment methods). Any of these method embodiments can be used to deploy or implant any of the implant or device embodiments disclosed herein. Any of the method embodiments disclosed herein can include advancing a delivery catheter having an implant coupled thereto outside or within a space adjacent to the cavity, advancing a distal tip of the delivery catheter near an opening of the cavity, and / or advancing the cavity in a first direction by at least expanding the implant in the first direction such that the ratio of the size of the cavity opening in the first direction to the size of the cavity opening in a second direction perpendicular to the first direction is at least 2 to 1. The method can also include withdrawing the delivery catheter with the implant positioned within the cavity.

[0048] Any embodiment of the method disclosed herein may, in further embodiments, include one or more of the following features, components, steps, and / or details, in any combination with any of the other features, components, steps, and / or details of any other embodiment disclosed herein: actuating a portion of the implant to reduce a size of the cavity opening adjacent to the cavity opening comprises folding tissue surrounding the cavity opening to reduce the size of the cavity opening; actuating the portion of the implant to reduce the size of the cavity opening comprises folding tissue surrounding the cavity opening to close the cavity opening; actuating the portion of the implant to reduce the size of the cavity opening comprises straightening the cavity opening; actuating the portion of the implant to reduce the size of the cavity opening comprises stretching the cavity opening; twisting one or more portions of tissue surrounding the cavity opening to contract or close the cavity opening when the second stage portion is in the second state; after positioning the implant to achieve bidirectional apposition, activating at least a portion of the implant to close the cavity opening; activating a means for folding a portion of the tissue to fold the tissue surrounding the cavity opening to reduce the size of the cavity opening; activating a tissue folding mechanism of the implant to fold the tissue surrounding the cavity opening to close the cavity opening; after assessing the cavity opening, reversing the tissue folding mechanism and reactivating the tissue folding mechanism of the implant to fold the tissue surrounding the cavity opening to close the cavity opening; assessing the position and / or orientation of the implant, contracting at least a portion of the implant, and repositioning at least a portion of the implant relative to the cavity; after assessing the position and / or orientation of the implant, contracting a first stage portion of the implant and repositioning at least a portion of the implant relative to the cavity, expanding the first stage portion of the implant to an at least partially expanded state; recapturing all or a portion of the implant, and repositioning the implant;Expanding the distal portion of the implant to the at least partially expanded state includes advancing the distal portion of the implant beyond the distal tip of the deployment catheter, and / or at least the distal portion of the implant is self-expanding.

[0049] Disclosed herein are additional embodiments of methods of treatment that include advancing a deployment device having an implant into a cavity, moving at least a portion of the exterior surface of the implant, or one or more tissue anchors extending away from the outer surface of the implant, relative to an inner wall surface of the cavity, rotating the implant from a first rotational position to a second rotational position to twist the cavity, 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 outer surface of the implant, relative to the inner wall surface of the cavity 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.

[0050] Additionally, any implant and / or device or system embodiment disclosed herein may be adapted and / or used for treating any tissue condition within the body that is desired to be occluded, restricted, or closed. For example, without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein may include an implant including a contact member and a fixation element that may (but need not) be configured to move between a first state and a second state, wherein the contact member may be configured to move from the first state to the second state such that at least a portion of the contact member engages a wall portion of the tissue condition after the contact member is advanced into the tissue state, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, and when the contact member rotates from the first rotational position to the second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue state in the first direction, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue state in a second direction when the fixation element is in an operable state, the second direction being opposite 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.

[0051] 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.

[0052] Additionally, some embodiments of the devices and systems for treating a tissue condition disclosed herein can include a method of treating a tissue condition including advancing a deployment device having an implant within or adjacent to the tissue condition, the implant may (but is not required to) be configured to move from a first state to a second state such that at least a portion of the implant may be radially expanded when the implant is in the second state compared to the first state; moving the implant from the first state to the second state within the tissue condition to move at least a portion of an 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.

[0053] Furthermore, any implant and / or device or system embodiment disclosed herein can be adapted and / or used for the treatment of any tissue condition in the body that is desired to be occluded, remodeled, restricted, or closed. For example, without limitation, some embodiments of devices and systems for treating tissue conditions disclosed herein can include an implant including a contact member configured to engage a wall portion of the tissue condition after the contact member is advanced into the tissue condition, the contact member may be configured to rotate in at least a first direction from a first rotational position to a second rotational position, the contact member may be configured to twist at least a portion of the tissue of the tissue condition in the first direction when the contact member rotates from the first rotational position to the second rotational position, and / or the fixation element may be configured to prevent rotation of at least a portion of the tissue of the tissue condition in a second direction when the fixation element is in an operable state, the second direction being opposite the first direction. In any embodiment, the tissue condition may be a cavity, a chamber, an opening, a passageway, a crevice in tissue, two adjacent or adjacent tissue surfaces, or otherwise.

[0054] 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.

[0055] Additionally, some embodiments of the devices and systems for treating tissue conditions disclosed herein can include a method of treating a tissue condition that includes advancing a deployment device having an implant within or adjacent to the tissue condition such that at least a portion of the implant engages a wall surface of the tissue condition; rotating the implant from a first rotational position to a second rotational position to twist the tissue condition and / or prevent the implant from rotating back to the first rotational position.

[0056] Disclosed herein are embodiments of methods for reshaping, closing, or occluding a body cavity or tissue defect, which may include rotating the body cavity or tissue defect and fixing the body cavity or tissue defect in the rotated position. Any embodiment of the methods and / or devices disclosed herein for reshaping, closing, or occluding a cavity or tissue defect in a body disclosed herein may, in further embodiments, include one or more of the following steps, features, or details, in any combination: rotating the cavity or tissue defect in a body can include rotating the cavity or tissue defect in a body to deform or occlude the cavity or tissue defect in a body; fixing the cavity or tissue defect in a rotated position in a body can include fixing the cavity or tissue defect in a rotated position where the cavity or tissue defect is reduced in volume; fixing the cavity or tissue defect in a rotated position can include fixing the cavity or tissue defect in a rotated position where the cavity or tissue defect is deformed or occluded; and fixing the cavity or tissue defect in a position where the cavity or tissue defect is deformed or occluded includes removing or substantially removing blood volume in the cavity or tissue defect. and rotating the cavity or tissue defect can include bending or curving the cavity or tissue defect, and fixing the cavity or tissue defect in the rotated position can include fixing the cavity or tissue defect in a position where blood communication between the cavity or tissue defect and the left atrium is inhibited, and fixing the cavity or tissue defect in the rotated position can include removing or substantially removing blood or other substance communication between the cavity or tissue defect and the left atrium, and rotating the cavity or tissue defect can include engaging a wall portion on an interior of the cavity or tissue defect and / or an opening of the cavity or tissue defect with a contact portion and rotating the contact member, the contact member being a balloon, the contact member being positioned on an implant coupled to the delivery system, the implant being self-expanding, balloon-expandable and / or mechanically expandable, and rotating the cavity or tissue defect can include engaging a wall portion on an interior of the cavity or tissue defect with a contact portion and rotating the contact member,The method may include engaging one or more tissue retention mechanisms, where the one or more tissue retention mechanisms may include one or more tissue anchors or one or more tissue grippers; rotating the cavity or tissue defect may include advancing the device into the cavity or tissue defect and further including rotating components of the device to rotate the cavity or tissue defect; rotating the device may include rotating the device at least approximately 90 degrees in either direction from an initial position; rotating the device may include rotating the device at least approximately 180 degrees in either direction from the initial position; and / or rotating the device may include rotating the device from approximately 90 degrees to approximately 360 degrees in either direction from the initial position.

[0057] Any embodiment of the methods and / or devices disclosed herein for reshaping, closing, or occluding a body cavity or tissue defect disclosed herein can, in additional embodiments, include one or more of the following steps, features, or details, in any combination, wherein rotating the device rotates components of the device to twist the cavity or tissue defect.

[0058] Rotating the cavity or tissue defect can include rotating a portion of the cavity or tissue defect about an axis to twist the cavity or tissue defect, and rotating the portion of the cavity or tissue defect about one or more axes from an initial position includes rotating the portion of the cavity or tissue defect at least approximately 90 degrees in either direction from the initial position.

[0059] Rotating the portion of the cavity or tissue defect about one or more axes from the initial position can include rotating the portion of the cavity or tissue defect at least approximately 180 degrees in either direction from the initial position; rotating the portion of the cavity or tissue defect about one or more axes from the initial position can include rotating the portion of the cavity or tissue defect from approximately 90 degrees to approximately 360 degrees in either direction from the initial position; rotating the portion of the cavity or tissue defect can include rotating the cavity or tissue defect until an opening of the cavity or tissue defect is substantially or completely closed; rotating the portion of the cavity or tissue defect can include rotating the cavity or tissue defect until blood communication between the cavity or tissue defect and the left atrium is inhibited; and rotating the portion of the cavity or tissue defect can include rotating the cavity or tissue defect until communication of blood or other material between the cavity or tissue defect and the left atrium is eliminated or substantially eliminated.

[0060] Securing the cavity or tissue defect in a rotated position can include engaging twisted bodily tissue, engaging the twisted bodily tissue can include engaging a tissue wall with an anchor element or gripping element, the anchor element can include a suture or a staple, securing the cavity or tissue defect in a rotated position can include securing bodily tissue outside an occluded portion of the cavity or tissue defect with the anchor element, securing the cavity or tissue defect in a rotated position can include securing tissue in an occluded portion of the cavity or tissue defect with the anchor element, the anchor element can include a plurality of tissue grippers on at least one surface thereof configured to engage an inner bodily wall outside the cavity or tissue defect, and / or the cavity is a mitral valve or a mitral valve junction.

[0061] Disclosed herein are embodiments of methods for reducing the opening of a body cavity or tissue defect, including twisting body tissue to shrink the opening of the body cavity or tissue defect, and fastening the deformed or contracted tissue as a result of twisting the body tissue. Any embodiment of the methods and / or devices disclosed herein for reshaping, closing, or occluding a body cavity or tissue defect may, in further embodiments, include one or more of the following steps, features, or details, in any combination: fastening the deformed or contracted tissue may include advancing a fixation element into the deformed or contracted tissue as a result of twisting the body tissue, and the fixation element may include a tissue anchor or tissue gripper; fastening the deformed or contracted tissue as a result of twisting the body tissue may include advancing a fixation element into the deformed or contracted tissue to compress the deformed or contracted tissue; and / or fastening the deformed or contracted tissue as a result of twisting the body tissue may include advancing one or more sutures or one or more staples into the deformed or contracted tissue as a result of twisting the body tissue.

[0062] Disclosed herein are embodiments of methods for treating a body cavity or tissue defect, including twisting the body cavity or tissue defect such that the body cavity or tissue defect is reduced in volume, and fixing the reduced-volume body cavity or tissue defect. Any embodiment of the methods and / or devices disclosed herein for reshaping, closing, or occluding a body cavity or tissue defect may, in further embodiments, include one or more of the following steps, features, or details, in any combination: fixing the body cavity or tissue defect in a reduced-volume configuration may include occluding the body cavity or tissue defect with an implant that is smaller than the size of the interior of the body cavity or tissue defect, and / or further includes unfixing and untwisting the body cavity or tissue defect. [Brief explanation of the drawings]

[0063] [Figure 1A] FIG. 1A shows a pathway through the venous system via the femoral vein and transseptal puncture to a target cavity within the heart, for example, the space outside the left atrium, that can be used to access a cavity within the heart.

[0064] [Figure 1B] FIG. 1B shows a cross-sectional view of a target cavity within the heart, for example, the space outside the left atrium, and shows a guidewire being advanced toward the cavity.

[0065] [Figure 2A] FIG. 2A illustrates an embodiment of a treatment system having an implant device advanced through a catheter into a cavity, the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0066] [Figure 2B] FIG. 2B illustrates the embodiment of the treatment system of FIG. 2A, showing the contact members expanded within the cavity.

[0067] [Figure 2C] FIG. 2C illustrates the embodiment of the treatment system of FIG. 2A, showing the contact members rotating to twist the cavity and cause the neck or opening of the cavity to contract around a portion of the implant device.

[0068] [Figure 2D] FIG. 2D illustrates the embodiment of the treatment system of FIG. 2A showing the fixation element of the embodiment of the implant device being advanced towards the contact member of the implant device.

[0069] [Figure 2E] FIG. 2E shows the fixation element of the treatment system of FIG. 2A engaging with patient tissue surrounding the proximal portion of the contact member of the implant device.

[0070] [Figure 2F]FIG. 2F shows the implant device of FIG. 2A disengaged and removed from the catheter.

[0071] [Figure 3] FIG. 3 illustrates an embodiment of an implant device having a cover member surrounding at least a portion of the implant device.

[0072] [Figure 4] FIG. 4 shows the implant device of FIG. 2A with the contact members in a second expanded state, the retention members in a first elongated state, and the fixation elements in a second open state.

[0073] [Figure 5] 5 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 5-5 of FIG.

[0074] [Figure 6] FIG. 6 shows the implant device of FIG. 2A with the contact members in the second open state, the retention members in the second contracted state, and the fixation elements in the second open state.

[0075] [Figure 7] 7 is a cross-sectional view of the implant device shown in FIG. 2A taken along line 7-7 of FIG.

[0076] [Figure 8A] FIG. 8A illustrates the embodiment of the implant device of FIG. 2A with the contact members advanced further distally into the cavity.

[0077] [Figure 8B] FIG. 8B illustrates the embodiment of the implant device of FIG. 2A, showing the contact member rotating to twist the cavity and contract the neck or opening of the cavity around a portion of the implant device.

[0078] [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.

[0079] [Figure 9A] FIG. 9A shows another embodiment of a treatment system in which an implant device is advanced through a catheter into a cavity, with the implant device in a collapsed state and constrained within the outer tube of the catheter.

[0080] [Figure 9B] FIG. 9B illustrates the embodiment of the treatment system of FIG. 9A, showing the contact members expanded within the cavity.

[0081] [Figure 9C] FIG. 9C illustrates the embodiment of the treatment system of FIG. 9A, showing the contact member being rotated to twist the cavity and cause the neck or opening of the cavity to contract around a portion of the implant device.

[0082] [Figure 9D] FIG. 9D illustrates the embodiment of the treatment system of FIG. 9A showing the fixation element of the embodiment of the implant device being advanced towards the contact member of the implant device.

[0083] [Figure 9E] FIG. 9E shows the fixation element of the treatment system of FIG. 9A engaging with patient tissue surrounding the proximal portion of the contact member of the implant device.

[0084] [Figure 9F] FIG. 9F shows the treatment system of FIG. 9A with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0085] [Figure 9G] FIG. 9G is a cross-sectional view of the treatment system shown in FIG. 9A taken along line 9G-9G of FIG. 9F.

[0086] [Figure 9H] FIG. 9H shows an enlarged side view of the treatment system of FIG. 9A.

[0087] [Figure 9I] FIG. 9I shows an exploded view of the treatment system of FIG. 9A.

[0088] [Figure 10] FIG. 10 illustrates another embodiment of a treatment system for treating a cavity, showing contact members of the treatment system expanded within the cavity.

[0089] [Figure 11] FIG. 11 shows an embodiment of a fixation element implanted adjacent to the blocked opening of a cavity.

[0090] [Figure 12] FIG. 12 shows another embodiment of a fixation element implanted adjacent to the blocked opening of a cavity.

[0091] [Figure 13] FIG. 13 illustrates another embodiment of a treatment system having an implant device with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0092] [Figure 14] 14 is a cross-sectional view of the treatment system shown in FIG. 13 taken along line 14-14 in FIG.

[0093] [Figure 15] FIG. 15 shows another embodiment of an implant device with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0094] [Figure 16]16 is a cross-sectional view of the treatment system shown in FIG. 15 taken along line 16-16 in FIG.

[0095] [Figure 17] FIG. 17 illustrates another embodiment of a treatment system in which the contact members are in a second expanded state, the retention members are in a second contracted state, and the fixation elements are in a second open state.

[0096] [Figure 18] FIG. 18 shows a side view of another embodiment of a treatment system with the contact members in a second expanded state, the retention members in a second contracted state, and the fixation elements in a second open state.

[0097] [Figure 19] 19 is a cross-sectional view of the treatment system shown in FIG. 18 taken along line 19-19 of FIG.

[0098] [Figure 20] FIG. 20 is another side view of the treatment system shown in FIG.

[0099] [Figure 21] 21 is a cross-sectional view of the treatment system shown in FIG. 18 taken along line 21-21 of FIG.

[0100] [Figure 22A] FIG. 22A shows a side view of another embodiment of a treatment system with the contact members in a second expanded state and the retention members in a first retracted state.

[0101] [Figure 22B] FIG. 22B shows a side view of the treatment system of FIG. 22 with the contact members in a second position and the retention members in a second deployed position.

[0102] [Figure 23A] FIG. 23A shows an isometric view of another embodiment of a fixation element.

[0103] [Figure 23B] FIG. 23B shows a side view of the embodiment of the fixation element shown in FIG. 23A.

[0104] [Figure 23C] FIG. 23C shows an isometric view of another embodiment of a fixation element.

[0105] [Figure 23D] FIG. 23D shows a side view of the embodiment of the fixation element shown in FIG. 23C.

