Variable tissue contraction

Abstract

An implant (222) includes a tether (26) and a series of anchors (230), each of the anchors including a tissue engaging element (34) and a head (232) coupled to the tissue engaging element. The head of each anchor is slidably coupled to the tether and includes a lock (210) configured to lock the head to the tether when it is locked. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to each of the following applications, each of which is incorporated herein by reference in its entirety for all purposes:

[0003] Provisional U.S. patent application 63 / 346,387, filed May 27, 2022, to Biran et al.;

[0004] Provisional U.S. patent application 63 / 369,571 to Biran et al., filed July 27, 2022; and

[0005] Provisional U.S. patent application 63 / 370,609, filed on August 5, 2022, to Biran et al. Background Art

[0006] Annuloplasty involves reshaping the tissue of the annulus. This can be accomplished by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to facilitate medical procedures, including annuloplasty, other reshaping of tissue, and securing implants. In some cases, tissue anchors can be used as a substitute for sutures. For example, tissue anchors can be used in procedures where there is no line of sight to the target. Summary of the invention

[0007] The present invention is intended to provide some examples, and is not intended to limit the scope of the present invention in any way. For example, unless the claim clearly states the feature, any feature included in the example of the present invention is not required by the claim. In addition, the features, components, steps, concepts, etc. described in the examples of the present invention and elsewhere in the present disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in the present disclosure can be included in the examples summarized here.

[0008] Described herein are systems, devices, and techniques for variably contracting tissue, such that different portions of the tissue can be contracted to different degrees, for example.

[0009] In some embodiments, an implant can be implanted along a path along the tissue and can be manipulated to shrink one portion of the path more than another portion of the path. For example, an implant can have (or can be implanted to have) multiple segments (the multiple segments can be elongated segments arranged colinearly and / or serially along the length of the implant), the multiple segments are fastened to the tissue, and the lengths of the multiple segments can be adjusted independently of the lengths of the other segments.

[0010] In some embodiments, the length of each section may be lockable after adjustment thereof, for example before adjustment of another section.

[0011] In some embodiments, each segment of the implant is adjustable (and typically lockable) prior to implantation of consecutive segments of the implant.

[0012] In some embodiments, a system including such an implant and a delivery tool for the implant can be provided, obtained, and / or used. The delivery tool can be configured to deliver, secure, and / or adjust the implant.

[0013] In some embodiments, the implant comprises a series of anchors slidably coupled to a tether. In some embodiments, each of the anchors has a head that is threadedly connected to the tether and can be locked to the tether.

[0014] In some embodiments, the length of each segment of the implant can be reduced by tensioning the tether, thereby pulling at least two of the anchors associated with this segment (e.g., the two anchors that define this segment) closer to each other.

[0015] In some embodiments, locking the head to the tether can lock the length of the section of the implant associated with (eg, defined by) such anchor.

[0016] In some embodiments, the implant is a segmented implant comprising a series of telescopic segments. In some embodiments, the length of each segment of the implant can be reduced by telescopically sliding one segment into an adjacent segment.

[0017] In some embodiments, a tension modifier is applied to the implant after implantation of the implant.

[0018] According to some embodiments, a system and / or device (e.g., usable at or for use at a subject's heart) includes an implant (which may be the same or similar to the implants described above or other implants described herein), the implant including a tether and a series of anchors. In some embodiments, each of the anchors may include a tissue engaging element (e.g., one or more of a spiral, a screw, a tip, a hook, a barb, a dart, an arm, a nail, a sharp portion, a clip, a swab, etc.), and may also optionally include a head.

[0019] In some embodiments, the anchor can be slidably coupled to the tether. In some embodiments, the head can be coupled to the tissue engaging element and / or slidably coupled to the tether. In some embodiments, the head can include a lock configured to lock the head to the tether when it is locked.

[0020] In some embodiments, the system / device further includes a tensioning tool, the tensioning tool including a gripper, and the gripper is configured to adjust the tension on the tether by advancing to the anchor for any anchor in the series, gripping the tether at the anchor, and forming a loop from the tether by pulling the tether through the lock, the lock being configured to lock the head to the loop when it is locked.

[0021] In some embodiments, the grasper is configured to be advanced through the lock to grasp the tether.

[0022] In some embodiments, the tensioning tool comprises a flexible tube, the gripper is configured to extend through the tube, the gripper is configured to pull the ring into the tube, and / or the tensioning tool is configured to release the bend once the lock has locked the head to the ring.

[0023] In some embodiments, for each of the anchors: (i) the tube is configured to unlock the lock by applying an unlocking force to the lock, and / or (ii) the lock is biased to lock in the absence of the unlocking force.

[0024] In some embodiments: (i) for each of the anchors, the lock includes a first locking arm and a second locking arm, each of the locking arms being hingedly connected to the head, and / or (ii) the tube is configured to transition the lock toward an unlocked state by pushing the locking arms in a manner that causes each of the locking arms to pivot away from each other.

[0025] In some embodiments, the lock is configured to lock onto the bend when the tube is withdrawn from the head such that the locking arms pivot toward each other.

[0026] In some embodiments, the implant further comprises a leader anchor secured to the distal end of the tether.

[0027] In some embodiments, for each of the anchors, the tissue engaging element is helical, defines a central longitudinal axis of the anchor, and is configured to be screwed into tissue of the heart by rotation of the tissue engaging element about the central longitudinal axis.

[0028] In some embodiments, for each of the anchors, the head is configured to facilitate threading of the tissue engaging element into the tissue while remaining slidably coupled to the tether.

[0029] In some embodiments, for each of the anchors: (i) the head includes a peripheral wall that limits the central longitudinal axis, and / or (ii) the head is slidably coupled to the tether by the tether extending transversely through the head through a hole defined in the peripheral wall.

[0030] In some embodiments, for each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

[0031] In some embodiments, for each of the anchors, the tissue engaging element is rotationally lockable relative to the peripheral wall.

[0032] In some embodiments, for each of the anchors, the lock is disposed inboard relative to the peripheral wall.

[0033] In some embodiments, for each of the anchors, the lock defines a pressing surface and is configured to lock the head to the tether by pressing the pressing surface against the tether.

[0034] In some embodiments, for each of the anchors, the lock includes a pressing plate defining the pressing surface.

[0035] In some embodiments, for each of the anchors, the lock comprises a spring configured to lock the head to the tether by pressing the pressing surface against the tether.

[0036] In some embodiments, for each of the anchors, the spring is configured to press the pressing surface against the tether by axially moving the pressing surface relative to the tissue engaging element.

[0037] In some embodiments, for each of the anchors: (A) the head includes a shell and a lateral button, and / or (B) the lock is configured such that: (i) the spring that axially moves the pressing surface relative to the tissue engaging element protrudes the button laterally from the shell, and / or (ii) the lock is unlocked by pressing the button inside by axially moving the pressing surface relative to the shell.

[0038] In some embodiments, for each of the anchors, the pressing surface is defined by a piston disposed within the housing, the piston further defining a first bearing surface, and the button defining a second bearing surface inclined relative to the first bearing surface, such that by sliding the second bearing surface over the first bearing surface, pressing the button from the inside causes the pressing surface to move axially relative to the housing.

[0039] In some embodiments, for each of the anchors, the first bearing surface is inclined relative to a central longitudinal axis of the anchor.

[0040] In some embodiments, for each of the anchors, the second bearing surface is inclined relative to a central longitudinal axis of the anchor.

[0041] In some embodiments, for each of the anchors, the button is attached to a wedge defining the second bearing surface.

[0042] In some embodiments, for each of the anchors, the spring is configured to press the pressing surface against the tether by moving the pressing surface axially away from the tissue engaging element.

[0043] In some embodiments, for each of the anchors: (i) the head defines a peripheral wall that limits the central longitudinal axis, (ii) the head is slidably coupled to the tether by having the tether extend transversely through the head through a hole defined in the peripheral wall, (iii) at least the pressing surface of the lock is disposed inwardly relative to the peripheral wall, and / or (iv) the spring is configured to press the pressing surface against the tether by moving the pressing surface across the hole.

[0044] In some embodiments, for each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

[0045] In some embodiments, for each of the anchors, the tissue engaging element is rotationally lockable relative to the peripheral wall.

[0046] In some embodiments, for each of the anchors, (i) the head includes a shell, the shell includes a proximal portion and a base portion, the proximal portion and the base portion are axially separated at a middle section, and the peripheral wall is disposed at the middle section, and / or (ii) the head is connected to the tissue engaging element via the base portion, and the proximal portion, the base portion and the tissue engaging element are rotationally and axially locked relative to each other and are rotatably connected to the peripheral wall.

[0047] In some embodiments, the lock and the peripheral wall axially traverse the intermediate section.

[0048] In some embodiments, the system / device further includes a delivery tool configured to advance the anchor transluminally to the heart and comprising: (i) a flexible tube that can be advanced transluminally to the heart, and / or (ii) a driver sized to extend through the flexible tube.

[0049] In some embodiments, the delivery tool is configured to, for each of the anchors, sequentially: (i) anchor the anchor to the tissue such that a segment of the tether extends from a previous one of the anchors to the anchor, (ii) subsequently adjust the tension on the segment of the tether, and / or (iii) subsequently lock the lock.

[0050] In some embodiments, for each of the anchors: (i) the lock is biased to lock, (ii) the head includes a shell and a lateral button, the lateral button is operably connected to the lock so that the button protrudes laterally from the shell when the lock is unlocked, and / or (iii) the delivery tool is configured to maintain the lock unlocked by medially constraining the button.

[0051] In some embodiments, for each of the anchors, the delivery tool is configured to maintain the lock unlocked by constraining the button inside the tube, and is configured to lock the lock by deploying the head out of the tube.

[0052] In some embodiments, the housing of each anchor is keyed with an anchor key, and the tube is complementarily keyed with a drive key, such that the delivery tool can apply torque to the anchor by rotation of the tube.

[0053] In some embodiments, for each anchor, the button is positioned at the anchor key.

[0054] In some embodiments, for each anchor, the anchor key comprises a countersunk key at which the button is seated, and the delivery tool is configured to maintain the lock unlocked by constraining the button inboard of the drive key.

[0055] In some embodiments, for each of the anchors, the lock is biased to lock, and the delivery tool is configured to constrain the anchor to unlock while adjusting the tension on the segment of the tether.

[0056] In some embodiments, for each of the anchors, the delivery tool is configured to constrain the anchor to unlock while advancing the anchor transluminally into the heart.

[0057] In some embodiments, for each of the anchors, the delivery tool is configured to constrain the anchor to unlock while anchoring the anchor to the tissue.

[0058] In some embodiments, for each of the anchors, the delivery tool is configured to transluminally advance the anchor to the heart after anchoring the previous one of the anchors to the tissue.

[0059] In some embodiments, for each of the anchors, the delivery tool is configured to transluminally advance the anchor into the heart after locking the lock of the previous one of the anchors.

[0060] According to some embodiments, a method (e.g., usable at or for use at tissue of a subject's heart) includes percutaneously implanting an elongated implant along the tissue such that the implant defines a path along the tissue by: (i) anchoring a first segment of the implant along a first portion of the path, and / or (ii) subsequently anchoring a second segment of the implant along a second portion of the path.

[0061] In some embodiments, the method includes, after anchoring the first segment and before anchoring the second segment: (i) contracting the first portion of the path by reducing the length of the first segment, and / or (ii) fixing the length of the first segment while the first portion of the path remains contracted.

[0062] In some embodiments, the method further includes, after anchoring the second segment and while the length of the first segment remains fixed: (i) contracting the second portion of the path by reducing the length of the second segment, and / or (ii) fixing the length of the second segment while the second portion of the path remains contracted.

[0063] In some embodiments: (i) the implant comprises a first segment, a second segment, and a third segment, wherein the first segment, the second segment, and the third segment are telescopically connected to each other in series, (ii) the first segment of the implant comprises a portion of the first segment and a portion of the second segment, (iii) the second segment of the implant comprises a portion of the second segment and a portion of the third segment, (iv) contracting the first portion of the path comprises contracting the first portion of the path by reducing the length of the first segment by telescopically contracting the first segment into the second segment, and / or (v) contracting the second portion of the path comprises contracting the second portion of the path by reducing the length of the second segment by telescopically contracting the second segment into the third segment.

[0064] In some embodiments: (i) fixing the length of the first segment includes locking the first segment to the second segment, and / or (ii) fixing the length of the second segment includes locking the second segment to the third segment.

[0065] In some embodiments: (i) the first segment includes a first anchor, the second segment includes a second anchor, and the third segment includes a third anchor, (ii) anchoring the first segment of the implant includes anchoring the first anchor and the second anchor to the tissue, and / or (iii) anchoring the second segment of the implant includes anchoring the second anchor and the third anchor to the tissue.

[0066] In some embodiments: (i) the implant includes a tether, (ii) contracting the first portion of the path includes contracting the first portion of the path by reducing the length of the first segment by applying tension to the tether, and / or (iii) contracting the second portion of the path includes contracting the second portion of the path by reducing the length of the second segment by applying tension to the tether.

[0067] In some embodiments, percutaneously implanting the implant along the tissue includes implanting the implant along the tissue such that the tether defines the path along the tissue.

[0068] In some embodiments: (i) fixing the length of the first segment includes locking a first lock to the tether, and / or (ii) fixing the length of the second segment includes locking a second lock to the tether.

[0069] In some embodiments, the method further comprises percutaneously advancing the first lock to the heart after anchoring the first section of the implant along the first portion of the path.

[0070] In some embodiments, advancing the first lock into the heart includes advancing the first lock into the heart before anchoring the second segment of the implant along the second portion of the path.

[0071] In some embodiments, percutaneously advancing the first lock to the heart comprises percutaneously sliding the lock over and along the tether.

[0072] In some embodiments, the implant includes a first locking anchor and a second locking anchor, each of which includes: (i) a tissue engaging element (e.g., one or more of a thread, a screw, a tip, a hook, a barb, a dart, an arm, a nail, a sharp portion, a clip, a swab, etc.), and / or (ii) a head attached to the tissue engaging element, slidably connected to the tether, and including a lock.

[0073] In some embodiments, percutaneously implanting the implant along the tissue includes anchoring the first locking anchor and the second locking anchor to the tissue.

[0074] In some embodiments, the first lock is a lock of the first locking anchor, and fixing the length of the first segment includes locking the lock of the first locking anchor to the tether. In some embodiments, the second lock is a lock of the second locking anchor, and fixing the length of the second segment includes locking the lock of the second locking anchor to the tether.

[0075] In some embodiments, the method further includes percutaneously sliding each of the first and second locking anchors over and along the tether to the heart.

[0076] In some embodiments, percutaneously implanting the implant along the tissue includes securing a distal portion of the tether to the tissue by anchoring a leader anchor coupled to the tether to the tissue.

[0077] In some embodiments, sliding each of the first and second locking anchors percutaneously over and along the tether to the heart includes, after securing the distal portion of the tether to the tissue by anchoring the lead anchor to the tissue, sliding each of the first and second locking anchors percutaneously distally over and along the tether toward the lead anchor.

[0078] In some embodiments, anchoring the first locking anchor and the second locking anchor to the tissue includes anchoring the first locking anchor and the second locking anchor to the tissue using an anchor driver.

[0079] In some embodiments, for each of the first locking anchor and the second locking anchor, the lock is biased toward locking, and anchoring the locking anchor to the tissue includes anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked.

[0080] In some embodiments, for each of the first locking anchor and the second locking anchor, locking the lock to the tether includes releasing the lock such that the lock responsively locks.

[0081] In some embodiments, for each of the first locking anchor and the second locking anchor, anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked includes anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked by inhibiting a button of the head from moving laterally outward from a housing of the head.

[0082] In some embodiments, for each of the first locking anchor and the second locking anchor, locking the lock to the tether includes applying a locking force to the lock using the anchor driver.

[0083] In some embodiments, for each of the first locking anchor and the second locking anchor, the locking force is a rotational locking force, and applying the locking force to the lock includes applying the rotational locking force to the lock.

[0084] The above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0085] According to some embodiments, a method (e.g., usable at or for use at tissue of a subject's heart) includes: (i) percutaneously anchoring a first anchor of an implant to a first portion of the tissue, and / or (ii) subsequently percutaneously anchoring a second anchor of the implant to a second portion of the tissue, with a first portion of the tissue disposed between the first portion and the second portion. In some embodiments, the method includes subsequently contracting the first portion of the tissue by pulling the first anchor and the second anchor together. In some embodiments, while the first portion of the tissue remains contracted, the method includes fixing a distance between the first anchor and the second anchor.

[0086] In some embodiments, the method includes subsequently percutaneously changing a distance between the third anchor and the second anchor of the implant by sliding the third anchor relative to the second anchor.

[0087] In some embodiments, the method includes subsequently anchoring the third anchor to a third location of the tissue, with a second portion of the tissue positioned between the second location and the third location, and subsequently contracting the second portion of the tissue by pulling the second anchor and the third anchor together while maintaining a fixed distance between the first anchor and the second anchor.

[0088] In some embodiments, the method further comprises fixing a distance between the second anchor and the third anchor while the second portion of the tissue remains contracted.

[0089] In some embodiments: the implant includes a tether, and percutaneously anchoring the second anchor includes percutaneously anchoring the second anchor while the tether is coupled to the first anchor and slidably coupled to the second anchor.

[0090] In some embodiments, drawing the first anchor and the second anchor together includes sliding the tether relative to the second anchor.

[0091] In some embodiments, fixing the distance between the first anchor and the second anchor includes inhibiting sliding of the tether relative to the second anchor by locking a first lock to the tether.

[0092] In some embodiments, drawing the second anchor and the third anchor together includes sliding the tether relative to the third anchor.

[0093] In some embodiments, fixing the distance between the second anchor and the third anchor includes locking a second lock to the tether.

[0094] In some embodiments, sliding the tether relative to the second anchor includes sliding the tether in a first direction relative to the second anchor.

[0095] In some embodiments, locking the first lock to the tether includes inhibiting sliding of the tether relative to the second anchor in a second direction opposite to the first direction by locking the first lock to the tether.

[0096] In some embodiments, the method further includes inhibiting additional sliding of the tether relative to the second anchor in the first direction by locking a third lock to the tether.

[0097] In some embodiments, locking the third lock to the tether includes locking the third lock to the tether before drawing the second anchor and the third anchor together.

[0098] The above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0099] According to some embodiments, a method (e.g., usable at or for use at tissue of a subject's heart) includes percutaneously implanting a first segment of an implant along a first portion of the tissue by anchoring a first anchor of the implant to a first location of the tissue, and anchoring a second anchor of the implant to a second location of the tissue, the first portion of the tissue being positioned between the first location and the second location.

[0100] In some embodiments, the method further comprises subsequently contracting the first portion of the tissue by reducing the length of the first segment. In some embodiments, the method comprises fixing the length of the first segment while the first portion of the tissue remains contracted.

[0101] In some embodiments, the method includes subsequently percutaneously implanting a second section of the implant along a second portion of the tissue by anchoring a third anchor of the implant to a third location in the tissue.

[0102] In some embodiments, the method includes subsequently contracting the second portion of the tissue by reducing the length of the second segment while the length of the first segment remains fixed. In some embodiments, the method includes fixing the length of the second segment while the second portion of the tissue remains contracted.

[0103] In some embodiments, the second portion of the tissue is positioned between the second site and the third site, and implanting the second segment of the implant along the second portion of the tissue includes implanting the second segment of the implant along the second portion of the tissue positioned between the second site and the third site.

[0104] In some embodiments: the second portion of the tissue is positioned between the third location and the fourth location, and implanting the second segment of the implant along the second portion of the tissue includes implanting the second segment of the implant along the second portion of the tissue by anchoring the third anchor of the implant to the third location of the tissue, and anchoring the fourth anchor of the implant to the fourth location of the tissue.

[0105] According to some embodiments, a system and / or device (e.g., usable at or for use at a subject's heart) includes: (i) a segmented implant comprising a plurality of segments telescopically coupled to one another in series, each of the segments comprising an anchor; and / or (ii) a delivery tool.

[0106] In some embodiments, the delivery tool is configured to: (i) deliver the implant percutaneously to the heart, (ii) anchor each of the anchors to tissue of the heart, and / or (iii) contract the tissue by telescopically contracting the implant while each of the anchors remains anchored to the tissue.

[0107] In some embodiments, the delivery tool is configured to telescopically extend the implant into the heart.

[0108] In some embodiments, each of the segments may be articulated relative to an adjacent segment of the segment.

[0109] In some embodiments, each of the segments further comprises a lock configured such that, for each of the segments, locking of the lock fixes an amount of telescoping between the segment and an adjacent segment of the segment.

[0110] In some embodiments, each of the anchors is biased toward a presumed anchoring position, and the delivery tool is configured to: (i) percutaneously deliver the implant to the heart while each of the anchors is constrained in the delivery position, and / or (ii) release each of the anchors within the heart to allow each of the anchors to responsively move toward the anchoring position.

[0111] In some embodiments, the implant has a delivery state in which, for each of the segments, the anchor is constrained in the delivery position by an adjacent one of the segments.

[0112] In some embodiments, in the delivery state, for each of the segments, the anchor is constrained in the delivery position by being disposed within an adjacent one of the segments.

[0113] In some embodiments, for each of the segments, the delivery tool is configured to release the anchor by telescopically extending the segment beyond an adjacent one of the segments.

[0114] In some embodiments, the delivery tool is configured to secure a first segment of the implant (e.g., an elongated member thereof) along a first portion of a path along the tissue by: (i) anchoring the anchor of a first segment of the plurality of segments to a first location on the tissue, and / or (ii) anchoring the anchor of a second segment of the plurality of segments to a second location on the tissue.

[0115] In some embodiments, the delivery tool is configured to secure a second segment of the implant (e.g., an elongated member thereof) along a second portion of a path along the tissue by anchoring an anchor of a third segment of the plurality of segments to a third location on the tissue, wherein the first segment includes a portion of the first segment and a portion of the second segment, and the second segment includes a portion of the second segment and a portion of the third segment.

[0116] In some embodiments, the delivery tool is configured to contract the tissue at the first portion of the pathway by telescopically contracting the first segment into the second segment.

[0117] In some embodiments, the delivery tool is configured to contract the tissue at the second portion of the pathway by contracting the second segment into the third segment independently of contracting the first segment into the second segment.

[0118] In some embodiments, the delivery tool is configured to lock the first segment to the second segment after telescopically contracting the first segment into the second segment, and to lock the second segment to the third segment after telescopically contracting the second segment into the third segment.

[0119] In some embodiments, the delivery tool is configured to contract the tissue at the second portion of the pathway by contracting the second segment into the third segment after locking the first segment to the second segment.

[0120] In some embodiments, the delivery tool is configured to telescopically extend the implant within the heart by: (i) telescopically extending the first segment from the second segment prior to anchoring the anchor of the second segment, and / or (ii) telescopically extending the second segment from the third segment after anchoring the anchor of the second segment and prior to anchoring the anchor of the third segment.

[0121] The above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0122] According to some embodiments, a system (eg, usable at or for use at tissue of a subject's heart) includes an implant and a delivery tool. In some embodiments, the implant includes an elongated member, a plurality of anchors, and a plurality of locks.

[0123] In some embodiments, the delivery tool is configured to implant the implant into the tissue such that the elongated member defines a path along the tissue by: (i) anchoring a first segment of the elongated member along a first portion of the path using one or more of the anchors, and (ii) subsequently anchoring a second segment of the elongated member along a second portion of the path using one or more of the anchors.

[0124] In some embodiments, the delivery tool is configured to contract the tissue by: (i) contracting the first portion of the path by reducing the length of the first segment after anchoring the first segment and before anchoring the second segment, (ii) fixing the length of the first segment using at least a first lock of the plurality of locks while the first portion of the path remains contracted, (iii) contracting the second portion of the path by reducing the length of the second segment after anchoring the second segment and while the length of the first segment remains fixed, and / or (iv) fixing the length of the second segment using at least a second lock of the plurality of locks while the second portion of the path remains contracted.

[0125] According to some embodiments, a system and / or device (e.g., usable at or for use at a subject's heart) includes an implant, a plurality of tension regulators, and a delivery tool. In some embodiments, the implant includes: (i) a tether, and / or (ii) a series of anchors, each of which includes a tissue engaging element (e.g., one or more of a spiral, a screw, a tip, a hook, a barb, a dart, an arm, a nail, a sharp portion, a clip, a swab, etc.), and optionally also includes a head connected to the tissue engaging element. In some embodiments, the anchor (e.g., its head, etc.) can be slidably connected to the tether.

[0126] In some embodiments, the delivery tool includes: (i) a tube that can be advanced transluminally into the heart, (ii) an anchor driver configured to advance the anchor through the tube and, for each of the anchors, sequentially anchor the anchor intracardially to tissue of the heart by driving the tissue engaging element into the tissue, and / or (iii) an applicator configured to intracardially connect the tension regulator to the implant.

[0127] In some embodiments, the applicator is configured to intracentrally connect the tension adjuster to an adjacent anchor in the series.

[0128] In some embodiments, the applicator is configured to intracentrally connect the tension adjuster to the tether.

[0129] In some embodiments, the applicator is configured to intracentrally connect the tension adjuster to the tether between adjacent anchors in the series.

[0130] In some embodiments, each of the tension adjusters is a connector configured to connect corresponding pairs of adjacent anchors in the series.

[0131] In some embodiments, each of the tension adjusters is configured to pull a corresponding pair of anchors toward each other.

[0132] In some embodiments, each of the tension adjusters is configured to inhibit a corresponding pair of anchors from moving away from each other.

[0133] In some embodiments, each of the tension adjusters is a spacer configured to connect to the tether between corresponding pairs of anchors in the series.

[0134] In some embodiments, each of the spacers is tubular.

[0135] In some embodiments, for each of the spacers, the spacer applicator is configured to intracentrally connect the spacer to the tether while the spacer is constrained in an open state in which the spacer has a substantially C-shaped cross-section.

[0136] In some embodiments, the tube defines a primary lumen, the anchor driver is configured to advance each of the anchors out of the lumen, and the spacer applicator is configured to advance each of the spacers out of a secondary lumen disposed laterally from the primary lumen.

