Devices and methods for reducing the area and closing cardiac openings or cavities - Patents.com

Abstract

The inner catheter (20) is transluminally extended to the subject's heart (42), and the tether (63) extends distally from a first end of the tether through the inner catheter, loops around the distal end portion (22) of the inner catheter at the subject's heart, then extends proximally parallel to the inner catheter and terminates at a second end of the tether outside the subject, so that both ends of the tether are positioned outside the subject. An anchor (150) is advanced through the inner catheter along the first portion of the tether and secured around the heart annulus, so that the tether forms slack around the annulus. Outside the subject, the first and second ends of the tether are slidably coupled, and the resulting slidable coupling is advanced toward the heart, so that the tether forms a closed loop around the annulus.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 106,324, by Spiegel et al., entitled "Devices and methods for area reduction and closure of cardiac openings or cavities," filed October 27, 2020, which is incorporated herein by reference in its entirety.

[0002] The heart is a muscular organ that pumps blood through the vessels of the circulatory system by contracting and expanding. In a healthy heart, blood flows unidirectionally through it, with heart valves facilitating this flow and preventing backflow of blood. During a normal cardiac contraction cycle, while the heart muscle contracts, the heart valves open and close accordingly. These cardiac tissues can contain various types of cavities and structures.

[0003] Various pathologies are associated with structural abnormalities, including abnormalities of openings and cavities formed within the heart. Dilation of the heart valve annulus can occur due to various cardiac conditions, such as enlargement of the heart chamber or leakage of the heart valve. Reshaping, strengthening, or tightening the valve annulus may require an annuloplasty procedure. Annuloplasty can be performed, for example, by implanting an annuloplasty device that reshapes and / or resizes the valve annulus to reduce its size.

[0004] Similarly, a need remains for simple yet effective systems and methods for remodeling other cardiac tissue, such as closing the left atrial appendage. Summary of the Invention

[0005] This Summary is intended to provide some examples and is not intended to limit the scope of the disclosure in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, the described features may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein. [Means for solving the problem]

[0006] The present disclosure relates, inter alia, to methods and systems for performing an annuloplasty procedure on a subject's heart. In some applications, the method includes using a transluminal (e.g., transfemoral) approach to advance a catheter to the subject's heart and implanting multiple anchors around a valve annulus of the heart. In some applications, the anchors may be threaded onto a tether (e.g., a wire) before advancing, such that implanting the anchors around the valve annulus places slack in the wire around the valve annulus and places the end of the wire outside the heart, e.g., outside the subject. The slack is then formed into a closed loop that is tightened to constrict the valve annulus, thereby reducing valve regurgitation.

[0007] In some applications, the catheter is an outer catheter, and the system further includes an inner catheter. The inner catheter is positioned within the lumen of the outer catheter while the anchors are implanted in the tissue of the valve annulus. The wire can be positioned so that a first portion of the wire extends from outside the subject, through the inner catheter, and out from the inner catheter at the valve annulus, and a second portion of the wire extends through a space defined between the inner and outer catheters (i.e., within the lumen of the outer catheter, not inside the inner catheter), and back to outside the subject, so that both ends of the wire are positioned outside the heart, such as outside the subject. The anchors can be advanced to the valve annulus while threaded over the wire, so that each anchor is advanced over the wire within the inner catheter toward the heart and implanted around the valve annulus. Thus, once the anchors are implanted around the valve annulus, the wire extends from outside the subject, through the inner catheter, and into the subject's heart, forming slack around the valve annulus, through the space defined between the inner and outer catheters, and outside the subject.

[0008] Once the anchor is implanted in the annular tissue, the inner catheter can be retracted from the outer catheter and the subject, and the wire can be extended from outside the subject, through the outer catheter, to the annulus, where it can be passed back through the outer catheter to the slack around the annulus and anchored outside the subject.

[0009] In some applications, to facilitate reduction of valve regurgitation, the wire is then formed into a closed loop around the valve annulus, for example, by slidably coupling the ends of the wire to one another from outside the subject. In some such applications, to slidably couple the ends of the wire to one another, one end of the wire defines a slidable coupling, for example, an end retainer (e.g., a thread, loop, opening, etc.), through which the other end of the wire (hereinafter referred to as the free end) is inserted. In some applications, the end retainer can be a thread defined by the end of the wire through which the free end is inserted, or any other retainer, as described in more detail below. Thus, the wire is positioned in a loop that extends from the end retainer through the outer catheter to the valve annulus where it is to be secured, back through the outer catheter, and outside the patient, with the free end secured in the loop by the end retainer portion. The free end of the wire (which is secured to the retainer portion at the end) is then pulled proximally and / or the slidable coupling is pushed distally, reducing the size of the loop and pulling the loop through the catheter toward the annulus.

[0010] In some applications, after advancing the closed loop toward the valve annulus, a first portion of the wire extends from the heart, and the first portion is coupled proximally through an outer catheter, out of the subject, to an end retainer. In some applications, the wire is then tensioned to reduce the size of the valve annulus, so that, for example, the tissue anchors move toward each other, further reducing the size of the closed loop. A cutting and locking assembly can be advanced over the first portion and along the wire toward the heart. The cutting and locking assembly can be used to cut excess wire extending away from the closed loop so that the first portion of the wire is cut slightly proximal to the end retainer. Tension in the closed loop can be maintained by a locker delivered by the cutting and locking assembly to maintain the closed loop in tension.

[0011] According to one aspect of the present disclosure, an implant configured to be advanced within a lumen of an inner catheter is provided. The implant includes a wire (or electrical lead, contraction member, etc.) and multiple anchors. The wire includes a first wire portion including a proximal free end and a second wire portion extending continuously from the first wire portion and including an end retainer. Each anchor includes a tissue-engaging element, e.g., a portion that attaches to tissue. The tissue-engaging element may be configured in various ways, e.g., as one or more of a helix or spiral, a hook, a barb, a harpoon, a needle, a clip, an adhesive, an arm, an extension, a gripper, etc. For some applications, the tissue-engaging element includes a sharp distal tip and a proximal end defining a helix therebetween, the tissue-engaging element configured to be driven into cardiac tissue of a subject. Each anchor further includes a threaded hole coupled to the proximal end of the tissue-engaging element, the threaded hole configured to allow a portion of the wire to extend therethrough.

[0012] The end retainer encloses an opening through which the proximal free end can be inserted. The end retainer is slidable over a section of the first wire portion. The end retainer is sized to be larger than the thread hole so as to prevent the retainer from passing through the thread hole.

[0013] According to some applications, the end retainer is a loop.

[0014] According to some applications, the end retainer is a terminal clamp with a hinged, spring-loaded gate.

[0015] According to some applications, the implant further comprises a clip removably coupled to the retainer at the end.

[0016] According to some applications, the plurality of anchors comprises between 3 and 30 anchors.

[0017] According to some applications, the plurality of anchors comprises between 5 and 25 anchors.

[0018] According to some applications, a system is provided that includes an implant and handle assembly, an outer catheter, and an inner catheter. The handle assembly includes an outer catheter handle and an inner catheter handle. The outer catheter extends from the outer catheter handle and has a distal end. The inner catheter extends from the inner catheter handle and has a distal end, and the inner catheter extends through the outer catheter.

[0019] For some applications, the first wire portion and the plurality of anchors are configured to be advanced distally through the inner catheter, and at least a first segment of the second wire portion is configured to extend through a plurality of threads of a corresponding plurality of anchors positioned distally at the distal end of the inner catheter.

[0020] According to some applications, at least a second segment of the second wire portion is looped proximally back from the anchor into an interior space defined between the inner and outer catheters.

[0021] For some applications, the second wire portion extends proximally relative to the outer catheter, with the end retainer positioned outwardly from the handle assembly.

[0022] According to some applications, the inner catheter and the handle of the inner catheter are removable from the system, so that upon removal of the inner catheter and the handle of the inner catheter, the proximal free ends are exposed and sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter.

[0023] According to some applications, the handle assembly further comprises a guide catheter handle, and the system further comprises a guide catheter extending from the guide catheter handle and having a guide catheter distal end, the guide catheter being disposed between the inner catheter and the outer catheter.

[0024] According to some applications, at least a second segment of the second wire portion is looped proximally back from the anchor into an interior space defined between the inner catheter and the guide catheter.

[0025] According to some applications, the second wire portion extends proximally into the guide catheter, with the end retainer positioned out of the handle assembly.

[0026] According to some applications, the inner catheter and the handle of the inner catheter are removable from the system, such that upon removal of the inner catheter and the handle of the inner catheter, the proximal free ends are exposed and sections of both the first wire portion and the second wire portion extend through the lumen of the guide catheter.

[0027] According to some applications, the guide catheter and the guide catheter handle are removable from the system, so that upon removal of the inner catheter and the inner catheter handle and the guide catheter and the guide catheter handle, the proximal free ends are exposed and sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter.

[0028] For some applications, the system further includes an anchor driver configured to reversibly engage the anchor and drive the anchor into tissue.

[0029] According to some applications, the inner catheter includes a lateral slit extending proximally from the distal end of the inner catheter such that the lateral slit is continuous with the distal opening at the distal end of the inner catheter, and the lateral slit is configured to allow a wire, but not an anchor, to exit the inner catheter laterally and proximally from the distal end of the inner catheter.

[0030] According to some applications, a clamping system is provided that includes an implant, a clamping catheter, and a cutting and locking assembly attached to the clamping catheter. The cutting and locking assembly includes a locker removable therefrom. A first wire portion extends through the clamping catheter and the cutting and locking assembly. A plurality of anchors and a first section of a second wire portion extending through the plurality of anchors are positioned distal to the cutting and locking assembly.

[0031] According to some applications, the locker includes a fastener configured to transition between an open state and a closed state, the fastener configured to allow axial movement of the wire through the locker in the open state, and the fastener configured to restrict movement of the wire relative to the plurality of anchors in the closed state.

[0032] According to some applications, the cutting and locking assembly includes at least one blade configured to cut a wire extending therethrough.

[0033] According to some applications, sections of both the first wire portion and the second wire portion extend through the clamping catheter and the cut and lock assembly.

[0034] According to another aspect of the present disclosure, there is provided a method comprising the steps of advancing multiple anchors of an implant through an inner catheter and sequentially securing the anchors to tissue surrounding a heart valve annulus or other tissue region (e.g., a mitral valve annulus, a tricuspid valve annulus, an appendage, a bulge, a portion of an atrioventricular wall, another tissue opening, etc.), wherein a first wire portion of a wire of the implant extends through and is advanced therethrough, and a second wire portion of the wire extends through the secured anchors and is looped back to extend along a space defined between the inner catheter and another catheter positioned over the inner catheter.

[0035] The method further includes retracting the inner catheter and the handle of the inner catheter, thereby exposing a proximal free end of the first wire portion. The method further includes inserting the proximal free end into an end retainer at the extracorporeal end of the second wire portion. The method further includes slidably advancing the end retainer over the first wire portion toward a first anchor of the multiple anchors. The method further includes applying tension to the wire to contract the implant secured to the annulus or other tissue region. The method further includes locking the implant wire in tension with a rocker advanced toward the implant, the end retainer being positioned distal to the rocker.

[0036] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends at least 270 degrees around the annulus or other tissue region.

[0037] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 270 to 320 degrees around the annulus or other tissue region.

[0038] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 320 to 360 degrees around the annulus or other tissue region.

[0039] According to some applications, the other catheter placed over the inner catheter is a guide catheter.

[0040] According to some applications, retracting the inner catheter and the handle of the inner catheter includes retracting the inner catheter from the guide catheter and separating the handle of the inner catheter from the handle of the guide catheter, so that upon removal of the inner catheter and the handle of the inner catheter, sections of both the first wire portion and the second wire portion extend through the lumen of the guide catheter and the proximal free end of the first wire portion is exposed outside the handle of the guide catheter.

[0041] According to some applications, advancing the end retainer includes pulling the first wire portion proximally, whereby the end retainer is slidable through the lumen of the guide catheter and out of the distal end portion of the guide catheter.

[0042] For some applications, the end retainer is sized to be slidable through the guide catheter.

[0043] According to some applications, the outer catheter is placed over the guide catheter.

[0044] According to some applications, retracting the inner catheter and the handle of the inner catheter includes retracting both the inner catheter and the guide catheter from the outer catheter and separating both the handle of the inner catheter and the handle of the guide catheter from the handle of the outer catheter, so that upon removal of these components, sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter and the proximal free end of the first wire portion is exposed outside the handle of the outer catheter.

[0045] According to some applications, another catheter placed over the inner catheter is an outer catheter, and storing the inner catheter and its handle includes storing the inner catheter from the outer catheter and separating the inner catheter handle from the outer catheter handle, so that upon removal of the inner catheter and its handle, sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter and the proximal free end of the first wire portion is exposed outside the outer catheter handle.

[0046] According to some applications, advancing the end retainer includes pulling the first wire portion in a proximal direction, whereby the end retainer is slidable through the lumen of the outer catheter and out of the distal end portion of the outer catheter.

[0047] For some applications, the end retainer is sized to be slidable through the guide catheter.

[0048] For some applications, the retainer at the end is larger than the thread hole of the first anchor of the plurality of anchors, preventing the retainer from passing through the thread hole.

[0049] According to some applications, the end retainer is a loop.

[0050] According to some applications, the end retainer is a terminal clamp with a hinged, spring-loaded gate.

[0051] According to some applications, the method further includes the step of releasing the end retainer from a clip removably coupled thereto prior to the step of inserting the proximal free end into the end retainer.

[0052] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the first wire portion inserted therein and extending therethrough toward the anchor of the implant.

[0053] According to some applications, advancing the cutting and locking assembly further facilitates slidably advancing the end retainer by utilizing the cutting and locking assembly to press against the end retainer toward the anchor of the implant.

[0054] According to some applications, the step of tensioning the wire includes pulling a first wire portion extending through the cutting and locking assembly and the clamping catheter.

[0055] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0056] According to some applications, the cutting step is performed after the locking step.

[0057] According to some applications, the cutting step is performed simultaneously with the locking step.

[0058] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0059] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0060] According to another aspect of the present disclosure, there is provided a method including the steps of advancing a plurality of anchors of an implant through an inner catheter and sequentially securing the anchors to tissue surrounding an annulus of a heart valve or other tissue region, wherein a first wire portion of a wire of the implant extends through and is advanced therethrough, and a second wire portion of the wire extends through the secured anchors and is looped back to extend along a space defined between the inner catheter and another catheter disposed over the inner catheter.

[0061] The method further includes the step of encasing the inner catheter and the handle of the inner catheter. The method further includes the step of inserting both the first and second wire portions into a cutting and locking assembly and a clamping catheter attached thereto. The method further includes the step of advancing the cutting and locking assembly over both wire portions toward the anchor of the implant. The method further includes the step of applying tension to the wire to contract the implant secured to the annulus or other tissue region. The method further includes the step of locking the wire of the implant in tension with a locker included in the cutting and locking assembly.

[0062] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends at least 270 degrees around the annulus or other tissue region.

[0063] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 270 to 320 degrees around the annulus or other tissue region.

[0064] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 320 to 360 degrees around the annulus or other tissue region.

[0065] According to some applications, the other catheter placed over the inner catheter is a guide catheter.

[0066] According to some applications, retracting the inner catheter and the handle of the inner catheter includes retracting the inner catheter from the guide catheter and separating the handle of the inner catheter from the handle of the guide catheter, such that upon removal of the inner catheter and the handle of the inner catheter, sections of both the first wire portion and the second wire portion extend through the lumen of the guide catheter.

[0067] According to some applications, the outer catheter is placed over the guide catheter.

[0068] According to some applications, retracting the inner catheter and the handle of the inner catheter includes retracting both the inner catheter and the guide catheter from the outer catheter and separating both the handle of the inner catheter and the handle of the guide catheter from the handle of the outer catheter, so that upon removal of these components, sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter.

[0069] According to some applications, another catheter placed over the inner catheter is an outer catheter, and retracting the inner catheter and its handle includes retracting the inner catheter from the outer catheter and separating the inner catheter handle from the outer catheter handle, such that upon removal of the inner catheter and its handle, sections of both the first wire portion and the second wire portion extend through the lumen of the outer catheter.

[0070] According to some applications, tensioning the wire includes simultaneously pulling both the first wire portion and the second wire portion in a proximal direction.

[0071] According to some applications, the step of tensioning the wire includes applying a pulling force to one of the first wire portion or the second wire portion while the other portion is held in place to prevent the one portion from sliding distally while the other wire portion is pulled.

[0072] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0073] According to some applications, the cutting step is performed after the locking step.

[0074] According to some applications, the cutting step is performed simultaneously with the locking step.

[0075] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0076] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0077] According to another aspect of the present disclosure, there is provided a method including advancing a first anchor of an implant through an inner catheter with an end clamp attached to a second wire portion of the implant wire, the end clamp being coupled to the first anchor via the second wire portion extending through an eyelet in the first anchor, the method further including securing the first anchor to tissue of a heart valve annulus or other tissue region.

[0078] The method further includes advancing additional anchors through the inner catheter and sequentially securing the anchors to tissue of the valve annulus or other tissue regions, with a first wire portion of the wire extending through and advanced therethrough and a second wire portion extending through the secured anchors. The method further includes manipulating the inner catheter to access a section of the wire extending therefrom to the terminal clamp and to press the wire section against a spring-biased gate of the terminal clamp, thereby inserting the wire section into an internal opening defined by the terminal clamp.

[0079] The method further includes the step of encasing the inner catheter and the handle of the inner catheter. The method further includes the step of inserting a first wire portion into the cutting and locking assembly and a clamping catheter attached thereto. The method further includes the step of advancing the cutting and locking assembly over the first wire portion toward the terminal clamp. The method further includes the step of applying tension to the wire to contract an implant secured to the valve annulus or other tissue region by applying a pulling force to the first wire portion extending through the cutting and locking assembly and the clamping catheter. The method further includes the step of locking the wire of the implant in tension with a locker included in the cutting and locking assembly.

[0080] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends at least 270 degrees around the annulus or other tissue region.

[0081] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 270 to 320 degrees around the annulus or other tissue region.

[0082] According to some applications, sequential fixation of multiple anchors is performed such that the anchors are implanted along a pathline that extends 320 to 360 degrees around the annulus or other tissue region.

[0083] According to some applications, the terminal clamp is sized to be slidable through the inner catheter.

[0084] For some applications, the end clamp is larger than the thread hole of the first anchor, preventing the end clamp from passing through the thread hole.

[0085] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0086] According to some applications, the cutting step is performed after the locking step.

[0087] According to some applications, the cutting step is performed simultaneously with the locking step.

[0088] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0089] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0090] According to another aspect of the present disclosure, a locker is provided that includes a housing defining a longitudinal axis, two sliding and locking elements, and a spring. The housing includes a proximal wire opening formed at a proximal end of the housing, a distal wire opening formed at a distal end of the housing, and two distal actuation openings located on either side of the distal wire opening at the distal end of the housing. The sliding and locking elements can be configured in a variety of different ways. In some applications, the sliding and locking elements are aligned with the distal actuation openings and are movable toward or away from each other. In some applications, a spring is configured to press between a wall of the housing and the sliding and locking elements and bias the sliding and locking elements distally and toward each other when no external force is applied to the sliding and locking elements.

[0091] According to some applications, the locker further comprises two guide elements on either side of the longitudinal axis, each guide element extending laterally between two side walls of the housing, and each sliding and locking element comprising an inclined slot that receives and is movable along a corresponding guide element.

[0092] According to some applications, the angled slot is angled relative to the longitudinal axis.

[0093] According to some applications, the spring is a finger disc spring having at least one spring arm.

[0094] According to some applications, the spring includes two spring arms.

[0095] According to some applications, the housing includes a first housing portion and a second housing portion that are attachable to one another.

[0096] According to some applications, each sliding and locking element further comprises a high friction surface oriented toward the longitudinal axis.

[0097] According to some applications, each high friction surface includes multiple teeth.

[0098] According to some applications, the teeth are oriented at a proximal angle.

[0099] According to some applications, the housing includes an inner angled wall and the sliding and locking element includes a complementary angled outer surface facing and slidable therealong.

[0100] According to some applications, a system is provided that includes a rocker and an actuation assembly. The actuation assembly includes an actuation element and two pressure arms. The actuation element includes a hinge portion positioned proximally to the rocker. The pressure arms are hinged to and pivotable about the hinge portion. The pressure arms extend from opposite sides of the rocker, and each pressure arm includes a pin insertable through a corresponding distal actuation opening and can be utilized to apply pressure against a corresponding sliding and locking element.

[0101] According to some applications, each push arm includes a proximal arm portion, a longitudinal arm portion, and a distal arm portion. Each proximal arm portion is hinged to the hinge portion and extends away from the longitudinal axis. Each longitudinal arm portion extends between the proximal arm portion and the distal arm portion. Each distal arm portion extends toward the longitudinal axis and includes a pin extending proximally therefrom.

[0102] In some applications, the length of each longitudinal arm portion is greater than the length of the rocker.

[0103] According to some applications, each longitudinal arm portion is angled at an obtuse angle relative to the proximal arm portion.

[0104] According to some applications, the actuation element includes a lumen aligned with the proximal wire opening.

[0105] According to another aspect of the present disclosure, a method is provided that includes advancing a sleeve of a sleeved implant toward the LAA ostium. The method further includes deploying a first anchor from within the sleeve and securing the anchor through the sleeve at the LAA ostium. The method further includes deploying subsequent anchor sleeves and securing the anchor sleeve through the sleeve around the LAA ostium at subsequent positions, each position being spaced a minimum distance from the previous position. The method further includes contracting the sleeve, thereby contracting the LAA ostium to which the sleeve is secured. The method further includes locking the implant in the contracted state.

[0106] According to some applications, the step of contracting the sleeve includes applying tension to a contraction member extending within the sleeve.

[0107] According to some applications, the subsequent anchor deploying step is performed such that the sleeve extends at least 270 degrees around the LAA ostium.

[0108] According to some applications, the subsequent anchor deployment step is performed such that the sleeve extends 320 to 360 degrees around the LAA ostium.

[0109] According to some applications, the minimum distance is at least 1 mm.

[0110] According to some applications, the minimum distance is selected from a range of approximately 3 to 20 mm.

[0111] According to some applications, the minimum distance is selected from a range of about 5 to 15 mm.

[0112] According to some applications, the implant is secured such that a portion of the sleeve extends over the edge of the LAA ostium.

[0113] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0114] According to another aspect of the present disclosure, a method is provided that includes advancing a fabric strip and an implant including a plurality of anchors and a wire extending through the plurality of anchors toward the LAA ostium. The method further includes securing a first anchor of the plurality of anchors through the fabric strip to the LAA ostium. The method further includes securing subsequent anchors through subsequent portions of the fabric strip at subsequent positions around the circumference of the LAA ostium, each position being spaced a minimum distance from the previous position. The method further includes contracting the wire, thereby approximating the anchors and contracting the LAA ostium to which the anchors are secured. The method further includes locking the implant in a contracted state.

[0115] According to some applications, the subsequent anchoring step is performed such that the fabric strip extends at least 270 degrees around the LAA ostium.

[0116] According to some applications, securing the subsequent anchors is performed so that the sleeve fabric is 320 to 360 degrees around the LAA ostium.

[0117] According to some applications, the minimum distance is at least 1 mm.

[0118] According to some applications, the minimum distance is selected from a range of approximately 3 to 20 mm.

[0119] According to some applications, the minimum distance is selected from a range of approximately 3 to 20 mm.

[0120] According to some applications, the implant is secured so that a portion of the fabric extends over the edge of the LAA ostium.

[0121] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the wire inserted therein and extending therethrough toward the anchor of the implant.

[0122] According to some applications, the step of contracting the wire includes pulling a portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0123] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0124] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0125] According to some applications, the cutting step is performed after the locking step.

[0126] According to some applications, the cutting step is performed simultaneously with the locking step.

[0127] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0128] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0129] According to another aspect of the present disclosure, there is provided a method including advancing an implant toward an LAA ostium, the implant including a plurality of anchors and a wire extending through the plurality of anchors. The method further includes fixing a first anchor of the plurality of anchors to the LAA ostium, the first anchor being connected to a first stopper via the wire. The method further includes fixing subsequent anchors at subsequent positions around the circumference of the LAA ostium, each position being spaced a minimum distance from the previous position. The method further includes contracting the wire, thereby approximating the anchors and contracting the LAA ostium to which the anchors are secured. The method further includes locking the implant in a contracted state.

[0130] According to some applications, the subsequent anchoring step is performed such that the implant extends at least 270 degrees around the LAA ostium.

[0131] According to some applications, the subsequent anchoring step is performed such that the implant extends 320 to 360 degrees around the LAA ostium.

[0132] According to some applications, the minimum distance is at least 1 mm.

[0133] According to some applications, the minimum distance is selected from a range of approximately 3 to 20 mm.

[0134] According to some applications, the minimum distance is selected from a range of about 5 to 15 mm.

[0135] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the wire inserted therein and extending therethrough toward the anchor of the implant.

[0136] According to some applications, the step of contracting the wire includes pulling a portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0137] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0138] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0139] According to some applications, the cutting step is performed after the locking step.

[0140] According to some applications, the cutting step is performed simultaneously with the locking step.

[0141] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0142] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0143] According to another aspect of the present disclosure, a method is provided that includes advancing an implant including a plurality of anchors and a wire extending through the plurality of anchors toward an opening in a patient's body. The method further includes anchoring a first anchor of the plurality of anchors to tissue bordering the opening, the first anchor being connected to a first stop via the wire. The method further includes anchoring a second anchor of the plurality of anchors to tissue on an opposite side of the opening. The method further includes anchoring subsequent anchors to subsequent positions positioned on the opposite side of the opening in tissue according to a zigzag formation between the anchors. The method further includes contracting the wire, thereby approximating the anchors and contracting the opening to which the anchors are secured. The method further includes locking the implant in a contracted state.

[0144] According to some applications, the opening is the LAA ostium.

[0145] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the wire inserted therein and extending therethrough toward the anchor of the implant.

[0146] According to some applications, the step of contracting the wire includes pulling a portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0147] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0148] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0149] According to some applications, the cutting step is performed after the locking step.