[0106] [Figure 23E] FIG. 23E shows an isometric view of another embodiment of a fixation element.

[0107] [Figure 23F] FIG. 23F shows a side view of the embodiment of the fixation element shown in FIG. 23E.

[0108] [Figure 24] 24-35 illustrate an embodiment of a deployment method for the embodiment of the treatment system shown in FIG. 22A. [Figure 25] Same as above. [Figure 26] Same as above. [Figure 27] Same as above. [Figure 28] Same as above. [Figure 29] Same as above. [Figure 30] Same as above. [Figure 31] Same as above. [Figure 32] Same as above. [Figure 33] Same as above. [Figure 34] Same as above. [Figure 35] Same as above.

[0109] [Figure 36] FIG. 36 shows another embodiment of an implant device in which a retention member engages the tissue surface surrounding the opening of the cavity.

[0110] [Figure 37] FIG. 37 illustrates another embodiment of a treatment system with the tab members of the fixation elements in a first engaged state.

[0111] [Figure 38] FIG. 38 shows the treatment system of FIG. 37 with the tab members in a second, disengaged state.

[0112] [Figure 39] FIG. 39 shows a fixation element of the treatment system of FIG.

[0113] [Figure 40] FIG. 40 shows the treatment system of FIG. 37 with the fixation element engaged with the contact member and the tab member of the fixation element in a first engaged state.

[0114] [Figure 41] FIG. 41 shows the treatment system of FIG. 37 with the tab members of the fixation elements moved to a second, disengaged state by axial advancement of the core member of the delivery system.

[0115] [Figure 42] FIG. 42 shows the treatment system 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.

[0116] [Figure 43] FIG. 43 shows the treatment system of FIG. 37 with the fixation elements retracted from the contact members.

[0117] [Figure 44] 44A and 44B are front and side views, respectively, of another embodiment of a treatment system configured to twist closed or occlude a cavity at the cavity opening.

[0118] [Figure 45]45A and 45B are front and side views, respectively, of the treatment system of FIG. 44, showing that the implant is used to twist the cavity and close or occlude the cavity at the opening.

[0119] [Figure 46] 46A and 46B are side views of the treatment system of FIG. 44, respectively, showing the delivery device being removed from the implant device after the cavity has been occluded.

[0120] [Figure 47] 47A-47F illustrate another embodiment of a treatment system for closing or occluding a cavity.

[0121] [Figure 48] 48A-48F illustrate several stages or steps illustrating an example deployment procedure for the expandable implant of FIGS. 47A-47F for the treatment of a cavity.

[0122] [Figure 49] 49A-49G illustrate another embodiment of a treatment system for closing or occluding a cavity.

[0123] [Figure 50] 50A-50F illustrate several stages or steps illustrating an example procedure for deploying the expandable implant of FIGS. 49A-49G for the treatment of a cavity.

[0124] [Figure 51] FIG. 51 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0125] [Figure 52] FIG. 52 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0126] [Figure 53]FIG. 53 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0127] [Figure 54] FIG. 54 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0128] [Figure 55] FIG. 55 illustrates another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0129] [Figure 56] 56A-56B illustrate another embodiment of a contact member that can be used with any of the treatment system embodiments disclosed herein.

[0130] [Figure 57] 57A-57B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0131] [Figure 58] 58A-58B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0132] [Figure 59] 59A-59B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0133] [Figure 60] 60A-60B show another embodiment of a fixation element that may be used with any of the treatment system embodiments disclosed herein.

[0134] [Figure 61]61A-61B illustrate another embodiment of a fixation element that can be used in conjunction with any of the treatment system embodiments disclosed herein.

[0135] [Figure 62] 62A-62B illustrate additional embodiments of contact members that can be used with any of the treatment system embodiments disclosed herein.

[0136] [Figure 63] FIG. 63 shows a side view of an embodiment of a contact member.

[0137] [Figure 64] 64A-64D show another embodiment of a device for treating a cavity and an embodiment of a method of using such a device.

[0138] [Figure 65] 65A-65H show embodiments of devices and methods for closing or occluding wounds.

[0139] [Figure 66] 66A-66H illustrate one embodiment of a device and one embodiment of a method for repairing a mitral valve.

[0140] [Figure 67] 67A-67G show an embodiment of a device and an embodiment of a method for resizing or reshaping the stomach. DETAILED DESCRIPTION OF THE INVENTION

[0141] This specification describes novel devices, systems, and methods for closing or occluding cavities in the body. As used herein, the term cavity refers to an opening, hole, incision, slit, wound, wound cavity, blood vessel, passageway, chamber, heart cavity, tissue void, or other space in the body. Furthermore, any reference herein or incorporated herein by reference to the left atrial appendage or LAA is also meant to refer to any cavity in the body, such that any description of a device used in the left atrial appendage or LAA, or a method of treating the left atrial appendage or LAA, includes a device for treating any cavity in the body or a method of treating any cavity in the body. Some embodiments include methods that include advancing a delivery system into the cavity, 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 which may have a generally spherical or spherical shape within the cavity, allowing the expandable element to distally and / or radially engage an inner wall surface of the cavity, and applying a rotation to an inner catheter member connected to the expandable element to twist the cavity and close and / or occlude the cavity at or near the opening of the cavity. By occluding the cavity, some embodiments disclosed herein can effectively eliminate, or significantly or nearly completely eliminate, communication of blood or other substances between the cavity and spaces adjacent to or outside the cavity. Any of the methods of deployment disclosed herein can 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 cavity and tissue adjacent to the cavity and / or tissue within the space adjacent to the cavity, thereby inhibiting or preventing untwisting of the cavity.

[0142] 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 other tissue openings other than cavities, 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.

[0143] A clinical benefit of some embodiments is that the resulting implant does not come into direct blood contact with blood or the flow outside or adjacent to the cavity, except for possible portions of the fixation function. The fixation elements of any embodiment can be configured to limit their exposure to blood in the space adjacent to or outside the cavity (i.e., limit the amount of fixation element that protrudes into the space adjacent to or outside the cavity). In some embodiments, the entire implant can be surrounded by cavity tissue, such that no portion of the implant is exposed to blood flow in the space adjacent to or outside the cavity, or only a minimal portion is exposed (e.g., less than 10% of the surface area, or less than 40% of the surface area). 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.

[0144] Any embodiment of the implant disclosed herein may have an expandable, atraumatic shape with tissue-grasping features located on the outer edge of the shape coupled with securing and / or latching features that can hold the implant in an initial or final closed position. Any embodiment of the implant disclosed herein may be configured to grip the internal tissue of the cavity with a radial force. In some embodiments, a vacuum or suction may be provided by the catheter or any component thereof to pull tissue portions of the cavity or atrium toward the implant. Any embodiment of the implant disclosed herein may have an atraumatic shape that is spherical, dome-shaped, or includes a coil of wire in a disk shape, 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 activated adhesive that grips the internal surface of the cavity. Additionally, in any embodiment disclosed herein, the tissue anchors may be positioned on or adjacent the ends of the implant for engaging the ends of the cavity, and in any embodiment, the barbs may be oriented to allow tissue engagement in one rotational direction and disengagement in the opposite rotational direction for possible repositioning, resizing, or removal from the cavity.

[0145] For any embodiment disclosed herein, the rotation used to twist closed or occlude (fully or substantially) the cavity can be a quarter turn (i.e., a turn), a half turn, a full turn, or up to multiple turns for deeper or longer cavities. 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 cavity. The fixation feature or element can also be configured to engage tissue adjacent to the cavity opening. 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 couple non-twisted tissue to a twisted implant. In some embodiments, the fixation element can also have a small diameter ring that can be configured to clamp to or engage tissue that connects to the implant's central hub (adjacent the cavity ostium). Alternatively, the implant can have clips that fold over and clip to the side of the wall of the space adjacent to or outside the cavity.

[0146] In some embodiments disclosed herein, the device can be configured to restrict the cavity opening (including the occlusion effect from the device) by reducing the cross-sectional area of ​​the cavity opening by at least 95%, or at least 90%, or at least approximately 80% to approximately 100% compared to the cross-sectional area of ​​the cavity opening before the device is implanted. Furthermore, in some embodiments, the method can include rotating the implant from a first rotational position to a second rotational position to twist the cavity until the cavity opening 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 cavity. For example, without limitation, any of the implant embodiments disclosed herein may be configured to be deployed or implanted into cavity y to improve occlusion of an implant already implanted in the cavity, 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 cavity.

[0147] Alternatively, in any embodiment disclosed herein, the fixation element may be configured to simply compress tissue of the cavity that has contracted around the space outside or adjacent to the cavity, the opening of the cavity, and / or the outer surface of the body portion of the implant between the distal surface of the fixation element and the contact member, i.e., prevent rotation of the implant in the second direction after rotation to the second rotational position without the contact member penetrating such tissue. For example, without limitation, in any embodiment disclosed herein, the fixation element may have a smooth body portion that is non-obstructive or non-penetrating, e.g., such that the fixation element does not have any tissue-penetrating features thereon that extend toward the tissue surface. In other embodiments, the arms (or at least the portions of the arms that extend axially when the fixation element is in the second state) or other tissue-penetrating portions of the fixation element may be shortened, such as from approximately 1 mm to approximately 5 mm in length, or from approximately 1 mm to approximately 3 mm in length, or from approximately 1 mm to approximately 2 mm in length, or any value or range of values ​​between any of the aforementioned ranges.

[0148] 1A and 1B show cross-sectional views of the space outside or adjacent a cavity, showing a guidewire G advancing from a catheter C toward the cavity. FIG. 2A shows an embodiment of an occlusion system 100 for occluding or closing an opening of a cavity. In any embodiment disclosed herein, the occlusion system (including embodiments of occlusion system 100) can be configured to rotate and twist the cavity to contract a neck or portion of the cavity adjacent the opening and substantially or completely close around the exterior surface of a portion of the implant device, thereby occluding the opening of the cavity. In any embodiment of an occlusion system, including embodiments of occlusion system 100, the system can have an implant device 102 having a contact member 104 (also referred to herein as a contact element or an expandable implant member), a fixation element or fixation element 110 (also referred to as a fixation member), and a retention member 108. The implant device 102 can be configured to be advanced into the cavity through a catheter 112. 2A is shown in a collapsed state and is constrained within an outer sleeve 114 of a catheter 112. As shown, the implant device 102 can be advanced distally out of the catheter 112 through a distal end 114a of the outer sleeve 114 by advancing a portion or member of the catheter, such as, but not limited to, the core member 113 of the catheter 112, so that the contact member 104 of the implant device 102 can be advanced and / or deployed within the cavity.

[0149] Alternatively, the catheter 112 with the implant device 102 therein can be advanced to a desired location within the cavity, 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 interior surface or wall of the cavity. In other embodiments, the contact members 104 can be mechanically expandable, for example, by a balloon expander, to expand against the interior surface or wall of the cavity. FIG. 2B shows the contact numbers 104 after they have been expanded against the interior wall of the cavity distal to the cavity opening O.

[0150] Alternatively, in any embodiment disclosed herein, the contact members may be configured to remain in a first state within the catheter during and / or after the entire treatment procedure. For example, without limitation, in any embodiment disclosed herein, the contact members may be configured so that the contact members are deployed from the catheter, advanced into contact with the tissue surface of the inner wall of the cavity, engage with the tissue surface of the inner wall of the cavity, and twist the cavity when torque and / or rotation is applied to the contact members, all without changing the state of the contact members. Alternatively, in any embodiment disclosed herein, the contact members advance into the cavity and engage with the inner surface of the cavity, and the cavity twists when torque and / or rotation is applied to the contact members. In any embodiment disclosed herein, the contact members and / or any other components of the device may be configured to be removed from the cavity (which may include the wound cavity, as described above) before treatment is terminated, such that no portion of the device remains in the cavity after treatment is completed.

[0151] 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.

[0152] Additionally, in any embodiment, the contact member 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 cavity when the contact member 104 is expanded against the tissue of the cavity and / or when the contact member 104 is rotated or twisted within the cavity, or other similar features configured to penetrate or engage tissue of the cavity. 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 member, 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.

[0153] 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 (as shown, at an angle perpendicular to the tissue surface of the cavity, relative to a line tangential to the outer surface of the contact member 104, or otherwise radially to penetrate or engage tissue. In some embodiments, each strut 116 may support multiple tapered tissue anchors that face circumferentially, as shown in FIG. 2B. All of the tissue anchors may face in a similar orientation relative to each strut, such as circumferentially relative to each strut. In the illustrated embodiment, each strut 104 has five tissue anchors 118. In this embodiment, when the contact member 104 is rotated in a first direction (indicated by arrow A1 in FIG. 2C, which can be clockwise or counterclockwise), one or more or all of the struts 116 and one or more or all of the tissue anchors 118 engage the tissue of the cavity. The cavity can be twisted or rotated in a first direction A1. Twisting or rotating the cavity in a first direction from a first rotational position to a second rotational position causes the cavity opening O to radially contract (represented or identified by arrow A2 in FIG. 2C ) such that the cavity opening O moves or contracts around the outer surface of the proximal portion 104a of the contact member 104. The operator can twist or rotate the core member 113 of the catheter 112 by twisting or rotating the contact member 104. Tightening or contracting the cavity opening O around the outer surface of the proximal portion 104a of the contact member 104 or other portion of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior portion of the cavity from the space outside the cavity. This significantly reduces the health risks associated with open cavities.

[0154] In some embodiments, as in the illustrated example, the contact members 104 are deployed and rotated to prevent the fixation element 110 from contacting tissue in the space outside the cavity or within the cavity and potentially lacerating or damaging such tissue, while the fixation element 110 may be maintained in the collapsed or first state by being constrained by the outer sleeve 114 of the catheter 112. An intermediate sleeve or tube 115 may be coupled to the fixation element 110 and can 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 members 104 to maintain the retention element in the first, extended state. In any of the implant device embodiments disclosed herein, the fixation element (for example, including but not limited to, fixation element 110) may be keyed, indexed, or otherwise rotationally secured to the contact member (for example, including but not limited to, contact member 104) such that the fixation element cannot rotate relative to the contact member and the contact member cannot rotate relative to the fixation element. In this configuration, the fixation element can prevent or substantially prevent or inhibit the contact member and cavity from rotating back toward the first rotated position.

[0155] 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 cavity remains constricted around the proximal portion 104a of the contact member 104 or other portion of the implant device and the cavity is substantially blocked from spaces outside or adjacent to the cavity, 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 can have an end portion 120a that extends generally in a distal axial direction (but can be angled slightly inward) as the fixation element 110 advances axially, so that the distal portion 120a of each of the one or more members 120 can penetrate and / or engage tissue portions outside or adjacent to a cavity, which may be within the heart or any other organ or body part, as shown in FIG. 2E . The tissue portions that the one or more members 120 can penetrate or engage can include portions of tissue including spaces outside or adjacent to a cavity, tissue at the opening of a cavity, and / or portions of tissue that include the cavity. As described above, the contact member 104 can be held in a generally fixed axial position using the core member 113 while the fixation element 110 is advanced distally toward the contact member 104. The retention member 108 can then be unconstrained to maintain the fixation element 110 in a second position in which the fixation element 110 engages tissue outside or adjacent to the cavity, as shown in FIG. 2E . In some embodiments, the fixation element may be axially biased toward a smaller size, such as with a spring member or the like. For example, the retention member 108 may be formed by a laser cut opening in a cylindrical tube, such as a hypotube, made of a resilient material such as Nitinol.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 cavity is prevented from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fix and maintain the cavity in a substantially or completely occluded or substantially or completely closed state.

[0156] The retention member 108 may then be unconstrained (e.g., released) to allow the fixation element 110 to retract to maintain the fixation element 110 in a second position engaging tissue outside or adjacent the cavity, as shown in FIG. 2E. In some embodiments, the fixed retention member 108 may be axially biased toward a smaller size length or size, such as with a spring member or the like. For example, the retention member 108 may be formed by a laser-cut opening in a cylindrical tube, such as a hypotube, made of a resilient material such as Nitinol.

[0157] 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 cavity is prevented, or at least inhibited or biased, from rotating to a first rotational position, which is an untwisted or relaxed position. In this configuration, the implant device 102 can fix and maintain the cavity in a substantially or completely occluded or substantially or completely closed state.

[0158] Components of any of the implant embodiments disclosed herein may be made from any other elastic or superelastic material, including nitinol or any other shape-memory material, or stainless steel or any other mechanically expandable material. In any embodiment disclosed herein, the contact member (such as contact member 104) may have a spherical, cylindrical, or other shape, such as an elongated bullet, a stent, a mushroom, or other non-circular or non-cylindrical shape, or any of the shapes described or shown with respect to any of the embodiments disclosed herein. In any embodiment disclosed herein, the contact member may include a series of interconnected struts (which can, but are not required to, form a diamond-shaped pattern across all or a portion of the surface of the contact member) or may be made from a series of ribs or paddles that form an expandable device.

