Variable tissue contraction

Abstract

The implant (222) includes a tether (26) and a series of anchors (230), each of the anchors comprising a tissue engagement element (34) and a head (232) coupled to the tissue engagement element. The head of each anchor is slidably coupled to the tether and includes a locking portion (210) configured to lock the head to the tether upon locking thereof. Other implementations are also described.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to each of the following applications, each of which is hereby incorporated by reference in its entirety for all purposes: U.S. Provisional Patent Application No. 63 / 346,387 by Biran et al., filed May 27, 2022, U.S. Provisional Patent Application No. 63 / 369,571 by Biran et al., filed Jul. 27, 2022, and U.S. Provisional Patent Application No. 63 / 370,609 by Biran et al., filed Aug. 5, 2022.

Background Art

[0002] Annuloplasty involves remodeling the tissue of the annulus. This can be done by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to facilitate medical procedures including annuloplasty, other remodeling of tissue, and fixing implants. In some cases, tissue anchors can be used as an alternative to sutures. For example, tissue anchors can be used in procedures where there is no line of sight to the target.

Summary of the Invention

[0003] The summary of the invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in an example of the summary of the invention does not become a requirement according to the claims unless the claims explicitly list those features. Also, the features, components, steps, concepts, etc. described in the examples in the summary of the invention and elsewhere in this disclosure can be combined in various ways. The various features and steps described elsewhere in this disclosure can be included in the examples outlined herein.

[0004] For example, systems, devices, and techniques for variably contracting tissue are described herein so that different portions of the tissue can be contracted to different degrees.

[0005] In some implementations, the implant can be implanted along a path through tissue and manipulated to contract one portion of the path more than another portion of the path. For example, the implant can have (or be implanted to have) a plurality of sections (which may be elongated sections arranged collinearly and / or continuously along the length of the implant) that are fixed to the tissue, the length of which is adjustable independently of the lengths of the other sections.

[0006] In some implementations, the length of each section can be lockable after its adjustment, for example, prior to the adjustment of another section.

[0007] In some implementations, each section of the implant is adjustable (and typically lockable) prior to the implantation of successive sections of the implant.

[0008] In some implementations, a system can be provided, obtained, and / or used that includes such an implant and a delivery tool for the implant. The delivery tool can be configured to deliver, secure, and / or adjust the implant.

[0009] In some implementations, the implant comprises a series of anchors slidably coupled to a tether. In some implementations, each of the anchors has a head that is threaded onto and lockable to the tether.

[0010] In some implementations, the length of each section of the implant can be reduced by applying tension to the tether, thereby bringing at least two of the anchors associated with that section (e.g., the two anchors delimiting that section) closer together.

[0011] In some implementations, the attachment of the head to the tether can lock the length of the section of the implant associated with (e.g., delimited by) its anchor.

[0012] In some implementations, the implant is a segmented implant comprising a series of telescoping segments. In some implementations, the length of each section of the implant can be reduced by telescopically sliding one section relative to an adjacent section.

[0013] In some implementations, the tension adjuster is applied to the implant after implantation of the implant.

[0014] According to some implementations, a system and / or device (e.g., usable in or for a subject's heart) includes an implant (which can be the same as or similar to the above-described implant or other implants herein) that includes a tether and a series of anchors. In some implementations, each of the anchors can include a tissue engagement element (e.g., one or more of a helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, pledget, etc.), and optionally can also include a head.

[0015] In some implementations, the anchor can be slidably coupled to the tether. In some implementations, the head can be coupled to the tissue engagement element and / or can be slidably coupled to the tether. In some implementations, the head can include a locking portion configured to lock the head to the tether upon its attachment.

[0016] In some implementations, the system / apparatus includes a gripper and, for any of a series of anchors, is configured to adjust the tension on the tether by advancing to the anchor, gripping the tether at the anchor, and forming a loop from the tether by pulling the tether through a locking portion, the locking portion further including a tension tool configured to lock the head to the loop upon its locking.

[0017] In some implementations, the gripper is configured to advance through the locking portion and grip the tether.

[0018] In some implementations, the tension tool includes a flexible tube, the gripper is configured to extend through the tube, the gripper is configured to pull the loop into the tube, and / or the tension tool is configured to release the loop when the locking portion locks the head to the loop.

[0019] In some implementations, for each of the anchors, (i) the tube is configured to unlock the locking portion by applying an unlocking force to the locking portion and / or (ii) the locking portion is biased to lock in the absence of an unlocking force.

[0020] In some implementations, (i) for each of the anchors, the locking portion includes a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to the head, and / or (ii) the tube is configured to transition the locking portion to an unlocked state by pressing against the locking arms in a manner that pivots the locking arms away from each other.

[0021] In some implementations, the locking portion is configured to lock onto the loop when the tube is withdrawn from the head such that the locking arms pivot towards each other.

[0022] In some implementations, the implant further includes a leading anchor fixed to the distal end of the tether.

[0023] In some embodiments, for each of the anchors, the tissue engagement element is helical, defines a central longitudinal axis of the anchor, and is configured to be screwed into the heart tissue by rotation of the tissue engagement element about the central longitudinal axis.

[0024] In some embodiments, for each of the anchors, the head is configured to facilitate screwing of the tissue engagement element into the tissue while remaining slidably coupled to the tether.

[0025] In some embodiments, for each of the anchors, (i) the head includes a circumferential wall surrounding the central longitudinal axis and / or (ii) the head is slidably coupled to the tether by a tether extending transversely through the head via an opening defined within the circumferential wall.

[0026] In some embodiments, for each of the anchors, the tissue engagement element is rotatable independently of the circumferential wall.

[0027] In some embodiments, for each of the anchors, the tissue engagement element is rotatably locked to the circumferential wall.

[0028] In some embodiments, for each of the anchors, the locking portion is disposed inwardly from the circumferential wall.

[0029] In some embodiments, for each of the anchors, the locking portion defines a pressing surface and is configured to lock the head to the tether by pressing the pressing surface against the tether.

[0030] In some embodiments, for each of the anchors, the locking portion includes a pressing plate that defines the pressing surface.

[0031] In some embodiments, for each of the anchors, the locking portion includes a spring configured to lock the head to the tether by pressing the pressing surface against the tether.

[0032] In some implementations, for each anchor, the spring is configured to press the pressing surface against the tether by axially moving the pressing surface relative to the tissue engagement element.

[0033] In some implementations, for each anchor, (A) the head includes the casing and a lateral push button, and / or (B) the locking portion is configured such that (i) axially moving the pressing surface relative to the tissue engagement element by the spring causes the push button to project laterally from the casing, and / or (ii) pressing the push button causes the locking portion to be unlocked inwardly by axially moving the pressing surface relative to the casing.

[0034] In some implementations, for each anchor, the pressing surface is defined by a piston disposed within the casing, the piston further defines a first bearing surface, the push button defines a second bearing surface that is inclined relative to the first bearing surface, whereby pressing the push button slides the second bearing surface onto the first bearing surface to axially move the pressing surface inwardly relative to the casing.

[0035] In some implementations, for each anchor, the first bearing surface is inclined relative to the central longitudinal axis of the anchor.

[0036] In some implementations, for each anchor, the second bearing surface is inclined relative to the central longitudinal axis of the anchor.

[0037] In some implementations, for each anchor, the button is attached to a wedge that defines the second bearing surface.

[0038] In some implementations, for each anchor, the spring is configured to press the pressing surface against the tether by moving the pressing surface axially away from the tissue engagement element.

[0039] In some implementations, for each anchor, (i) the head defines a circumferential wall surrounding a central longitudinal axis, (ii) the head is slidably coupled to the tether by a tether extending transversely through the head via a hole defined within the circumferential wall, (iii) at least the press surface of the engagement portion is disposed inwardly from the circumferential wall, and / or (iv) the spring is configured to press the press surface against the tether by moving the press surface across the hole.

[0040] In some implementations, for each anchor, the tissue engagement element is rotatable independently of the circumferential wall.

[0041] In some implementations, for each anchor, the tissue engagement element is rotatably locked to the circumferential wall.

[0042] In some implementations, for each anchor, (i) the head includes a casing including a proximal portion and a base axially separated in an intermediate section where the circumferential wall is disposed, and / or (ii) the head is coupled to the tissue engagement element via the base, and the proximal portion, the base, and the tissue engagement element are locked to each other in rotational and axial directions and are rotatably coupled to the circumferential wall.

[0043] In some implementations, the engagement portion and the circumferential wall axially traverse the intermediate section.

[0044] In some implementations, the system / apparatus further includes a delivery tool configured to advance the anchor transvascularly into the heart, including (i) a flexible tube that is transvascularly advanceable into the heart, and / or (ii) a driver sized to extend through the flexible tube.

[0045] In some implementations, for each anchor, the delivery tool is configured to (i) anchor the anchor to the tissue such that a section of the tether extends from a preceding anchor of the anchors to the anchor, (ii) then adjust the tension on the section of the tether, and / or (iii) then lock the locking portion.

[0046] In some implementations, for each anchor, (i) the locking portion is biased to lock, (ii) the head includes a casing, and a lateral push button is operably coupled to the locking portion such that the push button protrudes laterally from the casing while the locking portion is unlocked, and / or (iii) the delivery tool is configured to maintain unlocking of the locking portion by restraining the push button inwardly.

[0047] In some implementations, for each anchor, the delivery tool is configured to maintain the locking portion in an unlocked state by a tube restraining the push button inwardly and to lock the locking portion by deploying the head from the tube.

[0048] In some implementations, the casing 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 via rotation of the flexible tube.

[0049] In some implementations, for each anchor, the push button is disposed on the anchor key.

[0050] In some implementations, for each anchor, the anchor key includes a sunk key, the push button is disposed on the sunk key, and the delivery tool is configured to maintain the locking portion in an unlocked state by the drive key restraining the push button inwardly.

[0051] In some implementations, for each anchor, the locking portion is biased to lock, and the delivery tool is configured to restrain the anchor in an unlocked state while adjusting the tension on the tether section.

[0052] In some implementations, for each anchor, the delivery tool is configured to restrain the anchor in an unlocked state while advancing the anchor transapically through the heart.

[0053] In some implementations, for each anchor, the delivery tool is configured to restrain the anchor in an unlocked state while anchoring the anchor to tissue.

[0054] In some implementations, for each anchor, the delivery tool is configured to advance the anchor transapically through the heart following anchoring of a preceding anchor of the anchor to tissue.

[0055] In some implementations, for each anchor, the delivery tool is configured to advance the anchor transapically through the heart and then lock the locking portion of a preceding anchor of the anchor.

[0056] According to some implementations, a method (e.g., usable in or for a subject's heart tissue) includes percutaneously implanting an elongate implant along tissue such that the implant defines a path along the tissue by (i) anchoring a first section of the implant along a first portion of the path and / or (ii) subsequently anchoring a second section of the implant along a second portion of the path.

[0057] In some implementations, the method includes, following anchoring the first section and prior to anchoring the second section, (i) contracting a first portion of the path by decreasing the length of the first section and / or (ii) fixing the length of the first section while the first portion of the path remains contracted.

[0058] In some implementations, the method further includes, following anchoring the second section and while the length of the first section remains fixed, (i) contracting a second portion of the path by decreasing the length of the second section and / or (ii) fixing the length of the second section while the second portion of the path remains contracted.

[0059] In some implementations, (i) the implant includes a first segment, a second segment, and a third segment telescopically coupled in series with each other, (ii) the first section of the implant includes a portion of the first segment and a portion of the second segment, (iii) the second section 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 decreasing the length of the first section 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 decreasing the length of the second section by telescopically contracting the second segment into the third segment.

