System and methods for heart valve leaflet repair

Abstract

An implant (200) comprising a wing (220) and an interface (250) at a root portion (230) of the wing is useful for treating valve issues, including leaflet flail, prolapse, and restricted leaflet motion. In some implementations, the wing defines a curved contour along a long axis of the wing that extends from the root portion to a tip portion (232) of the wing. A delivery tool (150) is used to transluminally advance the implant to the heart. In some implementations, the delivery tool comprises (i) a catheter (140), housing the implant, (ii) a shaft (160), having a distal segment (163) reversibly couplable to the implant's interface.

Description

Attorney Docket No: TMTTMC-23775WO01SYSTEMS AND METHODS FOR HEART VALVE LEAFLET REPAIR CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority to Provisional US Patent Application 63 / 745,241 to May et al., titled "Systems and methods for heart valve leaflet repair," filed on January 14, 2025.

[0002] The above application is incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0003] The native heart valves (e.g., the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital malformations, inflammatory processes, infectious conditions, or disease. Such damage to the valves can result in serious cardiovascular compromise or death. Treatment for such disorders can be done with the surgical repair or replacement of the valve during open heart surgery or with transcatheter transvascular techniques for introducing and implanting prosthetic devices in a manner that is much less invasive than open heart surgery.

[0004] A healthy heart has a generally conical shape that tapers to a lower apex. The heart has four chambers: the left atrium, right atrium, left ventricle, and right ventricle. The left and right sides of the heart are separated by a wall generally referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve includes an annulus portion, which is an annular portion of the native valve tissue surrounding the mitral valve orifice, and a pair leaflets (as referred to as cusps) that extend downward from the annulus into the left ventricle. The mitral valve annulus can form a "D" shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. The anterior leaflet can be larger than the posterior leaflet, forming a generally "C" shaped boundary between the abutting free edges of the leaflets when they are closed together.

[0005] When operating properly, the anterior leaflet and the posterior leaflet function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the muscles of the left atrium contract and the muscles of the left ventricle relax, theAttorney Docket No: TMTTMC-23775WO01oxygenated blood that is collected in the left atrium flows into the left ventricle. When the muscles of the left atrium relax and the muscles of the left ventricle contract, the increased blood pressure in the left ventricle urges the two leaflets together, thereby closing the oneway mitral valve so that blood cannot flow back to the left atrium and is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing or flailing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tetherthe leaflets to papillary muscles in the left ventricle.

[0005] Valve regurgitation can occur when the native valve fails to close properly and blood flows into the left atrium from the left ventricle during the systole phase of heart contraction. Valve regurgitation (especially mitral valve regurgitation) is one of the most common forms of valvular heart disease. Mitral regurgitation has different causes, including leaflet prolapse or flail, restricted leaflet motion (e.g., due to leaflet rigidity / leaflet calcification), and / or dysfunctional papillary muscles stretching.

[0006] There is a continuing need for effective devices and methods for treating valve issues, including leaflet flail, prolapse, and restricted leaflet motion.SUMMARY

[0007] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0008] In some implementations, an implant comprises a wing and an interface at a root portion of the wing. In some implementations, the wing defines a curved contour along a long axis of the wing that extends from the root portion to a tip portion of the wing. For example, the wing can have two faces, and one of the faces defines an at least partially concave contour along the long axis.Attorney Docket No: TMTTMC-23775WO01

[0009] In some implementations, the contour of the wing's face is not uniformly curved along the long axis. In some implementations, the face is concave at the wing's root portion and tip portion, yet the face defines a flat portion (e.g., longer than the wing's root and tip portions) in between the root portion and tip portion. In some implementations, the wing's root and tip portions are symmetrically curved with respect to the flat portion.

[0010] In some implementations, the implant can be configured in other ways and be shaped and / or structured differently, e.g., not as a wing.

[0011] In some implementations, a delivery tool is used to transluminally advance the implant to the heart. In some implementations, the delivery tool comprises a catheter. In some implementations, the catheter houses the implant.

[0012] In some implementations, the delivery tool additionally comprises a shaft. In some implementations, the shaft has a distal segment reversibly coupled to the implant's interface.

[0013] In some implementations, the delivery tool additionally comprises a driver. In some implementations, the driver is useable to drive an anchor through the interface and into tissue of the heart. Other anchoring mechanisms are also possible, e.g., a clamp, clasp, stent, barbs, hooks, adhesive, rivets, screws, sutures, loops, etc.

[0014] In some implementations, the shaft's distal segment is coupled to a pair of interfaces by a pair of detents that reversibly fasten each interface to the shaft's distal segment. In some implementations, a release cord is connected to the detents and extends proximally through the catheter such that extracorporeally pulling the release cord unfastens each interface from the distal segment. In some implementations, a wire defines the detents and the release cord is thinner and more flexible than the wire, such that the release cord contributes less bulk or stiffness to the catheter than if the wire were to extend proximally through the catheter.

[0015] In some implementations, the shaft has a primary segment (e.g., a proximal segment) that can be reversibly disassociated from the implant, (e.g., from the distal segment to which the implant is coupled) in order to facilitate assessment of the implant's effect upon the heart's function.Attorney Docket No: TMTTMC-23775WO01

[0016] In some implementations, the shaft has a connector that reversibly (i) unmates the primary segment from the distal segment by retracting the primary segment proximally through the catheter, with respect to the distal segment, and (ii) remates the primary segment to the distal segment by advancing the primary segment distally through the catheter toward the distal segment. For example, the driver can be (i) advanced into the shaft's distal segment in order to drive the anchor into the tissue, and (ii) retracted into the shaft's primary segment in order to facilitate assessment of the implant's effect upon the heart's function.

[0017] In some implementations, the shaft defines a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and / or (ii) a second coupling fixed to a proximal end of the distal segment. In some implementations, the second coupling is shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, e.g., during delivery and / or deployment of the implant to the heart.

[0018] In some implementations, a tether serves as a rail along which the primary segment is retracted and advanced. In some implementations, the tether is kept under tension as the shaft's primary segment is advanced and retracted. In some implementations, tension on the tether is reduced while the primary segment remains retracted from the distal segment, in order to facilitate assessment of the implant's effect upon the heart's function.

[0019] In some implementations, the delivery tool comprises an extracorporeal handle to which the tether's proximal end portion is moored. In some implementations, the handle can be operated to advance and retract the shaft's primary segment along the tether (e.g., while keeping the tether under tension), with respect to the shaft's distal segment. In some implementations, the handle can also be operated to advance (i) the tether's proximal end portion and (ii) the shaft's primary segment (e.g., in tandem) with respect to the shaft's distal segment. For example, advancing the tether's proximal end portion and the shaft's primary segment with respect to the shaft's distal segment can reduce tension on the tether, thereby facilitating assessment of the implant's effect upon the heart's function.Attorney Docket No: TMTTMC-23775WO01

[0020] In accordance with some implementations, a system and / or an apparatus for use with tissue of a heart of a subject (e.g., a living subject, a simulation, etc.) includes one or more of an implant, an anchor, and / or a delivery tool.

[0021] In some implementations the delivery tool may include: (a) a handle assembly, (b) a catheter, extending distally from the handle assembly, and configured for transluminal advancement to the heart, (c) a shaft extending from the handle assembly distally through the catheter.

[0022] In some implementations, the shaft may have: a primary segment, a distal segment, and / or a connector, including (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment.

[0023] In some implementations, the second coupling may be shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment.

[0024] In some implementations, a tether may extend from the handle assembly distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling.

[0025] In some implementations, the delivery tool may include an anchor driver, extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and / or configured to anchor the implant to the tissue by driving the anchor out of the shaft and into the tissue.

[0026] In some implementations, the handle assembly may include a handle (e.g., a first handle, a distal handle, an unsheathing handle, a relative motion handle, a retraction handle, an advancement handle, etc.) fixed to a proximal end of the catheter. In some implementations, the handle includes a controller (e.g., a first controller, a distal controller, an unsheathing controller, a relative motion controller, a retraction controller, an advancement controller, etc.), operably coupled to the catheter such that operation of the controller retracts the catheter from over the implant, the distal segment, and the first coupling.Attorney Docket No: TMTTMC-23775WO01

[0027] In some implementations, the handle assembly may include a handle (e.g., a second handle, a proximal handle, a coupling control handle, a coupling handle, a connection handle, a testing handle, etc.) disposed proximally from the first handle. In some implementations, the second handle defines a mooring to which a proximal end portion of the tether is fixed. In some implementations, the second handle includes a controller (e.g., a second controller, proximal controller, a coupling controller, a coupling control controller, a connection controller, a testing controller, etc.) that is operably coupled to the shaft. In some implementations, the controller (e.g., second controller, coupling control controller, etc.) is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and / or (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0028] In some implementations, at least one of the implant, the anchor, and the delivery tool is sterile.

[0029] In some implementations, the second controller is operable to, prior to remating the first coupling with the second coupling, increase tension on the tether.

[0030] In some implementations, the delivery tool is configured such that tension on the tether facilitates unmating the first coupling from the second coupling.

[0031] In some implementations, the second handle (or coupling control handle, proximal handle, etc.) further defines: a rail, and / or a handle-shaft interface to which the primary segment is fixedly coupled. In some implementations, the second handle (e.g., proximal handle, coupling control handle, etc.) is operable to slide the handle-shaft interface along the rail, with respect to the mooring.

[0032] In some implementations, second controller (e.g., proximal controller, coupling controller, etc.) is operable to (i) unmate the first coupling from the second coupling and (ii) remate the first coupling with the second coupling. In some implementations, this can be done while (a) the implant remains anchored to the tissue, and (b) the implant remains coupled to the distal segment of the shaft. In some implementations, unmating and / orAttorney Docket No: TMTTMC-23775WO01remating the first and second couplings involves sliding the primary segment along the tether, with respect to the distal segment, while maintaining tension on the tether.

[0033] In some implementations, the handle assembly is configured such that the second handle (e.g., proximal handle, coupling control handle, etc.) is slidable with respect to the first handle (e.g., distal handle, unsheathing handle, etc.), in a manner that adjusts tension on the tether.

[0034] In some implementations, the handle assembly is configured such that sliding the second handle (e.g., proximal handle, coupling control handle, etc.) toward the first handle (e.g., distal handle, unsheathing handle, etc.) reduces tension on the tether.

[0035] In some implementations, the second handle (e.g., proximal handle, coupling control handle, etc.) is slidable toward the first handle (e.g., distal handle, unsheathing handle, etc.), in a manner that adjusts tension on the tether, without adjusting a position of the distal segment of the shaft.

[0036] In some implementations, the second handle (e.g., proximal handle, coupling control handle, etc.) is slidable toward the first handle (e.g., distal handle, unsheathing handle, etc.), in a manner that reduces tension on the tether, while the first coupling is unmated from the second coupling.

[0037] In some implementations, the system further includes a support assembly, configured to support the handle assembly in a manner that facilitates adjusting tension on the tether.

[0038] In some implementations, the support assembly includes a track and a foot, configured to facilitate adjusting tension on the tether by, while the handle assembly is positioned along the track, operating the foot to slide the second handle (e.g., proximal handle, coupling control handle, etc.) toward the first handle (e.g., distal handle, unsheathing handle, retraction / advancement handle, etc.).

[0039] In some implementations, the anchor defines a helical tissue-engaging element that extends distally from an anchor head. In some implementations, the anchor head is shaped to define a forward -torque face and a reverse-torque face.Attorney Docket No: TMTTMC-23775WO01

[0040] In some implementations, the anchor driver defines a driveshaft, and a drive head at a distal end of the driveshaft. In some implementations, the drive head is shaped such that: while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a forward rotational direction screws the tissueengaging element into the tissue by applying forward torque to the forward -torque face. In some implementations, rotation of the drive head in a reverse rotational direction: hooks the drive head onto the anchor head in a manner that facilitates tensioning of the driveshaft while the drive head remains in contact with the anchor head, and / or unscrews the tissueengaging element from the tissue by applying reverse torque to the reverse-torque face while the drive head remains hooked onto the anchor head and the driveshaft is under tension, In some implementations, tensioning the driveshaft while the drive head is not hooked onto the anchor head pulls the drive head away from the anchor head.

[0041] In some implementations, the reverse-torque face of the anchor head is configured to hook the drive head in a manner that maintains contact between the anchor head and the drive head while the driveshaft is under tension.