[0137] According to some embodiments, a method includes: (i) implanting an implant along tissue of the heart of a subject (e.g., a living subject, a simulator, etc.) by anchoring a series of anchors of the implant to the tissue, the anchors being slidably connected to a tether of the implant; (ii) subsequently, applying tension to the tether; and / or (iii) subsequently, adjusting the tension by applying a tension adjuster between adjacent pairs of anchors in the series.

[0138] In some embodiments, the tension adjuster comprises a spacer, and applying the tension adjuster between the pair of adjacent anchors comprises urging the pair of adjacent anchors away from each other by connecting the spacer to the tether between the pair of adjacent anchors.

[0139] In some embodiments, the tension adjuster includes a connector, and applying the tension adjuster between the pair of adjacent anchors includes pulling the pair of adjacent anchors toward each other by connecting the connector to two anchors in the pair of adjacent anchors.

[0140] The above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0141] According to some embodiments, a method includes: (i) identifying a subject (e.g., a living subject, a simulant, etc.) in which an implant has been implanted along tissue of the subject's heart, the implant comprising a series of anchors slidably coupled to a tether, and the implant has been implanted by anchoring the series of anchors to the tissue; and / or (ii) in response to the identification, adjusting the tension on the tether by applying a tension adjuster between adjacent pairs of anchors in the series.

[0142] In some embodiments, the tension adjuster comprises a spacer, and applying the tension adjuster between the pair of adjacent anchors comprises urging the pair of adjacent anchors away from each other by connecting the spacer to the tether between the pair of adjacent anchors.

[0143] In some embodiments, the tension adjuster includes a connector, and applying the tension adjuster between the pair of adjacent anchors includes pulling the pair of adjacent anchors toward each other by connecting the connector to two anchors in the pair of adjacent anchors.

[0144] In accordance with some embodiments, a system and / or device (e.g., usable or for use with a tether) includes a lock comprising: (i) a tubular wall defining a lumen sized to receive the tether therethrough; (ii) a window cut from the wall; and / or (iii) a tab cut from the wall and positioned opposite the window and biased to deflect across the lumen and protrude into the window in a manner that locks the lock to the tether received through the lumen.

[0145] In some embodiments, the window is the first window of a plurality of windows cut from the wall.

[0146] In some embodiments, the tab is the first tab of a plurality of tabs cut from the wall.

[0147] In some embodiments, each tab of the plurality of tabs is biased to deflect across the lumen and protrude into a corresponding window facing that tab in a manner that locks the lock to the tether.

[0148] In some embodiments, the system / device further comprises a cutter. In some embodiments, the cutter comprises a cutting element (e.g., a blade, a knife, scissors, clamps, a razor, a scalpel, an edge, a sharp edge, a cutting edge, etc.) sized to receive the tether passing therethrough.

[0149] In some embodiments, the distal portion of the cutting element defines a pair of cutting edges facing each other.

[0150] In some embodiments, the cutter includes an outer sleeve that can be slid over and along the cutting element in a manner that moves the cutting edges toward each other, thereby cutting the tether.

[0151] In some embodiments, the cutting element is manufactured from a single piece of reserve tube.

[0152] In some embodiments, the cutter is advanceable over and along the tether to the heart while maintaining the outer cannula stationary relative to the cutting element.

[0153] In some embodiments, the cutter is adapted to advance the lock transluminally over and along the tether to the heart of a subject (eg, a living subject, a simulator, etc.).

[0154] In some embodiments, the cutter is adapted to advance the lock transluminally over the tether and along the tether to the heart by pushing the distal end of the cutter against the proximal end of the lock.

[0155] In some embodiments, the cutting element comprises an arm pair, each arm having: (i) a proximal portion that extends distally and away from the proximal portion of the other arm in the pair, and / or (ii) a distal portion that extends distally and toward the distal portion of the other arm in the pair.

[0156] In some embodiments, each arm defines a discrete elbow between the proximal portion and the distal portion.

[0157] In some embodiments, each arm defines a continuous curve from the proximal portion to the distal portion.

[0158] In some embodiments, for each arm in the pair, the cutting edge in the pair of cutting edges is defined by the distal portion of the arm.

[0159] In some embodiments, the proximal portion extends outwardly such that the arms collectively define a diameter wider than an inner diameter of the outer sleeve, such that sliding the outer sleeve distally over and along the proximal portion squeezes the proximal portion together, thereby causing the arms to pivot inwardly toward each other.

[0160] In some embodiments, for each arm of the pair, the proximal portion is disposed at a shallower angle relative to a central axis of the cutter than the distal portion is disposed at an angle relative to the central axis.

[0161] In some embodiments, for each arm of the pair, the proximal portion is longer than the distal portion.

[0162] In some embodiments, the system / device further comprises a blocking rod adapted to maintain the lock in an unlocked state in which the tab is prevented from deflecting across the lumen and into the window.

[0163] In some embodiments, the rod is adapted to extend through the lumen along the tether, and withdrawing the rod from the lock transitions the lock toward a locked state in which the tab is deflected across the lumen and into the window.

[0164] According to some embodiments, a method is further provided (e.g., usable with or for use with a subject's heart), the method comprising using a cutter to push a lock over a tether and distally along the tether toward the heart cavity, the lock comprising: a tubular wall that limits a lumen through which the tether extends; a window cut from the wall; and a tab cut from the wall and positioned opposite the window.

[0165] In some embodiments, the method further comprises subsequently withdrawing a blocking rod from the lock, causing the tab to responsively deflect across the lumen and into the window, thereby locking the lock to the tether.

[0166] In some embodiments, the method further comprises subsequently cutting the tether by advancing an outer sleeve over and along the cutter such that the outer sleeve presses the pair of cutting edges defined by the cutter toward each other.

[0167] In some embodiments, the method further comprises subsequently withdrawing the cutter from the heart.

[0168] In some embodiments, pushing the lock distally over and along the tether includes pushing the lock over and along the tether while the rod extends through the lock.

[0169] In some embodiments, pushing the lock distally over and along the tether includes pushing the lock over and along the tether while the rod extends distally out of the cutter and through the lock.

[0170] In some embodiments, withdrawing the rod from the lock includes withdrawing the rod proximally into the cutter.

[0171] According to some embodiments, a method includes implanting an implant along tissue of a heart of a subject (eg, a living subject, a mimic, etc.) by anchoring a series of anchors of the implant to the tissue.

[0172] In some embodiments, the anchor is slidably coupled to a tether of the implant.

[0173] In some embodiments, the method further comprises subsequently pulling the tether through a lock of a head of the series of anchors to form a loop of the tether.

[0174] In some embodiments, the method further comprises subsequently locking the lock to the ring.

[0175] In some embodiments, pulling the loop of the tether through the lock includes grasping the tether and pulling the tether into the lock.

[0176] In some embodiments, locking the lock to the ring includes withdrawing an unlocking tool from the lock such that the lock responsively transitions toward a locked state.

[0177] In some embodiments, the method further comprises unlocking the lock prior to pulling the tether through the lock.

[0178] The above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0179]

[0013] According to some embodiments, there is further provided a system (eg, usable or for use with a tether) comprising an anchor.

[0180] In some embodiments, the anchor has an anchor head and a tissue engaging element extending distally away from the head to define an anchor axis of the anchor.

[0181] In some embodiments, the anchor head defines a channel extending through the head transverse to the anchor axis and is sized to be threaded onto the tether so as to be slidable over and along the tether and includes a lock in communication with the channel.

[0182] In some embodiments, the anchor head defines a proximal opening that provides access to the channel and the lock.

[0183] In some embodiments, the system comprises a tool comprising a grasper configured to be advanced through the lock (eg, through the opening) to the passageway.

[0184] In some embodiments, the system includes the tether threaded through the channel, and the grasper is configured to grasp the tether within the channel and form the tether into a loop by pulling the tether proximally through the lock.

[0185] In some embodiments, the lock is configured to lock to the ring in response to withdrawing the tool from the lock.

[0186] In some embodiments, the tool comprises a tube and the grasper is configured to extend through the tube. In some embodiments, the grasper is configured to pull the loop into the tube.

[0187] In some embodiments, the gripper is configured to release the ring once the lock has locked onto the ring.

[0188] In some embodiments, the tube is configured to unlock the lock by applying an unlocking force to the lock.

[0189] In some embodiments, the lock is biased to lock in the absence of the unlocking force.

[0190] In some embodiments, the tube is configured to access the lock through the opening.

[0191] In some embodiments, the lock includes a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to the head.

[0192] In some embodiments, the tube is configured to transition the lock toward the unlocked state by pushing against the locking arms in a manner that causes each of the locking arms to pivot away from each other.

[0193] In some embodiments, the lock is configured to lock to the ring in response to withdrawal of the tube from the head by the locking arms pivoting toward each other.

[0194] According to some embodiments, a system and / or device (eg, usable or for use with a tether) includes a lock comprising an outer tube and an inner tube coaxially positioned within the outer tube.

[0195] In some embodiments, the inner tube is secured to the outer tube at an attachment point.

[0196] In some embodiments, the inner tube is shaped to define a lumen along a longitudinal axis of the lock, the lumen being sized to receive the tether therethrough.

[0197] In some embodiments, the inner tube is axially compressible toward the attachment point in a manner that clamps the inner tube to the tether within the lumen.

[0198] In some embodiments, the inner tube is deformable in such a way that axially compressing the inner tube toward the attachment point causes the inner tube to bend inwardly against the tether.

[0199] In some embodiments, the inner tube has a first end and a second end, and the inner tube is axially compressible toward the attachment point by moving the second end toward the first end.

[0200] In some embodiments, the inner tube is annular at each of the first end and the second end thereof.

[0201] In some embodiments, the attachment point is at the first end.

[0202] In some embodiments, the inner tube is axially compressible toward the attachment point by applying a torque to the second end.

[0203] In some embodiments, the inner tube defines a helix having a series of turns, and applying the torque reduces a pitch of the helix.

[0204] In some embodiments, the helix is ​​a double helix.

[0205] In some embodiments, the inner tube is axially compressible toward the attachment point by pushing the second end toward the first end.

[0206] In some embodiments, the lumen is disposed along the longitudinal axis of the lock, and the inner tube is axially compressible toward the attachment point by pushing the other end of the inner tube toward the other end of the inner tube along the longitudinal axis.

[0207] In some embodiments, the lock has an unlocked state in which the lock is slidable along the tether, and / or the lock is transitionable toward a locked state by axially compressing the inner tube.

[0208] In some embodiments, the lock is transitionable toward the locked state by moving the second end into the outer tube.

[0209] In some embodiments, in the unlocked state of the lock, the second end is disposed outside the outer tube, and / or in the locked state of the lock, the second end is disposed inside the outer tube.

[0210] In some embodiments, the lock comprises a snap-fit ​​mechanism between the inner tube and the outer tube, and the inner tube is axially compressible toward the attachment point until the inner tube snaps into the outer tube, the snap fit preventing axial decompression of the inner tube.

[0211] In some embodiments, the inner tube defines a window and the outer tube defines a tongue adapted to extend into the window, and the inner tube is axially compressible toward the attachment point until the tongue extends into the window.

[0212] In some embodiments, the outer tube defines a window and the inner tube defines a tongue adapted to extend into the window, and the inner tube is axially compressible toward the attachment point until the tongue extends into the window.

[0213] In some embodiments, the inner tube is shaped to define an hourglass form having a first bulb, a second bulb, and a waist therebetween, and the inner tube is axially compressible toward the attachment point in a manner that clamps the waist to the tether.

[0214] In some embodiments, the inner tube is axially compressible toward the attachment point by pushing the first bulb toward the second bulb.

[0215] In some embodiments, each of the first bulb and the second bulb is annular.

[0216] According to some embodiments, a method (e.g., usable or for use with a tether) includes advancing a lock transluminally into the heart of a subject (e.g., a living subject, a simulant, etc.) over and along the tether, the lock comprising an inner tube coaxially positioned within an outer tube and secured to the outer tube at an attachment point, the tether extending through a lumen defined by the inner tube.

[0217] In some embodiments, the method includes locking the lock to the tether at the heart by axially compressing the inner tube toward the attachment point such that the inner tube clamps to the tether within the lumen.

[0218] In some embodiments, compressing the inner tube toward the attachment point such that the inner tube clamps to the tether includes compressing the inner tube toward the attachment point such that a diameter of the inner tube narrows.

[0219] In some embodiments, axially compressing the inner tube toward the attachment point includes pushing the inner tube further into the outer tube.

[0220] In some embodiments, the inner tube has a first end and a second end, and axially compressing the inner tube toward the attachment point includes axially compressing the inner tube by pushing the second end toward the first end.

[0221] In some embodiments, the attachment point is disposed at the first end.

[0222] In some embodiments, advancing the lock transluminally includes advancing the lock transluminally while the second end is disposed outside the outer tube, and / or pushing the second end toward the first end includes pushing the second end into the outer tube.

[0223] In some embodiments, the lumen is disposed along a longitudinal axis of the lock, and axially compressing the inner tube toward the attachment point comprises axially compressing the inner tube by pushing one end of the inner tube axially along the longitudinal axis toward another end of the inner tube.

[0224] In some embodiments, axially compressing the inner tube toward the attachment point includes axially compressing the inner tube toward the attachment point until the inner tube snaps fit to the outer tube, the snap fit preventing axial decompression of the inner tube.

[0225] In some embodiments, the lock defines a window and a tongue, and compressing the inner tube axially toward the attachment point until the inner tube snaps into the outer tube includes compressing the inner tube axially toward the attachment point until the tongue protrudes into the window.

[0226] In some embodiments, compressing the inner tube axially toward the attachment point until the tongue protrudes into the window includes compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window and automatically protrudes into the window in response to becoming aligned with the window.

[0227] In some embodiments, compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window includes compressing the inner tube axially toward the attachment point such that the tongue moves into axial alignment with the window.

[0228] In some embodiments, compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window includes compressing the inner tube axially toward the attachment point by twisting the inner tube toward the attachment point until the tongue moves into rotational alignment with the window.

[0229] In some embodiments, the outer tube defines the tongue and the inner tube defines the window, and compressing the inner tube axially toward the attachment point until the tongue extends into the window includes compressing the inner tube axially toward the attachment point until the tongue of the outer tube extends into the window of the inner tube.

[0230] In some embodiments, compressing the inner tube axially toward the attachment point such that the inner tube clamps to the tether includes compressing the inner tube axially toward the attachment point such that a portion of the inner tube bends against an inside of the tether.

[0231] In some embodiments, compressing the inner tube axially toward the attachment point such that a portion of the inner tube bends against the inside of the tether includes compressing the inner tube axially toward the attachment point such that the inner tube acquires an hourglass shape having a waist that is clamped to the tether.

[0232] In some embodiments, the inner tube has a first end portion and a second end portion and is formed to define a plurality of struts extending between the first end portion and the second end portion, and axially compressing the inner tube toward the attachment point such that the inner tube is clamped to the tether includes axially compressing the inner tube toward the attachment point such that the struts bend against the inside of the tether.

[0233] In some embodiments, each of the struts has an hourglass shape with a first bulb, a second bulb and a waist therebetween, and axially compressing the inner tube toward the attachment point so that the struts bend against the inside of the tether includes axially compressing the inner tube toward the attachment point so that the waist of each of the struts is clamped to the tether.

[0234] In some embodiments, axially compressing the inner tube toward the attachment point such that the inner tube clamps to the tether includes axially compressing the inner tube toward the attachment point in a manner that moves the first bulb toward the second bulb for each of the struts.

[0235] In some embodiments, axially compressing the inner tube toward the attachment point includes axially compressing the inner tube toward the attachment point such that the inner tube twists inwardly against the tether.

[0236] In some embodiments, the inner tube is shaped to define a helix having a series of turns and a pitch, and compressing the inner tube axially toward the attachment point so that the inner tube twists inwardly against the tether includes reducing the pitch by twisting the inner tube toward the attachment point.

[0237] In some embodiments, the spiral is a double spiral, and reducing the pitch includes reducing the pitch of the double spiral.

[0238] Any of the above methods and any methods using the systems, assemblies, devices, apparatus, etc. described herein can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). By simulation, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include a computerized and / or physical representation.

[0239] Any of the above-described systems, assemblies, devices, equipment, components, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure its safety for use on patients, and the methods herein may include (or the additional methods include or consist of) sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more of the systems, devices, equipment, components, etc. herein.

[0240] The present invention is not limited to what has been specifically shown and described above. On the contrary, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art, which will occur to those skilled in the art after reading the foregoing description. BRIEF DESCRIPTION OF THE DRAWINGS

[0241] Figure 1A -B and 2A-B are schematic illustrations of systems and techniques for use therewith according to some embodiments;

[0242] Figure 3-4 is a schematic illustration of an example of an implantation technique according to some embodiments;

[0243] Figure 5A - B and 6 are schematic illustrations showing systems, devices, and techniques for differentially contracting tissue along a path of an implant by applying tension modifiers to the implant, according to some embodiments;

[0244] Fig. 7A - F is a schematic illustration of a system and techniques for use therewith according to some embodiments;

[0245] Fig. 8A -C, 9A-B, 10A-B, 11A-G, 12A-C, 13A-B, 14A-B, 15A-C, and 16A-D are schematic illustrations of systems and techniques for use therewith according to some embodiments;

[0246] Fig.17A - E and 18 are schematic illustrations of systems and techniques for use therewith according to some embodiments;

[0247] Fig.19A - G is a schematic illustration of a system and technique for an implant of a tensioning system according to some embodiments;

[0248] Fig. 20A -C, 21, 22A-B, and 23A-E are schematic illustrations of systems or devices for use with a tether, according to some embodiments; and

[0249] Fig.24A -B, 25, and 26A-B illustrate various locks suitable for clamping to a tether of an implant according to some embodiments. DETAILED DESCRIPTION

[0250] This article describes systems, devices, methods, apparatuses, etc. for inhibiting tissue growth on implantable sheets. In some embodiments, systems, devices, methods, devices, etc. include equipment, and the equipment includes a sheet constructed of a multilayer structure and / or an implant incorporated into the sheet. The system, device, method, device, etc. can be configured to inhibit tissue growth thereon. Various examples of devices and / or methods for coating implants that inhibit tissue growth thereon are described. In some embodiments, the implant incorporated into the sheet is configured to support and / or guide the movement of the leaflets of the valve of the heart of a subject (e.g., a living subject, a simulator, etc.). An example in which such an implant may be useful is another problem of experiencing swinging, prolapse, rigidity, and / or causing regurgitation when used at the posterior leaflet of the mitral valve.

[0251] The described systems, devices, methods, apparatuses, etc. should not be construed as limiting in any way. On the contrary, the present disclosure relates to all novel and non-obvious features and aspects of each disclosed coating procedure and application, either individually or in various combinations and sub-combinations formed with each other. The disclosed systems, devices, methods, apparatuses, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, devices, methods, apparatuses, etc. require the presence of any one or more specific advantages or problem-solving. In addition, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a subject (e.g., a living subject or a non-living simulated object (such as a corpse, a cadaver heart, a simulated body, etc.)).

[0252] Various embodiments of systems, devices, examples of prosthetic implants, and the like may be coated using the coating methods disclosed herein, and any combination of the features, components, and options may be made unless specifically excluded. For example, various polymers that inhibit tissue growth thereon may be used with any appropriate method for incorporating them into a device, even if a specific combination of heat and / or pressure is not explicitly described. Likewise, different configurations and features of the devices may be mixed and matched, such as by combining any sheet material with any frame form, even if not explicitly disclosed. Simply put, the various components of the disclosed systems may be combined unless mutually exclusive or physically impossible.

[0253] Although the operations of some of the disclosed methods are described in a particular sequential order for ease of presentation, it should be understood that unless the specific language set forth below requires a particular ordering, this description encompasses rearrangements. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, devices, apparatuses, methods, etc. may be used in conjunction with other systems, devices, apparatuses, methods, etc.

[0254] refer to Figure 1A -B and 2A-B, which are schematic illustrations of a system 20 and a technique for implanting an implant 22 of the system, according to some embodiments. System 20 is a tissue adjustment system and can be used to adjust the size of tissue 10 (such as tissue of a subject's heart). For example, system 20 can be an annuloplasty system, and implant 22 can be an annuloplasty structure (e.g., an annuloplasty ring or band) to be implanted at the annulus of a valve of the heart (e.g., along the annulus of a valve of the heart). Implant 22 can include a plurality of anchors 30 and tethers 26 (e.g., retraction members), the anchors being slidably coupled to the tethers, such as by being threaded onto the tethers.

[0255] Tether 26 is an elongated member (e.g., a wire, cable, thread, suture, filament, ribbon, etc.) and is generally flexible. Tether 26 may comprise metal, polymer, and / or natural fibers. In some embodiments, tether 26 comprises suture. In some embodiments, tether 26 comprises a superelastic material. Tether 26 may comprise nitinol, ePTFE, PTFE, polyester, stainless steel, and / or cobalt chromium.

[0256] Each anchor 30 includes a tissue engaging element 34 (e.g., one or more of a spiral, a screw, a tip, a hook, a barb, a dart, an arm, a nail, a sharp portion, a clip, a swab, etc.). In some embodiments, each anchor may also optionally include a head 32, wherein the tissue engaging element extends distally away from the head. In some embodiments, the tissue engaging element 34 has a sharp distal tip 36 and is configured to be driven (e.g., screwed, pushed, etc.) into the tissue of the subject. The tissue engaging element 34 can define the central longitudinal axis of the anchor 30. For example, and as shown, the tissue engaging element 34 can be helical, wherein its screw axis is the central longitudinal axis of the anchor. Alternatively or in addition, the anchor 30 may include another type of tissue engaging element, such as a dart or a nail. In some embodiments, the tissue engaging element may include a barb or a barb portion to keep the tissue engaging element in the tissue.

[0257] In some embodiments, the head 32 can be coupled to the proximal side of the tissue engaging element 34 and can include a driver interface 38 and can also include an eyelet 39. The driver interface 38 can be rigidly coupled to the tissue engaging element 34. In some embodiments, and as shown, the driver interface 38 is disposed on the central longitudinal axis of the anchor 30. In some embodiments, and as shown, the eyelet 39 is disposed laterally from the central longitudinal axis of the anchor 30. In some embodiments, the inner diameter of the eyelet 39 is 0.25 mm-0.75 mm.

[0258] Tether 26 can comprise (e.g., consist essentially of) wires, cables, sutures, strings, yarns, threads, lines, and ribbons. Tether 26 can comprise (e.g., consist essentially of) metals, polymers, synthetic fibers, semisynthetic fibers, and / or natural fibers. The cross-section of tether 26 can be circular, oval, rectangular, or another shape. In some embodiments, tether 26 is 0.1 mm-0.6 mm (e.g., 0.18 mm-0.3 mm) thick.

[0259] In addition to the implant 22, the system 20 can also include a delivery tool 40 for percutaneous (e.g., transluminal (e.g., transfemoral)) implantation of the implant. The tool 40 includes a flexible anchor driver 42, which is configured to reversibly engage the driver interface 38 of each anchor 30. Through this engagement, the driver 42 is configured to drive (e.g., screw) the tissue engagement element 34 into the tissue, for example, by rotating the driver interface 38. For example, and as shown, the driver 42 can include an elongated and flexible shaft 44 and a driver head 46, which is connected to the distal end of the shaft and is configured to reversibly engage the driver interface 38. In some embodiments, and as shown, the tool 40 further includes a flexible tube 50 (e.g., a transluminal catheter), through which each anchor 30 can be advanced to the tissue 10 to which the anchor is to be anchored.

[0260] In some embodiments, the implant 22, delivery tool 40, and / or system 20 as a whole can share features with one or more implants, delivery tools, and / or systems described in one or more of the following references, each of which is incorporated herein by reference:

[0261] U.S. Patent Application 14 / 437,373, published as US2015 / 0272734, to Sheps et al.

[0262] U.S. Patent Application 15 / 782,687, published as US2018 / 0049875, to Iflah et al.

[0263] International Patent Application No. PCT / IB2020 / 060044, published as WO 2021 / 084407, to Kasher et al.

[0264] International patent application PCT / IB2021 / 058665, published as WO 2022 / 064401, to Halabi et al.

[0265] International patent application PCT / IB2022 / 051099 granted to Shafigh et al.

[0266] The anchor 30 (e.g., the eyelet 39 thereof) is configured to facilitate sliding of the anchor along the tether 26. In some embodiments, the anchor (e.g., the eyelet) is configured to facilitate such sliding both: (i) while the anchor (e.g., its central longitudinal axis) is aligned with the tether, e.g., so as to facilitate advancement of the anchor along the tether to the heart, and (ii) while the anchor (e.g., its central longitudinal axis) is oriented orthogonal to the tether, e.g., so as to subsequently facilitate contraction of the implant and thereby contraction of the tissue to which the implant is anchored. This can be achieved, mutatis mutandis, at least in part due to the shape and size of the eyelet 39, which can be as described in one or more of the references cited above.

[0267] In some embodiments, the eyelet 39 is rotatable about the central longitudinal axis of the anchor 30, for example by being mounted on a rotatably mounted sleeve 37. In some embodiments, despite the rotatability of the eyelet 39 about the central longitudinal axis of the anchor 30, the eyelet is disposed at a fixed angle relative to the central longitudinal axis, for example by being rigidly mounted on a rotatably but non-deflectably mounted sleeve 37.

[0268] Figure 1A Three anchors 30 are shown already anchored to tissue 10, and driver 42 delivers a fourth anchor through tube 50. Each anchor 30 can be delivered while tether 26 extends through eyelet 39 while being generally parallel to the central longitudinal axis of the anchor, e.g. Figure 1A For the previously anchored anchor (e.g., Figure 1A In the three rightmost anchors in FIG. 1 , the tether 26 has been oriented laterally relative to the anchor (eg, orthogonal to the central longitudinal axis of the anchor).