[0060] In some implementations, (i) fixing the length of the first section includes latching the first segment to the second segment and / or (ii) fixing the length of the second section includes latching the second segment to the third segment.

[0061] 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 section of the implant includes anchoring the first anchor and the second anchor to the tissue, and / or (iii) anchoring the second section of the implant includes anchoring the second anchor and the third anchor to the tissue.

[0062] 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 applying tension to the tether to reduce the length of the first section, and / or (iii) contracting the second portion of the path includes contracting the second portion of the path by applying tension to the tether to reduce the length of the second section.

[0063] In some embodiments, percutaneously implanting the implant along the tissue includes implanting the implant along the tissue such that the tether defines a path along the tissue.

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

[0065] In some embodiments, the method further includes percutaneously advancing the first locking portion into the heart and subsequently anchoring the first section of the implant along the first portion of the path.

[0066] In some embodiments, advancing the first locking portion into the heart includes advancing the first locking portion into the heart before anchoring the second section of the implant along the second portion of the path.

[0067] In some embodiments, advancing the first locking portion transcutaneously into the heart includes sliding the locking portion transcutaneously over and along the tether.

[0068] 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 helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, pledget, etc.), and / or (ii) a head attached to the tissue engaging element, slidably coupled to the tether, and including a locking portion.

[0069] In some embodiments, transcutaneously implanting the implant along the tissue includes anchoring the first and second locking anchors to the tissue.

[0070] In some embodiments, the first locking portion is the locking portion of the first locking anchor, and fixing the length of the first section includes locking the locking portion of the first locking anchor to the tether. In some embodiments, the second locking portion is the locking portion of the second locking anchor, and fixing the length of the second section includes locking the locking portion of the second locking anchor to the tether.

[0071] In some embodiments, the method further includes sliding each of the first and second locking anchors transcutaneously over and along the tether into the heart.

[0072] In some embodiments, transcutaneously implanting the implant along the tissue includes anchoring the distal portion of the tether to the tissue by anchoring a leading anchor coupled to the tether to the tissue.

[0073] In some implementations, for each of the first and second locking anchors, sliding each of them transcutaneously on and along the tether to the heart, and then anchoring the distal portion of the tether to the tissue by anchoring the leading anchor to the tissue, includes sliding each of the first and second locking anchors distally transcutaneously on and along the tether toward the leading anchor.

[0074] In some implementations, anchoring the first and second locking anchors to the tissue includes anchoring the first and second locking anchors to the tissue using an anchor driver.

[0075] In some implementations, for each of the first and second locking anchors, the locking portion is biased toward locking, and anchoring the locking anchor to the tissue includes anchoring the locking anchor to the tissue while the anchor driver holds the locking portion in an unlocked state.

[0076] In some implementations, for each of the first and second locking anchors, locking the locking portion to the tether includes releasing the locking portion so that it locks responsively.

[0077] In some implementations, for each of the first and second locking anchors, anchoring the locking anchor to the tissue while the anchor driver holds the locking portion in an unlocked state includes anchoring the locking anchor to the tissue while inhibiting the push button of the head from moving laterally outward from the casing of the head, so that the anchor driver holds the locking portion in an unlocked state.

[0078] In some implementations, for each of the first and second locking anchors, locking the locking portion to the tether includes applying a locking force to the locking portion using an anchor driver.

[0079] In some implementations, for each of the first and second locking anchors, the locking force is a rotational locking force, and applying a locking force to the locking portion includes applying a rotational locking force to the locking portion.

[0080] The above method can be implemented on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a 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.

[0081] According to some implementations, a method (e.g., a method for use in or on a tissue of a target heart) includes (i) percutaneously anchoring a first anchor of an implant to a first site of a tissue and / or (ii) subsequently percutaneously anchoring a second anchor of the implant to a second site of the tissue, wherein a first portion of the tissue is disposed between the first site and the second site. In some implementations, the method includes subsequently contracting the first portion of the tissue by pulling the first anchor and the second anchor together. In some implementations, the first portion of the tissue remains contracted, and the method includes fixing the distance between the first anchor and the second anchor.

[0082] In some implementations, the method includes subsequently percutaneously varying the distance between a third anchor and a second anchor of the implant by sliding the third anchor relative to the second anchor.

[0083] In some embodiments, the method further includes anchoring a third anchor to a third site of the tissue, with a second portion of the tissue disposed between the second site and the third site, and then contracting the second portion of the tissue by pulling the second anchor and the third anchor together while maintaining the distance between the first anchor and the second anchor fixed.

[0084] In some embodiments, the method also includes fixing the distance between the second anchor and the third anchor while the second portion of the tissue remains contracted.

[0085] In some embodiments, the implant includes a tether, and transcutaneously anchoring the second anchor includes transcutaneously anchoring the second anchor while the tether is coupled to the first anchor and slidably coupled to the second anchor.

[0086] In some embodiments, pulling the first anchor and the second anchor together includes sliding the tether relative to the second anchor.

[0087] 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 latching a first latch to the tether.

[0088] In some embodiments, pulling the second anchor and the third anchor together includes sliding the tether relative to the third anchor.

[0089] In some embodiments, fixing the distance between the second anchor and the third anchor includes latching a second latch to the tether.

[0090] In some embodiments, sliding the tether relative to the second anchor includes sliding the tether in a first direction relative to the second anchor.

[0091] In some implementations, locking the first locking portion to the tether includes inhibiting the tether from sliding in a second direction relative to the second anchor by locking the first locking portion to the tether, the second direction being opposite to the first direction.

[0092] In some implementations, the method further includes inhibiting the tether from further sliding in the first direction relative to the second anchor by locking a third locking portion to the tether.

[0093] In some implementations, locking the third locking portion to the tether includes locking the third locking portion to the tether before pulling the second anchor and the third anchor together.

[0094] The methods described above can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, body parts can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include computerized and / or physical representations.

[0095] According to some implementations, a method (e.g., usable in or for a subject's heart tissue) includes percutaneously implanting a first section of an implant along a first portion of 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.

[0096] In some embodiments, the method also includes, thereafter, shrinking a first portion of the tissue by reducing the length of the first section. In some embodiments, the method includes fixing the length of the first section while the first portion of the tissue remains shrunk.

[0097] In some embodiments, the method also includes, thereafter, percutaneously implanting a second section of the implant along a second portion of the tissue by fixing a third anchor of the implant to a third site of the tissue.

[0098] In some embodiments, the method also includes, thereafter, shrinking a second portion of the tissue by reducing the length of the second section while the length of the first section remains fixed. In some embodiments, the method includes fixing the length of the second section while the second portion of the tissue remains shrunk.

[0099] In some embodiments, the second portion of the tissue is disposed between the second site and the third site, and implanting the second section of the implant along the second portion of the tissue includes implanting the second section of the implant along the second portion of the tissue disposed between the second site and the third site.

[0100] In some embodiments, the second portion of the tissue is disposed between the third site and the fourth site, and implanting the second section of the implant along the second portion of the tissue includes implanting the second section of the implant along the second portion of the tissue by anchoring a third anchor of the implant to the third site of the tissue and anchoring a fourth anchor of the implant to the fourth site of the tissue.

[0101] According to some implementations, a system and / or device (e.g., for use in or for use on a target heart) includes (i) a segmented implant including a plurality of segments telescopically coupled to each other in series, each segment including an anchor, and / or (ii) a delivery tool.

[0102] In some implementations, the delivery tool is configured to (i) deliver the implant percutaneously to the heart, (ii) fix each of the anchors to the heart tissue, and / or (iii) contract the tissue by telescopically contracting the implant while each of the anchors remains fixed to the tissue.

[0103] In some implementations, the delivery tool is configured to telescopically extend the implant within the heart.

[0104] In some implementations, each of the segments is articulatable with respect to an adjacent one of the segments.

[0105] In some implementations, each of the segments further includes a locking portion configured such that locking of the locking portion fixes the amount of telescoping between a segment and an adjacent one of the segments for each of the segments.

[0106] In some implementations, each of the anchors is biased to assume an anchor fixation position, and the delivery tool is configured to (i) deliver the implant percutaneously to the heart while each of the anchors is constrained in a delivery position, and / or (ii) release each of the anchors within the heart to allow each of the anchors to move responsive toward the anchor fixation position.

[0107] In some implementations, the implant has a delivery state for each of the segments in which the anchor is constrained in a delivery position by an adjacent one of the segments.

[0108] In some implementations, in the delivered state, for each of the segments, the anchor is constrained to the delivery position by being disposed within one of the adjacent ones of the segments.

[0109] In some implementations, for each of the segments, the delivery tool is configured to release the anchor by extending the segment telescopically from one of the adjacent ones of the segments.

[0110] In some implementations, the delivery tool is configured to secure the first section (e.g., its elongate member) of the implant along a first portion of the path through the tissue by (i) anchoring the anchor of the first segment of the plurality of segments to a first site in the tissue and / or (ii) anchoring the anchor of the second segment of the plurality of segments to a second site in the tissue.

[0111] In some implementations, the delivery tool is configured to secure the second section (e.g., its elongate member) of the implant along a second portion of the path through the tissue by anchoring the anchor of the third segment of the plurality of segments to a third site in the tissue, where the first section includes a portion of the first segment and a portion of the second segment and the second section includes a portion of the second segment and a portion of the third segment.

[0112] In some implementations, the delivery tool is configured to contract the tissue at the first portion of the path by telescopically contracting the first segment within the second segment.

[0113] In some implementations, the delivery tool is configured to contract the tissue at the second portion of the path by contracting the second segment within the third segment, independent of contracting the first segment within the second segment.

[0114] In some implementations, the delivery tool is configured to lock a first segment to a second segment and then telescopically contract the first segment within the second segment, and then lock the second segment to a third segment and then telescopically contract the second segment within the third segment.

[0115] In some implementations, the delivery tool is configured to contract tissue in a second portion of the path by contracting a second segment within a third segment and then locking a first segment to the second segment.

[0116] In some implementations, the delivery tool is configured to telescopically extend an implant within the heart by (i) telescopically extending the first segment from the second segment before anchoring an anchor of the second segment, and / or (ii) telescopically extending the second segment from the third segment after anchoring an anchor of the second segment and before anchoring an anchor of the third segment.

[0117] The methods described above can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In a simulation, body parts can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include computerized and / or physical representations.

[0118] According to some implementations, a system (e.g., for use in or for use with tissue of a subject's heart) includes an implant and a delivery tool. In some implementations, the implant includes an elongate member, a plurality of anchors, and a plurality of locking portions.

[0119] In some implementations, the delivery tool is configured to implant the implant in the tissue such that the elongate member defines a path along the tissue by: (i) using one or more of the anchors to anchor a first section of the elongate member along a first portion of the path; and (ii) then using one or more of the anchors to anchor a second section of the elongate member along a second portion of the path.

[0120] In some implementations, the delivery tool is configured to contract the tissue by: (i) contracting a first portion of the path by reducing the length of the first section after anchoring the first section and before anchoring the second section; (ii) fixing the length of the first section using at least a first locking portion of the plurality of locking portions while the first portion of the path remains contracted; (iii) contracting a second portion of the path by reducing the length of the second section after anchoring the second section and while the length of the first section remains fixed; and / or (iv) fixing the length of the second section using at least a second locking portion of the plurality of locking portions while the second portion of the path remains contracted.

[0121] According to some implementations, a system and / or device (e.g., usable in or for use in a subject's heart) includes an implant, a plurality of tension adjusters, and a delivery tool. In some implementations, the implant includes: (i) a tether; and / or (ii) a series of anchors, each of the anchors including a tissue engagement element (e.g., one or more of a helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, preject, etc.), and optionally also including a head coupled to the tissue engagement element. In some implementations, an anchor (e.g., its head, etc.) is slidably coupled to the tether.