[0150] According to some applications, the cutting step is performed simultaneously with the locking step.

[0151] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0152] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0153] According to another aspect of the present disclosure, a method is provided that includes advancing a sleeve of an implant toward an opening in a patient's body. The method further includes deploying a first anchor from within the sleeve and securing the anchor through the sleeve to tissue bordering the opening. The method further includes deploying a second anchor from within the sleeve and securing the anchor through the sleeve to tissue on the opposite side of the opening. The method further includes deploying subsequent anchor sleeves according to a zigzag formation between the anchors and securing the anchor sleeve through the sleeve to subsequent positions positioned on the opposite side of the opening in the tissue. The method further includes contracting the sleeve, thereby contracting the opening. The method further includes locking the implant in a contracted state.

[0154] According to some applications, the opening is the LAA ostium.

[0155] According to some applications, the step of contracting the sleeve includes applying tension to a contraction member extending within the sleeve.

[0156] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0157] According to another aspect of the present disclosure, there is provided a method that includes advancing an implant comprising a plurality of anchors and a wire, the wire having a first portion extending through the plurality of anchors toward an opening in a patient's body, the wire comprising a first wire portion extending distally to a first anchor of the plurality of anchors and a second wire portion configured to extend through the plurality of anchors.

[0158] The method further includes the step of securing a first anchor to tissue bordering the opening. The method further includes the step of securing a second anchor to tissue on an opposite side of the opening. The method further includes the step of securing a subsequent anchor at a subsequent location positioned on the opposite side of the opening in the tissue, the second wire portion following a zigzag formation. The method further includes the step of inserting a proximal free end of the first wire portion through a loop of the second wire portion and advancing the loop over the first wire portion toward the anchor. The method further includes the step of contracting the wire, thereby approximating the anchors and contracting the opening in which the anchors are secured. The method further includes the step of locking the implant in a contracted state.

[0159] According to some applications, the opening is the LAA ostium.

[0160] For some applications, the loop is larger than the thread of the first anchor to prevent the loop from passing through the thread.

[0161] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the first wire portion inserted therethrough and extending toward the anchor of the implant.

[0162] According to some applications, the step of contracting the wire includes pulling a first wire portion extending through the cutting and locking assembly and the clamping catheter.

[0163] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0164] According to some applications, utilizing a cutting and locking assembly to cut a first wire portion extending proximally from the locker.

[0165] According to some applications, the cutting step is performed after the locking step.

[0166] According to some applications, the cutting step is performed simultaneously with the locking step.

[0167] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0168] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0169] According to another aspect of the present disclosure, a method is provided that includes advancing a first implant including a plurality of anchors and a wire extending through the plurality of anchors toward an opening in a patient's body. The method further includes anchoring a first anchor of the first implant to tissue bordering the opening, the first anchor being coupled to a first stop via the wire. The method further includes anchoring a second anchor of the first implant to tissue on an opposite side of the opening. The method further includes anchoring subsequent anchors of the first implant to subsequent positions positioned on opposite sides of the opening in tissue according to a zigzag formation between the anchors.

[0170] For some applications, the method further includes advancing a second implant including a plurality of anchors and a wire extending through the plurality of anchors toward the opening.

[0171] For some applications, the method further includes the step of securing a first anchor of the second implant to the border tissue of the opening, the first anchor being coupled to the first stopper via a wire.

[0172] For some applications, the method further includes securing a second anchor of a second implant to tissue on an opposite side of the opening.

[0173] In some applications, the method further includes a step of securing a subsequent anchor of a second implant to a subsequent position positioned on the opposite side of the tissue of the opening, following the zigzag formation between the anchors, resulting in a double zigzag pattern formed by the first implant and the second implant.

[0174] For some applications, the method further includes retracting the wires of the first and second implants, thereby approximating the anchors of both implants and retracting the openings in which the anchors are secured. For some applications, the method further includes locking the first and second implants in a retracted state.

[0175] According to some applications, the opening is the LAA ostium.

[0176] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the fastening catheter of the fastening system, over the wires of both the first and second implants inserted therein and extending therethrough toward the anchors of the implants.

[0177] According to some applications, the step of contracting the wires of both implants includes pulling the portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0178] According to some applications, the locking step is accomplished by utilizing a locker through which the wires of both implants extend.

[0179] According to some applications, the method further includes utilizing a cutting and locking assembly to cut wire portions of both implants extending proximally from the rocker.

[0180] According to some applications, the cutting step is performed after the locking step.

[0181] According to some applications, the cutting step is performed simultaneously with the locking step.

[0182] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to both implants.

[0183] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0184] According to another aspect of the present disclosure, there is provided a method including advancing an implant including a plurality of anchors and a wire extending through the plurality of anchors toward an opening in a patient's body, the method further including anchoring a first anchor of the plurality of anchors to tissue bordering the opening, the first anchor being coupled to an end clamp via the wire, and anchoring a second anchor of the plurality of anchors to tissue on an opposite side of the opening.

[0185] For some applications, the method further includes securing subsequent anchors to subsequent locations positioned on opposite sides of the tissue of the opening, following a zigzag formation between the anchors.

[0186] According to some applications, the method further includes the step of approaching and pressing a section of the wire extending from a final anchor of the plurality of anchors to the terminal clamp and pressing the wire section against a spring-biased gate of the terminal clamp, thereby inserting the wire section into an internal opening defined by the terminal clamp.

[0187] According to some applications, the method further includes contracting the wire, thereby approximating the anchors and contracting the openings in which the anchors are secured. The method further includes locking the implant in a contracted state.

[0188] According to some applications, the opening is the LAA ostium.

[0189] For some applications, the end clamp is larger than the thread hole of the first anchor, preventing the end clamp from passing through the thread hole.

[0190] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the clamping catheter of the clamping system, over the wire inserted therein and extending therethrough toward the terminal clamp.

[0191] According to some applications, the step of contracting the wire includes pulling a portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0192] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0193] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0194] According to some applications, the cutting step is performed after the locking step.

[0195] According to some applications, the cutting step is performed simultaneously with the locking step.

[0196] According to some applications, the method includes the steps of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the implant.

[0197] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0198] According to another aspect of the present disclosure, there is provided a method including advancing a tissue engaging portion of a helical advancement device retained within a delivery catheter toward an opening of a cavity within a patient's body, the method further including advancing the tissue engaging portion distally from the delivery catheter whereby the tissue engaging portion is expandable radially outward therefrom.

[0199] According to some applications, the method further includes rotating and advancing the tissue engaging portion distally via a drive shaft attached thereto, thereby driving the tissue engaging portion into the inner wall of the cavity.

[0200] According to some applications, the method further includes further driving the tissue engaging portion helically along the length of the inner wall until the distal end of the tissue engaging portion penetrates tissue near the distal inner wall, thereby securing a stopper positioned at the distal tip thereto.

[0201] According to some applications, the method further includes a step of rotating and retracting the drive shaft proximally to extract the tissue engaging portion from the inner wall, thereby exposing a wire held in the lumen of the tissue engaging portion, the wire being attached to a stopper and thus configured to remain fixed in a helical configuration within the inner wall.

[0202] According to some applications, the method further comprises the step of contracting the wire. According to some applications, the method further comprises the step of locking the wire in a contracted state.

[0203] According to some applications, the opening is the LAA ostium and the cavity is the LAA cavity.

[0204] According to some applications, the step of advancing towards the opening includes advancing further into the cavity.

[0205] According to some applications, the stopper has a distal sharp edge and a proximal blunt edge.

[0206] According to some applications, the method further includes the step of reinserting and sheathing the tissue engaging portion within the delivery catheter prior to the step of retracting the wire.

[0207] According to some applications, the method further includes advancing a cutting and locking assembly, including a locker and attached to the clamping catheter of the clamping system, over the wire inserted therein and extending therethrough toward the opening.

[0208] According to some applications, the step of contracting the wire includes pulling a portion of the wire that extends through the cutting and locking assembly and the clamping catheter.

[0209] According to some applications, the locking step is accomplished by utilizing a locker with a wire extending therethrough.

[0210] According to some applications, the method further includes utilizing a cutting and locking assembly to sever a first wire portion extending proximally from the rocker.

[0211] According to some applications, the cutting step is performed after the locking step.

[0212] According to some applications, the cutting step is performed simultaneously with the locking step.

[0213] According to some applications, the method further includes the step of detaching the locker from the cutting and locking assembly and retrieving the cutting and locking assembly and the clamping catheter from the patient's body, leaving the locker attached to the wire extending through the interior wall of the cavity.

[0214] According to some applications, a method for use in a subject's heart is provided, the method including transluminally advancing a distal end of an inner catheter to the subject's heart, wherein the inner catheter extends through a lumen of the outer catheter while both (i) a first end of a tether of the implant and (ii) a second end of the tether of the implant remain disposed outside the subject.

[0215] In some applications, the tether extends distally from a first end of the tether into and through the inner catheter, thereby defining a first portion of the tether out of the distal end of the inner catheter, loops around the distal end of the inner catheter, thereby defining a slack portion of the tether, and proximally from the distal end of the inner catheter and parallel to the inner catheter, thereby defining a second portion of the tether, which terminates at a second end of the tether.

[0216] For some applications, the method further includes subsequently sliding a plurality of anchors distally over and along the first portion of the tether through the inner catheter to the distal end of the inner catheter and securing the plurality of anchors to the tissue of the heart, thereby securing the slack of the tether to the tissue.

[0217] For some applications, the method further includes subsequently retracting the inner catheter from the outer catheter and the subject, such that the first portion of the tether and the second portion of the tether are positioned side-by-side within the lumen of the outer catheter.

[0218] For some applications, the method further includes thereafter, outside the subject, slidably coupling the first end of the tether to the second end of the tether, such that the tether forms a closed loop extending from outside the subject, through the lumen of the outer catheter, to the plurality of anchors secured to the tissue, back through the lumen of the outer catheter, and back to outside the subject.

[0219] In some applications, the method further includes subsequently sliding the slidable coupling distally through the outer catheter and out of the distal end of the outer catheter, so that the closed loop is reduced in size and positioned completely outside the distal end of the outer catheter within the heart.

[0220] In some applications, transluminally advancing the distal end of the inner catheter includes transluminally advancing the distal end of the inner catheter to the subject's heart, while a second portion of the tether extends proximally from the distal end of the inner catheter into and through an interior space defined between the inner wall of the outer catheter and the outer wall of the inner catheter.

[0221] In some applications, for each tissue anchor of the plurality of tissue anchors, the tissue anchor includes a helical tissue-engaging element, and securing the slack portion of the tether to the tissue includes threading the helical tissue-engaging element of each of the anchors into tissue of the heart.

[0222] In some applications, the helical tissue-engaging element defines a helical lumen therethrough, and sliding the plurality of anchors distally over and along a first portion of the tether includes sliding the plurality of anchors distally over and along the first portion while the tether extends through the helical lumen.

[0223] In some applications, the step of securing the slack portion of the tether to tissue by securing multiple anchors to cardiac tissue includes securing the multiple anchors to tissue by rotating the helical portion in a manner such that (i) the helical portion is secured to the tissue and (ii) the tether exits the helical lumen.

[0224] For some applications, the method includes, for each anchor of the plurality of anchors, threading a threading hole of the anchor onto a first end of the tether, and, for each anchor of the plurality of anchors, sliding the anchor distally onto and along a first portion of the tether including sliding the anchor distally onto and along the first portion of the tether while the threading hole of the anchor remains threaded onto the tether.

[0225] In some applications, transluminally advancing the distal end of the inner catheter to the subject's heart includes transluminally advancing the distal end of the inner catheter to the subject's heart, while an end retainer is disposed on a second end of the tether, and slidably coupling a first end of the tether to the second end of the tether includes slidably coupling the first end of the tether to the end retainer.

[0226] For some applications, the end retainer includes an end loop defined by the second end of the tether, and slidably coupling the first end of the tether to the second end of the tether includes threading the first end through the end loop.

[0227] For some applications, sliding the slidable coupling distally through the outer catheter and out of the distal end of the outer catheter includes sliding the end loop along a first portion of the wire.

[0228] For some applications, sliding the slidable coupling distally through the outer catheter and out of the distal end of the outer catheter includes pulling the first end proximally.

[0229] According to some applications, a system for use at an annulus of a heart valve of a subject's heart is provided, the system including a delivery assembly including an outer catheter configured for transluminal advancement toward the subject's heart, the outer catheter defining a lumen extending therethrough. The delivery assembly may also include an inner catheter configured to extend through the lumen of the outer catheter, the inner catheter defining a lumen extending therethrough. In some applications, the system and / or delivery assembly includes an anchor driver.

[0230] For some applications, the system includes a tether having a first end and a second end disposed proximally from the catheter assembly. For some applications, the tether extends distally from the first end through the inner catheter, thereby defining a first portion of the tether. For some applications, the tether extends out from the distal end of the inner catheter and loops around the distal end of the inner catheter, thereby defining slack. For some applications, the tether extends proximally from the distal end of the catheter, parallel to the inner catheter, thereby defining a second portion of the tether. For some applications, the second portion of the tether terminates at the second end of the tether. For some applications, the tether has an end retainer at the second end of the tether.

[0231] In some applications, the system includes multiple anchors.

[0232] In some applications, the delivery assembly is configured to advance the slack of the tether to the valve annulus so that both the first end and the second end are positioned outside of the subject, while both the first end and the second end remain outside of the subject to secure the slack around the valve annulus. Securing the slack to the valve annulus can be performed by using an anchor driver to advance, for each anchor of the multiple anchors, an anchor onto the tether, threaded distally through the inner catheter over a first portion of the tether, and toward the valve annulus, and driving the anchor onto the tether and threaded through tissue.

[0233] In some applications, the end retainer is configured to slidably couple the second end of the tether to the first end of the tether while the slack remains fixed around the annulus, and the delivery assembly is configured to facilitate distal sliding of the slidable coupling along the first portion and up to the slack at the annulus, such that the tether forms a closed loop around the annulus.

[0234] For some applications, a second portion of the tether extends proximally from the distal end of the inner catheter into and through an interior space defined between the inner wall of the outer catheter and the outer wall of the inner catheter.

[0235] For some applications, each tissue anchor of the plurality of anchors includes a tissue-engaging element. The tissue-engaging element may be the same as or similar to any of the tissue-engaging elements described herein. For some applications, each tissue anchor of the plurality of anchors includes a helical tissue-engaging element or a tissue-engaging element that includes a helical shape.

[0236] For some applications, each anchor of the plurality of anchors has a proximal portion defining a threaded hole for receiving a tether therethrough.

[0237] For some applications, the end retainer includes an end loop defined by the second end of the tether, the first end being insertable through the end loop.

[0238] In some applications, the end loop is slidable along the first portion of the wire.

[0239] In some applications, the inner catheter defines a lateral slit extending proximally from the distal end of the inner catheter, the lateral slit being shaped to allow the tether, but not the anchor, to exit the inner catheter laterally.

[0240] In some applications, the inner catheter can be retracted from the outer catheter after securing the slack portion to the annulus and before sliding the slidable coupling distally along the first portion.

[0241] The above methods may be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, hearts, tissues, etc.), and the like.

[0242] Particular applications of the present disclosure may include some, all, or none of the above advantages. Additional advantages may be readily apparent to those skilled in the art from the drawings, descriptions, and claims contained herein. Aspects and applications of the present disclosure are further described herein below in the specification and appended claims.

[0243] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. In the event of a conflict of interpretation, the patent specification, including definitions, shall prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly indicates otherwise.

[0244] The following applications and aspects thereof are described and illustrated in conjunction with systems, tools, and methods that are meant to be exemplary, but not limiting in scope. In various applications, one or more of the problems discussed above are mitigated or eliminated, while other applications are directed to other advantages or improvements. [Brief explanation of the drawings]

[0245] Some applications of the present disclosure are described herein with reference to the accompanying drawings. This description, together with the drawings, will make it clear to those skilled in the art how some applications may be practiced. The drawings are for illustrative purposes, and no attempt is made to show structural details of the applications in more detail than is necessary for a fundamental understanding of the present disclosure. For clarity, some objects shown in the drawings are not to scale.

[0246] [Figure 1] FIG. 1 is a schematic diagram of a multi-component tubular system that provides one or more steerable catheters configured to deliver an implant to a subject's heart, according to some applications. [Figure 2] 2 and 3A-3B are schematic illustrations of exemplary steps in implanting an implant to repair a mitral valve, according to some applications. [Figure 3A] Same as above. [Figure 3B] Same as above. [Figure 4A] 4A and 4B and 5 are schematic illustrations of other examples of tissue anchors and implants including such anchors, according to some applications. [Figure 4B] Same as above. [Figure 5] Same as above. [Figure 6A] 6A and 6B are schematic illustrations of exemplary steps in a procedure for securing an implant, according to some applications. [Figure 6B] Same as above. [Figure 7A] 7A and 7B are schematic diagrams of exemplary steps performed on the extracorporeal components of the system and implant according to some applications. [Figure 7B] Same as above. [Figure 8A] 8A and 8B are schematic diagrams of exemplary steps performed on the extracorporeal components of the system and implant according to some applications. [Figure 8B] Same as above. [Figure 9A]9A and 9B are schematic illustrations of exemplary steps of a procedure for fastening an implant with a loop, according to some applications. [Figure 9B] Same as above. [Figure 10A] 10A and 10B illustrate an exemplary application of an exemplary locker included within a cut and lock assembly of a fastening system according to some applications. [Figure 10B] Same as above. [Figure 11A] 11A and 11B are schematic illustrations of exemplary steps in implanting an implant to repair a mitral valve, according to some applications. [Figure 11B] Same as above. [Figure 12] FIG. 12 is a schematic diagram of an example implant, according to some applications. [Figure 13A] 13A and 13B are schematic illustrations of exemplary steps of a procedure for fastening an implant using a fastening system, according to some applications. [Figure 13B] Same as above. [Figure 14] 14 and 15A-15C are schematic illustrations of example procedures for fastening an implant with an end clamp, according to some applications. [Figure 15A] Same as above. [Figure 15B] Same as above. [Figure 15C] Same as above. [Figure 16] 16 and 17 are schematic illustrations of an example procedure for tightening an implant with a first stop, according to some applications. [Figure 17] Same as above. [Figure 18] FIG. 18 is a schematic diagram of an example of a locker that may be included in a cut and lock assembly, according to some applications. [Figure 19] FIG. 19 is a perspective exploded view of the rocker of FIG. 18 according to some applications. [Figure 20A]20A and 20B are cross-sectional views of the locker of FIGS. 18 and 19 in its locked and unlocked states, according to some applications. [Figure 20B] Same as above. [Figure 21A] 21A-21C are perspective views of an exemplary actuation assembly that can be used in combination with the rocker of FIGS. 18-20B in various stages of operation according to some applications. [Figure 21B] Same as above. [Figure 21C] Same as above. [Figure 22] FIG. 22 is a schematic diagram of an exemplary system advanced toward the left atrial appendage (LAA), according to some applications. [Figure 23A] 23A-23G are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 23B] Same as above. [Figure 23C] Same as above. [Figure 23D] Same as above. [Figure 23E] Same as above. [Figure 23F] Same as above. [Figure 23G] Same as above. [Figure 24A] 24A-24G are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 24B] Same as above. [Figure 24C] Same as above. [Figure 24D] Same as above. [Figure 24E] Same as above. [Figure 24F] Same as above. [Figure 24G] Same as above. [Figure 25A] 25A-25C are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 25B] Same as above. [Figure 25C]Same as above. [Figure 26A] 26A-26E are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 26B] Same as above. [Figure 26C] Same as above. [Figure 26D] Same as above. [Figure 26E] Same as above. [Figure 27A] 27A-27D are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 27B] Same as above. [Figure 27C] Same as above. [Figure 27D] Same as above. [Figure 28A] 28A-28B are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 28B] Same as above. [Figure 29A] 29A-29E are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 29B] Same as above. [Figure 29C] Same as above. [Figure 29D] Same as above. [Figure 29E] Same as above. [Figure 30A] FIG. 30A is a cross-sectional view of an exemplary advancement device, according to some applications. [Figure 30B] 30B-30G are schematic illustrations of exemplary steps of a method for closure of an opening (eg, the LAA, or other opening), according to some applications. [Figure 30C] Same as above. [Figure 30D] Same as above. [Figure 30E] Same as above. [Figure 30F] Same as above. [Figure 30G] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0247] In the following description, various aspects of the present disclosure are described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of different aspects of the present disclosure. However, it will be apparent to those skilled in the art that the present disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure.

[0248] Throughout the drawing figures, different superscripts for the same reference number are used to indicate different examples of the same element. Applications of the disclosed devices and systems may include any combination of different implementations of the same element. Specifically, any reference to an element without a superscript may refer to another example of the same type of element indicated by the superscript. To avoid undue confusion due to a plethora of reference numbers and leading lines on a particular drawing, some components may be introduced through more than one drawing and not explicitly identified in all subsequent drawings that include that component.

[0249] The present disclosure relates, inter alia, to methods and systems for performing annuloplasty procedures on a subject's heart. Some methods include using a transluminal (e.g., transfemoral) approach to advance a catheter to the subject's heart and implanting multiple anchors around the annulus of a heart valve, as shown, for example, in Figures 6A and 6B. The anchors may be threaded onto wires prior to their advancement, such that implanting the anchors around the annulus places the slack of the wire around the annulus (as shown, for example, in Figures 6A and 6B) and the ends of the wire are positioned outside the heart, e.g., outside the subject, as shown, for example, in Figures 7A and 8A. Subsequently, as shown in FIG. 9A and described herein below, the ends of the wires are slidably coupled (e.g., as shown in FIGS. 7B and 8B), and the slidable coupling is then advanced toward the annulus and slack so that the slack forms a closed loop that can be tightened to constrict the annulus, thus reducing valvular regurgitation, as shown, for example, in FIGS. 9A and 9B.

[0250] In some applications, the catheter is an outer catheter, and the system further includes an inner catheter. The inner catheter is positioned within the lumen of the outer catheter while the anchor is implanted into the tissue of the valve annulus. As shown in FIG. 1 , a wire extends such that a first portion of the wire extends from outside the subject, through the inner catheter, and out of the inner catheter at the valve annulus, and a second portion of the wire extends out of the subject back through a space defined between the inner and outer catheters (i.e., into the lumen of the outer catheter, not inside the inner catheter), so that both ends of the wire are located outside the subject, e.g., outside the heart ( FIG. 8A shows both ends extending proximally from the exterior of the catheter).

[0251] The anchors may be threaded over the wire and advanced to the valve annulus, such that each anchor is advanced over a wire within the inner catheter toward the heart and implanted around the valve annulus. Once implanted around the annulus, the wire may extend from outside the subject, through the inner catheter, to the subject's heart, forming slack around the annulus, passing back through a space defined between the inner and outer catheters, and terminating outside the subject at a second end of the wire.

[0252] Once the anchor is implanted in the annular tissue, the inner catheter can be retracted from the outer catheter and the subject, and the wire can be extended from outside the subject, through the outer catheter, to the annulus, where it can be passed back through the outer catheter to the slack around the annulus and anchored outside the subject.

[0253] In some applications, to facilitate the reduction of valve regurgitation, the wire is then formed into a closed loop around the valve annulus, for example, by slidably coupling the ends of the wire to each other from outside the subject. In some applications, as shown in FIGS. 7A and 7B and 8A and 8B, to slidably couple the ends of the wire to each other, one end of the wire defines a slidable coupling, such as an end retainer (e.g., a thread), through which the other end of the wire (hereinafter referred to as the free end) is inserted. The end retainer may be a thread defined by the end of the wire or any other retainer, as described in detail below. Thus, the wire is positioned in a loop extending from the annulus where it will be secured, through the catheter (e.g., both the first and second portions extend proximally from the annulus within the outer catheter), and outside the patient, with the two ends of the wire secured within the loop at the end retainer portion (see FIGS. 7B and 8B). The free end of the wire (which is secured to the retainer portion at the end) is then pulled proximally and / or the slidable coupling is pushed distally, reducing the size of the loop and pulling the loop through the catheter toward the annulus.

[0254] Subsequently, the end retainer is advanced over the first portion of the wire toward the heart, thereby advancing the closed loop toward the annulus (FIG. 9A), after which the first portion of the wire extends proximally from the heart and the end retainer, through the outer catheter, and out of the subject. In some applications, the wire is then tensioned to reduce the size of the annulus, e.g., so that the tissue anchors move toward each other, further reducing the size of the closed loop (e.g., as shown in the transition between FIGS. 9A and 9B, which illustrate the reduced annulus size). A cutting and locking assembly can be advanced over the first portion and along the wire toward the heart, as shown in FIG. 9B. The cutting and locking assembly can be used to cut excess wire extending away from the closed loop so that the first portion of the wire is cut slightly proximal to the end retainer. Tension in the closed loop can be maintained by a locker delivered by the cutting and locking assembly to maintain the closed loop in tension.

[0255] It should be noted that while other similar systems in which two lengths of wire extend from the heart to outside the subject may require cutting both lengths of wire, the annuloplasty procedure described above advantageously only requires cutting a single length of wire (i.e., only requires cutting a first portion of the wire and not a second portion of the wire). For example, this may facilitate the use of smaller and / or simpler tools and / or may be easier for the operator to perform.

[0256] The systems, instruments, devices, implants, anchors, tethers (e.g., wires), components, etc. used herein may be the same as, similar to, or substituted for the systems, instruments, devices, implants, anchors, wires, components, etc. described in and used in International Patent Application No. PCT / IB2020 / 060044, which is incorporated herein in its entirety for all purposes, mutatis mutandis. Furthermore, the methods described herein may be practiced using the systems, instruments, devices, implants, anchors, wires, components thereof, etc. described in International Patent Application No. PCT / IB2020 / 060044, mutatis mutandis. For example, spacers may be placed between the anchors of the present disclosure (e.g., threaded onto the wires of the present disclosure), e.g., as described in International Patent Application No. PCT / IB2020 / 060044, mutatis mutandis, to distribute forces between the anchors and / or limit overall retraction of the implant by preventing the anchors from moving too closely together. Such spacers can be threaded onto the tether in an alternating arrangement with the anchors, such that the anchor-spacer-anchor arrangement ensures proper force distribution along the implant and / or inhibits excessive contraction of the implant around the annulus by the anchors moving together.