[0042] In some implementations, the forward -torque face of the anchor head defines a smooth face that is closer to being perpendicular to the forward torque than to being parallel to the forward torque.

[0043] In some implementations, the anchor driver is configured to (i) screw the tissueengaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and / or (iv) disengage from the anchor head, without any change of conformation of the anchor head.

[0044] In some implementations, the anchor driver is configured to (i) screw the tissueengaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and / or (iv) disengage from the anchor head, without any change of conformation of the drive head.

[0045] There is further provided, in accordance with some implementations, a method for use at a heart of a subject, the method including one, some, or all of: (a) transluminally advancing a distal segment of a shaft of a delivery tool to the heart, the shaft having a primary segment mated to the distal segment, the delivery tool further including a catheter,Attorney Docket No: TMTTMC-23775WO01(b) to tissue at a site of the heart, anchoring an implant that is coupled to the distal segment of the shaft, by using an anchor driver that extends through the shaft to drive an anchor into tissue at the site; and / or (c) subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant. In some implementations, disassociating the primary segment from the implant includes: (i) disengaging the anchor driver from the anchor, and / or (ii) unmating the primary segment from the distal segment by retracting the primary segment proximally through the catheter, with respect to the distal segment.

[0046] In some implementations, the method also includes subsequently to the step of disassociating, remating the primary segment to the distal segment. In some implementations, this is done by advancing the primary segment distally through the catheter toward the distal segment.

[0047] In some implementations, the method also includes, while the primary segment remains remated with the distal segment: (i) uncoupling the distal segment from the implant, (ii) retracting the shaft from the implant, and / or (iii) withdrawing the delivery tool from the subject.

[0048] In some implementations, the method further includes sterilizing the delivery tool, the implant and the anchor.

[0049] In some implementations: the primary segment defines a shaft-axis; and / or the step of unmating includes unmating the primary segment of the shaft from the distal segment of the shaft in a manner that increases a deflectability of the distal segment and the implant with respect to the shaft-axis.

[0050] In some implementations: the delivery tool includes a handle, operably coupled to the catheter, and / or the method further includes operating the handle to retract the catheter from over the implant and the distal segment.

[0051] In some implementations, disengaging the anchor driver from the anchor further includes retracting the anchor driver into the primary segment.Attorney Docket No: TMTTMC-23775WO01

[0052] In some implementations, advancing includes transluminally advancing the distal segment of the shaft to the heart, while the shaft is housed within a distal part of the catheter.

[0053] In some implementations: the distal segment of the shaft bifurcates into a first branch and a second branch, and / or advancing includes transluminally advancing the distal segment of the shaft to the heart, while the first and second branches are arranged in parallel within the distal part of the catheter.

[0054] In some implementations, the method further includes deploying the implant from the catheter by proximally retracting the distal part of the catheter over the implant and the distal segment of the shaft, such that the first and second branches become skewed with respect to each other.

[0055] In some implementations, the step of deploying is prior to the step of anchoring.

[0056] In some implementations: the anchor is a first anchor, the anchor driver is a first anchor driver, and / or the method further includes using a second anchor driver that extends through the shaft to drive a second anchor into tissue at the site.

[0057] In some implementations: the distal segment of the shaft bifurcates into a first branch and a second branch; and / or disengaging the anchor driver from the anchor further includes retracting each anchor driver from a respective one of the first and second branches, into the primary segment of the shaft.

[0058] In some implementations: the distal segment of the shaft bifurcates into a first branch and a second branch. In some implementations, the step of anchoring includes anchoring the implant, that is coupled to each of the first branch and the second branch, using the first and second anchor drivers that: extend in parallel through the primary segment of the shaft, and / or diverge into the first and second branches to drive the first and second anchors into tissue at the site.

[0059] In some implementations, the step of anchoring includes anchoring the implant, that is coupled to each of the first branch and the second branch, using the first and second anchor drivers that: extend in parallel through the primary segment of the shaft, and / orAttorney Docket No: TMTTMC-23775WO01diverge into the first and second branches to simultaneously drive the first and second anchors into tissue at the site.

[0060] In some implementations: the shaft defines a connector, including (i) a first coupling fixed to a distal end of the primary segment, and / or (ii) a second coupling fixed to a proximal end of the distal segment. In some implementations, the step of remating includes mating the first coupling with the second coupling to provide a rigid connection between the primary segment and the distal segment.

[0061] In some implementations, a tether extends distally through the primary segment and the distal segment such that subsequently to the step of anchoring and while the implant remains coupled to the distal segment of the shaft: the step of unmating includes retracting the primary segment proximally, along the tether, with respect to the distal segment, and / or the step of remating includes advancing the primary segment distally, along the tether, toward the distal segment.

[0062] In some implementations, while a proximal portion of the delivery tool is supported by a support assembly including a track and a foot, the steps of unmating and remating include, while the proximal portion of the delivery tool is positioned alongthe track, operating the foot to slide the primary segment over and along the tether.

[0063] In some implementations: a proximal end portion of the tether is fixed to a handle. In some implementations, a distal end portion of the tether is fixed to the distal segment, such that subsequently to the step of anchoring, while the implant remains coupled to the distal segment of the shaft, the step of unmating does not include reducing tension on the tether between the proximal end portion and the distal end portion.

[0064] In some implementations: a proximal end portion of the tether is fixed to a handle. In some implementations, the method further includes, subsequently to the step of anchoring, applying tension to the tether via the handle.

[0065] In some implementations, the step of remating includes, while applying tension to the tether via the handle, advancing the primary segment distally, along the tether, toward the distal segment.Attorney Docket No: TMTTMC-23775WO01

[0066] In some implementations, the method further includes, subsequently to the step of unmating, reducing tension on the tether.

[0067] In some implementations, reducing tension includes reducing tension on the tether by advancing the handle distally with respect to the distal segment.

[0068] In some implementations, the step of reducing tension is prior to the step of remating.

[0069] In some implementations, the handle is fixedly coupled to the primary segment of the shaft. In some implementations, the step of reducing tension includes advancing (i) the primary segment of the shaft and (ii) the proximal end portion of the tether, toward the distal segment of the shaft.

[0070] In some implementations, the handle is a first handle (e.g., distal handle, unsheathing handle, advancement / retraction handle, etc.). In some implementations, a second handle (e.g., proximal handle, coupling control handle, coupling handle, etc.) is operably coupled to the catheter, wherein reducing tension includes reducing tension on the tether by reducing a distance between the first handle and the second handle.

[0071] In some implementations, the first handle is a proximal handle. In some implementations, the second handle is a distal handle. In some implementations, the method further includes operating the distal handle to retract the catheter from over the implant and the distal segment.

[0072] In some implementations, reducing tension includes reducing tension on the tether by advancing the proximal handle toward the distal handle.

[0073] In some implementations, the method further includes, prior to the step of remating, testing functionality of the heart.

[0074] In some implementations, the site is a first site of the heart. In some implementations, the method further includes, responsively to the tested functionality, and subsequently to the step of remating: reengaging the anchor driver to the anchor, retracting the anchorfrom the tissue into the shaft, usingthe shaft, advancing the implant to a second site of the heart. In some implementations, the method includes, using the anchor driver,Attorney Docket No: TMTTMC-23775WO01anchoring the implant to tissue at the second site by driving the anchor into tissue at the second site.

[0075] In some implementations, the method further includes, while the implant is anchored to tissue at the second site, repeating the step of testing.

[0076] In some implementations: the engagement between the anchor driver and the anchor is between: a drive head defined by the anchor driver, and / or an anchor head of the anchor. In some implementations, the anchor head is shaped to define: a forward-torque face, and a reverse-torque face. In some implementations, the steps of disengaging and reengaging do not include changing a shape or a conformation of the drive head or the anchor head.

[0077] In some implementations, the drive head is disposed at a distal end of a driveshaft of the anchor driver. In some implementations, the anchor defines a helical tissueengaging element extending distally from the anchor head. In some implementations, driving the anchor into the tissue includes, while compressing the driveshaft, screwing the tissue-engaging element into the tissue by applying forward torque from the drive head to the forward -torque face of the anchor head. In some implementations, retracting the anchor from the tissue into the shaft includes, while tensioning the driveshaft, retracting the tissueengaging element from the tissue by applying reverse torque from the drive head to the reverse-torque face of the anchor head.

[0078] In some implementations, applying reverse torque from the drive head to the reverse-torque face includes hooking the drive head onto the anchor head by rotating the anchor driver in a reverse rotational direction, while pulling the anchor proximally using the drive head hooked onto the anchor head.

[0079] In some implementations, the step of hooking includes hooking the drive head onto the anchor head by sliding the drive head proximally with respect to the anchor head, while rotating the anchor driver in the reverse rotational direction.

[0080] In accordance with some implementations, a method for use at a heart (e.g., a simulated heart, a living heart, etc.) of a subject (e.g., a living subject, a simulation, etc. includes transluminally advancing a distal segment of a shaft of a delivery tool to the heart.Attorney Docket No: TMTTMC-23775WO01In some implementations, the shaft has a primary segment mated to the distal segment. In some implementations, the delivery tool further includes a catheter. In some implementations, the method further includes anchoring to tissue at a site of the heart an implant that is coupled to the distal segment of the shaft. In some implementations, the anchoring is done by using an anchor driver that extends through the shaft to drive an anchor (e.g., at least one anchor, a first anchor, one or more anchors, etc.) into tissue at the site.

[0081] In some implementations, the method further includes, subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant by: (i) disengaging the anchor driver from the anchor, and / or (ii) unmating the primary segment from the distal segment by retracting the primary segment proximally through the catheter, with respect to the distal segment.

[0082] In some implementations, the method further includes, subsequently to the step of disassociating, remating the primary segment to the distal segment by advancing the primary segment distally through the catheter toward the distal segment.

[0083] In some implementations, the method further includes one or more of, while the primary segment remains remated with the distal segment: (i) uncoupling the distal segment from the implant, (ii) retracting the shaft from the implant, and / or (iii) withdrawing the delivery tool from the subject.

[0084] In accordance with some implementations, a system and / or an apparatus for use with a valve of a heart of a subject includes an implant. The valve can include a first leaflet and an opposing leaflet. The heart can have a chamber upstream of the valve.

[0085] In some implementations, the implant includes a wing. In some implementations, the wing can have a long axis extending from a root portion of the wing to a tip portion of the wing. In some implementations, the wing can additionally or alternatively have a contact face. In some implementations, the contact face defines, along the long axis, a contour that defines: a first concave region at the root portion, a flat portion between the root portion and the tip portion, and / or a second concave region at the tip portion.Attorney Docket No: TMTTMC-23775WO01

[0086] In some implementations, the wing may include, at the root portion, an interface configured to be anchored to a site upstream of the valve, such that the wing extends, away from the interface, and over the first leaflet toward the opposing leaflet, with the contact face facing the first leaflet.

[0087] In some implementations, the implant is sterile.

[0088] In some implementations, the root portion is stiffer than the flat portion. In some implementations, the root portion is stiffer than the tip portion. In some implementations, the flat portion is stiffer than the tip portion.

[0089] In some implementations, the flat portion has a greater length than the root portion. In some implementations, the flat portion has a greater length than the tip portion.

[0090] In some implementations, the flat portion has a greater length than a combined length of the root portion and the tip portion.

[0091] In some implementations, the first concave region is symmetrical to the second concave region.

[0092] In some implementations, a length of the flat portion is greater than a width of the wing.

[0093] In some implementations, the wing includes a flexible frame that provides mechanical support to the wing.

[0094] In some implementations, the wing includes a flexible sheet disposed over the frame.

[0095] In some implementations, the flexible sheet includes a polymer.

[0096] In accordance with some implementations, a system for use at tissue of a subject includes an implant including a first interface and a second interface; and / or a delivery tool.

[0097] In some implementations, the delivery tool can include a catheter, transluminally advanceable to the tissue. In some implementations, the delivery tool can include a shaft extending distally through the catheter. In some implementations, a distal part of the shaft bifurcates into a first branch and a second branch. In some implementations, the deliveryAttorney Docket No: TMTTMC-23775WO01tool can also include a cord, extending from a proximal portion of the delivery tool, distally through the catheter.

[0098] In some implementations, the system defines a first coupling and a second coupling, each of the first and second branches being fastened to a corresponding interface via a respective one of the first and second couplings.