[0122] In some embodiments, the delivery tool includes (i) a tube that is transvascularly advanceable into the heart, (ii) an anchor driver configured to advance an anchor through the tube, the anchor driver being configured to intra - cardiacly anchor the anchor to the heart tissue by driving tissue - engaging elements of each anchor into the tissue, and / or (iii) an applicator configured to connect a tension adjuster to the implant intracardially.

[0123] In some embodiments, the applicator is configured to intracardially connect a tension adjuster to a series of adjacent anchors.

[0124] In some embodiments, the applicator is configured to intracardially connect a tension adjuster to a tether.

[0125] In some embodiments, the applicator is configured to intracardially connect a tension adjuster to a tether between a series of adjacent anchors.

[0126] In some embodiments, each of the tension adjusters is a connector configured to connect respective pairs of adjacent anchors in series.

[0127] In some embodiments, each of the tension adjusters is configured to pull respective pairs of anchors toward each other.

[0128] In some embodiments, each of the tension adjusters is configured to inhibit respective pairs of anchors from moving away from each other.

[0129] In some embodiments, each of the tension adjusters is a spacer configured to be connected to a tether between respective pairs of anchors in series.

[0130] In some embodiments, each of the spacers is tubular.

[0131] In some implementations, for each of the spacers, the spacer applicator is configured to connect the spacer to the tether within the heart while the spacer is constrained in an open state where the spacer has a substantially C-shaped cross-section.

[0132] In some implementations, the tube defines a primary lumen, the anchor driver is configured to advance each of the anchors from within the lumen, and the spacer applicator is configured to advance each of the spacers from a secondary lumen disposed laterally from the primary lumen.

[0133] According to some implementations, the method includes (i) implanting an implant along tissue of a subject's heart (e.g., a live subject, a simulation, etc.) by anchoring a series of anchors of the implant to the tissue, wherein the anchors are slidably coupled to a tether of the implant; (ii) thereafter applying tension to the tether; and / or (iii) thereafter adjusting the tension by applying a tension adjuster between a series of adjacent pairs of the anchors.

[0134] In some implementations, the tension adjuster includes a spacer, and applying the tension adjuster between a pair of adjacent anchors includes connecting the spacer to the tether between the pair of adjacent anchors to bias the pair of adjacent anchors away from each other.

[0135] In some implementations, the tension adjuster includes a connector, and applying the tension adjuster between a pair of adjacent anchors includes connecting the connector to both of the pair of adjacent anchors to draw the pair of adjacent anchors toward each other.

[0136] The above method can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaveric heart, a virtual human, a simulator, etc.). In a simulation, body parts can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can optionally include computerized and / or physical representations.

[0137] According to some implementations, the method includes (i) identifying a subject (e.g., a living subject, a simulation, etc.) in which an implant is implanted along the tissue of the subject's heart, the implant including a series of anchors slidably coupled to a tether, the implant being implanted by anchoring the series of anchors to the tissue, and / or (ii) adjusting the tension of the tether by applying a tension adjuster between a series of adjacent pairs of anchors in response to the identifying.

[0138] In some implementations, the tension adjuster includes a spacer, and applying the tension adjuster between a pair of adjacent anchors includes biasing 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 implementations, the tension adjuster includes a connector, and applying the tension adjuster between a pair of adjacent anchors includes pulling the pair of adjacent anchors toward each other by connecting the connector to both of the pair of adjacent anchors.

[0140] According to some implementations, a system and / or apparatus (e.g., for use with or for use with a tether) includes: (i) a tubular wall surrounding a lumen sized to receive a tether therethrough; (ii) a window cut out of the wall; and / or (iii) a locking portion including a tab cut from the wall, positioned on the opposite side of the window, biased to project into the window in a manner that deflects across the lumen and locks a locking portion to a tether received through the lumen.

[0141] In some implementations, the window is a first window of a plurality of windows cut out of the wall.

[0142] In some implementations, the tab is a first tab of a plurality of tabs cut from the wall.

[0143] In some implementations, each tab of the plurality of tabs is biased to project into a respective window facing that tab across the lumen in a manner that locks the locking portion to the tether.

[0144] In some implementations, the system / apparatus further includes a cutter. In some implementations, the cutter includes a cutting element (e.g., blade, knife, scissors, pincers, shears, scalpel, edge, sharp edge, cutting edge, etc.) sized to receive a tether therethrough.

[0145] In some implementations, the distal portion of the cutting element defines a pair of cutting edges facing each other.

[0146] In some implementations, the cutter includes an overtube slidable over and along the cutting element in a manner that the cutting edges move towards each other and thereby cut the tether.

[0147] In some implementations, the cutting element is manufactured from a single piece of stock tubing.

[0148] In some embodiments, the cutter is capable of advancing over and along the tether towards the heart while maintaining the overtube in a stationary state relative to the cutting element.

[0149] In some embodiments, the cutter is adapted to be advanced trans-luminally over and along the tether towards the heart of a subject (e.g., a live subject, a simulation, etc.) to a locking portion.

[0150] In some embodiments, the cutter is adapted to advance the locking portion trans-luminally towards the heart over and along the tether by pressing the distal end of the cutter against the proximal end of the locking portion.

[0151] In some embodiments, the cutting element includes a pair of arms, each arm having (i) a proximal portion extending distally away from the proximal portion of the other arm of the pair, and / or (ii) a distal portion extending distally towards the distal portion of the other arm of the pair.

[0152] In some embodiments, each arm defines an individual elbow between the proximal portion and the distal portion.

[0153] In some embodiments, each arm defines a continuous curve from the proximal portion to the distal portion.

[0154] In some embodiments, for each arm of the pair, a cutting edge of the pair of cutting edges is defined by the distal portion of the arm.

[0155] In some embodiments, the proximal portions extend outwardly such that the arms collectively define a diameter wider than the inner diameter of the overtube, such that sliding the overtube distally over and along the proximal portions causes the proximal portions to be compressed together and the arms to pivot inwardly towards each other.

[0156] In some embodiments, for each arm of the pair, the angle at which the proximal portion is disposed relative to the central axis of the cutter is shallower than the angle at which the distal portion is disposed relative to the central axis.

[0157] In some embodiments, for each arm of the pair, the proximal portion is longer than the distal portion.

[0158] In some embodiments, the system / device further includes a blocking rod adapted to maintain the lock in a released state where the tab is prevented from deflecting across the lumen and into the window.

[0159] In some embodiments, the rod is adapted to extend through the lumen along the tether, and pulling the rod out of the lock causes the lock to transition towards a locked state where the tab deflects across the lumen and into the window.

[0160] According to some embodiments, a method (e.g., usable with or for use with a target heart) is further provided, the method including using a cutter and pushing a lock distally trans-luminally over and along a tether towards the heart, the lock including a tubular wall surrounding the lumen through which the tether extends, a window cut out of the wall, and a tab cut from the wall and positioned on the opposite side of the window.

[0161] In some embodiments, the method then further includes pulling out an interfering rod from the lock such that the tab deflects responsively across the lumen and into the window, thereby locking the lock to the tether.

[0162] In some embodiments, the method further includes advancing an overtube over and along the cutter such that the overtube compresses a pair of cutting edges defined by the cutter towards each other.

[0163] In some embodiments, the method then further includes pulling the cutter out of the heart.

[0164] In some implementations, pushing the locking portion proximally on and along the tether includes pushing the locking portion on and along the tether while the rod extends through the locking portion.

[0165] In some implementations, pushing the locking portion proximally on and along the tether includes pushing the locking portion on and along the tether while the rod extends distally from the cutter and through the locking portion.

[0166] In some implementations, pulling the rod out of the locking portion includes pulling the rod proximally into the cutter.

[0167] According to some implementations, the method includes implanting an implant along tissue of a target heart (e.g., a living target, a simulation, etc.) by anchoring a series of anchors of the implant to the tissue.

[0168] In some implementations, the anchor is slidably coupled to a tether of the implant.

[0169] In some implementations, the method further includes then pulling the tether through a locking portion of a head of the series of anchors to form a loop of the tether.

[0170] In some implementations, the method further includes then locking the locking portion to the loop.

[0171] In some implementations, pulling the loop of the tether through the locking portion includes gripping the tether and pulling the tether into the locking portion.

[0172] In some implementations, locking the locking portion to the loop includes pulling a release tool out of the locking portion such that the locking portion responds and transitions toward a locked state.

[0173] In some implementations, the method further includes unlocking the locking portion before pulling the tether through the locking portion.

[0174] The above method can be implemented on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver's heart, a virtual human, a simulator, etc.). In the simulation, the 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.

[0175] According to some implementations, a system including an anchor (e.g., for use with or for use with a tether) is further provided.

[0176] In some implementations, the anchor has an anchor head and a tissue engagement element that extends distally from the head so as to define the anchor shaft of the anchor.

[0177] In some implementations, the anchor head defines a channel that extends laterally through the head along the anchor shaft and is dimensioned to be screwed onto the tether and slidable thereon and along the tether, and includes a locking portion that communicates with the channel.

[0178] In some implementations, the anchor head defines a proximal opening that provides access to the channel and the locking portion.

[0179] In some implementations, the system comprises a tool including a gripper configured to advance into the channel through the locking portion (e.g., via an opening).

[0180] In some implementations, the system includes a tether screwed through a channel, and the gripper is configured to form a loop of the tether by gripping the tether within the channel and pulling the tether proximally through a locking portion.

[0181] In some implementations, the locking portion is configured to lock onto the loop in response to pulling the tool from the locking portion.

[0182] In some implementations, the tool includes a tube, and the gripper is configured to extend through the tube. In some implementations, the gripper is configured to pull the loop into the tube.

[0183] In some implementations, the gripper is configured to release the loop when the locking portion locks onto the loop.

[0184] In some implementations, the tube is configured to unlock the locking portion by applying a unlocking force to the locking portion.

[0185] In some implementations, the locking portion is biased to lock in the absence of an unlocking force.

[0186] In some implementations, the tube is configured to access the locking portion through an opening.

[0187] In some implementations, the locking portion includes a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to a head.

[0188] In some implementations, the tube is configured to transition the locking portion towards an unlocked state by pressing against the locking arms in a manner that pivots each of the locking arms away from each other.

[0189] In some implementations, the locking portion is configured to be locked onto the loop by the locking arms pivoting towards each other in response to the withdrawal of the tube from the head.

[0190] According to some implementations, a system and / or apparatus (e.g., usable with or for use with a tether) includes a locking portion that includes an outer tube and an inner tube coaxially positioned within the outer tube.

[0191] In some implementations, the inner tube is fixed to the outer tube at the attachment point.

[0192] In some implementations, the inner tube is shaped to define a lumen along the longitudinal axis of the locking portion, and the lumen is sized to receive the tether therethrough.

[0193] In some implementations, the inner tube is axially compressible towards the attachment point in a manner that clamps the inner tube to the tether within the lumen.

[0194] In some implementations, the inner tube is deformable in a manner that curves the inner tube inwards relative to the tether by axially compressing the inner tube towards the attachment point.

[0195] In some implementations, the inner tube has a first end and a second end, and the inner tube is axially compressible towards the attachment point by moving the second end towards the first end.

[0196] In some implementations, the inner tube is annular at each of its first and second ends.

[0197] In some implementations, the attachment point is at the first end.

[0198] In some implementations, the inner tube is axially compressible towards the attachment point by applying torque to the second end.

[0199] In some embodiments, the inner tube defines a helix having a series of turns, and application of torque reduces the pitch of the helix.

[0200] In some embodiments, the helix is a double helix.

[0201] In some embodiments, the inner tube is axially compressible towards the attachment point by pushing the second end towards the first end.