[0257] Reference is now made to Figures 1-3B. Figure 1 is a schematic illustration of a multi-component tubular system 10 that provides one or more rotationally controlled steering catheters configured to deliver an implant to a subject's heart, according to some applications. Figures 2-3B are schematic illustrations of at least some steps in using system 10 to implant a native valve, such as mitral valve 45, with an implant 180 to repair the valve, according to some applications.

[0258] According to some applications, the multi-component tubular system 10 is configured to implant an implant in a subject's heart. For some applications, the system 10 includes a first outer catheter 12 configured for transluminal advancement through the subject's vasculature. For some applications, the outer catheter 12 is configured to be advanced through the femoral artery toward the atrial septum of the subject's heart. A distal end portion 14 of the outer catheter 12 is configured to pass through the atrial septum of the subject and be oriented in a desired spatial orientation within the left atrium. According to some applications, the distal end portion 14 of the outer catheter 12 is steerable. That is, the distal end portion 14 is deflectable relative to an adjacent, more proximal portion of the catheter 12 (e.g., using an extracorporeal portion or element of the system 10 to deflect the distal end portion of the catheter).

[0259] According to some applications, the system 10 further includes a second or guide catheter 16 that passes through the outer catheter 12 (i.e., through its primary lumen), is positioned outside the distal end portion 14 of the outer catheter 12, and includes a distal end portion 18 configured to be oriented in a desired spatial orientation within the left atrium. According to some applications, the distal end portion 18 of the guide catheter 16 is steerable. That is, the distal end portion 18 is deflectable relative to an adjacent, more proximal portion of the guide catheter 16 (e.g., using an extracorporeal portion or element of the system 10 to deflect the distal end portion). The guide catheter 16 is steerable to a desired spatial orientation to facilitate advancement and implantation of the implant within the subject's body cavity.

[0260] According to some applications, the system 10 further includes a third or inner catheter 20 that passes through either the guide catheter 16 or the outer catheter 12 (i.e., through its primary lumen) and is positioned outside either the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and includes a distal end portion 22 configured to be oriented in a desired spatial orientation within the left atrium. According to some applications, the distal end portion 22 of the inner catheter 20 is steerable. That is, the distal end portion 22 is deflectable relative to an adjacent, more proximal portion of the inner catheter 20 (e.g., by using an extracorporeal portion or element of the system 10). The inner catheter 20 is steerable to a desired spatial orientation for advancement and implantation of the implant within a body cavity of a subject.

[0261] For some applications, the external handle assembly 40 is used to manipulate a catheter within a patient. The handle assembly 40 is supported by a support base 30, which may include a handle sliding track 32. The support base 30 may be moved to control the position of the handle assembly 40 and, for some applications, the position of the entire multi-component system 10. For some applications, the handle assembly 40 includes at least one of an outer catheter handle 24, a guide catheter handle 26, and / or an inner catheter handle 28. The outer catheter handle 24 is coupled to an outer catheter proximal end portion 34 of the outer catheter 12. The guide catheter handle 26 is coupled to a guide catheter proximal end portion 36 of the guide catheter 16. The inner catheter handle 28 is coupled to an inner catheter proximal end portion 38 of the inner catheter 20. For some applications, linear and / or rotational movement of the guide catheter handle 26 relative to the outer catheter handle 24 moves the guide catheter 16 through the outer catheter 12. According to some applications, the inner catheter 20 moves through the guide catheter 16 and / or outer catheter 12 by linear and / or rotational movement of the inner catheter handle 28 relative to the outer catheter handle 24 and / or guide catheter handle 26.

[0262] According to some applications, the implantation procedure begins with advancing a semi-rigid guidewire (not shown) into the right atrium 44 of the patient's heart 42. The procedure may be performed using imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography. The guidewire provides a guide for subsequent advancement of the outer catheter 12 along the guidewire into the right atrium 44. Once the distal end portion 14 of the catheter 12 enters the right atrium 44, the guidewire may be retracted from the subject's body. While in the right atrium, the system may be used to deliver an implant to the tricuspid valve and / or another portion of the right atrium.

[0263] For applications using the system 10 to deliver the implant 180 to the mitral atrium, LAA, or other tissue of a patient's left atrium, the outer catheter 12 may be configured to be advanced through the patient's vasculature to the right atrium 44, after which the distal end portion 14 of the outer catheter 12 is advanced into the left atrium 43. The steerable distal end portion 14 of the outer catheter 12 is then steered so that the distal end is positioned at a desired spatial orientation within the left atrium 43. The steering procedure may be performed using imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0264] According to some applications, the outer catheter 12 is advanced through the vascular system to the right atrium 44, using an appropriate origin typically determined for a given patient. According to some applications, the outer catheter 12 is introduced typically through the fossa ovalis, through the inferior vena cava 46, into the right atrium 44 of the subject's heart 42, transseptally to the left atrium 43, and into the femoral vein, as shown in FIG. 2 . According to some applications, the outer catheter 12 is introduced typically through the fossa ovalis (not shown), through the subclavian vein, into the superior vena cava, into the right atrium 44, transseptally to the left atrium 43, and into the basilic vein. According to some applications, the outer catheter 12 is introduced typically through the fossa ovalis (not shown), through the subclavian vein, into the superior vena cava, into the right atrium 44, transseptally to the left atrium 43, and into the external jugular vein. The outer catheter 12 is advanced distally until its distal end portion 14 reaches the lacrimal septum, at which point the guidewire is removed.

[0265] According to some applications, an elastic needle and dilator (not shown) are advanced through the outer catheter 12 and into the heart 42. To transseptally advance the outer catheter 12 into the left atrium 43, the dilator is advanced to the interatrial septum and a needle is pushed from within the dilator, puncturing the septum and creating an opening that facilitates passage of the dilator and subsequent outer catheter 12 therethrough into the left atrium 43.

[0266] According to some applications, after steering the distal end portion 14 of the outer catheter 12, a guide catheter 16 is advanced through the outer catheter 12 to facilitate delivery and implantation of an implant 180 or to guide the inner catheter 20 thereto, for example, along the annulus of a native valve or other tissue region (e.g., the annulus of the mitral valve 45, the annulus of the tricuspid valve, an appendage, a bulge, a portion of the atrioventricular wall, another tissue opening, etc.), as shown in FIG. 2 . According to some applications, the guide catheter 16 is a steerable catheter configured to guide the inner catheter 20 into cardiac tissue. At least a portion of its steerable distal end portion 18 may be exposed from the distal end portion 14 of the outer catheter 12 during implant delivery and thus can be freely steered toward tissue of the heart 42, such as the annulus of the mitral valve 45, an appendage, or the atrioventricular wall, as described below.

[0267] According to some applications, after steering the steerable distal end portion 18 of the guide catheter 16, the inner catheter 20 is advanced through the guide catheter 16 to facilitate delivery and implantation of the implant 180 along the native tissue, for example, along the native annulus of the mitral valve 45. At least a portion of the steerable distal end portion 22 of the inner catheter 20 may be exposed from the distal end portion 18 of the guide catheter 16 during delivery of the implant and thus may be freely steered toward cardiac tissue, such as the annulus of a native valve (such as the mitral valve 45) or other tissue region, as described below.

[0268] According to some applications, system 10 is configured to advance anchors 150 through guide catheter 16 and / or inner catheter 20 to a target site within a patient's heart 42. According to some applications, implant 180 includes a wire 63 having a first wire portion 62 and a second wire portion 64, and a plurality of anchors 150. While the term "wire" is used in this context, it will be understood that because the wire functions as a tether or lead, the terms "wire," "tether," and "lead" may be used interchangeably for such components.

[0269] Anchor 150 generally includes tissue-engaging element 152. The tissue-engaging element may be configured in a variety of ways, for example, as one or more of a helix or spiral, a hook, a barb, a harpoon, a needle, a clip, an adhesive, an arm, an extension, a gripper, etc. In some applications, the tissue is at sharp distal tip 154 ​​and is configured to allow a portion of wire 63 to extend therethrough, for example, through a thread 158 thereof.

[0270] According to some applications, implant 180 a 3A and 3B and includes a wire 63 having a first wire portion 62 and a second wire portion 64, and a plurality of anchors 150, of the type shown in FIGS. 3A and 3B and described herein below. a And, it is equipped with.

[0271] According to some applications, each anchor 150 shown in FIGS. 3A and 3B a The tissue engaging element 152 a and through holes 158 a According to some applications, the tissue engaging element 152 a may be the same as or similar to other tissue engaging elements herein. In some applications, the tissue engaging element may have a sharp distal tip 154 a , proximal end 156 a , defining a helical portion therebetween. a The tissue engaging element 152 a 156 at the proximal end of a According to some applications, through holes 158 a extends laterally across the proximal end 156 of the tissue engaging element 152. Optionally, the tissue engaging element 152 a may be another type of non-helical tissue engaging element, such as a dart or staple.

[0272] As will be described in more detail below, according to some applications, anchor 150 (e.g., anchor 150 a Through holes 158 a) is configured to easily slide the anchor along (or through) the wire 63 while the anchor is aligned with or oriented perpendicular to the wire 63.

[0273] According to some applications, wire 63 is inserted through threaded hole 158 before inserting anchors 150 into inner catheter 20. According to some applications, implant 180 includes 3-30 anchors 150, or 5-25 anchors 150, or 7-13 anchors 150, or 5-15 anchors 150, or 8-14 anchors 150, or 6-19 anchors 150. Each possibility represents a separate embodiment.

[0274] According to some applications, the system 10 further comprises a delivery tool 160 for percutaneous (e.g., transluminal, such as transfemoral) implantation of the implant 180. a Anchor 150 a a flexible anchor driver 161 configured for use with the anchor driver 161 and configured to reversibly engage the through hole 158; a Equipped with 161 drivers a The flexible shaft 74 a and shaft 74 a a driver head 76 coupled to the distal end of the a and a driver head 76. a 158 through holes a Anchor driver 161 reversibly engages a This engagement causes the driver 161 a For example, anchor 150 a By rotating (and pushing distally) the tissue engaging element 152 a into the tissue of the heart 42.

[0275] As used herein, the terms "wire," "tether," and "conductor" encompass other elongated structures that may perform similar functions, such as conductors, tethers, cables, threads, sutures, braids, fasteners, ribbons, and other known wires in the art. Wire 63 may be formed from at least one material selected from metallic materials, synthetic polymers, natural fibers, and combinations thereof. According to some applications, wire 63 is formed from a metallic material.

[0276] At least a portion of the wire 63, such as the first wire portion 62, is disposed within the lumen of the inner catheter 20 as the anchor 150 is advanced through the lumen over the first wire portion. Thus, once the first anchor 150a extends out of the inner catheter 20 and is secured to the tissue, the first wire portion 62 remains extended through the lumen of the inner catheter, from the handle 28 of the inner catheter to the distal end portion 22 of the inner catheter and the anchor. The first wire portion 62 is defined as the portion of the wire that extends from the proximal end of the wire to the first anchor 150a of the series of anchors 150.

[0277] The second wire portion 64 is defined as the remaining portion of the wire 63 that extends continuously from the first wire portion 62. In some applications, at least a section of a length of the second wire portion 64 is disposed within an interior space defined between the inner catheter 20 (e.g., the outer surface of the inner catheter 20) and the guide catheter 16 (e.g., the inner surface of the guide catheter 16), as shown in Figures 3A and 3B.

[0278] According to some applications, at least a first segment of the second wire portion 64 is connected to a corresponding anchor 150 a Through holes 158 a1 and 2, the first segment 64 is configured to extend through a plurality of thread holes 158 of a corresponding plurality of anchors 150, such as through a plurality of thread holes 158, such that the first segment forms slack in the wire 63 that is positioned around the valve annulus. In some such applications, as shown in FIGS. 3A and 3B, the second wire portion 64 may then extend proximally away from the slack and anchors 150 into an interior space defined between the inner catheter 20 and the guide catheter 16 and out of the guide catheter at its proximal extracorporeal portion. Optionally, the second wire portion 64 may extend out of the guide catheter handle 26, such as from its rear end 70 (see FIG. 1) or through any other opening in the guide catheter handle 26.

[0279] As used herein, the term "first wire portion" refers to a portion of the wire 63 that is advanced distally within the lumen of the inner catheter 20 and is defined as the portion of the wire 63 that extends into the patient's body to the distal end portion 22 of the inner catheter 20 or to the first anchor 150a of the multiple anchors 150 that are secured to tissue at the implantation site.

[0280] As used herein, the term "second wire portion" refers to a portion of the wire 63 that extends continuously from the first wire portion 62, may extend through at least one anchor 150, (e.g., through at least one thread 158 thereof) and loops around the patient's valve annulus or other body cavity, and then enters the lumen of either the guide catheter 16 or the outer catheter 12, which portion extends proximally parallel to (but out of) the inner catheter 20 toward the components of the handle assembly 40 and preferably terminates at a proximal end exposed to the external environment.

[0281] As used herein, the term "distal direction" refers to a direction toward the human heart of a subject (e.g., a patient) having a cardiac procedure. As used herein, the term "proximal direction" refers to a direction toward the user operating system 10 (e.g., a physician). As used herein, the term "longitudinal direction" refers to a direction toward the cardiac tissue being treated (e.g., perpendicular to the surface of the cardiac tissue).

[0282] According to some applications, a portion of the second wire portion 64 is disposed within the space defined between the guide catheter 16 and the outer catheter 12 and extends out of the outer catheter 12 at its proximal extracorporeal portion. Optionally, the second wire portion 64 may extend out of the outer catheter handle 24, such as from its rear end 72 (e.g., as shown in FIG. 8A ) or through any other opening in the outer catheter handle.

[0283] In some applications, the proximal end of second wire portion 64 may include a loop 66 (i.e., an end loop), as shown, for example, in FIGS. 1 , 7A and 7B , 8A and 8B , and 9A and 9B . In some applications, immediately after implantation of the anchor, end loop 66 may be positioned outside the body and accessible to an operator. According to some applications, end loop 66 extends outside of guide catheter handle 26, such as from its rear end 70, as shown, for example, in FIGS. 7A and 7B , so that end loop 66 is exposed and accessible to an operator of system 10. Because the size of end loop 66 may be small for an operator's hand, making it difficult to directly grasp and manipulate, end loop 66 may optionally, but need not, be removably coupled to a clip 68 shaped and dimensioned to provide the operator with suitable handling (e.g., manual grasping or gripping) of end loop 66.

[0284] According to some applications, during delivery of the implant 180, more specifically, the anchor 150 a During delivery and fixation of the annulus into the tissue, the anchor driver 161 a But through hole 158 a 1. While the first wire portion 62 extends longitudinally through the lumen of the inner catheter 20, the first wire portion 62 is continuously and reversibly engaged with the anchor 150. ais freely slidable along wire 63 (e.g., as shown in the first left frame of FIG. 3A and in FIG. 3B). As used herein, the term "longitudinal" refers to the length of anchor 150 in FIG. 3B. a 150. The anchor 150 is generally parallel to the central longitudinal axis 48 of the anchor 150, as shown. a Although described herein above as promoting smooth sliding of wire 63 while it is straight and parallel to axis 48, it should be understood that this is an ideal representation of the wire orientation, and that in actual use, the wire may not be perfectly straight or parallel to axis 48.

[0285] According to some applications, implant 180 a During delivery of the tissue engaging element 152 a As the helical tissue-engaging element 150 rotates, the first wire portion 62 rotates until the wire 63 eventually exits the helical tissue-engaging element proximally and engages the anchor 150. a Through holes 158 a until the tissue engaging element 152 is threaded through the a 3A, which shows the delivery tool 160. a But Anchor 150 a to tissue of the patient's heart 42, such as tissue surrounding the annulus of the mitral valve 45 or another valve. a By fixing the tool 160 a The system and / or implants are anchored to the anchor 150 a 152. The delivery state is transitioned to the implanted state by rotating the tissue engaging element 152. a is driven into the tissue, and the wire 63 is attached to the anchor 150 a Through holes 158 a As used herein, the term "lateral" refers to being generally perpendicular to the central longitudinal axis 48.

[0286] According to some applications, wire 63 may be threaded through hole 158 a Once extending laterally through the through-hole 158, the wire 63 is passed through the through-hole 158 while being oriented vertically along the axis 48.a This configuration may be useful in applications where tension is applied to the wire 63 to adjust an anatomical dimension, such as during an annuloplasty procedure.

[0287] According to some applications, multiple anchors 150 a is the delivery tool 160 described above. a Each anchor is fixed / implanted into the cardiac tissue using a 3A and 3B, the first wire portion 62 is threaded through the thread hole 158 while being generally parallel to the axis 48 within the inner catheter 20. a The anchor 150 is delivered to the tissue in a delivery state extending through the a is then secured around the same tissue at a different location, with second wire portion 64 oriented substantially parallel to the surface of the tissue to which the anchor is secured.

[0288] 4A-5, to which reference is now made, illustrate another type of tissue anchor 150, including such an anchor, according to some applications. b and Implant 180 b Anchor 150 b includes a tissue engaging element 152 configured to be driven (e.g., driven, pushed, etc.) into the tissue of a target. b The tissue engaging element may be the same as or similar to other tissue engaging elements herein. According to some applications, the tissue engaging element may include a proximal end 156 b and a sharp distal tip154 b and, equipped with Anchor 150 a , as well as defining a helical portion therebetween. Optionally, tissue engaging element 152 b may be another type of non-helical tissue engaging element, such as a dart or staple, and / or tissue engaging element 152 b may be configured in a variety of ways, for example, as curved tissue-engaging elements, as straight tissue-engaging elements, as barbed tissue-engaging elements, combinations thereof, etc.

[0289] Anchor 150 b is the proximal end 156b The anchor head 163 further includes an anchor head 163 coupled to the through hole 158. b and an anchor head interface 165. The anchor head interface 165 is connected to the anchor driver 161. b The coupling element is configured to be reversibly engaged by

[0290] In some applications, driver 161 b 5, includes an elongated flexible shaft 174 including a distal end of the shaft configured to reversibly engage the anchor head interface 165. b The anchor head interface 165 includes a tissue engaging element 152. b can be tightly linked to

[0291] According to some applications, anchor head interface 165 is located on the proximal superior surface of anchor head 163 that extends through central longitudinal axis 48 and through hole 158. b are disposed on the sides of the anchor head 163 that extend laterally from the shaft 48.

[0292] According to some applications, Anchor 150 b Anchor 150 b For example, while the shaft 48 is aligned with the anchor 150 a Similarly, the anchor 150 is configured to facilitate sliding of the anchor along (or through) the wire 63 while parallel to the wire 63. Also, as described in more detail below, the anchor 150 b Anchor 150 b While the axis 48 is oriented perpendicular to the wire 63, the anchor 150 is aligned along the wire 63. b Sliding (or anchor 150 b This is accomplished at least in part by the shape and dimensions of the thread holes 158.

[0293] According to some applications, through holes 158 b defines an opening 159 and is mounted on an anchor head 163, thereby forming a through hole 158. b And the opening 159 is inclined at a fixed angle relative to the axis 48 relative to the side of the anchor head 163 .

[0294] According to some applications, the opening 159 is shaped as an ellipse (e.g., a non-circular ellipse). b is shaped to define a first transparent linear path through the aperture 159 along a first conductor parallel to the axis 48 (e.g., as shown in the close-up on the left of FIG. 5 ) and a second transparent linear path through the aperture along a second conductor perpendicular to the first conductor (e.g., as shown in the close-up on the right of FIG. 5 ). The elliptical shape of the aperture 159 advantageously allows for through-hole 158 b It is envisioned that the wires can slide along the wires in either of these mutually orthogonal orientations. b It is noted that the shape of the through-hole 158 will similarly facilitate its sliding along the wire if it is in an orientation that lies between these mutually orthogonal orientations. However, the opening 159 may be shaped as a circle, a square, a rectangle, or in any of these orientations (and typically in a continuum of orientations therebetween) to allow the through-hole 158 to slide along the wire. b It should be understood that the grooves may have any other suitable shape that allows for smooth sliding of the grooves.

[0295] FIG. 5 illustrates an implant 180 along cardiac tissue, such as the annulus of the mitral valve 45 or another valve. b 1 illustrates the delivery and implantation of the anchor 150. At least a portion of the steerable distal end portion 22 of the inner catheter 20 is exposed from the distal end portion 18 of the guide catheter 16 during delivery and is therefore free to be steered toward the cardiac tissue, as described below. b The anchor 150 may be advanced longitudinally through the lumen of the inner catheter 20 as described herein above. bThe anchor head interface 165 of the anchor driver 161 b This engagement allows the driver 161 b For example, anchor 150 b By rotating (and / or pushing distally) the tissue engaging element 152 b into cardiac tissue.

[0296] According to some applications, multiple anchors 150 b are fixed / implanted into the cardiac tissue. Each anchor 150 b As shown in the enlarged view on the left of FIG. 5, the first wire portion 62 is inserted through the through-hole 158 while being generally parallel to the axis 48 within the inner catheter 20. b The subsequent anchor 150 is delivered to the tissue in a delivery state extending through the opening 159 of the b When the second wire portion 64 is secured to the same tissue, the second wire portion 64 is secured to the anchor 150 as shown in the enlarged view on the right of FIG. b Oriented transversely to the through hole 158 b Due to this configuration, despite this reorientation of second wire portion 64 around the tissue, wire 63 remains in place through hole 158. b According to some applications, the through hole 158 b is mounted so as to be rotatable about an axis 48 .

[0297] According to some applications, at least a first segment of the second wire portion 64 may be provided with a corresponding plurality of anchors 150. b Through holes 158 b and at least a second segment of second wire portion 64 is configured to be disposed within an interior space defined between inner catheter 20 and guide catheter 16, as shown in FIG. 5.

[0298] Anchor 150 b To secure the anchor 150 bis advanced out of the distal end portion 22 of the inner catheter 20 while the driver 161 b The anchor 150 is attached to the inner catheter 20. b (Thereby, tissue engaging element 152 b ) anchor head interface 165. For some applications, a distal portion of catheter 20 near distal end portion 22 may be rotated to engage anchor 150. b During fixation, it is advantageous for the catheter to be placed (or pressed) against the cardiac tissue.

[0299] The inner catheter 20 is used to insert the implant 180 b In applications where an implant having multiple anchors on a wire 63, such as an implant with multiple anchors on the wire 63, interference may occur between the wire 63 and contact between the distal end portion 22 of the inner catheter 20 and tissue. According to some applications, the inner catheter 20 includes a transverse slit 167 extending proximally from the distal end portion 22 such that the slit 167 is continuous with the distal opening of the distal end portion 22. According to some applications, the slit 167 may be configured to allow the anchors 150 to pass through the wire 63. b Instead, the second wire portion 64 is configured to be able to exit the inner catheter 20 laterally proximally from its distal end portion 22. Advantageously, this configuration of the distal end portion 22 of the inner catheter 20 allows for multiple anchors 150 coupled (e.g., threaded) to the wire 63. b Including 180 implants b This may facilitate improved implantation of implants such as:

[0300] Further details regarding the implant and system, including the inner catheter, the plurality of anchors, and the wires extending therefrom, including the manner in which such implants are secured to tissue, are described in International Patent Application No. PCT / IB2020 / 060044, which is incorporated herein by reference in its entirety and for all purposes.

[0301] 6A and 6B, which are now referred to, are schematic illustrations of steps in a procedure for securing an implant 180, according to some applications. a 180 implants with a , or Anchor 150 b 180 implants with b It should be understood that the present invention is directed to a system used to implant an implant 180 including an anchor 150, which may be either (as shown) or (as shown).

[0302] Throughout the following figures, any reference to implant 180 will be referred to as implant 180. a or 180 b Any reference to 150 can refer to anchor 150. a or Anchor 150 b It should be understood that the term "internal" can refer to:

[0303] According to some applications, the implant 180 is configured to be implanted around the annulus of a native valve or other tissue region or opening (e.g., the mitral valve 45, the LAA or other appendage, a tissue bulge, etc.) so as to extend around its entire circumference, as shown in Figures 6A and 6B. It is hypothesized that contraction of a wire extending along the entire circumference (i.e., completely surrounding the entire circumference) of a native valve annulus or other tissue region or opening, such as the mitral valve 45, may promote better and more uniform size reduction compared to contraction of a similar wire extending along only a portion of the circumference. According to some applications, the implant 180 is configured to be implanted around the entire circumference of the annulus of the mitral valve 45 or other tissue region. As used herein, the term "circumferential" refers to a path extending 360 degrees around a cavity, such as a valve annulus.

[0304] According to some applications, the plurality of anchors 150 are configured to be implanted along a path line 90 (see FIG. 6B) that extends at least 270 degrees around the annulus of the native valve or around another valve or tissue region. According to some applications, the plurality of anchors 150 are implanted along a path line 90 that extends 270 degrees to 360 degrees around the annulus of the native valve or around another valve or tissue region.

[0305] According to some applications, multiple anchors 150 are implanted along a path line 90 that extends 270 to 280 degrees around the native valve annulus or another tissue region, 280 to 290 degrees around the native valve annulus or another tissue region, 290 to 300 degrees around the native valve annulus or another tissue region, 310 to 320 degrees around the native valve annulus or another tissue region, 320 to 330 degrees around the native valve annulus or another tissue region, 330 to 340 degrees around the native valve annulus or another tissue region, 340 to 350 degrees around the native valve annulus or another tissue region, or 350 to 360 degrees around the native valve annulus or another tissue region. Each possibility represents a separate application. According to some applications, multiple anchors 150 are implanted along a path line 90 that extends 270 degrees to 320 degrees around the annulus of the native valve or another tissue region. According to some applications, multiple anchors 150 are implanted along a path line 90 that extends 320 degrees to 360 degrees around the annulus of the native valve or another tissue region.