[0159] 3 , the fixation elements of any device embodiment disclosed herein, including but not limited to fixation element 110, may have an outer size (e.g., outer diameter of fixation element arms 144) that is significantly smaller than the outer size (e.g., outer diameter) of contact member 104. For example, without limitation, the fixation elements of any device embodiment disclosed herein may have an outer size that is approximately half the outer size of contact member 104, or approximately 30% to approximately 80% of the outer size of contact member 104, or approximately 50% to approximately 60% of the outer size of contact member 104. In any embodiment, the outer size of the fixation element may be similar to, approximately the same as, or larger than the outer size of contact member 104.

[0160] 3, any embodiment of the implant device 102 disclosed herein may also have a cover member 121 that can provide an additional seal or barrier around the exterior surface of the contact member 104 and other portions of the implant device 102, providing an additional barrier for the implant device 102. In some embodiments, the cover may be positioned or disposed on or against an interior surface or portion of the contact member of the implant, which can improve the seal or occlusion that the implant device 102 creates within the cavity. In some embodiments, the cover member 121 can cover substantially or completely all of the contact member 102 of the implant device.

[0161] Further details regarding the implant system 100 are described with reference to FIGS. 4-7. FIG. 4 illustrates the contact member 104 in a second expanded state, the retention member 108 (also referred to herein as a biasing member) in a first elongated state, and the fixation element 110 in a second open state. In any embodiment disclosed herein, the retention member can be an axial spring-like member or other axially resilient member. In some embodiments, the contact member 104 can have a continuous, uninterrupted circumference at the proximal end 104a from which each of the strut members 116 extends distally. Each of the strut members 116 can be preformed into a curved shape such that when no external restraint or constraint is applied to the outer surface of the contact member 104 (e.g., in a relaxed state), the strut member 116 is biased to expand to the second state. At the distal end, each of the strut members 116 can be coupled to a hub member 122, although this is not required. 5-6, the hub member 122 may have a plurality of receptacles 123 configured to receive and restrain the distal end portions 116b of each of the strut members 116. Additionally, each of the receptacles 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 such that the distal end portions 116b of the strut members 116 may extend generally radially away from the hub member 123 when the contact members 104 are in the second expanded state. The hub member 123 may be configured to allow the distal end portions 116b of each of the strut members 116 to rotate relative to the hub member 122 without resistance or significant resistance. The distal end of each of the strut members 116 may have a tab or other feature (such as a T-shaped termination or other width increase) 119 that locks into, secures, or otherwise engages with, each of the receptacles 123 so as to axially restrain each end of the strut member 116 while rotating about the end.

[0162] In some embodiments, such as the embodiment illustrated in FIG. 4, the retention member 108 and the fixation element 110 may be integrally formed. For example, without limitation, the retention member 108 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape using a conventional or suitable process. In other embodiments, the fixation element 110 may be formed separately and coupled to the proximal end 108a of the retention member 108. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention member 108 may be biased to move to a second or folded state, as shown, for example, in FIGS. 2E, 6, and 7. Furthermore, in the relaxed state, the retention member 110 may be in a second, or open, position, as also shown in FIG. 2E. Further, with reference to FIG. 5, which is an enlarged cross-sectional view taken along line 5-5 of FIG. 4, a pin or cross member 124 may be coupled to the distal end 108b of the retention member 108 and may be configured to fit within a slot 126 formed in the distal end 113b of the core member 113. In this embodiment, the core member 113 may be advanced distally, resulting in the contact member 104 advancing distally. Furthermore, a core tube 128 may extend proximally from the distal end 113b of the core member 113 and couple to the proximal end 104a of the contact member 104. The pin 124 may extend through a pair of openings formed in the core tube 128 to secure the core tube 128 to the pin 124, and therefore to the distal end 108b of the retention member 108. Thus, the core tube 128 may be used to couple the contact member 104 to the retention member 108. A pin, tab, suture, tie, protrusion, clip, indentation, detent, or other feature may be used to couple the proximal end 104a of the contact member 104 with the proximal end of the core tube 128. Note that the core tube 128 is omitted from some of the figures for clarity.

[0163] Additionally, in any embodiment, the system 100 may be configured such that the implant device 102 is biased or selectively secured proximally relative to the core member 113. For example, without limitation, as shown in FIG. 5 , some embodiments of the implant device 102 may have a suture or thread 130 that extends through the interior of the core member 113 (e.g., 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 withdraw the implant device 102 proximally relative to the core member 113. In this configuration, both ends of the suture 130 may extend from the proximal end of the device 100 such that a physician can grasp both ends of the suture 130 and exert a biasing force around the pin 124 to maintain the pin against the proximal end of the slot 126 formed in the distal end 113b of the core member 113. When the implant device 102 is ready to be released from the core member 113, the physician can simply release one end of the suture and 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 cavities. This may occur after the contact members and fixation elements are fully deployed or implanted into the cavities and / or tissue adjacent to the cavities.

[0164] 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.

[0165] 8A-8C , in any embodiment, the contact member 104 of the implant device 102 can be advanced into the cavity as desired or appropriate by the surgeon. For example, without limitation, as shown in FIGS. 8A-8C , the contact member 104 can be advanced to contact, adjacent to, or near the distal end of the cavity before the contact member 104 is rotated. This allows more of the implant to be positioned within the cavity and, in some embodiments, allows more of the cavity tissue 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 cavity tissue. Any implant device embodiment disclosed herein can be configured to advance the contact member 104 to any extent within the cavity, including through the opening of the cavity, into a central portion of the cavity, and further into the cavity so as to contact, adjacent to, or near the distal end of the cavity before rotating.

[0166] 9A-9I illustrate another embodiment of a treatment system 140 for closing or occluding a cavity. In any embodiment disclosed herein, any component, feature, or other detail of the treatment system 140 or implant device 142 may have any of the components, features, or other details of any other treatment system embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100 or implant device 102 embodiments described above, in any combination with any of the treatment system and / or implant device components, features, or details below. Similarly, any component, feature, or other detail of any other treatment system embodiment or implant device embodiment disclosed herein may have any of the components, features, or other details of any of the treatment system and / or implant device embodiments disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0167] In any embodiment of occlusion system 140, including those of occlusion system 140, the system can have an implant device 142 having a contact member 144 (also referred to herein as a contact element or an expandable implant member), a fixation element or fixation element 150 (also referred to as a fixation member), and a retention member 148. FIG. 9A shows both contact member 144 and fixation element 150 in a first, contracted, or restrained state within an outer sleeve 154 of a catheter 152. The implant device 142 can be advanced distally out of the catheter 152 by advancing the core member 153 of the catheter 152 past the distal end 154a of the outer sleeve 154 such that the contact member 144 of the implant device 142 can be deployed into the cavity at any desired depth within the cavity, including, for example, without limitation, near the distal end of the cavity, the central portion of the cavity, 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 interior surface or wall of the cavity. In other embodiments, the contact member 144 can be mechanically expandable, such as by a balloon expander, to expand against the interior surface or wall of the cavity.

[0168] In any embodiment, the contact member 144 can have multiple arms or struts 156, each configured to self-expand radially 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 within the cavity when the contact member 144 is expanded against the tissue and / or when the contact member 144 is rotated or twisted within the cavity.

[0169] In this configuration, when the contact member 144 is rotated in a first direction (indicated by arrow A6 in FIG. 9C , which can be clockwise or counterclockwise), one or more or all of the struts 156 and one or more or all of the tissue anchors 158 engage tissue in the cavity, causing the cavity to twist or rotate in the first direction A6. Twisting or rotating the cavity in the first direction from the first rotational position to the second rotational position results in the cavity opening O constricting radially (represented or identified by arrow A7 in FIG. 9C ) so as to move or constrict the cavity opening O about the outer surface of the proximal portion 144a of the contact member 144. An operator can twist or rotate the contact member 144 by twisting or rotating the core member 153 of the catheter 152. Tightening or constriction of the cavity opening O around the exterior surface of the proximal portion 144a of the contact member 144 or other portion of the implant device can result in occlusion, or substantial occlusion, or substantial closure of the interior of the cavity from the space outside or adjacent to the cavity, thus significantly reducing the health risks associated with an open cavity. In any embodiment disclosed herein, the implant 142 can be configured such that the fixation element 150 is removed after being applied to the tissue constricted by twisting of the contact member, such that the only portion of the implant device 142 left within the cavity or in the space outside or adjacent to the cavity is the fixation element 150.

[0170] The retention member 148 is used to couple the fixation element 150 to the contact member 144 and allows a user (such as a surgeon) to move the fixation element 150 toward and away from the contact member 144. In any embodiment, the retention member 148 may have a helical thread on its outer surface. In any embodiment, the retention member 148 may include a threaded shaft. In this configuration, the retention member 148 may be rotated in a first direction to advance the fixation element 150 toward the contact member 144 and rotated in a second, opposite direction to move the fixation element 150 away from the contact member 144. The retention member 148 may be configured to engage the fixation element 150 such that, as the retention member 148 rotates, the fixation element 150 moves in an axial direction corresponding to the rotation of the retention member 148. For example, without limitation, the retaining member 148 can have an annular recess 149 near its proximal end 148 a configured to engage or couple with a tab or protrusion 151 on the fixation element 150. In some embodiments, the protrusion 151 can extend into the annular recess 149 to axially lock or engage the fixation element 150 with the retaining member 148. The interaction of the protrusion 151 and the annular recess 149, where the walls of the annular recess contact and press against the protrusion 151, causes the retaining member 148 to move the fixation element 150 when the retaining member 148 is rotated. In some embodiments, as in the illustrated embodiment, the fixation element 150 can have two tabs 151 that both engage with the annular recess 149. The contact member 144 can have a threaded neck portion 145 that threadingly engages with the threads of the retaining member 148 such that the retaining member 148 threadably engages in and out of the threaded neck portion 145. In this configuration, the retaining member 148 threads into and out of the contact member 144, moving the fixation element 150 relative to the contact member. As shown in FIG. 9H , the retaining member 148 is threaded almost fully into the contact member 144 and into a cavity or space 161 within the contact member 144, such that the fixation element 150 moves as far as possible toward the contact member 144. When the retaining member 148 is rotated in a second direction, the retaining member 148 moves out of the space 161 within the contact member 144, moving the fixation element 150 away from the contact member 144.

[0171] Referring to FIG. 9H , intermediate sleeve 155 can be advanced distally into contact with and engagement with proximal end 148a of retention member 148. Intermediate sleeve 155 can be configured such that when intermediate sleeve 155 engages proximal end 148a of retention member 148, rotating intermediate sleeve 155 in a first or second direction can rotate retention member 148 in a first or second direction. In some embodiments, intermediate sleeve 155 can move axially and rotate independently of other tubes or sleeves of catheter 152. For example, and without limitation, as shown in FIG. 9H , protrusions or tabs 159 on distal end 155b of intermediate sleeve 155 can selectively mate with or be advanced into recesses or indentations 147 formed in proximal end 148a of retention member 148, allowing intermediate tube 155 to be selectively keyed or indexed with retention member 148.

[0172] Additionally, in any embodiment, the retaining member 148 can be used to couple the implant 142 to the delivery catheter 152. For example, without limitation, the core member 153 of the delivery catheter 152 can be coupled to the retaining member 148 via a threaded protrusion 165 at the distal end 153b of the core member 153 that threadingly engages a threaded recess 167 formed in the proximal end 148a of the retaining member 148. The threaded protrusion 165 can be formed separately from and coupled to the distal end of the core member 153, or can be formed integrally therewith. In this configuration, the implant 142 can be removed from the catheter by disengaging the threaded protrusion 165 from the retaining member 148. This can be accomplished by using the intermediate tube 155 to prevent rotation of the retaining member 148 while the core member 153 is rotated in a second direction to withdraw the threaded protrusion 165 from the recess 167 of the retaining member 148.

[0173] Additionally, the second intermediate tube or sleeve 157 can be advanced distally into contact and engagement with the proximal end 150a of the fixation element 150. The second intermediate sleeve 157 can be configured such that when the second intermediate sleeve 157 engages the proximal end 150a of the fixation element 150, rotating the second intermediate sleeve 157 in a first direction or a second direction can cause the fixation element 150 to rotate in a first direction or a second direction. In some embodiments, the second intermediate sleeve 157 can move axially and rotate independently of the other tubes or sleeves of the catheter 152. For example, and without limitation, as shown in FIG. 9H , protrusions or tabs 169 on the distal end 157b of the second intermediate sleeve 157 can selectively couple with posts or arms of the fixation element 150 such that the second intermediate sleeve 157 can be keyed or indexed to the fixation element 150.

[0174] 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.

[0175] In this configuration, the second intermediate sleeve 155 may be coupled with the fixation element 150 and can be used to at least rotate the implant 142 in a first direction or a second direction. For example, without limitation, the second intermediate sleeve 155 can be rotated to rotate the contact member 144 and twist the cavity to a desired rotation and / or torque level. The second intermediate sleeve 155 can then be used to maintain the desired rotational position of the contact member 144 by contacting the fixation element 150 and maintaining the second intermediate sleeve 155 in a fixed rotational position, thus holding the contact member 144 in a fixed rotational position while the retention member 148 is rotated in a first direction to advance the fixation element 150 toward the contact member 144. Once the fixation element 150 is in the desired axial position (e.g., engaged with the tissue of the contracted LA / cavity as a result of twisting the contact member 144), the implant 142 can be removed from the catheter 152 by disengaging the threaded protrusion 165 from the retention member 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 cavity 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 cavity in a substantially or completely occluded or substantially or completely closed state.

[0176] Additionally, in any embodiment, the device may be configured such that contact member 144 can be removed from the patient's cavity after fixation element 150 has sufficiently engaged with tissue to hold the tissue closed or occluded, as shown, for example, in FIGS. 11-12 , with fixation element 177 and fixation element 150 being the only components remaining in the body after the implant procedure is complete. In this configuration, the implant may have a plug or cover (such as cover 178 coupled to fixation member 177) that can cover an opening in the implant from 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 from which contact member 144 is withdrawn. For example, but not limited to, a cover member, such as cover member 121, may be coupled to fixation element 150 in a configuration in which contact member 144 remains in the cavity after fixation element 150 is implanted, substantially covering any opening in the implant or coupling with contact member 144 in the cavity.

[0177] Additionally, in some embodiments, the contact members 144 may have a continuous, uninterrupted circumference at the proximal end 144a, from which each of the strut members 156 extends distally. Each of the strut members 156 may be preformed into a curved shape such that when no external restraint or constraint is applied to the outer surface of the contact members 144 (e.g., when in a relaxed state), the strut members 156 are biased to expand to a second state. At the distal end, each of the strut members 156 may be coupled to a hub member 162, although this is not required. Similar to the hub member 122 described above, the hub member 162 may have multiple receptacles (not shown) configured to receive and restrain the distal ends 156b of each of the strut members 156. Additionally, each of the receptacles 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 such that the distal end 156b of the strut member 156 can extend generally radially away from the hub member 163 when the contact member 144 is in the second, expanded state. The hub member 163 may be configured to allow the distal end 156b of each of the strut members 156 to rotate relative to the hub member 162 without resistance or significant resistance. In any embodiment, the distal end of each of the strut members 156 may have a tab or other feature (such as a T-shaped termination or other width increase) (not shown) that locks into, thereby securing, or otherwise engages with, the respective receptacle 163 to axially restrain the respective end of the strut member 156 while rotating about the end.

[0178] Additionally, as noted above, in any of the embodiments disclosed herein, the implant device may be configured to allow the contact member to be removed from the patient's cavity after the fixation element engages tissue to hold the cavity opening closed. For example, with reference to FIG. 10 , in any of the embodiments disclosed herein, the contact member may be a dilatation balloon, such as dilatation balloon 184, and / or any of the embodiments of the implants herein may include a balloon, such as a dilatation balloon. The balloon may have a smooth exterior surface or may have dimples, protrusions, a rough texture, tissue anchors, or the like to engage the interior surface of the cavity. In some embodiments, the balloon may be a typical dilatation balloon, such as those used in angioplasty procedures, and may be sized and configured for use in the cavity. In these configurations, after the cavity has been rotated and / or torqued to the desired extent and the fixation element has been implanted to hold the cavity opening sufficiently closed or contracted, the balloon may be deflated and removed from the cavity, leaving only the fixation element to maintain the cavity occluded, as shown in the non-limiting examples of FIGS. 11-12 .

[0179] 13 illustrates another embodiment of a treatment system 200 having an implant device 202 with the contact member 204 in a second expanded state, the retention member 208 in a second contracted state, and the fixation element 210 in a second open state. FIG. 14 is a cross-sectional view of the embodiment of treatment system 200 shown in FIG. 13 taken along line 14-14 in FIG. 13. In any embodiment disclosed herein, any component, feature, or other detail of treatment system 200 or implant device 202 may have any of the components, features, or other details of any other treatment system embodiment or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100 or implant device 102 embodiments described above, in any combination with any of the following treatment system 200 or implant device 202 components, features, or details. Similarly, any component, feature, or other detail of any of the other treatment system embodiments or implant device embodiments disclosed herein can have any of the components, features, or other details of any embodiment of treatment system 200 or implant device 202 disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0180] 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.

[0181] Additionally, in some embodiments, the contact members 204 may have an annular distal end 204b, and all of the arms or struts 230 may be coupled to the annular distal end 204b. The contact members 204 may have a bulbous shape, a cylindrical shape with a curved distal portion, an elongated spherical shape, or other. In some embodiments, the contact members 204 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise joined together. Each of the strut members 230 may be pre-formed into a curved shape (which may have a spherical or bulbous shape) and may be formed such that the strut members 230 are biased to expand to the second state when no external restraint or constraint is applied to the exterior surface of the contact members 204.