[0202] In some embodiments, the lumen is disposed along the longitudinal axis of the locking portion, and the inner tube is axially compressible towards the attachment point by pushing one end of the inner tube along the longitudinal axis towards the other end of the inner tube.

[0203] In some embodiments, the locking portion has an unlocked state in which the locking portion is slidable along the tether, and / or the locking portion is movable towards the locked state by axially compressing the inner tube.

[0204] In some embodiments, the locking portion is movable towards the locked state by moving the second end into the outer tube.

[0205] In some embodiments, in the unlocked state of the locking portion, the second end is disposed outside the outer tube, and / or in the locked state of the locking portion, the second end is disposed inside the outer tube.

[0206] In some embodiments, the locking portion includes a snap - fit mechanism between the inner tube and the outer tube, the inner tube is axially compressible towards the attachment point until the inner tube snap - fits to the outer tube, and the snap - fit prevents axial decompression of the inner tube.

[0207] In some implementations, the inner tube defines a window, the outer tube defines a tongue adapted to extend within the window, and the inner tube is axially compressible toward the attachment point until the tongue extends within the window.

[0208] In some implementations, the outer tube defines a window, the inner tube defines a tongue adapted to extend within the window, and the inner tube is axially compressible toward the attachment point until the tongue extends within the window.

[0209] In some implementations, the inner tube is shaped to define an hourglass configuration having a first spherical portion, a second spherical portion, and a constriction therebetween, and the inner tube is axially compressible toward the attachment point in a manner that clamps the constriction to the tether.

[0210] In some implementations, the inner tube is axially compressible toward the attachment point by pushing the first spherical portion toward the second spherical portion.

[0211] In some implementations, each of the first spherical portion and the second spherical portion is annular.

[0212] According to some implementations, a method (e.g., usable with or for use with a tether) includes advancing a locking portion trans-luminally over and along a tether to a target heart (e.g., a living target, a simulation, etc.), the locking portion including an inner tube coaxially positioned within an outer tube and fixed to the outer tube at an attachment point, and the tether extending through a lumen defined by the inner tube.

[0213] In some implementations, the method includes locking 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.

[0214] In some embodiments, compressing the inner tube toward the attachment point such that the inner tube is clamped to the tether includes compressing the inner tube toward the attachment point such that the diameter of the inner tube is reduced.

[0215] In some embodiments, axially compressing the inner tube toward the attachment point includes pushing the inner tube further into the outer tube.

[0216] 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.

[0217] In some embodiments, the attachment point is disposed at the first end.

[0218] In some embodiments, advancing the locking portion trans-luminally includes advancing the locking portion trans-luminally 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.

[0219] In some embodiments, the lumen is disposed along the longitudinal axis of the locking portion, and axially compressing the inner tube toward the attachment point includes axially compressing the inner tube by pushing one end of the inner tube toward the other end of the inner tube along the longitudinal axis.

[0220] 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 is snap-fitted to the outer tube, and the snap-fit prevents axial decompression of the inner tube.

[0221] In some embodiments, the locking portion defines a window and a tongue, and compressing the inner tube axially toward the attachment point until the inner tube snap-fits onto the outer tube includes compressing the inner tube axially toward the attachment point until the tongue protrudes into the window.

[0222] 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 aligns with the window and, in response to aligning with the window, automatically protrudes into the window.

[0223] In some embodiments, compressing the inner tube axially toward the attachment point until the tongue aligns with the window includes compressing the inner tube axially toward the attachment point such that the tongue moves to axially align with the window.

[0224] In some embodiments, compressing the inner tube axially toward the attachment point until the tongue aligns 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 to rotationally align with the window.

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

[0226] In some embodiments, 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 a portion of the inner tube bends inwardly relative to the tether.

[0227] In some implementations, axially compressing the inner tube toward the attachment point such that a portion of the inner tube bends inwardly relative to the tether includes axially compressing the inner tube toward the attachment point to obtain an hourglass shape having a constriction where the inner tube is clamped to the tether.

[0228] In some implementations, 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 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 inwardly relative to the tether.

[0229] In some implementations, each of the struts has an hourglass shape having a first spherical portion, a second spherical portion, and a constriction therebetween, and axially compressing the inner tube toward the attachment point such that the struts bend inwardly relative to the tether includes axially compressing the inner tube toward the attachment point such that the constriction of each of the struts is clamped to the tether.

[0230] In some implementations, 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 in a manner such that, for each of the struts, the first spherical portion moves toward the second spherical portion.

[0231] In some implementations, 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 relative to the tether.

[0232] In some implementations, the inner tube is shaped to define a helix having a series of turns and pitches, and compressing the inner tube axially toward the attachment point such that the inner tube twists inwardly relative to the tether includes reducing the pitch by twisting the inner tube toward the attachment point.

[0233] In some implementations, the helix is a double helix, and reducing the pitch includes reducing the pitch of the double helix.

[0234] The above methods and any methods using the systems, assemblies, devices, apparatuses, etc. described herein can be performed on a living subject (e.g., a human or other animal) or on a simulation (e.g., a cadaver, a cadaver heart, a virtual person, a simulator, etc.). In a simulation, body parts can optionally be referred to as “simulated” (e.g., a simulated heart, simulated tissue, etc.) and can optionally include computerized and / or physical representations.

[0235] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safe use on a patient, and the methods herein can include (or additional methods can include or consist of) sterilizing one or more of the systems, devices, apparatuses, components, etc. described herein (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0236] The present invention is not limited to what has been specifically described and illustrated above. Rather, the scope of the present invention includes both combinations and sub - combinations of the various features described above, as well as variations and modifications thereof that would occur to those skilled in the art upon reading the above description and that are not found in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0237]

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[0238] Systems, devices, methods, apparatuses, etc. for inhibiting tissue growth on an implantable sheet are described herein. In some implementations, the systems, devices, methods, apparatuses, etc. include an apparatus comprising a multi-layer structure incorporating a sheet and / or a sheet configured with an implant. The systems, devices, methods, apparatuses, etc. can be configured to inhibit tissue growth thereon. Various embodiments of devices and / or methods for coating an implant that inhibits tissue growth on itself are described. In some implementations, an implant incorporating a sheet is configured to support and / or guide the movement of the leaflet tips of a heart valve of a subject (e.g., a living subject, a simulation, etc.). An example where such an implant can be useful is when used at the posterior leaflet of the mitral valve experiencing another problem that results in fluttering, prolapse, stiffness, and / or regurgitation.

[0239] The disclosed systems, devices, methods, apparatuses, etc. should not be construed as limiting in any way. Instead, this disclosure is directed to all novel and non-obvious features and aspects of the various coating procedures and uses disclosed, which are disclosed both singly and in various combinations and sub-combinations with each other. The disclosed systems, devices, methods, apparatuses, etc. are not limited to any specific aspect, feature, or combination thereof, and also do not require the presence of any one or more specific advantages or the solution of any problems. Further, the techniques, methods, operations, steps, etc. described or suggested herein can be performed on a subject (e.g., a living animal, or a non-living simulation such as a cadaver, cadaver heart, simulator, etc.).

[0240] Various implementation modes such as examples of systems, devices, and artificial implants can be coated using the coating method disclosed in this specification, and any combination of the described features, components, and options can be made, unless specifically excluded. For example, even if a specific combination of heat and / or pressure is not explicitly described, various polymers that inhibit tissue growth can be used in any suitable method for joining to the device. Similarly, different structures and features of the device can be mixed or combined, such as combining any sheet with any form of frame, even if not explicitly disclosed. In summary, the individual components of the disclosed system can be combined unless they are mutually exclusive or physically impossible.

[0241] Some operations of the disclosed method are described in a specific sequential order for ease of presentation, but it should be understood that this mode of description includes rearrangement unless a specific order is required by the specific words defined below. For example, the operations described sequentially may, in some cases, be rearranged or performed simultaneously. Further, for simplicity, the accompanying figures may not show various ways in which the disclosed systems, devices, methods, etc. can be used in combination with other systems, devices, methods, etc.

[0242] Figures 1A - B and 2A - B are schematic diagrams of techniques for implanting system 20 and implant 22 of the system according to some implementation modes. System 20 is a tissue adjustment system and can be used to adjust the dimensions of tissue 10, such as the tissue of the target heart. For example, system 20 may be a valve formation system, and implant 22 may be a valve formation structure (such as a semi - formed ring or band) for implantation at the heart valve annulus (e.g., along the valve annulus). Implant 22 can include a plurality of anchors 30 and a tether 26 (e.g., a shrinkage member) on which the anchors are slidably coupled, for example, by screwing onto the tether.

[0243] The tether 26 is an elongated member (e.g., wire, cable, line, suture, filament, ribbon, etc.) and is typically flexible. The tether 26 can include metal, polymer, and / or natural fibers. In some implementations, the tether 26 includes a suture. In some implementations, the tether 26 includes a superelastic material. The tether 26 can include nitinol, ePTFE, PTFE, polyester, stainless steel, and / or cobalt chrome.

[0244] Each anchor 30 includes a tissue engagement element 34 (e.g., one or more of a helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, pretzel, etc.). In some implementations, each anchor can also optionally include a head 32, and the tissue engagement element extends distally from the head. In some implementations, the tissue engagement element 34 has a sharp distal tip 36 and is configured to be driven (e.g., screwed, pushed, etc.) into the subject tissue. The tissue engagement element 34 can define the central longitudinal anchor axis of the anchor 30. For example, as shown, the tissue engagement element 34 can be helical, and its screw axis is the longitudinal central axis of the anchor. Alternatively or additionally, the anchor 30 can comprise another type of tissue engagement element such as a dart or staple. In some implementations, the tissue engagement element can include barbs or barbed portions that hold the tissue engagement element in the tissue.

[0245] In some embodiments, the head 32 can be coupled to the proximal end of the tissue engagement element 34, can include a driver interface 38, and can also include an eyelet 39. The driver interface 38 can be firmly coupled to the tissue engagement element 34. In some embodiments, as shown, the driver interface 38 is disposed on the central longitudinal axis of the anchor 30. In some embodiments, 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 from 0.25 to 0.75 mm.

[0246] The tether 26 can include (e.g., can consist essentially of) a wire, cable, suture, cord, thread, line, and ribbon. The tether 26 can include (e.g., can consist essentially of) a metal, polymer, synthetic fiber, semi-synthetic fiber, and / or natural fiber. The tether 26 can have a circular, elliptical, rectangular, or other shaped cross-section. In some embodiments, the tether 26 is from 0.1 to 0.6 mm (e.g., from 0.18 to 0.3 mm) thick.

[0247] In addition to the implant 22, the system 20 can include a delivery tool 40 for percutaneously (e.g., trans-luminally such as trans-femoral) implanting the implant. The tool 40 includes a flexible anchor driver 42 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, such as by rotating the driver interface 38. For example, as shown, the driver 42 can include an elongated flexible shaft 44 and a driver head 46 coupled to the distal end of the shaft and configured to reversibly engage the driver interface 38. In some embodiments, also as shown, the tool 40 further includes a flexible tube 50 (e.g., a lumen catheter) through which each anchor 30 can be advanced to the tissue 10 where the anchor is to be anchored.

[0248] In some implementations, the implant 22, the delivery tool 40, and / or the 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 documents, each of which is incorporated herein by reference. U.S. Patent Application No. 14 / 437,373 by Sheps et al., published as US2015 / 0272734 U.S. Patent Application No. 15 / 782,687 by Iflah et al., published as US2018 / 0049875 International Patent Application No. PCT / IB2020 / 060044 by Kasher et al., published as WO2021 / 084407 International Patent Application No. PCT / IB2021 / 058665 by Halabi et al., published as WO2022 / 064401. International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al.