[0306] 6A illustrates a distal portion of the system 10 utilized to secure a series of anchors 150 around the annulus of a native valve (such as the mitral valve 45) or another tissue region. In the transitional phase illustrated in FIG. 6A, a first anchor 150a is secured to the tissue, and the inner catheter 20, along with the portion of the guide catheter 16 surrounding it, is moved to secure the next anchor 150 to the tissue. As illustrated, a first wire portion 62 extends from the inner catheter handle 28 through the lumen of the inner catheter 20 and out through a lateral slit 167, where it transitions to a second wire portion 64, which extends through the anchors 150 and loops back proximally into the space defined between the lumen of the guide catheter 16 and the inner catheter 20.

[0307] 6B illustrates the final stage of fixation, in which all of the anchors 150 of the implant 180 are secured around the annulus of the native valve or other tissue region, with the anchors 150 secured along a path line 90 extending circumferentially from the first anchor 150 a to the last anchor 150 b. However, as shown, the implant 180 still cannot define a full circumference around the annulus or other tissue region because both portions of the wire 63 still extend through the catheter of the system 10 in the region between the first and last anchors 150 a and 150 b, respectively. Thus, while the anchors are secured around the periphery of the annulus or other tissue region in this final stage, the wire 63 still does not completely surround the annulus or other tissue region so as to extend around the full circumference.

[0308] According to some applications, the first wire portion 62 c and second wire portion 64 c Includes 63 wires c , a second wire portion 64 is provided. c has a wire loop 66 at its end (see FIG. 1) that is placed outside the body and accessible to the operator of the system 10 at the beginning of the implantation procedure.

[0309] 7A and 7B, to which reference is now made, illustrate a wire 63, particularly a wire 63 including a loop 66, according to some applications. c 7A and 7B are schematic diagrams of some steps of a procedure for extending the implant 180 around the entire circumference surrounding a valve annulus or other tissue region. c 6B is a schematic diagram of the steps performed on the extracorporeal components of the system 10. Once all of the anchors 150 have been implanted along the path line 90 around the annulus of the native valve or around another tissue region, as shown in FIG. 6B, the inner catheter 20 is retracted / extracted from the patient's body, which may include detaching the inner catheter handle 28 from the guide catheter handle 26 and pulling the inner catheter 20 through the guide catheter, if possible, thereby removing the inner catheter from the system 10, as it is no longer needed for the following procedure steps.

[0310] In some implementations, the proximal section of the first wire portion 62 may initially be wound around a drum (e.g., a spool) positioned within the inner catheter handle 28. For such implementations, during or after separating the inner catheter handle 28 from the handle assembly 40 and / or pulling the inner catheter 20 apart, the first wire portion 62 may be unwound from the drum and pulled out of the inner catheter handle 28 and out of the distal end of the inner catheter 20 to expose a proximal free end 78 of the first wire portion 62, as shown in FIG.

[0311] Once the inner catheter 20 and inner catheter handle 28 are removed from the system 10, the wire 63 c Both ends of the first wire portion 62 c Free end 78 c and second wire portion 64 c The loop 66 of wire 63 may extend from the handle 26 of the guide catheter (FIG. 7A). cAlthough both portions of the wire 63 are shown extending out from the rear end 70 of the guide catheter handle 26 as shown in FIGS. 7A and 7B, this is shown by way of example and not limitation. c The opening through which the portion extends out of the guide catheter handle 26 may be located elsewhere in other implementations of the handle 26. When the end loop 66 is retained within a clip 68 during implantation of the anchor around a valve annulus or other body cavity, as shown in FIG. 1, the end loop may be uncliped so that it can be utilized by an operator of the system 10, as will be described in detail.

[0312] Second wire portion 64 c Extending along the space defined between the inner catheter 20 and the guide catheter 16 during implantation of the anchor, when the inner catheter 20 is removed, the wire 63 extends along the same lumen of the guide catheter 16. c This results in both parts running in parallel.

[0313] According to some applications, the end loop 66 may be attached to the first wire portion 62 c Proximal end of 78 c and is sized to be insertable and extendable through a lumen of a catheter of system 10 , such as the lumen of guide catheter 16 or the lumen of outer catheter 12 .

[0314] Generally, the second wire portion 64 c The end of the second wire portion 64, such as the end loop 66, may define an opening or through-hole through which another portion of the wire 63, such as a portion of the first wire portion 62, may extend, and may include an end retainer 82, such as the end loop 66, defined as the end of the second wire portion 64. In some cases, the end retainer 82 may be configured to be slidable over the section of the first wire portion 62 inserted therein. The end retainer 82 is shown as a loop formed by the wire material itself, and may be attached to the wire 63. cIn other implementations, the end retainer may be a ring or eyelet attached to the end of second wire portion 64 and used in the same manner as described throughout the present specification for end loop 66.

[0315] According to some applications, the first wire portion 62 is used to advance the end retainer 82 (e.g., end loop 66) through the guide catheter 16 toward the anchor 150 of the implant 180 that surrounds the annulus of the native valve (or another tissue region). c Proximal end of 78 c The wire 63 is pulled proximally away from the guide catheter handle 26, causing the end retainer 82 to be pulled into the guide catheter 16, toward the anchors and the slack in the loop. As shown in the transition from FIG. 9A to FIG. 9B, once the end retainer 82 reaches the anchors 150, specifically the first implanted anchor 150a (FIG. 9A), the wire 63 forms a closed loop around the annulus. The second wire portion 64 extending through the anchor c The annulus may then be tightened to reduce the size of the annulus, thereby improving coaptation of the valve leaflets, as shown in FIG. 9B.

[0316] According to some applications, first wire portion 62, as shown in FIG. c The proximal end 78 of the wire 63 is inserted and extended through the end loop 66 while both ends of the wire 63 are outside the handle 26 of the guide catheter and outside the patient. c may be pulled in a proximally oriented direction through the catheter 16 while the end loop 66 is pulled through the lumen of the guide catheter 16 to extend the first wire portion 62 c 150a and 150b, respectively. The distal end of the ...

[0317] 8A and 8B, both the inner catheter, and in applications where a guide catheter is used, the guide catheter, may be withdrawn from the patient's body before advancing the distal retainer through the catheter toward the valve annulus and anchor, so that both portions of the wire extend side-by-side along the same lumen of the outer catheter 12 (FIG. 8A). According to some embodiments, as shown, the inner catheter 20 and guide catheter 16 are retracted / extracted from within the outer catheter 12 through the rear end 72 of the outer catheter handle 24. After retraction of the inner catheter 20 and guide catheter 16, the first wire portion 62 disposed within the lumen of the inner catheter 20 is retracted / extracted. c At least a segment of the first wire portion 62 is extracted therefrom and released to the external environment, thereby c Proximal end of 78 c According to some applications, after retraction of the inner catheter 20 and the guide catheter 16 from the outer catheter 12, the first wire portion 62 c 8A, the second wire portion 64 extends from the rear end 72 of the outer catheter handle toward the outside environment. c Extends adjacent to the end loop 66 of the

[0318] The resulting configuration, as shown in FIG. 8A, has wire 63 extending out from outer catheter handle 24, as opposed to FIGS. 7A and 7B, which show embodiments in which both ends of wire 63 extend out from the guide catheter handle. c Although both portions of the wire are shown extending out from the rear end 72 of the outer catheter handle 24, this is shown by way of example and not limitation, and the openings through which the wire portions extend out from the outer catheter handle 24 may be located anywhere in other implementations of the handle 24.

[0319] According to some applications, first wire portion 62, as shown in FIG. cThe proximal end 78 of the wire 63 is inserted and extended through the end loop 66 while both ends of the wire 63 are outside the outer catheter handle 24 and the patient.

[0320] According to some applications, the end loop 66 is then advanced distally through the catheter 16 over the free end 78 and first portion 62 until it exits the distal end portion 18 of the guide catheter 16 or the distal end 14 of the outer catheter 12, so that the end loop 66 is positioned at the implantation site around the valve annulus or other tissue region, for example, between first anchor 150a and final anchor 150b, respectively, as shown in FIG. 9A. In some applications, once the end retainer 82 (e.g., end loop 66) reaches first anchor 150a, the wire extending through the anchor can be tensioned to reduce the size of the valve annulus and thereby improve coaptation of the valve leaflets (FIG. 9B).

[0321] An end retainer 82, such as an end loop 66, can be threaded through an anchor 150 through a threaded hole 158 (e.g., through an anchor 150). a Through holes 158 a and / or Anchor 150 b Through holes 158 b ) to prevent end loop 66 from passing through thread hole 158, thus ensuring that the loop is held securely between anchors 150a and 150b. As described in further detail below, when tension is applied to wire 63, end retainer 82 is pressed against first anchor 150a, and particularly against thread hole 158a, so that end retainer 82 can provide a counterforce to the tension applied to the opposite end of wire 63, thereby tightening the entire implant 180.

[0322] 9A-10B, which are referenced herein, illustrate an implant 180, and more specifically, an implant 180, utilizing a fastening system 200, according to some applications. c 1 is a schematic diagram of steps in a procedure for tightening the implant 180. c is a wire 63 having an end loop 66 cand Anchor 150 a or 150 b and a plurality of anchors 150, which may be implemented as any type of anchor, such as a stent or a stent.

[0323] According to some applications, a clamping system 200 is provided that includes a clamping catheter 224 extending from a clamping handle (not shown) and a cut and lock assembly 222 coupled to the distal end of the clamping catheter.

[0324] As shown in FIG. 9A, in use, once anchor 150 is implanted, for example as shown in FIG. 6B, end loop 66 is advanced distally through either the lumen of guide catheter 16 or outer catheter 12, and first wire portion 62 c The extracorporeal section of the first wire portion 62 can be inserted into the cutting and locking assembly 222, along with the clamping catheter 224, into the handle (not shown) of the clamping system. The cutting and locking assembly 222 and attached clamping catheter 224 are then threaded toward the implantation site along the first wire portion 62. c In some applications, the cut and lock assembly 222 and clamping catheter 224 are advanced through the lumen of the guide catheter 16 or outer catheter 12 toward the implantation site.

[0325] The cutting and locking assembly 222 is adapted to connect the implant 180 to perform annuloplasty or tissue remodeling. c the second wire portion 64 in the vicinity of c (or any other embodiment of the end retainer 82). A fastening system 200 is attached to the end loop 66 of the first wire portion 62, for example. c By applying a proximal pulling force to the wire 63 c while the second wire portion 64 is configured to facilitate fastening of the c The end loop 66 of the first wire portion 64 is pressed against the first anchor 150a, thereby clamping the second wire portion 64 and securing the implant 180. c Tighten.

[0326] As used herein, the term "neighborhood" refers to a distance within a radius of less than about 100 mm in a given three-dimensional (3D) space. According to some applications, the term "neighborhood" refers to a distance within a radius of less than about 50 mm, less than about 10 mm, less than about 1 mm, or less than about 0.1 mm in a given 3D space.

[0327] The cutting and locking assembly 222 includes a locker 210 configured to lock the wire 63 in place once the wire 63 has been sufficiently tightened, and the locker may be configured to be released therefrom and remain attached to the implant 180, holding it in a locked state, while the tightening system 200 can be withdrawn from the patient's body after completion of the implantation procedure.

[0328] During some implementations, the first wire portion 62 c Simply applying a pulling force thereon may be sufficient to consistently advance the end loop 66 toward the anchor 150, and more specifically, to the first implant 150a. However, in some situations, this may not be sufficient, and additional mechanisms may be required to advance the end loop 66 through the vasculature and toward the implantation site, such as the annulus of the mitral valve 45 or other tissue region. According to some applications, the cut and lock assembly 222 may be used to advance an end retainer 82, such as the end loop 66, through, for example, the guide catheter 16 or outer catheter 12, to the implant 180. c , more specifically, to the vicinity of first anchor 150a, thereby advancing it.

[0329] According to some applications, the second wire portion 64 extends between the anchors 150. c By providing tension to the anchors, the anchors are drawn closer together, thereby contracting the tissue around which the anchors 150 are secured, resulting in annuloplasty or tissue remodeling (FIGS. 9A and 9B). b, while the wire is perpendicular to the anchor as described above, the second wire portion 64 c This may be facilitated by a through hole 158 therethrough, for example, sliding smoothly through an opening 159 .

[0330] According to some applications, the second wire portion 64 c The application of tension to the first wire portion 62 is continued until the wire sufficiently contracts the implant or annuloplasty structure, as described above. c This is accomplished by pulling the locking assembly 222 proximally away from the handle of any catheter from which the first wire portion may extend. The locker 210 may be positioned near the end retainer 82 (e.g., near the end loop 66), as shown in FIG. 9B, and may include at least one fastening mechanism configured to lock the wire in its clamped state. The cutting and locking assembly 222 may include a cutting or trimming mechanism configured to sever the first wire portion 62 extending proximally from the locker 210 after being locked thereby. This severing may result in an excess portion of the wire 63 extending proximally from the locker 210 and terminating in a free cut end 62a, as shown, for example, in FIG. 9B.

[0331] According to some applications, once the first wire portion 62 is clipped or cut after tightening of the implant 180 to perform annuloplasty or tissue remodeling, it may be advantageous to cover any excess portion of the first wire portion 62, including the free cut end 62a, as shown in FIG. 10B . According to some applications, the locker 210 is further configured to cover the excess portion of the wire 62, which may terminate at the free cut end 62a. Covering the excess portion of the first wire portion 62, which terminates at the free cut end 62a, prevents potential damage that may otherwise be caused by exposing the metal of the first wire portion 62 to tissue. Additionally, covering the excess portion of the first wire portion 62, which terminates at the free cut end 62a, prevents additional fibrosis therearound.

[0332] 10A and 10B show fastening system 200 a Cutting and locking assembly 222 a Included: 210 lockers a According to some applications, the locker 210 a The clip includes a housing 212 that houses a wire fastener 214 that defines the system's locking mechanism. The fastener 214 is shaped to define a generally rectangular, planar clip comprising a superelastic material, e.g., Nitinol. The fastener 214 includes a deformable element. The deformable element can be configured in a variety of different ways and shapes. For example, the deformable element can be or include one or more of a bendable component, a flexible component, a disc-shaped component or disk, a flat component, an expandable component (e.g., balloon, stent), a rectangular component, a square, a cubic component, a circular or spherical component, a semicircular or hemispherical component, a component with struts, a slit-like component, a component with legs and / or arms, a friction-improving component, a component with teeth or barbs, and the like. In some applications, the deformable element is shaped to define a plurality of slits surrounded by a plurality of flexible legs 216 that allow the clip to transition between an angled state ( FIG. 10A ) and a straight state ( FIG. 10B ). In some applications, the wire-engaging surface of the clip is shaped to define a plurality of teeth (not shown for clarity of illustration). In some applications, the teeth are jagged. In some applications, the top surface of the clip is flat without teeth. The teeth are configured to increase friction between the first wire portion 62 and the fastener 214. It should be noted that the fastener 214 is used for purposes of illustration and not limitation, and any suitable securing means, fastener, clip, etc. may be used.

[0333] According to some applications, the fastener 214 includes a clamping structure that is transitionable between an open state and a closed state. The clamping structure is naturally biased to a closed state (FIG. 10B), in which it is configured to clamp onto an excess portion of the first wire portion 62 passed through it, including the free cut end 62a. The clamping structure can be bent to an open state (FIG. 10A) that allows the first wire portion 62 to move therethrough. In the closed state, the fastener 214 is configured to limit movement of the first wire portion 62 relative to the plurality of anchors 150.

[0334] According to some applications, first wire portion 62 extends through opening 218 in housing 212 and through a stop 220 (e.g., a holder) that is disposed within the opening of housing 212 near wire fastener 214. Stop 220 may be shaped to define a lumen therethrough to surround first wire portion 62. Stop 220 may be configured to secure clamping catheter 224 to clamping catheter 224. a Engageable by a disconnect and lock assembly 222 coupled to the assembly 222 a 10A , the clip is deformed and no longer presses against the first wire portion 62. In the tilted state, shown in FIG. 10A , the first wire portion 62 is secured to the clamping catheter 224. a , Locker 210 a , fastener 214, assembly 222 a , housing 212, and / or stop 220, so that first wire portion 62 can be withdrawn until it sufficiently contracts the implant or annuloplasty structure and the end retention device 82 (e.g., loop 66) is near anchor 150 of implant 180.

[0335] 10B, the stop 220 has been separated and removed from the housing 212. With no force being applied by the stop 220 to the contraction wire-engaging surface of the clip, the clip returns to its resting, straight state, capturing the first wire portion 62 between the contraction wire-engaging surface of the clip and a surface 226 of the housing 212, such as an interior wall. Thus, the fastener 214 is now in a locked state in which the clip locks and crimps the first wire portion 62.

[0336] According to some applications, the proximal end 78 of the first wire portion 62 is threaded through either the clamping catheter 224, the locker 210, and / or the cut and lock assembly 222, and the end retainer 82 (e.g., the end loop 66) is advanced along the lumen of the clamping catheter 224 until it reaches the first anchor 150a of the implant 180. The relative spatial orientation of the components of the assembly 222 allows the first wire portion 62 to pass straight and directly through the lumen of the clamping catheter 224 along the longitudinal axis of the clamping catheter 224 and the assembly 222 without undergoing a tortuous path therethrough. This direct unwinding path of the wire through the assembly 222 and the clamping catheter 224 reduces friction on the wire as it moves therethrough. This direct path of the wire 62 is enabled by the orientation of the components of the assembly 222.

[0337] In some applications, the disconnect and lock assembly 222 a comprises a static cutting element 228 and a movable dynamic cutting element 230, each of the cutting elements 228 and 230 defining a cutting edge. In some applications, the cutting edge may be sharp, but this is not required. In some applications, the dynamic cutting element 230 slides proximally and diagonally relative to the static cutting element 228. The dynamic cutting element and / or the static cutting element may be configured as one or more of a blade, a block, a movable block, a disk, a rotating component, a razor, scissors, a scissor-like component, a wire cutter, an aperture, etc.

[0338] In some applications, the disconnect and lock assembly 222 a includes a stop 220 and is configured to facilitate proximal movement of the stop 220 as the stop 220 is displaced from within the housing 212 through the opening 218. Once the stop 220 is displaced from within the housing 212, the fastener 214 assumes a closed position to capture the wire between a clamping surface of the fastener 214 and a surface 226 of the housing 212. This displacement of the stop 220 allows the stop 220 to be pushed proximally (e.g., by hammering) on ​​the dynamic cutting element 230, causing the dynamic cutting element 230 to slide diagonally proximally along the static cutting element 228 in a manner that causes the elements 228 and 230 to cut the first wire portion 62. Thus, the cutting and locking assembly 222 a allows for simultaneous cutting and locking of the first wire portion 62, thereby providing a mechanism for locking the implant 180 in a clamped configuration.

[0339] According to some uses, Rocker 210 a further includes a flap 232 disposed on the exterior of the housing 212. The flap 232 is movable from a first open state in which the flap 232 is spaced apart from the housing 212 to a second closed state in which the flap 232 is disposed parallel to the housing 212 in a manner such that the flap 232 presses the excess portion of the first wire portion 62 terminating in the free cut end 62 a against the exterior surface of the housing 212 while covering the excess portion of the first wire portion 62 and the free cut end 62 a.

[0340] Additionally, flap 232 covers opening 218 of housing 212. Flap 232 is coupled to housing 212 in a pivotal manner from an open position aligned with a first side wall of housing 212, as shown in FIG. 10A, to a closed position aligned with a second side wall of housing 212, as shown in FIG. 10B. In the second position, flap 232 captures an excess portion of the wire terminating in free cut end 62a between flap 232 and the second side wall of housing 212. In some applications, rocker 210 atends to assume the second closed position when no force is applied to it.

[0341] The cut and lock assembly 222 described herein above with respect to FIGS. 10A and 10B a and Locker 210 a It will be appreciated that this assembly serves as merely one example of a locker configured to lock a portion of the wire extending therethrough in a clamped state of the implant, an assembly that can cut the wire extending therethrough. Further details regarding various configurations of clamping systems, lockers configured to lock the implant in a clamped configuration and cover any slack in the wire that forms after cutting it with the cutting and locking assembly are provided in detail in International Patent Application No. PCT / IB2020 / 060044, which is incorporated herein by reference in its entirety and for all purposes.

[0342] According to some applications, the clamping system 200 is configured so that the locker 210 can (i) simultaneously cut and lock the first wire portion 62 extending therethrough, thereby closing and locking the implant 180, and (ii) capture excess wire therein. Optionally, but not necessarily, the clamping system 200 can also be utilized to advance the end retainer 82. According to some applications, after the excess first wire portion 62 is captured within the locker 210, the assembly 222 and clamping catheter 224 are removed therefrom and extracted from within the guide catheter 16 or outer catheter 12, thereby leaving the locker 210 attached to the implant 180.

[0343] According to some applications, a method is provided for contracting an implant secured to a native valve annulus or other tissue region (e.g., the annulus of the mitral valve 45, an appendage, a bulge, a portion of the atrioventricular wall, another tissue opening, etc.), which may include an initial step (a) of providing or obtaining a multi-component tubular system 10 configured to deliver the implant 180 to the vicinity of the tissue surrounding the annulus or other tissue. In some applications, the system 10 includes at least one, two, or more of an outer catheter 12, a guide catheter 16, and an inner catheter 20.

[0344] In some applications, the distal end portion 22 of the inner catheter 20 is configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., its primary lumen) and be positioned outside the distal end portion 14 of the outer catheter 12 and / or the distal end portion 18 of the guide catheter 16, and be oriented in a desired spatial orientation near the tissue surrounding the annulus of the mitral valve 45 or other tissue region.

[0345] For some applications, the method further includes step (b) of using system 10 to advance implant 180 to tissue surrounding a native valve annulus or other tissue region (e.g., along an atrioventricular wall of mitral valve 45, another native valve, an appendage, etc., within left atrium 43 of subject heart 42), wherein implant 180 includes multiple anchors 150 and a first wire portion 62 configured to be advanced with anchors 150 within a lumen of inner catheter 20. c Includes 63 wires c and the second wire portion 64 cmay be configured to extend outside the distal end portion 22 of the inner catheter 20, distally within the left atrium 43, toward and further between the anchor 150 of the implant 180, and loop back proximally from the anchor 150 toward the proximal end of the catheter. For example, the second wire portion may extend through an interior space defined between the inner catheter 20 and either the guide catheter 16 or the outer catheter 12. In some applications, the external portion of the second wire portion may be configured to extend through the handle of the respective catheter, such as through the handle 26 of the outer guide catheter or the handle 24 of the outer catheter, and / or be exposed to the external environment (e.g., accessible for grasping by an operator's hand outside the patient).

[0346] In some applications, the method may further include step (c) of longitudinally advancing a plurality of anchors 150 through the lumen of catheter 20 and sequentially driving / securing the anchors into tissue surrounding the valve annulus or other tissue region. This may be done by reversibly engaging each anchor of the plurality of anchors with anchor driver 161 described above. Each anchor 150 is connected to second wire portion 64. c , the second wire portion 64 may be driven to different positions around the annulus of the mitral valve 45 or other tissue region while coupled to the second wire portion 64. c At least a first segment of the second wire portion 64 extends through the plurality of anchors 150. In some applications, the second wire portion 64 c The second segment may be configured to be disposed within an interior space defined between the inner catheter 20 and the guide catheter 16 or the handle 24 of the outer catheter.

[0347] In some applications, the method may include assembling the implant 180 with a plurality of anchors 150 and wires 64 extending therebetween. cand (d) securing the anchors via the anchors, thereby connecting the anchors to each other and around the tissue surrounding the annulus or other tissue region of the mitral valve 45, so that the anchors are implanted along a pathline that extends around the annulus or other tissue region, e.g., 250 to 360 degrees around the annulus or other tissue region, 270 degrees or more around the annulus or other tissue region, etc.

[0348] For some applications, the method further includes step (e) of retracting / extracting the catheter 20, and optionally the guide catheter 16, from or through the outer catheter 12, and removing the first wire portion 62 disposed within the inner catheter. c extends out from either the guide catheter handle 26 or the outer catheter handle 24 and is exposed to the external environment, and a second wire portion 64 c This allows for its positioning next to the end loop 66 formed at the end of the

[0349] In some applications, the method may include passing the first wire portion 62 through the end loop 66. c The method may further include step (f) inserting a retainer 82 for the proximal end 78 of the wire 62, or any other type of end retainer. c into a component of the fastening system 200, such as through any of the locker 210, the cut and lock assembly 222, and the fastening catheter 224 of the fastening system 200.

[0350] In some applications, the method may further include step (g) of advancing an end retainer 82 (e.g., end loop 66) through the guide catheter 16 and / or outer catheter 12, optionally with a fastening system 200, to a position adjacent to the implant 180, more specifically, adjacent to the first anchor 150a.

[0351] In some applications, the method may involve, for example, extending first wire portion 62 through clamping catheter 224 to sufficiently contract the annulus of the native valve and / or to contract / reshape the tissue region. c By pulling the wire 63 proximally, c The method may further include the step (h) of applying tension to the

[0352] In some applications, the method further comprises: c 1. Utilizing a rocker 210 and a cutting and locking assembly 222 to simultaneously lock the second wire portion 64 and cut it proximally relative to the rocker, thereby closing and locking the implant 180, and optionally, utilizing a flap 232, for example, as described herein above, to close the second wire portion 64. c The method may further comprise the step (i) of capturing and utilizing any excess portion of the mixture by means of a rocker.

[0353] In some applications, the method may further include step (j) of separating the cut and lock assembly 222 from the locker 210 and extracting it, along with the clamping catheter coupled thereto, from the patient's body, leaving the locker 210 coupled to the implant 180. This step may include simultaneously extracting the guide catheter 16 and / or the outer catheter 12, or extracting either the guide catheter 16 and / or the outer catheter after extraction of the clamping catheter 224 and assembly 222.

[0354] The techniques, methods, steps, etc. described above may be performed on a live animal or on a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.).

[0355] 11A-12. Figures 11A and 11B are schematic illustrations of exemplary steps in implanting an implant 180 to repair a mitral valve 45, according to some applications. Figure 12 is a schematic illustration of an example embodiment of an implant 180, according to some applications.