[0182] In some embodiments, such as the illustrated embodiment, the retention member 208 and the fixation element 210 may be integrally formed. For example, without limitation, the retention member 208 and the fixation element may be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material such as Nitinol, and then formed into the desired shape. In other embodiments, the fixation element 210 may be coupled to the proximal end 208a of the retention member 208. In a relaxed state (i.e., a state in which no external force is acting thereon), some embodiments of the retention member 208 may be biased to move, for example, to a second state, or a collapsed state, and the fixation element 210 may be in the second state, or an open state.

[0183] 14 , a pin or cross member 268 may be coupled to the distal end 208b of the retention member 208 and may be configured to fit within a slot 270 formed in the distal end 218b of the core member 218. In this embodiment, the core member 218 may be advanced distally, thereby advancing the contact member 204 distally. Furthermore, a core tube 274 may extend proximally from the distal end 218b of the core member 218 and couple with the proximal end 204a of the contact member 204. The pin 268 may extend through a pair of openings formed in the core tube 274 to secure the core tube 274 to the pin 268 and, therefore, to the distal end 208b of the retention member 208. Thus, the core tube 274 may be used to couple the contact member 204 to the retention member 208. A pin, tab, suture, tie, protrusion, clip, indentation, detent, or other feature may be used to connect the proximal end 204 a of the contact member 204 with the proximal end of the core tube 274 .

[0184] Additionally, in any embodiment, the system 200 can be configured such that the implant device 202 is biased proximally relative to the core member 218. For example, without limitation, as shown in FIG. 14 , some embodiments of the implant device 202 can have a suture or thread 280 that extends through the interior of the core member 218 (e.g., 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 withdraw the implant device 202 proximally relative to the core member 218. In this configuration, both ends of the suture 280 can extend from the proximal end of the device 200 such that a physician can grasp both ends of the suture 280 and exert a biasing force around the pin 268 to maintain the pin against the proximal end of the slot 270. When the implant device 202 is ready to be released from the core member 218, the physician can simply release one end of the suture and withdraw the other end of the suture until 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.

[0185] 15 illustrates another embodiment of an implant device 302 in which the contact members 304 are in a second expanded state, the retention members 308 are in a second contracted state, and the fixation element 310 is in a second open state. In any embodiment disclosed herein, any component, feature, or other detail of the treatment system 300 or implant device 302 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100, 200 or implant device 102, 202 embodiments described above, in any combination with any of the treatment system and / or implant device components, features, or details. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein may have any of the components, features, or other details of any of the treatment system and / or implant device embodiments disclosed herein, in any combination with any of the treatment system and / or implant device components, features, or details.

[0186] In any embodiment, the length of the retention members (including retention member 308) and / or the distance between the fixation element and the contact member can be adjusted or varied beyond that shown and described, e.g., to accommodate different anatomical sizes and characteristics of the cavity and / or spaces outside or adjacent to the cavity, or to accommodate different amounts or thicknesses of gathered or twisted cavity tissue. For example, without limitation, in some embodiments, the length of the retention member or the distance between the fixation element and the contact member can be approximately the same as the length of the contact member when the retention member is in a relaxed or folded state (e.g., the second state), or approximately half the length of the contact member when the retention member is in the second state, or between one-quarter and one-half the length of the contact member when the retention member is in the second state, or the like.

[0187] In some embodiments, the contact member 304 may have an annular proximal end 304a, and all (six are shown) of the arms or struts 330 of the contact member 304 extend distally from the proximal end 304a. Further, in some embodiments, the contact member 304 may have an annular distal end 304b, and all of the arms or struts 330 may be coupled to the annular distal end 304b. In some embodiments, the contact member 304 may be laser cut from hypotube or formed from different components and welded, brazed, or otherwise joined together. Each of the strut members 330 may be pre-formed into a curved shape (which may have a rounded or bulbous shape) and may be formed such that the strut members 330 are biased to expand to a second state when no external restraint or constraint is applied to the exterior surface of the contact member 304. The struts 330 may have any form of tissue anchor 332 thereon or attached thereto, such as any of the tissue anchors 118 described above.

[0188] In some embodiments, the contact members 304, retention members 308, and fixation elements 310 can be cut or otherwise integrally formed from a single length of hypotubing. For example, without limitation, the retention members 308 and fixation elements can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact members 304, retention members 308, and / or fixation elements 310 can be formed separately and welded, brazed, or otherwise bonded together to form a single, unitary component. In some embodiments, the distance between the contact members 304 and fixation elements 310 can be greater, for example, without limitation, than the length of the contact members when they are in the second, expanded state, so that the contact members 304 can be advanced further distally into the cavity and then rotated to twist the opening of the cavity and contract the opening of the cavity around the outer surface of the retention member. A longer length of the retention member 310 may accommodate a greater degree of twisting or rotation of the cavity, or a greater number of turns or twists, before the fixation element engages.

[0189] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 310 and can be used to manipulate and control the position and / or orientation of the fixation element 310, including holding the proximal end 310a of the fixation element in a fixed axial position while a distally directed force is exerted on the contact member 304 to maintain the retention member 310 in a first extended state. Additionally, a core member (not shown) can engage the distal end 304b of the contact member 304b to allow a distally directed force to be exerted on the contact member 304. Pins, tabs, sutures, ties, protrusions, clips, indentations, detents, or other features can be used to selectively (i.e., reversibly) couple the contact member 304 to the core member.

[0190] After the desired degree of cavity twisting has been achieved, the fixation element 310 can be moved to a second expanded state, for example, by advancing the fixation element 310 out of the distal end of the delivery catheter tube, expanding the fixation element to its second state. Thereafter, while maintaining the contact members 304 in a desired axial and rotational position (e.g., the second rotational position), the fixation element 310 can be advanced into the contracted tissue around the outer surface of the implant to secure the tissue in its twisted and / or contracted state. In some embodiments, this can be achieved or implemented by simply holding the contact members in a desired position and allowing the retention member 308 to retract to its retracted or relaxed state, thereby advancing the fixation element 310 into the tissue. Once deployment is complete, the user can disengage the core member from the contact members 304 so that the core member can be 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.

[0191] 17 illustrates another embodiment of an implant device 402 in which the contact members 404 are in a second expanded state, the retention members 408 are in a second contracted state (or at least partially contracted or retracted state), and the fixation element 410 is in a second open state. Any embodiment of the treatment system 400 or implant device 402 can have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the treatment system 100, 200, 300 or implant device 102, 202, 302 embodiments described above, in any combination with any of the components, features, or details of the treatment system 400 or implant device 402 described below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any of the components, features, or other details of any of the treatment system 400 or implant device 402 embodiments disclosed herein, in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0192] 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.

[0193] 17 , a pin or cross member 468 may be coupled to the implant device 402, for example, but not limited to, at the distal end 408b of the retaining member 408 or between the retaining member 410 and the contact member 404. The pin 468 may be configured to engage an end of the catheter core member 418 or a feature formed within the distal end of the catheter core member to selectively couple the implant device 402 to the catheter core member, similar to other embodiments disclosed herein.

[0194] 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.

[0195] In some embodiments, the contact member 404, the retention member 408, and / or the fixation element 410 can be laser cut or otherwise integrally formed from a single length of hypotubing. For example, without limitation, the retention member 408 and fixation element can be laser cut from a single length of tubing, e.g., from an elastic or shape-memory material, and then formed into the desired shape. In other embodiments, the contact member 404, the retention member 408, and / or the fixation element 410 can be formed separately and welded, brazed, or otherwise bonded 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 advance further distally into the cavity and then rotate, twisting the opening of the cavity and causing the opening of the cavity to contract around the outer surface of the retention member. A longer length of the retention member 410 can also accommodate a greater number of rotations or twists of the cavity before the fixation element engages.

[0196] An intermediate sleeve or tube (not shown) can be coupled to the fixation element 410 and can be used to manipulate and control the position and / or orientation of the fixation element 410, including holding the proximal end 410a of the fixation element in a fixed axial position, while a distally directed force is exerted on the contact member 404 to maintain the retention member 410 in the first extended state. Deployment of the device 402 can include any combination of the steps described with respect to any of the other embodiments disclosed herein.

[0197] 18-21 show another embodiment of a treatment system 500 having an implant device 502 with a contact member 504 in a second expanded state, a retention member 508 in a second contracted state, and a fixation element 510 in a second open state. Any embodiment of the treatment system 500 or implant device 502 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described embodiments of the treatment system 100, 200, 300, 400 or implant device 102, 202, 302, 402, in any combination with any of the components, features, or details of the treatment system 500 or implant device 502 disclosed herein. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any component, feature, or other detail of any embodiment of treatment system 500 or implant device 502 disclosed herein in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0198] 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.

[0199] Similar to the other embodiments described above, any embodiment of the treatment system 500 can have a suture or thread 580 extending through the interior of the core member 518 (e.g., through a lumen of the core member 518) and looping around the pin 568 or other retention member coupled with the contact member 504, thereby allowing a user to retract or withdraw the suture 580 to draw 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 can extend from the proximal end of the device 500 such that a physician can grasp both ends of the suture 580 and exert a proximally directed force around the pin 568 to pull the contact member 504 toward the fixation element 510, with the pin 568 positioned within the slot 570 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 position to the second, engaged position (shown in FIGS. 18-21 ).

[0200] In some embodiments, when the contact members 504 are maintained in a fixed position using the catheter or core member 518, the user can move the fixation element 510 from the first position to the second position by pulling back or withdrawing the suture 580 (while the contact members 504 are held in a fixed position within the cavity) 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 cavity has been achieved by twisting or torquing the core member 518 or other portions of the catheter. With reference to FIG. 19 , in some embodiments, this can involve advancing the fixation element 510, and the body portion 572 of the fixation element, distally relative to the contact members 504, thereby forcing the fixation element into tissue of the cavity, or tissue adjacent to or outside the cavity, to hold the tissue in a closed or contracted position.

[0201] Additionally, any embodiment of the device can be configured to use a retention member to prevent the fixation element 510 from moving away from the second position toward the first position when the fixation element 510 is advanced to the second position and engages tissue to hold the cavity in an occluding or closed position, thereby maintaining the position of the fixation element and maintaining occlusion of the cavity. For example, without limitation, one or more tabs 582 formed on or coupled with the body portion 584 of the contact member 504 can be biased into or into engagement with each of the plurality of recesses or openings 586 to prevent or inhibit the fixation element 510 from moving back toward the first position relative to the contact member 504. The tabs 582 (which may be any other type of locking feature, such as a ball and detent, or a zip-tie type locking feature, or otherwise) can be configured to allow the fixation element 510 to move freely from the first, expanded position to the second, collapsed position and selectively prevent or inhibit movement from the first position to the second position, thereby essentially locking the fixation element in the second position. 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, but not limited to, sutures with slip knots that can be tightened during deployment. The sutures can then be trimmed to length during final deployment to hold the fixation element and contact members together and maintain the cavity 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.

[0202] In some embodiments, the implant device 502 may be configured such that the ratchet or retention mechanism formed by the engagement of the tabs 582 and the openings 586 is reversible or removable, such that the fixation element can be moved from a second position to or toward a first position to disengage the fixation element from tissue, for example, to re-twist or otherwise reposition the cavity. For example, some embodiments of the implant device 502 may be configured to rotate or twist the fixation element (and thus the tab(s) 582) relative to the body portion 584 of the contact member 504 such that the tabs 582 disengage the openings 586. Further, in some embodiments, the tabs may be positioned on the body portion 584 of the contact member 504, and the openings may be formed in the body portion of the fixation element 510. Furthermore, the tabs may be formed in both directions such that the fixation element can ratchet or be selectively locked in both axial directions of movement. Additionally, in any of the embodiments disclosed herein, the tabs may be shaped and configured such that they are movable from a locked position or state to an unlocked (or sliding) state. Examples of these embodiments are described below.

[0203] FIG. 22A illustrates another embodiment of a treatment system 600 having an implant device 602 with the contact members 604 in a second, expanded state and the fixation element 610 in a first, retracted, or pre-deployed state. FIG. 23 illustrates an embodiment of an implant device 602 with the fixation element 610 moved to a second, deployed, or locked state. FIGS. 24-35 illustrate an embodiment of a method of deployment of the embodiment of the treatment system 600 illustrated in FIGS. 22-23. Any embodiment of the treatment system 600 or implant device 602 can have any of the components, features, or other details of any other implant device embodiment disclosed herein, including, but not limited to, any of the embodiments of implant devices 100, 200, 300, 400, and 500 described above, in any combination with any of the components, features, or details of the treatment system 600 or implant device 602 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any component, feature, or other detail of any embodiment of treatment system 600 or implant device 602 disclosed herein in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0204] 22A-22B, the fixation element 610 may have a body portion 611 that may have a curved or helical (or corkscrew) shape that may extend from the proximal end 610a of the fixation element 610 to the distal end 610b of the fixation element 610, and may have a pointed distal tip 612 at the distal end 610b of the fixation element 610 that may engage with (or, in some embodiments, at least partially penetrate) tissue of the cavity and / or tissue outside or adjacent the cavity after the contact member 604 is rotated to a second position, thereby securing the tissue and closing or occluding the opening of the cavity 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.

[0205] The fixation element 610 may define an axial opening 615 therethrough. In some embodiments, the opening 615 may be larger than the distal portion of the catheter's inner core member and / or the implant's body portion 614, such that the fixation element 610's body portion 611 wraps around or curves (helically or otherwise) and / or is rotatable around the catheter's inner core member and / or the implant's body portion 614.

[0206] 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 .

[0207] Additionally, in any embodiment disclosed herein, the fixation element 610 may also have a rotational or axial locking feature that can secure the fixation element in a desired rotational and / or axial position and / or inhibit reversal of the fixation element. The rotational or axial lock may be selectively reversible, allowing the user to return the fixation element to a freely movable state as desired. For example, without limitation, with reference to FIGS. 23C-23D , any embodiment of the fixation element disclosed herein may have one or more tissue anchors or barbs 621 extending away from the proximal end 610 a of the fixation element 610 to improve the fixation element's grip on the target tissue and / or prevent or inhibit the fixation element 610 from retracting out of the tissue after the fixation element 610 has been advanced into such tissue. In any embodiment, the tissue anchors or barbs 621 may face axially, radially, or at an angle relative to the axial direction of the fixation element 610. The tissue anchors or barbs 621 may be angled or otherwise configured to easily penetrate tissue, have vertical faces or otherwise be configured to engage and / or lock with tissue to prevent re-rotation of the fixation element 610.

[0208] 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.

[0209] As mentioned above, in some embodiments, the fixation element 610 may have two or more curved or spiral (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 in the cavity and / or tissue in spaces outside or adjacent to the cavity after the contact member is rotated to the second position. In any embodiment disclosed herein, a fixation element having a spiral shape (such as the embodiment of the fixation element 610 shown in FIGS. 22A-22B) may have two spiral-shaped body portions 611, each of which may be configured to penetrate and engage tissue that has contracted around a portion of the implant. In any embodiment, including the 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 may engage all or only a proximal portion of the tissue of the cavity and / or tissue outside or adjacent to the cavity, such as approximately 1 mm to approximately 2 mm of the tissue of the cavity and / or tissue outside or adjacent to the cavity, or approximately 2 mm to approximately 5 mm of the tissue of the cavity and / or tissue outside or adjacent to the cavity, or more.

[0210] Additionally, in any embodiment, one or more body portions 611 may define a cylindrical shape along the length of the fixation member 610, as shown, a conical shape along the length of the fixation member 610, or the like. For example, without limitation, in any embodiment, 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 can cause tissue to be gathered and packed widely (i.e., radially inward) as the fixation element 610 is advanced into tissue of the cavity and / or tissue in spaces outside or adjacent to the cavity.

[0211] 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 cavity and / or tissue of spaces outside or adjacent to the cavity that have gathered around the body portion 614 or other portions of the implant device 602. In this configuration, the fixation element 610 is configured to be rotatable relative to the contact member 604 such that holding the contact member 604 in a stationary position allows the fixation element 610 to be rotated to pass through tissue of the cavity and / or tissue of spaces outside or adjacent to the cavity while the cavity is held substantially stationary in a second rotated position. In any embodiment, a sleeve or other component of the catheter or delivery system engages a fixation element (including, but not limited to, fixation element 610) to allow a user to move the fixation element from a second state to a first state (which should be interpreted as including movement from the second state to the first state), rotate the fixation element in either direction, move the fixation element between a first position and a second position, and / or otherwise manipulate the fixation element. In some embodiments, the catheter or delivery system may be configured to perform these actions independently of any other movement or movement of the catheter, such as, for example, allowing the fixation element to be advanced axially toward the contact member while the contact member is held in a fixed position by the catheter.