[0269] After the desired number of anchors 30 have been anchored, tension is applied to the tether 26 (e.g., by sliding the tether relative to one or more of the anchors 30), and locking is effected into the tether (e.g., by inhibiting further sliding and / or reverse sliding of the tether relative to one or more of the anchors). For example, Figure 1B An adjustment tool 60 is shown having been introduced (e.g., over and along the proximal portion of the tether 26), having applied tension to the tether 26, and having locked the tension by locking the lock (e.g., stop) 24 to the tether at the last anchor 30 that has been anchored. This last anchor 30 that has been anchored is labeled 30z and can be considered the most proximal anchor of the implant 22.

[0270] The tensioning of the tether 26 pulls the anchors 30 closer together, thereby contracting the tissue 10 to which the anchors are anchored. To facilitate the tensioning of the tether 26, the adjustment tool 60 can provide a reference force (e.g., pressing against the last anchor 30 that has been anchored) while the tether (e.g., the proximal end of the tether) is pulled proximally. In the example shown, the adjustment tool 60 also trims the excess tether 26 and withdraws it from the heart. The adjustment tool 60 can be a component of the system 20. In some embodiments, the adjustment tool 60, the lock 24, and / or the techniques for tensioning, locking, and / or trimming the tether 26 can be as described, mutatis mutandis, and / or can share features, mutatis mutandis, with one or more of those adjustment tools, locks, and / or techniques described in one or more of the following references, each of which is incorporated herein by reference:

[0271] U.S. Patent Application 16 / 534,875, filed August 7, 2019, and published as US2020 / 0015971 to Brauon et al.

[0272] International Patent Application No. PCT / IB2020 / 060044, published as WO 2021 / 084407, to Kasher et al.

[0273] International patent application PCT / IB2022 / 051099 granted to Shafigh et al.

[0274] The connection of the tether 26 with the first anchor 30 to be anchored makes it possible to pull the tether 26 so as to tighten the tether without causing the tether (e.g., its first end) to become released (e.g., slide out) from the first anchor already anchored. This first anchor 30 to be anchored is labeled 30a and can be considered as the most distal anchor of the implant 22. In some embodiments, and as shown, a lock (e.g., a stopper) 24 can be locked to the tether 26 at the anchor 32a, such as where the anchor 30a is the same as the other anchors 30 of the implant 22. This lock 24 is labeled 24a, and the lock at the anchor 30z is labeled 24z. In some embodiments, the lock 24a is the same as the lock 24z. In some embodiments, the lock 24a and 24z are different from each other, for example, due to their slightly different roles. In some embodiments, the anchor 30a can be fixedly attached to the tether 26, such as where the anchor 30a includes a specific feature or component (e.g., a lock) to facilitate such attachment. In some embodiments, implant 22 does not include lock 24a discrete from anchor 30a.

[0275] For simplicity, Figure 1A and 1BThe implant 22 is shown in a linear configuration. However, for annuloplasty, the implant 22 is typically implanted in a curve (or even a full annulus) around the annulus so that contraction reduces the size of the annulus, thereby improving coaptation of the leaflets. Figure 2A An example is shown in which implant 22 is implanted in a curve surrounding the annulus of a mitral valve 4 of a heart of a subject, for example in which tissue 10 is tissue of the mitral valve annulus. Figure 2B An example is shown in which implant 22 is implanted in a curve surrounding the annulus of tricuspid valve 5 of a heart of a subject, for example in which tissue 10 is tissue of the tricuspid annulus.

[0276] In the above description of implant 22, reference is made to Figures 1A-2B , the tension along the entire tether 26, and thereby the contraction of the tissue 10 between the first / most distal anchor 30a and the rear / most proximal anchor 30z (e.g., along the entire implant) is substantially uniform. Described below, inter alia, are systems, implants, and techniques for differentially contracting tissue along an implant (e.g., by different tensions along the implant and / or tethers) and / or for differentially contracting tissue of an annulus of a heart valve along the annulus.

[0277] refer to Figure 3-4 , which is a schematic illustration of an example embodiment of an implant 22 according to some embodiments. Figure 3 A first implant 22a is shown having been anchored along a first portion of the annulus and a second implant 22b has been anchored along a second portion of the annulus, leaving a space between the first and second portions of the annulus. Figure 4 A first implant 22c is shown having been anchored along a first portion of the annulus and a second implant 22d has been anchored along a second portion of the annulus such that there is an overlap between the first and second portions of the annulus.

[0278] Implants 22a, 22b, 22c, and 22d can be as described for implant 22, and can be considered variations of implant 22. In some embodiments, these variations are identical to implant 22. In some embodiments, these variations are identical to implant 22 except for their length (e.g., the length of their tethers 26) and / or the number of anchors 30 they contain.

[0279] exist Figure 3In the example shown, implants 22a and 22b are anchored along the annulus of the tricuspid valve 5, wherein a first portion of the annulus (along which the first implant 22a is anchored) extends between the roots of the septal leaflet SL and the posterior leaflet PL including the posterior septal commissure PSC; and a second portion of the annulus (along which the second implant 22b is anchored) extends between the roots of the anterior leaflet AL and the posterior leaflet PL including the anterior-posterior commissure APC. After implantation and contraction of the implants 22a and 22b, tissue 10a (e.g., tissue of the annulus) in the space between the first and second portions of the annulus (e.g., between implants 22a and 22b) can remain uncontracted. It should be understood that other similar arrangements are possible in which a gap is left between two annuloplasty implants, and similar arrangements are applicable to other valves of the heart, such as the mitral valve, with the necessary modifications.

[0280] exist Figure 4 In the example shown, implants 22c and 22d are anchored along the annulus of the tricuspid valve 5, wherein a first portion of the annulus (along which the first implant 22c is anchored) extends from the posterior septal commissure PSC, along the root of the posterior leaflet PL, through the anterior-posterior commissure APC, to the root of the anterior leaflet AL; and a second portion of the annulus (along which the second implant 22d is anchored) extends from the anterior septal commissure ASC, along the root of the anterior leaflet AL, through the anterior-posterior commissure APC, to the root of the anterior leaflet PL. After implantation and contraction of the implants 22c and 22d, tissue 10b (e.g., tissue of the annulus) where the first and second portions of the annulus overlap (e.g., where the implants 22c and 22d overlap) may experience increased contraction and / or contractile forces compared to portions of the annulus where only a single implant is present. In the example shown, the tissue 10b is at the anterior-posterior commissure APC. It will be appreciated that other similar arrangements are possible in which a gap is left between two annuloplasty implants, and that similar arrangements are applicable mutatis mutandis to other valves of the heart, such as the mitral valve.

[0281] Reference again Figure 3-4 Such techniques using multiple implants can provide greater control of annular contraction, for example by implanting implants only along portions of the annulus where contraction is desired and / or by implanting more than one implant along portions of the annulus where additional contraction and / or contraction strength is desired. It should be noted that in some embodiments, reference is made mutatis mutandis to Figure 3 The described techniques can be used in conjunction with reference Figure 4 Combinations of those techniques described.

[0282] Reference now Figure 5A-B and 6, which are schematic illustrations showing systems, devices, and techniques for differentially contracting tissue along the path of an implant 22 by applying tension modifiers to the implant, according to some embodiments. Figure 5A -B shows the use of a tension adjuster in the form of a spacer 80, and Figure 6 The use of a tension adjuster in the form of a connector 90 is shown.

[0283] Figure 5A A system 70 is shown that includes an implant 22 and a delivery tool 40a, which can be as described for the delivery tool 40 except that it further includes an applicator 56. The applicator 56 is configured to intracentrally connect a spacer 80 to the implant 22 by intracentrally connecting the spacer to the tether 26 (e.g., threading the spacer intracentrally onto the tether). Each spacer 80 or more than one spacer can be connected to the tether 26 between adjacent pairs of anchors 30. For example, Figure 5A Applicator 56 is shown connecting spacer 80 to tether 26 after the third anchor has been anchored to tissue and before the fourth anchor is anchored to tissue. Figure 5B The implant 22 is shown already implanted, with this same spacer and two more spacers connected to a tether 26, each spacer being positioned between a respective pair of adjacent anchors 30.

[0284] In some embodiments, each spacer 80 is elongated and, as shown, can be substantially tubular (at least when stationary). The applicator 56 can be configured to connect each spacer 80 centrally to the tether 26 while the spacer is constrained in an open state in which the spacer has a substantially C-shaped cross-section. In some embodiments, the entire spacer is constrained in this open state at the same time. In some embodiments, each area of ​​the spacer is temporarily moved into the open state when introduced onto the tether, so that the open area of ​​the spacer passes along the spacer like a wave when the spacer is introduced onto the tether. For example, for an application in which the spacer is advanced distally onto the tether, this wave can move from the distal end of the spacer to the proximal end.

[0285] Applicator 56 can be configured to advance septum 80 out of a secondary lumen disposed laterally from the primary lumen of tube 50. In some embodiments, and as shown, applicator 56 can include a tube defining this secondary lumen.

[0286] The applicator 56 can be controlled from outside the subject, for example, by an applicator controller on the handle of the delivery tool 40a. For example, the applicator controller can be a button or trigger that, when pressed, applies the spacer 80 to the tether 26. For example, the applicator controller can be operably coupled to a pusher of the applicator 56, such that operation of the applicator controller causes the pusher to push the spacer 80 distally out of the applicator / external and onto the tether 26.

[0287] In some embodiments, the applicator 56 includes a mandrel 58, which constrains each spacer 80 in its open state. As shown, at least a portion of the mandrel 58 (e.g., the distal portion) can be hollow (e.g., tubular or funnel-like). In addition, at least the distal portion of the mandrel 58 (e.g., at least a portion in the hollow portion) can have a lateral slit 59 (e.g., parallel to the axis of the mandrel or the axis of the entire applicator) through which the tether 26 can pass. In some embodiments, throughout the implantation of the implant 22, the tether 26 keeps extending through the slit into the hollow portion of the mandrel 58 and outside the distal end of the mandrel, and when the implant is implanted step by step, the tether slides linearly while maintaining this arrangement. In some embodiments, the mandrel 58 can be advanced above the tether 26 (e.g., so that the tether passes through the slit) to apply each spacer, and then withdrawn until another spacer is applied. In either case, for applications where the mandrel 58 is hollow and has a lateral slit 59, the tether 26 can be extended into the mandrel through the slit and out of the mandrel through the end opening of the mandrel, such as shown, while the tether 26 is positioned through the slit. Thus, the spacer 80 can be applied to the tether by pushing the spacer out of the end of the mandrel 58 while the tether 26 is positioned through the slit. As each region of the spacer 80 leaves the mandrel 58, it is no longer constrained in its open state and thus responsively closes around the tether 26. In the resulting closed state of the spacer 80, the spacer can be tubular, such as with the two open edges of its c-shape meeting edge to edge or wrapped around each other.

[0288] Each spacer 80 is configured to inhibit the anchor pairs disposed on either side of the spacer from moving toward each other during contraction of the implant 22 (e.g., during tensioning of the tether 26), for example to limit how close the anchors can become to each other. For example, the spacer 80 can have features and / or functions as described in International Patent Application PCT / IB2020 / 060044, published as WO 2021 / 084407 to Kasher et al. and / or International Patent Application PCT / IB2022 / 051099 to Shafigh et al., each of which is incorporated herein by reference, depending on the spacing between the associated pairs of adjacent anchors 30 when the spacer 80 is applied, applying a spacer between adjacent anchor pairs can cause the adjacent anchor pairs to move away from each other.

[0289] Figure 5B The inter-anchor region 72 of tissue 10 is schematically illustrated between pairs of anchors 30 between which no spacer 80 is disposed. Thus, the region 72 is shown as being contracted, mutatis mutandis, similar to the example of FIG. Figures 1A-2B or even shrink to a greater extent. Figure 5B Also schematically illustrated is an inter-anchor region 74 of tissue 10 between pairs of anchors having spacer 80 disposed therebetween. Thus, region 74 is shown as being retracted below region 72.

[0290] The system 70 thus facilitates control of the degree of contraction to be applied to different segments of the implant 22, and thereby to different regions of the tissue 10 along which the implant is implanted. In the particular example shown, region 74 is shown on the annulus of the mitral valve 4 near the P2 sector of the posterior leaflet, while region 72 is shown near the commissures and / or P1 and P3 sectors, for example, to provide greater contraction along the anterior-posterior axis of the valve and less contraction along the commissure-to-commissure axis of the valve. However, because the spacer 80 is added to the implant 22 during implantation, an operator (e.g., a physician) can decide intraoperatively whether to apply a spacer between a given pair of anchors (e.g., between the most recently anchored anchor and the next anchor to be anchored), for example, based on data acquired during surgery (e.g., imaging and / or digital data). For example, a spacer can be applied between a given pair of anchors based on specific anatomical features of the implant and / or a specific effect observed on the tissue.

[0291] Figure 6An implant 22 according to some embodiments is shown, wherein two connectors 90 are connected to corresponding pairs of anchors 30. Each connector 90 is configured to pull the anchor pairs disposed on either side of the connector toward each other, and / or inhibit the anchors from moving away from each other. The connector 90 can be applied intracardially. In some embodiments, the connector 90 is applied during implantation, such as by using an applicator as part of a delivery tool, with necessary modifications, for example, similar to that described for the applicator 56. In some embodiments, the connector 90 is applied after implantation of the implant and optionally after contraction (e.g., initial contraction). For example, once all anchors 30 of the implant have been pulled toward each other by applying tension to the tether 26, adding a connector between the anchor pairs can further pull the anchor pairs toward each other, thereby optionally increasing the distance between at least one anchor in the anchor pair and another anchor not in the pair.

[0292] In the example shown, the connector 90 is shown as a band wrapped around the head of each anchor 30 in the pair (see inset). However, the scope of the present disclosure includes other embodiments of the connector 90, such as a secondary tether (e.g., in parallel with the tether 26).

[0293] In some embodiments, and as shown, each connector 90 can be substantially parallel to a portion of the tether 26 .

[0294] Figure 6 The inter-anchor region 76 of the tissue 10 is schematically illustrated between pairs of anchors 30 that are not connected by connectors 90. Thus, the region 76 is shown as being contracted, mutatis mutandis, similar to the example of FIG. Figures 1A-2B or even shrunk to a smaller extent. Figure 6 Also schematically illustrated is an inter-anchor region 78 of tissue 10 between a pair of anchors connected by connector 90. Thus, region 78 is shown as being more contracted than region 72.

[0295] A system utilizing connector 90 thus facilitates control of the degree of contraction to be applied to different segments of implant 22 and thereby to different regions of tissue 10 along which the implant is implanted. In the particular example shown, region 76 is shown as being located on the annulus of the mitral valve 4 primarily near the P2 sector of the posterior leaflet, while region 78 is shown near the commissures and / or P1 and P3 sectors, for example, so as to provide greater contraction along the anterior-posterior axis of the valve and less contraction along the commissure-to-commissure axis of the valve. However, in some embodiments in which connector 90 is added to implant 22 during implantation, an operator (e.g., a physician) can decide intraoperatively whether to apply a connector between a given pair of anchors (e.g., between the most recently anchored anchor and the next anchor to be anchored), for example, based on data acquired during surgery (e.g., imaging and / or digital data). For example, a connector can be applied between a given pair of anchors based on specific anatomical features of the implant and / or a specific effect observed on the tissue.

[0296] It should be noted that the tension adjuster described above can be introduced after the initial implantation of the implant, for example as a result of post-implantation observation (e.g., using imaging techniques). According to some embodiments, a method comprises (1) identifying a subject in which an implant has been implanted along tissue of the subject's heart, the implant comprising a series of anchors slidably coupled to a tether, and the implant has been implanted by anchoring the series of anchors to the tissue; and (2) in response to the identification, adjusting the tension on the tether by applying a tension adjuster between adjacent pairs of anchors in the series.

[0297] refer to Fig. 7A -F, which is a schematic illustration of a system 120 and a technique for implanting an implant 122 of the system according to some embodiments. System 120 is a tissue adjustment system and can be used to adjust the size of tissue 10 (such as tissue of a subject's heart). For example, system 120 can be an annuloplasty system, and implant 122 can be an annuloplasty structure (e.g., an annuloplasty ring or band) to be implanted at the annulus of a valve of the heart (e.g., along the annulus of a valve of the heart). Implant 122 can include a plurality of anchors 30 and a tether 26 (e.g., a contraction member), the anchors being slidably coupled to the tether, such as by being threaded onto the tether. Thus, in some embodiments, implant 122 and its implantation are as described for implant 22, mutatis mutandis, except as noted. Furthermore, in some embodiments, implant 122 can be considered a variant of implant 22.

[0298] In addition to the implant 122, the system 120 may also include a delivery tool 140 for percutaneous (e.g., transluminal (e.g., transfemoral)) implantation of the implant. The tool 40 may include a flexible anchor driver 142 configured to reversibly engage the driver interface 38 of each anchor 30. Through this engagement, the driver 142 is configured to drive (e.g., screw) the tissue engagement element 34 into the tissue, for example, by rotating the driver interface 38. For example, and as shown, the driver 142 may include an elongated and flexible shaft 144 and a driver head 146, which is coupled to the distal end of the shaft and is configured to reversibly engage the driver interface 38. In some embodiments, and as shown, the tool 140 further includes a flexible tube 150 (e.g., a transluminal catheter), through which each anchor 30 can be advanced to the tissue 10 to which the anchor is to be anchored. Therefore, in some embodiments, except for the indicated cases, the tool 140 is as described for the tool 40, with necessary modifications. Furthermore, in some embodiments, tool 140 may be considered a variation of tool 40 .

[0299] Fig. 7A -F shows implant 122 being implanted along tissue 10 (eg, along the annulus of valve 5) such that the implant defines an elongated path along the tissue. Fig. 7A The first section 123a of the implant 122 is shown, which has been anchored by some of the implant's anchors 30 that have been anchored to the tissue 10 by the tool 140 along the first portion 10c of the path, with modifications, such as described above for the implant 22 and the tool 40. In the specific example shown, the first section 123a includes three anchors 30, such as the first anchor 30a (described above), the second anchor 30b and the third anchor 30c. That is, in the specific example shown, the anchor 30a is the most distal anchor of the first section 123a (and the entire implant 122), and the anchor 30c is the most proximal anchor of the first section 123a. However, more or less anchors may be used. More generally, the first section 123a may be defined as between the most distal anchor of the first section (the anchor 30a in the example shown) and the most proximal anchor of the first section (the anchor 30c in the example shown).

[0300] Fig.7D-E shows the second section 123b of implant 122, which is then anchored by some more anchors 30 of implant that have been anchored to tissue by tool 140 along the second part 10d of the path. In the specific example shown, the second section 123b includes three more anchors 30, such as the fourth anchor 30d, the fifth anchor 30e and the sixth anchor 30f. That is, in the specific example shown, anchor 30d is the most distal anchor of the second section 123b, and anchor 30f is the most proximal anchor of the second section 123b. In addition, in the specific example shown, the sixth anchor 30f is the most proximal anchor of the entire implant 122, and therefore can correspond substantially to the anchor 30z of implant 22. However, more or less anchors can be used. More generally, the second segment 123b can be defined between the distal-most anchor of the second segment (anchor 30d in the example shown) and the proximal-most anchor of the second segment (anchor 30d in the example shown).

[0301] After anchoring the first segment 123a and before anchoring the second segment 123b, by increasing the length of the first segment, for example, from the first length d1 ( Fig. 7A ) is reduced to a second length d1' ( Figure 7B ) to contract the first portion 10c of the tissue (e.g., along the path of the tissue). The lengths d1 and d1' can be measured along the tether 26 between the most distal anchor of the first segment 123a (anchor 30a in the example shown) and the most proximal anchor of the first segment (anchor 30c in the example shown). That is, the distance can represent the length of the first portion 26a of the tether extending between the most distal anchor of the first segment 123a (anchor 30a in the example shown) and the most proximal anchor of the first segment (anchor 30c in the example shown).

[0302] Contraction of the first portion 10c of the tissue can be achieved by tensioning the tether 26, which is facilitated by an adjustment tool 160 that can provide a reference force (e.g., pressing against the anchor 30c) while the tether is pulled proximally, mutatis mutandis, such as described for implant 22. In some embodiments, the adjustment tool 160 is the same as the adjustment tool 60 described above. In some embodiments, the delivery tool 140 is withdrawn from the subject before the adjustment tool 160 is advanced to the implant 122 (e.g., to the anchor 30c). In some embodiments, only the driver 142 is withdrawn, and the adjustment tool 160 is advanced to the implant 122 (e.g., to the anchor 30c) through the tube 150.

[0303] While the first portion 10c of the path remains constricted, the length of the first segment 123a is fixed, for example at a length d1' ( Figure 7B ). This fixation can be achieved by locking the lock 24c to the tether 26 at the most proximal anchor of the first section 123a, namely the anchor 30c. For example, and as shown, the lock 24c can be advanced over and along the tether 26 (e.g., by adjusting the tool 160), and / or can be locked to the tether just proximally from the anchor 30c. The lock 24c can be as described for any other lock described herein.

[0304] After anchoring the second segment 123b, and while the length of the first segment 123a remains fixed, by increasing the length of the second segment, for example, from the first length d2 ( Fig. 7E ) is reduced to a second length d2' ( Figure 7F ) to contract the tissue (e.g., along the path of the tissue). The lengths d2 and d2' can be measured along the tether 26 between the most distal anchor of the second segment (anchor 30d in the example shown) and the most proximal anchor of the second segment (anchor 30f in the example shown). That is, the distance can represent the length of the second portion 26b of the tether extending between the most distal anchor of the second segment 123b (anchor 30d in the example shown) and the most proximal anchor of the second segment (anchor 30f in the example shown).

[0305] While the second portion 10d of the path remains constricted, the length of the second segment 123b is fixed, for example at a length d2' ( Figure 7F ). This fixation can be achieved using lock 24f, mutatis mutandis, such as described above for lock 24z. Similarly, excess tether 26 can be trimmed, such as by adjusting tool 60, mutatis mutandis, such as described above.

[0306] In some embodiments, lock 24c can inhibit the re-increase in length of first segment 123a simply by, for example, blocking tether 26 from sliding distally through the eyelet of anchor 30c. This may be sufficient for embodiments in which the tension in tether 26 is greater in segment 123a than in segment 123b. However, in some embodiments, including some embodiments in which the tension may be greater in segment 123b than in segment 123a, an additional lock 24d is applied at the distal-most anchor of segment 123b (anchor 30d in the example shown). For example, and as shown, lock 24d can be advanced over and along tether 26 (e.g., by adjusting tool 160), and / or can be moved from a location where anchor 30d is to be positioned on the tether ( Figure 7C) is locked distally to the tether. This can be achieved by anchoring the anchor 30d ( Fig.7D ). Lock 24d inhibits further reduction in the length of first segment 123a by blocking proximal sliding of tether 26 through the eyelet of anchor 30d. Thus, in some embodiments, locks 24c and 24d can be used to fix the length of first segment 123a prior to retraction of second segment 123b.

[0307] In some embodiments where both lock 24c and lock 24d are used, the tension in the portion 26x of the tether placed between portions 26a and 26b (e.g., between lock 24c and 24d) is different from the tension of both portions 26a and 26b. For example, portion 26x may have almost no tension applied thereto, such as the portion may actually be slack. Therefore, although portions 10c and 10d placed at either end of portion 10e and that can define portion 10e contract, the portion 10e (e.g., the portion along the path of the tissue) of the portion 26x of the tether 26 may not contract. Therefore, the uncontracted section 123x of the implant 122 may be defined.

[0308] It should be noted that, according to some embodiments, implant 122 and the described techniques for use therewith advantageously promote contraction of first segment 123a (and thereby the first portion of the path of tissue) independently of contraction of second segment 123b (and thereby the second portion of the path of tissue), and independently of portion 10c of the path between the first segment and the second segment. Thus, an operator may advantageously apply different degrees of contraction to different portions of the valve annulus, and / or may apply different magnitudes of tension to tethers 26 in different segments of the implant as desired by the individual subject being treated.

[0309] It should be noted that although implant 122 is shown as having two contraction sections (sections 123a and 123b) and a single uncontracted section 123x therebetween, it should be understood that the scope of the present disclosure includes implants with more contraction sections and / or more uncontracted sections. In addition, in some embodiments, one or more uncontracted sections can be placed at the end of the implant, for example, not defined by the contraction section. It should be noted that although implant 122 is shown as having three anchors for each contraction section, the scope of the present disclosure includes implants with more or less anchors for each contraction section. It should be noted that although implant 122 is shown as having no anchors in the uncontracted section (e.g., between locks 24c and 24d), the scope of the present disclosure includes implants with one or more anchors in one or more sections in its uncontracted section. More generally, it should be understood that the scope of the present disclosure facilitates the operator to decide (during preoperative planning and / or during the implantation operation itself) how to arrange the various contractions and uncontracted sections of the implant.

[0310] Reference now Fig. 8A -C, 9A-B, 10A-B, 11A-G, 12A-C, 13A-B, 14A-B, 15A-C and 16A-D, which are schematic illustrations of systems and techniques for use with implants according to some embodiments. In each case, the system comprises an implant and a delivery tool for implanting the implant, such as so that the implant defines a path along a subject's tissue, such as along the annulus of a subject's heart valve.

[0311] Therefore, reference Figures 8A-16DAccording to some embodiments, various systems for use at the tissue of the subject's heart are provided. Each such system comprises an implant and may further comprise a delivery tool. The implant comprises an elongated member (e.g., a tether 26, etc.), a plurality of anchors, and a plurality of locks. The delivery tool is configured to implant the implant at the tissue so that the elongated member is defined along the path of the tissue by: (i) using one or more of the anchors to anchor the first section of the elongated member along the first portion of the path, and (ii) subsequently using one or more of the anchors to anchor the second section of the elongated member along the second portion of the path. The delivery tool is further configured to contract tissue by: (i) contracting a first portion of the path by reducing the length of the first segment after anchoring the first segment and before anchoring the second segment, (ii) fixing the length of the first segment using at least a first lock of a plurality of locks while the first portion of the path remains contracted, (iii) contracting the second portion of the path by reducing the length of the second segment after anchoring the second segment and while the length of the first segment remains fixed, and (iv) fixing the length of the second segment using at least a second lock of a plurality of locks while the second portion of the path remains contracted.