[0356] According to some applications, the implant 180 shown in FIGS. 11A and 11B may be the same as the implant 180 shown in FIGS. 3A and 3B described herein above. a 8A , except that the second wire portion 64 extends from the distal end portion 22 of the inner catheter 20, or from the first anchor 150a, through the plurality of anchors 150, and loops rearwardly during implantation to extend along the interior space defined between the guide catheter 16 and the outer catheter 12 toward, into, and out of the outer catheter handle 24. The second wire portion 64 can exit through an opening formed in the rear end 72 of the outer catheter handle 24 (similar to the view in FIG. 8A ), or any other opening formed in the outer catheter handle 24.

[0357] The implant 180 shown in FIG. 12 is the same as the implant 180 shown in FIG. b 1, except that the second wire portion 64 extends through the anchor 150 and loops rearwardly to extend along the interior space defined between the guide catheter 16 and the outer catheter 12 toward, into, and out of the handle 24 of the outer catheter. b By way of example, and not limitation, the same configuration is shown in FIG. 12 , where multiple implants 150 a It will be appreciated that a similar implementation may be performed for the wire 63 extending through the

[0358] Some or all of the same methods and / or steps for implanting and contracting an implant (e.g., annuloplasty structure) in the native valve annulus (e.g., of the mitral valve 45) or other tissue region described above may be performed using a wire 63 having a loop 66 as described herein above with respect to FIGS. 6A and 6B and 9A and 9B. c 180 implants with c16. This may include, mutatis mutandis, the methods and / or steps described with respect to contracting the outer catheter 12 and the guide catheter 16, and may be performed on the implant 180. This may include, for example, having the second wire portion 64 extend along the space defined between the outer catheter 12 and the guide catheter 16 during the implantation step. Additionally, these techniques and methods may be performed on a live animal or a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.).

[0359] In some applications, system 10 may be provided with only two of the three catheters described above, such as outer catheter 12 and inner catheter 20. In such cases, the configuration of system 10 and implant 180 may be similar to that shown in Figures 11A-12, except without the guide catheter (16), where second wire portion 64 extends through anchor 150 in a similar manner but loops back along the interior space defined between inner catheter 20 and outer catheter 12 to extend toward, into, and out of the handle 24 of the outer catheter.

[0360] The same or similar methods and / or some or all of the same steps for implanting and contracting an implant (e.g., annuloplasty structure) in a native valve annulus (e.g., mitral valve 45) or other tissue region described above may be performed using a wire 63 having a loop 66 as described herein above with respect to FIGS. 6A and 6B and 9A and 9B. c 180 implants with c8A and 8B , can be performed on implant 180. These techniques, methods, steps, etc., may be performed on a live animal or a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.), or the like. As an example, second wire portion 64 may extend along the space defined between outer catheter 12 and inner catheter 20 during the implantation step. In some applications, detaching inner catheter handle 28 from handle assembly 40 (with inner catheter 20 being completely removed from system 10) may result in a configuration of both ends of wire 63 extending side-by-side out of outer catheter handle 24, as shown in FIGS. 8A and 8B . These techniques, methods, steps, etc., may be performed on a live animal or a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.), or the like.

[0361] 13A and 13B, to which reference is now made, are schematic illustrations of examples of tightening procedures for an implant 180 with a wire 63 that does not include a loop 66, according to some applications.

[0362] According to some applications, the implant 180 may include a plurality of anchors 150 and a wire 63. c and a wire 63 that is identical to any of the wire applications described above, including, but not limited to, the implant not necessarily including loops 66 or any other type of end retainer 82. During implantation of implant 180, i.e., during the step of securing multiple anchors 150 around a valve annulus or other tissue region, both first wire portion 62 and second wire portion 64 of wire 63 extend through the catheter of system 10 in any of a variety of configurations.

[0363] According to some applications, the first wire portion 62 of the wire 63 extends at least partially through the lumen of the inner catheter 20, while the second wire portion 64 extends at least partially through the space defined between the inner catheter 20 and the guide catheter 16, similar to the configurations described above in this specification with respect to Figures 3A and 3B and 5.

[0364] In some applications, the first wire portion 62 of the wire 63 extends at least partially through the lumen of the inner catheter 20, while the second wire portion 64 extends at least partially through the space defined between the outer catheter 12 and the guide catheter 16, similar to the configuration described above in this specification with respect to Figures 11A-12.

[0365] In such other applications, the first wire portion 62 of the wire 63 extends at least partially through the lumen of the inner catheter 20, while the second wire portion 64 extends at least partially through the space defined between the outer catheter 12 and the inner catheter, similar to the configurations described herein above.

[0366] In some applications, both the first wire portion 62 and the second wire portion 64 of the wire 63 extend at least partially, optionally in parallel, through a lumen of the inner catheter 20. In some such applications, the inner catheter 20 may be a multi-lumen shaft including at least two lumens, with the first wire portion 62 of the wire 63 extending at least partially through one lumen of the inner catheter 20 while the second wire portion 64 extends at least partially through another lumen of the inner catheter 20, thereby reducing the risk of entanglement between both wire portions.

[0367] The process of extending the catheters of system 10 toward an implantation site, such as the annulus of mitral valve 45, and securing multiple anchors 150 around the periphery of the annulus or other tissue region can be performed in the same manner as described above with respect to Figures 2 and 6A and 6B. After securing the last anchor 150b, the inner catheter 20 is removed from the patient's body, while components of the cinching system 200, such as assembly 222 and cinching catheter 224, can be advanced over wire 63 extending therethrough toward implant 80 in a manner similar to that described above, with some modifications as detailed herein.

[0368] 13A , both the first wire portion 62 and the second wire portion 64 extend in parallel through components of the clamping system 200, such as the clamping catheter 224, the cutting and locking assembly 222, and its locker 210. For example, both the first wire portion 62 and the second wire portion 64 may extend through the opening 218 of the locker 210 and through the lumen of the stop 220. According to a further application, the lumen of the stop 220 is a dual lumen including a first stop lumen and a second stop lumen, with the first wire portion 62 extending through the first stop lumen and the second wire portion 64 extending through the second stop lumen.

[0369] In some applications, the clamping catheter 224 is a multi-lumen catheter, such as a dual-lumen catheter, and the first wire portion 62 and the second wire portion 64 each extend through a different lumen to prevent the wire portions from becoming entangled with each other within the clamping catheter 224.

[0370] According to some applications, the cutting and locking assembly 222, including the locker 210, is configured to be advanced within the lumen of the guide catheter 16 or outer catheter 12 toward the vicinity of the implant 180, and more specifically, the vicinity of the first anchor 150a, as shown in FIG. 13A. According to further applications, the fastening system 200 is configured to allow both the first wire portion 62 and the second wire portion 64 to be pulled therethrough to sufficiently contract the implant or annuloplasty structure (e.g., in a native valve, mitral valve 45, etc.), as shown in FIG. 13B. Proximal portions of both the first wire portion 62 and the second wire portion 64 may extend outside the body, for example, within a handle of the fastening system 200 (not shown).

[0371] In some implementations, contraction of implant 180 is achieved by simultaneously pulling both first wire portion 62 and second wire portion 64 in a proximal direction. In other implementations, contraction of implant 180 is achieved by applying a tension force to one of first wire portion 62 or second wire portion 64 while the other portion is held in place, preventing it from sliding distally while the other wire portion is pulled.

[0372] According to some applications, the cutting and locking assembly is configured to lock the wire 63 in a clamped or contracted state on the implant 180, for example, by the locker 210, and sever both the first wire portion 62 and the second wire portion 64 extending through the stop lumen using a cutting clamping and cutting mechanism in a manner similar to that described above, mutatis mutandis.

[0373] Cutting both wire portions 62 and 64 may result in the excess portions extending proximally to locker 210, as shown, for example, in FIG. 13B. According to some applications, locker 210 may be further configured to utilize flap 232, mutatis mutandis, in a manner similar to that described above, to capture any excess portions of first wire portion 62 and second wire portion 64 therein.

[0374] 14-15C, to which reference is now made, illustrate wire 63 having end clamp 240 according to some applications. d 180 implants with d 10 is a schematic diagram of an example of a procedure for tightening the

[0375] Implant 180 d is the implant 180 described herein above. c 1. The wire 63 is the same as or similar to the wire 63 of the present invention, except that it has an end retainer 82 in the form of an end clamp 240 instead of an end loop 66. d1. The end clamp 240 may be in the form of a shackle or carabiner including a body and a spring-biased gate or arm 242 hinged thereto, which together enclose an interior opening in the free state of the clamp 240. The spring-biased gate of the clamp is biased in its free state toward the end of the body of the clamp, at an end opposite the hinge point between the gate and the body, and may be forced open, biasing it inward when a force is applied to the gate. The end clamp 240 may be attached to the end of the second wire portion 64 in the same region as described hereinabove with respect to the end loop 66.

[0376] End clamp 240 may be sized to be advanceable through a lumen of at least one of the catheters of system 10, such as a lumen of inner catheter 20, a lumen of guide catheter 16, and / or a lumen of outer catheter 12. End clamp 240 is further sized to prevent it from passing through thread hole 158 of anchor 150, and more specifically, thread hole 158 of first anchor 150a. Implant 180 d may include any type of anchor 150. b 14-15C are illustrative and not limiting, and implant 180 d But Anchor 150 a or Anchor 150 b It will be appreciated that the present invention may include any type of anchor 150, such as

[0377] According to some applications, the first anchor 150a is advanced through the inner catheter 20 toward the implantation site, with the end clamp 240 extending from one side thereof, such as along one side of its threaded bore 158. In this manner, as shown in FIG. 14 , once the first anchor 150a is secured in tissue, and subsequent anchors 150 are further secured along the annulus or other tissue region, the first wire portion 62 d14, the second wire portion 64 extends at least partially through the inner catheter 20, for example, from its extracorporeal end to the distal end portion 22 of the inner catheter, or to the last fixed anchor 150 in a series of anchors 150. However, as further shown in FIG. d The first wire portion 62 d 2 and 3. The catheters extend continuously from the first anchor 150a through the anchors 150, and in this particular configuration, none of the catheters are looped back through, but rather terminate at an end clamp 240 located next to the first anchor 150a.

[0378] 6A and 6B, for example, in the same manner as described hereinabove with respect to FIGS. 6A and 6B, system 10 may be utilized to secure multiple anchors 150 around the periphery of a valve annulus or other tissue region (e.g., the annulus of a native valve, the annulus of a mitral valve 45, an appendage orifice, an atrioventricular wall region, etc.), resulting in the configuration shown in FIG. 15A, where second wire portion 64 d extends between first anchor 150a and final anchor 150b. As noted above, throughout the drawings and specification, first anchor 150a is defined as the first anchor implanted during the implantation procedure of implant 180 around a valve annulus or tissue region, while final anchor 150b is defined as the final anchor implanted.

[0379] According to some applications, terminal clamp 240 includes a spring-loaded gate 242 configured to be movable from a closed position to an open position, which allows wire 63 extending between final anchor 150d and inner catheter distal end portion 22 to be secured. d section can be inserted therethrough, thereby closing off the implant 180 .

[0380] As used herein, the term "closing implant" refers to extending the wire 63 around the entire circumference of the valve annulus (e.g., the annulus of the mitral valve 45) or other tissue region to which the anchor 150 of the implant 180 is secured. In other words, as used herein, a "closing implant" refers to an implant 180 that has been implanted such that its wire 63 extends 360 degrees in a closed loop around the valve annulus or tissue region to which the anchor is secured.

[0381] According to a further application, the distal end portion 22 of the inner catheter 20 may include a wire 63 extending therethrough to the final anchor 150b. d The wire 63 is steerable so that the distal end portion can be manipulated to allow a section of the wire to be approximated to the end clamp 240, pressed against the spring-loaded gate 242, and then inserted into the end clamp 240. d Once this section of the implant 180 extends through the end clamp 240, the gate 242 can spring back to its naturally biased closed position, thereby preventing the implant 180 from d will be closed.

[0382] According to some applications, the implant 180 may be placed around a valve annulus (e.g., of the mitral valve 45) or tissue region. d After implantation, so that the implant expands over its entire circumference, the inner catheter 20, and optionally, but not necessarily, the guide catheter 16, are retracted / extracted from the outer catheter 12, and the wire 63 is removed. d the extracorporeal section of the wire 62, more specifically the first wire portion 62 d The sections are inserted into the components of the clamping system 200 (ie, the locker 210, the assembly 222, and the clamping catheter 224) in a manner similar to that described above.

[0383] According to some applications, the fastening system 200 may include a second wire portion 64 sufficient to constrict the implant or annulus structure around the valve annulus (e.g., around the mitral valve 45) or around a tissue region, as shown in FIG. 15B. dTo apply tension to the wire 63 d section, more specifically, first wire portion 62 d Specifically, the first wire portion 62 is configured to allow a section of the wire to be drawn therethrough. d is pulled proximally, the terminal clamp 240 presses against the first anchor 150a to provide a counterforce, thereby causing the second wire portion 64 extending between the first anchor 150a and the final anchor 150b to d But the size was reduced and the implant was 180 d The whole can be contracted with it.

[0384] According to some applications, the fastening system 200 may be configured such that the assembly 222 is secured to the wire 63 extending therethrough in the same manner as described hereinabove. d 15C, allowing the section of implant 180 to be locked and cut. d Close and lock the wire 63 d Although an excess portion of wire 63 is shown extending from rocker 210 in FIG. 15C according to some applications, rocker 210 utilizes flap 232 shown above herein to prevent wire 63 from being pulled out. d The membrane may be further configured to trap any excess portion of the membrane therein.

[0385] According to some applications, implant 180 d Implantation of the second wire portion 64 does not involve advancing the end clamp 240 with the first anchor 150a through the inner catheter 20, but rather involves advancing the second wire portion 64 with the first anchor 150a positioned outside the patient's body. d and a terminal clamp 240 for the wire 63. c The end loop 66 of the wire 63 d The implant 180 described above may be replaced by the end clamp 240 of the implant 180. cThe implantation procedure involves following the same implantation steps as described for the first wire portion 62. The implantation procedure includes the steps of securing a series of anchors 150 to tissue, d inserting the free end of the first wire portion 62 through the terminal clamp 240 and clamping the terminal clamp 240 to the first wire portion 62. d and advancing the wire 63 with the end loop 66 distally toward the first anchor 150a. c 15A. Once the end clamp 240 is positioned adjacent the first anchor 150a, the implant 180 is then clamped to the implant 180. d The remaining steps of the method for contracting and locking the stent may be performed in the same manner as described herein above with respect to Figures 15A-15C.

[0386] 16 and 17, which are now referred to, illustrate wire 63 having first stopper 244 according to some applications. e 180 implants with e 5-9B, for example, the implant 180 described above. c 13A and 13B, and the implant 180 shown in FIGS. 14-15C. d Unlike configurations of implant 180 configured to extend around the entire circumference of a valve annulus or tissue region, such as e is structured to extend along a path line 90 that is not a perfect circle (e.g., may be C-shaped, etc.), rather than being able to surround the entire periphery of the annulus or tissue region, as shown in FIG.

[0387] Implant 180 e For example, implant 180 d The implant 180 may be generally similar to other embodiments of the implant 180 described herein above, such as eHowever, instead of an end clamp 240 or any other type of end retainer 82, the wire 63 includes a first stopper 244. e The first stop 244 is attached to the second wire portion 64 in the same area as described above with respect to the end retainer 82. e The first stopper 244 is attached to the end of the second wire portion 64. e The first stopper 244 may be in the form of a bead or crimp that includes only a single opening for the end of the stopper 244 to extend through. Although the first stopper 244 is shaped as a sphere in FIG. 16, it should be understood that the first stopper 244 may be shaped as a square, rectangle, or any other suitable polyhedron.

[0388] First stopper 244 may be sized to allow advancement through the lumen of inner catheter 20, while simultaneously preventing it from passing through thread hole 158 of anchor 150, and more specifically, through thread hole 158 of first anchor 150a. e may include any type of anchor 150. b 16 and 17, which are illustrative and not limiting, and implant 180 e But Anchor 150 a or Anchor 150 b It will be appreciated that the present invention may include any type of anchor 150, such as

[0389] According to some applications, the first anchor 150a is advanced through the inner catheter 20 toward the implantation site, with the first stop 244 extending parallel to the anchor on the wire (e.g., extending from the wire distal to the anchor), such as along the distal side of its thread 158. In this manner, as shown in FIG. 16 , once the first anchor 150a is secured in tissue, and subsequent anchors 150 are further secured along the annulus or other tissue region, the first wire portion 62 eThe second wire portion 64 extends at least partially through the inner catheter 20, for example, from its extracorporeal end to the distal end portion 22 of the inner catheter, or to the last anchor 150 in a series of anchors 150. As further shown in FIG. e The first wire portion 62 e , extends continuously through anchor 150, and in this particular configuration, none of the catheters are looped back through, but rather terminate at a first stopper 244 located next to first anchor 150a.

[0390] The system 10 may be utilized, for example, to secure multiple anchors 150 around a portion of the circumference of the annulus or other tissue region of the mitral valve 45, which do not necessarily extend entirely around the annulus or other tissue region (as shown in FIG. 17), but rather may be C-shaped.

[0391] According to some applications, the implant 180 may be placed around a portion of a valve annulus (e.g., mitral valve 45) or tissue region. e After implantation, the inner catheter 20, and optionally, but not necessarily, the guide catheter 16, are retracted / extracted from the outer catheter 12, and the wire 63 is removed. e the extracorporeal section of the wire 62, more specifically the first wire portion 62 e The sections are inserted into the components of the fastening system 200 (ie, the locker 210, the assembly 222, and the catheter 224) in a manner similar to that described above.

[0392] According to some applications, the fastening system 200 may include a second wire portion 64 sufficient to constrict an implant (e.g., an annuloplasty structure, etc.) surrounding a portion of the periphery of a native valve (e.g., mitral valve 45, etc.) or other tissue region. e To apply tension to the wire 63 e section, more specifically, first wire portion 62 e Specifically, first wire portion 62 eis pulled proximally, first stop 244 presses against first anchor 150a, providing a counterforce, thereby increasing the length of second wire portion 64 extending between first anchor 150a and final anchor 150b. e The size of the implant is reduced to 180 e The whole can be contracted with it.

[0393] According to some applications, the fastening system 200 may be configured such that the assembly 222 is secured to the wire 63 extending therethrough in the same manner as described hereinabove. e 17, the implant 180 is configured to be able to lock and disconnect portions of the implant 180. e The wire 63 is locked in a tightened or contracted state. e Although an excess portion of wire 63 is shown extending from rocker 210 in FIG. 17 according to some applications, rocker 210 utilizes flap 232 presented hereinabove to prevent wire 63 from being pulled out. e The membrane may be further configured to trap any excess portion of the membrane therein.

[0394] 18-21C, which are referenced herein, illustrate a rocker 210 according to some applications. b FIG. 18 shows a cut and lock assembly 222 according to some applications. b A locker 210 may be configured within and connected to b FIG. 19 is a schematic diagram of an embodiment of a locker 210 according to some applications. b 20A and 20B are perspective exploded views of the locker 210 in its locked and unlocked states, according to some applications. b 21A-21C show a cross section of a rocker 210 in various stages of operation according to some applications. b 1 is a perspective view of an actuation assembly 292 used in conjunction with the locker 292. The locker may be the same as or similar to other lockers herein.

[0395] Fastening System 200 b The fastening system 200 aand a clamping catheter 224. a Clamping catheter 224, which may be the same as or similar to b The clamping system may also include a cutting or trimming mechanism. b disconnect and lock assembly 222 connected to b (which may be the same as or similar to other cutting and locking assemblies herein). The cutting or trimming mechanism may be provided with static and dynamic cutting elements 228 and 230 operable to sever the wire 63 extending therethrough. In some applications, this may be the case with respect to FIGS. 10A and 10B, where locking assembly 222 a may be configured and implemented in a manner similar to that described hereinabove. b is connected to the rocker 210, as described in further detail herein below. a locker 210 configured to lock the wire 63 extending therethrough in a manner different from that shown for b Equipped with.

[0396] According to some uses, Rocker 210 b performs the annuloplasty or tissue remodeling, and then cuts off the excess portion of the first wire portion 62, thereby enabling its locking, thereby securing the implant 180 to the first wire portion 62 and the fastening system 200. b and / or comprises a fastener and / or clamping structure configured to allow proximal advancement of a wire extending through implant 180 for separation from any other component of system 10.

[0397] In some applications, Rocker 210 b19 includes a housing 254 that houses a spring 256, a first sliding and locking element 258a, a second sliding and locking element 258b, a first guide element 260a, and a second guide element 260b, which together define a locking mechanism or clamping structure of the system. According to some applications, the housing 254 may be integrally formed as a single unit. According to some applications, the housing 254 may be formed from separate parts that are attachable to one another, including a first housing portion 254a and a second housing portion 254b, and the spring 256, the first sliding and locking element 258a, the second sliding and locking element 258b, the first guide element 260a, and the second guide element 260b form the locking mechanism or clamping structure of the system. b The separate parts that can be attached together to form the housing 254, such as the first housing portion 254a and the second housing portion 254b, are parallel to the longitudinal axis 290 of the housing 254 and are housed therebetween. b This can be utilized to simplify assembly of the locker 210b by allowing its internal components to be positioned and attached before being attached to one another.

[0398] According to some applications, a wire such as wire 63, and in some applications, first wire portion 62, may extend forward through a proximal wire opening 262 formed at a proximal end of housing 254, such as the proximal end of second housing portion 254b, through or parallel to spring 256, and through a distal wire opening 264 formed at a distal end of housing 254, such as the distal end of first housing portion 254a. According to some applications, a wire such as first wire portion 62 extends along longitudinal axis 290 through housing 254 between first sliding and locking element 258a and second sliding and locking element 258b. According to some applications, first housing portion 254a further includes first and second distal actuation openings 268a and 268b, which are located on either side of distal wire opening 264 at the distal end of housing 254 and each of which aligns with one of the sliding and locking elements.

[0399] According to some applications, spring 256 may be a finger disk spring, a spring washer, a lift spring, a compression spring, or any other suitable spring. Each option represents a different example. According to some applications, spring 256 is a finger disk spring having at least one spring arm. According to some applications, spring 256 is a finger disk spring having at least two spring arms. According to some applications, spring 256 is a finger disk spring having at least three spring arms. According to some applications, spring 256 is a finger disk spring having a first spring arm 256a and a second spring arm 256b, as shown in FIG. 19 . Advantageously, spring 256 in the form of a finger disk spring may be provided with a substantially flat profile of relatively small dimensions, for example, having a much shorter length, as compared to a compression spring. This allows for the locker 210, which is preferably provided as a compact, small sized component configured to lock a wire, such as the wire 63 of the implant 180, in a clamped state and remain attached to the implant 180 within the patient's body after the implantation procedure is completed. b This may allow for a reduction in the size of the

[0400] According to some applications, the first sliding and locking element 258a may be b The first spring arm 256a is movable on a first guide element 260a configured to move along the first sliding and locking element 258a between an open state and a closed state. According to some applications, the first spring arm 256a is disposed between the first sliding and locking element 258a and a proximal inner wall of the housing 254, such as the proximal inner wall of the second housing portion 254b. The first spring arm 256a is configured to press against the first sliding and locking element 258a and urge the first sliding and locking element distally toward a distal inner wall of the housing 254, such as the distal inner wall of the first housing portion 254a, toward the free closed state. Similarly, according to some applications, the second sliding and locking element 258b ... the distal inner wall of the housing 254, such as the distal inner wall of the first housing portion 254a, toward the free closed state. bThe second spring arm 256b is movable over a second guide element 260b configured to move along the second guide element 256b between an open state and a closed state. According to some applications, the second spring arm 256b is disposed between the second sliding and locking element 258b and a proximal inner wall of the housing 254, such as the proximal inner wall of the second housing portion 254b. The second spring arm 256b is configured to press against the second sliding and locking element 258b and urge the second sliding and locking element distally toward a distal inner wall of the housing 254, such as the distal inner wall of the first housing portion 254a, toward the free closed state.

[0401] The first sliding and locking element 258a and the second sliding element 258b can be configured in a variety of ways using a variety of different shapes and materials. In some applications, the first sliding and locking element 258a and the second sliding element 258b can be two sides or halves of the same sliding component. In some applications, the first sliding and locking element 258a and the second sliding element 258b can include one or more of a conical shape, a semi-conical shape, a circular shape, a rectangular or cubic shape, an opening, an aperture, a slot, a post, an arm, a leg, a high friction surface, etc. According to some applications, the first sliding and locking element 258a includes a high-friction first surface 266a oriented toward the longitudinal axis 290 of the housing 254, and the second sliding and locking element 258b includes a high-friction second surface 266b oriented toward the longitudinal axis 290 of the housing 254, such that both surfaces 266a and 266b face each other prior to extending the wire therebetween, preventing the wire from sliding against the rocker 210. b , it faces the wire (e.g., wire 63).

[0402] In the illustrative illustration, surfaces 266a and 266b are disposed on opposite sides of a wire extending therebetween, such as first wire portion 62. High friction surfaces 266a and 266b are configured to increase friction between a wire extending therebetween, such as first wire portion 62, when engaged therewith. bIn its free state, spring 256 biases both sliding and locking elements 258 distally and toward each other so as to press against and engage the wire extending therebetween, thereby locking the wire to the locking element 210. b The locking mechanism is configured to lock the locking mechanism in place in the closed state.

[0403] High-friction surface 266 may include surface features or treatments configured to enhance its friction against the wire extending therebetween. According to some applications, surfaces 266a and 266b may be wavy surfaces. According to some applications, surfaces 266a and 266b include a plurality of teeth preferably oriented at a proximal angle to engage wire 63 to prevent spontaneous sliding when held thereby, as shown in FIG. 19 .