[0099] In some implementations, each of the couplings defining: a window, a tab, protruding through the window, and / or a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0100] In some implementations, the cord is connected to the detent of the first coupling and to the detent of the second coupling, such that proximalward pulling of the cord unfastens the first and second branches from the first and second interfaces by pulling the detent of each of the first and second couplings out of its respective tab.

[0101] In some implementations, the implant and the delivery tool are sterile.

[0102] In some implementations, the unfastening facilitates pulling the shaft proximally with respect to the implant.

[0103] In some implementations, respective ends of a single wire define each detent.

[0104] In some implementations, the wire is v-shaped and generally follows the shape of the branches, from the bifurcation of the shaft to a distal end portion of each branch.

[0105] In some implementations, the cord is connected to a bight of the wire at a vertex of the v-shape of the wire.

[0106] In some implementations, the delivery tool includes a handle at a proximal portion of the delivery tool, the handle operable to pull the detent of each of the first and second couplings out of its respective tab.

[0107] In some implementations, the handle is operable to simultaneously pull the detent of each of the first and second couplings out of its respective tab.

[0108] In some implementations, the system further includes a first anchor and a second anchor. In some implementations, the system includes a first anchor driver, extending distally through the shaft, and into the first branch where a drive head of the first driver isAttorney Docket No: TMTTMC-23775WO01engaged with the first anchor. In some implementations, the system includes a second anchor driver, extending distally through the shaft alongside the first anchor driver, and into the second branch where a drive head of the second anchor driver is engaged with the second anchor.

[0109] In some implementations, the first anchor driver is configured to anchor the first interface to the tissue by driving the first anchor distally through the first interface and into the tissue. In some implementations, the second anchor driver is configured to anchor the second interface to the tissue by driving the second anchor distally through the second interface and into the tissue.

[0110] In some implementations, the shaft includes: a primary segment, a distal segment, and / or a connector. In some implementations, the connector includes (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment. In some implementations, the second coupling is operable to: mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, unmate from the first coupling, and / or remate with the first coupling.

[0111] In some implementations, the connector is configured such that unmating the second coupling from the first coupling, while each branch is coupled to the corresponding interface, facilitates deflection of the second coupling and the implant, with respect to the primary segment of the shaft.

[0112] In some implementations, the distal part of the shaft bifurcates into the first branch and the second branch, distally from the connector.

[0113] In some implementations, each detent is configured to obstruct the tab from being withdrawn from the window during the unmating and remating of the first coupling with the second coupling.

[0114] In some implementations, the system is configured to inhibit proximalward pulling of the cord while the second coupling is unmated from the first coupling.Attorney Docket No: TMTTMC-23775WO01

[0115] In accordance with some implementations, a system for use at tissue of a subject (e.g., a living subject, a simulation, etc.) includes an implant including a first interface and a second interface. In some implementations, the system can further include a delivery tool.

[0116] In some implementations, the delivery tool includes a catheter, transluminally advanceable to the tissue. In some implementations, the delivery tool includes a cord, extending from a proximal portion of the delivery tool, distally through the catheter.

[0117] In some implementations, the system defines a coupling mechanism, fastened to the first and second interfaces. In some implementations, the coupling mechanism defines: a window, a tab, protruding through the window, and / or a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0118] In some implementations, the cord is connected to the detent of the coupling mechanism, such that proximalward pulling of the cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.

[0119] In some implementations: the delivery tool further includes a shaft extending distally through the catheter, a distal part of the shaft bifurcating into a first branch and a second branch, each of the first and second branches being fastened to a corresponding interface.

[0120] In some implementations, the coupling mechanism includes a first coupling and a second coupling. In some implementations, one or each of the first and second couplings define: a window, a tab, protruding through the window, and / or a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0121] In some implementations, the coupling mechanism includes a first coupling and a second coupling, the distal part of the shaft being fastened to a corresponding interface via a respective one of the first and second couplings.

[0122] In some implementations, the cord is connected to the detent such that proximalward pulling of the cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.Attorney Docket No: TMTTMC-23775WO01

[0123] In accordance with some implementations, a system for use at tissue of a subject (e.g., a living subject, a simulation, etc.) includes an implant and / or a delivery tool. In some implementations, the implant includes an interface.

[0124] In some implementations, the delivery tool includes a catheter, transluminally advanceable to the tissue. In some implementations, the delivery tool includes a cord extending from a proximal portion of the delivery tool distally through the catheter.

[0125] In some implementations, the system defines a coupling mechanism, fastened to the interface. In some implementations, the coupling mechanism defines: a window, a tab, protruding through the window, and / or a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0126] In some implementations, the cord is connected to the detent of the coupling mechanism, such that proximalward pulling of the cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.

[0127] In accordance with some implementations, a system for use at tissue of a subject (e.g., a living subject, a simulation, etc.) includes an implant including a first interface and a second interface. In some implementations, the system further includes a delivery tool.

[0128] In some implementations, the delivery tool includes a catheter, transluminally advanceable to the tissue. In some implementations, the delivery tool includes a shaft extending distally through the catheter. In some implementations, a distal part of the shaft bifurcates into a first branch and a second branch.

[0129] In some implementations, the system defines a first coupling and a second coupling, each of the first and second branches being fastened to a corresponding interface via a respective one of the first and second couplings.

[0130] In some implementations, one or both of the couplings define: a window, a tab, protruding through the window, and / or a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0131] In some implementations, pulling the detent of each of the first and second couplings out of its respective tab unfastens the first and second branches from the first and second interfaces.Attorney Docket No: TMTTMC-23775WO01

[0132] In accordance with some implementations, a system and / or an apparatus for use with tissue of a heart of a subject (e.g., a living subject, a simulation, etc.) includes one or more of an implant, an anchor, and / or a transluminal delivery tool.

[0133] In some implementations, the delivery tool includes a handle. In some implementations, a shaft extends distally from the handle. In some implementations, the shaft has a primary segment and / or a distal segment.

[0134] In some implementations, the delivery tool comprises a connector, including (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment.

[0135] In some implementations, the delivery tool comprises a tether extending from the handle distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling.

[0136] In some implementations, the delivery tool comprises an anchor driver, extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and configured to anchor the implant to the tissue by driving the anchor out of the shaft and into the tissue.

[0137] In some implementations, the handle defines a mooring to which a proximal end portion of the tether is fixed.

[0138] In some implementations, the handle includes a controller that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0139] In some implementations, the delivery tool includes a catheter, extending distally from the handle. In some implementations, a shaft extends from the handle distally through the catheter.Attorney Docket No: TMTTMC-23775WO01

[0140] In some implementations, the handle is a first handle (e.g., distal handle, unsheathing handle, retraction / advancement handle, etc.) of a handle assembly. In some implementations, the first handle is fixed to a proximal end of the catheter. In some implementations, the first handle includes a controller. In some implementations, the controller is operably coupled to the catheter such that operation of the controller (e.g. distal controller, unsheathing controller, retraction / advancement controller, etc.) at least one of (1) retracts the catheter from over the implant, the distal segment, and / or the first coupling, and / or (2) advances the implant, the distal segment, and / or the first coupling out of the catheter.

[0141] In some implementations, the handle assembly further includes a second handle (e.g., proximal handle, coupling control handle, coupling handle, etc.). In some implementations, the second handle defines the mooring to which the proximal end portion of the tether is fixed.

[0142] In some implementations, the second handle includes a controller (e.g., proximal controller, coupling controller, etc.) that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0143] In accordance with some implementations, a system and / or an apparatus for use with tissue of a subject (e.g., a living subject, a simulation, etc.) includes a delivery tool, including a shaft extending distally from the handle. In some implementations, the shaft has a primary segment, a distal segment, and / or a connector.

[0144] In some implementations, the connector includes (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling.

[0145] In some implementations, the delivery tool comprises a tether extending from the handle distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling.Attorney Docket No: TMTTMC-23775WO01

[0146] In some implementations, the delivery tool comprises a controller that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling, and (ii) remate the first coupling with the second coupling.

[0147] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0148] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.

[0149] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0150] Figs. 1-5 are schematic illustrations showing an implant and a delivery tool for use with the implant, in accordance with some implementations; and

[0151] Figs. 6, 7A-I and 8A-D are schematic illustrations showing use of a system comprising the delivery tool and a support assembly, in accordance with some implementations.DETAILED DESCRIPTION OF EMBODIMENTS

[0152] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variantsAttorney Docket No: TMTTMC-23775WO01the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein may include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (e.g. any other variant of the element) having the same reference numeral, independent of any suffix.

[0153] In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements are introduced via one or more drawings and not explicitly identified in every other drawing that contains that element.

[0154] Reference is made to Fig. 1. which is a schematic illustration showing a perspective view of an implant 200, in accordance with some implementations.

[0155] In some implementations, implant 200 comprises a wing 220 that extends away from an interface 250 (e.g., a pair of interfaces, as shown). In some implementations, wing 220 comprises a flexible frame 224 (e.g., coupled to each interface 250 by clips 558) that provides mechanical support to the wing. In some implementations, wing 220 comprises a flexible sheet 225 (e.g., comprising a polymer) disposed over the frame.

[0156] In some implementations, and as shown, interfaces 250 are disposed at the wing's root portion 230, from which the wing extends along the wing's long axis to a tip portion 232 of the wing. In some implementations, and as shown, wing 220 has a contact face 222 and an opposing face 223. For example, and as shown, contact face 222 defines an at least partially concave contour along the long axis. That is, wing 220 can have an at least partially concave contour profile when viewed from a side of the wing that extends from root portion 230 to tip portion 232. Alternatively or in addition, contact face 222 can define a non-linear contour along a width of the wing (not shown).

[0157] In some implementations, and as shown, the contour defined by contact face 222 is not uniform. That is, not all portions of wing 220 are equally curved when viewed from the side. For example, and as shown, the wing's contact face 222 can define a first concave region 226 at root portion 230, a flat portion 227 between the root portion and tip portionAttorney Docket No: TMTTMC-23775WO01232, and a second concave region 228 at the tip portion. In some implementations, flat portion 227 and concave regions 226, 228 are dimensioned in order to fit the wing's contact face 222 to tissue of the heart, e.g., to a leaflet 12 of a mitral valve 10 of the heart.

[0158] In some implementations, the contact face's contour can facilitate using wing 220 to support leaflet 12 of a valve 10 of the heart. For example, and as described hereinbelow with reference to Figs. 7A-I, interface 250 can be anchored to a site upstream of valve 10 (e.g., at the valve's annulus 11) such that wing 220 extends away from the interface and over a first leaflet 12 and toward an opposing leaflet (not shown), such that contact face 222 faces the first leaflet.

[0159] In some implementations, the wing's regions 226, 227, 228 each have properties that facilitate supporting leaflet 12, e.g., in the case of the leaflet's flailing and / or regurgitation of blood through the valve. For example, regions 226, 227, 228 can have different degrees of flexibility. In some implementations, concave region 226 is stiffer than (i) flat portion 227 and / or (ii) concave region 228. For example, wing 220 can have progressively greater flexibility along the long axis, e.g., from root portion 230 to tip portion 232.

[0160] In some implementations, flat portion 227 is the main region of wing 220, e.g., most of the wing's length and / or area is defined by the flat region. In some implementations, flat portion 227 has a greater length along the long axis than at least one of the concave regions 226, 228. For example, flat portion 227 can have a greater length along the long axis than the combined length of both concave regions 226, 228. Alternatively or in addition, flat portion 227 can be longer than the wing is wide.

[0161] In some implementations, and as shown, wing 220 is shaped such that concave regions 226, 228 define a symmetrical contour of contact face 222. For example, concave regions 226, 228 can each have an equal degree of curvature and / or an equal length along the long axis.

[0162] Reference is made to Figs. 2-5, which are schematic illustrations showing perspective (Figs. 2, 4) and cross-sectional (Figs. 3, 5) views of a delivery tool 150 for use with implant 200, in accordance with some implementations. In some implementations, and as shown, delivery tool 150 comprises a shaft 160 that extends from the tool's proximalAttorney Docket No: TMTTMC-23775WO01portion 152, through a delivery catheter 140, to the tool's distal portion 154, e.g., at which the shaft's primary segment 167 extends distally from within the catheter's distal portion 144.