[0249] The anchor 30 (e.g., its eyelet 39) is configured to facilitate sliding of the anchor along the tether 26. In some implementations, the anchor (e.g., the eyelet) is configured to facilitate such sliding (i) while the anchor (e.g., its central longitudinal axis) is aligned with the tether, e.g., to facilitate advancing 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., to facilitate subsequent contraction of the implant, thereby facilitating contraction of the tissue to which the implant is anchored. This can be achieved at least in part due to the shape and dimensions of the eyelet 39, which can be modified as necessary to be as described in one or more of the documents cited herein.

[0250] In some embodiments, the outlet 39 is rotatable about the central longitudinal axis of the anchor 30, for example, by being attached to a rotatably attached cuff 37. In some embodiments, despite its rotatability about the central longitudinal axis of the anchor 30, the outlet 39 is fixedly angled relative to the central longitudinal axis by being fixedly attached, for example, to a cuff 37 that is rotatable but not deflectably attached.

[0251] FIG. 1A shows three anchors 30 anchored to tissue 10 and a driver 42 for delivering a fourth anchor via a tube 50. Each anchor 30 can be delivered while a tether 26 extends through an outlet 39 generally parallel to the central longitudinal axis of the anchor, as shown, for example, for the fourth anchor in FIG. 1A. For previously anchored anchors (e.g., the three anchors at the right end in FIG. 1A), the tether 26 is oriented transverse to the anchor (e.g., orthogonal to the central longitudinal axis of the anchor).

[0252] After a desired number of anchors 30 are anchored, tension is applied to the tether 26 (e.g., by sliding the tether relative to one or more of the anchors 30) and locked in 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, FIG. 1B shows a state where an adjustment tool 60 is introduced (e.g., over and along the proximal portion of the tether 26), tension is applied to the tether 26, and the tension is locked by locking a locking portion (e.g., a stopper) 24 to the tether at the last anchored anchor 30. This last anchored anchor 30 is labeled 30z and can be considered the most proximal anchor of the implant 22.

[0253] The tension of the tether 26 pulls the anchor 30, thereby causing the tissue 10 to which the anchor is anchored to contract. To facilitate the application of the tension of the tether 26, the adjustment tool 60 can provide a reference force (e.g., press against the last anchored anchor 30) while the tether (e.g., the proximal end of the tether) is pulled proximally. In the illustrated embodiment, the adjustment tool 60 also cuts off the excess tether 26 and is withdrawn from the heart. The adjustment tool 60 can be a component of the system 20. In some implementations, the adjustment tool 60, the locking portion 24, and / or the techniques for applying, locking, and / or cutting off the tension of the tether 26 can be modified as necessary as described, and / or the features can be shared with one of those described in one or more of the following references with the necessary modifications, each of which is incorporated herein by reference. U.S. Patent Application No. 16 / 534,875, by Brauon et al., filed on August 7, 2019 and published as US2020 / 0015971 International Patent Application No. PCT / IB2020 / 060044, by Kasher et al., published as WO2021 / 084407 International Patent Application No. PCT / IB2022 / 051099, by Shafigh et al.

[0254] The coupling of the tether 26 to the first anchor 30 to be anchored is such that pulling the tether 26 to apply tension to the tether does not cause the tether (e.g., its first end) to be released (e.g., slip off) from the anchored first anchor. This first anchor 30 to be anchored is labeled 30a and can be considered the most distal anchor of the implant 22. In some implementations, as shown, the locking portion (e.g., stopper) 24 can lock to the tether 26 at the anchor 32a. For example, the anchor 30a is the same as the other anchors 30 of the implant 22. This locking portion 24 is labeled 24a, and the locking portion of the anchor 30z is labeled 24z. In some implementations, the locking portion 24a is the same as the locking portion 24z. In some implementations, the locking portions 24a and 24z are different from each other, for example, due to their slightly different roles. In some implementations, the anchor 30a can be fixedly attached to the tether 26 using an anchor 30a having specific features or components (e.g., a locking portion) to facilitate such attachment. In some implementations, the implant 22 does not include a locking portion 24a separated from the anchor 30a.

[0255] For simplicity, in FIGS. 1A and 1B, the implant 22 is shown in a linear configuration. However, in the case of annuloplasty, the implant 22 is often implanted curvilinearly (or in a complete ring shape) around the annulus so that the size of the annulus is reduced by contraction and the junction of the valve leaflets is improved. FIG. 2A shows an example in which the implant 22 is implanted curvilinearly around the annulus of the mitral valve 4 of a subject's heart, where, for example, the tissue 10 is tissue of the mitral annulus. FIG. 2B is an example in which the implant 22 is implanted curvilinearly around the annulus of the tricuspid valve 5 of a subject's heart, where, for example, the tissue 10 is tissue of the tricuspid annulus.

[0256] In the above description of the implant 22 with reference to FIGS. 1A - 2B, the tension along the entire tether 26, and thus the contraction of the tissue 10 between the first / farthest anchor 30a and the last / nearest anchor 30z (e.g., along the entire implant), is substantially uniform. Below, in particular, systems, implants, and techniques are described for differentially contracting tissue along an implant (e.g., by varying the tension along the implant and / or tether) and / or for differentially contracting tissue of the annulus of a heart valve along the annulus.

[0257] See FIGS. 3 and 4, which are schematic diagrams of exemplary implantations of the implant 22 according to some implementations. FIG. 3 shows a first implant 22a anchored along a first portion of the annulus and a second implant 22b anchored along a second portion of the annulus, leaving a space between the first and second portions of the annulus. FIG. 4 shows a first implant 22c anchored along a first portion of the annulus and a second implant 22d anchored along a second portion of the annulus, with an overlap between the first and second portions of the annulus.

[0258] The implants 22a, 22b, 22c, and 22d can be as described for the implant 22 and can be considered variations of the implant 22. In some implementations, these variations are identical to the implant 22. In some implementations, these variations are identical to the implant 22 except for their length (e.g., the length of their tethers 26) and / or the number of anchors 30 they include.

[0259] In the embodiment shown in FIG. 3, the implants 22a and 22b are anchored along the annulus of the tricuspid valve 5, with a first portion of the annulus (to which the first implant 22a is anchored) extending between the root of the septal leaflet SL, including the posterior commissure PSC, and the root of the posterior leaflet PL, and a second portion of the annulus (to which the second implant 22b is anchored) extending between the root of the anterior leaflet AL, including the anterior commissure APC, and the root of the posterior leaflet PL. After implantation and contraction of the implants 22a and 22b, the tissue 10a (e.g., annular tissue) in the space between the first and second portions of the annulus (e.g., between the implants 22a and 22b) may remain uncontracted. It will be appreciated that other similar arrangements that leave a gap between the two annuloplasty implants are possible, and that similar arrangements may be applied, mutatis mutandis, to other heart valves, such as the mitral valve.

[0260] In the embodiment shown in FIG. 4, implants 22c and 22d are anchored along the annulus of tricuspid valve 5, with a first portion of the annulus (where first implant 22c is anchored) extending from the posterior commissure PSC along the root of the posterior leaflet PL, past the anterior commissure APC to the root of the anterior leaflet AL, and a second portion of the annulus (where second implant 22d is anchored) extending from the anterior commissure ASC along the root of the anterior leaflet AL, past the anterior commissure APC to the root of the posterior leaflet PL. After implantation and contraction of implants 22c and 22d, tissue 10b (e.g., tissue of the annulus) overlaid with the first and second portions of the annulus (e.g., overlaid with implants 22c and 22d) may experience increased contraction and / or contractile forces compared to a portion of the annulus where only a single implant is present. In the embodiment shown, tissue 10b is at the anterior commissure APC. It will be appreciated that other similar arrangements that leave a gap between the two annuloplasty implants are also possible and that similar arrangements, mutatis mutandis, can also be applied to other heart valves, such as the mitral valve.

[0261] Referring again to FIGS. 3 and 4. Such use of multiple implant techniques can provide greater control over the contraction of the ring, for example, by implanting the implant only along the portion of the ring where contraction is desired and / or by implanting two or more implants along the portion of the ring where additional contraction and / or contraction strength is desired. Note that in some implementations, the techniques described with reference to FIG. 3 can be combined with the techniques described with reference to FIG. 4 with the necessary modifications.

[0262] Next, referring to FIGS. 5A - B and 6, which are schematic diagrams showing systems, devices, and techniques for differentially contracting tissue along the path of implant 22 by applying a tension regulator to the implant according to some implementations. FIGS. 5A - B show the use of a tension regulator in the form of a spacer 80, and FIG. 6 shows the use of a tension regulator in the form of a connector 90.

[0263] FIG. 5A shows a system 70 including an implant 22 and a delivery tool 40a, which may be as described for delivery tool 40 except that delivery tool 40a further includes an applicator 56. The applicator 56 is configured to connect the spacer to the implant 22 intracardially by connecting the spacer to the tether 26 intracardially (e.g., screwing the spacer onto the tether intracardially). Each spacer 80, or two or more spacers, can be connected to the tether 26 between a pair of adjacent anchors 30. For example, FIG. 5A shows an applicator 56 connecting a spacer 80 to the tether 26 after a third anchor has been anchored to the tissue and before a fourth anchor is anchored to the tissue. FIG. 5B shows the same spacer and an implant 22 implanted using two or more spacers connected to the tether 26, with each spacer disposed between each pair of adjacent anchors 30.

[0264] In some embodiments, each spacer 80 is elongate and, as illustrated, can be at least stationary and substantially tubular. The applicator 56 can be configured to connect each spacer 80 to the tether 26 within the heart while the spacer is constrained in an open state having a substantially C-shaped cross-section. In some embodiments, the entire spacer is simultaneously constrained in this open state. In some embodiments, when the spacer is introduced onto the tether, each region of the spacer transiently moves to an open state, such that the open region of the spacer passes along the spacer like a wave as the spacer is introduced onto the tether. For example, in an application where the spacer advances distally onto the tether, this wave can move from the distal end to the proximal end of the spacer.

[0265] The applicator 56 can be configured to advance the spacer 80 from a secondary lumen disposed laterally from the primary lumen of the tube 50. In some embodiments, also as illustrated, the applicator 56 can comprise a tube that defines this secondary lumen.

[0266] The applicator 56 can be controllable from outside the subject, for example, via 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 distally move the spacer 80 away from the applicator and extrude it onto the tether 26.

[0267] In some implementations, the applicator 56 includes a mandrel 58 that constrains each spacer 80 in its open state. As shown, at least a portion (e.g., the distal portion) of the mandrel 58 can be hollow (e.g., tubular or funnel-like). Further, at least the distal portion of the mandrel 58 (e.g., at least a portion of 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 implementations, throughout the implantation of the implant 22, the tether 26 remains within the hollow of the mandrel 58 through the slit and extends from the distal end of the mandrel, and as the implant is progressively implanted, the tether slides linearly while remaining in this configuration. In some implementations, the mandrel 58 can be advanced on the tether 26 (e.g., such that the tether passes through the slit) to apply each spacer, and then withdrawn until another spacer is to be applied. In any case, in applications where the mandrel 58 is hollow and has a lateral slit 59 and the tether 26 is disposed through the slit, the tether can extend into the mandrel through the slit and exit the mandrel through the end opening of the mandrel, for example, as shown. Thus, the tether 26 is disposed through the slit, but the spacer 80 can be applied to the tether by pushing the spacer out from the end of the mandrel 58. As each region of the spacer 80 moves away from the mandrel 58, the spacer 80 is no longer constrained in its open state and thus closes around the tether 26 in response. In the resulting closed state of the spacer 80, the spacer can become tubular, for example, with its two open edges of its C-shaped form meeting edge to edge or enclosing each other.