[0404] According to some uses, Rocker 210 b The locker 210 includes a clamping structure that can be biased to a closed state (FIG. 20A) and bent to an open state. In the closed state, the clamping structure is configured to clamp onto a wire extending therethrough, such as the first wire portion 62. b In its open state, a wire, such as first wire portion 62, can move freely therethrough, thereby allowing the wire to be pulled. For example, first wire portion 62 can be held in place by rocker 210 in its open state until it has sufficiently contracted implant or annuloplasty structure 180, as described above. b Locker 210 b In the closed state, the locker 210 is configured to resist movement of the wire extending therethrough. For example, the first wire portion 62 is immobile relative to the plurality of anchors 150 of the implant 180. b It can be locked within

[0405] According to some uses, Rocker 210 bTo transition rocker 210 to the open state, external pressure / force is directed on first and second sliding and locking elements 258a and 258b in a proximal direction 282 through first and second distal actuation openings 268a and 268b, respectively, thereby urging elements 258a and 258a, respectively, against spring 256, and optionally against spring arms 256a and 256b, toward the rear inner wall of housing 254 and spaced apart surfaces 266a and 266b of elements 258a and 258b from the wire (e.g., first wire portion 62) disposed therebetween. This causes rocker 210 to b transitions to an open state, and the wire (e.g., first wire portion 62) moves to the rocker 210. b can move freely through

[0406] According to some applications, each sliding and locking element 258 includes an angled slot 288 having a proximal end 289 configured to receive a corresponding guide element 260, as shown in Figures 20A and 20B. Each guide element 260 may be constructed in a variety of different ways and using a variety of different materials, including, for example, one or more pins, rods, pegs, rings, leads, wires, etc. In some applications, each guide element 260 may be provided in the form of a pin or rod that extends laterally between two side walls of the housing 254.

[0407] In some applications, the first sliding and locking element 258a includes a first angled slot 288a that receives the first guide element 260a therein, and the second sliding and locking element 258b includes a second angled slot 288b that receives the second guide element 260b therein. The guide element 260 is attached to and immovable relative to the housing 254, while each of the angled slots 288 of the sliding and locking element 258 is slidable over the immovable guide element 258. Each of the angled slots 288 is angled or angled relative to the longitudinal axis 290 of the housing 254, such that the distal ends of the angled slots 288 are closer to each other and to the longitudinal axis 290 of the housing 254, and the proximal ends of the angled slots 288 are farther from each other and away from the longitudinal axis 290 of the housing 254.

[0408] In some applications, the first sliding and locking element 258a and the second sliding and locking element 258b are configured to move on the first guide element 260a and the second guide element 260b, respectively, along an angular path relative to the longitudinal axis 290, such that they are aligned with the rocker 210. b When pushed proximally in direction 282 from the closed state to the open state, surfaces 266 a and 266 a simultaneously move away from one another, thereby spacing their surfaces 266 a and 266 a away from one another and / or from the wires extending therebetween.

[0409] According to some usage, the default state of the locker is Locker 210 b , whereby the locker 210 bWithout an external pressure or force induced thereon, spring 256 (e.g., first spring arm 256a and second spring arm 256b) can freely engage and press against elements 258a and 258b, thereby urging the elements in a distal direction 284 toward the distal end of housing 254. As a result, elements 258a and 258b can engage and clamp a wire extending therebetween, such as first wire portion 62, to lock it and prevent its axial movement. As described herein, when an external force is induced on rocker 210, b Locker 210 unless directed upwards b It will be appreciated that the closure is configured to continuously maintain a closed state, thereby preventing any axial movement of the wire extending therethrough.

[0410] According to some applications, the housing 254 includes an inner angled wall 255 facing the elements 258, and each element 258 includes a complementary angled outer surface 278 facing the inner wall of the housing 254 opposite the high-friction surface 266. The inner angled wall 255 may taper distally toward the axis 290. The elements 258 are dimensioned so that their outer surfaces 278 contact and slide over the inner wall 255 of the housing 254. The angled orientation of the inner wall 255 and the outer surface 278 may advantageously promote smoother sliding of the elements 258 in the proximal and / or distal directions. In contrast to the high-friction surface 266, the outer surface 278, as well as the inner wall 255, may preferably be designed with smooth surfaces to enhance their sliding relative to one another.

[0411] Advantageously, the rocker 210 bThe locker (e.g., when equipped with proximally angled teeth) may be a self-tightening locker such that, when wire 63 is pulled distally, elements 258 slide distally further up guide element 260 and toward each other, thereby exerting a stronger grip on wire 63. According to some applications, angled slot 288 is dimensioned so that when the locker is in a closed or locked state with both elements 258 pressing against wire 63 extending therebetween, as shown in FIG. 20A , a space or gap G′ remains between guide element 260 and proximal end 289 of angled slot 288. This gap G′ allows elements 258 to move further toward each other and toward wire 63 extending therebetween when wire 63 is pulled distally, thereby strengthening the grip thereon.

[0412] According to some uses, Rocker 210 b In its open state, a wire (e.g., first wire portion 62) extending through the locker 210 b To allow free movement through the fastening system 200, an external pressure / force is directed onto the elements 258a and 258b, urging them in the proximal direction 282, using an actuation assembly 292, as shown in FIGS. b It can be a component of.

[0413] According to some applications, actuation assembly 292 includes actuation element 274. Actuation element may be constructed in a variety of different ways using a variety of different materials, including, for example, one or more of wire, rod, electrical lead, suture, tubing, etc. In some applications, actuation element 274 may be coupled to first push arm 270a and second push arm 270b by hinge portion 286 located at a distal end of actuation element 274. First push arm 270a and second push arm 270b may be coupled to rocker 210, as shown, for example, in FIGS. 21A-21C. b Each pressure arm 270 is hinged to a hinge portion 286 and is configured to include a locking mechanism 286. ba proximal arm portion 271 extending away from the longitudinal axis 290 of the rocker 210; and a proximal arm portion 272 extending substantially longitudinally continuously from the proximal arm portion, e.g., a rocker 210. b and a longitudinal arm portion 272 extending from the longitudinal arm portion 272 to the rocker 210, the longitudinal arm portion 272 being substantially parallel to the longitudinal axis 290 of the rocker 210. b and a distal arm portion 273 extending continuously toward the longitudinal axis 290 of the distal end portion 272 .

[0414] The actuation element 274 is b Along the longitudinal axis 290 of the rocker 210 b 271a and 271b, so that both hinge portion 286 and proximal arm portions 271a and 271b are in contact with rocker 210. b The length of each longitudinal arm portion 272a and 272b is b 210. b Each push arm 270 includes a pin 276 extending proximally from its distal arm portion 273. According to some applications, actuation element 274 is a tube or shaft having an internal lumen aligned with proximal wire opening 262, through which wire 62 passes to and from rocker 210. b It may extend towards and through

[0415] Locker 210 b In the closed state, the pusher arms 270 are oriented such that their pins 276 are positioned outside the housing 254 and, in particular, spaced apart from the distal actuation opening 268. FIG. 21A shows the rocker 210 in its closed state. b , with pin 276 disengaged therefrom. As shown, actuation element 274 engages hinge portion 286 and proximal arm portion 271 with rocker 210. b , so that both of the proximal arm portions 271 are in the distal-most position. b The longitudinal axis 290 of the casing 200 is oriented substantially perpendicular to the longitudinal axis 290 of the casing 200 .

[0416] According to some applications, each longitudinal arm portion 272 is angled at an obtuse angle relative to the proximal arm portion 271 so that, in the state shown in FIG. 21A, each longitudinal arm portion 272 extends distally relative to the rocker 210. b Each distal arm portion 273 can be substantially perpendicular to longitudinal arm portion 272, resulting in both the distal arm portion 273 and the pin 276 extending therefrom being oriented away from distal actuation opening 268.

[0417] FIG. 21B shows the locker 210 b 2 illustrates an intermediate stage in the process of actuating actuation assembly 292 to move rocker 210 to the open state. As shown, actuation element 274 is pulled proximally, moving hinged portion 286 toward rocker 210. b 21B, the pressure arm 270 is spaced apart from the rocker 210 such that the longitudinal arm portion 272 is in contact with the rocker 210. b 254, and optionally pressed onto the outer surface of housing 254. In this state, pins 276a and 276b are aligned with distal actuation openings 268a and 268b, respectively, but are not yet inserted into housing 254.

[0418] 21C, applying further pulling force to retract actuation element 274 in the proximal direction 282 facilitates entry of pin 276 into distal actuation opening 268. The length of pin 276 is such that, in this state, it is pressed against the distal end of element 258 and engages rocker 210, as described above with respect to FIG. b The actuation element 274 is selected to be able to push the distal end in a proximal direction 282 sufficiently to transition the actuation element 274 to its open state. Pushing the actuation element 274 distally releases the pin 276, causing the rocker 210 to move to its open state, as shown in FIGS. 21A and 20A. b returns backward to the closed state.

[0419] An actuation assembly 292, as described herein above, selectively pushes component 258 proximally to activate rocker 210. b to an open state or release such force therefrom, thereby causing the rocker 210 b serves as one optional assembly that can be utilized to lock a wire extending therethrough, and locker 210 b It will be appreciated that other mechanisms or assemblies configured to selectively transition the valve between its open and closed states may be used in combination therewith.

[0420] According to some uses, Rocker 210 b To allow a wire (e.g., first wire portion 62) extending therethrough to move freely therethrough in its open state, actuation element 274 is pulled in a proximal direction 282, causing pins 276a and 276b to urge elements 258b and 258a, respectively, in a proximal direction 282, as shown in FIG. 21C.

[0421] According to some applications, after implantation of the implant 180 around the annulus of a native valve (e.g., mitral valve 45, etc.) or other tissue region described herein, the inner catheter 20, and optionally, but not necessarily, the guide catheter 16, are retracted / extracted from the outer catheter 12, and the remaining section of the wire 62 is secured to the fastening system 200. b Inserted into Locker 210 b is coupled to actuation assembly 292 and is configured to be advanced through either guide catheter 16 or outer catheter 12 to the vicinity of implant 180 for performing annuloplasty or tissue remodeling. According to some applications, first wire portion 62, in its open state (for purposes of annuloplasty or tissue remodeling), b , the actuation assembly 292 is able to move freely through the rocker 210, as described hereinabove. b The rocker 210 is utilized to induce external pressure / force on the element 258. Once the implant or annuloplasty structure in the native valve (e.g., mitral valve 45) or other tissue region is sufficiently contracted, the rocker 210b is configured to use its closed state to lock the first wire portion 62 extending therethrough.

[0422] According to some applications, an implant 180 or annuloplasty structure in a native valve (e.g., mitral valve 45) or other tissue region may be configured to connect first wire portion 62 to actuation assembly 292 and fastening system 200. b Once fully retracted by pulling proximally through or along the other components of the locking mechanism, actuation element 274 is disengaged, as shown in FIG. 21B, causing pins 276a and 276b to cease pressing against elements 258b and 258a, respectively, and optionally exit housing 254. Actuation assembly 292 retracts rocker 210. b Once the external force induced on the element is no longer acting, the rocker 210 b is configured to continuously maintain a closed state, thereby locking and preventing axial movement of the first wire portion 62 therethrough, effectively locking the implant 180 in a clamped or contracted state. b and the fastening system 200 b can be extracted together with the rest of the

[0423] According to some uses, Rocker 210 b A disconnect and lock assembly 222 comprising: b The locker 210 is further configured to simultaneously lock and cut the first wire portion 62 extending therethrough. b Make any necessary changes to the locker 210 a In the same manner as described hereinabove, the housing 254 may further include a flap 232 attached thereto that is configured to capture any excess portion of the wire therein.

[0424] Locker 210 b Disconnect and lock assembly 222 bAlthough shown as part of the cut and lock assembly 222 in other applications, b It will be appreciated that the locker 210 may be used as a stand-alone component not coupled to the b However, the fastening system 200 b Although described as part of, it should be understood that it may be used independently as a component of other systems for locking wires, cables, sutures, etc. that may extend therethrough.

[0425] Locker 210 b 1 is described for use in combination with an implant 180 utilized to lock a wire 63, and more specifically, a first wire portion 62 extending therethrough, which is connected to a locker 210. b It should be understood that the present invention may similarly be used with any other type of wire, cable, string, suture, etc. that needs to transition between a free state where it can move axially through a wire, cable, string, suture, etc., and a locked state where axial movement is restricted.

[0426] Implant 180 c Wire 63 c , the wire 63 having both portions thereof extending through the rocker 210, the implant 180 d Wire 63 d , and Implant 180 e Wire 63 e Any of the applications described above utilizing the locker 210 to lock the wire 63 of an implant 180, such as b It should be understood that the above may be utilized in combination with the above.

[0427] Reference is now made to Figures 22-30G. Figure 22 is a schematic illustration of a system advanced toward and used to treat the left atrial appendage (LAA) according to some applications. While these Figures 22-30G are primarily described herein with respect to the LAA, the same or similar techniques, methods, steps, etc., may be used, mutatis mutandis, with respect to other tissue regions (e.g., other appendages, ridges, atrioventricular walls, openings, gaps, etc.).

[0428] According to some applications, several methods 300 for closure of the LAA ostium and / or closure of the LAA cavity are provided herein to prevent thrombus formation therein. These techniques and methods may be performed on a live animal or on a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.).

[0429] As used herein, the term "closure of the LAA ostium" refers to constricting the ostium of the LAA, for example, until complete contact between the boundaries of the ostium. Closure of the ostium can refer to either complete closure of the opening defined by the ostium, thereby preventing fluid flow between the left atrium and the LAA, or partial closure in a manner that does not necessarily result in complete sealing of the opening defined by the ostium, but may result in narrowing the opening defined by the ostium sufficiently to reduce the risks associated therewith, for example, resulting in a reduction in the area of ​​the opening defined by the ostium, such that large thrombi formed in the cavity of the LAA may be prevented from escaping into the left atrium.

[0430] According to some applications, the method 300 described herein below allows for closure of the LAA ostium, such that the ostium remains open and in fluid communication with the left atrium when the ostium opening area is less than about 10%-50%. According to some applications, the method 300 described herein below allows for closure of the LAA ostium, such that the ostium remains open and in fluid communication with the left atrium when the ostium opening area is less than about 10%. According to some applications, the method 300 described herein below allows for closure of the LAA ostium, such that the ostium remains open and in fluid communication with the left atrium when the ostium opening area is less than about 5%. According to some applications, the method 300 described herein below allows for closure of the LAA ostium, such that the ostium remains open and in fluid communication with the left atrium when the ostium opening area is less than about 1%.

[0431] As used herein, the term "closure of the LAA cavity" refers to constricting the inner surface of the LAA cavity, thereby providing complete closure thereof and preventing fluid flow from the left atrium.

[0432] While method 300 is described below and illustrated in FIGS. 22-30G with respect to closure of the LAA ostium or LAA cavity, it should be understood that the same method, mutatis mutandis, may be performed for closure of any other tissue region, opening, or cavity within a patient's body in need thereof. For example, any of the methods 300 described for closure of the LAA ostium may be performed for closure of an opening in the cardiac septum or an opening in another organ that needs closure. Similarly, any of the methods 300 described for closure of an LAA cavity may be performed for closure of other cavities, such as aneurysms. In some applications, the same or similar techniques, methods, steps, etc. may be used to reshape the atrioventricular wall and / or to close a portion of the heart wall (e.g., to separate diseased or problematic tissue). In some applications, similar techniques, methods, steps, etc. may be used for valve reshaping without completely closing the valve. The techniques, methods, and steps described herein may be performed on a live animal or on a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.).

[0433] 22 and 23A-23G, according to some applications, method 300 includes a method 300a for closing an opening or tissue region within a patient's body, such as an LAA ostium 304, to restrict or prevent fluid communication between an LAA cavity 302 and the left atrium 43 of the patient's heart 42. It will be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," and / or "tissue region" for performing the method with other openings, cavities, and / or regions.

[0434] According to some applications, the method 300a includes providing an implant 310 near the LAA ostium 304 within the left atrium 43 of a patient's heart 42 using a multi-component system 10, which may include an outer catheter 12 and a guide catheter 16, as described above. It should be understood that all methods 300 described below with reference to FIGS. 22-25C that utilize a guide catheter 16 extending through the outer catheter 12 may be implemented in the same or similar manner utilizing an inner catheter 20 extending through the outer catheter 12 instead of the guide catheter 16. Thus, any references to the guide catheter 16 and its distal end portion 18 may be equivalently substituted for the inner catheter 20 and its distal end portion 22, respectively. Additionally, these techniques and methods may be implemented on live animals or simulations, such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissue, LAA, etc.), etc.

[0435] According to some applications, the guide catheter 16 including the implant 310 is advanced through the outer catheter 12 into the left atrium 43. According to some applications, the implant or structure 310 is loaded into the guide catheter 16 before, during, or after advancing the guide catheter 16 into the left atrium 43. The distal end portion 18 of the guide catheter 16 extends beyond the distal end 14 of the outer catheter 12. The distal end portion 18 is then steered (i.e., deflected) in a second steering plane, which in some embodiments may be perpendicular to the steering plane of the outer catheter 12, more typically toward the LAA ostium 304.

[0436] 23A shows an implant 310 comprising a flexible sleeve 312 and an adjustment mechanism 314 advanced via a guide catheter 16 to near the opening of the LAA ostium 204. According to some applications, the sleeve 312 comprises a braided tissue mesh, for example, comprising polyethylene terephthalate (such as Dacron™).

[0437] The sleeve 312 can be configured to be fully or partially positioned around the LAA ostium 304 and, once secured in place, be contracted to circumferentially tighten the ostium 304. For some applications, the sleeve 312 includes a flexible, elongated contraction member 322 extending along the sleeve 312. For some applications, the elongated contraction member 322 can include one or more of a wire, ribbon, rope, band, suture, or the like, which can include a flexible and / or resilient material such as, for example, nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the adjustment mechanism 314 is configured to facilitate contraction of the LAA ostium 304 to facilitate adjustment and tightening of its circumferential circumference.

[0438] 23A , during advancement of the implant or sleeved implant 310, the adjustment mechanism 314 is positioned distal to (i.e., forward of) the sleeve 312. The adjustment mechanism 314 may be coupled to the sleeve 312 via one or more connectors 316, such as sutures, that provide a flexible and / or articulating coupling. A guide member 318 (e.g., a wire, ribbon, tube, band, suture, etc.) may extend distally from an opening located on the lumen of the guide catheter 16 near its distal end portion 18 toward the end wall 320 of the sleeve 312, where the guide member 318 is coupled to the adjustment mechanism 314. The guide member 318 may be identical to the wire 63 described herein above.

[0439] According to some applications, implant 310 further comprises a plurality of anchors 324. Each of anchors 324 may be similar to anchor 150 described herein above, and more specifically, anchor 150. a , but does not necessarily include a through-hole (158). Nevertheless, in some applications, anchor 324 includes a through-hole 158.

[0440] According to some applications, the contraction member 322 is a wire that extends through and along the sleeve, or is woven into a portion of the sleeve. In some applications, the multiple anchors 324 are not directly connected to the contraction member 322, but only secure the sleeve to tissue while the contraction member is separately connected to the sleeve (e.g., they are indirectly connected). In some applications, the multiple anchors are directly connected to the contraction member, such as by passing through a threaded hole therein.

[0441] According to some applications, contraction member 322 is a wire that connects adjustment mechanism 314 to sleeve 312 and / or plurality of anchors 324. According to some applications, contraction member 322 is a wire that is connected to guide member 318 via adjustment mechanism 314. According to some applications, contraction member 322 and guide member 318 are the same wire that extends through adjustment mechanism 314. Contraction member 322 may be the same as wire 63 described herein above.

[0442] Anchor 324 may be deployed from within sleeve 312 and secured / threaded therethrough around the tissue of LAA ostium 304 to attach the outer surface of sleeve 312 thereto, as shown in FIG. 23C. Anchor 324 may be advanced and deployed from sleeve 312 utilizing a delivery tool, such as any of the embodiments of delivery tool 160 described herein above, or any other suitable advancement and drive mechanism.

[0443] In some applications, a first tissue anchor 324 is deployed distal-most within sleeve 312 (generally at or within a few millimeters of end wall 320 of sleeve 312), and each subsequent anchor 324 is deployed and secured more proximally and around ostium 304. The already deployed first one of anchors 324 holds the secured end of sleeve 312 in place, so that sleeve 312 is withdrawn, utilizing steerable distal end portion 18 of guide catheter 16, from the site of first tissue anchor 324 toward the site of second tissue anchor 324, as shown in FIG. 23E.

[0444] 23F illustrates the entire length of the sleeve 312 secured around the LAA cavity 304 by the anchors 324. According to some applications, the implanted sleeve 312 extends at least 270 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 270 degrees to 360 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 270 degrees to 280 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 280 degrees to 290 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 290 degrees to 300 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 300 degrees to 310 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 310 degrees to 320 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 320 degrees to 330 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 330 degrees to 340 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 340 degrees to 350 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 350 degrees to 360 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 270 degrees to 320 degrees around the LAA ostium 304. According to some applications, the implanted sleeve 312 extends 320 degrees to 360 degrees around the LAA ostium 304.

[0445] In some applications, after securing the anchor about the LAA, an adjustment tool (not shown) is threaded over and advanced along the guide member 318. In some applications, the actuation mechanism comprises a spool, winch, spindle, etc. that can rotate in one direction to occupy a portion of the contraction member and rotate in the opposite direction to release a portion of the contraction member, thereby increasing or decreasing tension on the implant and, thereby, the tissue region. In some applications, the adjustment tool can comprise a rotation tool configured to actuate (e.g., rotate) the adjustment mechanism 314 to tension / tighten the contraction member 322 extending within the sleeve 312, thereby contracting the sleeve 312.

[0446] In some applications, tension is maintained within the implant after tension is applied to the implant using adjustment mechanism 314. In some applications, adjustment mechanism 314 includes a locking mechanism that prevents reversal of tightening (e.g., loosening) of contraction member 322, thereby maintaining extended contraction member 322 tightly within sleeve 312 under tension.

[0447] Further details regarding the sleeved implants, sleeves, adjustment mechanisms, and adjustment tools that may be used herein, including the manner in which such components are manipulated to secure the implant to tissue and to shrink or reshape tissue, are described in more detail in International Publication Nos. WO 2016 / 174669 and WO 2020 / 012481, which are incorporated by reference in their entirety for all purposes.

[0448] In some applications, a rocker 210, which may be similar to the embodiments of rocker 210 described above herein, or a rocker including at least some components of rocker 210 described above herein, such as flap 232, may be used in place of or in combination with adjustment mechanism 314. For example, after tightening of LAA ostium 304, contraction member 322 may be locked, as shown in FIG. 23F, and any excess portion of contraction member 322 may be covered using rocker 210. Additionally, in some applications, the excess portion of contraction member 322 may be cut using assembly 222 in a manner similar to that described for assembly 222 above.

[0449] FIG. 23G illustrates complete closure of an LAA ostium 304 utilizing the sleeved implant 310 described above. The shape of the LAA ostium 304 is, in most cases, oval, so that tightening the implant 310 may approximate the two sides of the ostium 304 until they are in complete contact therebetween. However, in some cases, tightening the implant 310 may not be sufficient to compress the boundaries of the ostium to completely close the ostial opening. According to some applications, the implant 310 is secured such that a portion of the sleeve 312 may extend over the edges of the ostium 304. Advantageously, this configuration allows the portions of the sleeve 312 extending inwardly over the edges of the ostium 304 to approximate and contact each other even when the tissue boundaries of the ostium 304 do not contact each other, thereby forming a physical barrier over the gap between the boundaries of the ostium 304 and thereby facilitating its sealing.

[0450] Thus, according to some applications, a method 300a for closing or reducing an opening in a patient's body, such as an LAA ostium 304, includes step (a) providing an implant 310, as described above, the implant 310 comprising a flexible sleeve 312, an adjustment mechanism 314, a flexible elongate contraction member 322 extending along the sleeve 312, a guide member 318, and a plurality of anchors 324. It will be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," or "tissue region" for practicing the method with other openings, cavities, and / or tissue regions.

[0451] According to some applications, the method further includes step (b) utilizing the outer catheter 12 and guide catheter 16, and / or inner catheter 20, of the system 10, as described herein above, to advance the implant 310 to the vicinity of the LAA ostium 304 within the left atrium 43 of the patient's heart 42.

[0452] According to some applications, the method further includes step (c) of deploying a first anchor 324 from within the sleeve 312 and anchoring / penetrating the anchor through the sleeve 312 into tissue at the LAA ostium 304 at the first location.

[0453] According to some applications, the method further includes step (d) of deploying subsequent anchors 324 around the LAA ostium 304 at subsequent locations, each location spaced a minimum distance from the previous location, thereby securing the entire length of the sleeve 312 around the LAA ostium 304 via the multiple anchors 324, as described above in this specification, so that the sleeve 312 extends at least 270 degrees around the LAA ostium 304.

[0454] According to some applications, the method further includes step (e) of applying tension to the contraction member 322 extending within the sleeve 312, thereby constricting the LAA ostium 304, which may thereby close it.

[0455] According to some applications, the method further includes the step (f) of locking and optionally cutting any excess portion of the contraction member 322.

[0456] According to some applications, the minimum distance between anchor locations is at least about 0.1 mm. According to some applications, the minimum distance is at least about 1 mm. According to some applications, the minimum distance is selected from a range of about 1-100 mm. According to some applications, the minimum distance is selected from a range of about 1-50 mm. According to some applications, the minimum distance is selected from a range of about 1-30 mm. According to some applications, the minimum distance is selected from a range of about 3-20 mm. According to some applications, the minimum distance is selected from a range of about 5-15 mm. According to some applications, the minimum distance is selected from a range of about 7-12 mm.

[0457] 24A-24G . According to some applications, the method 300 includes a method 300b for occluding an LAA ostium 304 utilizing a fabric strip 326, the method 300b including (a) providing a multi-component tubular system 10 configured to provide an implant 180 near the LAA ostium 304, the system 10 including one, two, or more of an outer catheter 12, a guide catheter 16, and an inner catheter 20. The distal end portion 22 of the inner catheter 20 can be configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., its primary lumen) and be positioned outside the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and be oriented in a desired spatial orientation within the vicinity of the LAA ostium 304.

[0458] According to some applications, the method further includes step (b) of using the system 10 to advance and deliver an implant 180 to tissue surrounding the LAA ostium 304 within the left atrium 43 of the patient's heart 42, the implant 180 comprising a plurality of anchors 150, a wire 63 including a first wire portion 62 configured to be advanced within the lumen of the inner catheter 20 together with the anchors 150, a second wire portion 64 configured to extend between the anchors 150, and a piece of cloth 326 advanced within either the inner catheter 20 or the guide catheter 16.