[0163] Fig. 2 shows tool 150 after implant 200 has been deployed from delivery catheter 140, e.g., by retracting the catheter's distal portion 144 proximally over implant 200 and the shaft's distal segment 163. In some implementations, and as shown in the inset of Fig. 2, tool 150 comprises a connector 480 that mates a proximal coupling 486, fixed to a distal end of the shaft's primary segment 167, to a distal coupling 488 that is fixed to a proximal end of the shaft's distal segment 163. In some implementations, and as shown couplings 486, 488 mate to provide a rigid connection between primary segment 167 and distal segment 163.

[0164] In some implementations, and as shown, the shaft's distal segment 163 is bifurcated into branches 161, e.g., distally from connector 480. In some implementations, branches 161 are disposed in parallel within catheter 140 (not shown) as the catheter is advanced to the heart, and the branches pivot away from each other (e.g., become skewed with respect to each other) as they are exposed from the catheter.

[0165] In some implementations, and as shown in the inset of Fig. 2, the shaft's distal segment 163 is coupled to interfaces 250 by a coupling mechanism 164 comprising tabs 165 of the distal segment (e.g., of each branch 161) that protrude through windows 252 in the distal end portion of each interface 250. Although the Figures illustrate an embodiment in which windows 252 are defined by interfaces, and tabs 165 are defined by the shaft's distal segment 163, alternative arrangements of coupling mechanism, e.g., in which the shaft's distal segment defines the windows, and the interfaces define the tabs, are contemplated.

[0166] In some implementations, and as shown, tabs 165 are fastened to windows 252 by distal ends 182 of a detent (e.g., respective distal ends 182 of a wire 180, as shown) that are threaded through the tabs. In some implementations, and as shown, wire 180 is v-shaped and generally follows the shape of branches 161, from the bifurcation of shaft 160 to a distal end portion of each branch.

[0167] In some implementations, implant 200 can be released from tool 150 by uncoupling the shaft's distal segment 163 from interfaces 250, e.g., by retracting the wire 180 from tabs 165. In some implementations, wire 180 is retracted extracorporeally byAttorney Docket No: TMTTMC-23775WO01pulling a release cord 184 proximally. For example, and as shown in the inset of Fig. 3, release cord 184 can be connected (e.g., tied by a knot 183) to a bight of wire 180 (e.g., at a vertex of the wire's v-shape). In this way, pulling extracorporeally on release cord 184 unfastens each branch 161 from an interface 250 by pulling the wire's distal ends 182 out from tabs 165. In some implementations, after pulling the wire's distal ends 182 out from the tabs 165, pulling shaft 160 proximally with respect to implant 200 (e.g., as described hereinbelow with reference to Fig. 71) releases each interface 250 from the corresponding branch 161.

[0168] In some implementations, and as shown in Fig. 3, release cord 184 is thinner and more flexible than wire 180. In this way, wire 180 can be sufficiently stiff to inhibit unintentional release from tabs 165, yet without adding stiffness to shaft 160, e.g., to primary segment 167 thereof. In some implementations, release cord 184 comprises a suture or other suitable material. In this way, release cord 184 can contribute less bulk or stiffness to shaft 160 and / or catheter 140 than if wire 180 were to extend proximally from coupling mechanism 164, through the shaft and to the tool's proximal portion 152.

[0169] In some implementations, and as shown in Fig. 2, the tool's proximal portion 152 comprises a handle assembly 120 that facilitates unfastening each branch 161 from interface 250 by pulling the wire's distal ends 182 out from tabs 165. In some implementations, handle assembly comprises a release button 186 (Figs. 2, 5) that is used to pull the wire's distal ends 182 out from tabs 165. For example, release button 186 may pull release cord 184 proximally when depressed, and / or may uncouple the release cord from handle assembly 120, thereby allowing the user to manually pull the release cord.

[0170] In accordance with some implementations, Fig. 3 shows couplings 486, 488 being reversibly mated (upper frame) and unmated (lower frame). In this way, connector 480 can repeatedly transition from rigidly connecting the shaft's primary segment 167 to the shaft's distal segment 163 (upper frame), to distancing proximal coupling 486 from distal coupling 488, e.g., in order to allow the distal coupling and implant 200 to deflect with respect to the shaft's primary segment 167 (e.g., as described hereinbelow with reference to Figs 7F).

[0171] In some implementations, and as shown in Fig. 3, a tether 490 extends distally through the shaft's primary segment 167 and the connector 480 (e.g., via a tether-lumenAttorney Docket No: TMTTMC-23775WO01496 thereof, to a distal portion of distal coupling 488). In some implementations, tether 490 facilitates mating and unmating of couplings 486, 488, e.g., by serving as a rail along which proximal coupling 486 is retracted and advanced. For example, and as shown, tether 490 can remain under tension as proximal coupling 486 is retracted, e.g., such that respective mating faces 485, 487 of the couplings continue to face each other, even when separated (bottom frame). In some implementations, tension on tether 490 helps to maintain couplings 486, 488 in a desirable orientation for remating.

[0172] In some implementations, and as shown in Figs. 2 and 4-5, handle assembly 120 comprises a proximal handle 122 and a distal handle 132. In some implementations, handles 122, 132 each have respective functions, e.g., operating distal handle 132 (e.g., unsheathing handle, retraction / advancement handle, etc.) by rotating the distal handle's dial 133 can deploy implant 200 by retracting catheter 140 proximally over distal segment 163 and implant 200 (or advancing the distal segment and implant out of the catheter), whereas operating proximal handle 122 (e.g., coupling control handle, coupling handle, etc.) by rotating the proximal handle's knob 124 can advance and retract primary segment 167 and proximal coupling 486, as described hereinbelow.

[0173] In some implementations, and as shown, handle assembly 120 is configured to actively steer the tool's distal portion 154, e.g., the delivery catheter's distal portion 144. In some implementations, and as shown, handle assembly 120 (e.g., distal handle 132, as shown) comprises a steering control element such as knob 134 that is operatively coupled to one or more pull-wires (not shown) that are connected to the delivery catheter's distal portion 144. For example, rotating knob 134 in one direction can pull one of the pull-wires, thereby steering the catheter's distal portion in a first direction, and rotating the knob in an opposite direction can pull another of the pull-wires, thereby steering the catheter's distal portion in an opposite direction.

[0174] Figs. 4 and 5 show perspective and cross-sectional views of handle assembly 120. In some implementations, and as shown, a pair of drivers 170 (e.g., driveshafts 174 thereof) extend through handle assembly 120 and proximally out of the handle assembly, (e.g., through driver sleeves 175) to driver handles 176 that are exposed for manual manipulation (e.g., rotation) thereof. In some implementations, and as described hereinbelow withAttorney Docket No: TMTTMC-23775WO01reference to Figs. 7A-B, rotating handles 176 while anchor heads 172 engage anchors 30 can drive the anchors into heart tissue.

[0175] In some implementations, and as shown in Fig. 5, a proximal end portion 492 of tether 490 is fixed to a mooring 491 of proximal handle 122 (e.g., withing the proximal handle's housing 121). In this way, mooring 491 serves as a point of reference to which the tether's proximal end portion 492 is fixed, and in relation to which primary segment 167 and proximal coupling 486 can be advanced and retracted over tether (Fig. 3).

[0176] In some implementations, the shaft's primary segment 167 passes longitudinally through handle assembly 120. In some implementations, and ss shown in the insets of Figs.4-5, tether 490 (e.g., two lengths of the tether) and release cord 184 each pass through the shaft's primary segment 167, from within handle assembly 120 to the delivery tool's distal portion 154.

[0177] In some implementations, primary segment 167 of shaft 160 is fixedly coupled to a portion of proximal handle 122. In some implementations, and as shown in left inset of Fig.4, primary segment 167 is fixed to (e.g., embedded within and / or glued to) a handle-shaft interface 128. For example, and as shown in the inset of Fig. 5, handle-shaft interface 128 is enclosed within the proximal handle's housing 121. For example, and as shown in Figs. 4-5, proximal handle 122 can define a rail 126 along which rotating proximal knob 124 slides handle-shaft interface 128 and primary segment 167 (to which proximal coupling 486 is fixed) along: (i) tether 490 with respect to mooring 491, and (ii) release cord 184 with respect to release button 186.

[0178] In some implementations, in addition to advancing and retracting handle-shaft interface 128 and primary segment 167, with respect to mooring 491 over tether 490, handle assembly is also configured to advance both the tether's mooring and the shaft's primary segment 167 with respect to distal coupling 488. In some implementations and as described hereinbelow with reference to Fig. 7E, this is accomplished by sliding proximal handle 122 with respect to distal handle 132. For example, sliding proximal handle 122 can advance and retract the shaft's primary segment 167 and proximal coupling 486 with respect to distal coupling 488. In some implementations, and as shown in the right inset of Fig. 4,Attorney Docket No: TMTTMC-23775WO01sliding proximal handle 122 can slide primary segment 167 through a washer 137 disposed within distal handle 132.

[0179] In some implementations, and as shown in Fig. 5, handle assembly 120 comprises a tension-adjustment mechanism 130 that is manipulated to slide the shaft's primary segment 167, together with proximal handle 122 with respect to distal handle 132, e.g., by sliding slide proximal handle 122 with respect to distal handle 132. In some implementations, and as shown in the inset of Fig. 5, tension-adjustment mechanism 130 is disposed between proximal handle 122 and distal handle 132, and is coupled to proximal handle 122.

[0180] In some implementations, since mooring 491 fixes the proximal end portion 492 of tether 490 to proximal handle 122, sliding tension-adjustment mechanism 130 distally adjusts e.g., reduces) tension on the tether. In some implementations, tension-adjustment mechanism 130 can reduce tension on tether 490 while proximal coupling 486 is unmated from distal coupling 488, as described hereinbelow with respect to Fig. 7E, thereby adjusting tension on the tether without adjusting a position of the shaft's distal segment 163, or of implant 200.

[0181] Reference is made to Figs. 6, 7A-I and 8A-D, which are schematic illustrations showing use of a system 100 comprising delivery tool 150 and a support assembly 610 to implant implant 200, in accordance with some implementations.

[0182] In some implementations, support assembly 610 comprises a pedestal 611, e.g., defining a track 612 on which delivery tool 150 is mounted. In some implementations, assembly 610 facilitates operation of delivery tool 150, e.g., via one or more feet 615, 616, 617, some or all of which can be operated to advance and / or retract along track 612. For example, operating a control e.g., spinning a dial 613) can advance or retract one or more of feet 615, 616, 617. Alternatively or in addition, assembly 610 can be operated to (i) steer the delivery catheter's distal portion 144 (e.g., by operating the handle assembly's knob / controller 134), (ii) mate and unmate the connector's couplings 486, 488 (e.g., by adjusting the proximal handle's knob 124) and / or (iii) deploy implant 200 from within catheter 140, e.g., by operating the distal handle's dial 133.Attorney Docket No: TMTTMC-23775WO01

[0183] In some implementations, a distal foot 615 grasps (e.g., by a clip 614) a portion of distal handle 132 and / or the delivery catheter's proximal portion 142, e.g., such that holding the distal foot stationary on track 612 holds the proximal handle in place as other parts of handle assembly 120 are slid in relation thereto.

[0184] In some implementations, and as shown, a middle foot 616 supports tensionadjustment mechanism 130 (e.g., grasps the tension-adjustment mechanism by a clip 619), such that advancing or retracting the middle foot can adjust tension on tether 490 by distally advancing the tension-adjustment mechanism.

[0185] In some implementations, a proximal foot 617 (e.g., not comprising a clip) supports proximal handle 122 in a manner that facilitates advancing and retracting the proximal handle. For example, and as shown below in Figs. 7D-H, proximal foot 617 can act as a platform that supports proximal handle 122 and allows the proximal handle to slide thereupon. Alternatively, proximal foot 617 may advance and retract along track 612 in concert with the proximal handle, e.g., proximal handle 122 can be advanced and retraced by operating the proximal foot.

[0186] In accordance with some implementations, Figs. 7A-I and 8A-D show use of system 100 to implant implant 200 to tissue 3 of an annulus 11 of a valve 10, e.g., a mitral valve of the heart. In accordance with some such implementations, the delivery tool's proximal portion 152 (e.g., handle assembly 120 thereof) is shown supported by support assembly 610 while the delivery tool's distal portion 154 is disposed at valve 10.