[0312] Similarly, according to some embodiments, a method comprises percutaneously implanting an elongated implant along a tissue such that the implant defines a path along the tissue by: (i) anchoring a first segment of the implant along a first portion of the path, and (ii) subsequently anchoring a second segment of the implant along a second portion of the path. After anchoring the first segment and before anchoring the second segment, (i) contracting the first portion of the path by reducing the length of the first segment, and (ii) fixing the length of the first segment while the first portion of the path remains contracted. After anchoring the second segment and while the length of the first segment remains fixed, (i) contracting the second portion of the path by reducing the length of the second segment, and (ii) fixing the length of the second segment while the second portion of the path remains contracted.

[0313] Similarly, according to some embodiments, a method includes: (i) percutaneously implanting a first segment of an implant along a first portion of tissue by anchoring a first anchor of the implant to a first location of the tissue, and anchoring a second anchor of the implant to a second location of the tissue, the first portion of the tissue being positioned between the first location and the second location; (ii) subsequently, contracting the first portion of the tissue by reducing the length of the first segment; (iii) fixing the length of the first segment while the first portion of the tissue remains contracted; (iv) subsequently, percutaneously implanting a second segment of the implant along the second portion of the tissue by anchoring a third anchor of the implant to a third location of the tissue; (v) subsequently, contracting the second portion of the tissue by reducing the length of the second segment while the length of the first segment remains fixed; and (vi) fixing the length of the second segment while the second portion of the tissue remains contracted.

[0314] Similarly, according to some embodiments, a method includes (i) percutaneously anchoring a first anchor of an implant to a first location of tissue; (ii) subsequently, percutaneously anchoring a second anchor of the implant to a second location of tissue, with a first portion of the tissue disposed between the first location and the second location; (iii) subsequently, contracting the first portion of the tissue by pulling the first anchor and the second anchor together; (iv) fixing the distance between the first anchor and the second anchor while the first portion of the tissue remains contracted; (v) subsequently, percutaneously changing the distance between the third anchor and the second anchor of the implant by sliding the third anchor relative to the second anchor; (vi) subsequently, anchoring the third anchor to a third location of tissue, with a second portion of the tissue disposed between the second location and the third location; (vii) subsequently, contracting the second portion of the tissue by pulling the second anchor and the third anchor together while the distance between the first anchor and the second anchor remains fixed; and (viii) fixing the distance between the second anchor and the third anchor while the second portion of the tissue remains contracted.

[0315] In some embodiments, a system (e.g., an implant of a system) provides or facilitates the above, the system comprising a series of anchors slidably coupled to a tether. In system 200 ( Figures 8A-11G )、System 300( Figures 12A-13B )、System 400( Fig.14A -B) and System 500( Figures 15A-16D) in each system, the implant comprises a tether and a series of anchors, each anchor comprising a tissue engaging element (e.g., one or more of a thread, screw, tip, hook, barb, dart, arm, nail, sharp portion, clip, swab, etc.), and each anchor may optionally also include a head. In some embodiments, the anchor (e.g., its head, etc.) is slidably coupled (or connectable) to the tether and comprises a lock configured to lock the head to the tether when it is locked. These systems are configured to facilitate techniques by which sections of the implant can be adjusted independently of other sections, such as allowing portions along a path through which the implant is implanted to retract independently of other portions of the path. In some embodiments, these techniques may be considered similar to those of reference 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84 Fig. 7A The techniques described in -F are generally similar.

[0316] Figures 8A-11G is a schematic illustration of a system 200 and techniques for use therewith, according to some embodiments. Fig. 8A An overview of system 200 is shown. System 200 includes an implant 222, which includes a tether and a series of anchors 230. In the example shown, the tether of implant 222 is tether 26 (described above), but implant 222 may alternatively or additionally include another tether, mutatis mutandis. System 200 is shown with five anchors 230, but it should be understood that this is illustrative and the system may have more or fewer anchors 230. System 200 may further include a delivery tool 240 for percutaneous (e.g., transluminal (e.g., transfemoral)) implantation of the implant, such as by anchoring of anchors 230.

[0317] although Fig. 8A The tether of the implant 222 is shown separate from the anchor of the implant, but the implant can be provided with an anchor already connected to the tether, mutatis mutandis, for example as described in International Patent Application PCT / IB2021 / 058665 to Halabi et al., published as WO 2022 / 064401, and / or International Patent Application PCT / IB2022 / 051099 to Shafigh et al. In some embodiments, the implant 222 can be provided with one or more of the anchors separate from the tether and configured to be connected to the tether.

[0318] Figure 8B One of the anchors 230 is shown, and Figure 8CAn exploded view of an anchor is shown. Each anchor 230 includes a tissue engagement element 34 (e.g., one or more of a spiral, a screw, a tip, a hook, a barb, a dart, an arm, a nail, a sharp portion, a clip, a swab, etc.), and may also include a head 232 that is coupled to the tissue engagement element (e.g., coupled to the proximal end of the tissue engagement element). In some embodiments, the anchor (e.g., the head 232, etc.) is slidably coupled to the tether 26, or is configured to be slidably coupled to the tether, such as described in more detail below. Although in the example shown, the tissue engagement element of the anchor 230 is a tissue engagement element 34 (as described above), with necessary modifications, the anchor 230 may alternatively or additionally include another tissue engagement element. In some embodiments, the head 232 includes a lock 210, which is configured to lock the head to the tether 26 when it is locked.

[0319] In some embodiments, implant 222 may include a leading anchor 224, the tissue engaging element of which may be similar to that of anchor 230, but the head of which may not have the locking function of head 232 (e.g., may not include lock 210). Instead, leading anchor 224 may be fixedly (rather than slidably) directly coupled to tether 26, or may be inhibited from sliding along the tether and / or sliding outside the tether by one or more separate locks or stops (such as lock 24 described above). In some embodiments, leading anchor 224 may be as described above for anchor 30, mutatis mutandis. In some embodiments, leading anchor 224 may be as described above for leading anchor 324, mutatis mutandis.

[0320] The delivery tool 240 is configured to advance the anchor 230 (and thus, generally, the implant 222) transluminally to the heart of the subject. The delivery tool 240 may include a driver 242. The delivery tool 240 may also include a flexible tube (e.g., a catheter) 250 that can be advanced transluminally to the heart and through which the driver 242 can extend. The delivery tool 240 may be configured to sequentially (i) anchor the anchor to the tissue for each anchor 230 so that a segment of the tether 26 extends from the previous anchor in the anchor (e.g., the anchor that has been most recently anchored) to the anchor, then adjust the tension on the segment of the tether, and then adjust the lock 210 of the anchor. Fig.11A -G illustrates this by showing some of the steps of implanting implant 222 according to some embodiments.

[0321] In some embodiments, the delivery tool 240 is also configured to anchor the leading anchor 224. For example, the driver interface of the head of the leading anchor 224 can be similar to the driver interface of the anchor 230. In some embodiments, a separate delivery tool is provided and used to anchor the leading anchor 224.

[0322] Fig. 9A -B shows the anchor 230 in longitudinal cross-section, whereby for each of these figures, the cross-section of the left frame is orthogonal to the cross-section of the right frame. Fig. 9A -B, the central longitudinal axis ax1 of the anchor 230 (e.g., defined by the tissue engaging elements 34) lies in the respective planes of the two cross sections, where the plane of the cross section of one frame is rotated 90 degrees about the axis ax1 relative to the plane of the cross section of the other frame.

[0323] Fig. 10A -B also shows the anchor 230 in longitudinal cross-section, albeit in perspective. In addition to this different perspective, Fig. 10A The cross section and Fig. 9A The cross section of the left frame is the same as that of Fig. 10B The cross section and Fig. 9B The cross section of the left frame is the same. However, Fig. 10A -B also shows the tether 26 threaded laterally through the head 232.

[0324] Fig. 9A and 10A The anchor 230 is shown in its unlocked state, and Fig. 9B and 10B The anchor is shown in its locked state.

[0325] In some embodiments, and as shown, lock 210 defines a pressing surface 211 and is configured to lock head 232 to tether 26 by pressing the pressing surface against the tether. As shown, lock 210 can include a pressing plate 212 defining a pressing surface.

[0326] The lock 210 may include a spring 214 configured to lock the head 232 to the tether 26 by pressing the pressing surface 211 against the tether, for example, biasing the lock 210 to lock. In some embodiments, the spring 214 is configured to press the pressing surface 211 against the tether 26 by axially moving the pressing surface relative to the tissue engaging element 34. In the example shown, the pressing surface 211 is a proximal surface of the pressing plate 212 (e.g., the surface of the pressing plate facing away from the tissue engaging element 34), and the spring 214 is configured to push the pressing surface 211 proximally (e.g., away from the tissue engaging element). For example, the spring 214 can be a compression spring disposed between the pressing plate 212 and the tissue engaging element 34. In the specific example shown, the spring 214 is disposed between the pressing plate 212 and the base plate 266 of the head 232. The base plate 266 can be fixedly attached to the tissue engaging element 34.

[0327] In some embodiments, and as shown, the head 232 (e.g., the lock 210 thereof) can include or define a peripheral wall 216 that circumscribes (e.g., is coaxial with) the central longitudinal axis ax1 and has one or more holes 218 defined therein. In some embodiments, the head 232 is slidably coupled to the tether 26 via a tether extending transversely through the head through the hole 218. In some embodiments, the pressing surface 211 can be disposed inboard of the peripheral wall 216 (e.g., the peripheral wall circumscribes the pressing plate 212).

[0328] In some embodiments where the head 232 includes a wall 216 with holes 218, the spring 214 can be configured to move the pressing surface 211 across at least one of the holes 218. This can lock the head 232 to the tether 26 by clamping the tether between the pressing surface 211 and the edge of the hole 218, for example Fig. 10B The embedding is indicated by the arrow in the figure.

[0329] The lock 210 may be unlocked by a force applied by the driver 242, or may be inhibited from being locked. For example, the control rod 248 of the driver 242 may apply a force (e.g., push distally) to a surface (e.g., a proximal-facing surface) 213 defined by or connected to the hold-down plate 212, thereby tightening the spring 214 (e.g., compressing the spring against the base plate 266) or inhibiting the spring from relaxing (e.g., pushing distally). Fig. 9A and 10A ). Thus, surface 213 can function as a button. Retraction of lever 248 allows spring 214 to relax (e.g., decompress), thereby causing lock 210 to transition toward its locked state ( Fig. 9B and 10B ).

[0330] In some embodiments, such as in some embodiments where the tissue engaging element 34 is a spiral / screw-in tissue engaging element, the tissue engaging element can be rotatable independently of the peripheral wall 216. This enables the tissue engaging element 34 to be screwed into the tissue without wrapping the tether 26 around the anchor, for example, where the tether keeps the wall 216 stationary while the tissue engaging element rotates. The tissue engaging element 34 is driven (e.g., screwed) into the tissue and can be performed by a driver 242. The driver 242 can include a drive head 246 and a shaft 244 extending from an external portion (e.g., a control handle) to the drive head. The drive head 246 can be reversibly engaged with the driver interface 238 of the head 232 of the anchor 230. Fig.11A The anchor 230 is shown having been threaded into the tissue 10 as the tether 26 extends from the previously anchored anchor (in this case the leading anchor 224) laterally through the head 232 of the anchor 230 being anchored and proximally away without the tether becoming entangled around the head 232.

[0331] In some embodiments, and as shown, the anchor 230 (e.g., its head 232) includes a torque assembly 260, through which torque is transferred from the interface 238 to the tissue engaging element 34. The torque assembly 260 can be arranged from the inside of the peripheral wall 216, and can include one or more torque shafts extending between the interface 238 and the tissue engaging element 34. These torque shafts can be located on the central longitudinal axis ax1. In the example shown, the torque assembly 260 includes at least a first torque shaft 262 and a second torque shaft 264, which are operably connected to each other to transfer torque, for example due to their respective shapes that rotationally lock them to each other. For example, and as shown, the non-circular and / or protruding portion 265 of the torque shaft 264 can cooperate with the non-circular and / or recessed portion 263 of the torque shaft 262 to define a keyed joint.

[0332] Thus, in some embodiments, the head 232 comprises a housing having a proximal portion (e.g., including the interface 238) and a base portion (e.g., including the base plate 266) by which the head is coupled to the tissue engaging element 34. The proximal and distal portions of the head are axially separated at a mid-section where the peripheral wall 216 is disposed. Although the proximal portion, the base portion, and the tissue engaging element are rotationally (and typically axially) locked relative to each other, they are (e.g., collectively) rotatably coupled to the peripheral wall 216. The lock 210 and / or the peripheral wall 216 may axially traverse the mid-section.

[0333] In some embodiments, and as shown, some components of the head 232 may be common to both the torque assembly 260 and the lock 210. For example, and as shown, the integral assembly 270 may be formed to define the surface 213, the shaft 262, and the press plate 212 (see Figure 8C ). Component 270 can be shaped to be rotationally locked to interface 238 and / or keyed to be rotationally locked to the interface. For example, and as shown, surface 213 can be non-circular. In some embodiments, shaft 262 is also used to transfer the unlocking force applied to surface 213 by control rod 248, for example, the shaft pushes the pressing plate 212 against spring 214, thereby compressing the spring between the pressing plate and base plate 266. Therefore, in some embodiments, component 270 can be considered a piston. In order to provide this function, the operative connection between shafts 262 and 264 can allow shaft 262 to slide axially relative to shaft 264. For example, and as shown, portion 263 can be a groove or slit that runs substantially parallel to axis ax1, and the size of the groove or slit is set to allow portion 265 to slide axially along it.

[0334] In some embodiments, and as shown (e.g., in Fig. 10A -B), the tether 26 extends laterally through the head 232 by: (i) reaching into the hole 218, (ii) passing through the hold-down plate 212 and / or passing through (e.g., at least partway around) the torque assembly 260 (e.g., the torque shaft 262 and / or the torque shaft 264), and (ii) passing out of another hole 218.

[0335] As described above, the drive head 246 of the driver 242 can be reversibly engaged with the interface 238. This engagement can be controlled by the control rod 248. For example, and as shown, when the control rod 248 is in the retracted position, the chamber (or recess) 249 defined by the drive head 246 can receive and release the crossbar 239 (and / or another component) of the interface 238; and while the crossbar is disposed in the chamber, the control rod can be advanced distally from the retracted position to lock the crossbar to the drive head. Thus, in some embodiments, the control rod 248 controls both: (i) the engagement between the driver 242 and the anchor 230, and (ii) the lock 210. For example, in some embodiments, while the driver 242 is engaged with the anchor 30, (i) the control rod 248 in the advanced position maintains engagement and maintains the lock 210 unlocked (see, e.g., Fig. 9A , 10A and 11A-B); (ii) the lever is retracted to the intermediate position to maintain engagement but allow the lock to lock (see, e.g., Fig. 9B , 10Band 11C); and (iii) further retraction of the control rod into the retracted position causes or allows the driver to disengage from the anchor while the lock remains locked (see, e.g., Fig.11D ).

[0336] Fig.11A A leading anchor 224 and an anchor 230 are shown already anchored to tissue 10, with a tether 26 extending from the leading anchor, through the anchor 230 (as described above), and proximally away from the tissue (e.g., away from the heart, and possibly away from the subject altogether), for example, via a delivery tool 240 (e.g., tube 250 thereof). Subsequently, the tether 26 is tensioned to a desired degree of tension ( Fig. 11B ), for example, guided by one or more imaging techniques (such as fluoroscopy and / or ultrasound) to determine the effect of tensioning on the structure and / or function of tissue and / or surrounding structures, such as the effect on regurgitation through a heart valve. At this point, the tension may be repeatedly increased and decreased to determine the desired tension level. As described above, once it has been determined that the desired tension level has been achieved, the lock 210 of the anchor 230 is locked to the tether 26 (for example, by retracting the rod 248). Fig. 11C ), thereby locking the applied tension into the section of the tether (e.g., the tether of implant 222) between the leading anchor 224 and the first anchor 230. Subsequently, the tool 240 (e.g., its driver 242) is disengaged from the anchor 230, for example by further retracting the rod 248 ( Fig.11D ). The driver 242 (and optionally the entire tool 240) can then be retracted from the subject and then used to advance another anchor 230 (e.g., by sliding it along the tether 26) and anchor it to the tissue ( Fig.11E Because the lock 210 of the first anchor 230 has been locked to the tether 26, the tension in the segment of the tether proximal to the first anchor 230 can be different from (e.g., less than or greater than) the tension in the segment of the tether between the lead anchor 224 and the first anchor 230. Fig.11E Small (eg, substantially no) tension in the tether proximal to the first anchor 230 is shown. Fig.11F This lower level of tension is shown by locking the second anchor 230 into the section of the tether 26 that has been secured (i.e., "locked") between the first anchor 230 and the second anchor 230. In this way, the implant 222 can be anchored and tensioned incrementally until implantation and adjustment are complete. Fig.11G An example is shown in which implantation and adjustment of an implant 222 has been completed, wherein the implant defines a path around the annulus of the mitral valve 4 (eg, around the posterior annulus) generally from commissure to commissure.

[0337] Thus, in the particular example shown, once the implant 222 has been implanted so that it defines a path along the tissue 10 and has been differentially contracted as described above, (i) a portion 10f of the path has been contracted by a first contraction amount, and a first segment 223a of the implant has been secured (e.g., anchored) along said portion; (ii) a portion 10g of the path has not been substantially contracted, and a second segment 223b of the implant has been secured along said portion; and (iii) a portion 10h of the path has been contracted by a second contraction amount less than the first contraction amount, and a third segment 223c of the implant has been secured along said portion. In the example shown, segment 223a extends between the leading anchor 224 and the first anchor of the anchors 230 that has been anchored, segment 223b extends between the first anchor of the anchors 230 that has been anchored and the second anchor, and segment 223c extends between the second anchor of the anchors 230 that has been anchored and the final anchor of the implant.

[0338] It should be noted that although the final anchor of the implant 222 to be anchored is shown as an anchor 230 that itself includes the lock 210, in some embodiments, for the purpose of additional locking strength, an additional / discrete lock (e.g., another lock 24) can still be added and locked to the tether 26 adjacent to the final anchor, such as Fig.11G Furthermore, in some embodiments, the final anchor of the implant 222 to be anchored may be an anchor other than the anchor 230, for example, may be an anchor that does not itself include a lock, in which case an additional / discrete lock may be desired.

[0339] Figures 12A-13B is a schematic illustration of a system 300 according to some embodiments. Fig. 12A An overview of system 300 is shown. System 300 includes an implant 322, which includes a tether and a series of anchors 330. In the example shown, the tether of implant 322 is tether 26 (as described above), but implant 322 may alternatively or additionally include another tether, mutatis mutandis. System 300 is shown with four anchors 330, but it should be understood that this is illustrative and the system may have more or fewer anchors 330. System 300 may further include a delivery tool 340 for percutaneous (e.g., transluminal (e.g., transfemoral)) implantation of an implant, such as by anchoring of anchors 330.

[0340] although Fig. 12AThe tether of the implant 322 is shown separate from the anchor of the implant, but the implant can be provided with an anchor already connected to the tether, for example as described in International Patent Application PCT / IB2021 / 058665 to Halabi et al., published as WO 2022 / 064401, and / or International Patent Application PCT / IB2022 / 051099 to Shafigh et al. In some embodiments, the implant 322 can be provided with one or more of the anchors separate from the tether and configured to be connected to the tether.

[0341] Fig. 12B One of the anchors 330 is shown, and Fig. 12C An exploded view of an anchor is shown. Each anchor 330 includes a tissue engaging element 34, and may also optionally include a head 332 that is coupled to the tissue engaging element (e.g., coupled to the proximal end of the tissue engaging element). In some embodiments, with modifications made, the anchor (e.g., head 332, etc.) is slidably coupled to the tether 26, or is configured to be slidably coupled to the tether, for example, in a manner similar to the head 232 of the anchor 230. Although in the example shown, the tissue engaging element of the anchor 330 is a tissue engaging element 34 (as described above), with modifications made, the anchor 330 may alternatively or additionally include another tissue engaging element. In some embodiments, the head 332 includes a lock 310, which is configured to lock the head to the tether 26 when it is locked.

[0342] In some embodiments, system 300 may be considered a variation of system 200 and may be used similarly mutatis mutandis, the primary differences being the mechanism of lock 310 as compared to that of lock 210, and the manner in which anchor 330 is engaged by its anchor driver.

[0343] In some embodiments, implant 322 can include a leading anchor 324 whose tissue engaging element can be similar to that of anchor 330, but whose head may not have the locking function of head 332 (e.g., may not include lock 310). Instead, leading anchor 324 can be fixedly (rather than slidably) directly coupled to tether 26 (e.g., as shown), or can be inhibited from sliding along the tether and / or sliding outside the tether by one or more separate locks or stops (e.g., lock 24) (e.g., as shown for leading anchor 224 of implant 222). In some embodiments, leading anchor 324 can be as described above for anchor 30, mutatis mutandis.

[0344] The delivery tool 340 is configured to advance the anchor 330 (and thereby the implant 322 in general) transluminally into the heart of a subject. The delivery tool 340 may include a driver 342. The delivery tool 340 may also include a flexible tube (e.g., a catheter) 350 that is transluminally advanceable into the heart and through which the driver 342 may extend. The tube 350 may be similar to or the same as the tube 250 described above. The delivery tool 340 may be configured to, for each anchor 330, sequentially (i) anchor the anchor to tissue such that a segment of the tether 26 extends from a previous one of the anchors (i.e., the anchor that has been most recently anchored) to the anchor, then adjust the tension on the segment of the tether, and then adjust the lock 310 of the anchor. Implantation of the implant 322 may be substantially similar to implantation of the implant 222, and / or similar to, for example, Fig.11A -G shown.

[0345] In some embodiments, the delivery tool 340 is also configured to anchor the leading anchor 324. For example, the driver interface of the head of the leading anchor 324 can be similar to the driver interface of the anchor 330. In some embodiments, a separate delivery tool is provided and used to anchor the leading anchor 324.

[0346] Fig.13A -B shows the anchor 330 in longitudinal cross-section, whereby for each of these figures, the cross-section of the left frame is orthogonal to the cross-section of the right frame. Fig.13A -B, the central longitudinal axis ax2 of the anchor 330 (e.g., defined by the tissue engaging element 34) lies in the respective planes of the two cross-sections, wherein the plane of the cross-section of one frame is rotated 90 degrees about the axis ax2 relative to the plane of the cross-section of the other frame. Thus, Fig.13A -B is similar to Fig. 9A -B, but anchor 330 is shown instead of anchor 230.

[0347] Fig. 9A The anchor 330 is shown in its unlocked state, and Fig. 9B The anchor is shown in its locked state.

[0348] In some embodiments, and as shown, lock 310 defines a pressing surface 311 and is configured to lock head 332 to tether 26 by pressing the pressing surface against the tether. As shown, lock 310 can include a pressing plate 312 defining a pressing surface.

[0349] The lock 310 can include a spring 314 configured to lock the head 332 to the tether 26 by pressing the pressing surface 311 against the tether, for example, biasing the lock 310 to lock. In some embodiments, the spring 314 is configured to press the pressing surface 311 against the tether 26 by axially moving the pressing surface relative to the tissue engaging element 34. In the example shown, the pressing surface 311 is a proximal surface of the pressing plate 312 (e.g., the surface of the pressing plate facing away from the tissue engaging element 34), and the spring 314 is configured to push the pressing surface 311 proximally (e.g., away from the tissue engaging element). For example, the spring 314 can be a compression spring disposed between the pressing plate 312 and the tissue engaging element 34. In the specific example shown, the spring 314 is disposed between the pressing plate 312 and the base plate 366 of the head 332. The base plate 366 can be fixedly attached to the tissue engaging element 34.

[0350] In some embodiments, and as shown, the head 332 (e.g., the lock 310 thereof) can include or define a peripheral wall 316 that circumscribes (e.g., is coaxial with) the central longitudinal axis ax2 and has one or more holes 318 defined therein. In some embodiments, the head 332 is slidably coupled to the tether 26 via a tether extending transversely through the head through the hole 318. In some embodiments, the pressing surface 311 can be disposed inboard of the peripheral wall 316 (e.g., the peripheral wall circumscribes the pressing plate 312).

[0351] In some embodiments where the head 332 includes a wall 316 with holes 318, the spring 314 can be configured to move the pressing surface 311 across at least one of the holes 318. This can lock the head 332 to the tether 26 by clamping the tether between the pressing surface 311 and the edge of the hole 318.

[0352] The lock 310 may be unlocked by a force applied by the actuator 342, or may be inhibited from locking. For example, the actuator 242 may directly push (e.g., distally) a surface (e.g., a proximally facing surface) 313 defined by or connected to the hold-down plate 312, thereby tightening the spring 314 (e.g., compressing the spring against the base plate 366) or inhibiting the spring from relaxing (e.g., Fig. 9A). This indirect push can be achieved by the driver 242 pushing one or more lateral buttons 334 as a component of the head 332. In the example shown, the button 334 is a lateral button, for example, mounted laterally on the head 332, and optionally protruding laterally from the housing 337 of the head. Therefore, the lock 310 can be configured so that when the spring 314 axially moves the pressing surface 311 relative to the tissue engagement element 34 (e.g., away from the tissue engagement element), this movement laterally protrudes the button 334 from the housing 337. The pressing button 334 unlocks the lock 310 inwardly by, for example, axially moving the pressing surface 311 relative to the housing and / or relative to the tissue engagement element 34.

[0353] In the example shown, this functionality is provided by (i) each button 334 defining (or being connected to) a corresponding bearing surface 336, and (ii) a surface 313 (which may also be considered a bearing surface) inclined relative to the surface 336, so that for each button 334, pressing the button inwardly by sliding the surface 336 over the surface 313 causes the pressing surface 311 to move axially. The surface 336 and / or the surface 313 may be inclined relative to the axis ax2. As shown, each button 334 may define (or may be attached to) a wedge defining the surface 336, for example the button may be wedge-shaped.