[0268] Each spacer 80 is configured to inhibit the movement of a pair of anchors disposed on both sides of the spacer toward each other, for example, to limit how close the anchors can get to each other during the shrinkage of the implant 22 (e.g., during the application of tension to the tether 26). For example, the spacer 80 can have features and / or functionality as described in International Patent Application No. PCT / IB2020 / 060044 by Kasher et al. published as WO2021 / 084407, and / or International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al., with the necessary modifications, each of which is incorporated herein by reference. Thus, depending on the spacing between the pair of adjacent anchors 30 at the time the spacer 80 is applied, applying a spacer between the pair of adjacent anchors can bias the pair of adjacent anchors away from each other.

[0269] FIG. 5B schematically illustrates the inter-anchor region 72 of the tissue 10 between a pair of anchors 30 without the spacer 80 disposed therebetween. Thus, the region 72 is shown as being contracted, with the necessary modifications, or even more so, as described in FIGS. 1A - 2B. FIG. 5B also schematically illustrates the inter-anchor region 74 of the tissue 10 between a pair of anchors with the spacer 80 disposed therebetween. Thus, the region 74 is shown as being less contracted than the region 72.

[0270] This enables the system 70 to facilitate control of the degree of shrinkage to be applied to different sections of the implant 22 and, thereby, to different regions of the tissue 10 in which the implant is implanted. In the particular example shown, region 74 is shown as being on the annulus of the mitral valve 4 near the posterior cusp P2 scallop, and region 72 is shown as being near the commissure and / or near the P1 and P3 scallops, for example, to provide greater shrinkage along the anteroposterior axis of the valve and less shrinkage along the intercommissural axis of the valve. However, since the spacer 80 is added to the implant 22 during implantation, an operator (e.g., a physician) can determine during the procedure whether to apply a spacer between a given pair of anchors (e.g., between the most recently anchor-fixed anchor and the next-to-be-anchor-fixed anchor), based on data obtained during the procedure (e.g., image data and / or numerical data). For example, the spacer can be applied between a given pair of anchors in view of specific anatomical features and / or specific observed effects of the implant on the tissue.

[0271] Figure 6 shows an implanted state of the implant 22 in which two connectors 90 are each connected to a respective pair of anchors 30, according to some implementations. Each connector 90 is configured to draw a pair of anchors disposed on opposite sides of the connector toward each other and / or to inhibit movement of the anchors away from each other. The connector 90 can be applied within the heart. In some implementations, the connector 90 is applied during implantation, with necessary modifications, using an applicator that is part of a delivery tool, for example, in a manner similar to that described for the applicator 56. In some implementations, the connector 90 is applied after implantation of the implant and, optionally, after shrinkage of the implant (e.g., initial shrinkage). For example, when all of the anchors 30 of the implant are drawn toward each other by applying tension to the tether 26, adding a connector between the pair of anchors can draw the pair of anchors further toward each other and, optionally, increase the distance between at least one of the pair of anchors and another anchor that is not in that pair.

[0272] In the illustrated embodiment, the connector 90 is illustrated as a band that is wrapped around the head of each anchor 30 of the pair (see the inset). However, other implementations of the connector 90, such as a secondary tether (e.g., aligned with the tether 26), are included within the scope of the present disclosure.

[0273] In some implementations, as shown, each connector 90 can be substantially parallel to a portion of the tether 26.

[0274] FIG. 6 schematically illustrates the inter-anchor region 76 of the tissue 10 between a pair of anchors 30 that are not connected by the connector 90. Thus, the region 76 is shown as being either modified as necessary or contracted as described in FIGS. 1A - 2B. FIG. 6 schematically illustrates the inter-anchor region 78 of the tissue 10 between a pair of anchors that are connected by the connector 90. Thus, the region 78 is shown as being contracted relative to the region 72.

[0275] A system that utilizes connector 90 thereby facilitates control of the degree of contraction to be applied to different sections of implant 22 and thus to different regions of tissue 10 in which the implant is embedded. In the particular embodiment shown, region 76 is shown as being primarily on the annulus of mitral valve 4 near the posterior cusp's P2 scallop, and region 78 is shown as being, for example, near commissures and / or the P1 and P3 scallops to provide greater contraction along the anteroposterior axis of the valve and less contraction along the intercommissural axis of the valve. However, in some implementations where the connector 90 is added to the implant 22 during implantation, an operator (e.g., a physician) may determine intraoperatively whether to apply the connector between a given pair of anchors (e.g., between the most recently anchor-fixed anchor and the next-to-be-anchor-fixed anchor), based on, for example, data (e.g., image data and / or numerical data) obtained during the procedure. For example, the connector may be applied between a given pair of anchors in consideration of specific anatomical features and / or the observed effects of the implant on the tissue.

[0276] It should be noted that the tension adjuster described herein may be introduced, for example, as a result of post-implantation observations (e.g., using imaging techniques), following the initial implantation of the implant. According to some implementations, the method includes (1) identifying a subject in which an implant has been embedded along tissue of the subject's heart, the implant including a series of anchors slidably coupled to a tether, the implant being embedded by anchor-fixing the series of anchors to the tissue, and (2) adjusting the tension of the tether by applying a tension adjuster between a series of adjacent pairs of anchors in response to the identifying.

[0277] Refer to FIGS. 7A - F, which are schematic diagrams of techniques for implanting system 120 and implant 122 of the system according to some implementations. System 120 is a tissue adjustment system and can be used to adjust the dimensions of tissue 10, such as the tissue of a target heart. For example, system 120 may be a valve formation system, and implant 122 may be a valve formation structure (e.g., a semi - formed ring or band) for implantation in the heart valve annulus (e.g., along the valve annulus). Implant 122 can include a plurality of anchors 30 and a tether 26 (e.g., a contraction member) on which the anchors are slidably coupled, for example, by screwing onto the tether. Thus, in some implementations, implant 122 and its implantation are, unless otherwise described, the same as described for implant 22 with necessary modifications. Further, in some implementations, implant 122 can be considered a variation of implant 22.

[0278] In addition to the implant 122, the system 120 can include a delivery tool 140 for percutaneously (e.g., trans-luminally such as transfemoral) implanting the implant. The tool 40 can 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, such as by rotating the driver interface 38. For example, as shown, the driver 142 can include an elongated flexible shaft 144 and a driver head 146 coupled to the distal end of the shaft and configured to reversibly engage the driver interface 38. In some embodiments, also as shown, the tool 140 further includes a flexible tube 150 (e.g., a lumen catheter) through which each anchor 30 can be advanced to the tissue 10 where the anchor is to be anchored. Thus, in some implementations, the tool 140 is as described for the tool 40, with necessary modifications where not otherwise stated. Further, in some implementations, the tool 140 can be considered a variation of the tool 40.

[0279] Figures 7A - F show an implant 122 implanted along tissue 10 (e.g., along the annulus of valve 5) such that the implant defines an elongate path along the tissue. Figure 7A shows a first section 123a of the implant 122 anchored along a first portion 10c of the path by some of the anchors 30 of the implant that are anchored to the tissue 10 by a tool 140, with the necessary modifications as described above for the implant 22 and tool 40, for example. In the particular embodiment shown, the first section 123a includes three anchors 30, for example, a first anchor 30a (described above), a second anchor 30b, and a third anchor 30c. That is, in the particular embodiment shown, the anchor 30a is the most distal anchor of the first section 123a (and of the implant 122 as a whole), and the anchor 30c is the most proximal anchor of the first section 123a. However, more or fewer anchors can be used. More generally, the first section 123a can be defined as being between the most distal anchor of the first section (anchor 30a in the embodiment shown) and the most proximal anchor of the first section (anchor 30c in the embodiment shown).

[0280] Figures 7D - E show the second section 123b of the implant 122 being anchored along a second portion 10d of the path by some of the anchors 30 of the implant that have been anchored to the tissue by the tool 140. In the particular embodiment shown, the second section 123b includes three further anchors 30, for example, a fourth anchor 30d, a fifth anchor 30e, and a sixth anchor 30f. That is, in the particular embodiment shown, the anchor 30d is the most distal anchor of the second section 123b, and the anchor 30f is the most proximal anchor of the second section 123b. Further, in the particular embodiment shown, the sixth anchor 30f is the most proximal anchor of the entire implant 122, and thereby can generally correspond to the anchor 30z of the implant 22. However, more or fewer anchors can be used. More generally, the second section 123b can be defined as being between the most distal anchor of the second section (anchor 30d in the embodiment shown) and the most proximal anchor of the second section (anchor 30d in the embodiment shown).

[0281] After anchoring the first section 123a and before anchoring the second section 123b, a first portion 10c of the tissue (e.g., along the path through the tissue) is contracted by shortening the length of the first section from, for example, a first length d1 (Figure 7A) to a second length d1' that is shorter than the length d1 (Figure 7B). The lengths d1 and d1' can be measured along the tether 26 between the most distal anchor of the first section 123a (anchor 30a in the embodiment shown) and the most proximal anchor of the first section (anchor 30c in the embodiment shown). That is, these can represent the length of a first portion 26a of the tether that extends between the most distal anchor of the first section 123a (anchor 30a in the embodiment shown) and the most proximal anchor of the first section (anchor 30c in the embodiment shown).

[0282] The contraction of the first portion 10c of the tissue can be achieved by applying tension to the tether 26, facilitated by an adjustment tool 160 that can make the necessary changes (e.g., press against the anchor 30c) to provide a reference force while the tether is pulled proximally, as described, for example, for the implant 22. In some implementations, the adjustment tool 160 is the same as the adjustment tool 60 described above. In some implementations, the delivery tool 140 is withdrawn from the subject before advancing the adjustment tool 160 to the implant 122 (e.g., the anchor 30c). In some implementations, only the driver 142 is withdrawn and the adjustment tool 160 advances through the tube 150 to the implant 122 (e.g., to the anchor 30c).

[0283] The first portion 10c of the path remains contracted, but the length of the first section 123a is fixed, for example, to a length d1’ (FIG. 7B). This fixation can be achieved by locking the locking portion 24c to the tether 26 at the most proximal anchor of the first section 123a - anchor 30c. For example, as shown, the locking portion 24c can advance on and along the tether 26 (e.g., by the adjustment tool 160) and / or can be locked to the tether immediately proximal to the anchor 30c. The locking portion 24c can be as described for any other locking portion described herein.

[0284] Following anchoring of the second section 123b, while the length of the first section 123a remains fixed, a second portion 10d of the tissue (e.g., along a path through the tissue) contracts the length of the second section, e.g., from a first length d2 (FIG. 7E) to a second length d2' that is shorter than the length d2 (FIG. 7F). The lengths d2 and d2' can be measured along the tether 26 between the most distal anchor of the second section (anchor 30d in the illustrated embodiment) and the most proximal anchor of the second section (anchor 30f in the illustrated embodiment). That is, these can represent the length of a second portion 26b of the tether that extends between the most distal anchor of the second section 123b (anchor 30d in the illustrated embodiment) and the most proximal anchor of the second section (anchor 30f in the illustrated embodiment).

[0285] The second portion 10d of the path remains contracted, while the length of the second section 123b is fixed, e.g., at the length d2' (FIG. 7F). This fixation can be achieved, e.g., using the locking portion 24f with the necessary modifications, as described above for the locking portion 24z. Similarly, the excess tether 26 can be trimmed, e.g., using the adjustment tool 60 with the necessary modifications, as described above herein.