[0187] In accordance with some implementations, Fig. 7A shows the tool's proximal portion 152 in a starting state, in which a portion of the shaft's primary segment 167 is visible between tension-adjustment mechanism 130 and distal handle 132. In accordance with some such implementations, Fig. 7A shows shaft 160 having been transluminally advanced to the heart, e.g., within delivery catheter 140. For example, Fig. 7A shows the shaft's distal segment 163 having seated implant 200 at annulus 11, such that root portion 230 abuts annulus 11 and wing 220 extends over leaflet 12 (e.g., a posterior leaflet of the mitral valve) toward an opposite leaflet (e.g., an anterior leaflet of the mitral valve, not shown). In some implementations, wing 220 is positioned such that the wing's tip portion 232 is adjacent (e.g., coapts with and / or facilitates the posterior leaflet 12 coapting with) anAttorney Docket No: TMTTMC-23775WO01opposite leaflet during ventricular systole. For example, coaptation between the leaflets and / or wing 220 can help reduce regurgitation of blood from ventricle 8 to atrium 6.

[0188] In accordance with some implementations, the inset of Fig. 7A shows driver 170 having been advanced such that driveshaft 174 passes through handle assembly 120, shaft 160 and the shaft's distal segment 163 (e.g., a branch 161 thereof). In some implementations, a pair of drivers 170 (see the pair of driver handles 176 in Figs. 2, 4 and 6) are advanced in parallel through shaft 160, until the shaft's bifurcation, at which point the drivers each advance into a respective branch 161. In this way, each of the drivers 170 can simultaneously drive an anchor 30 through one of the implant's interfaces 250 and into tissue 3.

[0189] In some implementations, and as shown in the inset of Fig. 7B, drive head 172 defines a smooth, forward-facing driver screw-in surface 540 (e.g., shaped complementarity to the anchor head's forward -torque face 542), and a reverse-facing driver hook 544 (e.g., shaped complementarily to an anchor hook 547 defined by the anchor head's reversetorque face 546). In some implementations, and as shown, smooth forward -torque face 542 is closer to being perpendicular to the forward torque than to being parallel to the forward torque.

[0190] Fig. 7B shows the torque having driven anchor 30 (e.g., having screwed the anchor's tissue-engaging element 34) through interface 250 into tissue 3 of annulus 11, thereby securing the wing's root portion 230 to the annulus. In some implementations, and as shown, the driver's drive head 172 is engaged to the anchor's anchor head 32. such that rotating the driver's handle 176 transfers torque, via driveshaft 174, drive head 172 and anchor head 32 (e.g., forward -torque face 542 thereof), to the anchor's helical tissueengaging element 34.

[0191] In some implementations, and as shown in the inset of Fig 7C, driver 170 is then retracted proximally, e.g., into the shaft's primary segment 167. In some implementations, and as shown, tensioning driveshaft 174 while drive head 172 is not hooked onto the anchor head 32 pulls the drive head away from the anchor head, e.g., exposing a portion of driver sleeve 175 (upper view of Fig. 7C) as each anchor driver 170 is retracted through a respective branch 161 and into the shaft's primary segment 167.Attorney Docket No: TMTTMC-23775WO01

[0192] In accordance with some implementations, the upper view of Fig. 7D shows proximal handle 122 having been operated by rotating knob 124 such that the handle's housing 121 and handle-shaft interface 128 slide the shaft's primary segment 167 proximally through distal handle 132 and catheter 140. In some implementations, and as shown, rotating knob 124 slides handle-shaft interface 128 proximally over rail 126, a portion of which becomes exposed from the proximal handle's housing 121.

[0193] In accordance with some implementations, the lower view of Fig. 7D shows a cross-sectional view of the tool's distal portion 154 in an open state, in which the shaft's primary segment 167 has pulled the connector's proximal coupling 486 proximally, thereby separating the proximal coupling from distal coupling 488, e.g., which remains fixed, via coupling mechanism 164, to implant 200. In accordance with some such implementations, driver 170 has been retracted proximally together with primary segment 167 and proximal handle 122, e.g., such that drive head 172 is at least partially disposed within proximal coupling 486 and / or primary segment 167.

[0194] In some implementations, and as shown, retracting proximal handle 122 applies and / or maintains tension on tether 490. In some implementations, and as described hereinabove, the tether's proximal end portion 492 is anchored to the proximal handle's housing 121 via mooring 491, such that retracting the tether's proximal end portion through the shaft's primary segment 167 applies tension to the tether. In some implementations, and as shown, release cord 184 is not fully tensioned (e.g., is slack) while the proximal coupling 486 is retracted, in order to reduce a risk of prematurely releasing coupling mechanism 164 (e.g., by unfastening wire 180 from the coupling mechanism's tabs 165) while the tool is in the open state.

[0195] In some implementations, handle assembly 120 includes a safety mechanism designed to prevent the user from unintentionally releasing coupling mechanism 164 (e.g., by pulling release cord 184) while tool 150 is in the open state. In some implementations, and as shown in the lower right inset of Fig. 7D, retracting proximal handle 122 to unmate proximal coupling 486 from distal coupling 488 slides a window 187 defined by the handle's housing 121 proximally with respect to release button 186, such that the release button is not disposed underneath the window and therefore becomes temporarily inaccessible to the user.Attorney Docket No: TMTTMC-23775WO01

[0196] In accordance with some implementations, the upper view of Fig. 7E shows tension-adjustment mechanism 130 having advanced distally, together with proximal handle 122 and primary segment 167, toward distal handle 132, e.g., such that the tensionadjustment mechanism abuts the distal handle. In some implementations, and as shown, tension-adjustment mechanism 130 is advanced by operating support assembly 610 (e.g., by rotating dial 613, Fig. 6) such that middle foot 616 slides the tension-adjustment mechanism distally.

[0197] In accordance with some implementations, the lower view of Fig. 7E shows that sliding tension-adjustment mechanism 130 distally has pushed primary segment 167 and the connector's proximal coupling 486 distally. In some implementations, and as shown, advancing tension-adjustment mechanism 130 distally has advanced primary segment 167 by a limited distance, e.g., such that proximal coupling 486 remains unmated from distal coupling 488. For example, advancing tension-adjustment mechanism 130 distally may advance primary segment 167 by less than half of the distance between couplings 486, 488.

[0198] In some implementations, and as described hereinabove with reference to Fig. 5, the tether's proximal end portion 492 and / or the release cord's proximal end portion 185 are fixed to proximal handle 122. In some implementations, and as shown, since the tether's proximal end portion 492 is fastened to proximal handle 122 via mooring 491, sliding the proximal handle distally reduces tension on tether 490. In some implementations, and as shown, since the release cord's proximal end portion 185 is fastened to proximal handle 122 via release button 186, sliding the proximal handle distally has further reduced tension on release cord 184.

[0199] In some implementations, and as shown in Fig. 7F, reducing tension on tether 490 and / or release cord 184 facilitates deflection of distal segment 163 and implant 200 with respect to the shaft's primary segment 167 (e.g., with respect to a shaft-axis defined by the primary segment). As shown, the slack in tether 490 and release cord 184 allow distal coupling 488 and implant 200 to reciprocatingly deflect, together with tissue of the valve's annulus 11 into which anchor 30 is anchored, during the cardiac cycle.

[0200] In some implementations, function of the heart (e.g., function of valve 10 at which implant 200 is implanted) is assessed by imaging bloodflow and / or tissue of the heartAttorney Docket No: TMTTMC-23775WO01as the implant deflects with the tissue. In this way, the user can assess the influence of implant 200 upon the valve's function while primary segment 167 is disassociated from the implant, yet before releasing the implant from delivery tool 150. Disassociating the shaft's primary segment 167 from implant 200 can reduce a degree to which the shaft supports tissue of valve 10, such that the assessment may more accurately predict the implant's influence upon the valve's function after withdrawal of delivery tool 150.

[0201] In some implementations, in the case that the user finds the influence of implant 200 upon the function of valve 10 to be satisfactory, the user can decide to uncouple the implant from delivery tool 150 and withdraw the delivery tool from the subject (Fig. 71 below). In some implementations, in the case that the user finds the influence of implant 200 upon the function of valve 10 to be suboptimal, the user can unscrew anchor 30 from annulus 11. For example, the user may choose to redeploy the implant to another site in the annulus (Figs. 8A-D). Alternatively, the user may choose to resheath the implant within catheter 140 and to remove the implant from the subject (not shown).

[0202] In some implementations, regardless of whether the user finds the influence of implant 200 upon the function of valve 10 to be satisfactory, the user remates primary segment 167 to distal segment 163 after assessing the influence of implant 200 upon the function of valve 10. In accordance with some implementations, Fig. 7G shows proximal portion 152 having been operated to increase tension upon tether 490. In accordance with some such implementations, the upper view of Fig. 7G shows middle foot 616 having been operated to slide tension-adjustment mechanism 130 proximally, thereby retensioning tether 490. In this way, tether 490 can serve as a rail over which proximal coupling 486 and primary segment 167 can be advanced toward distal coupling 488 (Fig. 7H).

[0203] In accordance with some implementations, the upper view of Fig. 7H shows proximal portion 152 having been operated to remate couplings 486, 488 of connector 480. In some implementations, and as shown, the proximal handle's knob or controller 124 has been rotated (e.g., in an opposite direction from that in which the knob was rotated in Fig.7D, in order to remate couplings 486, 488. In some implementations, and as shown, couplings 486, 488 can be remated while tension-adjustment mechanism 130 remains in its proximal position, e.g., while a portion of primary segment 167 is exposed between the tension-adjustment mechanism and distal handle 132.Attorney Docket No: TMTTMC-23775WO01

[0204] In some implementations, and as shown in Fig. 71, in the case that the imaging indicated satisfactory influence of implant 200 upon the function of valve 10, distal segment 163 of shaft 160 is unfastened from interfaces 250, e.g., by removing wire 180 from tabs 165. In some implementations, release cord 184 is pulled, e.g., by pushing release button 186, which was made reaccessible through window 187 by readvancing proximal handle 122 distally along rail 126, as shown in the lower right inset of Fig. 71. In some implementations, and as shown, after unfastening tabs 165 from windows 252, pulling shaft 160 proximally will remove tabs 165 from windows 252, such that distal portion 154 can be withdrawn proximally away from implant 200, e.g., and transluminally withdrawn from the subject.

[0205] In some implementations, in the case that the imaging indicated suboptimal influence of implant 200 upon the function of valve 10, rather than withdrawing delivery tool 150 as shown in Fig. 71, implant can be repositioned. In some implementations, and as shown, driver 170 is readvanced (Fig. 8A) until drive head 172 reengages anchor head 32 such that a partial reverse rotation of the drive head engages the anchor head to the drive head, e.g., such that the drive head's hook 544 hooks the anchor head's hook 547 (inset of Fig. 8B). In this way, rotating driver handle 176 in the reverse direction while the driveshaft 174 is kept under tension applies reverse torque to the anchor head's reverse-torque face 546 while pulling proximally upon anchor 30, thereby removing the anchor's tissue-engaging element 34 from the tissue (Fig. 8D).

[0206] In some implementations, implanting implant 200 can be an iterative process by which tool 150 is used to redeploy implant 200 to a second site in the heart, at which the anchors can be driven through interfaces 250 and into tissue at the second site, e.g., as described hereinabove with reference to Figs. 7A-L

[0207] Example Applications (some non-limiting examples of the concepts herein are recited below):

[0208] Example 1. A system and / or an apparatus for use with tissue of a heart of a subject, the system / apparatus comprising: an implant; an anchor; and a delivery tool, comprising: a handle assembly, a catheter, extending distally from the handle assembly, and configured for transluminal advancement to the heart, a shaft extending from the handle assembly distally through the catheter, and having: a primary segment, a distal segment, andAttorney Docket No: TMTTMC-23775WO01a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, a tether extending from the handle assembly distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling, and an anchor driver, extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and configured to anchor the implant to the tissue by driving the anchor out of the shaft and into the tissue, wherein the handle assembly comprises: a first handle: fixed to a proximal end of the catheter, and comprising a first controller, operably coupled to the catheter such that operation of the first controller retracts the catheter from over the implant, the distal segment, and the first coupling; and a second handle: disposed proximally from the first handle, defining a mooring to which a proximal end portion of the tether is fixed, and comprising a second controller that is operably coupled to the shaft such that the second controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0209] Example 2. The system / apparatus according to example 1, wherein at least one of the implant, the anchor, and the delivery tool is sterile.