[0354] In some embodiments, and as shown, the anchor 330 can include two buttons 334 (e.g., opposite each other). In some embodiments, and as shown, when the buttons are pushed medially, portions of the two buttons slide past each other. As shown, the two buttons can be shaped to slide into each other when pushed medially.

[0355] In some embodiments, and as shown, surface 313 is curved (e.g., convex). For example, and as shown, surface 313 can be shaped as an arch or a hemisphere. In some embodiments, and as shown, surface 336 is curved (e.g., convex).

[0356] In some embodiments, and as shown, the driver 242 can include a shaft 344 that defines (or is coupled to) a chamber 345 at a distal portion of the shaft that is sized to receive at least a portion of the head 332. This shaft and / or one or more control rods 348 that can reversibly extend from the shaft 344 (e.g., inboard and / or into the chamber 345) can configure the driver 242 to reversibly engage the head 332, such as its driver interface 338. In some embodiments, the driver 242 (e.g., the shaft 344) is sized such that the placement of the head 332 within the chamber 345 maintains the button 334 pushed inwardly, and thereby maintains the lock 310 unlocked ( Fig.13A In some embodiments, withdrawal of the head 332 from the chamber 345 (e.g., upon withdrawal of the actuator 242 after the anchor 330 has been anchored) allows the spring 214 to relax (e.g., decompress), thereby causing the lock 310 to transition toward its locked state ( Fig. 13B ).

[0357] In some embodiments, shaft 344 is a tube, wherein chamber 345 is a distal portion of the lumen of the tube.

[0358] In some embodiments, such as in some embodiments where the tissue engaging element 34 is a spiral / screw-in tissue engaging element, the tissue engaging element can be rotatable independently of the peripheral wall 316. That is, the peripheral wall 316 can be rotatable relative to the tissue engaging element 34 and / or the interface 338. This enables the tissue engaging element 34 to be screwed into the tissue without wrapping the tether 26 around the anchor, for example, where the tether keeps the wall 316 stationary while the tissue engaging element rotates. Driving (e.g., screwing) the tissue engaging element 34 into the tissue can be performed by a driver 342. The head 332 (e.g., its interface 338) can be keyed with an anchor key 339, and the driver 342 (e.g., the shaft 244 and / or the chamber 345) can be keyed with a drive key 346 complementary to the anchor key. Together, the keys 339 and 346 thus define a keyed joint, through which the driver 242 can apply torque to the interface 338 of the anchor 330, for example, by the rotation of the shaft 344.

[0359] In some embodiments, and as shown, the anchor 330 (e.g., its head 332) includes a torque assembly 360, through which torque is transferred from the interface 338 to the tissue engaging element 34. The torque assembly 360 can be placed from the inner side of the peripheral wall 316, and can include one or more torque shafts extending between the interface 338 and the tissue engaging element 34. These torque shafts can be located on the central longitudinal axis ax2. In the example shown, the torque assembly 360 includes at least a first torque shaft 362 and a second torque shaft 364, which are operably connected to each other to transfer torque, for example, due to their respective shapes that are rotationally locked to each other. For example, and as shown, the non-circular and / or protruding portion 365 of the torque shaft 364 can cooperate with the non-circular and / or recessed portion 363 of the torque shaft 362 to define a keyed joint.

[0360] Thus, in some embodiments, the head 332 comprises a housing having a proximal portion (e.g., including the interface 238) and a base portion (e.g., including the base plate 266) by which the head is coupled to the tissue engaging element 34. The proximal and distal portions of the head are axially separated at a mid-section where the peripheral wall 316 is disposed. Although the proximal portion, the base portion, and the tissue engaging element are rotationally (and typically axially) locked relative to each other, they are (e.g., collectively) rotatably coupled to the peripheral wall 316. The lock 310 and / or the peripheral wall 316 may axially traverse the mid-section.

[0361] In some embodiments, and as shown, some components of the head 323 may be common to both the torque assembly 360 and the lock 310. For example, and as shown, the integral assembly 370 may be formed to define the surface 313, the shaft 362, and the press plate 312 (see Fig. 12C ). Component 370 can be shaped to be rotationally locked to interface 338 and / or keyed to be rotationally locked to the interface. For example, and as shown, surface 313 can be non-circular. In some embodiments, shaft 362 is also used to transfer the unlocking force applied to surface 313 by button 334, such as the shaft pushes the pressing plate 312 against spring 314, thereby compressing the spring between the pressing plate and the base plate 366. Therefore, in some embodiments, component 370 can be considered a piston. In order to provide this function, the operative connection between shafts 362 and 364 can allow shaft 362 to slide axially relative to shaft 364. For example, and as shown, portion 363 can be a groove or slit that runs substantially parallel to axis ax2, and the size of the groove or slit is set to allow portion 365 to slide axially along it.

[0362] In some embodiments, tether 26 extends laterally through head 332 by: (i) passing into hole 318, (ii) passing through hold-down plate 312 and / or passing through (e.g., at least partway around) torque assembly 360 (e.g., torque shaft 362 and / or torque shaft 364), and (ii) passing out of another hole 318, mutatis mutandis, e.g., similar to the embodiments described above. Fig. 10A As shown for anchor 230 in FIG.

[0363] As described above, the driver 342 can be reversibly engaged with the interface 338. This engagement can be controlled by one or more control rods 348. For example, and as shown, when in the advanced position, the control rods can protrude medially into the chamber 345 to block axial movement of the anchor 330. In some embodiments, and as shown, one or more of the control rods 348 protrude distally from the head 332 to block the anchor 330 from moving distally out of the chamber 345. In some embodiments, and as shown, one or more of the control rods 348 protrude proximally from the head 332 to block the anchor 330 from moving proximally into the chamber 345. In some embodiments, while the control rods 348 protrude in this manner, the anchor 330 can be anchored to tissue. To disengage the driver 342 from the anchor 330 , one or more of the rods 348 (eg, those protruding distally from the head 332 ) may be pulled proximally so that they retract, such as into the wall of the shaft 344 .

[0364] In some embodiments, the control rods 348 coincide circumferentially with the drive keys 346. In the example shown, the two control rods 348 are disposed opposite each other on the same plane where the two drive keys 346 are located. Furthermore, in the example shown, the control rods 348 extend medially beyond the drive keys 346. However, other alignments and arrangements of the control rods 348 are possible, such as the control rods 348 being disposed opposite each other on a plane orthogonal to the plane where the drive keys 346 are located.

[0365] In some embodiments, and as shown, each button 334 is seated at a corresponding anchor key 339, for example, such that a drive key 346 complementary to the anchor key pushes / constrains the corresponding button inwardly.

[0366] Fig.14A-B is a schematic illustration of system 400 according to some embodiments. Except where noted, system 400 is as described mutatis mutandis for system 300. Except where noted, system 400 differs from system 300 in its anchor 430, which may be as described mutatis mutandis for anchor 330.

[0367] Anchor 430 includes tissue engaging element 34, and may also include a head 432 coupled to the tissue engaging element (e.g., coupled to the proximal end of the tissue engaging element). In some embodiments, the anchor (e.g., head 432) is slidably coupled to tether 26, for example, in a manner similar to the head 332 of anchor 330, or is configured to be slidably coupled to the tether, with modifications made. Although in the illustrated example, the tissue engaging element of anchor 430 is tissue engaging element 34 (as described above), anchor 330 may alternatively or additionally include another tissue engaging element, with modifications made. In some embodiments, head 432 includes a lock, which is configured to lock the head to tether 26 when it is locked. In some embodiments, this lock may share features with lock 210 or lock 310, with modifications made.

[0368] Similar to anchor 330, anchor 430 has a peripheral wall 416 that circumscribes (e.g., is coaxial with) a central longitudinal axis of the anchor and has one or more apertures 418 defined therein. In some embodiments, head 432 is slidably coupled to tether 26 via a tether that extends transversely through the head through aperture 418. However, while peripheral wall 316 is generally rotatable relative to the tissue engaging elements and / or interface of anchor 330, peripheral wall 416 is generally rotationally locked relative to the tissue engaging elements and / or interface of anchor 430. Thus, with anchor 430, threading tissue engaging elements 34 into tissue also wraps tether 26 around peripheral wall 416, thereby tensioning the tether and contracting the tissue ( Fig. 14B ).

[0369] In some embodiments, anchor 430 is not as described for anchor 330, except that peripheral wall 416 is rotationally fixed, but is as described for anchor 230, except that peripheral wall 416 is rotationally fixed. For example, anchor 430 can be as described above, but with the interface described for anchor 230 and engagement by an anchor driver.

[0370] Fig.15A-C and 16A-D are schematic illustrations of system 500 according to some embodiments. System 500 includes an implant 522 and a delivery tool 540 for percutaneous (e.g., transluminal (e.g., transfemoral)) implantation of the implant. Except as indicated, system 500 can be as described for system 200, with modifications made. For example, the anchor 530 and driver 542 of system 500 are different from those of system 200. However, the functions of system 500 and the techniques used therewith are generally similar to those of system 200 and the techniques used therewith. For example, system 500 allows tensioning of the tether 26 after anchoring of each anchor, and allows this tension to be fixed by locking the head of the anchor to the tether, for example, by locking the head of the lock. Although only a single anchor 530 is shown, system 500 can include multiple anchors 530, with modifications made, for example, as described for systems 200, 300 and 400. In the example shown, the tether of implant 222 is tether 26 (described above), but implant 522 may alternatively or additionally include another tether, mutatis mutandis.

[0371] although Fig.15A The tether 26 is shown separate from the anchor 530 of the implant 522, but the implant can be provided with multiple anchors 530 already connected to the tether, for example as described in International Patent Application PCT / IB2021 / 058665 to Halabi et al., published as WO 2022 / 064401, and / or International Patent Application PCT / IB2022 / 051099 to Shafigh et al., mutatis mutandis. In some embodiments, the implant 522 can be provided with one or more of the anchors 530 separate from the tether 26 and configured to be connected to the tether.

[0372] Fig. 15B A cross section of anchor 530 is shown, and Fig. 15C An exploded view of the anchor is shown. Anchor 530 includes a tissue engaging element 34 and may include a head 532 coupled to the tissue engaging element (e.g., coupled to the proximal end of the tissue engaging element). Although in the illustrated example, the tissue engaging element of anchor 530 is tissue engaging element 34 (as described above), anchor 530 may alternatively or additionally include another tissue engaging element, mutatis mutandis.

[0373] The head 532 can be slidably coupled to the tether 26, or can be configured to be slidably coupled to the tether. For example, and as shown, the head 532 (e.g., a housing of the head) can include or define a peripheral wall 516 that limits (e.g., is coaxial with) the central longitudinal axis ax3 of the anchor 530 and has one or more holes 518 defined therein. The head 532 can be slidably coupled to the tether 26 by extending the tether 26 transversely through the head through the hole 518. Fig.16A -D).

[0374] The delivery tool 540 is configured to advance the anchor 530 (and thus, in general, the implant 522) transluminally to the heart of the subject. The delivery tool 540 may include a driver 542. The delivery tool 540 may also include a flexible tube (e.g., a catheter) 550 that can be advanced transluminally to the heart and through which the driver 542 can extend. The delivery tool 540 may be configured to sequentially (i) anchor the anchor to the tissue for each anchor 530 so that a segment of the tether 26 extends from the previous anchor in the anchor (i.e., the anchor that has been most recently anchored) to the anchor, then adjust the tension on the segment of the tether, and then fix the tension by locking the lock 510 of the anchor.

[0375] In some embodiments, implant 522 can include a leading anchor, such as, with modifications, similar to the leading anchor of other systems described herein. In some embodiments, driver 542 (e.g., delivery tool 540) is also configured to anchor the leading anchor. For example, the driver interface of the head of the leading anchor can be a similar driver interface 538 of anchor 530, as described below. In some embodiments, a separate driver (e.g., a separate delivery tool) can be provided for the leading anchor.

[0376] The lockability of the anchor 530 is provided by the set screw 513 being installed (e.g., within a housing of the head 532, which may have complementary internal threads) such that rotation of the set screw moves the pressing surface 511 (e.g., defined by the set screw) toward the opposing surface 566. In the illustrated example, the opposing surface 566 is the interior of the head 532 and, as shown, may be defined by a base plate of the head. When the tether 26 extends through the head 532, the tether extends between the pressing surface 511 and the opposing surface 566, such that movement of the pressing surface toward the opposing surface clamps the tether therebetween, thereby locking the locking anchor 530 to the tether. Thus, the set screw 513, the pressing surface 511, and the opposing surface 566 may be considered components of the lock 510 of the head 532.

[0377] The lock 510 can be locked by a force applied by the driver 542. For example, the driver 542 can apply a torque to the set screw 513 (e.g., by engaging with a recess / slot of the set screw (e.g., an inner surface thereof). Similarly, the driver 542 can apply a reverse torque to unlock the lock 510. In the example shown, the torque is applied by a lever 548 of the driver 542. For example, when the driver 542 is engaged with the anchor 530, a keyed portion (e.g., a protrusion) 549 of the lever 548 can extend into a recess of the set screw 513, so that rotation of the lever applies torque to the set screw.

[0378] In some embodiments, such as in some embodiments where the tissue engaging element 34 is a spiral / screw-in tissue engaging element, the tissue engaging element can be rotatable independently of the peripheral wall 516. This enables the tissue engaging element 34 to be screwed into the tissue without wrapping the tether 26 around the anchor, for example, where the tether and / or driver 542 keep the wall 516 stationary while the tissue engaging element rotates. The tissue engaging element 34 can be driven (e.g., screwed) into the tissue by the driver 542. The driver 542 can include a drive head 546 and an axis (e.g., a drive shaft) 544 extending from an external portion (e.g., a control handle) to the drive head. The drive head 546 can be reversibly engaged with the driver interface 538 of the head 532 of the anchor 530, and together they can be considered to define a torque assembly. Fig.16A Anchor 530 is shown being brought into proximity with tissue 10 by driver 542 .

[0379] In some embodiments, and as shown (e.g., in Fig.16A -B), the tether 26 extends laterally through the head 532 by: (i) passing into the hole 518, (ii) crossing the pressing surface 511 and / or the relative surface 566, and / or passing through (e.g., at least partway around) the interface 538 and / or the drive head 546, and (ii) exiting another hole 218.

[0380] Fig. 16BIt is shown that when the tether 26 extends laterally from the previously anchored anchor through the head 532, the anchor 530 (e.g., its tissue engaging element 34) has been screwed into the tissue 10 without the need for the tether to become wrapped around the head 532, such as through the peripheral wall 516 (and thereby through the hole 518), so as to remain stationary during the rotation of the tissue engaging element 34. As described above, the torque for this screwing can be provided by rotating the shaft 544 when the drive head 546 is engaged with the driver interface 538. This rotation of the shaft 544 can be relative to the control rod 548, which can hold the set screw 513 from rotating relative to the peripheral wall 516, which itself can be held from rotating relative to the tissue by the tether 26.

[0381] Fig. 16C The lock 510 is shown to have been locked by the control rod 548 rotating the set screw 513 (e.g., relative to the housing of the head 532, such as its peripheral wall 516) so that the tether 26 becomes clamped between the pressing surface 511 and the opposing surface 566. This locking can be performed after the desired degree of tension has been applied to the tether 26, mutatis mutandis, such as described above for other systems. During this locking, the shaft 544 can hold the interface 538 (and thereby the tissue engaging element 34) from rotating relative to the tissue. Subsequently, the driver 542 can be disengaged from the anchor 530 and withdrawn ( Fig.16D ).

[0382] It should be noted that the interface 538 is disposed distally of the lock 510 (i.e., closer to the tissue engaging element 34 than the lock). It should also be noted that the shaft 544 extends distally beyond the lock 510 (e.g., the set screw 513) to a position where the drive head 546 engages the interface 538. As shown, the control rod 548 can extend through the set screw 513 (e.g., the axial passage in the set screw) without engaging the set screw, so that the control rod can apply torque to the tissue engaging element 34 without rotating the set screw.

[0383] Reference now Fig.17A -E and 18, described figure is according to the system 600 of some embodiments and the schematic illustration of the technology used therefor.System 600 and the technology used therefor and other systems (for example, system 200,300,400 and / or 500) shared features described above.The example of such shared features can be that the section of implant (for example, the section extending between two anchors) is fastened to tissue, shrinks this section, and then makes the iterative process of same behavior for subsequent sections.However, system 600 provides telescopically extending and retractable implant through segmentation, rather than providing the implant comprising the anchor threaded on the tether.

[0384] The system 600 includes an implant 622 and may also include a delivery tool 640 for percutaneously (e.g., transluminally (e.g., transfemorally) implanting the implant). The implant 622 is a segmented implant that includes a plurality of segments 624 telescopically coupled to one another in series, each of the segments including an anchor 630. The delivery tool 640 is configured to deliver the implant 622 percutaneously to the heart to anchor each of the anchors 630 to tissue 10 of the heart (e.g., an annulus of a valve (e.g., tricuspid valve 5) as shown), and to contract the tissue by telescopically contracting the implant while each of the anchors remains anchored to the tissue. In some embodiments, this is performed in a continuous manner, whereby a segment 626 of the implant (e.g., extending between two anchors 630 and / or overlapping two segments 624) is secured to tissue (e.g., by two of the two anchors between which the anchoring segment extends), then telescopically contracted and can be locked, and the same action is then performed with a continuous segment of the implant.

[0385] The first segment 624a of the implant 622 is secured to the tissue 10 by anchoring the segmented anchor 630 to the tissue ( Fig.17A ). In some embodiments, the anchor 630 automatically becomes deployed when exposed from the delivery tool 640. In some embodiments, a discrete driver (not shown) can be placed in the implant 622 (e.g., extending into the segment 624, such as extending into the lumen defined by the segment), and the deployment of the anchor can be controlled independently of the exposure of the anchor 630 from the delivery tool. For example, the driver can initially constrain the anchor 630, and can be operated to release the anchor at a desired time. That is, the anchor 630 can be biased toward the assumed anchoring position, but during the delivery of the implant, the delivery tool constrains the anchor in the delivery position. In some embodiments, each anchor 630 can be constrained in the delivery position by an adjacent segment 624 (e.g., a previously anchored segment or a next segment to be anchored). For example, the anchor can be constrained in the delivery position by being placed in an adjacent segment, and the delivery tool can release the anchor by extending the segment telescopically beyond the segment constraining the anchor.

[0386] Then, the second segment 624b extends telescopically from the segment 624a ( Fig. 17B ), and its anchor 630 is anchored to the tissue ( Fig. 17C ).therefore, Fig.17A-C shows a first segment 626a of the implant secured along a portion of the path of tissue 10. The first segment 626a includes a portion of segment 624a and a portion of segment 624b. Subsequently, by reducing the length of segment 626a, the desired degree of contraction is applied to the portion of the path along which the first segment 626a is secured ( Fig.17D ). As shown, this can be achieved by telescopically contracting segment 624b into segment 624a. This reduced length (and thus this desired degree of contraction) is fixed by locking segment 624a to segment 624b (i.e., fixing the amount of telescoping between the segments). This locking can be performed as a discrete action after the length is reduced (e.g., by locking a lock), or may be inherent to the manner in which the length is reduced, such as one or both of segments 624a and 624b including a ratchet and / or thread that prevents the length from passively re-increasing.

[0387] In some embodiments, contraction of segment 626a of implant 622 is performed by one component of delivery tool 640 pulling segment 624b, while another component of the delivery tool pushes segment 624a. In some embodiments, implant 622 includes a tether that extends along the implant (e.g., through the implant) and is tensioned each time segment 626 is contracted, mutatis mutandis, e.g., as similar to that described above for other implants.

[0388] These steps are iteratively repeated for each section 626 of the implant using additional segments 624 . Fig.17E An implant 622 having six segments (segment 624a, segment 624b, segment 624c, segment 624d, segment 624e, and segment 624f) is shown, which define five sections (section 626a, section 626b, section 626c, section 626d, and section 626e). In the example shown, section 626a is fastened along a portion 10i of tissue 10 (e.g., along a portion of a path of tissue); sections 626b and 626c are fastened along a portion 10j of tissue; section 626d is fastened along a portion 10k of tissue, and section 626e is fastened along a portion 10l of tissue. Portions 10i and 101 are shown as having contracted to a similar degree of contraction, portion 10k is shown as having contracted to a lesser degree than portions 10i and 101 (e.g., shown as not contracted at all), and portion 10j is shown as having contracted to a greater degree than portions 10i and 101. It should be understood that the degree of contraction of various portions of tissue and the specific implantation arrangements of implant 622 are intended to be illustrative examples and are not limiting.

[0389] In some embodiments, each segment 624 of the implant 622 is hingedly coupled relative to its adjacent segments, at least during implantation, thereby allowing the implant to be implanted along a tortuous path (eg, around the annulus of a valve), as shown.

[0390] refer to Fig.19A -G, which is a schematic illustration of a system 700 and techniques for tensioning an implant 722 of the system, according to some embodiments. Similar to system 20, system 700 is a tissue adjustment system and can be used to adjust the size of tissue 10 (e.g., tissue of a subject's heart). In some embodiments, system 700 is adapted to allow tensioning of the tethers of the implant (e.g., once all anchors of the implant have been anchored to the tissue and / or once the tethers have been trimmed and locked to the implant) once the implant has been fully implanted within the heart. Fig.19A ).

[0391] In some embodiments, system 700 can be an annuloplasty system, and implant 22 can be an annuloplasty structure (e.g., an annuloplasty ring or band) for implantation at the annulus of a valve of the heart (e.g., along the annulus of a valve of the heart). Implant 722 can include a plurality of anchors 730 and tethers 26 that are slidably coupled to the tethers, such as by being threaded onto the tethers.

[0392] Each anchor 730 includes a head 732 and extending distally away from the head is a tissue engaging element 34. The tissue engaging element 34 defines an anchor axis of the anchor, ie, the axis along which the anchor is advanced during anchoring.

[0393] In some embodiments where the tissue engaging element 34 is substantially linear (e.g., a dart, etc.), the tissue engaging element can be located on the anchor axis. In some embodiments where the tissue engaging element 34 is helical, the anchor axis can be the helical axis of the tissue engaging element, such as shown.

[0394] In some embodiments, the tether 26 extends through the head 732, such as through a horizontal channel 748 defined by the head transverse to the axis of the anchor. In some embodiments, the tether 26 can slide through the channel 748.

[0395] In some embodiments, similar to systems 200 and 300, each head 732 includes a lock 770 configured to lock the head to the tether 26 when the lock is locked.

[0396] In some embodiments, the lock 770 can include a first locking element 772a and a second locking element 772b, which are adapted to lock the head 732 to the tether 26 by capturing the tether between the locking elements. The first locking element and the second locking element can be configured in a variety of ways. In some embodiments, the locking element can be the same or similar to one or more of the following: a lever, a ratchet, a tooth, a barb, a leg, a clamp, a bead, a crimper, etc.

[0397] In some embodiments, lock 770 is biased to assume a locked state in which the lock is locked to the tether if the tether is disposed between the locking elements. This bias can be achieved by biasing the locking elements 772a and 772b to pivot in a manner that reduces the size of the gap between them.

[0398] In some embodiments, each locking element 772a and 772b has an associated spring 774a and 774b adapted to bias the locking element toward the locked state, for example, in the absence of an unlocking force applied to the lock.

[0399] In some embodiments, each locking element in locking elements 772a and 772b defines capture surfaces 776a and 776b, respectively. In some embodiments, the locking element is biased to pivot in a manner that reduces the size of the gap between the capture surfaces. The capture surface can be knurled and / or can define a plurality of teeth to facilitate engagement with the tether 26. In some embodiments, the locking element is configured so that while the lock 770 is locked to the tether 26, the lock has a ratchet-like property, such as to facilitate the tether to move between the locking elements in only one direction. In some embodiments, and as shown, the lock can even increase its grip on the tether 26 in response to pulling the tether in another direction (e.g., in the direction in which the tether will be released from the lock in other ways). In the example shown, this is achieved by the geometry of the corresponding hinge points 777a and 777b of the locking element and the locking element installed therethrough, such as the eccentric positioning of the hinge points relative to the position and / or curvature of the capture surface.

[0400] In addition to the implant 722, the system 700 may also include a tensioning tool 740 for percutaneously (e.g., transluminally (e.g., transfemorally)) tensioning the implant. In some embodiments, the tool 740 is adapted to advance and engage with any anchor 730 of the implant after the implant 722 is implanted within the heart (e.g., once all or at least some of the anchors of the implant have been implanted at the tissue). Thus, the system 700 may advantageously allow for adjustment (e.g., increase) of the tension on the tether 26 if it is determined that this would be desirable after the initial locking of the tension in the tether.

[0401] In some embodiments, the tool 740 comprises a catheter 750 (e.g., a transluminal catheter) adapted to engage the anchor head 732 of the anchor 730 (e.g., Fig.19B ). Tool 740 may include an unlocker 752, which may include a tube. Unlocker 752 may be disposed within catheter 750 and / or disposed to be advanced through the catheter. Unlocker 752 may be adapted to transition lock 770 toward an unlocked state, for example, by applying an unlocking force to the lock.

[0402] Tool 740 includes a grasper 754 (e.g., a hook, jaws, or clamp) adapted to grasp tether 26 and increase tension on the tether by pulling the tether through the gap between locking elements 722a and 722b ( Fig.19D As shown, the grasper 754 can be adapted to be advanced through the catheter 750 and / or through the unlocker 752.

[0403] Fig.19B -G represents a series of steps that can be performed by the operator to apply tension to the implant 722. It should be noted that Fig.19A -G is intended primarily to illustrate the capabilities of system 700 rather than to strictly define the sequence of steps for a procedure.

[0404] Fig.19A Implant 722 is shown implanted in a heart, with anchor 730 anchored to tissue 10 (eg, to the annulus of a valve of the heart). Fig.19A It is schematically illustrated that the tension on the tether 26 is insufficient to optimally contract the tissue 10. This insufficiency may have occurred during implantation or may have developed since implantation.