[0459] According to some applications, the method further includes step (c) of inserting and advancing the piece of fabric 326 longitudinally through the lumen of either the inner catheter 20 or the guide catheter 16, and extracting the piece of fabric from the distal end portion 22 of the inner catheter 20 or the distal end portion 18 of the guide catheter 16, respectively, distally within the left atrium 43 toward the LAA ostium 304, so that at least a portion of the piece of fabric 326 is positioned between the distal end portion 22 of the inner catheter 20 and a location along the tissue of the opening 304 of the LAA cavity 302 where the first anchor 150a is fixed / driven, as shown in Figures 24B and 24C.

[0460] According to some applications, the fabric strip 326 is attached at its distal end to the first anchor 150 a and advanced therewith through the inner catheter 20 toward the LAA ostium 304 .

[0461] According to some applications, the method further includes step (d) of advancing a first anchor 150a longitudinally through the lumen of the inner catheter 20 and driving the anchor through the cloth piece 326 and into the tissue of the LAA ostium 304 at the first location by being reversibly engaged by the anchor driver 161, as described above.

[0462] According to some applications, the piece of fabric 326 is attached at its distal end to the first anchor 150a and advanced therewith through the inner catheter 20 toward the LAA ostium 304, so that step (d) may include advancing the first anchor 150a, carrying the end of the piece of fabric 326 attached thereto, through the lumen of the inner catheter 20 and driving the anchor into the tissue of the LAA ostium 304 at the first location by being reversibly engaged by the anchor driver 161, as described above.

[0463] According to some applications, the first anchor 150a is coupled to the first stopper 244 via the second wire portion 64, as shown in FIG. 24D, thereby securing at least a portion of the fabric piece 326 at the LAA ostium 304 in a first position.

[0464] According to some applications, the method further includes step (e) of deploying / driving subsequent anchors 150 through subsequent portions of the cloth strip 326 at subsequent locations around the circumference of the LAA ostium 304, each location being spaced apart from the previous location by a minimum distance, thereby securing the implant 180 through the cloth strip 326 via the multiple anchors 150 and the wires 63 extending therebetween, such that the cloth strip 326 extends at least 270 degrees around the LAA ostium 304, as shown in FIG. 24F, or extends around the LAA ostium 304 according to any of the embodiments described above with respect to the sleeve 312 extending around the ostium 304.

[0465] According to some applications, the method further includes step (f) of retracting / extracting the inner catheter 20, and optionally the guide catheter 16, from the outer catheter 12, and inserting the remaining section of the wire 63 disposed therein into a fastening system 200, which includes a locker 210, a cutting and locking assembly 222, and a fastening catheter 224, as shown in FIG. 24F.

[0466] According to some applications, the method further includes step (g) of applying tension to the section of wire 63 inserted into system 200 during step (f) proximally through clamping catheter 224 to sufficiently constrict the LAA ostium 304 for closure thereof, as shown in FIG. 24G.

[0467] According to some applications, the method further includes step (h) utilizing locker 210 and assembly 222, as described herein above, to cut and lock, possibly simultaneously, the section of wire 63 extending from and passing through final anchor 150b, thereby locking implant 180, for example, utilizing flap 232 described above, and optionally capturing any excess portion of wire 63 therein.

[0468] According to some applications, the method further includes step (i) of separating the assembly 222 from the locker 210 and extracting the assembly 222, together with the clamping catheter 224 connected thereto, from either the guide catheter 16 or the outer catheter 12, thereby leaving the locker 210 attached to the implant 180.

[0469] It should be understood that the multi-component system 10 and fastening system utilized for the above-described method 300b may be implemented according to any of the embodiments of the systems 10 and 200 described elsewhere in the present specification. The implant 180 with multiple anchors 150 and wire 63 utilized for the above-described method 300b may be implemented according to any of the other implants 180 described hereinabove, particularly the implant 180 described hereinabove with respect to FIGS. 16 and 17. e It will be appreciated that the following may be similar to:

[0470] 24G illustrates the complete closure of the LAA ostium 304 utilizing the implant 180 and fabric strip 326, as described above with respect to method 300b. According to some applications, the fabric strip 326 is secured such that a portion of the fabric strip 326 may extend inwardly over the edges of the ostium 204. Advantageously, this configuration allows the portions of the fabric strip 326 that extend inwardly over the edges of the ostium 304 to approach, contact, or partially overlap one another, even if the tissue boundaries of the ostium 304 do not contact one another after contraction of the implant 180, thereby forming a physical barrier over and facilitating sealing of the gap between the boundaries of the ostium 304.

[0471] According to some applications, the fabric piece 326 is shaped as an elongated strip having dimensions suitable for being advanced within the lumen of either the inner catheter 20 or the guide catheter 16, and having a length suitable for encircling at least 270 degrees around the LAA ostium 304, at least 300 degrees around the LAA ostium 304, at least 330 degrees around the LAA ostium 304, or at least 360 degrees around the LAA ostium 304. Each possibility is a separate embodiment.

[0472] According to some applications, fabric strip 326 comprises a biocompatible polymer such as polyethylene terephthalate (PET). Further examples of suitable polymers include, but are not limited to, copolymers of dimethylsiloxane and methylvinylsiloxane, ethylene / vinyl acetate copolymer (EVA), polyethylene, polypropylene, ethylene / propylene copolymers, acrylic acid polymers, ethylene / ethyl acrylate copolymers, polytetrafluoroethylene (PTFE), polyurethane, thermoplastic polyurethane and polyurethane elastomers, polybutadiene, polyisoprene, poly(methacrylate), polymethyl methacrylate, styrene-butadiene-styrene block copolymers, poly(hydroxyethyl methacrylate) (pHEMA), polyvinyl chloride, vinyl acetate, polyethers, polyacrylonitrile, polyethylene glycol, polymethylpentene, polybutadiene, polyhydroxyalkanoates, poly(lactic acid), poly(glycolic acid), polyanhydrides, polyorthoesters, hydrophilic polymers such as hydrophilic hydrogels, cross-linked polyvinyl alcohol, and combinations and variations thereof. Each possibility is a separate example.

[0473] 25A-25C. According to some applications, method 300 may be used in combination with systems 10 and 200 to provide implant 180, as described herein above with respect to FIGS. e The present invention includes a method 300c for reconstructing an opening or tissue region within a patient's body, such as an LAA ostium 304, utilizing a closure.

[0474] According to some applications, the method 300c may include: eThe method includes step (a) of providing a multi-component tubular system 10 configured to deliver a catheter to the vicinity of the LAA ostium 304, the system 10 comprising at least one, two, or more of an outer catheter 12, a guide catheter 16, and an inner catheter 20. According to some applications, a distal end portion 22 of the inner catheter 20 is configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., its primary lumen) and be positioned outside the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and be oriented in a desired spatial orientation within the vicinity of the LAA ostium 304. It should be understood that the terms "LAA ostium" and "LAA cavity" may be interchangeable with "opening," "cavity," or "tissue region" for practicing the method having other openings, cavities, and / or tissue regions.

[0475] According to some applications, the method further comprises: e and (b) using the system 10 to advance and deliver the implant 180 to tissue surrounding the LAA ostium 304 within the left atrium 43 of the patient's heart 42. e The inner catheter 20 includes a plurality of anchors 150 and a first wire portion 62 configured to advance within the lumen of the inner catheter 20. e a wire 63 along which the anchor 150 is delivered within the lumen of the inner catheter to the heart; e and a second wire portion 64 configured to extend between the anchor 150. e And, it is equipped with.

[0476] According to some applications, the method further includes step (c) of longitudinally advancing a first anchor 150a through the lumen of the inner catheter 20 using an anchor driver 161 reversibly engaged to the anchor, as described above, to drive the anchor into tissue at the LAA ostium 304 at a first location, the first anchor 150a being connected to the second wire portion 64 as shown in FIG. 25A and further described herein above with respect to FIGS. 16 and 17 . e , and is connected to the first stopper 244 via the

[0477] According to some applications, the method further includes step (d) deploying subsequent anchors 150 about the LAA ostium 304 at subsequent locations, each location spaced apart from the previous location by a minimum distance, thereby securing the implant 180 e The wire 63 extends between the anchors 150. e Through, fixation, resulting in implant 180 e extends at least 270 degrees around the LAA ostium 304, as shown in FIG. 25B, or extends around the LAA ostium 304 according to any of the embodiments described above with respect to the sleeve 312 extending around the ostium 304.

[0478] According to some applications, the minimum distance between anchor locations is at least about 0.1 mm. According to some applications, the minimum distance is at least about 1 mm. According to some applications, the minimum distance is selected from a range of about 1-100 mm. According to some applications, the minimum distance is selected from a range of about 1-50 mm. According to some applications, the minimum distance is selected from a range of about 1-30 mm. According to some applications, the minimum distance is selected from a range of about 3-20 mm. According to some applications, the minimum distance is selected from a range of about 5-15 mm. According to some applications, the minimum distance is selected from a range of about 7-12 mm.

[0479] According to some applications, the method includes retracting / extracting the inner catheter 20, and optionally the guide catheter 16, from the outer catheter 12 and removing the wire 63 disposed therein. e 25B. The method further includes step (e) of inserting the remaining section of the catheter into a fastening system 200, which includes a locker 210, a cutting and locking assembly 222, and a fastening catheter 224, as shown in FIG. 25B.

[0480] According to some applications, the method may further include extending wire 63 inserted into system 200 during step (e) proximally through clamping catheter 224 to sufficiently constrict LAA ostium 304 for closure thereof, as shown in FIG. 25C. e The method further includes the step (f) of applying tension to the section.

[0481] According to some applications, the method includes extending a wire 63 from and passing through the final anchor 150b, as described above in this specification. e 1. The method further includes step (g) of utilizing the locker 210 and assembly 222 to cut and lock, possibly simultaneously, the section of the implant 180, thereby locking the implant 180, for example, utilizing the flap 232 described above, and optionally, the wire 63. e Any excess portion of is captured therein.

[0482] According to some applications, the method further includes step (h) of separating assembly 222 from rocker 210 and extracting assembly 222, along with clamping catheter 224 connected thereto, from either guide catheter 16 or outer catheter 12, thereby securing rocker 210 to implant 180. e Leave it attached.

[0483] Implant 180 e Although described and illustrated in conjunction with an implant 180 described above, it should be understood that in some applications, method 300c may be performed mutatis mutandis in a similar manner in conjunction with implant 180 described above to completely surround the periphery of LAA ostium 304. For example, implant 180 described with respect to FIGS. c 13A and 13B, an implant 180 having both its portions pulled and locked into a locker; and an implant 180 described in connection with FIGS. 15A-15C. dAny of the above may be utilized, in conjunction with the steps of method 300c and any necessary modifications, to secure the implant and contract it around the LAA ostium 304 or another appendage or protuberance instead of the native valve annulus.

[0484] 26A-26E. According to some applications, method 300 may be used in conjunction with systems 10 and 200 to provide implant 180, as described herein above with respect to FIGS. e and a method 300d for closure of an opening or reshaping a tissue region within a patient's body, such as the LAA ostium 304, utilizing the LAA ostium. It should be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," or "tissue region" for performing the method with other openings, cavities, and / or tissue regions.

[0485] According to some applications, the method 300d may include implanting 180 e to the vicinity of the LAA ostium 304, the system 10 comprising at least one, two, or more of an outer catheter 12, a guide catheter 16, and an inner catheter 20. According to some applications, a distal end portion 22 of the inner catheter 20 is configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., through its primary lumen) and be positioned outside the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and be oriented in a desired spatial orientation within the vicinity of the LAA ostium 304.

[0486] According to some applications, the method further comprises: e and (b) using the system 10 to advance and deliver the implant 180 to tissue surrounding the LAA ostium 304 within the left atrium 43 of the patient's heart 42. e The inner catheter 20 includes a plurality of anchors 150 and a first wire portion 62 configured to extend within the lumen of the inner catheter 20. e Includes 63 wirese and a second wire portion 64 configured to extend between the anchor 150. e And, it is equipped with.

[0487] According to some applications, the method includes attaching the first anchor 150a to the first wire portion 62. e 26A and 26B, further comprising step (c) of longitudinally advancing the first anchor 150a through the lumen of the inner catheter 20 while threaded over the second wire portion 64, and driving the anchor into tissue of the LAA ostium 304 at a first location by reversibly engaging the anchor using an anchor driver 161, as described above, wherein the first anchor 150a is threaded over the second wire portion 64, as shown in FIG. 26A and further described herein above with respect to FIGS. 16 and 17. e , and is connected to the first stopper 244 via the

[0488] According to some applications, the method includes attaching the second anchor 150c to the first wire portion 62. e 26B , such that the first and second positions are located on opposite sides of the opening defined by the ostium 304.

[0489] According to some applications, the method further includes step (e) of longitudinally advancing a third anchor 150d through the lumen of the inner catheter 20 and driving the anchor into the LAA ostium 304 at a third location by being reversibly engaged by an anchor driver 161, as provided above, the third location being located at the ostium 304 such that the first location and the third location are located on the same side of the ostium 304 and are spaced apart from each other by a minimum distance, and the third location and the second location are located on opposite sides of the ostium 304, as shown in FIG. 26C , and the second wire portion 64 is driven by the third anchor 150d. eextend between anchors 150, thereby forming an alternating pattern (ie, a zigzag formation).

[0490] According to some applications, the method further includes a step (f) of deploying subsequent anchors 150 to subsequent locations positioned on alternate sides of the tissue of the LAA ostium 304, thereby e The wire 63 extends between the anchors 150. e 26D, the anchors are connected to each other over the opening 304 in a zigzag formation between the first anchor 150a and the final anchor 150b.

[0491] According to some applications, the method includes retracting / extracting the inner catheter 20, and optionally the guide catheter 16, from the outer catheter 12 and removing the wire 63 disposed therein. e 26D. The method further includes step (g) of inserting the remaining section of the catheter into a fastening system 200, which includes a locker 210, a cutting and locking assembly 222, and a fastening catheter 224, as shown in FIG. 26D.

[0492] According to some applications, the method may further include extending wire 63 inserted into system 200 during step (g) proximally through clamping catheter 224 to sufficiently constrict LAA ostium 304 for closure thereof, as shown in FIG. 26E. e The method further includes the step (h) of applying tension to the section.

[0493] According to some applications, the method includes providing a wire portion 63 extending from and passing through the final anchor 150b, as described herein above. e 1. The method further includes step (i) of utilizing the locker 210 and assembly 222 to cut and lock, possibly simultaneously, a section of the implant 180, thereby locking the implant 180, for example, utilizing the flap 232 described above, and optionally, the wire 63. eAny excess portion of is captured therein.

[0494] According to some applications, the method further includes step (j) of separating assembly 222 from rocker 210 and extracting assembly 222, along with clamping catheter 224 connected thereto, from either guide catheter 16 or outer catheter 12, thereby securing rocker 210 to implant 180. e Leave it attached.

[0495] 23A-23G and 26A-26E, the method 300d described above with respect to FIGS. e 180 implants with e 23A-23G may be modified to extend the implant 310 over the LAA ostium 304 instead of over the LAA ostium 304. Accordingly, the implant 310 is implanted mutatis mutandis to define an alternating pattern (i.e., a zigzag formation) across the LAA ostium 304 (or any other body orifice), similar to that shown in FIG. 26D. Advantageously, the additional contact area formed by the outer surface of the sleeve 312 may provide additional material to cover and seal the LAA ostium 304.

[0496] 27A-27D. According to some applications, method 300 may be used in combination with systems 10 and 200 to provide implant 180, as described herein above with respect to FIGS. 5-10B. c The present invention includes a method 300e for closing an opening in a patient's body, such as an LAA ostium 304, utilizing a catheter-guided catheter. It should be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," and "tissue region" for performing the method with other openings, cavities, and / or tissue regions.

[0497] According to some applications, the method 300e includes: cto the vicinity of the LAA ostium 304, the system 10 including at least two of an outer catheter 12, a guide catheter 16, and an inner catheter 20, the distal end portion 22 of the inner catheter 20 configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., its primary lumen) and positioned outside the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and oriented in a desired spatial orientation within the vicinity of the LAA ostium 304.

[0498] According to some applications, the method comprises implanting 180 c and (b) using the system 10 to advance and deliver the implant 180 to tissue surrounding the LAA ostium 304 within the left atrium 43 of the patient's heart 42. e The inner catheter 20 includes a plurality of anchors 150 and a first wire portion 62 configured to extend within the lumen of the inner catheter 20. c , and a second wire portion 64 configured to extend between the anchor 150, loop rearward, and extend through a defined interior space extending proximally between the inner catheter 20 and either the guide catheter 16 or the outer catheter 12, and further to and possibly through the handle of the respective catheter, which is exposed to the outside environment. c and a wire 63 comprising: c And, it is equipped with.

[0499] According to some applications, the method includes extending a first anchor 150a longitudinally through the lumen of the inner catheter 20 and connecting the first wire portion 62 c and driving the anchor into tissue at the LAA ostium 304 at a first location using an anchor driver 161, as described above, wherein the first anchor 150a is connected to the second wire portion 64. c , resulting in a second wire portion 64 c At least a first segment of the second wire portion 64 is configured to extend through the plurality of anchors 150.c At least a second segment of the catheter is configured to be disposed within an interior space defined between the inner catheter 20 and either the guide catheter 16 or the outer catheter 12, as shown in FIG. 27A.

[0500] According to some applications, the method further includes step (d) of advancing a second anchor 150c longitudinally through the lumen of the inner catheter 20 and driving the anchor to an opposite side of the LAA ostium 304 at a second position while reversibly engaged by an anchor driver 161 as provided above, the second position being located at the ostium 304, such that the first and second positions are located on opposite sides of the opening defined by the ostium 304, as shown in FIG. 27B.

[0501] According to some applications, the method further includes step (e) of longitudinally advancing a third anchor 150d through the lumen of the inner catheter 20 and driving the anchor into the LAA ostium 304 at a third location while reversibly engaged by an anchor driver 161, as provided above, the third location being located at the ostium 304, such that the first location and the third location are located on the same side of the ostium 304 and are spaced apart from each other by a minimum distance, and the third location and the second location are located on opposite sides of the ostium 304, thereby driving the second wire portion 64 extending between the anchors 150d. c forming an alternating pattern (i.e., a zigzag formation).

[0502] According to some applications, the method further includes the step (f) of deploying a subsequent anchor 150 at a subsequent location positioned on the tissue opposite side of the LAA ostium 304, thereby deploying the implant 180. c The wire 63 extends between the anchors 150. c , and the anchors are connected to each other above the opening 304 after the zigzag formation between the first anchor 150a and the final anchor 150b.

[0503] According to some applications, the method further includes step (g) of advancing subsequent anchors 150 in an opposite direction relative to the longitudinal direction 330, shown as a direction parallel to the longer diameter of the LAA ostium 304, to form a double zigzag formation over the opening 304 and deploying them to subsequent positions positioned on opposite sides of the ostium 304, with the final anchor 150b being implanted adjacent to the first anchor 150a, as shown in FIG. 27C.

[0504] According to some applications, the method further includes step (h) of retracting / extracting the inner catheter 20 and, optionally, the guide catheter 16 from the outer catheter 12, thereby removing the first wire portion 62. c The external end of the first wire portion 62 is exposed to the external environment. c and second wire portion 64 c both extend, optionally in parallel, through a single catheter, such as guide catheter 16 or outer catheter 12.

[0505] According to some applications, the method may include, for example, removing first wire portion 62 c 1. The proximal free end 78 of the first wire portion 62 is inserted through the end loop 66, or any other type of end retainer 82, and optionally the end loop 66 is advanced, for example, toward the first anchor 150a, to secure the first wire portion 62. c The method further includes step (i) inserting the remaining section of the catheter into a fastening system 200, which includes a locker 210, a cutting and locking assembly 222, and a fastening catheter 224.

[0506] According to some applications, the end retainer 82 (e.g., loop 66) may be attached to the first wire portion 62 as described above. c or by assembly 222 pushing the wire portion distally through the respective catheter, the wire portion can be advanced through guide catheter 16 and / or outer catheter 12 toward first anchor 150a.

[0507] According to some applications, the method includes extending wire 63 inserted into system 200 during step (i) proximally through clamping catheter 224 to sufficiently constrict LAA ostium 304 for closure thereof, as shown in FIG. 27D. c The method further includes the step (j) of applying tension to the section of

[0508] According to some applications, the method includes the step of removing the wire portion 63 extending from and passing through the end retainer 82, as described herein above. c 1. The method further includes step (k) of utilizing the locker 210 and assembly 222 to cut and lock, possibly simultaneously, the section of the wire 63, thereby locking the implant 180 and, optionally, utilizing, for example, the flap 232 described above. c Any excess portion of is captured therein.

[0509] According to some applications, the method further includes step (l) of separating assembly 222 from rocker 210 and extracting assembly 222, along with clamping catheter 224 connected thereto, from either guide catheter 16 or outer catheter 12, thereby securing rocker 210 to implant 180. e Leave it attached.

[0510] According to some applications, method 300e may include implant 180 surrounding the annulus as described above with respect to FIGS. 9A and 9B, instead of the zigzag formation shown in FIGS. 27B-27D. c The implant 180 is placed around the periphery of the LAA cavity 304, similar to the pattern of c This includes transplanting the

[0511] 28A-28B. According to some applications, method 300 includes a method 300f for closing an opening in a patient's body, such as an LAA ostium 304, utilizing implant 180 in combination with systems 10 and 200, as described herein above with respect to FIGS. 13A and 13B. It should be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," and "tissue region" for performing the method with other openings, cavities, and / or tissue regions.

[0512] According to some applications, method 300f can include steps similar to those of method 300d described above with respect to Figures 26A-26E. According to some applications, method 300f includes step (k) of performing one, some, or all of steps (a)-(f) of method 300d described above to secure first implant 180a over LAA ostium 304 forming a first zigzag formation via multiple anchors 150 and wires 63a extending therebetween.

[0513] According to some applications, the method further includes step (l) of repeating steps (a) to (f) of the above-described method 300d to fix a second implant 180b over the LAA ostium 304 via multiple anchors 150 and wires 63b extending therebetween, forming a second zigzag formation, and together forming a double zigzag formation on the ostium 304 via implants 180a and 180b.

[0514] According to some applications, the method further includes step (m) of retracting / extracting the inner catheter 20, and optionally the guide catheter 16, from the outer catheter 12, and the remaining sections of the wire 63a of the first implant 180a and the wire 63b of the second implant 180b are inserted into the fastening system 200. In some applications, the locker 210 of the system 200 comprises a dual lumen configured to allow the wire 63a of the first implant 180a and the wire 63b of the second implant 180b to extend therethrough, in a manner similar to that described above with respect to Figures 13A and 13B.

[0515] According to some applications, the method further includes step (n) of applying tension to sections of wire 63a of first implant 180a and wire 63b of second implant 180b inserted into system 200 during step (m) in a proximal direction through clamping catheter 224 to sufficiently constrict LAA ostium 304 for the purpose of closing it, as shown in FIG. 28B.

[0516] According to some applications, the method further includes step (o) of utilizing locker 210 and assembly 222, as described herein above, to cut and lock, possibly simultaneously, sections of wires 63a and 63b extending from the final anchors of implants 180a and 180b, respectively, thereby locking implant 180, for example, utilizing flap 232 described above, and optionally capturing any excess portions of wires 64a and 64b therein.

[0517] According to some applications, the method further includes step (p) of separating assembly 222 from locker 210 and extracting assembly 222, together with clamping catheter 224 connected thereto, from either guide catheter 16 or outer catheter 12, thereby leaving locker 210 attached to implants 180a and 180b.

[0518] 29A-29E. According to some applications, method 300 may be used in combination with systems 10 and 200 to provide implant 180, as described herein above with respect to FIGS. d The present invention includes a method 300g for closing an opening in a patient's body, such as an LAA ostium 304, utilizing a catheter-guided catheter. It should be understood that the terms "LAA ostium" and "LAA cavity" may be interchanged with "opening," "cavity," or "tissue region" for performing the method with other openings, cavities, and / or tissue regions.

[0519] According to some applications, the method 300g is implant 180 c to the vicinity of the LAA ostium 304, the system 10 comprising at least one, two, or more of an outer catheter 12, a guide catheter 16, and an inner catheter 20. According to some applications, a distal end portion 22 of the inner catheter 20 is configured to pass through the guide catheter 16 or the outer catheter 12 (i.e., through its primary lumen) and be positioned outside the distal end portion 14 of the outer catheter 12 or the distal end portion 18 of the guide catheter 16, and be oriented in a desired spatial orientation within the vicinity of the LAA ostium 304.

[0520] According to some applications, the method further comprises: d and (b) using the system 10 to advance and deliver the implant 180 to tissue surrounding the LAA ostium 304 within the left atrium 43 of the patient's heart 42. d The inner catheter 20 includes a plurality of anchors 150 and a first wire portion 62 configured to extend within the lumen of the inner catheter 20. d , and a second wire portion 64 configured to extend between the anchor 150 d and a wire 63d including the wire 63a.

[0521] According to some applications, the second wire portion 64 dis further looped rearward and extends through a defined interior space between the inner catheter 20 and either the guide catheter 16 or the outer catheter 12 in a proximal direction, and further extends to and possibly through the handle of the respective catheter, which is exposed to the outside environment, and a second wire portion 64 d The extracorporeal end of the second wire portion 64 includes an end clamp 240. In some applications, the end clamp 240 may be attached to the second wire portion 64. d via the first anchor 150a and therewith, ready to be advanced into tissue. Further details of both applications are detailed above with respect to Figures 14-15C.

[0522] According to some applications, the method includes extending the first anchor 150a longitudinally through the lumen of the inner catheter 20 and the first wire portion 62 d and (c) advancing the anchor while threaded onto the LAA ostium 304 and driving the anchor into tissue at the LAA ostium 304 at the first location using the anchor driver 161, as described above.