[0210] Example 3. The system / apparatus according to any one of examples 1-2, wherein the second controller is operable to, prior to remating the first coupling with the second coupling, increase tension on the tether.

[0211] Example 4. The system / apparatus according to any one of examples 1-3, wherein the delivery tool is configured such that tension on the tether facilitates unmating the first coupling from the second coupling.

[0212] Example 5. The system / apparatus according to example 4, wherein: second handle further defines: a rail, and a handle-shaft interface to which the primary segment is fixedly coupled; and the second handle is operable to slide the handle-shaft interface along the rail, with respect to the mooring.Attorney Docket No: TMTTMC-23775WO01

[0213] Example 6. The system / apparatus according to any one of examples 4-5, wherein second controller is operable to (i) unmate the first coupling from the second coupling and (ii) remate the first coupling with the second coupling, while (a) the implant remains anchored to the tissue, and (b) the implant remains coupled to the distal segment of the shaft, by sliding the primary segment along the tether, with respect to the distal segment, while maintaining tension on the tether.

[0214] Example 7. The system / apparatus according to any one of examples 1-6, wherein the handle assembly is configured such that the second handle is slidable with respect to the first handle, in a manner that adjusts tension on the tether.

[0215] Example 8. The system / apparatus according to example 7, wherein the handle assembly is configured such that sliding the second handle toward the first handle reduces tension on the tether.

[0216] Example 9. The system / apparatus according to any one of examples 7-8, wherein the second handle is slidable toward the first handle, in a manner that adjusts tension on the tether, without adjusting a position of the distal segment of the shaft.

[0217] Example 10. The system / apparatus according to any one of examples 7-9, wherein the second handle is slidable toward the first handle, in a manner that reduces tension on the tether, while the first coupling is unmated from the second coupling.

[0218] Example 11. The system / apparatus according to any one of examples 7-10, further comprising a support assembly, configured to support the handle assembly in a manner that facilitates adjusting tension on the tether.

[0219] Example 12. The system / apparatus according to example 11, wherein the support assembly comprises a track and a foot, configured to facilitate adjusting tension on the tether by, while the handle assembly is positioned along the track, operating the foot to slide the second handle toward the first handle.

[0220] Example 13. The system / apparatus according to any one of examples 1-12, wherein: the anchor defines a helical tissue-engaging element that extends distally from an anchor head, the anchor head being shaped to define a forward -torque face and a reversetorque face; and the anchor driver defines a driveshaft, and a drive head at a distal end ofAttorney Docket No: TMTTMC-23775WO01the driveshaft, the drive head being shaped such that: while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a forward rotational direction screws the tissue-engaging element into the tissue by applying forward torque to the forward-torque face, and rotation of the drive head in a reverse rotational direction: hooks the drive head onto the anchor head in a manner that facilitates tensioning of the driveshaft while the drive head remains in contact with the anchor head, and unscrews the tissue-engaging element from the tissue by applying reverse torque to the rev rse-torque face while the drive head remains hooked onto the anchor head and the driveshaft is under tension, and tensioning the driveshaft while the drive head is not hooked onto the anchor head pulls the drive head away from the anchor head.

[0221] Example 14. The system / apparatus according to example 13, wherein the reverse-torque face of the anchor head is configured to hook the drive head in a manner that maintains contact between the anchor head and the drive head while the driveshaft is under tension.

[0222] Example 15. The system / apparatus according to any one of examples 13-14, wherein the forward -torque face of the anchor head defines a smooth face that is closer to being perpendicular to the forward torque than to being parallel to the forward torque.

[0223] Example 16. The system / apparatus according to any one of examples 13-15, wherein the anchor driver is configured to (i) screw the tissue-engaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and (iv) disengage from the anchor head, without any change of conformation of the anchor head.

[0224] Example 17. The system / apparatus according to any one of examples 13-16, wherein the anchor driver is configured to (i) screw the tissue-engaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and (iv) disengage from the anchor head, without any change of conformation of the drive head.

[0225] Example 18. A method for use at a heart of a subject, the method comprising: transluminally advancing a distal segment of a shaft of a delivery tool to the heart, the shaft having a primary segment mated to the distal segment, the delivery tool further including aAttorney Docket No: TMTTMC-23775WO01catheter; to tissue at a site of the heart, anchoring an implant that is coupled to the distal segment of the shaft, by using an anchor driver that extends through the shaft to drive an anchor into tissue at the site; and subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant by: disengaging the anchor driver from the anchor, and unmating the primary segment from the distal segment by retracting the primary segment proximally through the catheter, with respect to the distal segment, subsequently to the step of disassociating, remating the primary segment to the distal segment by advancing the primary segment distally through the catheter toward the distal segment; and while the primary segment remains remated with the distal segment: uncoupling the distal segment from the implant, retracting the shaft from the implant, and withdrawing the delivery tool from the subject.

[0226] Example 19. The method according to example 18, further comprising sterilizing the delivery tool, the implant and the anchor.

[0227] Example 20. The method according to any one of examples 18-19, wherein: the primary segment defines a shaft-axis; and the step of unmating comprises unmating the primary segment of the shaft from the distal segment of the shaft in a manner that increases a deflectability of the distal segment and the implant with respect to the shaft-axis.

[0228] Example 21. The method according to any one of examples 18-20, wherein: the delivery tool includes a handle, operably coupled to the catheter, and the method further comprises operating the handle to retract the catheter from over the implant and the distal segment.

[0229] Example 22. The method according to any one of examples 18-21, wherein disengaging the anchor driver from the anchor further comprises retracting the anchor driver into the primary segment.

[0230] Example 23. The method according to any one of examples 18-22, wherein advancing comprises transluminally advancing the distal segment of the shaft to the heart, while the shaft is housed within a distal part of the catheter.Attorney Docket No: TMTTMC-23775WO01

[0231] Example 24. The method according to example 23, wherein: the distal segment of the shaft bifurcates into a first branch and a second branch, and advancing comprises transluminally advancing the distal segment of the shaft to the heart, while the first and second branches are arranged in parallel within the distal part of the catheter.

[0232] Example 25. The method according to example 24, further comprising deploying the implant from the catheter by proximally retracting the distal part of the catheter over the implant and the distal segment of the shaft, such that the first and second branches become skewed with respect to each other.

[0233] Example 26. The method according to example 25, wherein the step of deploying is prior to the step of anchoring.

[0234] Example 27. The method according to any one of examples 18-26, wherein: the anchor is a first anchor, the anchor driver is a first anchor driver, and the method further comprises using a second anchor driver that extends through the shaft to drive a second anchor into tissue at the site.

[0235] Example 28. The method according to example 27, wherein: the distal segment of the shaft bifurcates into a first branch and a second branch; and disengaging the anchor driver from the anchor further comprises retracting each anchor driver from a respective one of the first and second branches, into the primary segment of the shaft.

[0236] Example 29. The method according to any one of examples 27-28, wherein: the distal segment of the shaft bifurcates into a first branch and a second branch; and the step of anchoring comprises anchoring the implant, that is coupled to each of the first branch and the second branch, using the first and second anchor drivers that: extend in parallel through the primary segment of the shaft, and diverge into the first and second branches to drive the first and second anchors into tissue at the site.

[0237] Example 30. The method according to example 29, wherein the step of anchoring comprises anchoring the implant, that is coupled to each of the first branch and the second branch, using the first and second anchor drivers that: extend in parallel through the primary segment of the shaft, and diverge into the first and second branches to simultaneously drive the first and second anchors into tissue at the site.Attorney Docket No: TMTTMC-23775WO01

[0238] Example 31. The method according to any one of examples 18-30, wherein: the shaft defines a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and the step of remating comprises mating the first coupling with the second coupling to provide a rigid connection between the primary segment and the distal segment.

[0239] Example 32. The method according to any one of examples 18-31, wherein a tether extends distally through the primary segment and the distal segment such that subsequently to the step of anchoring and while the implant remains coupled to the distal segment of the shaft: the step of unmating comprises retracting the primary segment proximally, along the tether, with respect to the distal segment, and the step of remating comprises advancing the primary segment distally, along the tether, toward the distal segment.

[0240] Example 33. The method according to example 32, wherein, while a proximal portion of the delivery tool is supported by a support assembly comprising a track and a foot, the steps of unmating and remating comprise, while the proximal portion of the delivery tool is positioned along the track, operating the foot to slide the primary segment over and along the tether.

[0241] Example 34. The method according to any one of examples 32-33, wherein: a proximal end portion of the tether is fixed to a handle, and a distal end portion of the tether is fixed to the distal segment, such that subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, the step of unmating does not comprise reducing tension on the tether between the proximal end portion and the distal end portion.

[0242] Example 35. The method according to any one of examples 32-33, wherein: a proximal end portion of the tether is fixed to a handle; and the method further comprises, subsequently to the step of anchoring, applying tension to the tether via the handle.

[0243] Example 36. The method according to example 35, wherein the step of remating comprises, while applying tension to the tether via the handle, advancing the primary segment distally, along the tether, toward the distal segment.Attorney Docket No: TMTTMC-23775WO01

[0244] Example 37. The method according to any one of examples 35-36, further comprising, subsequently to the step of unmating, reducing tension on the tether.

[0245] Example 38. The method according to example 37, wherein reducing tension comprises reducing tension on the tether by advancing the handle distally with respect to the distal segment.

[0246] Example 39. The method according to example 38, wherein the step of reducing tension is prior to the step of remating.

[0247] Example 40. The method according to any one of examples 38-39, wherein: the handle is fixedly coupled to the primary segment of the shaft, and the step of reducing tension comprises advancing (i) the primary segment of the shaft and (ii) the proximal end portion of the tether, toward the distal segment of the shaft.

[0248] Example 41. The method according to example 40, wherein: the handle is a first handle, and a second handle is operably coupled to the catheter, wherein reducing tension comprises reducing tension on the tether by reducing a distance between the first handle and the second handle.

[0249] Example 42. The method according to example 41, wherein: the first handle is a proximal handle, the second handle is a distal handle, and the method further comprises operating the distal handle to retract the catheter from over the implant and the distal segment.

[0250] Example 43. The method according to example 42, wherein reducing tension comprises reducing tension on the tether by advancing the proximal handle toward the distal handle.

[0251] Example 44. The method according to any one of examples 18-43, further comprising, prior to the step of remating, testing functionality of the heart.

[0252] Example 45. The method according to example 44, wherein: the site is a first site of the heart, and the method further comprises, responsively to the tested functionality, and subsequently to the step of remating: reengaging the anchor driver to the anchor, retracting the anchor from the tissue into the shaft, using the shaft, advancing the implant toAttorney Docket No: TMTTMC-23775WO01a second site of the heart, and using the anchor driver, anchoring the implant to tissue at the second site by driving the anchor into tissue at the second site.

[0253] Example 46. The method according to example 45, further comprising, while the implant is anchored to tissue at the second site, repeating the step of testing.

[0254] Example 47. The method according to any one of examples 45-46, wherein: the engagement between the anchor driver and the anchor is between: a drive head defined by the anchor driver, and an anchor head of the anchor that is shaped to define: a forwardtorque face, and a reverse-torque face; and the steps of disengaging and reengaging do not comprise changing a shape or a conformation of: the drive head or the anchor head.

[0255] Example 48. The method according to example 47, wherein: the drive head is disposed at a distal end of a driveshaft of the anchor driver; the anchor defines a helical tissue-engaging element extending distally from the anchor head; driving the anchor into the tissue comprises, while compressing the driveshaft, screwing the tissue-engaging element into the tissue by applying forward torque from the drive head to the forwardtorque face of the anchor head; and retracting the anchor from the tissue into the shaft comprises, while tensioning the driveshaft, retracting the tissue-engaging element from the tissue by applying reverse torque from the drive head to the reverse-torque face of the anchor head.

[0256] Example 49. The method according to example 48, wherein applying reverse torque from the drive head to the reverse-torque face comprises hooking the drive head onto the anchor head by rotating the anchor driver in a reverse rotational direction, while pulling the anchor proximally using the drive head hooked onto the anchor head.

[0257] Example 50. The method according to example 49, wherein the step of hooking comprises hooking the drive head onto the anchor head by sliding the drive head proximally with respect to the anchor head, while rotating the anchor driver in the reverse rotational direction.