[0405] After implantation of the implant 722 (e.g., during the same medical procedure or during a subsequent medical procedure), the catheter 750 is advanced to the heart and engages the anchor head 732 of the implant's anchor 730 ( Fig.19B The unlocker 752 is then used to transition the lock 770 toward the unlocked state, for example by pressing against the locking elements 772a and 772b (eg, against a lever defined by the locking elements). Fig.19C). In some embodiments, the unlocker 752 is advanced to the lock 770 through an opening defined by the anchor head 732, the opening providing access to the lock for the unlocker, e.g., as shown. In some embodiments, the unlocker 752 transitions the lock toward an unlocked state by pivoting the locking elements 772a and 772b away from each other, thereby increasing the size of the gap therebetween, as shown. While the lock remains in the unlocked state (e.g., while the unlocker 752 remains against the lock 770), the grasper 754 is advanced through the gap between the locking elements to engage the tether 26 within the channel 748, e.g., the grasper grasps the tether (e.g., hooks onto the tether) ( Fig.19D ).

[0406] Grasper 754 can then be pulled proximally through lock 770 (eg, through a gap between locking elements), thereby forming loop 28 in the tether ( Fig.19E ).like Fig.19E As shown, this tensions the implant 722, thereby reducing the distance between the anchors 730 (eg, by the tethers pulling the anchors toward each other), thereby constricting the tissue 10 of the heart.

[0407] To lock the tension in the implant, the unlocker 752 can then be retracted ( Fig.19F ), thereby allowing lock 770 to transition toward its locked state, such as by locking elements 772a and 772b pivoting inwardly toward each other and clamping the tether therebetween. In this state, tether 26 (e.g., loop 28 thereof) is arranged so that the tether extends away from passage 748 and through lock 770, and around back through the lock to the passage.

[0408] The catheter 750 can then be retracted ( Figure 19G ), thereby allowing the implant 722 to be implanted into the tissue 10 in a tensioned state.

[0409] Fig.19A -G shows an implant 722 with three anchors, but it should be understood that the implant 722 can have more or fewer anchors. In some embodiments, the above-mentioned techniques for applying tension to the anchors 730 of the implant 722 are performed on an as-needed basis, for example, based on intra-procedural imaging. Thus, only one or a selected subset of the anchors 730 can be tensioned in this manner. In some embodiments, all anchors of the implant can be tensioned sequentially in this manner.

[0410] It should be further noted that the anchor 730 and / or catheter 750 can be used in combination with other systems and / or implants described herein and / or in International Patent Application No. PCT / IB2022 / 051099 to Shafigh et al., filed on February 8, 2022, which is incorporated herein by reference. For example, one or more anchors of such an implant can be replaced with the anchor 730 to provide the options for post-implantation adjustment described herein.

[0411] Reference now Fig. 20A -C, 21, 22A-B, and 23A-E, which are schematic illustrations of devices for use with a tether, according to some embodiments. Fig. 20A -C shows a cutter 810 for use with a tether, according to some embodiments. Fig.21 and Fig.22A -B shows a lock 990 for use with a tether according to some embodiments. Fig.23A -E shows a system 1000 comprising a cutter 810 and a lock 990 for use with a tether 26, according to some embodiments.

[0412] Lock 990 can be a variant of or alternative to the lock 24 mentioned above. As mentioned with reference to lock 24, lock 990 can be locked to the tether of the implant (e.g., the tether 26 of any implant mentioned above) to maintain tension in the implant.

[0413] The lock 990 includes a tubular wall 992 that defines a lumen 980 that is sized to receive a tether (e.g., tether 26) therethrough. A window 994 (e.g., an aperture, hole, or opening) is cut from the wall and positioned on the side of the wall opposite the window is a tab 996 also cut from the wall (e.g., having only a single edge attached to the wall 992). In some embodiments, the tab 996 is biased (e.g., shaped) to deflect across the lumen 980 and protrude into the window 994 in a manner that locks the lock to the tether.

[0414] In some embodiments, and as shown, the wall 992 defines a plurality of windows 994 cut from the wall and a plurality of corresponding tabs 996 cut from the wall, each tab facing a respective window and adapted to be deflected across the lumen and into the respective window to capture the tether within the lock.

[0415] In some embodiments, the lock 990 is advantageously manufactured simply by cutting it out of a single piece of stock tubing (eg, nitinol tubing) and the shape-setting tab 996 .

[0416] In some embodiments, the blocking rod 920 is adapted to maintain the lock in an unlocked state in which the tab is prevented from deflecting across the lumen and into the window ( Fig.22A In some embodiments, in the unlocked state of the lock, the rod extends through the lumen along the tether, thereby protecting the tether from the tab. In some embodiments, withdrawing the rod from the lock transitions the lock toward the locked state by allowing the tab to deflect across the lumen and push the tether into the window. Fig. 22B ).

[0417] It should be noted that although rod 920 may have a circular cross-section, the rod may alternatively have an elongated (e.g., rectangular) cross-section or a curved cross-section (e.g., arc) similar to a strap, for example to facilitate securing of tether 26.

[0418] Figures 20A-20C The cutting of the tether 26 of the implant according to some embodiments is shown. In some embodiments, and as will be referred to below Fig.23A As explained in the foregoing, the cutter 810 can be configured for use with the lock 990, for example, to lock and cut the tether. The cutter 810 includes a cutting element 860 suitable for cutting the tether 26. The cutter 810 can include one or more of a variety of cutting elements, such as a blade, a knife, scissors, clamps, a razor, a scalpel, an edge, a sharp edge, a cutting edge, etc.

[0419] In some embodiments, cutter 810 (eg, cutting element 860 thereof) can define a lumen sized to receive a tether therethrough.

[0420] In some embodiments, at the distal end of the cutting element 860, the cutting element defines a pair of cutting edges 862 that face each other such that the tether 26 can extend therebetween ( Fig. 20A ). Cutter 810 further includes an outer sleeve 850 that can slide over and along cutting element 860 in a manner that forces the cutting edges toward each other, thereby cutting the tether ( Fig. 20B -C).

[0421] In some embodiments, the cutting element 860 includes a pair of arms 868, each arm having a proximal portion 864 extending distally and away from the proximal portion of the other arm of the pair, and a distal portion 866 extending distally from the proximal portion and toward the distal portion of the other arm of the pair. In the example shown, each arm 868 has a discrete elbow 870 between the proximal portion 864 and the distal portion 866. However, it should be understood that in some embodiments, the arms may not have discrete elbows (e.g., may define a continuous curve from the proximal portion to the distal portion).

[0422] The cutting edge 862 can be coupled to or defined by a distal portion 866 of the arm, such as Fig. 20A In some embodiments, when at rest, the proximal portion 864 extends outwardly so that the arms 868 collectively define a diameter d3 that is wider than the inner diameter of the outer sleeve 850, so that the outer sleeve slides distally over and along the proximal portion 864 to squeeze the proximal portion together, thereby causing the arms to pivot inwardly toward each other and the cutting edge 862 to cut the tether 26 ( Fig. 20B -C). In some embodiments, and as Fig. 20A As shown, at rest, the angle at which the proximal portion 864 is disposed relative to the central axis of the cutter is shallower than the angle at which the distal portion 866 is disposed relative to the central axis. In some embodiments, and as shown, the proximal portion 864 is longer than the distal portion 866.

[0423] In some embodiments, cutting element 860 is advantageously manufactured simply by cutting it from a single piece of stock tubing (e.g., a nitinol tube) and shaped arms and cutting edges. Similarly, outer sleeve 850 can be a simple tube. That is, in some embodiments, cutter 810 can be essentially comprised of two concentric tubes, the interiors of which have been cut and shaped to define arms and / or cutting edges. In some embodiments, this advantageously allows cutter 810 to be small enough in size to be delivered transluminally to the heart (e.g., having a diameter small enough to fit through other components of the delivery system). For example, while adjustment tool 60 is shown / described as being advanced toward an implant after tube 50 is withdrawn from the subject, cutter 810 can be advanceable through such a tube, such as tube 50. In some embodiments, this can allow for the subsequent introduction of more anchors. For example, this can facilitate the implantation of multiple implants (e.g., reference 1 to FIG. 1 ). Figure 3 and 4 50. In another example, the cutter 810 can be used after a subset of anchors have been anchored but before another subset of anchors have been anchored, for example using a similar Fig. 7A -F to advance lock 990. That is, in some embodiments and / or for certain steps, cutter 810 can be used to advance the anchor, but without cutting the tether. Such advantages can similarly be imparted by cutting lock 990 from a single piece of reserve tube, mutatis mutandis.

[0424] Cutting element 860 can be advanced into the heart over and along tether 26 (i.e., while tether 26 extends through the cutting element). In some embodiments, cutter 810 is advanced into the heart by advancing cutting element 860 and outer cannula 850 over and along the tether, e.g., without advancing the outer cannula relative to the cutting element until it is desired for the cutting element to cut the tether.

[0425] Reference now Fig.23A -E, the figure is a schematic illustration of a system 1000 for locking and cutting the tether 26 of an implant 1022 according to some embodiments. In some embodiments, the implant 1022 is a variation of any of the implants described above or is substantially the same as it, and the implant includes a plurality of anchors 1030, which can be a variation of any of the anchors described above. The system 1000 can include a cutter 810 and a lock 990 to lock and cut the tether.

[0426] In some embodiments, the cutter 810 is adapted to advance (e.g., push) the lock 990 transluminally to the implant 1022 implanted at the heart. For example, and as shown, the cutter 810 can be advanced to the heart with the distal portion of the cutter 810 (e.g., the distal portion of the cutting element 860) abutting the proximal end of the lock, such that advancing the cutter 810 distally toward the implant 1022 implanted at the heart pushes the lock 990 distally toward the implant.

[0427] In some embodiments, the lock 990 is advanced into the implant with the blocking rod 920 extending through the lock to maintain the lock in an unlocked state ( Fig.23A In some embodiments, blocking rod 920 can extend proximally from lock 990 through cutter 810 (e.g., through cutting element 860) to the exterior of the subject. In some embodiments, tether 26 can be tensioned (e.g., by pulling the tether proximally from the exterior of the subject) while the tether extends through lock 990. Fig. 23B ). The reference force can be provided by cutter 810 and lock 990 (eg, by maintaining the lock against the proximal-most anchor 1030).

[0428] Subsequently (e.g., once tether 26 has been sufficiently tensioned), blocking rod 920 is withdrawn from lock 990 (e.g., by pulling the rod proximally from outside the subject), causing tab 994 to deflect across lumen 980 and into window 996, thereby locking the lock to tether 26 ( Fig.23C ).

[0429] With lock 990 locked to tether 26, the tether may then be cut, for example, by sliding outer cannula 850 distally over cutting element 860, thereby moving cutting edges 862 toward each other and severing the tether ( Fig.23D ).

[0430] Cutter 810 can then be withdrawn from the subject, leaving implant 1022 implanted at the heart, with lock 990 maintaining tension in tether 26 ( Fig.23E ).

[0431] Reference now Fig.24A -B, 25 and 26A-B, the figures show various locks 1100, 1100a and 1200 suitable for clamping to the tether of the implant according to some embodiments. The locks 1100, 1100a and / or 1120 can be a variation of any of the locks described herein or used in place of them, for example, in place of the locks 24 and / or 990 mentioned above. For example, and as mentioned with reference to lock 24, the locks 1100, 1100a and / or 1120 can be locked to the tether of the implant (e.g., the tether 26 of any of the implants mentioned above) to maintain tension in the implant. Alternatively or in addition, the locks 1100, 1100a and / or 1120 can be used in surgical procedures, for example, as suture locks for replacing knots.

[0432] Each of the locks 1100 , 1100a , and 1200 includes an outer tube and an inner tube coaxially disposed within the outer tube.

[0433] exist Fig.24A , 24B In each of 26A, 26B, the center image is a perspective view of the corresponding lock on the tether 26; the upper image shows the same view, but in which the outer tube of the lock is transparent so as to show the inner tube of the lock; and the lower image is a longitudinal cross-section indicated by AA. For the purpose of simplicity, Fig.25 Only a cross section of the lock 1100a is shown.

[0434] Fig.24A -B schematically illustrates a lock 1100 according to some embodiments. The lock 1100 comprises an outer tube 1110 and an inner tube 1120 coaxially positioned within the outer tube. The tether 26 extends through the lock 1100 through a lumen 1122 defined by the inner tube 1120.

[0435] Fig.24A The lock 1100 is shown in an unlocked state in which the tether 26 can be slid through the lock (ie, through the lumen 1122 thereof), and Fig. 24B The lock is shown in a locked state in which it is locked to the tether.

[0436] The inner tube 1120 is secured to the outer tube 1110 at an attachment point 1112, such as by welding. In some embodiments, and as shown, the attachment point 1112 is disposed at a first end 1115 of the lock 1100, such as where the base of the inner tube is secured to the base of the outer tube.

[0437] In some embodiments, and as Fig.24A and 24B As shown in the transition between, pushing the inner tube further into the outer tube and toward the attachment point 1112 causes a portion of the inner tube (e.g., a middle section of the inner tube) to bend (e.g., flex) inwardly, thereby clamping to the tether 26 within the lumen 1122, and thereby locking the lock to the tether. That is, the inner tube 1120 can be axially compressed toward the attachment point 1112 in a manner that causes the inner tube to clamp to the tether 26, such as causing the diameter of the inner tube to narrow and thereby press against the tether. This can be achieved by pushing against an end of the inner tube 1120 (e.g., the end of the inner tube located at the second end 1116 of the lock 1100). For example, and as shown, in the unlocked state of the lock 1100, at the second end 1116, the inner tube 1120 can extend out of the outer tube 1110 ( Fig.24A ), and transitioning the lock to its locked state is accomplished by pushing the end of the inner tube toward the attachment point, thereby reducing (e.g., eliminating) the amount of inner tube protruding beyond the outer tube ( Fig. 24B ). In some embodiments, once the inner tube is clamped to the tether 26, the tether 26 can no longer slide within the lock 1100, and the lock is thereby locked to the tether (eg, thereby maintaining tension in the tether).

[0438] In some embodiments, in order to maintain the lock 1100 in its locked state (e.g., to prevent axial decompression of the inner tube), the lock can define a snap-fit ​​mechanism between the outer tube 1110 and the inner tube 1120, so that once the inner tube has been pushed a predetermined amount into the outer tube, the inner tube snaps into the outer tube.

[0439] The snap-fit ​​mechanism can be provided by an inner tube 1120 defining a first snap-fit ​​component and an outer tube 1110 defining a second snap-fit ​​component that is complementary to the first snap-fit ​​component. In the example shown, the first snap-fit ​​component is a window 1124, and the second snap-fit ​​component is a tongue 1114. When the inner tube 1120 is axially compressed a predetermined amount, the tongue 1114 becomes aligned with the window 1124 (e.g., axially aligned), and in response to this alignment, automatically protrudes (e.g., snaps) into the window ( Fig. 24B Due to the geometry and / or angular placement of the tongue 1114 and the window 1124, axial decompression of the inner tube is inhibited.

[0440] In some embodiments, and as shown, the bending (eg, flexion) of the inner tube 1120 can cause the inner tube to acquire an overall hourglass shape with a waist (eg, a flexure) that is clamped to the tether. Fig. 24B ). In some embodiments, the inner tube 1120 defines a plurality of struts 1126 extending longitudinally, for example, between the ends of the inner tube. Each of the struts 1126 can itself be hourglass-shaped, for example, having a first bulb 1127, a second bulb 1129, and a waist 1128 therebetween. In some embodiments, bending (e.g., flexion) of the inner tube 1120 moves the bulb 1127 toward the bulb 1129 and causes the struts to bend medially so that the waist 1128 clamps collectively to the tether 26, thereby locking the inner tube to the tether. At each end of the inner tube 1120 (e.g., axially beyond the struts 1126), the inner tube can be annular, for example, can define a complete ring.

[0441] Fig.25 A lock 1100a according to some embodiments is shown. The lock can be considered a variation of the lock 1100 as described for lock 1100, except that the pillars 1126a of the lock 1100a are preset to be bent medially to a certain extent, even in the unlocked state of the lock. Therefore, the inner tube 1120a of the lock can have an hourglass shape in both the unlocked state of the lock and the locked state of the lock. In some embodiments, axially compressing the inner tube 1120a causes the waist of the pillars 1126a to bend medially further inwardly, so that the waist contacts the tether 26 and clamps to the tether. Compared to the lock 1100, this preset hourglass shape of the inner tube 1120 can advantageously require less force and / or movement for the inner tube to clamp to the tether. Alternatively or in addition, this preset hourglass shape can advantageously maintain the tether 26 centrally within the lumen 1122a of the lock, and thereby maintain it in a suitable position to be clamped by the pillars 1126a.

[0442] Fig.26A -B schematically illustrates lock 1200 according to some embodiments. Lock 1200 can be similar to lock 1100, except that the inner tube is pushed toward the attachment point to clamp the inner tube to the tether, and the inner tube can be twisted inwardly toward the attachment point so that the inner tube "wraps" the tether within the lumen, thereby clamping to the tether.

[0443] The lock 1200 includes an outer tube 1210 fixed (e.g., welded) to an inner tube 1220 at an attachment point 1212. The inner tube 1220 has a lumen 1222 and is shaped to define a spiral 1240 around the lumen. The spiral 1240 has a series of turns and a pitch p1. The spiral 1240 can be a single spiral or a double spiral. The lock 1200 is locked to the tether 26 by applying a torque to the inner tube 1220 (e.g., when a reference force is provided to the outer tube 1210), so that the spiral 1240 twists inward to clamp onto the tether within the lumen 1222.

[0444] The torque can be applied to an interface end 1228 of the inner tube 1220, e.g., the end opposite the attachment point 1212. The interface end 1228 can extend beyond the outer tube 1210, e.g., as shown. The interface end 1228 (e.g., its outer surface) can be keyed and / or can have a notch cut therein so that a tool applies a torque thereto. The outer tube 1210 can be similarly keyed and / or have a notch cut therein so that a tool applies a reference force thereto.

[0445] It should be noted that the conformational change of the helix 1240 caused by the applied torque includes a decrease in the pitch pi, and thus a shortening (ie, axial compression) of the tube 1220.

[0446] In some embodiments, and similar to as described above with reference to lock 1100, lock 1200 includes a snap-fit ​​mechanism for maintaining lock 1200 locked to tether 26 (e.g., to prevent axial decompression of inner tube 1220 and / or untwisting of thread 1240). In some embodiments, rotation of inner tube 1220 relative to outer tube 1210 causes rotation of snap-fit ​​components of the inner tube (e.g., snap-fit ​​components of window 1224) relative to snap-fit ​​components of the outer tube (e.g., tongue 1214), which become aligned and thus automatically snap-fit ​​to each other. This alignment may include rotational alignment and / or axial alignment, such as shown. Thus, upon a predetermined amount of axial compression (and / or torsion) of the inner tube, tongue 1214 moves into rotational and / or axial alignment with window 1224, and thus automatically protrudes into the window.

[0447] Reference again Figures 24A-26BIn some embodiments, any of the locks 1100, 1100a, and / or 1200 can be advanced transluminally to the heart by sliding the lock over and along the tether 26 while the lock is in its unlocked state. The rod of the delivery assembly can be used to advance the lock toward the heart by pushing the lock over and along the tether distally (e.g., in a catheter of the delivery assembly). Once the lock is in the heart and / or once the tether is appropriately tensioned (e.g., as described above with reference to other figures), the lock is locked to the tether by axially compressing the inner tube toward the attachment point (e.g., by axially pushing and / or twisting the inner tube) so that the inner tube clamps to the tether in the lumen. The locking force and / or reference force can be provided by the delivery assembly (e.g., by its rod), which is used to push the lock to the heart, for example, by pushing and / or twisting the inner tube distally. As described above, the inner tube can be compressed toward the attachment point until the inner tube snaps into the outer tube, thereby preventing axial decompression of the inner tube.

[0448] In some embodiments, any of locks 1100, 1100a, and / or 1200 can have multiple stable (e.g., locked) states, e.g., to allow various degrees of gripping of tether 26. In some embodiments, this is provided by multiple snap-fit ​​mechanisms arranged in a ratchet-like arrangement, e.g., by an inner tube defining multiple windows along its length, such that once a tongue on the outer tube protrudes into a first window of the mechanism, the inner tube is further axially compressed into the outer tube such that the tongue protrudes into a second window further toward the attachment point than the first window.

[0449] For example, it may be particularly advantageous in terms of manufacturing and / or reliability that locks 1100, 1100a, and / or 1200 may be formed (e.g., cut) from only two pieces of reserve tube that are secured to each other at an attachment point (e.g., at one end). In some embodiments, the wall thickness of the reserve tube may be at least 75 microns (e.g., at least 100 microns) and / or no more than 600 microns (e.g., no more than 400 microns), such as 75 microns-600 microns (e.g., 75 microns-400 microns, such as 100 microns-400 microns).

[0450] In some embodiments, the outer diameter of the outer tube of the lock (e.g., the reserve tube cut therefrom) is at least 1500 microns (e.g., at least 2000 microns) and / or no more than 6000 microns (e.g., no more than 4000 microns). For example, the outer diameter of the outer tube can be 1500 microns-6000 microns (e.g., 1500 microns-4000 microns, such as 2000 microns-4000 microns).

[0451] In some embodiments, the inner diameter of the outer tube of the lock is at least 1350 microns (e.g., at least 1800 microns) and / or no more than 4800 microns (e.g., no more than 3200 microns). For example, the inner diameter of the outer tube can be 1350 microns-4800 microns (e.g., 1350 microns-3200 microns, such as 1800 microns-3200 microns).

[0452] In some embodiments, the outer diameter of the inner tube of the lock (e.g., the reserve tube cut therefrom) is at least 1350 microns (e.g., at least 1800 microns) and / or no more than 4800 microns (e.g., no more than 3200 microns). For example, the outer diameter of the inner tube can be 1350 microns-4800 microns (e.g., 1350 microns-3200 microns, such as 1800 microns-3200 microns).

[0453] In some embodiments, the inner diameter of the inner tube is at least 1000 microns (e.g., at least 1600 microns) and / or no more than 3800 microns (e.g., no more than 2500 microns). For example, the inner diameter of the inner tube can be 1000 microns-3800 microns (e.g., 1000 microns-2500 microns, such as 1600 microns-2500 microns).

[0454] In some embodiments, the ratio between the length (L) of the lock and the outer diameter (OD) of the lock (i.e., the L:OD ratio) can be between 1.6: 1 and 2.2: 1. In some embodiments, the ratio between the OD and the thickness (T) of the stock tube from which the outer tube is cut (i.e., the OD:T ratio) can be between 10: 1 and 20: 1.

[0455] In some embodiments, the length of the outer tube of the lock is at least 1000 microns (e.g., at least 3000 microns) and / or no more than 10000 microns (e.g., no more than 7500 microns). For example, the length of the outer tube can be 1000 microns-10000 microns (e.g., 1000 microns-7500 microns, such as 3000 microns-7500 microns). In some embodiments, the length of the inner tube of the lock is at least 1000 microns (e.g., at least 3000 microns) and / or no more than 10000 microns (e.g., no more than 7500 microns). For example, the length of the inner tube can be 1000 microns-10000 microns (e.g., 1000 microns-7500 microns, such as 3000 microns-7500 microns).

[0456] In some embodiments, the outer tube of the lock (e.g., the reserve tube cut therefrom) comprises (e.g., is formed from, etc.) a metal such as stainless steel, cobalt chromium, titanium, and / or nitinol. In some embodiments, the inner tube of the lock (e.g., the reserve tube cut therefrom) comprises (e.g., is formed from, etc.) a metal such as stainless steel, cobalt chromium, titanium, and / or nitinol. In some embodiments, the outer tube of the lock comprises (e.g., is formed from, etc.) a polymer. In some embodiments, the inner tube of the lock comprises (e.g., is formed from, etc.) a polymer. In some embodiments, the material of the inner tube is the same as the material of the outer tube. In some embodiments, the material of the inner tube is different from the material of the outer tube.

[0457] Example Implementation (Some non-limiting examples of the concepts herein are described below)

[0458] Example 1. A system and / or device for use at a subject's heart, the system / device comprising an implant comprising:

[0459] Tether; and / or

[0460] A series of anchors, each of the anchors comprising:

[0461] Tissue engaging elements, and / or

[0462] A head is coupled to the tissue engaging element, is slidably coupled to the tether, and includes a lock configured to lock the head to the tether when the lock is locked.

[0463] Example 2. A system / device according to Example 1, further comprising a stop member that can be locked to the tether, the stop member defining: (i) a tubular wall that limits a lumen that is sized to accommodate the tether passing therethrough; (ii) a window that is cut from the wall; and / or (iii) a tab that is cut from the wall and is positioned opposite to the window and is biased to deflect across the lumen and protrude into the window in a manner that locks the lock to the tether received through the lumen.

[0464] Example 3. A system / device according to Example 1, further comprising a stop member that can be locked to the tether, the stop member comprising: (A) an outer tube; and / or (B) an inner tube, the inner tube (i) being coaxially positioned within the outer tube, (ii) being fixed to the outer tube at an attachment point, (iii) being shaped to define a lumen along the longitudinal axis of the lock, the lumen being sized to accommodate the tether therethrough, and / or (iv) being axially compressible toward the attachment point in a manner such that the inner tube clamps the tether within the lumen.

[0465] Example 4. A system / device according to Example 1, further comprising a tensioning tool, the tensioning tool comprising a gripper, and the gripper is configured to adjust the tension on the tether by advancing to the anchor for any anchor in the series, gripping the tether at the anchor, and forming a loop from the tether by pulling the tether through the lock, the lock being configured to lock the head to the loop when it is locked.

[0466] Example 5. The system / device of Example 4, wherein the gripper is configured to be advanced through the lock to grip the tether.

[0467] Example 6. A system / device according to Example 4, wherein: (i) the tensioning tool includes a tube and the gripper is configured to extend through the tube, (ii) the gripper is configured to pull the ring into the tube, and / or (iii) the tensioning tool is configured to release the ring once the lock has locked the head to the ring.

[0468] Example 7. A system / device according to Example 6, wherein, for each of the anchors: (i) the tube is configured to unlock the lock by applying an unlocking force to the lock, and / or (ii) the lock is biased to lock in the absence of the unlocking force.