[0212] The fixation element 610 can thereby hold tissue of the cavity and / or tissue of the space outside or adjacent to the cavity in a contracted state around the implant device to occlude the cavity. 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 rotation of the contact member 604 toward the first position. In any embodiment, the fixation element 610 and / or contact member 604 can have one or more teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue-engaging features or anchoring members around the exterior surface of the fixation element 610 to prevent or inhibit the fixation element 610 from disengaging from tissue in the cavity and / or tissue outside or adjacent to the cavity when in the second condition. Additionally, in any embodiment, the fixation element can be biased to the second position by a biasing member (not shown), such as an axially resilient member, or using one or more sutures, wires, ratchets, tabs and openings, or other locking features. However, in some embodiments, engagement of the fixation element 610 with tissue in the cavity and / or tissue outside or adjacent to the cavity can be sufficient to secure the fixation element 610 in the second position and maintain the cavity in an occluded state.

[0213] 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 cavity. With reference to Figure 27, the contact member 604 can be advanced to any desired depth, including to the end of the cavity. In some embodiments, the contact member 610 can be advanced to a desired position relative to the cavity and then expanded to a second state to contact the interior surface or tissue of the cavity. 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 the second position to twist the cavity in the first direction toward the second state, as also shown by arrow A3 in Figures 28-29. As explained, twisting can cause the opening of the cavity to contract around a portion of the body of the implant device 602, sealing the cavity from the LA, as shown in Figures 28-29.

[0214] 30-31 , while maintaining the contact member 604 in the second rotational position and / or maintaining the tissue of the cavity and / or tissue outside or adjacent to the cavity in an occluded or contracted state and the cavity 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 cavity and / or tissue outside or adjacent to the cavity contracted around the body of the implant device. Before the distal end of the fixation element 610 reaches the tissue of the cavity and / or tissue outside or adjacent to the cavity, 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 to penetrate and / or engage the tissue of the cavity and / or tissue outside or adjacent to the cavity contracted around 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 cavity and / or tissue outside or adjacent to the cavity, as shown in Figures 34-35. In some embodiments, the fixation element 610 can be configured to engage and / or only partially penetrate the tissue of the cavity and / or tissue outside or adjacent to the cavity. The implant device 602 is then released from the delivery catheter, and the delivery catheter can be withdrawn from the space outside or adjacent to the cavity, which may be the heart or any other organ or space within the body, leaving the cavity in an occluded position, as shown in Figures 34-35.

[0215] 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 backing member 654 coupled to the proximal end 652a of the fixation element 652 that can provide an additional seal against tissue in the cavity and / or tissue outside or adjacent to the cavity when the fixation element is in the second or deployed position.

[0216] 37-38 show another embodiment of a treatment system 700 having an implant device 702 with the contact members 704 in a second expanded state and the fixation elements 710 in a second open state. Any embodiment of treatment system 700 or implant device 702 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment system 100, 200, 300, 400, 500, 600 or implant device 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or details of treatment system 700 or implant device 702 disclosed below; similarly, a component, feature, or other detail of any other treatment system or implant device embodiment disclosed herein may have any of the components, features, or other details of any of the treatment system or implant device embodiments disclosed herein, in any combination with any of the components, features, or details of treatment system or implant device embodiments disclosed herein.

[0217] In any embodiment, the contact member 704 may have a body portion 706, which may, but need not, have a cylindrical shape. An opening or recess 708 may be formed in the body portion 706 as part of a retention element to hold the fixation element 710 in a desired axial position relative to or locked to the coupling member 704. The fixation element 710 may also have a body portion 712, which may, but need not, have a cylindrical shape. In some embodiments, the body portion 712 may extend into the body portion 706 of the contact member 704 even when the fixation element 710 is in the first retracted state. The body portion 706 may have an opening 708 extending therethrough and sized and configured to selectively receive the body portion 712 of the fixation element 710. The body portion 712 may have an opening 722 extending therethrough and sized and configured to selectively receive a core member 720 of a delivery catheter of the treatment system 700.

[0218] 39, the fixation element 710 may have a deflectable tab member 714 that is movable or can be moved from a first engaged position (as shown in FIG. 37) to a second disengaged position (as shown in FIG. 38). The tab member 714 may be configured to rotate about a pin that may be coupled with the tab member 714 and the body portion 712, or may be configured to rotate about a thin strip of material (referred to herein as material strip 715) used to form the body portion 712 and / or tab member 714. For example, without limitation, the body portion 712, the tab member 714, and one or more material strips 715 (two shown) may be integrally formed. Furthermore, in some embodiments, one or more arms 711 (four shown) of the fixation element 710 may also be integrally formed with other features of the fixation element 710. In some embodiments, the tab 714 may be biased toward a first engaged position (as shown in FIGS. 37 and 39 ), but is physically deflectable or rotatable toward a second disengaged position (as shown in FIG. 38 ) by advancing a core member 720 or other component through an opening 722 extending through the body portion 712 of the fixation element 710. For example, without limitation, as shown in FIG. 38 , the core member 720 may be advanced distally through the opening 722 of the fixation element 710 to deflect or rotate the tab member 714, thereby moving the tab member 714 from the first engaged position to the second disengaged position.

[0219] 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 cavity to a closed or obstructed position or condition, as described above. However, in some embodiments, if a user desires to disengage or separate the fixation element 710 from the contact member 704, the user can accomplish this by moving the tab member 714 to, for example, as described above and without limitation, a second disengaged position, thereby disengaging the tab member 714 from the opening 708. The user can then axially retract the fixation element 710.

[0220] 40-43 illustrate another embodiment of an implant device 732. Any embodiment of the implant device 732 can have any of the components, features, or details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment systems 100, 200, 300, 400, 500, 600, 700, or implant devices 102, 202, 302, 402, 502, 602 embodiments, in any combination with any of the components, features, or other details of the implant device 732 disclosed below. Similarly, any component, feature, or other detail of any of the other treatment system or implant device embodiments disclosed herein can have any of the components, features, or other details of any of the implant device 732 embodiments disclosed herein, in any combination with any of the components, features, or other details of the treatment system or implant device embodiments disclosed herein.

[0221] As shown in FIG. 40 , the deflectable tab member 744 of the implant device 732 engages with the opening 738 of the contact member 734, thereby engaging the fixation element 740 with the contact member 734. In any embodiment, the deflectable tab member 744 is movable or can be moved from the first engaged position (shown in FIG. 40 ) to the second disengaged position (shown in FIG. 41 ) by distally advancing the fixation element 710 such that the body portion 739 of the contact member 734 changes and moves the tab member 744 to the second disengaged position, as shown in FIG. 41 . Thereafter, the fixation element 740 can be rotated in either direction (e.g., by 90 degrees) to a position where the tab member 744 is not aligned with, and therefore cannot be engaged with, the opening 738, as shown in FIG. 42 . The body portion 739 of the contact member 734 can hold the tab member 744 in the second, disengaged position while the securing element 740 is withdrawn or disengaged from the contact member, as shown in FIG.

[0222] Figures 44A and 44B are front and side views, respectively, of another embodiment of a treatment system 750 configured to twist and close or occlude a cavity at its opening. Figures 45A and 45B are front and side views, respectively, of the treatment system 750 of Figure 44, showing an implant used to twist the cavity to close or occlude the cavity at its opening. The cavity, or tissue of the cavity and / or tissue opening in the space outside or adjacent to the cavity, contracted around the implant device can be clipped or locked in the contracted state, as in any embodiment disclosed herein, and using any fixation feature or component disclosed herein. Figures 46A and 46B are side views, respectively, of the treatment system of Figure 44, showing the delivery device being removed from the implant device after the cavity has been occluded.

[0223] In some embodiments, the deploying and implanting steps can include, in any combination, and in any combination with any other steps, (a) inserting a catheter and implant device through the cavity opening; (b) rotating a contact member or other engaging component of the implant to twist the cavity and fold at least the opening of the cavity onto itself, thereby closing or occluding the cavity opening; (c) clipping, holding, or securing tissue in the cavity and / or tissue outside or adjacent to the cavity in an occluded or closed state; and / or (d) releasing and withdrawing the delivery catheter from the implant. As shown in the figures, the treatment system twists the cavity closed at the opening and clips to hold it in place, effectively closing the cavity. In some embodiments, the deploying and implanting steps include inserting a catheter centered in the cavity opening; rotating a paddle of the implant to twist the cavity and cause it to self-fold; clipping and holding it in place against the atrial wall; and releasing the delivery catheter from the implant.

[0224] 47A-47F illustrate another embodiment of a treatment system 1100 for closing or occluding a cavity having an embodiment of a delivery device 1101 and an expandable cavity implant or implant 1102, 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.

[0225] The barbs 1108 may be configured to engage tissue upon torsional movement or motion of the body portion 1104 relative to the interior wall of the cavity after the body portion 1104 is expanded from the first state to the second state, wherein the struts 1106 and barbs 1108 can engage or contact tissue on the interior wall of the cavity. Additionally, any embodiment of the implant 1102 can have one or more anchor elements 1112 configured to engage tissue adjacent to or surrounding the cavity to prevent the implant 1102 from rotating back to the first rotated position after the implant 1102 is rotated to the second rotated position within the cavity. In any embodiment, the anchor element 1112 can include two arms or members, each capable of engaging a tissue surface and each having multiple barbs thereon, configured to prevent the implant from rotating back to the first rotated position. 48A-48E illustrate several stages or steps illustrating the deployment procedure of the expandable implant 1102 of FIGS. 47A-47F as the implant 1102 is deployed within the cavity.

[0226] 49A-49G illustrate an embodiment of an implant 1202 that can be used to close or substantially close a cavity. In some embodiments, the implant 1202 can be formed by laser cutting a tube of a resilient material such as Nitinol. The implant 1202 and any other implant embodiments disclosed herein can be self-expanding or mechanically expandable, such as using balloon expansion techniques. Additionally, any embodiment of the implant 1202 can have any of the same features, components, or details of any other implant embodiment disclosed herein, instead of, or in combination with, any of the features, components, or details of the embodiments of the implant 1202 disclosed herein. In some embodiments, the implant 1202 can have a contact member 1204 that can be covered with multiple microbarbs or other tissue anchors 1208 and a fixation element 1212 (also referred to herein as an anchor element) that can include a single foldable clip anchor. The fixation element 1212 can be configured to lock the implant 1202 in a fixed rotational position after the implant has rotated the cavity to the desired level of twist and closure or occlusion.

[0227] 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 cavity. In any embodiment, the implant 1202 can be advanced into the cavity, expanded, and then rotated from a first rotational position to a second rotational position to twist the cavity and cause the cavity opening and / or other tissue to contract or close around a portion of the implant 1202. The implants disclosed herein, or any implants, can be configured to rotate clockwise (and rotate clockwise and / or counterclockwise during any procedure disclosed herein) to twist closed or substantially close the cavity opening or to contract the cavity opening 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) to the side of the cavity so that it is approximately perpendicular to the axial centerline of the implant, and can forcibly engage tissue adjacent to the cavity adjacent the cavity opening to prevent unwinding of the implant and opening of the cavity. The body portion of the fixation element 1212 can have tissue anchors 1216 thereon, coupled to, or integrally formed therewith that can engage, penetrate, and / or grasp tissue in the cavity and / or tissue outside or adjacent to the cavity that has contracted as a result of twisting the cavity. 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 .

[0228] 51, 52, and 53 illustrate additional embodiments of implant devices 1220, 1222, and 1224 (note that implant devices are also referred to herein as implants) that can be used in conjunction with any of the treatment system, delivery device, or procedure embodiments disclosed herein to treat cavities. The implant device 1220 shown in FIG. 51 can have ribbons or struts made from 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 point in one or both circumferential directions. The implant device shown in FIG. 52 can have a stent-like body made from nitinol or any other suitable material that is self-expanding or balloon-expandable into an approximately spherical or elongated spherical shape. The body of the implant can be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors). 53 may be made from nitinol or any other suitable material and may have a woven wire body that may be configured to expand into an approximately spherical or elongated spherical shape. The body of the implant device 1224 may be uniformly or otherwise covered with small barbs or cleats (or other tissue anchors).

[0229] 54 illustrates another embodiment of an implant device 1230 that is (or can be) expanded to an approximately spherical or elongated spherical shape. For example, without limitation, the implant device 1230 can be configured with an inflatable balloon covering that expands the implant device 1230 into contact with the tissue of the cavity when the implant device 1230 is in a desired position within the cavity. The implant body 1230 is covered with small barbs or cleats or other tissue anchors.

[0230] FIG. 55 illustrates another embodiment of an implant device 1232 that can be used with any of the treatment system embodiments disclosed herein. In some embodiments, the implant device 1232 can have a helical-shaped body when in a second, expanded state that can be used to exert at least a torque and twisting effect on the cavity. 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.

[0231] 56A-56B illustrate an embodiment of a treatment system 1240 having an implant device 1242 generally contained within a catheter body 1244 of the treatment system 1240 in FIG. 56A , with at least a contact member 1246 of the implant device 1242 in a second, expanded state in FIG. 56B . The contact member 1246 can have multiple barbs or anchor members around its outer surface and can be configured to expand into an approximately spherical or elongated spherical shape. The contact member 1246 can be self-expanding or mechanically expandable and can have a half-dome shape with a rounded distal end 1248. In some embodiments, the rounded end 1248 can be approximately the same size as the internal lumen of the delivery system, or can be smaller or larger and expandable.

[0232] 57-61 show additional different embodiments of anchor or fixation elements that may be used with any of the other components of the implant device embodiments disclosed herein. Fig. 57A shows an embodiment of a dual-arm fixation element. Fig. 57B shows the dual-arm fixation element of Fig. 57A retracted around the body portion of the implant device and advanced into tissue of the cavity and / or tissue outside or adjacent the cavity adjacent the opening of the cavity.

[0233] 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 being rotated or clipped against tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening, retracted around the body portion of the implant device. In any embodiment, the fixation element can be biased to remain in the fixed or locked position. FIG. 59A shows an embodiment of a disc anchor or fixation element. FIG. 59B shows the circular disc fixation element of FIG. 59A being advanced toward tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening, retracted around the body portion of the implant device, such that one or more tissue anchors of the fixation element of FIG. 59A can engage and / or penetrate the tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening.

[0234] FIG. 60A shows an embodiment of a single foldable clip anchor or fixation element with a helical or screw-type tissue anchor that can be used to engage and / or penetrate tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening, retracted around the body portion of the implant device. FIG. 60B shows the single foldable clip anchor or fixation element of FIG. 60A rotated or clipped against tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening, retracted 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 with two helical or screw-type tissue anchors. FIG. 61B shows the dual-arm fixation element of FIG. 61A rotated against tissue of the cavity and / or tissue outside or adjacent to the cavity adjacent the cavity opening, retracted around the body portion of the implant device, allowing the tissue anchors on the arms to engage and / or penetrate into 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.

[0235] 62A-62B show side and end views of different embodiments of contact members that can be deployed within a cavity to engage tissue in the cavity such that the cavity twists when torque is applied to the contact member. FIGS. 62A-62B show contact member embodiments having cylindrical or disc-shaped body portions, spherically shaped body portions, conical shaped body portions, and hemispherically and / or semispherically shaped body portions configured to better engage or bond with cavity tissue. Any of the contact member embodiments shown in FIGS. 62A-62B can have multiple barbs, microbarbs, or other tissue anchors on their exterior surfaces. Additionally, any of the contact member embodiments shown in FIGS. 62A-62B can have an exterior surface uniformly covered with barbs, microbarbs, 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 flat region on a portion thereof to allow for a lower profile. Figure 63 shows a side view of an embodiment of a contact member expanded against the tissue surface of the cavity after torque has been applied to the contact member causing contraction of the LA / cavity tissue around a portion of the body of the implant device. Figure 63 also shows a tissue anchor of the implant device advanced into the LA / cavity tissue to secure the cavity in a second position.

[0236] Additionally, any embodiment of the implant disclosed herein may have a drug coating, a fabric or other at least substantially impermeable covering (similar to, but not limited to, the cover member 121 described above), electrical contacts to eliminate conduction of the electrical signals that cause Afib, or other features to improve the performance of the implant. Some embodiments of the implant may be delivered percutaneously via a catheter and a detachable element between the implant element and the delivery system, which would allow for permanent separation and thus permanent implantation of the implant. Furthermore, in any embodiment disclosed herein, the implant may be delivered without the use of a catheter, for example, surgically or otherwise.

[0237] Some embodiments include a device for closing or occluding a cavity 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 cavity. The implant can be advanced into the cavity when the implant is in the first state, and the implant moves from the first state to the second state after the implant is advanced into the cavity such that at least some of the plurality of tissue anchors engage an inner wall surface of the cavity. Any embodiment of the implant or insert can have multiple tissue anchors on its exterior surface.

[0238] Additionally, the catheter can be configured to rotate the implant in a first direction from a first rotational position to a second rotational position, allowing the implant to twist the wall of the cavity. As described above, the catheter can rotate the implant 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 cavity on the implant itself, or about the exterior surface of the implant.

[0239] Any embodiment of the implant is self-expandable so that the implant automatically expands when the 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 may be biased to maintain the expanded state after deployment into the cavity.

[0240] 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 surface of a cavity 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 opposite the first direction.

[0241] In any embodiment, as described above, the implant can be configured to prevent the contact members from rotating back to the first rotational position after they are 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 cavity, such as tissue on the inner wall of a space outside the cavity. Some embodiments of the implant can have a fixation element with multiple tissue anchors configured to engage the inner wall of a space outside or adjacent to the cavity.