[0258] Example 51. A method for use at a simulated heart of a subject, the method comprising: transluminally advancing a distal segment of a shaft of a delivery tool to the heart, the shaft having a primary segment mated to the distal segment, the delivery toolAttorney Docket No: TMTTMC-23775WO01further including a catheter; to tissue at a site of the heart, anchoring an implant that is coupled to the distal segment of the shaft, by using an anchor driver that extends through the shaft to drive an anchor into tissue at the site; and subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant by: disengaging the anchor driver from the anchor, and unmating the primary segment from the distal segment by retracting the primary segment proximally through the catheter, with respect to the distal segment, subsequently to the step of disassociating, remating the primary segment to the distal segment by advancing the primary segment distally through the catheter toward the distal segment; and while the primary segment remains remated with the distal segment: uncoupling the distal segment from the implant, retracting the shaft from the implant, and withdrawing the delivery tool from the subject.

[0259] Example 52. A system and / or an apparatus for use with a valve of a heart of a subject, the valve having a first leaflet and an opposing leaflet, the heart having a chamber upstream of the valve, the system / apparatus comprising an implant, the implant comprising: a wing, having a long axis extending from a root portion of the wing to a tip portion of the wing, and having a contact face defining, along the long axis, a contour that defines: a first concave region at the root portion, a flat portion between the root portion and the tip portion, and a second concave region at the tip portion; and at the root portion, an interface configured to be anchored to a site upstream of the valve, such that the wing extends, away from the interface, and over the first leaflet toward the opposing leaflet, with the contact face facing the first leaflet.

[0260] Example 53. The system / apparatus according to example 52, wherein the implant is sterile.

[0261] Example 54. The system / apparatus according to any one of examples 52-53, wherein the root portion is stiffer than the flat portion.

[0262] Example 55. The system / apparatus according to any one of examples 52-54, wherein the root portion is stiffer than the tip portion.

[0263] Example 56. The system / apparatus according to any one of examples 52-55, wherein the flat portion is stiffer than the tip portion.Attorney Docket No: TMTTMC-23775WO01

[0264] Example 57. The system / apparatus according to any one of examples 52-56, wherein the flat portion has a greater length than the root portion.

[0265] Example 58. The system / apparatus according to any one of examples 52-57, wherein the flat portion has a greater length than the tip portion.

[0266] Example 59. The system / apparatus according to any one of examples 52-58, wherein the flat portion has a greater length than a combined length of the root portion and the tip portion.

[0267] Example 60. The system / apparatus according to any one of examples 52-59, wherein the first concave region is symmetrical to the second concave region.

[0268] Example 61. The system / apparatus according to any one of examples 52-60, wherein a length of the flat portion is greater than a width of the wing.

[0269] Example 62. The system / apparatus according to any one of examples 52-61, wherein the wing comprises a flexible frame that provides mechanical support to the wing.

[0270] Example 63. The system / apparatus according to example 62, wherein the wing comprises a flexible sheet disposed over the frame.

[0271] Example 64. The system / apparatus according to example 63, wherein the flexible sheet comprises a polymer.

[0272] Example 65. A system for use at tissue of a subject, the system comprising: an implant comprising a first interface and a second interface; and a delivery tool comprising: a catheter, transluminally advanceable to the tissue, a shaft extending distally through the catheter, a distal part of the shaft bifurcating into a first branch and a second branch, and a cord, extending from a proximal portion of the delivery tool, distally through the catheter, wherein: the system defines a first coupling and a second coupling, each of the first and second branches being fastened to a corresponding interface via a respective one of the first and second couplings, each of the couplings defining: a window, a tab, protruding through the window, and a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window, and the cord is connected to the detent of the first coupling and to the detent of the second coupling, such that proximalward pulling of theAttorney Docket No: TMTTMC-23775WO01cord unfastens the first and second branches from the first and second interfaces by pulling the detent of each of the first and second couplings out of its respective tab.

[0273] Example 66. The system according to example 65, wherein the implant and the delivery tool are sterile.

[0274] Example 67. The system according to any one of examples 65-66, wherein the unfastening facilitates pulling the shaft proximally with respect to the implant.

[0275] Example 68. The system according to any one of examples 65-67, wherein respective ends of a single wire define each detent.

[0276] Example 69. The system according to example 68, wherein the wire is v-shaped and generally follows the shape of the branches, from the bifurcation of the shaft to a distal end portion of each branch.

[0277] Example 70. The system according to example 69, wherein the cord is connected to a bight of the wire at a vertex of the v-shape of the wire.

[0278] Example 71. The system according to any one of examples 65-70, wherein the delivery tool comprises a handle at a proximal portion of the delivery tool, the handle operable to pull the detent of each of the first and second couplings out of its respective tab.

[0279] Example 72. The system according to example 71, wherein the handle is operable to simultaneously pull the detent of each of the first and second couplings out of its respective tab.

[0280] Example 73. The system according to any one of examples 65-72, further comprising: a first anchor and a second anchor; a first anchor driver, extending distally through the shaft, and into the first branch where a drive head of the first driver is engaged with the first anchor; and a second anchor driver, extending distally through the shaft alongside the first anchor driver, and into the second branch where a drive head of the second anchor driver is engaged with the second anchor.

[0281] Example 74. The system according to example 73, wherein: the first anchor driver is configured to anchor the first interface to the tissue by driving the first anchor distally through the first interface and into the tissue, and the second anchor driver isAttorney Docket No: TMTTMC-23775WO01configured to anchor the second interface to the tissue by driving the second anchor distally through the second interface and into the tissue.

[0282] Example 75. The system according to any one of examples 65-74, wherein the shaft comprises: a primary segment, a distal segment, and a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and operable to: mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, unmate from the first coupling, and remate with the first coupling.

[0283] Example 76. The system according to example 75, wherein the connector is configured such that unmating the second coupling from the first coupling, while each branch is coupled to the corresponding interface, facilitates deflection of the second coupling and the implant, with respect to the primary segment of the shaft.

[0284] Example 77. The system according to any one of examples 75-76, wherein the distal part of the shaft bifurcates into the first branch and the second branch, distally from the connector.

[0285] Example 78. The system according to any one of examples 75-77 , wherein each detent is configured to obstruct the tab from being withdrawn from the window during the unmating and remating of the first coupling with the second coupling.

[0286] Example 79. The system according to any one of examples 75-78, wherein the system is configured to inhibit proximalward pulling of the cord while the second coupling is unmated from the first coupling.

[0287] Example 80. A system for use at tissue of a subject, the system comprising: an implant comprising a first interface and a second interface; and a delivery tool comprising: a catheter, transluminally advanceable to the tissue, a cord, extending from a proximal portion of the delivery tool, distally through the catheter, wherein: the system defines a coupling mechanism, fastened to the first and second interfaces, the coupling mechanism defining: a window, a tab, protruding through the window, and a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window, and the cord is connected to the detent of the coupling mechanism, such that proximalward pulling of theAttorney Docket No: TMTTMC-23775WO01cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.

[0288] Example 81. The system according to example 80, wherein: the delivery tool further comprises a shaft extending distally through the catheter, a distal part of the shaft bifurcating into a first branch and a second branch, each of the first and second branches being fastened to a corresponding interface.

[0289] Example 82. The system according to any one of examples 80-81, wherein the coupling mechanism comprises a first coupling and a second coupling, each of the first and second couplings defining: a window, a tab, protruding through the window, and a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window.

[0290] Example 83. The system according to any one of examples 80-82, wherein the coupling mechanism comprises a first coupling and a second coupling, the distal part of the shaft being fastened to a corresponding interface via a respective one of the first and second couplings.

[0291] Example 84. The system according to example 83, wherein the cord is connected to the detent such that proximalward pulling of the cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.

[0292] Example 85. A system for use at tissue of a subject, the system comprising: an implant comprising an interface; and a delivery tool comprising: a catheter, transluminally advanceable to the tissue, a cord, extending from a proximal portion of the delivery tool, distally through the catheter, wherein: the system defines a coupling mechanism, fastened to the interface, the coupling mechanism defining: a window, a tab, protruding through the window, and a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window, and the cord is connected to the detent of the coupling mechanism, such that proximalward pulling of the cord unfastens the first and second interfaces from the coupling mechanism by pulling the detent out of its tab.

[0293] Example 86. A system for use at tissue of a subject, the system comprising: an implant comprising a first interface and a second interface; and a delivery tool comprising: aAttorney Docket No: TMTTMC-23775WO01catheter, transluminally advanceable to the tissue, and a shaft extending distally through the catheter, a distal part of the shaft bifurcating into a first branch and a second branch, wherein: the system defines a first coupling and a second coupling, each of the first and second branches being fastened to a corresponding interface via a respective one of the first and second couplings, each of the couplings defining: a window, a tab, protruding through the window, and a detent, protruding through the tab in a manner that obstructs the tab from being withdrawn from the window, and pulling the detent of each of the first and second couplings out of its respective tab unfastens the first and second branches from the first and second interfaces.

[0294] Example 87. A system and / or an apparatus for use with tissue of a heart of a subject, the system / apparatus comprising: an implant; an anchor; and a transluminal delivery tool, comprising: a handle, a shaft extending distally from the handle distally, and having: a primary segment, a distal segment, and a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, a tether extending from the handle distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling, and an anchor driver, extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and configured to anchor the implant to the tissue by driving the anchor out of the shaft and into the tissue, wherein the handle: defines a mooring to which a proximal end portion of the tether is fixed, and comprises a controller that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0295] Example 88. The system / apparatus according to example 87, wherein: the delivery tool comprises a catheter, extending distally from the handle; and the shaft extends from the handle distally through the catheter.Attorney Docket No: TMTTMC-23775WO01

[0296] Example 89. The system / apparatus according to example 88, wherein: the handle is a first handle of a handle assembly, the first handle: fixed to a proximal end of the catheter, and comprising a proximal controller, operably coupled to the catheter such that operation of the first controller retracts the catheter from over the implant, the distal segment, and the first coupling.

[0297] Example 90. The system / apparatus according to example 89, wherein the handle assembly further comprises a second handle: defining the mooring to which the proximal end portion of the tether is fixed, and comprising the controller that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0298] Example 91. A system and / or an apparatus for use with tissue of a subject, the system / apparatus comprising: a delivery tool, comprising: a shaft extending distally from the handle distally, and having: a primary segment, a distal segment, and a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling; a tether extending from the handle distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling; and a controller that is operably coupled to the shaft such that the controller is operable to (i) unmate the first coupling from the second coupling, and (ii) remate the first coupling with the second coupling.

[0299] Example 92. A system for use with tissue of a heart of a subject, the system comprising an implant, and a delivery tool, comprising: a handle assembly, a catheter, extending distally from the handle assembly, and configured for transluminal advancement to the heart, and a shaft extending from the handle assembly distally through the catheter, the shaft having a primary segment, a distal segment, and a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, and a tetherAttorney Docket No: TMTTMC-23775WO01extending from the handle assembly distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling.

[0300] Example 93. The system according to example 92, further comprising an anchor and an anchor driver, wherein the anchor driver is extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and configured to anchor the implant to the tissue by driving the anchor into the tissue.

[0301] Example 94. The system according to example 93, wherein the anchor defines a helical tissue-engaging element that extends distally from an anchor head, the anchor head being shaped to define a forward -torque face and a reverse-torque face; and the anchor driver defines a driveshaft, and a drive head at a distal end of the driveshaft, the drive head being shaped such that: while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a forward rotational direction screws the tissue-engaging element into the tissue by applying forward torque to the forwardtorque face.

[0302] Example, 95. The system according to example 94, wherein the drive head is further shaped such that while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a reverse rotational direction: (i) hooks the drive head onto the anchor head in a manner that facilitates tensioning of the driveshaft while the drive head remains in contact with the anchor head, and (ii) unscrews the tissue-engaging element from the tissue by applying reverse torque to the reversetorque face while the drive head remains hooked onto the anchor head and the driveshaft is under tension.

[0303] Example 96. The system according to any one of examples 93-95, wherein the drive head is configured such that tensioning the driveshaft while the drive head is not hooked onto the anchor head pulls the drive head away from the anchor head.

[0304] Example 97. The system according to any one of examples 94-96, wherein the reverse-torque face of the anchor head is configured to hook the drive head in a manner that maintains contact between the anchor head and the drive head while driveshaft is under tension.Attorney Docket No: TMTTMC-23775WO01

[0305] Example 98. The system according to any one of examples 93-97, wherein the anchor driver is configured to (i) screw the tissue-engaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and (iv) disengage from the anchor head, without any change of conformation of at least one of or both of the anchor head and the drive head.