[0286] In some embodiments, the locking portion 24c may simply inhibit a further increase in the length of the first section 123a by, for example, interfering with the distal sliding of the tether 26 through the eyelet of the anchor 30c. This may be sufficient for embodiments where the tension in the tether 26 is greater in section 123a than in section 123b. However, in some embodiments, including some embodiments where the tension may increase in section 123b relative to section 123a, an additional locking portion 24d is applied at the most distal anchor of section 123b (anchor 30d in the illustrated embodiment). For example, as shown, the locking portion 24d can advance over and along the tether 26 (e.g., by adjustment tool 160) and / or can lock to the tether immediately distal from the location where the anchor 30d is to be positioned on the tether (FIG. 7C). This can be done prior to securing the anchor 30d (FIG. 7D). The locking portion 24d inhibits a further decrease in the length of the first section 123a by interfering with the proximal sliding of the tether 26 through the eyelet of the anchor 30d. Thus, in some embodiments, the locking portions 24c and 24d can be used to fix the length of the first section 123a prior to contraction of the second section 123b.

[0287] In some embodiments where both the locking portion 24c and the locking portion 24d are used, the tension in the portion 26x of the tether disposed between the portions 26a and 26b (e.g., between the locking portions 24c and 24d) may differ compared to the tension in both the portions 26a and 26b. For example, the portion 26x may have little or no tension applied thereto and may, for example, actually be slack. Thus, the portion 10e of the tissue 10 where the portion 26x of the tether 26 is disposed (e.g., the path along the tissue) is disposed at both ends of the portion 10e and may not contract despite the contraction of the portions 10c and 10d that may delimit the portion 10e. Thus, a non-contracting section 123x of the implant 122 can be defined.

[0288] According to some implementations, the techniques described for use with implant 122 and implant 122 advantageously facilitate contraction of the first section 123a (and thus the first portion of the path along the tissue) independent of contraction of the second section 123b (and thus the second portion of the path along the tissue), and independent of the portion 10c of the path between the first and second sections. Thus, the operator may advantageously apply different degrees of contraction to different portions of the valve annulus and / or apply different degrees of tension to the tethers 26 of different sections of the implant according to the requirements of the individual subject being treated.

[0289] Implant 122 is shown as having two contractile sections (sections 123a and 123b) and a single non - contractile section 123x therebetween, but it should be understood that the scope of the present disclosure includes implants having more contractile sections and / or more non - contractile sections. Further, in some implementations, one or more non - contractile sections can be disposed at the ends of the implant, for example, not delimited by contractile sections. Implant 122 is shown as having three anchors per contractile section, but it should be noted that the scope of the present disclosure includes implants having a greater or lesser number of anchors per contractile section. Implant 122 is shown as not having an anchor within the non - contractile section (e.g., between locking portions 24c and 24d), but it should be noted that the scope of the present disclosure includes implants having one or more anchors within one or more of those non - contractile sections. More generally, it should be understood that the scope of the present disclosure facilitates the operator's determination of how to arrange the various contractile and non - contractile sections of the implant (during pre - treatment planning and / or during the implantation procedure itself).

[0290] Next, refer to FIGS. 8A-C, 9A-B, 10A-B, 11A-G, 12A-C, 13A-B, 14A-B, 15A-C, and 16A-D, which are schematic diagrams of systems and techniques for use with an implant according to several implementations. In each case, the system includes an implant and a delivery tool for implanting the implant such that, for example, the implant defines a path along the tissue of the subject, such as along the annulus of the subject's heart valve.

[0291] Accordingly, referring to FIGS. 8A-16D, various systems for use in the tissue of a subject's heart are provided according to several implementations. Each such system can include an implant and further include a delivery tool. The implant includes an elongate member (e.g., such as tether 26), a plurality of anchors, and a plurality of locking portions. The delivery tool is configured to implant the implant in the tissue such that the elongate member defines a path along the tissue by: (i) anchoring a first section of the elongate member along a first portion of the path using one or more of the anchors, and (ii) subsequently anchoring a second section of the elongate member along a second portion of the path using one or more of the anchors. The delivery tool is further configured to contract the tissue by: (i) contracting a first portion of the path by reducing the length of the first section after anchoring the first section and before anchoring the second section; (ii) fixing the length of the first section using at least a first locking portion of the plurality of locking portions while the first portion of the path remains contracted; (iii) contracting a second portion of the path by reducing the length of the second section after anchoring the second section and while the length of the first section remains fixed; and (iv) fixing the length of the second section using at least a second locking portion of the plurality of locking portions while the second portion of the path remains contracted.

[0292] Similarly, according to some implementations, the method includes percutaneously implanting an elongate implant along tissue such that the implant defines a path along the tissue by (i) anchoring a first section of the implant along a first portion of the path, and (ii) subsequently anchoring a second section of the implant along a second portion of the path. Following anchoring of the first section and prior to anchoring of the second section, (i) the first portion of the path is contracted by reducing the length of the first section, and (ii) the length of the first section is fixed while the first portion of the path remains contracted. Following anchoring of the second section and while the length of the first section remains fixed, (i) the second portion of the path is contracted by reducing the length of the second section, and (ii) the length of the second section is fixed while the second portion of the path remains contracted.

[0293] Similarly, according to some implementations, the method includes percutaneously implanting a first section of an implant along a first portion of tissue by (i) anchoring a first anchor of the implant to a first site of the tissue and 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, and (ii) subsequently contracting the first portion of the tissue by reducing the length of the first section; (iii) fixing the length of the first section while the first portion of the tissue remains contracted; (iv) 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 site of the tissue; (v) subsequently contracting the second portion of the tissue by reducing the length of the second section while the length of the first section remains fixed; and (vi) fixing the length of the second section while the second portion of the tissue remains contracted.

[0294] Similarly, according to some implementations, the method comprises: (i) percutaneously anchoring a first anchor of the implant to a first site of the tissue; (ii) thereafter, percutaneously anchoring a second anchor of the implant to a second site of the tissue, wherein a first portion of the tissue is disposed between the first site and the second site; (iii) thereafter, 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) thereafter, percutaneously varying the distance between a third anchor of the implant and the second anchor by sliding the third anchor relative to the second anchor; (vi) thereafter, percutaneously anchoring the third anchor to a third site of the tissue, wherein a second portion of the tissue is disposed between the second site and the third site; (vii) thereafter, 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; (viii) fixing the distance between the second anchor and the third anchor while the second portion of the tissue remains contracted.

[0295] In some implementations, the above is provided by, or facilitated by, a system (e.g., an implant of the system) that includes a series of anchors slidably coupled to a tether. In each of systems 200 (Figs. 8A - 11G), 300 (Figs. 12A - 13B), 400 (Figs. 14A - B), and 500 (Figs. 15A - 16D), the implant includes a tether and a series of anchors, each anchor including a tissue engagement element (e.g., one or more of a helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, preject, etc.), and each anchor can also optionally include a head. In some implementations, the anchor (e.g., its head, etc.) is slidably coupled (or couplable) to the tether and includes a locking portion configured to lock the head to the tether upon its locking. These systems are configured to facilitate techniques that allow a section of the implant to be adjusted independently of other sections, such that, for example, a portion of the path in which the implant is implanted can contract independently of other portions of the path. In some implementations, these techniques can be considered to be broadly similar to those described with reference to Figs. 7A - F with necessary modifications.

[0296] Figs. 8A - 11G are schematic diagrams of a system 200 and techniques for use therewith, according to some implementations. Fig. 8A shows an overview of system 200. System 200 includes an implant 222 that includes a tether and a series of anchors 230. In the illustrated embodiment, the tether of implant 222 is tether 26 (described above herein), but implant 222 can alternatively or additionally include another tether with necessary modifications. System 200 is shown as having five anchors 230, but this is illustrative, and it should be understood that the system can have more or fewer anchors 230. System 200 can further include a delivery tool 240 for percutaneously (e.g., trans-luminally such as trans-femoral) implanting the implant, e.g., via anchor fixation of the anchors 230.

[0297] Figure 8A shows the tether of implant 222, which is separate from the anchor of the implant. However, the implant can be provided with an anchor already connected to the tether, with the necessary modifications, as described, for example, in International Patent Application No. PCT / IB2021 / 058665 by Halabi et al., published as WO2022 / 064401, and / or International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al. In some implementations, implant 222 can include one or more of the anchors that are configured to be separated from and connected to the tether.

[0298] Figure 8B shows one of the anchors 230, and Figure 8C shows an exploded view of the anchor. Each anchor 230 can include a tissue engagement element 34 (such as one or more of a helix, screw, point, hook, barb, dart, arm, staple, sharp portion, clip, swab, etc.), and can also include a head 232 coupled to the tissue engagement element (such as the proximal end of the tissue engagement element). In some implementations, the anchor (such as head 232, etc.) is slidably coupled to, or configured to be slidably coupled to, tether 26, as described in more detail below. In the example shown, the tissue engagement element of anchor 230 is tissue engagement element 34 (described above herein), but anchor 230 can alternatively or additionally include another tissue engagement element, with the necessary modifications. In some implementations, head 232 includes a locking portion 210 that is configured to lock the head to tether 26 upon its locking.

[0299] In some embodiments, the implant 222 can include a lead anchor 224 where the tissue engagement elements can be similar to those of the anchor 230, but the head may not have the locking function of the head 232 (e.g., may not include the locking portion 210). Instead, the lead anchor 224 can be directly coupled (not slidably) to the tether 26, or can be inhibited from sliding along and / or off the tether by one or more separate locking portions or stoppers such as the locking portion 24 described above. In some embodiments, the lead anchor 224 can be as described above for the anchor 30 with the necessary modifications. In some embodiments, the lead anchor 224 can be as described below for the lead anchor 324 with the necessary modifications.

[0300] The delivery tool 240 is configured to advance the anchor 230 (and thereby generally typically the implant 222) trans-luminally to the target heart. The delivery tool 240 can include a driver 242. The delivery tool 240 can also include a flexible tube (e.g., a catheter) 250 that is transluminally advanceable relative to the heart and through which the driver 242 can extend. For each anchor 230, the delivery tool 240 can be configured to sequentially anchor the anchor to the tissue such that (i) a section of the tether 26 extends from the preceding anchor among the anchors to the anchor (e.g., the last anchored anchor), then the tension on the section of the tether is adjusted, and then extends to the locking portion 210 of the anchor. FIGS. 11A - G illustrate this by showing some of the steps in the implantation of the implant 222 according to some embodiments.

[0301] In some implementations, 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 implementations, a separate delivery tool is provided and used to anchor the leading anchor 224.

[0302] Figures 9A - B show the anchor 230 in longitudinal cross - section, such that for each of these figures, the cross - section of the left frame is orthogonal to the cross - section of the right frame. That is, for each of Figures 9A - B, the central longitudinal axis ax1 of the anchor 230 (e.g., defined by the tissue engagement element 34) is placed on the plane of each of the two cross - sections, and the plane of the cross - section of one frame is rotated 90 degrees about the axis ax1 with respect to the plane of the cross - section of the other frame.

[0303] Figures 10A - B also show the anchor 230 in longitudinal cross - section, but in perspective view. Except for this different viewing angle, the cross - section of Figure 10A is the same as the cross - section of the left frame of Figure 9A, and the cross - section of Figure 10B is the same as the cross - section of the left frame of Figure 9B. However, Figures 10A - B also show the tether 26 screwed laterally through the head 232.

[0304] Figure 9A and Figure 10A show the anchor 230 in its unlocked state, and Figure 9B and Figure 10B show the anchor in its locked state.

[0305] In some implementations, as shown, the locking portion 210 defines a pressing surface 211 and is configured to lock the head 232 to the tether 26 by pressing the pressing surface against the tether. As shown, the locking portion 210 can include a pressing plate 212 that defines the pressing surface.