[0242] For example, without limitation, the implant of any of the device, device, and method embodiments disclosed herein can include a fixation element configured to engage with the inner wall of the cavity exterior or adjacent space. The fixation element can have one or more arms and / or tissue anchors configured to engage with the inner wall of the cavity exterior or adjacent space, or can be configured to be sutured or otherwise attached to the inner wall of the cavity exterior or adjacent space. In any embodiment, the implant can be configured to prevent or inhibit reverse rotation of the contact member or other portion of the implant to a first rotational position after the contact member or other portion of the implant is fully deployed. In any embodiment, the implant can 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.

[0243] 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.

[0244] Several embodiments of methods for closing or occluding a cavity 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 members into a space outside or adjacent to a cavity in a patient, moving or expanding a portion of the implant from a first state to a second state within the cavity or the space outside the cavity, such that the expandable member or contact members are substantially collapsed in the first state and expanded in the second state, engaging a wall portion inside the cavity with the expandable member or contact members (which may, but need not, have one or more tissue anchors on their outer surface), rotating the expandable member or contact members from a first rotated position to a second rotated position to twist the wall portion inside the cavity, and preventing the expandable member or contact members from rotating back to the first rotated position. Any portion of the implant, including but not limited to the expandable member or contact member, may be self-expanding, and moving the expandable member or contact member from the first state to the second state includes advancing the expandable member or contact member out of the distal end of the deployment device.

[0245] Furthermore, in any embodiment disclosed herein, engaging the inner wall portion of the cavity can include engaging the inner wall portion of the cavity with one or more tissue anchors positioned on an exterior surface of the expandable member or contact member or other portion of the implant. Furthermore, preventing the implant from rotating back to the first rotated position can include engaging a tissue wall outside the cavity with an anchor or fixation element. In some embodiments, the anchor or fixation element can be rotationally fixed to the expandable member or contact member and / or other portion of the implant to prevent relative movement between the anchor element and the expandable member or contact member and / or other portion of the implant. Preventing the expandable member or contact member and / or other portion of the implant from rotating back to the first rotated position can include engaging a tissue wall outside or adjacent the cavity with the anchor or fixation element, and the anchor element can be rotatably fixed relative to the implant and configured to prevent the expandable member or contact member and / or other portion of the implant from rotating back to the first rotated position or from engaging an inner wall outside the cavity 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 being configured to engage with the inner wall of an outer or adjacent space of the cavity.

[0246] In any embodiment disclosed herein, the implant may be configured to automatically rotate from a first rotational position to a second rotational position after the contact member and / or other portions of the implant are in the second state, or may be activated to self-rotate at any desired time. For example, without limitation, the implant may have a spring or other torsion member configured to rotate the contact member and / or other portions of the implant or other portions of the body of the implant upon release or activation of the spring, or may be configured to be pre-wound or pre-twisted 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 cavity and after a portion of the implant engages at least a portion of the inner wall surface of the cavity, such that rotation or twisting of a portion of the implant can cause twisting of the cavity, thereby closing or occluding the opening of the cavity.

[0247] 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 twisting of the cavity as a result of torsional release of the shaft or a spring surrounding at least a portion of the shaft.

[0248] 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 a wall or tissue outside or adjacent to the cavity before the shaft or body portion engages with an inner wall portion of the cavity and before the shaft or body portion is rotated to the second position.

[0249] Further, in any device, implant device, method, or other embodiment disclosed herein, the second rotational position can be at least or approximately one-eighth of a full rotation (i.e., 45 degrees or approximately 45 degrees) relative to the first rotational position, at or approximately one-quarter of a full rotation (i.e., 90 degrees or approximately 90 degrees) relative to the first rotational position, or at least or approximately half of a full rotation (i.e., 180 degrees or approximately 180 degrees) relative to the first rotational position, or the second rotational position can be from at or approximately one-eighth of a full rotation (i.e., 45 degrees or approximately 45 degrees) to at or approximately half of a full rotation (i.e., 180 degrees or approximately 180 degrees) relative to the first rotational position. In any device, 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 or approximately 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 approximately 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 approximately 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.

[0250] Further, in embodiments of any device, implant device, or method disclosed herein, the catheter can be configured to exert a torque on the implant to rotate the implant from the first rotation 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 can 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.

[0251] 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.

[0252] 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.

[0253] Another embodiment of the implant device 1920 is configured to fold or twist the cavity at the opening and then clip to hold the position, effectively closing the cavity. Figures 64A-64D show one variation of a series of steps to accomplish this. In some embodiments, the deployment and implantation steps include inserting a catheter centered in the cavity opening, bending a portion of the implant 1920 in a first direction (which may be upward as shown), clipping the bent portion of the implant 1920 to the chamber wall to hold the position (using an additional anchor to secure the implant to the lower chamber wall), and / or releasing the delivery catheter from the implant 1920.

[0254] Additionally, any embodiment of the devices and methods disclosed herein may be adapted or modified for use with a robotic surgical device or apparatus. For example, without limitation, any of the deployment catheters disclosed herein may be modified for use with such robotic surgical devices and apparatus. All such applications of the devices and methods disclosed herein for use with robotic systems are contemplated as forming part of this disclosure.

[0255] Also described herein are novel devices, systems, and methods for reshaping, closing, or occluding cavities, occluding or obstructing holes, slits, valves, and other openings within the body, such as tissue or blood vessels, valves, passageways, organs, and other tissue bodies, and / or treating other conditions for which closure or obstruction is desirable. In any embodiment disclosed herein, the cavity, opening, blood vessel, valve, and / or tissue may be a surface wound, an internal wound, a chamber, a valve, or tissue of a cavity in the heart, lung, stomach, or other organ, a gastrointestinal chamber or cavity, a blood vessel or other duct, or tissue of any other chamber or enclosure within the body (which may be the body of any living being), including chambers and pockets within the body created by the methods and devices disclosed herein, such as for volumetric reduction of a chamber or tissue collection, as further described below. All such conditions that any embodiment of the devices and methods disclosed herein may be configured to treat are collectively referred to herein as cavities, and as a result, unless specifically stated otherwise, any use of the term cavities is meant to include any of the above-mentioned conditions or abnormalities.

[0256] Some embodiments include advancing a treatment system into a cavity (internal or external), advancing and deploying a contact member, which in some embodiments may be covered with barbs, texture, or other tissue-engaging features, or alternatively may be smooth, into the cavity, allowing the contact member to distally and / or radially engage the inner wall surface of the cavity, and applying a rotation to an inner catheter member connected to the contact member to twist the cavity and close and / or occlude the cavity. The cavity may close near the entrance of the cavity opening. For superficial wounds, the cavity can be closed near the surface of the wound, drawing the tissue surrounding the wound together to close the wound.

[0257] By reforming, closing, and / or occluding the cavity, some embodiments disclosed herein can effectively seal the wound, reducing the risk of wound exposure or infection and halting blood loss through the wound. Any of the methods of deployment disclosed herein can 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 contact members, thereby inhibiting or preventing untwisting of tissue pulled by the treatment device. When used to treat internal cavities and / or when applied to an external surface of the body, the fixation element of any embodiment disclosed herein can have a low profile to limit the amount of the implant that protrudes away from the tissue surface, thereby reducing the impact the implant has on the function of the organ in which it is placed. For example, in the stomach, in some embodiments, the fixation element can be configured to be flush or nearly flush with the inside of the tissue surface, or to protrude only slightly away from the tissue surface (e.g., in some embodiments, approximately 5% or less of the total length of the implant in the implanted state, or approximately 10% or less of the total length of the implant in the implanted state, or approximately 15% or less of the total length of the implant in the implanted state). In some embodiments configured to treat superficial wounds, the fixation element can be configured to be flush or nearly flush with the epidermis, or to protrude only slightly away from the tissue surface (e.g., in some embodiments, approximately 5% or less of the total length of the implant in the implanted state, or approximately 10% or less of the total length of the implant in the implanted state, or approximately 15% or less of the total length of the implant in the implanted state). In some embodiments, the entire implant can be surrounded by tissue of the cavity tissue such that no portion of the implant is exposed to blood flow within the cavity, or only a minimal portion (e.g., less than 10% of the surface area, or less than 40% of the surface area) is exposed. Any of the devices used in any of the methods described herein may be advanced under any of a variety of visualization techniques, such as, for example, visualization under fluoroscopy, ultrasound, etc.

[0258] Any embodiment of the implant disclosed herein has an expandable, atraumatic shaped contact member, including tissue-grasping features located on the outer edge of the shape, coupled to a fixation element function that holds the implant in a final closed position. Any embodiment of the implant disclosed herein can be configured to grip the internal tissue of the cavity with a radial force. The contact member of any embodiment disclosed herein can be a spherical, dome-shaped, or atraumatic shape including a coil of wire in a disk shape, can have an expanded cut pattern in the shape of a stent, or can have any other shape that can have rounded edges. In some embodiments, the surface of the contact member, such as the exterior surface of the contact member, may have barbs (which may be tissue anchors), metal hooks, plastic cleats, rough texture or surface features, a coating or activated adhesive configured to grip the interior surface of the cavity, teeth, cleats, barbs, nubs, texture, studs, anchors, or other tissue-engaging mechanisms configured to penetrate or engage tissue in the cavity, or other similar features (collectively referred to herein as tissue anchors, and the use of this term is meant to describe and include any of the foregoing features individually and / or any combination of these features). Furthermore, in any embodiment disclosed herein, the tissue anchors may be positioned on or adjacent the end of the implant for engagement with the end of the cavity. In any embodiment, the barbs may be oriented to allow tissue engagement in one rotational direction and disengagement in the opposite rotational direction for possible repositioning, resizing, or removal from the cavity.

[0259] For any embodiment disclosed herein, the rotation used to twist closed or (completely or substantially) occlude the cavity can be as little as a quarter turn (i.e., a rotation), half a turn, one full turn, or up to multiple turns for deeper or longer cavities or applications requiring additional rotations, such as volume reduction of the gastric chamber. 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 coupled to the implant body to be positioned and rotated within the closed or substantially closed cavity. The fixation feature or element can be configured to engage tissue adjacent to the cavity. In any embodiment, the fixation element can have multiple arms or members, or any other suitable shape of anchor configured to engage tissue and prevent it from untwisting or unraveling. In some embodiments, the fixation element can have an annular ring and can have a cover member, such as a disk, proximal to the arms and configured to provide a cover or seal over the implant. In some embodiments, the fixation element can also have a smaller diameter ring that can be configured to clamp or engage tissue that contacts the implant's central hub (adjacent the cavity opening). Or it can have clips that fold and fasten the implant to the side of the wall of the space outside or adjacent to the cavity.

[0260] FIG. 65A shows an embodiment of a treatment system 4100 having a delivery catheter or other delivery device 4102 advanced toward a wound on the surface of the body and a wound W having a cavity C. An implant device 4103 is supported within or by the delivery device 4102. As used herein, a wound can be any type of surface wound, an internal wound within the body, or other condition where there is separation of tissues intended to be joined, including chronic wounds, gunshot wounds, traumatic wounds, combat wounds, or others. The delivery device 4102 can be advanced into the cavity C of the wound W, as shown in FIG. 65B. A sheath or sleeve 4112 (which can be an intermediate sleeve or an outer sleeve) of the delivery device 4102 can then be retracted to expose a contact member 4104 that can expand within the wound cavity C. In some embodiments, the contact members may have a series of self-expanding struts or arms made from a shape memory material such as Nitinol, or may be any other expandable device such as an expansion balloon used to expand a stent or other expandable implant or the like.

[0261] A user of the treatment system 4100 can advance the contact member further into the cavity to position the contact member 4104 at any desired depth. In any embodiment disclosed herein, the contact member 4104 can be self-expanding, such that it expands against one or more walls of tissue within the cavity as it advances out of the sleeve 4112 of the delivery device. In other embodiments, the contact member 4104 can be an expandable device that is mechanically expanded using a balloon or other mechanical mechanism to expand the arms or outer surface of the contact member against the tissue surface.

[0262] Once the contact member 4104 is in a desired position within cavity C such that the contact member 4104 contacts one or more surfaces of the cavity, the core member 4113 of the delivery device 4102, which is rotatably coupled to the contact member 4104, is rotated to rotate the contact member 4104 as shown by the arrow in FIG. 65D and twist the tissue associated with the cavity. The contact member can be rotated in either direction. As shown in FIG. 65E, the twisting of the tissue within the cavity causes the tissue to fold around the implant device 4103, such as a body portion of the implant device 4103 that can be used to connect the contact member 4104 to a fixation element or portion of the delivery device, such as the core member 4113. In any of the embodiments disclosed herein, the folding of the tissue in the cavity or wound can result in complete closure of the cavity or wound, significantly complete closure of the cavity, significant obstruction of the cavity, and / or a significant reduction in the surface area of ​​the wound surface, for example, in a superficial wound (the foregoing conditions are collectively referred to as the second condition).

[0263] Sutures, staples, or other tissue fasteners can then be used to hold the edges of the cavity together or in a position resulting from twisting or rotation of the contact member. Alternatively, in some embodiments, referring to FIGS. 65F-65G, the fixation element 4110 can be deployed from the delivery device 4102, where it can engage and couple with the tissue surrounding the cavity or unfixed tissue, or the tissue surrounding the cavity or wound, in a position resulting from twisting or rotation of the contact member. The fixation element 4110 can have any form of tissue anchor or anchors thereon extending away from the tissue-facing surface of the fixation element 4110, including features of any of the other tissue anchors disclosed herein with respect to any other embodiment disclosed herein. Additionally, in some embodiments, the fixation element 4110 can include a mesh cover with tissue anchors capable of engaging with the tissue surrounding the cavity. After the fixation element 4110 engages the tissue surrounding the cavity or wound, it can be disengaged from the delivery device 4102, as shown in FIG. 65H, to complete the procedure. If desired, the user can apply any form of therapeutic substance, such as an antimicrobial or antibiotic substance, underneath the fixation element 4110.

[0264] In any embodiment disclosed herein, a retention member such as or similar to any of the other retention members disclosed with respect to any of the other implant embodiments disclosed herein can be used to couple the fixation element 4110 to the contact member 4104. Additionally, in some embodiments, the retention member can be used to bias the fixation element 4110 toward the tissue surface and / or contact member 4104, or to control the positioning or spacing between the fixation element 4110 and the contact member 4104.

[0265] In any embodiment disclosed herein, the implant device 4103 may be configured so that the contact member can be removed from the cavity or wound after the cavity has been secured in a closed, substantially closed, reduced, or occluded state (e.g., a second state) by a desired fixation element or elements, such as staples, sutures, or other tissue anchors, or other device or connector. For example, but not limited to, the contact member can be collapsed or contracted and removed from the cavity after the cavity has been secured in the second state. For example, but not limited to, the implant device 4103 may have an opening in a hollow tube or body portion thereof that can be withdrawn through the contact member. A fixation element can then be used to cover the opening as well as the collapsed cavity. Alternatively, a plug or other device may be positioned within the hollow opening or body portion from which the contact member was withdrawn as part of the contact member removal process, such as, for example, a plug that automatically retracts into the opening in the hollow tube or body portion when the contact member is withdrawn or a separate plug is inserted after the contact member is withdrawn. In other embodiments, the contact member may remain within the cavity in an expanded state. In some embodiments, the contact member may be folded or contracted (e.g., if the contact member is an expandable balloon) and remain within the cavity. In any embodiment disclosed herein, the contact member may be biodegradable or bioabsorbable so that the contact member can degrade within the body over time, which may be particularly useful when treating wounds. In other embodiments, the system may be configured so that the contact member is removable after the fixation element is positioned to close and secure the wound. In any embodiment disclosed herein, the contact member may have a surface coating that may be drug-eluting, antimicrobial, or antibacterial, or have other therapeutic benefits or benefits to the cavity or wound.

[0266] Any embodiment of the treatment system 4100, delivery device 4102, implant device 4103, contact member 4104, fixation element 4110, and / or any other component disclosed herein can have any of the components, features, or other details of any other treatment system, delivery device, implant device, fixation element, or any other component embodiment disclosed herein, including but not limited to any of the components of any of the embodiments of the treatment system 100, 200, 300, 400, implant device 102, 202, 302, 402, and / or fixation element 110, 210, 310, 410, in any combination with any of the components, features, or details of the treatment system 4100, delivery device 4102, implant device 4103, fixation element 4110, and / or any other component of the treatment system 4100 disclosed herein. For example, but not limited to, in any embodiment, the contact member can have any of a number of arms or struts, tissue anchors, or other tissue engaging mechanisms, or can be an expandable balloon with a smooth surface or with a textured surface or other gripping features thereon.

[0267] 66A-66H illustrate another embodiment of a treatment system 4200 that can be used for mitral or tricuspid valve repair, and another embodiment of the use of an embodiment of a treatment system disclosed herein for use in mitral valve repair. Any embodiment of the treatment system 4200 or implant device 4203 can have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described embodiments of the treatment system 100, 200, 300, 400 or implant device 102, 202, 302, 402, in any combination with any of the components, features, or details of the treatment system 4200 or implant device 4203 below. Similarly, any component, feature, or other detail of any embodiment of the treatment system or implant device disclosed herein can have any of the components, features, or other details of any embodiment of the treatment system 4200 or implant device 4203 disclosed herein, in any combination with any of the components, features, or details of the other treatment system or implant device embodiments disclosed herein.