[0306] Example 99. The system according to any one of examples 92-98, wherein the handle assembly comprises a handle fixed to a proximal end of the catheter, the handle comprises a first controller operably coupled to the catheter such that operation thereof causes relative movement between the catheter and at least one of the implant, the distal segment, and the first coupling.

[0307] Example 100. The system according to any one of examples 92-99, wherein the handle assembly comprises a coupling control handle defining a mooring to which a proximal end portion of the tether is fixed, and comprises a coupling controller that is operably coupled to the shaft such that the coupling controller is operable to (i) unmate the first coupling from the second coupling, and (ii) remate the first coupling with the second coupling.

[0308] Example 101. The system according to example 100, wherein the coupling controller is operably coupled to the shaft such that the coupling controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

[0309] Example 102. The system according to any one of examples 100-101, wherein the coupling control handle further defines a rail, and a handle-shaft interface to which the primary segment is fixedly coupled; and the second handle is operable to slide the handleshaft interface along the rail, with respect to the mooring.

[0310] Example 103. The system according to any one of examples 100-102, wherein coupling controller is operable to (i) unmate the first coupling from the second coupling and (ii) remate the first coupling with the second coupling, while (a) the implant remains anchored to the tissue, and (b) the implant remains coupled to the distal segment of theAttorney Docket No: TMTTMC-23775WO01shaft, by sliding the primary segment along the tether, with respect to the distal segment, while maintaining tension on the tether.

[0311] Example 104. The system according to any one of examples 92-103, further comprising a support assembly.

[0312] Example 105. A method for use at a heart of a subject, the method comprising: (i) transluminally advancing a distal segment of a shaft of a delivery tool to the heart, the shaft having a primary segment mated to the distal segment, the delivery tool further including a catheter; (ii) to tissue at a site of the heart, anchoring an implant that is coupled to the distal segment of the shaft; and (iii) subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant by unmating the primary segment from the distal segment, (iv) subsequently to the step of disassociating, remating the primary segment to the distal segment; and (v) while the primary segment remains remated with the distal segment: uncoupling the distal segment from the implant, retracting the shaft from the implant, and withdrawing the delivery tool from the subject.

[0313] The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub-combinations with one another. The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor is it required that any one or more specific advantages be present or problems be solved.

[0314] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0315] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using theAttorney Docket No: TMTTMC-23775WO01systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as "simulated" (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term "simulation" covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0316] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.

[0317] The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

Attorney Docket No: TMTTMC-23775WO01WHAT IS CLAIMED IS:

1. A system for use with tissue of a heart of a subject, the system comprising: an implant;a delivery tool, comprising:a handle assembly,a catheter, extending distally from the handle assembly, and configured for transluminal advancement to the heart,a shaft extending from the handle assembly distally through the catheter, and having:a primary segment,a distal segment, anda connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, and shaped to mate with the first coupling to provide a rigid connection between the primary segment and the distal segment, anda tether extending from the handle assembly distally through the primary segment and the connector, such that the tether facilitates mating and unmating of the first coupling and the second coupling.

2. The system according to claim 1, further comprising an anchor and an anchor driver, wherein the anchor driver is extendible through the handle assembly and the shaft, reversibly couplable to the anchor, and configured to anchor the implant to the tissue by driving the anchor into the tissue.

3. The system according to claim 2, wherein:the anchor defines a helical tissue-engaging element that extends distally from an anchor head, the anchor head being shaped to define a forward -torque face and a reverse-torque face; andAttorney Docket No: TMTTMC-23775WO01the anchor driver defines a driveshaft, and a drive head at a distal end of the driveshaft, the drive head being shaped such that:while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a forward rotational direction screws the tissue-engaging element into the tissue by applying forward torque to the forward-torque face.

4. The system according to claim 3, wherein the drive head is further shaped such that while the driveshaft is under compression and the drive head is fitted to the anchor head, rotation of the drive head in a reverse rotational direction:hooks the drive head onto the anchor head in a manner that facilitates tensioning of the driveshaft while the drive head remains in contact with the anchor head, andunscrews the tissue-engaging element from the tissue by applying reverse torque to the reverse-torque face while the drive head remains hooked onto the anchor head and the driveshaft is under tension.

5. The system according to any one of claims 3-4, wherein the drive head is configured such that tensioning the driveshaft while the drive head is not hooked onto the anchor head pulls the drive head away from the anchor head.

6. The system according to any one of claims 3-5, wherein the reverse-torque face of the anchor head is configured to hook the drive head in a manner that maintains contact between the anchor head and the drive head while the driveshaft is under tension.

7. The system according to any one of claims 3-6, wherein the forward-torque face of the anchor head defines a smooth face that is closer to being perpendicular to the forward torque than to being parallel to the forward torque.

8. The system according to any one of claims 3-7, wherein the anchor driver is configured to (i) screw the tissue-engaging element into the tissue, (ii) hook the drive head onto the anchor head, (iii) unscrew the tissue-engaging element from the tissue, and (iv) disengage from the anchor head, without any change of conformation of at least one of or both of the anchor head and the drive head.Attorney Docket No: TMTTMC-23775WO019. The system according to any one of claims 1-8, wherein the handle assembly comprises a handle fixed to a proximal end of the catheter, wherein the handle comprises a first controller, operably coupled to the catheter such that operation of the first controller causes relative movement between the catheter and at least one of the implant, the distal segment, and the first coupling.

10. The system according to any one of claims 1-9, wherein the handle assembly comprises a coupling control handle defining a mooring to which a proximal end portion of the tether is fixed, and comprises a coupling controller that is operably coupled to the shaft such that the coupling controller is operable to (i) unmate the first coupling from the second coupling, and (ii) remate the first coupling with the second coupling.

11. The system according to claim 10, wherein the coupling controller is operably coupled to the shaft such that the coupling controller is operable to (i) unmate the first coupling from the second coupling by sliding the primary segment and the first coupling proximally over and along the tether away from the second coupling, and (ii) remate the first coupling with the second coupling by sliding the primary segment and the first coupling distally over and along the tether toward the second coupling.

12. The system according to any one of claims 10-11, wherein the coupling controller is operable to, prior to remating the first coupling with the second coupling, increase tension on the tether.

13. The system according to any one of claims 10-12, wherein:the coupling control handle further defines:a rail, anda handle-shaft interface to which the primary segment is fixedly coupled; and the second handle is operable to slide the handle-shaft interface along the rail, with respect to the mooring.

14. The system according to any one of claims 10-13, wherein coupling controller is operable to (i) unmate the first coupling from the second coupling and (ii) remate the first coupling with the second coupling, while (a) the implant remains anchored to the tissue, andAttorney Docket No: TMTTMC-23775WO01(b) the implant remains coupled to the distal segment of the shaft, by sliding the primary segment along the tether, with respect to the distal segment, while maintaining tension on the tether.

15. The system according to any one of claims 10-14, wherein the handle assembly is configured such that the coupling control handle is slidable with respect to the handle, in a manner that adjusts tension on the tether.

16. The system according to claim 15, wherein the coupling control handle is slidable toward the handle, in a manner that adjusts tension on the tether, without adjusting a position of the distal segment of the shaft.

17. The system according to any one of claims 15-16, wherein the coupling control handle is slidable toward the handle, in a manner that reduces tension on the tether, while the first coupling is unmated from the second coupling.

18. The system according to any one of claims 15-17, further comprising a support assembly, configured to support the handle assembly in a manner that facilitates adjusting tension on the tether.

19. The system according to claim 18, wherein the support assembly comprises a track and a foot, configured to facilitate adjusting tension on the tether by, while the handle assembly is positioned along the track, operating the foot to slide the coupling control handle toward the handle.

20. A method for use at a heart of a subject, the method comprising: transluminally advancing a distal segment of a shaft of a delivery tool to the heart, the shaft having a primary segment mated to the distal segment, the delivery tool further including a catheter;to tissue at a site of the heart, anchoring an implant that is coupled to the distal segment of the shaft; andsubsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, disassociating the primary segment from the implant by unmating the primary segment from the distal segment,Attorney Docket No: TMTTMC-23775WO01subsequently to the step of disassociating, remating the primary segment to the distal segment; andwhile the primary segment remains remated with the distal segment:uncoupling the distal segment from the implant,retracting the shaft from the implant, andwithdrawing the delivery tool from the subject.

21. The method according to claim 20, wherein anchoring the implant involves using an anchor driverthat extends through the shaft to drive an anchor into tissue at the site.

22. The method according to any one of claims 20-21, wherein unmating the primary segment from the distal segment involves retracting the primary segment proximally through the catheter relative to the distal segment.

23. The method according to claim 22, wherein remating the primary segment to the distal segment involves advancing the primary segment distally through the catheter toward the distal segment.

24. The method according to any one of claims 20-23, further comprising sterilizing the delivery tool and / or the implant.

25. The method according to any one of claims 20-24, wherein:the primary segment defines a shaft-axis; andthe step of unmating comprises unmating the primary segment of the shaft from the distal segment of the shaft in a manner that increases a deflectability of the distal segment and the implant with respect to the shaft-axis.

26. The method according to any one of claims 20-25, wherein:the delivery tool includes a handle, operably coupled to the catheter, andAttorney Docket No: TMTTMC-23775WO01the method further comprises operating the handle to at least one of (1) retract the catheter from over the implant and the distal segment, and / or (2) advance the implant and the distal segment distally out of the catheter.

27. The method according to any one of claims 20-26, wherein:the distal segment of the shaft bifurcates into a first branch and a second branch, and advancing comprises transluminally advancing the distal segment of the shaft to the heart, while the first and second branches are arranged in parallel within the distal part of the catheter.

28. The method according to claim 27, further comprising deploying the implant from the catheter such that the first and second branches become skewed with respect to each other.

29. The method according to any one of claims 20-28, wherein:the implant is anchored to the tissue with a first anchor driven by a first anchor driver, andthe method further comprises using a second anchor driver that extends through the shaft to drive a second anchor into tissue at the site.

30. The method according to claim 29, wherein:the distal segment of the shaft bifurcates into a first branch and a second branch; and the step of anchoring comprises anchoring the implant, that is coupled to each of the first branch and the second branch, using the first and second anchor drivers that:extend in parallel through the primary segment of the shaft, and diverge into the first and second branches to drive the first and second anchors into tissue at the site.

31. The method according to any one of claims 20-30, wherein:Attorney Docket No: TMTTMC-23775WO01the shaft defines a connector, comprising (i) a first coupling fixed to a distal end of the primary segment, and (ii) a second coupling fixed to a proximal end of the distal segment, andthe step of remating comprises mating the first coupling with the second coupling to provide a rigid connection between the primary segment and the distal segment.

32. The method according to any one of claims 20-31, wherein a tether extends distally through the primary segment and the distal segment such that subsequently to the step of anchoring and while the implant remains coupled to the distal segment of the shaft:the step of unmating comprises retracting the primary segment proximally, along the tether, with respect to the distal segment, andthe step of remating comprises advancing the primary segment distally, along the tether, toward the distal segment.

33. The method according to claim 32, wherein, while a proximal portion of the delivery tool is supported by a support assembly comprising a track and a foot, the steps of unmating and remating comprise, while the proximal portion of the delivery tool is positioned along the track, operating the foot to slide the primary segment over and along the tether.

34. The method according to any one of claims 32-33, wherein:a proximal end portion of the tether is fixed to a handle, anda distal end portion of the tether is fixed to the distal segment, such that subsequently to the step of anchoring, and while the implant remains coupled to the distal segment of the shaft, the step of unmating does not comprise reducing tension on the tether between the proximal end portion and the distal end portion.

35. The method according to any one of claims 20-34, further comprising, prior to the step of remating, testing functionality of the heart.

36. The method according to claim 35, wherein:Attorney Docket No: TMTTMC-23775WO01the site is a first site of the heart, andthe method further comprises, responsively to the tested functionality, and subsequently to the step of remating:disengaging or unanchoring the implant from the tissue at the first site, advancing the implant to a second site of the heart, andanchoring the implant to tissue at the second site.

37. The method according to claim 36, further comprising, while the implant is anchored to tissue at the second site, repeating the step of testing.

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