[0523] According to some applications, terminal clamp 240 is coupled to first anchor 150a and advanced therewith toward the ostium of the LAA, as shown in FIG. 29A.

[0524] According to some applications, the method further includes step (d) of advancing a second anchor 150c longitudinally through the lumen of the inner catheter 20 and driving the anchor to an opposite side of the LAA ostium 304 at a second position while reversibly engaged by an anchor driver 161 as provided above, the second position being located at the ostium 304, such that the first and second positions are located on opposite sides of the opening defined by the ostium 304, as shown in FIG. 29B.

[0525] According to some applications, the method further includes step (e) of longitudinally advancing a third anchor 150d through the lumen of the inner catheter 20 and driving the anchor into the LAA ostium 304 at a third location by being reversibly engaged by an anchor driver 161, as provided above, the third location being located at the ostium 304, such that the first location and the third location are located on the same side of the ostium 304 and are spaced apart from each other by a minimum distance, and the third location and the second location are located on opposite sides of the ostium 304, thereby driving the second wire portion 64 extending between the anchors 150d. d forming an alternating pattern (i.e., a zigzag formation).

[0526] According to some applications, the method further includes step (f) of advancing subsequent anchors 150 along the longitudinal direction 330 and deploying them at subsequent locations positioned on alternate sides of the ostium 304 of the LAA, thereby deploying the implant 180. d The wire 63 extends between the anchors 150. d 29B, and is secured over mouth 304 along the zigzag formation shown in FIG. 29B. According to some applications, intermediate anchor 150e, shown in FIG. 29B, spaced longitudinally 330 from first anchor 150a at the opposite end of mouth 304, is the final anchor implanted during the current step.

[0527] According to some applications, the method further includes step (g) of advancing subsequent anchors 150 in opposite directions relative to the longitudinal direction 330 and deploying them to subsequent locations positioned on opposite sides of the tissue of the mouth 304 to form a double zigzag formation over the opening 304, with a final anchor 150b being implanted adjacent to the first anchor 150a, as shown in FIG. 29C.

[0528] According to some applications, the terminal clamp 240 is positioned adjacent to the first anchor 150a, and the method continues with the wire 63 extending from the final anchor 150b, as shown in FIG. 29C. dThe method further includes a step (h) of steering / manipulating the distal end portion 22 of the inner catheter 20 to allow the section to be inserted into the terminal clamp 240 through a spring-loaded gate 242 attached thereto.

[0529] According to some applications, the method further comprises the step (i) of retracting / extracting the inner catheter 20 and, optionally, the guide catheter 16 from the outer catheter 12 .

[0530] Not all steps are required, and the steps may be performed in a different order. For example, in some applications, terminal clamp 240 may be positioned outside the patient's body instead of near first anchor 150a, and step (i) may be performed after step (g), e.g., after first wire portion 62 d The procedure includes inserting the proximal end 78 of the catheter through the end clamp 240 and advancing the end clamp 240 towards the first anchor 150c.

[0531] According to some applications, step (i), whether performed after step (g) or step (h), may be performed after first wire portion 62 d 29D, which includes inserting the remaining section into a fastening system 200, which includes a locker 210, a cut and lock assembly 222, and a fastening catheter 224.

[0532] According to some applications, the method may further include extending wire 63 inserted into system 200 during step (i) proximally through clamping catheter 224 to sufficiently constrict LAA ostium 304 for closure thereof, as shown in FIG. 29E. c The method further includes the step (j) of applying tension to the section of

[0533] According to some applications, the method includes removing wire portion 63 extending from and passing through terminal clamp 240, as described herein above. d1. The method further includes step (k) of utilizing the locker 210 and assembly 222 to cut and lock, possibly simultaneously, a section of the wire portion 63, thereby locking the implant 180, and optionally utilizing, for example, the flap 232 described above. d Any excess portion of is captured therein.

[0534] According to some applications, the method further includes step (l) of separating assembly 222 from locker 210 and extracting assembly 222, along with clamping catheter 224 connected thereto, from either guide catheter 16 or outer catheter 12, thereby removing rocker 210 from implant 180. d Leave it attached.

[0535] According to some applications, method 300g may include, instead of the zigzag formation shown in FIGS. 29B-29E, implant 180 surrounding the annulus as described above with respect to FIGS. 15A and 15B. d The implant 180 is positioned around the periphery of the LAA cavity 304, similar to the pattern of d Additionally, these techniques and methods may be performed on live animals or on simulations such as, for example, cadavers, cadaver hearts, simulators (e.g., simulated body parts, hearts, tissues, LAA, etc.).

[0536] 30A-30G. According to some applications, an advancement device or spiral advancement device 350 is provided that is configured to facilitate closure of a cavity within a patient's body, such as the LAA cavity 302, for example, by constricting the inner wall 306 of the cavity 302. The spiral advancement device 350 includes a tissue-engaging portion 352 having a sharpened distal tip 354, which is coupled to a stopper 356. It will be understood that the terms "LAA ostium" and "LAA cavity" may be interchangeable with "opening," "cavity," or "tissue region" for performing methods having other openings and / or cavities.

[0537] According to some applications, tissue-engaging portion 352 is a helical coil or spring having a plurality of spaced bends. According to some applications, stopper 356 includes a sharpened distal tip 362 configured to be flush with or otherwise form a continuous sharp edge therewith, and a stopper proximal surface 358 oriented perpendicular to the surface of the bend of tissue-engaging portion 352, as shown in the enlarged section of FIG. 30B. Stopper proximal surface 358 is attached to wire 360, which is disposed within and through the bend of tissue-engaging portion 352. According to some applications, tissue-engaging portion 352 includes a hollow lumen within the bend that accommodates wire 360 ​​extending therethrough. Wire 360 ​​may be the same as wire 63.

[0538] According to some applications, the advancement device or spiral advancement device 350 is configured to be advanced to the vicinity of the LAA ostium 304 or further into the LAA cavity 302 utilizing a multi-component tubular system, which may be similar or different from the multi-component system 10 described above with respect to FIG.

[0539] According to some applications, the advancement device or spiral advancement device 350 is attached to the distal end portion 22 of the inner catheter 20 and is configured to be advanced within the lumen of the outer catheter 12 or guide catheter 16 using the inner catheter 20.

[0540] According to other applications, the advancement device or helical advancement device 350 further comprises a drive shaft 364 attached to the tissue engaging portion 352 at a proximal end 368 thereof. According to some applications, the tissue engaging portion 352 extends from the proximal end 368 to a distal tip 354. According to some applications, the drive shaft 364 comprises a hollow lumen that accommodates the wire 360 ​​extending therethrough.

[0541] According to some applications, the helical advancement device 350 is configured to be advanced within a lumen of a delivery catheter selected from the outer catheter 12, the guide catheter 16, or the inner catheter 20, and the tissue engaging portion 352 is retained within the delivery catheter along its entire length, as shown in FIG. 30A , such that the distal tip 354 is positioned at the level of or proximal to a distal lip 366 of the delivery catheter. The delivery catheter distal lip 366 may be selected from the distal end portion 14 of the outer catheter 12, the distal end portion 18 of the guide catheter 16, or the distal end portion 22 of the inner catheter 20, depending on the type of delivery catheter device 350 being advanced therein. According to some applications, the drive shaft 364 is configured to enable advancement of the tissue engaging portion 352 within the lumen of the delivery catheter.

[0542] According to some applications, the distal-most bend of tissue engaging portion 352 terminates in distal tip 354 and has an outer diameter d2 that is greater than diameter d1 of drive shaft 364.

[0543] According to some applications, the delivery catheter has a diameter d3 that is greater than d1. It is envisioned that tissue engaging portion 352 is in a compressed spring state during advancement of tissue engaging portion 352 within the lumen of the delivery catheter, and tissue engaging portion 352 is exposed to an external force provided by the inner wall of the delivery catheter. Thus, the maximum diameter of the distal-most bend of tissue engaging portion 352 is constricted by the inner wall of the delivery catheter when tissue engaging portion 352 is held toward LAA ostium 304 or LAA cavity 302 during delivery.

[0544] According to some applications, once tissue engaging portion 352 is advanced distally relative to the delivery catheter, for example, by drive shaft 364, through and beyond delivery catheter distal lip 366, tissue engaging portion 352 is free to expand to its free spring state. According to some applications, each subsequent, adjacent bend increases in diameter in the free spring state from the proximal end 368 to the distal tip 354 of tissue engaging portion 352, such that d2 is greater than d3 in the free spring state.

[0545] 30B shows the tissue-engaging portion 352 fully extended beyond the distal lip 366 of the delivery catheter, allowing its bends to expand to its unsprung state. As described above, this may be facilitated by advancing the drive shaft 364 in a distal direction 370 relative to the delivery catheter lip 366. According to some applications, the tissue-engaging portion 352 includes internal flexibility such that it is spring-biased radially outward during the unsprung state and can be urged radially inward by a force exerted thereon during the compressed spring state. When no external force is applied to the bends of the tissue-engaging portion 352 during the unsprung state, the bends expand radially apart from one another.

[0546] According to some applications, tissue engaging portion 352 is configured to transition between an unexpanded (or contracted) state of its bends when retained within the lumen of the delivery catheter, where it is maintained in a compressed spring state, as shown in FIGS. 30A-30B , and an expanded state in which it extends radially outward and transitions to a spring-free state when the bends are advanced distally from delivery catheter lip 366. According to some applications, the shape of the expanded state of tissue engaging portion 352 is configured to anatomically match the interior shape of the inner wall 306 of LAA cavity 302 during the spring-free state. According to some applications, diameter d2 is configured to be larger than the average diameter of LAA ostium caliber 304 and / or the average diameter of LAA cavity 302.

[0547] According to some applications, the tissue engaging portion 352 is configured to be inserted and advanced by a drive shaft 364 within the lumen of a delivery catheter selected from the outer catheter 12, the guide catheter 16, or the inner catheter 20 toward the vicinity of the LAA ostium 304 or into the LAA cavity 302, and when advanced distally from the delivery catheter lip 366, switches from a compressed spring state to a spring-free state, thereby expanding radially outward therefrom.

[0548] According to some applications, the tissue engaging portion 352 is configured to be inserted and advanced by a drive shaft 364 within the lumen of the outer catheter 12 toward the vicinity of the LAA ostium 304 or into the LAA cavity 302, and when advanced distally from the distal end portion 14 of the outer catheter 12, transitions from a compressed spring state to a spring-free state, thereby expanding radially outward therefrom.

[0549] According to some applications, the tissue engaging portion 352 is configured to be inserted and advanced by a drive shaft 364 within the lumen of the guide catheter 16 toward the vicinity of the LAA ostium 304 or into the LAA cavity 302, and when advanced distally from the distal end portion 18 of the guide catheter 16, switches from a compressed spring state to a spring-free state, thereby expanding radially outward therefrom.

[0550] According to some applications, the tissue engaging portion 352 is configured to be inserted and advanced by a drive shaft 364 within the lumen of the inner catheter 20 toward the vicinity of the LAA ostium 304 or into the LAA cavity 302, and when advanced distally from the distal end portion 22 of the inner catheter 20, switches from a compressed spring state to a spring-free state, thereby expanding radially outward therefrom.

[0551] According to some applications, the tissue engaging portion 352 is configured to pierce / puncture tissue surrounding the LAA ostium 304 using the sharp distal tip 354. According to some applications, the drive shaft 364 is configured to be rotated and advanced in a distal direction 370 from a delivery catheter lip 366 of the delivery catheter, thereby driving the tissue engaging portion 352 into the tissue surrounding the LAA ostium 304 and then in a helical advancement pattern into the tissue of the inner wall 306 of the LAA cavity 302, and then along the length of the inner wall 306, as shown in FIG. 30C . According to some applications, the tissue engaging portion 352 is configured to be advanced in a screw-like advancement manner within the tissue of the inner wall 306 of the LAA cavity 302 during advancement of the drive shaft 364 in the distal direction 370.

[0552] After penetration of the tissue, stopper 356 is configured to be secured thereto by attaching stopper proximal surface 358 to the surrounding tissue. According to some applications, stopper proximal surface 358 is a high-friction surface configured to increase friction between itself and the surrounding tissue. Stopper proximal surface 358 may include a burnished surface, multiple teeth, or any other shape or texture that allows for the creation of high friction. Advantageously, stopper proximal surface 358 is shaped and positioned in a manner that allows stopper 356 to be secured in its position within the surrounding tissue.

[0553] According to some applications, after locking of stopper 356, drive shaft 364 is further configured to rotate and retract in the opposite distal direction 370 toward the delivery catheter, thereby spiraling tissue engaging portion 352 out of the tissue of inner wall 306 of LAA cavity 302. While tissue engaging portion 352 threads out of the tissue of inner wall 306 of LAA cavity 302 during retraction of drive shaft 364, the stopper remains at its original distal-most penetration point with its relatively flat surface 358 pressed against inner wall 306.

[0554] Wire 360 ​​is configured to be exposed / extracted out of its lumen during extraction of inner wall 306 of tissue engaging portion 352 from the tissue, thereby remaining fixed in a helical / thread-like configuration within the tissue of inner wall 306 of LAA cavity 302 with stopper 356 held in a distal position pressed against the tissue, thereby providing a counter force that pulls wire 360 ​​out of the lumen of tissue engaging portion 352, as shown in FIG. 30D . Advantageously, stopper proximal surface 358 is shaped and positioned in a manner that allows stopper 356 to be fixed in its position within the tissue surrounding it, thereby allowing wire 360 ​​to remain fixed in a helical / thread-like configuration within the tissue of inner wall 306 of LAA cavity 302 during extraction of tissue engaging portion 352 therefrom.

[0555] The tissue engaging portion 352 is configured to re-enter the lumen of the delivery catheter through the delivery catheter lip 366 and be withdrawn proximally therefrom and extracted after the tissue engaging portion 352 has been sufficiently or completely extracted from the tissue of the inner wall 306, thereby leaving the wire 360 ​​helically fixed around the tissue of the inner wall 306 of the LAA cavity 302 in the form of a thread-like formation, as shown in FIG. 30E.

[0556] According to some applications, the clamping system 200 is threaded over the wire 360, as shown in FIG. 30F. The clamping system 200 includes a locker 210, a cut and lock assembly 222, and a clamping catheter 224, as described hereinabove and throughout the present specification. According to some applications, the clamping system 200 is utilized to provide tension to a section of the wire 360 ​​inserted therein, for example, by withdrawing the section proximally through the clamping catheter 224, as shown in FIG. 30G, to sufficiently contract the inner wall 306 of the LAA cavity 302 for closure thereof. According to some applications, the locker 210 and assembly 222 are configured to lock and cut, possibly simultaneously, the section of wire 360 ​​extending therethrough, as described above in this specification, thereby locking the wire 360 ​​extending through the inner wall 306 of the LAA cavity 302 in its tension or clamped state, and optionally capturing any excess portion of the wire 360 ​​therein, for example, utilizing the flap 232 described above.

[0557] According to other applications, the tissue engaging portion 352 is configured to be inserted and advanced by a drive shaft 364 within a lumen of a delivery catheter, the delivery catheter being configured to be inserted past the LAA ostium 304 and at least partially into the LAA cavity 302. According to some applications, the tissue engaging portion 352 is configured to be advanced distally from a delivery catheter lip 366 of the delivery catheter to switch from a compressed spring state within the LAA cavity 302 to a spring-free state. According to some applications, the tissue engaging portion 352 is configured to penetrate and advance within tissue of the inner wall 306 of the LAA cavity 302 in a threaded advancement configuration, as described herein above, for purposes of closure thereof.

[0558] According to some applications, the method 300 includes a method 300h for closing the LAA cavity 302, the method including step (a) of providing a multi-component tubular system (e.g., system 10) configured to deliver the spiral advancement device 350 described above to the vicinity of the LAA ostium 304 of the LAA, or optionally to the LAA cavity 302, the system (10) comprising at least one delivery catheter selected from an outer catheter 12, a guide catheter 16, an inner catheter 20, or any combination thereof.

[0559] According to some applications, the method further includes step (b) of inserting and advancing a tissue engaging portion 352 of the helical advancement device 350 coupled to the drive shaft 364, both of which are positioned within the lumen of the delivery catheter from step (a), toward the vicinity of the LAA ostium 304, or optionally, into the LAA cavity 302.

[0560] According to some applications, the method further includes step (c) of advancing the tissue engaging portion 352 distally from the delivery catheter lip 366, whereby the portion transitions from a compressed spring state to a spring-free state from which it is expandable radially outward.

[0561] According to some applications, the method further includes step (d) rotating and advancing the drive shaft 364 in a distal direction 370 relative to a delivery catheter lip 366 of the delivery catheter, thereby driving the tissue engaging portion 352 into the inner wall 306 of the LAA cavity 302. The rotation in the first direction to advance the tissue engaging portion 352 distally through the tissue can be either clockwise or counterclockwise.

[0562] According to some applications, driving the tissue engaging portion 352 into the inner wall 306, as described in step (d), is achieved by driving the tissue engaging portion 352 into the tissue surrounding the LAA ostium 304 and from there spirally advancing into the tissue of the inner wall 306 of the LAA cavity 302.

[0563] If the tissue engaging portion 352 is already positioned within the LAA cavity 302, the spring transitions toward a non-acting state. According to some applications, driving the tissue engaging portion 352 into the inner wall 306 is accomplished by simply rotating the portion within the cavity 302, as described in step (d), urging its distal tip 354 toward and through the wall 306.

[0564] According to some applications, the method further includes step (e) of further driving the tissue engaging portion 352 in a spiral fashion along the length of the inner wall 306 and therefrom into the tissue of the inner wall 306 of the LAA cavity 302 until the distal tip 354 penetrates the tissue near the distal inner wall 332 of the inner wall 306, thereby securing the stopper 356 therethrough.

[0565] According to some applications, the method further includes a step (f) of rotating and retracting the drive shaft 364 in the opposite proximal direction, toward the delivery catheter, to extract the tissue engaging portion 352 out of the tissue of the inner wall 306 of the LAA cavity 302, thereby exposing the wire 360 ​​configured to remain fixed in a helical configuration within the tissue of the inner wall 306 of the LAA cavity 302 with the stopper 356 held in place at a distal position relative to the tissue. The rotation in step (f) is performed in a second direction that is opposite to the first direction of rotation in steps (d) and (e).

[0566] According to some applications, the method further includes step (g) of reinserting the tissue engaging portion 352 into the lumen of the delivery catheter through the delivery catheter lip 366 and, optionally, extracting the tissue engaging portion therefrom.

[0567] According to some applications, the method further includes inserting the proximal section of wire 360 ​​into clamping system 200, which includes locker 210, cutting and locking assembly 222, and clamping catheter 224, as described above, and step (h) advancing system 200 within the lumen of the delivery catheter to the vicinity of LAA ostium 304.

[0568] According to some applications, the method further includes step (i) of applying tension to a section of wire 360 ​​inserted into clamping system 200 during step (h) proximally through clamping catheter 224 to sufficiently contract inner wall 306 of LAA cavity 302 for the purpose of closing it.

[0569] According to some applications, the method further includes (j) utilizing the locker 210 and assembly 222, as described herein above, to cut and lock, possibly simultaneously, a section of the wire 360 ​​extending therethrough, thereby locking the wire 360 ​​extending through the inner wall 306 of the LAA cavity 302 in a tensioned or clamped state, and optionally capturing any excess portion of the wire 360 ​​therein, for example, utilizing the flap 232 described herein above.

[0570] According to some applications, the method further includes the step of separating the assembly 222 from the locker 210 and extracting the assembly 222, along with the clamping catheter 224 connected thereto, from the delivery catheter, thereby leaving the locker 210 attached to its tensioned wire 360 ​​threaded through the inner wall 306 of the LAA cavity 302. Additionally, these techniques and methods may be performed on a live animal or a simulation, such as, for example, a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, heart, tissue, etc.).

[0571] As used herein, the term "plurality" means two or more.

[0572] As used herein, the term "about," when referring to a measurable value such as an amount, temporal duration, etc., is meant to encompass variations from the specified value of ±10%, more preferably ±5%, even more preferably ±1%, and even more preferably ±0.1%, as such variations are appropriate for the disclosed devices, systems, and / or methods.

[0573] It is understood that certain features of the present disclosure that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single application. Conversely, various features of the present disclosure that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described application of the present disclosure. Features described in the context of an embodiment should not be considered essential features of that embodiment unless expressly designated as such.

[0574] While the present disclosure has been described in conjunction with specific examples thereof, it is apparent that numerous alternatives, modifications, and variations are possible that will be apparent to those skilled in the art. It will be understood that the present disclosure is not necessarily limited in its application to the details of construction and arrangement of components and / or methods described herein. Other applications may be implemented, and certain applications may be implemented in various ways. The methods described herein do not require all of the steps described, and the steps may be performed in an order other than that presented. Accordingly, the present disclosure includes all such alternatives, modifications, and variations that fall within the scope of the appended claims. Furthermore, the various techniques, methods, operations, steps, etc. described or suggested herein may be implemented in live animals or in non-living simulations, e.g., cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0575] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art and which would occur to one skilled in the art upon reading the above description.

Claims

1. 1. An implant configured to be advanced within a lumen of an inner catheter, comprising: a wire having a free end and a second end including an end retainer; A plurality of anchors, each anchor comprising: a tissue engaging element having a sharp distal tip and a proximal end, the tissue engaging element configured to be driven into cardiac tissue of a subject; a plurality of anchors coupled to the proximal ends of the tissue engaging elements and comprising a through-hole configured to allow a portion of the wire to extend therethrough; the end retainer defines an opening through which the free end can be inserted such that the end retainer is slidable over the wire and away from the free end; The implant wherein the end retainer is sized to be larger than the through hole so as to prevent the retainer from passing through the through hole.

2. 10. The implant of claim 1, wherein the end retainer is a loop.

3. 10. The implant of claim 1, wherein the end retainer is a terminal clamp with a hinged, spring-loaded gate.

4. The implant of any one of claims 1 to 3, further comprising a clip removably coupled to the end retainer.

5. The implant of any one of claims 1 to 4, wherein the plurality of anchors comprises 3 to 30 anchors.

6. The implant of any one of claims 1 to 4, wherein the plurality of anchors comprises 5 to 25 anchors.

7. A system comprising an implant according to any one of claims 1 to 6, said system comprising: a handle assembly including an outer catheter handle and an inner catheter handle; an outer catheter extending from the outer catheter handle and having an outer catheter distal end; an inner catheter extending from the inner catheter handle and having an inner catheter distal end, the inner catheter extending through the outer catheter; a first wire portion of the wire extending distally from the free end through the inner catheter to the distal end of the inner catheter; a second wire portion of the wire extends from the distal end of the inner catheter, within the outer catheter, proximally along the outside of the inner catheter, and exits the proximal end of the outer catheter, with the end retainer disposed outside the outer catheter.

8. The system described in claim 7, wherein the second wire portion extends within an internal space defined between the outside of the inner catheter and the inner wall of the outer catheter.

9. At the distal end of the inner catheter, the wire extends back around the distal end of the inner catheter, thereby defining a slack portion of the wire between the first wire portion and the second wire portion; The system is adapted to secure the plurality of anchors to the tissue of the heart, thereby securing the slack to the tissue, and for each of the plurality of anchors, while the wire is threaded through the respective thread hole, advancing the anchor distally through the inner catheter along the first wire portion and out the distal end of the inner catheter; The system of claim 8 , wherein each of the tissue engaging elements is driven into the tissue such that the plurality of anchors form an open loop within the heart.

10. The system described in claim 9, wherein the end retainer slides over the first wire portion and moves to the fixed anchor within the heart to form the slack portion into a closed loop within the heart.

11. The system of any one of claims 7 to 9, wherein the inner catheter and the handle of the inner catheter are removable from the system, such that upon removal of the inner catheter and the handle of the inner catheter, the free ends are exposed and the first wire portion and the second wire portion extend parallel to each other within the lumen of the outer catheter.

12. 8. The system of claim 7, wherein the handle assembly further comprises a guide catheter handle, and the system further comprises a guide catheter extending from the guide catheter handle and having a guide catheter distal end, the guide catheter being positioned between the inner catheter and the outer catheter.

13. The system of claim 12 , wherein the second wire portion extends proximally within an interior space defined between an exterior of the inner catheter and an interior wall defined by the guide catheter.

14. The system described in claim 13, wherein the end retainer is positioned outside the handle assembly.

15. 15. The system of claim 13 or 14, wherein the inner catheter and the handle of the inner catheter are removable from the system, such that upon removal of the inner catheter and the handle of the inner catheter, the free ends are exposed and the first wire portion and the second wire portion extend parallel to each other within the lumen of the guide catheter.

16. 16. The system of claim 15, wherein the guide catheter and the handle of the guide catheter are removable from the system, such that upon removal of the inner catheter and the handle of the inner catheter and upon removal of the guide catheter and the handle of the guide catheter, the free ends are exposed and the first wire portion and the second wire portion extend parallel to each other within the lumen of the outer catheter.

17. The system of any one of claims 7 to 16, further comprising an anchor driver configured to reversibly engage the anchor and drive each of the tissue engaging elements into tissue.

18. 18. The system of any one of claims 7 to 17, wherein the inner catheter comprises a slit extending proximally from the distal end of the inner catheter such that the slit is continuous with a distal opening at the distal end of the inner catheter, and the slit is configured to allow the wire, but not the anchor, to exit the inner catheter laterally and proximally from the distal end of the inner catheter.

19. A fastening system comprising an implant according to any one of claims 1 to 6, wherein the fastening system comprises: a clamping catheter; a cut and lock assembly attached to the clamping catheter and comprising a locker removable therefrom; the wire extends through the clamping catheter and the cutting and locking assembly; The cutting and locking assembly is adapted to slidably push the end retainer along the wire and into the heart.

20. 20. The fastening system of claim 19, wherein the locker comprises a fastener configured to transition between an open state and a closed state, the fastener configured to allow axial movement of the wire through the locker in the open state and the fastener configured to limit movement of the wire relative to the plurality of anchors in the closed state.

21. 21. The fastening system of claim 19 or 20, wherein the cutting and locking assembly comprises at least one blade configured to cut the wire extending therethrough.

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