[0469] Example 8. A system / device according to Example 7, wherein: (i) for each of the anchors, the lock comprises a first locking arm and a second locking arm, each of the locking arms being hingedly connected to the head, and / or (ii) the tube is configured to unlock the lock by pushing the locking arms in a manner that causes each of the locking arms to pivot away from each other.

[0470] Example 9. A system / device according to Example 7, wherein the lock is configured to lock onto the ring when the tube is withdrawn from the head so that the locking arms pivot toward each other.

[0471] Example 10. A system / device according to Example 1, wherein the implant further comprises a leader anchor fixed to the distal end of the tether.

[0472] Example 11. A system / device according to any one of Examples 1 to 10, wherein, for each of the anchors, the tissue engaging element is helical, defines a central longitudinal axis of the anchor, and is configured to be screwed into tissue of the heart by rotation of the tissue engaging element about the central longitudinal axis.

[0473] Example 12. The system / device of Example 11, wherein, for each of the anchors, the head is configured to facilitate threading of the tissue engaging element into the tissue while remaining slidably coupled to the tether.

[0474] Example 13. A system / device according to Example 11, wherein, for each of the anchors: (i) the head includes a peripheral wall that limits the central longitudinal axis, and / or (ii) the head is slidably connected to the tether via the tether extending transversely through the head through a hole defined in the peripheral wall.

[0475] Example 14. The system / device of Example 13 wherein, for each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

[0476] Example 15. The system / device of Example 13 wherein, for each of the anchors, the tissue engaging element is rotationally lockable relative to the peripheral wall.

[0477] Example 16. The system / device of Example 13, wherein, for each of the anchors, the lock is disposed inboard relative to the peripheral wall.

[0478] Example 17. A system / device as described in any of Examples 1 to 16, wherein, for each of the anchors, the lock defines a pressing surface and is configured to lock the head to the tether by pressing the pressing surface against the tether.

[0479] Example 18. The system / device of Example 17, wherein, for each of the anchors, the lock comprises a pressing plate defining the pressing surface.

[0480] Example 19. The system / device of Example 17, wherein, for each of the anchors, the lock comprises a spring configured to lock the head to the tether by pressing the pressing surface against the tether.

[0481] Example 20. The system / device of Example 19 wherein, for each of the anchors, the spring is configured to press the pressing surface against the tether by axially moving the pressing surface relative to the tissue engaging element.

[0482] Example 21. A system / device according to Example 20, wherein, for each of the anchors: (A) the head includes a shell and a button, and / or (B) the lock is configured such that: (i) the spring that axially moves the pressing surface relative to the tissue engaging element protrudes the button laterally from the shell, and / or (ii) the lock is unlocked by pressing the button inside by axially moving the pressing surface relative to the shell.

[0483] Example 22. A system / device according to Example 21, wherein, for each of the anchors, the pressing surface is defined by a piston disposed within the housing, the piston further defining a first bearing surface, and the button defining a second bearing surface inclined relative to the first bearing surface, such that by sliding the second bearing surface over the first bearing surface, pressing the button from the inside causes the pressing surface to move axially relative to the housing.

[0484] Example 23. The system / device of Example 22, wherein, for each of the anchors, the first bearing surface is inclined relative to a central longitudinal axis of the anchor.

[0485] Example 24. The system / device of Example 22, wherein, for each of the anchors, the second bearing surface is inclined relative to a central longitudinal axis of the anchor.

[0486] Example 25. The system / device of Example 22, wherein, for each of the anchors, the button is attached to a wedge defining the second bearing surface.

[0487] Example 26. The system / device of Example 20 wherein, for each of the anchors, the spring is configured to press the pressing surface against the tether by moving the pressing surface axially away from the tissue engaging element.

[0488] Example 27. A system / device according to Example 20, wherein, for each of the anchors: (i) the head defines a peripheral wall that limits the central longitudinal axis of the anchor, (ii) the head is slidably connected to the tether by the tether extending transversely through the head through a hole defined in the peripheral wall, (iii) at least the pressing surface of the lock is disposed inwardly relative to the peripheral wall, and / or (iv) the spring is configured to press the pressing surface against the tether by moving the pressing surface across the hole.

[0489] Example 28. The system / device of Example 27 wherein, for each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

[0490] Example 29. The system / device of Example 27 wherein, for each of the anchors, the tissue engaging element is rotationally locked relative to the peripheral wall.

[0491] Example 30. A system / device according to Example 27, wherein, for each of the anchors: (A) the head includes a shell, the shell includes a proximal portion and a base portion, the proximal portion and the base portion are axially separated at a middle section, and the peripheral wall is disposed at the middle section, (B) the head is connected to the tissue engaging element via the base portion, and / or (C) the proximal portion, the base portion and the tissue engaging element: (i) are rotationally and axially locked relative to each other, and / or (ii) are rotatably connected to the peripheral wall.

[0492] Example 31. A system / device as described in Example 30, wherein the lock and the peripheral wall axially traverse the intermediate section.

[0493] Example 32. The system / device of any one of Examples 1 to 31, further comprising a delivery tool configured to advance the anchor transluminally to the heart and comprising:

[0494] a flexible tube that can be advanced transluminally into the heart, and / or

[0495] an actuator sized to extend through the flexible tube,

[0496] wherein the delivery tool is configured to, for each of the anchors, sequentially:

[0497] anchoring the anchors to tissue of the heart such that a segment of the tether extends from a preceding one of the anchors to the anchor,

[0498] subsequently adjusting the tension on the section of the tether, and / or

[0499] The lock is then locked.

[0500] Example 33. A system / device according to Example 32, wherein, for each of the anchors: (i) the lock is biased to lock, (ii) the head includes a shell and a button, the button is operably connected to the lock so that the button protrudes laterally from the shell when the lock is unlocked, and / or (iii) the delivery tool is configured to maintain the lock unlocked by restraining the button medially.

[0501] Example 34. A system / device according to Example 33, wherein, for each of the anchors, the delivery tool is configured to: (i) maintain the lock unlocked by constraining the button inside the flexible tube, and / or (ii) lock the lock by deploying the head outside the flexible tube.

[0502] Example 35. A system / device as described in Example 33, wherein the housing of each anchor is keyed with an anchor key and the flexible tube is complementarily keyed with a drive key so that the delivery tool can apply torque to the anchor by rotation of the flexible tube.

[0503] Example 36. The system / device of Example 35, wherein, for each anchor, the button is positioned at the anchor key.

[0504] Example 37. The system / device of Example 36, wherein, for each anchor, the anchor key comprises a countersunk key at which the button is seated, and the delivery tool is configured to maintain the lock unlocked by constraining the button inboard of the drive key.

[0505] Example 38. The system / device of Example 32, wherein, for each of the anchors, the lock is biased to lock and the delivery tool is configured to constrain the anchor to unlock while adjusting the tension on the segment of the tether.

[0506] Example 39. The system / device of Example 38, wherein, for each of the anchors, the delivery tool is configured to constrain the anchor to unlock while advancing the anchor transluminally into the heart.

[0507] Example 40. The system / device of Example 38, wherein, for each of the anchors, the delivery tool is configured to constrain the anchor to unlock while anchoring the anchor to the tissue.

[0508] Example 41. A system / device according to Example 32, wherein, for each of the anchors, the delivery tool is configured to advance the anchor transluminally into the heart after anchoring the previous one of the anchors to the tissue.

[0509] Example 42. The system / device of Example 41, wherein, for each of the anchors, the delivery tool is configured to advance the anchor transluminally into the heart after locking the lock of the previous one of the anchors.

[0510] Example 43. A system for use at tissue of a subject's heart, the system comprising:

[0511] An implant comprising:

[0512] Slender member,

[0513] Multiple anchors, and / or

[0514] Multiple locks; and / or

[0515] A delivery tool, the delivery tool being configured to:

[0516] The implant is implanted at the tissue such that the elongated member defines a path along the tissue by:

[0517] anchoring a first section of the elongate member along a first portion of the path using one or more of the anchors, and / or

[0518] subsequently anchoring a second section of the elongate member along a second portion of the path using one or more of the anchors, and

[0519] The tissue was contracted by:

[0520] after anchoring the first segment and before anchoring the second segment, contracting the first portion of the path by reducing the length of the first segment,

[0521] securing the length of the first section using at least a first lock of the plurality of locks while the first portion of the path remains contracted,

[0522] After anchoring the second segment, and while the length of the first segment remains fixed, contracting the second portion of the path by reducing the length of the second segment, and / or

[0523] The length of the second section is fixed using at least a second lock of the plurality of locks while the second portion of the path remains contracted.

[0524] Example 44. A system and / or device for use at a subject's heart, the system / device comprising:

[0525] An implant comprising:

[0526] Tether;

[0527] A series of anchors, each of the anchors comprising:

[0528] Tissue engaging elements, and / or

[0529] a head coupled to the tissue engaging element and slidably coupled to the tether;

[0530] multiple tension regulators; and / or

[0531] A delivery tool, the delivery tool comprising:

[0532] a tube that can be advanced transluminally into the heart,

[0533] an anchor driver configured to advance the anchors through the tube and, for each of the anchors, sequentially anchor the anchors intracardially to tissue of the heart by driving the tissue engaging elements into the tissue, and / or

[0534] An applicator is configured to intracardially connect the plurality of tension modifiers to the implant.

[0535] Example 45. The system / device of Example 44 wherein the applicator is configured to intracentrally connect the tension adjuster to an adjacent anchor in the series.

[0536] Example 46. A system / device as described in any of Examples 44 to 45, wherein the applicator is configured to connect the tension adjuster intracentrally to the tether.

[0537] Example 47. The system / device of Example 46 wherein the applicator is configured to intracentrally connect the tension adjuster to the tether between adjacent anchors in the series.

[0538] Example 48. A system / device according to any of Examples 44 to 47, wherein each of the tension adjusters is a connector configured to connect corresponding pairs of adjacent anchors in the series.

[0539] Example 49. A system / device according to Example 48, wherein each of the tension adjusters is configured to pull the corresponding anchor pairs toward each other.

[0540] Example 50. The system / device of Example 48, wherein each of the tension adjusters is configured to inhibit the corresponding pair of anchors from moving away from each other.

[0541] Example 51. A system / device as described in any of Examples 44 to 50, wherein each of the tension adjusters is a spacer configured to be connected to the tether between corresponding pairs of anchors in the series.

[0542] Example 52. A system / device according to Example 51, wherein each of the spacers is tubular.

[0543] Example 53. A system / device as described in Example 51, wherein, for each of the spacers, the applicator is configured to connect the spacer centrally to the tether while the spacer is constrained in an open state in which the spacer has a substantially C-shaped cross-section.

[0544] Example 54. A system / device as described in Example 51, wherein the tube defines a primary lumen, the anchor driver is configured to advance each of the anchors out of the primary lumen, and the applicator is configured to advance each of the spacers out of a secondary lumen disposed laterally from the primary lumen.

[0545] Example 55. A method for use at tissue of a subject's heart, the method comprising:

[0546] An elongated implant is implanted percutaneously along the tissue such that the implant defines a path along the tissue by:

[0547] anchoring a first section of the implant along a first portion of the path, and / or

[0548] subsequently, anchoring a second section of the implant along a second portion of the path;

[0549] After anchoring the first segment and before anchoring the second segment:

[0550] contracting the first portion of the path by reducing the length of the first segment, and / or

[0551] fixing the length of the first section while the first portion of the path remains contracted; and / or

[0552] After anchoring the second segment, and while the length of the first segment remains fixed:

[0553] contracting the second portion of the path by reducing the length of the second section, and / or

[0554] The length of the second section is fixed while the second portion of the path remains constricted.

[0555] Example 56. A method according to Example 55, wherein: (i) the implant includes a first segment, a second segment and / or a third segment, and the first segment, the second segment and / or the third segment are telescopically connected to each other in series, (ii) the first segment of the implant includes a portion of the first segment and a portion of the second segment, (iii) the second segment of the implant includes a portion of the second segment and a portion of the third segment, (iv) contracting the first portion of the path includes contracting the first portion of the path by reducing the length of the first segment by telescopically contracting the first segment into the second segment, and / or (v) contracting the second portion of the path includes contracting the second portion of the path by reducing the length of the second segment by telescopically contracting the second segment into the third segment.

[0556] Example 57. A method according to Example 56, wherein: (i) fixing the length of the first segment includes locking the first segment to the second segment, and / or (ii) fixing the length of the second segment includes locking the second segment to the third segment.

[0557] Example 58. A method according to Example 56, wherein: (i) the first segment includes a first anchor, the second segment includes a second anchor, and / or the third segment includes a third anchor, (ii) anchoring the first segment of the implant includes anchoring the first anchor and the second anchor to the tissue, and / or (iii) anchoring the second segment of the implant includes anchoring the second anchor and the third anchor to the tissue.

[0558] Example 59. A method according to any one of Examples 55 to 58, wherein: (i) the implant includes a tether, (ii) contracting the first portion of the path comprises contracting the first portion of the path by reducing the length of the first segment by applying tension to the tether, and / or (iii) contracting the second portion of the path comprises contracting the second portion of the path by reducing the length of the second segment by applying tension to the tether.

[0559] Example 60. The method of Example 59, wherein percutaneously implanting the implant along the tissue comprises implanting the implant along the tissue such that the tether defines the path along the tissue.

[0560] Example 61. A method according to Example 59, wherein: (i) fixing the length of the first segment includes locking a first lock to the tether, and / or (ii) fixing the length of the second segment includes locking a second lock to the tether.

[0561] Example 62. The method of Example 61, further comprising percutaneously advancing the first lock to the heart after anchoring the first segment of the implant along the first portion of the path.

[0562] Example 63. A method according to Example 62, wherein advancing the first lock into the heart includes advancing the first lock into the heart before anchoring the second segment of the implant along the second portion of the path.

[0563] Example 64. The method of Example 62, wherein percutaneously advancing the first lock to the heart comprises percutaneously sliding the lock over and along the tether.

[0564] Example 65. The method of Example 61, wherein:

[0565] The implant comprises a first locking anchor and a second locking anchor, each of the first locking anchor and the second locking anchor comprising:

[0566] Tissue engaging elements, and / or

[0567] a head attached to the tissue engaging element, slidably coupled to the tether, and / or comprising a lock,

[0568] implanting the implant percutaneously along the tissue comprises anchoring the first locking anchor and the second locking anchor to the tissue,

[0569] The first lock is the lock of the first locking anchor, fixing the length of the first section comprises locking the lock of the first locking anchor to the tether, and / or

[0570] The second lock is the lock of the second locking anchor, and fixing the length of the second section includes locking the lock of the second locking anchor to the tether.

[0571] Example 66. The method of Example 65 further comprising percutaneously sliding each of the first and second locking anchors over and along the tether to the heart.

[0572] Example 67. A method according to Example 66, wherein: (i) percutaneously implanting the implant along the tissue includes securing a distal portion of the tether to the tissue by anchoring a lead anchor coupled to the tether to the tissue, and / or (ii) percutaneously sliding each of the first locking anchor and the second locking anchor over the tether and along the tether to the heart includes percutaneously sliding each of the first locking anchor and the second locking anchor distally over the tether and along the tether toward the lead anchor after securing the distal portion of the tether to the tissue by anchoring the lead anchor to the tissue.

[0573] Example 68. The method of Example 65, wherein anchoring the first locking anchor and the second locking anchor to the tissue comprises anchoring the first locking anchor and the second locking anchor to the tissue using an anchor driver.

[0574] Example 69. A method according to Example 68, wherein, for each of the first locking anchor and the second locking anchor, the lock is biased toward locking, and anchoring the locking anchor to the tissue includes anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked.

[0575] Example 70. The method of Example 69, wherein, for each of the first locking anchor and the second locking anchor, locking the lock to the tether includes releasing the lock such that the lock responsively locks.

[0576] Example 71. A method according to Example 69, wherein, for each of the first locking anchor and the second locking anchor, anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked includes anchoring the locking anchor to the tissue while the anchor driver constrains the lock to be unlocked by inhibiting a button of the head from moving laterally outward from a housing of the head.

[0577] Example 72. The method of Example 68, wherein, for each of the first locking anchor and the second locking anchor, locking the lock to the tether comprises applying a locking force to the lock using the anchor driver.

[0578] Example 73. A method according to Example 72, wherein, for each of the first locking anchor and the second locking anchor, the locking force is a rotational locking force, and / or applying the locking force to the lock includes applying the rotational locking force to the lock.

[0579] Example 74. A method for use at tissue of a subject's heart, the method comprising:

[0580] percutaneously anchoring a first anchor of the implant to a first location in the tissue;

[0581] subsequently percutaneously anchoring a second anchor of the implant to a second site of the tissue, the first portion of the tissue being disposed between the first site and the second site;

[0582] subsequently contracting the first portion of the tissue by drawing the first anchor and the second anchor together;

[0583] fixing a distance between the first anchor and the second anchor while the first portion of the tissue remains contracted;

[0584] subsequently percutaneously changing a distance between the third anchor and the second anchor of the implant by sliding the third anchor relative to the second anchor;

[0585] then anchoring the third anchor to a third location of the tissue, with a second portion of the tissue disposed between the second location and the third location;

[0586] subsequently contracting the second portion of the tissue by pulling the second anchor and the third anchor together while the distance between the first anchor and the second anchor remains fixed; and / or

[0587] While the second portion of the tissue remains contracted, a distance between the second anchor and the third anchor is fixed.

[0588] Example 75. The method of Example 74, wherein:

[0589] The implant comprises a tether,

[0590] percutaneously anchoring the second anchor comprises percutaneously anchoring the second anchor while the tether is coupled to the first anchor and slidably coupled to the second anchor,

[0591] pulling the first anchor and the second anchor together comprises sliding the tether relative to the second anchor,

[0592] fixing the distance between the first anchor and the second anchor comprises inhibiting sliding of the tether relative to the second anchor by locking a first lock to the tether,

[0593] Pulling the second anchor and the third anchor together comprises sliding the tether relative to the third anchor, and / or

[0594] Fixing the distance between the second anchor and the third anchor includes locking a second lock to the tether.

[0595] Example 76. A method according to Example 75, wherein: (i) sliding the tether relative to the second anchor includes sliding the tether in a first direction relative to the second anchor, (ii) locking the first lock to the tether includes inhibiting sliding of the tether relative to the second anchor in a second direction by locking the first lock to the tether, the second direction being opposite to the first direction, and / or (iii) the method further includes inhibiting further sliding of the tether in the first direction relative to the second anchor by locking a third lock to the tether.

[0596] Example 77. The method of Example 76, wherein locking the third lock to the tether comprises locking the third lock to the tether before pulling the second anchor and the third anchor together.

[0597] Example 78. A method for use at tissue of a subject's heart, the method comprising:

[0598] percutaneously implanting a first section of the implant along a first portion of the tissue by anchoring a first anchor of the implant to a first site of the tissue, and anchoring a second anchor of the implant to a second site of the tissue, the first portion of the tissue being disposed between the first site and the second site;

[0599] subsequently contracting the first portion of the tissue by reducing the length of the first segment;

[0600] fixing the length of the first section while the first portion of the tissue remains contracted;

[0601] subsequently percutaneously implanting a second section of the implant along a second portion of the tissue by anchoring a third anchor of the implant to a third location of the tissue;

[0602] subsequently contracting the second portion of the tissue by reducing the length of the second segment while the length of the first segment remains fixed; and / or

[0603] The length of the second section is fixed while the second portion of the tissue remains contracted.

[0604] Example 79. A method according to Example 78, wherein: (i) the second portion of the tissue is positioned between the second site and the third site, and / or (ii) the second segment of the implant implanted along the second portion of the tissue includes the second segment of the implant implanted along the second portion of the tissue positioned between the second site and the third site.

[0605] Example 80. A method according to Example 78, wherein: (i) the second portion of the tissue is positioned between the third location and the fourth location, and / or (ii) implanting the second segment of the implant along the second portion of the tissue comprises implanting the second segment of the implant along the second portion of the tissue by anchoring the third anchor of the implant to the third location of the tissue and / or anchoring the fourth anchor of the implant to the fourth location of the tissue.

[0606] Example 81. A system and / or device for use at a subject's heart, the system / device comprising:

[0607] A segmented implant comprising a plurality of segments telescopically coupled to one another in series, each of the segments comprising an anchor; and / or

[0608] A delivery tool, the delivery tool being configured to:

[0609] delivering the implant percutaneously to the heart,

[0610] anchoring each of the anchors to tissue of the heart, and / or

[0611] The tissue is contracted by telescopically contracting the implant while each of the anchors remains anchored to the tissue.

[0612] Example 82. A system / device according to Example 81, wherein the delivery tool is configured to telescopically extend the implant within the heart.

[0613] Example 83. A system / device according to any of Examples 81 to 82, wherein each of the segments is articulated relative to an adjacent segment of the segment.

[0614] Example 84. A system / device according to any one of Examples 81 to 83, wherein each of the segments further comprises a lock, and the lock is configured such that for each segment of the segments, locking of the lock fixes the expansion and contraction amount between the segment and an adjacent segment of the segment.

[0615] Example 85. A system / device according to any of Examples 81 to 84, wherein: (A) each of the anchors is biased toward a presumed anchoring position, and / or (B) the delivery tool is configured to: (i) percutaneously deliver the implant to the heart while each of the anchors is constrained in the delivery position, and / or (ii) release each of the anchors within the heart to allow each of the anchors to responsively move toward the anchoring position.

[0616] Example 86. A system / device as described in Example 85, wherein the implant has a delivery state in which, for each of the segments, the anchor is constrained in the delivery position by an adjacent segment of the segment.

[0617] Example 87. A system / device according to Example 86, wherein, in the delivery state, for each of the segments, the anchor is constrained in the delivery position by being positioned within an adjacent segment of the segment.

[0618] Example 88. The system / device of Example 87, wherein, for each of the segments, the delivery tool is configured to release the anchor by telescopically extending the segment beyond an adjacent one of the segments.

[0619] Example 89. A system / device according to any of Examples 81 to 88, wherein the delivery tool is configured to: (A) secure a first segment of the implant along a first portion of a path along the tissue by: (i) anchoring the anchor of a first segment of the plurality of segments to a first location on the tissue, and / or (ii) anchoring the anchor of a second segment of the plurality of segments to a second location on the tissue; (B) secure a second segment of the implant along a second portion of a path along the tissue by anchoring the anchor of a third segment of the plurality of segments to a third location on the tissue, the first segment comprising a portion of the first segment and a portion of the second segment, and the second segment comprising a portion of the second segment and a portion of the third segment; (C) contract the tissue at the first portion of the path by telescopically contracting the first segment into the second segment; and / or (D) contract the tissue at the second portion of the path by contracting the second segment into the third segment independently of contracting the first segment into the second segment.

[0620] Example 90. A system / device according to Example 89, wherein the delivery tool is configured to lock the first segment to the second segment after telescopically contracting the first segment into the second segment, and to lock the second segment to the third segment after telescopically contracting the second segment into the third segment.

[0621] Example 91. A system / device according to Example 90, wherein the delivery tool is configured to contract the tissue at the second portion of the path by contracting the second segment into the third segment after locking the first segment to the second segment.

[0622] Example 92. A system / device according to Example 91, wherein the delivery tool is configured to telescopically extend the implant within the heart by: (i) telescopically extending the first segment from the second segment prior to anchoring the anchor of the second segment, and / or (ii) telescopically extending the second segment from the third segment after anchoring the anchor of the second segment and prior to anchoring the anchor of the third segment.

[0623] Example 93. A method comprising: (i) implanting an implant along tissue of a subject's heart by anchoring the implant to the tissue with a series of anchors, the anchors being slidably connected to a tether of the implant; (ii) subsequently applying tension to the tether; and / or (iii) subsequently adjusting the tension by applying a tension adjuster between adjacent pairs of anchors in the series.

[0624] Example 94. A method according to Example 93, wherein the tension adjuster includes a spacer, and wherein applying the tension adjuster between the adjacent anchor pair includes urging the adjacent anchor pair away from each other by connecting the spacer to the tether between the adjacent anchor pair.

[0625] Example 95. A method according to Example 93, wherein the tension adjuster includes a connector, and wherein applying the tension adjuster between the adjacent anchor pair includes pulling the adjacent anchor pair toward each other by connecting the connector to two anchors in the adjacent anchor pair.

[0626] Example 96. A method comprising: (i) identifying a subject in which an implant has been implanted along tissue of the subject's heart, the implant comprising a series of anchors slidably connected to a tether, and the implant has been implanted by anchoring the series of anchors to the tissue; and / or (ii) in response to the identification, adjusting the tension on the tether by applying a tension adjuster between adjacent pairs of anchors in the series.

[0627] Example 97. A method according to Example 96, wherein the tension adjuster includes a spacer, and wherein applying the tension adjuster between the adjacent anchor pair includes urging the adjacent anchor pair away from each other by connecting the spacer to the tether between the adjacent anchor pair.

[0628] Example 98. A method according to Example 96, wherein the tension adjuster includes a connector, and wherein applying the tension adjuster between the adjacent anchor pair includes pulling the adjacent anchor pair toward each other by connecting the connector to two anchors in the adjacent anchor pair.

[0629] Example 99. A system and / or device for use with a tether, the system / device comprising a lock comprising: (i) a tubular wall defining a lumen sized to receive the tether therethrough; (ii) a window cut from the wall; and / or (iii) a tab cut from the wall and positioned opposite the window and biased to deflect across the lumen and protrude into the window in a manner that locks the lock to the tether received through the lumen.

[0630] Example 100. A system / device as described in Example 99, wherein: (i) the window is the first window of a plurality of windows cut from the wall, (ii) the tab is the first tab of a plurality of tabs cut from the wall, and / or (iii) each of the plurality of tabs is biased to deflect across the lumen and protrude into a corresponding window facing the tab in a manner that locks the lock to the tether.

[0631] Example 101. A system / device according to any of Examples 99 to 100, further comprising a cutter comprising: (i) a cutting element sized to receive the tether passing therethrough, a distal portion of the cutting element defining a pair of cutting edges facing each other; and / or (ii) an outer sleeve that can slide over and along the cutting element in a manner that moves the cutting edges toward each other, thereby cutting the tether.