[0268] Some embodiments of the devices disclosed herein for treating a mitral valve can include a first implant having at least a contact member and a fixation element, and the contact member can be configured to move between a first state and a second state. The contact member can be configured to engage at least a portion of the tissue at the mitral valve's coaptation after the contact member advances into the mitral valve and can be configured to rotate in at least a first direction from a first position to a second position to twist at least a portion of the tissue at the mitral valve's coaptation, drawing the tissue together into the coaptation and reducing the size of the mitral valve. The contact member can be rotated, for example, but not limited to, by rotating a core member or other member of a delivery device coupled to the contact member. Sutures, staples, and / or fixation elements can be implanted adjacent to or in contact with the contact member to prevent rotation of the tissue drawn together by the contact member in a second direction opposite the first direction. The contact member and / or fixation element can have any of the features, components, and / or details of any of the other embodiments of the contact members and fixation elements disclosed herein. In some embodiments, the device can have a second contact member of the second implant configured to engage at least a portion of tissue at a second junction of the mitral valve after the contact member is advanced into the mitral valve and can be configured to rotate in at least a first direction from a first position to a second position, twisting at least a portion of tissue at the second junction of the mitral valve to draw the tissue at the second junction together and reduce the size of the mitral valve annulus. In some embodiments, a connecting bar or connecting member can be used to couple the second implant to the first implant and maintain a desired spacing between the first and second implants. The length of the connecting member can be adjustable to draw the first and second implants, and thus the first and second junctions, together or apart.

[0269] Referring to FIGS. 66A-66B, the delivery device 4202 can be advanced through the patient's heart toward the mitral valve M to perform tissue repair at the mitral valve's coaptation C. The term coaptation describes the area where the anterior and posterior leaflets of the mitral valve come together upon insertion into the annulus. FIG. 66B shows the contact members 4204 being advanced to a first coaptation of the mitral valve. The contact members 4204 can be advanced into the space adjacent the coaptation and then expanded to a second state such that the contact members 4204 extend against one or more tissue surfaces at the coaptation. In other embodiments, the contact members 4204 can be expanded to a second state and then advanced into the space adjacent the coaptation and contact one or more tissue surfaces at the coaptation.

[0270] A similar device can be used with tricuspid valves with similar rotating implants at the coaptation sites to gather tissue and reduce the annular distance by gathering the tissue at each coaptation. The septal and posterior leaflets are generally smaller than the anterior leaflets and should be rotated accordingly. The septal implant can be rotated clockwise and the posterior leaflet can be rotated counterclockwise to bring the posterior leaflet back into coaptation. Connecting members can also connect the implants, and the members may be adjustable, allowing one to be pulled closer to the other for further annular reduction. Some embodiments can be configured to push the implants apart, thereby extending the valve opening. A third implant between the septal and posterior sites can add further plication or reduction.

[0271] Referring to FIG. 66C, the contact members 4204 are then rotated by, for example, but not limited to, rotating the core member or other members 4213 of the delivery device 4202 to twist the tissue in the coaptation, drawing such tissue together and changing the size of the mitral valve annulus. As with any of the other embodiments disclosed herein, in some embodiments used to treat a mitral valve, the contact member 4204 is rotatable at or about one-eighth of a rotation (i.e., 45 degrees or about 45 degrees) relative to a first rotational position (which may be an initial position, i.e., initial rotational position), at or about one-quarter of a rotation (i.e., 90 degrees or about 90 degrees) relative to the first rotational position, or at or about one-half of a rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position, or the second rotational position may be from or about one-eighth of a rotation (i.e., 45 degrees or about 45 degrees) to or about one-half of a rotation (i.e., 180 degrees or about 180 degrees) relative to the first rotational position. In any device, 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 or approximately 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 approximately 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 approximately 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. It should be noted that the first rotational position and the second rotational position may refer to the first position and the second position, respectively, herein.In any of the embodiments disclosed herein, the torsional movement or step may be achieved by a torque catheter.

[0272] Further, in embodiments of any apparatus, implant device, or method disclosed herein, the catheter can be configured to exert a torque on the contact member 4204 and / or other component of the implant, rotating the contact member 4204 and / or other component of the implant from the first rotated position until a threshold predetermined torque level is reached or until the user decides to stop rotating, whichever occurs first. In some embodiments, the threshold predetermined torque level can be between or equal to 0.25 in-oz torque and 10 in-oz torque, or between or equal to 0.5 in-oz torque and 5 in-oz torque.

[0273] When rotation of the contact members 4204 achieves a sufficient or desired degree of tissue closure, resizing, or reduction at the junction, the pulled together tissue can be secured using any desired or available technique, including, but not limited to, sutures, staples, or other fasteners, to cover and engage the pulled together tissue, or by deploying a fixation element 4210, as shown in FIGS. 66E-66F. After the pulled together tissue is sufficiently secured, the delivery device 4202 can be disengaged from the implant member 4203 such that the implant member 4203 remains in place at the junction of the mitral valve. In some embodiments, the contact members 4204 can be removed from the mitral valve prior to completion of the procedure. In some embodiments, a second implant 4203 can be deployed at a second junction of the mitral valve if needed or desired.

[0274] In any embodiment disclosed herein, a retention member such as or similar to any of the other retention members disclosed with respect to any of the other implant embodiments disclosed herein can be used to couple the fixation element 4210 to the contact member 4204. In other embodiments, the fixation element 4210 can be separate and / or independent from the contact member 4204. Additionally, in some embodiments, the retention member can be used to bias the fixation element 4210 toward the tissue surface and / or contact member 4204 and / or to control the positioning or spacing between the fixation element 4210 and the contact member 4204.

[0275] Referring to FIG. 66H , in some embodiments, a treatment system 4200 can be configured to implant a first implant device 4203, which can have a fixation element 4210 within or adjacent to a first joint, a second implant device 4203, which can have a fixation element 4210 within or adjacent to a second joint, and a bar or other connecting member 4220 coupled to the first and second implant devices 4203. The connecting member 4220 can be used to maintain a desired spacing between the first and second implant devices and can be adjustable to draw one closer to the other, thereby applying additional tissue reduction 4203, or can be used to push the implant devices apart as described above. In some embodiments, the connecting member 4220 can have any desired shape, including a curved shape, and can be used to reshape the mitral valve. The connecting member can be used to secure the rotating implants in their respective positions and to hold them in proximity to the valve annulus. The connecting member can also be adjustable in length to move the rotating members toward or away from each other. As shown in FIG. 66H, in any embodiment, the connecting member 4220 can be positioned so as not to block blood flow through the valve, but can be positioned on the posterior surface, in a plane with the mitral valve (for example, and without limitation, it can be positioned opposite the aortic valve).

[0276] 67A-67G illustrate another embodiment of a treatment system 4300 that can be used for weight loss surgery (e.g., stomach reshaping / reduction), or another embodiment of the use of other treatment system embodiments disclosed herein for weight loss surgery. Any embodiment of the treatment system 4300 or implant device 4303 may have any of the components, features, or other details of any other treatment system or implant device embodiment disclosed herein, including, but not limited to, any of the above-described treatment system 100, 200, 300, 400 or implant device 102, 202, 302, 402 embodiments, in any combination with any of the components, features, or details of the treatment system 4300 or implant device 4303 below. Similarly, any component, feature, or other detail of any other treatment system or implant device embodiment disclosed herein may have any of the components, features, or other details of any of the treatment system 4300 or implant device 4303 embodiments disclosed herein, in any combination with any of the components, features, or details of the treatment system or implant device embodiments disclosed herein.

[0277] Referring to FIGS. 67A-67B, the delivery device 4302 can be advanced through a patient's body toward the stomach S or other intestinal cavity (collectively referred to herein as the stomach). FIG. 67B shows the contact member 4304 being advanced toward the stomach wall such that at least an end of the contact member 4304 is positioned in contact with the stomach wall. As with other described applications, the contact member 4304 can be further advanced against the stomach wall to distract the stomach wall and create a closable cavity C within the stomach S by rotating the contact member 4304 and drawing stomach tissue together to occlude or close the cavity C, as shown in FIG. 67D. In some embodiments, the contact member 4304 can be rotated as it is forced axially against the stomach wall. As shown in FIG. 67D, the creation and closure of the cavity C can reduce the overall size and volume of the stomach S, as compared to FIG. 67C.

[0278] Thereafter, referring to FIG. 67E, when the desired level of torsion and tissue collection has been achieved, the fixation element 4310 can be deployed from the delivery device 4302 to maintain the collected tissue in the collected or second state and to hold the created cavity C in the second or collected state. In other embodiments, sutures, staples, or other tissue fasteners or anchors can be used to hold the tissue in the collected state. Once the tissue has been secured by the fixation element 4310 or otherwise, the implant 4303 can be disengaged from the delivery device and the delivery device can be removed from the body, as shown in FIG. 67G. This procedure can be repeated multiple times to create multiple cavities and reduce the desired stomach volume.

[0279] In any embodiment disclosed herein, a retention member such as or similar to any of the other retention members disclosed with respect to any of the other implant embodiments disclosed herein can be used to couple the fixation element 4310 to the contact member 4304. Additionally, in some embodiments, the retention member can be used to bias the fixation element 4310 toward the tissue surface and / or contact member 4304, or can be used to control the positioning or spacing between the fixation element 4310 and the contact member 4304.

[0280] While specific embodiments of the present invention are described, these embodiments are presented by way of example only and are not intended to limit the scope of the present disclosure. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and modifications may be made in the systems and methods described herein without departing from the spirit of the present disclosure. The appended claims and their equivalents are intended to cover such forms or modifications as would be within the scope and spirit of the present disclosure. Accordingly, the scope of the present invention is defined solely by reference to the appended claims.

[0281] Any feature, material, characteristic, or group described in connection with a particular aspect, embodiment, or example should be understood to apply to any other aspect, embodiment, or example described in this section or elsewhere herein, unless incompatible therewith. All features disclosed herein (including the accompanying claims, abstract, and drawings), and / or all steps of any method or process so disclosed, may be combined with or include any combination of at least some of such features and / or steps that are mutually exclusive. The features may be combined in any combination except for a combination of the above. Protection for this invention is not limited to the details of any of the preceding embodiments. Protection extends to any novel, or any novel combination of, features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or to any novel, or any novel combination of steps of any method or process similarly disclosed.

[0282] Furthermore, certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Furthermore, while features may be described above as acting in a particular combination, one or more features from a claimed combination may, in some cases, be removed from that combination, and the combination may be claimed as a subcombination or a variation of the subcombination.

[0283] Furthermore, while operations may be illustrated in figures or described in a particular order in the specification, such operations need not be performed in the particular order shown, or sequentially, to achieve desirable results, or even that all operations need not be performed. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or reordered in other implementations. Those skilled in the art will recognize that in some embodiments, the actual steps performed in the illustrated or disclosed processes may differ from those shown in the figures. In some embodiments, certain of the steps described above may be removed and others may be added. Furthermore, the features and characteristics of the specific embodiments disclosed above may be combined in various ways to form additional embodiments, all of which will fall within the scope of the present disclosure. Also, the separation of various system components in the above-described implementations should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems may generally be integrated into a single product or packaged into multiple products.

[0284] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or carried out in a way that achieves one advantage or group of advantages as taught herein without necessarily achieving other objectives that may be taught or suggested herein.

[0285] Conditional language such as "can," "could," "might," or "may," unless specifically stated otherwise or interpreted otherwise within the context in which it is used, is typically intended to convey that certain embodiments include certain features, elements, or steps, while other embodiments do not. Thus, such conditional language is not necessarily intended to suggest that features, elements, and / or steps are required in any way in one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without user input or instruction, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment.

[0286] Unless otherwise specified, connective language such as the phrase "at least one of X, Y, and Z" is otherwise understood in the context in which it is used to generally convey that an item, term, etc. can be either X, Y, or Z. Thus, such connective language is not generally intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0287] As used herein, terms expressing degrees, such as "approximately," "about," "generally," and "substantially," refer to values, amounts, or characteristics that are close to a given value, amount, or characteristic while still performing a desired function or achieving a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to amounts that are within 10%, 5%, 1%, 0.1%, and 0.01% of a given amount. As another example, in certain embodiments, the terms "generally parallel" and "substantially parallel" refer to values, amounts, or characteristics that deviate from exact parallelism by 15 degrees or less, 10 degrees or less, 5 degrees or less, 3 degrees or less, 1 degree or less, or 0.1 degrees or less. Ranges disclosed herein also encompass any and all overlaps, subranges, and combinations thereof, as well as any specific value within those ranges. Language such as "up to," "at least," "greater than," "less than," and "between" includes the recited numbers. Numerical values ​​and values ​​used herein, for example, terms such as "about" or "approximately," include the recited numbers. For example, "approximately 7 mm" includes "7 mm," and numerical values ​​and ranges preceded by terms such as "about" or "approximately" should be construed as disclosing the numerical values ​​and ranges with or without such terms preceding the numerical values ​​or values ​​as this application supports the claim of the numerical values, and this application supports the claim of the numbers, values, and ranges disclosed in the specification and / or claims, with or without terms such as "about" or "approximately" preceding such numbers, values, or ranges, such that, for example, "approximately 2 times to approximately 5 times" also includes the disclosure of the range "2 times to 5 times." The scope of the disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims presented or to be presented in the future in this section or elsewhere herein. The claim language should be interpreted broadly based on the language used in the claims and not limited to the examples described herein or during the prosecution of this application, which examples should be construed as non-exclusive.