[0632] Example 102. The system / apparatus of Example 101, wherein the cutting element is made from a single piece of stock tubing.

[0633] Example 103. A system / device according to Example 101 wherein the cutter is advanceable over and along the tether to the subject's heart while maintaining the outer sleeve stationary relative to the cutting element.

[0634] Example 104. A system / device as described in Example 101 wherein the cutter is adapted to advance the lock transluminally over and along the tether to the subject's heart.

[0635] Example 105. A system / device according to Example 104 wherein the cutter is adapted to advance the lock transluminally over the tether and along the tether to the heart by pushing the distal end of the cutter against the proximal end of the lock.

[0636] Example 106. A system / device according to Example 101, wherein the cutting element comprises a pair of arms, each arm having: (i) a proximal portion that extends distally and away from the proximal portion of the other arm in the pair, and / or (ii) a distal portion that extends distally and toward the distal portion of the other arm in the pair.

[0637] Example 107. A system / device as described in Example 106, wherein each arm defines a discrete elbow between the proximal portion and the distal portion.

[0638] Example 108. A system / device as described in Example 106, wherein each arm defines a continuous curve from the proximal portion to the distal portion.

[0639] Example 109. A system / device as described in Example 106, wherein, for each arm in the pair, the cutting edge in the pair of cutting edges is defined by the distal portion of the arm.

[0640] Example 110. A system / device according to Example 109, wherein the proximal portion extends outwardly such that the pair of arms collectively define a diameter wider than an inner diameter of the outer sleeve, such that the outer sleeve slides distally over and along the proximal portion to squeeze the proximal portion together, thereby causing the arms to pivot inwardly toward each other.

[0641] Example 111. A system / device as described in Example 110, wherein, for each arm in the pair, the proximal portion is disposed at a shallower angle relative to the central axis of the cutter than the distal portion is disposed at an angle relative to the central axis.

[0642] Example 112. A system / device as described in Example 106, wherein, for each arm in the pair, the proximal portion is longer than the distal portion.

[0643] Example 113. The system / device of any one of Examples 99 to 112, further comprising a blocking rod adapted to maintain the lock in an unlocked state in which the tab is prevented from deflecting across the lumen and into the window.

[0644] Example 114. A system / device as described in Example 113, wherein the rod is adapted to extend through the lumen along the tether, and / or wherein withdrawing the rod from the lock causes the lock to transition toward a locked state in which the tab is deflected across the lumen and into the window.

[0645] Example 115. A method for use with a subject's heart, the method comprising: (A) using a cutter, pushing a lock over a tether and along the tether distally transluminally toward the heart, the lock comprising: (i) a tubular wall that limits a lumen through which the tether extends, (ii) a window cut from the wall, and / or (iii) a tab cut from the wall and positioned opposite the window; (B) subsequently withdrawing a blocking rod from the lock so that the tab responsively deflects across the lumen and into the window, thereby locking the lock to the tether; (C) subsequently cutting the tether by advancing an outer sleeve over and along the cutter so that the outer sleeve squeezes a pair of cutting edges defined by the cutter toward each other; and / or (D) subsequently withdrawing the cutter from the heart.

[0646] Example 116. A method according to Example 115, wherein pushing the lock distally over and along the tether includes pushing the lock over and along the tether as the rod extends through the lock.

[0647] Example 117. A method according to Example 116, wherein pushing the lock distally over and along the tether includes pushing the lock over and along the tether as the rod extends distally out of the cutter and passes through the lock.

[0648] Example 118. The method of Example 117 wherein withdrawing the rod from the lock comprises withdrawing the rod proximally into the cutter.

[0649] Example 119. A method comprising: (i) implanting an implant along tissue of a subject's heart by anchoring the implant to the tissue with a series of anchors, the anchors being slidably connected to a tether of the implant; (ii) subsequently pulling the tether through a lock at the head of an anchor in the series to form a loop of the tether; and / or (iii) subsequently locking the lock to the loop.

[0650] Example 120. A method according to Example 119, wherein pulling the loop of the tether through the lock includes grasping the tether and pulling the tether into the lock.

[0651] Example 121. A method according to any of Examples 119 to 120, wherein locking the lock to the ring includes withdrawing an unlocking tool from the lock so that the lock responsively transitions toward a locked state.

[0652] Example 122. A method according to any one of Examples 119 to 121, further comprising unlocking the lock before pulling the tether through the lock.

[0653] Example 123. A system for use with a tether, the system comprising:

[0654] An anchor having an anchor head and a tissue engaging element extending distally away from the head so as to define an anchor axis of the anchor, the anchor head:

[0655] defining a passage extending through the anchor head transverse to the anchor axis and sized to be threaded onto the tether so as to be slidable over and along the tether,

[0656] comprising a lock, the lock being in communication with the passage, and / or

[0657] defining a proximal opening providing access to the channel and the lock; and / or

[0658] A tool includes a gripper configured to be advanced through the opening and the lock into the channel.

[0659] Example 124. A system according to Example 123, wherein the system includes the tether, which is threaded through the channel, and wherein the grasper is configured to grasp the tether within the channel and form the tether into a loop by pulling the tether proximally through the lock.

[0660] Example 125. A system according to Example 124, wherein the lock is configured to lock to the ring in response to withdrawing the tool from the lock.

[0661] Example 126. A system according to Example 125, wherein the tool includes a tube, the gripper is configured to extend through the tube, the gripper is configured to pull the ring into the tube, and / or the gripper is configured to release the ring once the lock has been locked onto the ring.

[0662] Example 127. A system according to Example 126, wherein: (i) the tube is configured to unlock the lock by applying an unlocking force to the lock, and / or (ii) the lock is biased to lock in the absence of the unlocking force.

[0663] Example 128. A system according to Example 127, wherein the tube is configured to access the lock through the opening.

[0664] Example 129. A system according to Example 127, wherein: (i) the lock includes a first locking arm and a second locking arm, each of the locking arms being hingedly connected to the anchor head, and / or (ii) the tube is configured to unlock the lock by pushing the locking arms in a manner that causes each of the locking arms to pivot away from each other.

[0665] Example 130. The system of Example 129, wherein the lock is configured to lock to the ring in response to withdrawal of the tube from the anchor head by the locking arms pivoting toward each other.

[0666] Example 131. A system and / or device for use with a tether, the system / device comprising a lock, the lock comprising:

[0667] External pipe; and / or

[0668] An inner tube, the inner tube:

[0669] coaxially positioned within said outer tube;

[0670] secured to the outer tube at an attachment point;

[0671] shaped to define a lumen along a longitudinal axis of the lock, the lumen being sized to receive the tether therethrough; and / or

[0672] The tether can be axially compressed toward the attachment point in a manner that causes the inner tube to clamp to the lumen.

[0673] Example 132. A system / device according to Example 131, wherein the inner tube is deformable in a manner such that axial compression of the inner tube toward the attachment point causes the inner tube to bend inwardly against the tether.

[0674] Example 133. A system / device according to any of Examples 131 to 132, wherein the inner tube has a first end and a second end, and / or wherein the inner tube is axially compressible toward the attachment point by moving the second end toward the first end.

[0675] Example 134. A system / device according to Example 133, wherein the inner tube is annular at each of its first end and second end.

[0676] Example 135. A system / device as described in Example 133, wherein the attachment point is located at the first end.

[0677] Example 136. A system / device as described in Example 133, wherein the inner tube is axially compressible toward the attachment point by applying a torque to the second end.

[0678] Example 137. A system / device as described in Example 136, wherein the inner tube defines a spiral having a series of turns, and / or applying the torque reduces the pitch of the spiral.

[0679] Example 138. A system / device according to Example 137, wherein the spiral is a double spiral.

[0680] Example 139. A system / device as described in Example 133, wherein the inner tube is axially compressible toward the attachment point by pushing the second end toward the first end.

[0681] Example 140. A system / device according to Example 139, wherein the lumen is disposed along the longitudinal axis of the lock, and / or wherein the inner tube is axially compressible toward the attachment point by pushing one end of the inner tube toward the other end of the inner tube along the longitudinal axis.

[0682] Example 141. A system / device according to Example 133, wherein: (i) the lock has an unlocked state in which the lock can slide along the tether, and / or (ii) the lock can be transformed toward a locked state by axially compressing the inner tube.

[0683] Example 142. A system / device as described in Example 141, wherein the lock is transitionable toward the locked state by moving the second end into the outer tube.

[0684] Example 143. A system / device according to Example 141, wherein: (i) in the unlocked state of the lock, the second end is disposed outside the outer tube, and / or (ii) in the locked state of the lock, the second end is disposed inside the outer tube.

[0685] Example 144. A system / device according to any one of Examples 131 to 143, wherein the lock comprises a snap-fit ​​mechanism between the inner tube and the outer tube, and / or wherein the inner tube can be axially compressed toward the attachment point until the inner tube snaps into the outer tube, the snap-fit ​​preventing axial decompression of the inner tube.

[0686] Example 145. A system / device according to Example 144, wherein the inner tube defines a window, and / or the outer tube defines a tongue adapted to extend into the window, and / or wherein the inner tube is compressible axially toward the attachment point until the tongue extends into the window.

[0687] Example 146. A system / device according to Example 144, wherein the outer tube defines a window, and / or the inner tube defines a tongue adapted to extend into the window, and / or wherein the inner tube is compressible axially toward the attachment point until the tongue extends into the window.

[0688] Example 147. A system / device according to any one of Examples 131 to 146, wherein the inner tube is shaped to define an hourglass form having a first bulb, a second bulb and / or a waist therebetween, and / or wherein the inner tube is axially compressible toward the attachment point in a manner that clamps the waist to the tether.

[0689] Example 148. A system / device as described in Example 147, wherein the inner tube is axially compressible toward the attachment point by pushing the first bulb toward the second bulb.

[0690] Example 149. A system / device according to Example 147, wherein each of the first sphere and the second sphere is annular.

[0691] Example 150. A method for use with a tether, the method comprising: (i) advancing a lock transluminally into a subject's heart over and along the tether, the lock comprising an inner tube coaxially positioned within an outer tube and secured to the outer tube at an attachment point, the tether extending through a lumen defined by the inner tube; and / or (ii) subsequently locking the lock to the tether by axially compressing the inner tube toward the attachment point such that the inner tube clamps to the tether within the lumen.

[0692] Example 151. A method according to Example 150, wherein compressing the inner tube toward the attachment point so that the inner tube is clamped to the tether includes compressing the inner tube toward the attachment point so that the diameter of the inner tube is narrowed.

[0693] Example 152. A method according to any one of Examples 150 to 151, wherein compressing the inner tube axially toward the attachment point includes pushing the inner tube further into the outer tube.

[0694] Example 153. A method according to any one of Examples 150 to 152, wherein the inner tube has a first end and a second end, and / or wherein compressing the inner tube axially toward the attachment point includes axially compressing the inner tube by pushing the second end toward the first end.

[0695] Example 154. A method according to Example 153, wherein the attachment point is disposed at the first end.

[0696] Example 155. A method according to Example 153, wherein: (i) advancing the lock transluminally includes advancing the lock transluminally while the second end is disposed outside the outer tube, and / or (ii) pushing the second end toward the first end includes pushing the second end into the outer tube.

[0697] Example 156. A method according to Example 153, wherein the lumen is disposed along a longitudinal axis of the lock, and / or wherein axially compressing the inner tube toward the attachment point comprises axially compressing the inner tube by pushing one end of the inner tube axially along the longitudinal axis toward the other end of the inner tube.

[0698] Example 157. A method according to any one of Examples 150 to 156, wherein axially compressing the inner tube toward the attachment point includes axially compressing the inner tube toward the attachment point until the inner tube snaps into the outer tube, the snap fit preventing axial decompression of the inner tube.

[0699] Example 158. A method according to Example 157, wherein the lock defines a window and a tongue, and / or wherein compressing the inner tube axially toward the attachment point until the inner tube snaps into the outer tube includes compressing the inner tube axially toward the attachment point until the tongue protrudes into the window.

[0700] Example 159. A method according to Example 158, wherein compressing the inner tube axially toward the attachment point until the tongue protrudes into the window includes compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window and automatically protrudes into the window in response to becoming aligned with the window.

[0701] Example 160. A method according to Example 159, wherein compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window includes compressing the inner tube axially toward the attachment point so that the tongue moves into axial alignment with the window.

[0702] Example 161. A method according to Example 159, wherein compressing the inner tube axially toward the attachment point until the tongue becomes aligned with the window includes compressing the inner tube axially toward the attachment point by twisting the inner tube toward the attachment point until the tongue moves into rotational alignment with the window.

[0703] Example 162. A method according to Example 158, wherein the outer tube defines the tongue, and / or the inner tube defines the window, and / or wherein compressing the inner tube axially toward the attachment point until the tongue extends into the window includes compressing the inner tube axially toward the attachment point until the tongue of the outer tube extends into the window of the inner tube.

[0704] Example 163. A method according to any one of Examples 150 to 162, wherein compressing the inner tube axially toward the attachment point so that the inner tube is clamped to the tether includes compressing the inner tube axially toward the attachment point so that a portion of the inner tube bends against the inside of the tether.

[0705] Example 164. A method according to Example 163, wherein compressing the inner tube axially toward the attachment point so that a portion of the inner tube bends against the inner side of the tether includes compressing the inner tube axially toward the attachment point so that the inner tube acquires an hourglass shape having a waist, which is clamped to the tether.

[0706] Example 165. A method according to any one of Examples 150 to 164, wherein the inner tube has a first end portion and a second end portion and is shaped to define a plurality of struts extending between the first end portion and the second end portion, and / or wherein compressing the inner tube axially toward the attachment point such that the inner tube is clamped to the tether includes compressing the inner tube axially toward the attachment point such that the struts bend against the inside of the tether.

[0707] Example 166. A method according to Example 165, wherein each of the struts has an hourglass shape with a first bulb, a second bulb and / or a waist therebetween, and / or wherein compressing the inner tube axially toward the attachment point so that the struts bend against the inside of the tether includes compressing the inner tube axially toward the attachment point so that the waist of each of the struts is clamped to the tether.

[0708] Example 167. A method according to Example 166, wherein compressing the inner tube axially toward the attachment point so that the inner tube is clamped to the tether includes compressing the inner tube axially toward the attachment point in a manner such that the first ball moves toward the second ball for each of the struts.

[0709] Example 168. A method according to any one of Examples 150 to 167, wherein compressing the inner tube axially toward the attachment point includes compressing the inner tube axially toward the attachment point such that the inner tube twists inwardly against the tether.

[0710] Example 169. A method according to Example 168, wherein the inner tube is formed to define a spiral having a series of turns and a pitch, and / or wherein compressing the inner tube axially toward the attachment point so that the inner tube is twisted inward against the tether includes reducing the pitch by twisting the inner tube toward the attachment point.

[0711] Example 170. A method according to Example 169, wherein the spiral is a double spiral, and / or wherein reducing the pitch includes reducing the pitch of the double spiral.

[0712] Example 171. A system according to any of the preceding system examples, wherein the implant is sterile.

[0713] Example 172. A system / device according to any of the preceding system / device examples, wherein the implant is sterile.

[0714] Example 173. A system / device according to any of the preceding system / device examples, wherein the delivery vehicle is sterile.

[0715] The present invention is not limited to the examples specifically shown and described above.On the contrary, the scope of the present invention includes both the combination and sub-combination of various features described above, and its variant and modification that are not in the prior art, and those skilled in the art will think of said variant and modification after reading the aforementioned description.In addition, the technology, method, operation, step, etc. described or suggested in this article (including in the above-mentioned example) or the reference incorporated herein can be carried out on living subjects (for example, people, other animals, etc.) or on simulators (such as corpses, corpse hearts, simulation bodies, virtual people, etc.).When carried out on simulators, body parts (for example, heart, tissue, valve, etc.) can be assumed to be simulated or can be optionally referred to as "simulated" (for example, simulated heart, simulated tissue, simulated valve, etc.), and can optionally include computerized and / or physical representations of body parts, tissues, etc.

[0716] Any of the various systems, assemblies, devices, components, equipment, etc. in the present disclosure (including in the examples listed above) can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure its safety for use with patients, and the methods herein may include (or additional methods include or consist of) sterilizing the associated systems, devices, components, equipment, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

Claims

1. A device for use at the heart of a subject, the device comprising an implant, the implant comprising: tether; and A series of anchors, each of the anchors comprising: a tissue engaging element, and A head is coupled to the tissue engaging element, is slidably coupled to the tether, and includes a lock configured to lock the head to the tether when the lock is locked.

2. The apparatus of claim 1 , further comprising a stopper lockable to the tether, the stopper defining: a tubular wall defining a lumen sized to receive the tether therethrough; a window, said window being cut out of said wall; as well as A tab is cut from the wall and positioned opposite the window and is biased to deflect across the lumen and project into the window in a manner that locks the lock to the tether received through the lumen.

3. The apparatus of any one of claims 1 to 2, further comprising a stopper lockable to the tether, the stopper comprising: Foreign control; and An inner tube, the inner tube: coaxially positioned within said outer tube, secured to the outer tube at an attachment point, shaped to define a lumen along a longitudinal axis of the lock, the lumen being sized to receive the tether therethrough, and The tether can be axially compressed toward the attachment point in a manner that causes the inner tube to clamp to the lumen.

4. The apparatus of any one of claims 1 to 3, further comprising a tensioning tool, the tensioning tool comprising a gripper, and the tensioning tool being configured to adjust the tension on the tether by: for any anchor in the series, advancing to the anchor, gripping the tether at the anchor, and forming a loop from the tether by pulling the tether through the lock, the lock being configured to lock the head to the loop when it is locked.

5. The apparatus of claim 4, wherein the gripper is configured to be advanced through the lock to grip the tether.

6. The apparatus of claim 4, wherein: The tensioning tool includes a tube, the gripper being configured to extend through the tube, The gripper is configured to pull the ring into the tube, and The tensioning tool is configured to release the ring once the lock has locked the head to the ring.

7. The device according to claim 6, wherein: For each of the anchors: The tube is configured to unlock the lock by applying an unlocking force to the lock, and The lock is biased to lock in the absence of the unlocking force.

8. The apparatus of claim 7, wherein: For each of the anchors, the lock comprises a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to the head, and The tube is configured to unlock the lock by being pushed against the locking arms in a manner that causes each of the locking arms to pivot away from each other.

9. The apparatus of claim 7, wherein the lock is configured to lock onto the ring when the tube is withdrawn from the head such that the locking arms pivot toward each other.

10. The apparatus of any one of claims 1 to 9, wherein the implant further comprises a leader anchor secured to a distal end of the tether.

11. The apparatus according to any one of claims 1 to 10, wherein: For each of the anchors, the tissue engaging element is helical, defines a central longitudinal axis of the anchor, and is configured to be screwed into tissue of the heart by rotating the tissue engaging element about the central longitudinal axis.

12. The device according to claim 11, wherein For each of the anchors, the head is configured to facilitate threading of the tissue engaging element into the tissue while remaining slidably coupled to the tether.

13. The device according to claim 11, wherein: For each of the anchors: The head includes a peripheral wall defining the central longitudinal axis, and The head is slidably coupled to the tether by extending the tether transversely through the head through an aperture defined in the peripheral wall.

14. The device according to claim 13, wherein: For each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

15. The apparatus according to claim 13, wherein: For each of the anchors, the tissue engaging element is rotationally locked relative to the peripheral wall.

16. The apparatus according to claim 13, wherein: For each of the anchors, the lock is disposed inboard relative to the peripheral wall.

17. The apparatus according to any one of claims 1 to 16, wherein: For each of the anchors, the lock defines a pressing surface and is configured to lock the head to the tether by pressing the pressing surface against the tether.

18. The apparatus according to claim 17, wherein: For each of the anchors, the lock comprises a pressing plate defining the pressing surface.

19. The apparatus according to claim 17, wherein: For each of the anchors, the lock includes a spring configured to lock the head to the tether by pressing the pressing surface against the tether.

20. The apparatus of claim 19, wherein: For each of the anchors, the spring is configured to press the pressing surface against the tether by moving the pressing surface axially relative to the tissue engaging element.

21. The apparatus according to claim 20, wherein: For each of the anchors: The head comprises a housing and a button, The lock is configured such that: The spring that moves the pressing surface axially relative to the tissue engaging element causes the button to project laterally from the housing, and Depressing the button unlocks the lock by moving the pressing surface axially inwardly relative to the housing.

22. The apparatus according to claim 21, wherein For each of the anchors, the pressing surface is defined by a piston disposed within the housing, the piston further defining a first bearing surface, and the button defines a second bearing surface inclined relative to the first bearing surface, so that pressing the button moves the pressing surface axially relative to the housing by sliding the second bearing surface inboard over the first bearing surface.

23. The apparatus of claim 22, wherein: For each of the anchors, the first bearing surface is inclined relative to a central longitudinal axis of the anchor.

24. The apparatus of claim 22, wherein: For each of the anchors, the second bearing surface is inclined relative to a central longitudinal axis of the anchor.

25. The apparatus of claim 22, wherein: For each of the anchors, the button is attached to a wedge defining the second bearing surface.

26. The apparatus of claim 20, wherein: For each of the anchors, the spring is configured to press the pressing surface against the tether by moving the pressing surface axially away from the tissue engaging element.

27. The apparatus of claim 20, wherein: For each of the anchors: The head defines a peripheral wall that circumscribes a central longitudinal axis of the anchor, the head being slidably coupled to the tether by extending the tether transversely through the head through an aperture defined in the peripheral wall, At least the pressing surface of the lock is disposed inwardly relative to the peripheral wall, and The spring is configured to press the pressing surface against the tether by moving the pressing surface across the aperture.

28. The apparatus of claim 27, wherein: For each of the anchors, the tissue engaging element is rotatable independently of the peripheral wall.

29. The apparatus of claim 27, wherein: For each of the anchors, the tissue engaging element is rotationally locked relative to the peripheral wall.

30. The apparatus of claim 27, wherein: For each of said anchors, The head comprises a housing, the housing comprising a proximal portion and a base portion, the proximal portion and the base portion being axially separated at an intermediate section, the peripheral wall being disposed at the intermediate section, The head portion is coupled to the tissue engaging element via the base portion, and The proximal portion, the base portion and the tissue engaging element: are rotationally and axially locked relative to each other, and Rotatably coupled to the peripheral wall.

31. The apparatus of claim 30, wherein the lock and the peripheral wall axially traverse the intermediate section.

32. The apparatus of any one of claims 1 to 31, further comprising a delivery tool configured to advance the anchor transluminally to the heart and comprising: a flexible tube that is transluminally advanceable into the heart, and an actuator sized to extend through the flexible tube, wherein the delivery tool is configured to, for each of the anchors, sequentially: anchoring the anchors to tissue of the heart such that a segment of the tether extends from a preceding one of the anchors to the anchor, then adjusting the tension on the section of the tether, and The lock is then locked.

33. The apparatus of claim 32, wherein: For each of the anchors: The lock is biased to lock, The head includes a housing and a button operably coupled to the lock such that the button protrudes laterally from the housing while the lock is unlocked, and The delivery tool is configured to maintain the lock unlocked by restraining the button medially.

34. The apparatus of claim 33, wherein: For each of the anchors, the delivery tool is configured to: The lock is maintained unlocked by causing the flexible tube to restrain the button inside, and The lock is locked by deploying the head out of the flexible tube.

35. The apparatus of claim 33, wherein the housing of each anchor is keyed with an anchor key and the flexible tube is complementarily keyed with a drive key such that the delivery tool can apply torque to the anchor by rotation of the flexible tube.

36. The apparatus of claim 35, wherein: For each anchor, the button is positioned at the anchor key.

37. The apparatus of claim 36, wherein: For each anchor, the anchor key includes a countersunk key at which the button is seated, and the delivery tool is configured to maintain the lock unlocked by constraining the button inboard of the drive key.

38. The apparatus of claim 32, wherein: For each of the anchors, the lock is biased to lock, and the delivery tool is configured to constrain the anchor to unlock while adjusting the tension on the segment of the tether.

39. The apparatus of claim 38, wherein: For each of the anchors, the delivery tool is configured to constrain the anchor to unlock while advancing the anchor transluminally into the heart.

40. The apparatus of claim 38, wherein: For each of the anchors, the delivery tool is configured to constrain the anchor to unlock while anchoring the anchor to the tissue.

41. The apparatus of claim 32, wherein: For each of the anchors, the delivery tool is configured to transluminally advance the anchor to the heart after anchoring the previous one of the anchors to the tissue.

42. The apparatus of claim 41, wherein: For each of the anchors, the delivery tool is configured to transluminally advance the anchor into the heart after locking the lock of the preceding one of the anchors.

43. A system for use at tissue of a heart of a subject, the system comprising: An implant comprising: Slender member, Multiple anchors, and Multiple locks; and A delivery tool, the delivery tool being configured to: The implant is implanted at the tissue such that the elongated member defines a path along the tissue by: anchoring a first section of the elongated member along a first portion of the path using one or more of the anchors, and subsequently anchoring a second section of the elongate member along a second portion of the path using one or more of the anchors, and The tissue was contracted by: after anchoring the first segment and before anchoring the second segment, contracting the first portion of the path by reducing the length of the first segment, securing the length of the first section using at least a first lock of the plurality of locks while the first portion of the path remains contracted, After anchoring the second segment, and while the length of the first segment remains fixed, contracting the second portion of the path by reducing the length of the second segment, and The length of the second section is fixed using at least a second lock of the plurality of locks while the second portion of the path remains contracted.

44. An apparatus for use at the heart of a subject, the apparatus comprising: An implant comprising: Tether; A series of anchors, each of the anchors comprising: a tissue engaging element, and a head coupled to the tissue engaging element and slidably coupled to the tether; a plurality of tension adjusters; and A delivery tool, the delivery tool comprising: a tube that can be advanced transluminally into the heart, an anchor driver configured to advance the anchors through the tube and, for each of the anchors, sequentially anchor the anchors intracardially to tissue of the heart by driving the tissue engaging elements into the tissue, and An applicator is configured to intracardially connect the plurality of tension modifiers to the implant.

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