[0288] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but rather may be defined by the claims presented in this section or elsewhere herein or presented in the future. The claim language is to be interpreted broadly based on the language used in the claims and is not limited to the examples described herein or during the prosecution of this application, but rather such examples are to be construed as non-exclusive. [Embodiment A] (1) 1. A device for reshaping, closing, or occluding a cavity, comprising: An implant, a contact member configured to move between a first state and a second state; and a fixation element, the contact member is configured to engage a wall portion of the cavity after the contact member advances into the cavity; the contact member is configured to rotate in at least a first direction from a first position to a second position; the contact member is configured to twist at least a portion of the wall portion of the cavity in the first direction when the contact member engages the wall portion of the cavity and rotates from the first position to the second position to pull at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; the fixation element is configured to prevent rotation of the wall portion of the cavity in a second direction when the fixation element is operatively implanted, the second direction being opposite to the first direction; the device is configured to contract tissue of the cavity about an outer surface of a body portion of the device when the contact member is rotated to the second position; The device, wherein the fixation element is configured to engage the tissue of the cavity or tissue adjacent to the cavity contracted around the outer surface of the body portion of the device to prevent rotation of the implant and / or the tissue in the second direction. (2) A device as described in embodiment 1, 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. (3) A device as described in embodiment 1 or 2, wherein the fixation element has a plurality of tissue anchors configured to engage with a portion of the tissue of the cavity that has contracted around the outer surface of the body portion of the device, or tissue adjacent to the cavity, to prevent rotation of the implant and / or the tissue in the second direction. (4) the implant is configured to rotate in a first direction from the first position to the second position; A device described in any one of embodiments 1 to 3, wherein the implant is configured to prevent at least a portion of the implant from rotating in a second direction after the implant is fully deployed, the second direction being opposite to the first direction. (5) A device described in any one of embodiments 1 to 4, wherein the contact member has a plurality of tissue anchors on its outer surface, the plurality of tissue anchors being configured to engage with the inner wall surface of the cavity after the contact member is moved to the second state. (6) A device described in any one of embodiments 1 to 5, wherein the second position is approximately one-quarter of a rotation to one or more full rotations relative to the first position. (7) A device described in any one of embodiments 1 to 6, comprising a retaining member configured to bias the fixing element toward the contact member. (8) A device described in any one of embodiments 1 to 7, comprising a retaining member configured to connect the fixation element to the contact member. (9) A device described in any one of embodiments 1 to 8, comprising a retaining member configured to connect the fixation element with the contact member, the retaining member comprising a threaded shaft. (10) A device described in any one of embodiments 1 to 9, wherein only a portion of the fixation element extends out of the cavity after deployment of the device, and all other portions of the device are inside the cavity after deployment of the device. (11) A device described in any one of embodiments 1 to 10, wherein the fixing element is removably connectable to the contact member. (12) 12. A device according to any one of the preceding embodiments, wherein the cavity is a wound or a wound cavity. (13) 1. A device for reshaping, closing, or occluding a cavity, comprising: an implant having a contact member; a catheter configured to advance the contact member into the cavity and move the contact member against an inner wall surface of the cavity after advancing the contact member into the cavity; a fixing element; the catheter is 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, causing the contact member to rotate from a first position to a second position such that the contact member can twist at least a portion of the cavity; A device wherein the fixation element is configured to prevent the cavity from completely untwisting. (14) the cavity is the mitral valve or the coaptation of the mitral valve; A device described in any one of embodiments 1 to 13, wherein the contact member is configured to rotate in at least the first direction from the first position to the second position to twist at least a portion of the tissue at the junction of the mitral valve, drawing the tissue together in the junction and reducing the size of the mitral valve annulus. (15) a second implant including a second contact member and a second fixation element coupled with the second contact member; the second contact member is configured to rotate to twist at least a portion of tissue at a second commissure of the mitral valve to draw the tissue at the second commissure together and reduce the size of the mitral valve annulus; 15. The device of embodiment 14, wherein the second fixation element is configured to prevent rotation of the second joint into the tissue wall portion when the second fixation element is implanted in an operative state. [Embodiment B] (1) 1. A device for reshaping, closing, or occluding a cavity, comprising: An implant, a contact member configured to move between a first state and a second state; and a fixation element, the contact member is configured to engage a wall portion of the cavity after the contact member advances into the cavity; the contact member is configured to rotate in at least a first direction from a first position to a second position; the contact member is configured to twist at least a portion of the wall portion of the cavity in the first direction when the contact member engages the wall portion of the cavity and rotates from the first position to the second position to pull at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; The device, wherein the fixation element is configured to prevent rotation of the wall portion of the cavity in a second direction when the fixation element is operably implanted, the second direction being opposite to the first direction. (2) A device as described in embodiment 1, 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. (3) A device described in any one of embodiments 1 to 2, wherein the contact member is biased to remain in the second state after deployment into the cavity. (4) A device described in any one of embodiments 1 to 3, wherein the contact member is configured to be removable from the cavity after the fixation element is implanted. (5) A device described in any one of embodiments 1 to 4, wherein the contact member is configured to rotate clockwise or counterclockwise, or configured to rotate clockwise or counterclockwise after the contact member engages with a wall portion of the cavity. (6) 6. The device of any one of claims 1 to 5, wherein the device is configured to contract tissue of the cavity around an outer surface of the body portion of the device when the contact member is rotated to the second position, and the fixation element is configured to engage the tissue of the cavity or tissue adjacent to the cavity contracted around the outer surface of the body portion of the device to prevent rotation of the implant and / or the tissue in the second direction. (7) A device described in any one of embodiments 1 to 6, wherein the fixation element has a plurality of tissue anchors configured to engage with a portion of the tissue of the cavity or tissue adjacent to the cavity that has contracted around the outer surface of the main body portion of the device, preventing rotation of the implant and / or the tissue in the second direction. (8) A device described in any one of embodiments 1 to 7, wherein the fixation element has a spiral shape and is configured to rotate around the body portion of the implant during the implantation procedure. (9) the implant is configured to rotate in a first direction from the first position to the second position; A device described in any one of embodiments 1 to 8, wherein the implant is configured to prevent at least a portion of the implant from rotating in a second direction after the implant is fully deployed, the second direction being opposite to the first direction. (10) A device described in any one of embodiments 1 to 9, wherein the contact member has multiple tissue anchors on its outer surface. (11) A device as described in embodiment 10, wherein the plurality of tissue anchors on the outer surface of the contact member are configured to engage with the inner wall surface of the cavity after the contact member is moved to the second state. (12) A device described in any one of embodiments 1 to 11, wherein the second position is approximately one-quarter of a rotation to one or more full rotations relative to the first position. (13) A device described in any one of embodiments 1 to 12, comprising a retaining member configured to bias the fixing element toward the contact member. (14) A device described in any one of embodiments 1 to 13, comprising a retaining member configured to connect the fixation element to the contact member. (15) A device described in any one of embodiments 1 to 14, comprising a retaining member configured to connect the fixation element with the contact member, the retaining member comprising a threaded shaft. (16) 16. A device described in any one of embodiments 1 to 15, wherein the contact member is configured to rotate in at least a first direction from a first position to a second position when torque is applied to the contact member. (17) A device described in any one of embodiments 1 to 16, wherein the device is configured so that the contact member can be removed from the cavity after the fixation element is deployed to the operable state of the fixation element. (18) A device described in any one of embodiments 1 to 17, wherein only a portion of the fixation element extends out of the cavity after deployment of the device, and all other portions of the device are inside the cavity after deployment of the device. (19) A device described in any one of embodiments 1 to 18, wherein only approximately 10% or less of the total length of the deployed device extends out of the cavity after deployment of the device. (20) A device described in any one of embodiments 1 to 19, wherein the contact member is expandable and contractible. (twenty one) A device described in any one of embodiments 1 to 20, wherein the contact member is a balloon. (twenty two) A device described in any one of embodiments 1 to 21, wherein the fixing element is removably connectable to the contact member. (twenty three) 23. A device according to any one of embodiments 1 to 22, wherein the cavity is a wound or a wound cavity. (twenty four) 1. A device for reshaping, closing, or occluding a cavity, comprising: an implant having a contact member configured to move between a first state and a second state; a catheter configured to advance the contact member into the cavity when the contact member is in the first state, and to move the contact member from the first state to the second state after the contact member has advanced into the cavity such that an outer surface of the contact member expands against an inner wall surface of the cavity; The device is configured such that when at least a portion of the catheter is rotated until a predetermined torque level is reached, a torque is applied to the contact member, causing the contact member to rotate from a first position to a second position such that the contact member can twist at least a portion of the cavity. (twenty five) 25. The device of embodiment 24, comprising a fixation element configured to prevent the cavity from completely untwisting. (26) 1. A device for reshaping, closing, or occluding a cavity, comprising: an implant having a contact member; a catheter configured to advance the contact member into the cavity and to move the contact member against an inner wall surface of the cavity after advancing the contact member into the cavity; The device is configured such that when at least a portion of the catheter is rotated until a predetermined torque level is reached, a torque is applied to the contact member, causing the contact member to rotate from a first position to a second position such that the contact member can twist at least a portion of the cavity. (27) 27. The device of embodiment 26, comprising a fixation element configured to prevent the cavity from completely untwisting. (28) 1. A method of reforming, closing, or occluding a cavity, comprising: advancing a deployment device having an implant within the cavity, the implant configured to move from a first state to a second state, such that at least a portion of the implant is radially expanded when the implant is in the second state compared to the first state; moving the implant within the cavity from a first state to a second state so as 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, relative to an inner wall surface of the cavity; rotating the implant from a first position to a second position to twist the cavity; preventing the implant from rotating back to the first position. (29) 1. A method of reforming, closing, or occluding a cavity, comprising: advancing a deployment device having an implant into the cavity; moving the implant to move at least a portion of an outer surface of the implant, or one or more tissue anchors extending away from the outer surface of the implant, against an inner wall surface of the cavity; rotating the implant from a first position to a second position to twist the cavity; preventing the implant from rotating back to the first position. (30) 30. The method of any one of embodiments 28 to 29, wherein the implant is self-expanding and moving the implant from the first state to the second state comprises advancing the implant out of the distal end of the deployment device. (31) A method according to any one of embodiments 28 to 30, comprising engaging an inner wall portion of the cavity with one or more tissue anchors disposed on the outer surface of the implant. (32) A method as described in any one of embodiments 28 to 31, wherein preventing the implant from rotating back to the first position includes engaging the tissue wall with an anchor element to prevent relative movement between the implant and the tissue wall. (33) A method as described in any one of embodiments 28 to 32, wherein preventing the implant from rotating back to the first position includes engaging a tissue wall with an anchor element, the anchor element being configured to be fixed to the implant to prevent rotation between the implant and the anchor element. (34) A method according to any one of embodiments 28 to 33, wherein preventing the implant from rotating back to the first position includes engaging a tissue surface adjacent to the cavity with an anchor element, the anchor element being rotatably fixed to the implant and configured to prevent the implant from rotating back to the first position. (35) 35. The method of any one of embodiments 28-34, wherein preventing the implant from rotating back to the first position comprises engaging a tissue surface adjacent the cavity outside the closed portion of the cavity with an anchor element, the anchor element being rotatably fixed relative to the implant and configured to prevent the implant from rotating back to the first position. (36) A method described in any one of embodiments 30 to 35, wherein the anchor element comprises a plurality of tissue anchors on at least one surface thereof configured to engage tissue outside the cavity. (37) A method as described in any one of embodiments 28 to 36, wherein rotating the implant from the first position to the second position to twist the cavity comprises rotating the implant until the opening of the cavity is substantially or completely closed. (38) the cavity is the gastric cavity; advancing a contact member into contact with the stomach wall to create an indentation in the stomach wall; twisting and / or further advancing the contact member to form a secondary cavity in the wall of the stomach; 38. The method of any one of embodiments 28 to 37, further comprising closing the secondary cavity by twisting the contact member until the opening of the secondary cavity is folded around a portion of the implant. (39) A method according to any one of embodiments 28 to 38, wherein the cavity is a space within the mitral valve coaptation, and the method comprises reducing the annular diameter of the mitral valve or reducing the annular space of the mitral valve to bring the posterior leaflet closer to the anterior leaflet. (40) 40. The method of any of embodiments 28 to 39, wherein rotating the implant from the first position to the second position to twist the cavity comprises rotating the implant at least approximately 180 degrees in either direction from the first position. (41) A method as described in any one of embodiments 28 to 39, wherein rotating the implant from the first position to the second position to twist the cavity comprises rotating the implant from the first position from approximately 90 degrees to approximately 360 degrees in either direction. (42) rotating the implant from the first position to the second position to twist the cavity; applying a torque on the implant to rotate the implant in either direction from the first position until a threshold predetermined torque level is reached; holding the implant in the second position; 40. A method as described in any one of embodiments 28 to 39, comprising fixing the implant in an approximately second position relative to the tissue surface surrounding the cavity. (43) 43. The method of claim 42, wherein the threshold predetermined torque level is between approximately 0.25 in-oz and approximately 50 in-oz of torque. (44) 43. The method of claim 42, wherein the threshold predetermined torque level is between approximately 5 in-oz and approximately 25 in-oz of torque. (45) 1. An implant for deployment within a cavity or vessel, comprising: An expandable body and 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; an anchoring element coupled to the expandable body configured to engage a tissue surface adjacent the interior wall surface of the cavity or vessel. (46) 1. A device for closing or occluding a cavity, comprising: an expandable implant having a plurality of tissue anchors on an exterior surface of a portion thereof, the expandable implant being configured to move between a first state in which the implant is substantially collapsed and a second state in which at least a portion of the implant is expanded; a catheter configured to advance the implant into the cavity when the implant is in the first state and selectively move the implant from the first state to the second state such that at least some of the tissue anchors engage an inner wall surface of the cavity after the implant is advanced into the cavity; The device, wherein the catheter is configured to rotate the implant in a first direction from a first position to a second position such that the implant can twist through the cavity. (47) 1. A device for reshaping, closing, or occluding a cavity, comprising: an implant configured to move between a first state and a second state; a catheter configured to advance the implant into the cavity when the implant is in the first state and to move the implant from the first state to the second state such that an outer surface of the implant moves against an inner wall surface of the cavity after the implant has been advanced into the cavity; The device, wherein the catheter is configured to rotate the implant in a first direction from a first position to a second position such that the implant can twist at least a portion of the cavity when the implant is in the second state. (48) 1. A device for reshaping, closing, or occluding a cavity, comprising: Implants and a catheter configured to advance the implant into the cavity and to move the implant against an inner wall surface of the cavity after the implant has advanced into the cavity; The device, wherein the catheter is configured to rotate the implant in a first direction from a first position to a second position such that the implant can twist at least a portion of the cavity when the implant is in the second state. (49) 1. A method of reforming, closing, or occluding a cavity, comprising: advancing a deployment device having an implant within the cavity, the implant configured to move from a first state to a second state, wherein at least a portion of the implant is of a radially larger size 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 cavity to move at least a portion of the implant relative to a portion of an interior wall surface of the cavity; rotating the implant from a first position to a second position to twist the cavity and draw tissue in the cavity together; holding the tissue pulled together with a fixation element to hold the tissue together; continuing to hold the tissue drawn together with the fixation element while rotating the implant or allowing the implant to rotate back toward the first position. (50) The method of embodiment 49, wherein moving the implant within the cavity from the first state to the second state so as to move at least a portion of the implant relative to a portion of the inner wall surface of the cavity comprises moving at least a portion of the outer wall of the implant and / or one or more tissue anchors extending away from the outer surface of the implant relative to the inner wall surface of the cavity. (51) 1. A method of reforming, closing, or occluding a cavity, comprising: advancing a deployment device having an implant into the cavity; moving at least a portion of the implant relative to a portion of an interior wall surface of the cavity; rotating the implant from a first position to a second position to twist the cavity and draw tissue in the cavity together; holding the tissue pulled together with a fixation element to hold the tissue together; continuing to hold the tissue drawn together with the fixation element while rotating the implant or allowing the implant to rotate back toward the first position. (52) 52. The method of claim 51, comprising implanting the fixation element in an operable position to hold the tissue pulled together, and then removing the implant. (53) 1. A device for pulling a first tissue surface toward a second tissue surface, comprising: a contact member configured to expand from a first condition to a second condition; a fixation element configured to move from a first state to a second state; the contact member is configured to expand from the first condition to the second condition such that at least a portion of the contact member engages at least a distal portion of the first tissue surface and at least a distal portion of the second tissue surface; the contact member is configured to rotate in at least a first direction from a first position to a second position; 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; The device, wherein 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 to the first direction. (54) 54. The device of embodiment 53, wherein the device is configured to occlude or close a cavity within a body having the first and second tissue surfaces. (55) 54. The device of embodiment 53, wherein the first and second tissue surfaces are tissue surfaces within a cavity within the body. (56) 54. The device of embodiment 53, wherein the rotation of the contact member causes the proximal portion of the second tissue surface to twist and move further toward the proximal portion of the first tissue surface. (57) 10. A method of reforming, closing or occluding a cavity substantially as described or shown in the accompanying drawings. (58) A device configured to substantially reshape, close or occlude a cavity as hereinbefore described or shown in the accompanying drawings.

Claims

1. 1. A device for reshaping, closing, or occluding a cavity, comprising: An implant, a contact member configured to move between a first state and a second state, the contact member including one or more tissue engaging features, the contact member positioned along a longitudinal axis; and a fixation element, the contact member is configured to engage a wall portion of the cavity after the contact member advances into the cavity; the contact member is configured to rotate in at least a first direction from a first position to a second position; the contact member is configured such that, when the contact member engages the wall portion of the cavity and rotates from the first position to the second position, engagement between the one or more tissue engagement features and tissue of the cavity twists at least a portion of the wall portion of the cavity in the first direction and pulls at least a first portion of the wall portion of the cavity toward a second portion of the wall portion of the cavity; The device, wherein the fixation element is configured to prevent rotation of the wall portion of the cavity in a second direction when the fixation element is operably implanted to maintain tissue of the wall portion in a twisted state, the second direction being opposite to the first direction about the longitudinal axis.

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

3. the device is configured to contract the tissue of the cavity about an outer surface of a body portion of the device when the contact member is rotated to the second position; 3. The device of claim 1 or 2, wherein the fixation element is configured to engage the tissue of the cavity or tissue adjacent to the cavity that has contracted around the outer surface of the body portion of the device and prevent rotation of the implant and / or the tissue of the cavity or the tissue adjacent to the cavity in the second direction.

4. 4. The device of claim 3, wherein the fixation element has a plurality of tissue anchors configured to engage a portion of the tissue of the cavity or the tissue adjacent to the cavity that has contracted around the outer surface of the body portion of the device, preventing rotation of the implant and / or the tissue of the cavity or the tissue adjacent to the cavity in the second direction.

5. the implant is configured to rotate in the first direction from the first position to the second position; 5. The device of claim 1, wherein the implant is configured to prevent at least a portion of the implant from rotating in the second direction after the implant is fully deployed, the second direction being opposite to the first direction.

6. 6. The device of claim 1, wherein the one or more tissue engagement mechanisms include a plurality of tissue anchors disposed on an outer surface of the contact member, the plurality of tissue anchors configured to engage an inner wall surface of the cavity after the contact member is moved to the second state.

7. The device of any one of claims 1 to 6, wherein the second position is rotated between 90 degrees and 360 degrees, or more than 360 degrees, from the first position.

8. The device of any one of claims 1 to 7, comprising a retaining member configured to bias the fixation element towards the contact member.

9. The device of any one of claims 1 to 7, comprising a retaining member configured to couple the fixation element to the contact member.

10. The device of any one of claims 1 to 7, comprising a retaining member configured to couple the fixation element with the contact member, the retaining member comprising a threaded shaft.

11. 11. The device of claim 1, wherein only a portion of the fixation element extends out of the cavity after deployment of the device, and all other portions of the device are inside the cavity after deployment of the device.

12. The device of any one of claims 1 to 11, wherein the fixation element is removably coupleable with the contact member.

13. The device according to any one of claims 1 to 12, wherein the cavity is a wound or a wound cavity.

14. The device of claim 1 , further comprising a catheter configured to advance the contact member into the cavity and to move the contact member against an inner wall surface of the cavity after advancing the contact member into the cavity.

15. 2. The device of claim 1, wherein the contact member includes a plurality of struts, and the one or more tissue engagement mechanisms include a plurality of tissue anchors disposed on each of the plurality of struts, the plurality of tissue anchors configured to engage with an inner wall surface of the cavity after the contact member is moved to the second state.

16. The device of claim 4 , wherein the fixation element is disc-shaped.

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