[0306] The engagement portion 210 can 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, by biasing the engagement portion 210 to lock. In some implementations, 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 engagement element 34. In the illustrated embodiment, the pressing surface 211 is the proximal surface of the pressing plate 212 (e.g., the surface of the pressing plate facing away from the tissue engagement element 34), and the spring 214 is configured to press the pressing surface 211 proximally (e.g., away from the tissue engagement element). For example, the spring 214 can be a compression spring disposed between the pressing plate 212 and the tissue engagement element 34. In the particular illustrated embodiment, 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 engagement element 34.

[0307] In some implementations, as shown, the head 232 (e.g., its engagement portion 210) can include or define a circumferential wall 216 that surrounds (e.g., is coaxial with) and has one or more holes 218 defined therein along a central longitudinal axis ax1. In some implementations, the head 232 is slidably coupled to the tether 26 by a tether that extends transversely through the head via the hole 218. In some implementations, the pressing surface 211 can be disposed inwardly from the circumferential wall 216 (e.g., the circumferential wall surrounds the pressing plate 212).

[0308] In some implementations where the head 232 includes a wall 216 having the hole 218, the spring 214 can be configured to move the pressing surface 211 across at least one of the holes 218. Thereby, the head 232 can be locked to the tether 26, for example, by sandwiching the tether between the pressing surface 211 and the edge of the hole 218 as indicated by the arrow in the inset of FIG. 10B.

[0309] The locking portion 210 may be unlocked or its locking may be inhibited by the force applied by the driver 242. For example, the control rod 248 of the driver 242 can apply a force (e.g., push distally) to a surface (e.g., the proximally facing surface) 213 defined by or connected to the press plate 212, whereby the spring 214 is pulled (e.g., the spring is compressed against the base plate 266) or the relaxation of the spring is inhibited (Figs. 9A and 10A). Therefore, the surface 213 can function as a push button. When the control rod 248 retracts, the spring 214 is allowed to relax (e.g., decompress), and the locking portion 210 transitions to its locked state (Figs. 9B and 10B).

[0310] In some implementations, such as some implementations where the tissue engagement element 34 is a helical / screw-in tissue engagement element, the tissue engagement element can be rotatable independently of the circumferential wall 216. Thereby, the tissue engagement element 34 can be screwed into the tissue, for example, while the tissue engagement element rotates and the tether retaining wall 216 remains stationary, without wrapping the tether 26 around the anchor. The driving (e.g., screwing) of the tissue engagement element 34 into the tissue can be performed by the driver 242. The driver 242 can include a drive head 246 and a shaft 244 extending from an extracorporeal portion (e.g., a control handle) to the drive head. The drive head 246 can be reversibly engageable with the driver interface 238 of the head 232 of the anchor 230. Fig. 11A shows the anchor 230 screwed into the tissue 10, while the tether 26 extends proximally laterally from a previously fixed anchor (in this case, the lead anchor 224), through the head 232 of the anchor 230 to which the tether is fixed, without wrapping around the head 232.

[0311] In some implementations, as shown, the anchor 230 (e.g., its head 232) includes a torque assembly 260, and torque is transmitted through it from the interface 238 to the tissue engagement element 34. The torque assembly 260 can be disposed inwardly from the circumferential wall 216 and can include one or more torque shafts that extend between the interface 238 and the tissue engagement element 34. These torque shafts can be positioned on the central longitudinal axis ax1. In the illustrated embodiment, the torque assembly 260 includes at least a first torque shaft 262 and a second torque shaft 264, and these torque shafts are operatively coupled to each other to transmit torque, for example, by being rotationally locked to each other by their respective shapes. For example, as shown, the non-circular portion and / or protrusion 265 of the torque shaft 264 can cooperate with the non-circular portion and / or recess 263 of the torque shaft 262 to define a keyed joint.

[0312] Accordingly, in some implementations, the head 232 includes a casing that has a proximal portion (e.g., including the interface 238) and a base (e.g., including the base plate 266) to which the head is coupled to the tissue engagement element 34. The proximal and distal portions of the head are axially separated in an intermediate section where the circumferential wall 216 is disposed. The proximal portion, the base, and the tissue engagement element are rotationally (and typically axially) locked to each other, but they are rotationally coupled (e.g., collectively) to the circumferential wall 216. The locking portion 210 and / or the circumferential wall 216 can extend axially across the intermediate section.

[0313] In some implementations, as shown, some components of the head 232 can be common to both the torque assembly 260 and the locking portion 210. For example, as shown, a single component 270 can be shaped to define a surface 213, a shaft 262, and a press plate 212 (see FIG. 8C). The component 270 can be shaped and / or keyed to be rotationally locked to the interface 238. For example, as shown, the surface 213 can be non-circular. In some implementations, the shaft 262 also serves to transmit the unlocking force applied to the surface 213 by the control rod 248, such that, for example, the shaft presses the press plate 212 against the spring 214, thereby compressing the spring between the press plate and the base plate 266. Thus, in some implementations, the component 270 can be regarded as a piston. To provide this function, an operable coupling between the shafts 262 and 264 can allow the shaft 262 to slide axially relative to the shaft 264. For example, as shown, the portion 263 can be a groove or slit extending substantially parallel to the axis ax1, dimensioned such that the portion 265 can slide axially along it.

[0314] In some implementations, as shown (e.g., FIGS. 10A - B), the tether 26 extends laterally through the head 232 by (i) passing through the hole 218, (ii) crossing the press plate 212, and / or passing through (e.g., at least a portion around) the torque assembly 260 (e.g., the torque shaft 262 and / or the torque shaft 264), and (ii) exiting through another hole 218.

[0315] As described above, the drive head 246 of the driver 242 can be reversibly engaged with the interface 238. This engagement can be controlled via the control rod 248. For example, as shown, while 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 within the chamber, the control rod can be advanced distally from the retracted position to lock the crossbar to the drive head. Thus, in some implementations, the control rod 248 controls both (i) the engagement between the driver 242 and the anchor 230, and (ii) the locking portion 210. For example, in some implementations, while the driver 242 is engaged with the anchor 30, (i) the control rod 248 in the advanced position maintains the engagement and keeps the locking portion 210 in the unlocked state (e.g., FIGS. 9A, 10A, and 11A - B), (ii) retraction of the control rod to an intermediate position maintains the engagement but allows the locking portion to be locked (see, e.g., FIGS. 9B, 10B, and 11C), and (iii) further retraction of the control rod to the retracted position causes the driver to be disengaged from the anchor or allows disengagement while the locking portion remains locked (see, e.g., FIG. 11D).

[0316] Figure 11A shows the state where the leading anchor 224 and one anchor 230 are anchored to the tissue 10. The tether 26 extends proximally from the leading anchor, through the anchor 230 (as described above in this specification), away from the tissue (e.g., from the heart and, in some cases, completely from the subject), for example, via the delivery tool 240 (e.g., its tube 250). Thereafter, the tether 26 is tensioned to the desired degree of tension while being guided by one or more imaging techniques (such as fluoroscopy and / or ultrasound examination) to determine the effect of the applied tension on the structure and / or function of the tissue and / or the surrounding structure, such as the effect on the backflow through the heart valve (Figure 11B). At this point, it is possible to repeat the increase and decrease of the tension to determine the desired degree of tension. Once it is determined that the desired degree of tension has been achieved, the locking portion 210 of the anchor 230 is locked to the tether 26 (Figure 11C), for example, by retracting the rod 248 as described above in this specification, thereby locking the applied tension to the section of the tether between the leading anchor 224 and the first anchor 230 (e.g., of the implant 222). Thereafter, the tool 240 (e.g., its driver 242) is disengaged from the anchor 230, for example, by further retracting the rod 248 (Figure 11D). The driver 242 (and optionally the entire tool 240) is then retracted from the subject and can then be advanced (e.g., by sliding along the tether 26) to anchor another anchor 230 to the tissue for use (Figure 11E). Since the locking portion 210 of the first anchor 230 is locked to the tether 26, the tension in the section of the tether proximal to the first anchor 230 may be different (e.g., smaller or larger) from the tension in the section of the tether between the leading anchor 224 and the first anchor 230. Figure 11E shows that the tension in the tether proximal to the first anchor 230 is low (e.g., substantially non-existent). Figure 11F shows this lower degree of tension fixed (i.e., "locked") to the section of the tether 26 between the first anchor 230 and the second anchor 230 by locking the second anchor 230 to the tether.In this manner, the implant 222 can be progressively anchored and tensioned until implantation and adjustment are complete. FIG. 11G shows an example where implantation and adjustment of the implant 222 are complete, and the implant defines a path around the mitral valve 4, for example, around the posterior annulus, generally from annulus to annulus.

[0317] Thus, in the illustrated particular example, when the implant 222 is implanted to define a path along the tissue 10 and differentially contracted as described above herein, (i) the portion 10f of the path where the first section 223a of the implant is fixed (e.g., anchored) contracts by the first amount of contraction, (ii) the portion 10g of the path where the second section 223b of the implant is fixed does not contract substantially, and (iii) the portion 10h of the path where the third section 223c of the implant is fixed contracts by a second amount of contraction that is less than the first amount of contraction. In the example shown, section 223a extends between the leading anchor 224 and the first anchored anchor of the anchors 230, section 223b extends between the first anchored anchor and the second anchored anchor of the anchors 230, and section 223c extends between the second anchored anchor of the anchors 230 and the last anchor of the implant.

[0318] The last anchor of the implant 222 to be anchored is shown as an anchor 230 that itself includes a locking portion 210. However, in some implementations, nevertheless, additional / separate locking portions (e.g., another locking portion 24) can be added to and locked to the tether 26 adjacent the last anchor for additional locking strength, as shown, for example, in FIG. 11G. Further, in some implementations, the last anchor of the implant 222 to be anchored can be an anchor other than the anchor 230, for example, an anchor that itself does not include a locking portion, in which case additional / separate locking portions may be required.

[0319] Figures 12A - 13B are schematic diagrams of system 300 according to some implementations. Figure 12A shows an overview of system 300. System 300 includes an implant 322 with a tether and a series of anchors 330. In the example shown, the tether of implant 322 is tether 26 (described above herein), but implant 322 can alternatively or additionally include another tether with the necessary modifications. System 300 is shown as having four anchors 330, but this is illustrative, and it should be understood that the system can have more or fewer anchors 330. System 300 can further include a delivery tool 340 for percutaneously (e.g., trans-luminal such as trans-femoral) implanting the implant via, for example, anchor fixation of the anchors 330.

[0320] Figure 12A shows the tether of implant 322 separate from the anchors of the implant, but the implant can include anchors already connected to the tether, as described, for example, in International Patent Application No. PCT / IB2021 / 058665 by Halabi et al., published as WO2022 / 064401, and / or International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al. In some implementations, implant 322 can include one or more of the anchors that are separated from the tether and configured to be connected to the tether.

[0321] FIG. 12B shows one of the anchors 330, and FIG. 12C shows an exploded view of the anchor. Each anchor 330 includes a tissue engagement element 34 and can optionally also include a head 332 coupled to the tissue engagement element (e.g., the proximal end of the tissue engagement element). In some implementations, the anchor (e.g., the head 332, etc.) is configured to be slidably coupled to the tether 26, or configured to be slidably coupled, with the necessary modifications, similar to the head 232 of the anchor 230. In the illustrated embodiment, the tissue engagement element of the anchor 330 is the tissue engagement element 34 (described above), but the anchor 330 can alternatively or additionally include another tissue engagement element with the necessary modifications. In some implementations, the head 332 includes a locking portion 310 configured to lock the head to the tether 26 upon its locking.

[0322] In some implementations, the system 300 can be considered a variation of the system 200 and can be used similarly with the necessary modifications. The main differences are the mechanism of the locking portion 310 compared to the locking portion 210 and the mechanism by which the anchor 330 is engaged by its anchor driver.

[0323] In some implementations, the implant 322 can include a leading anchor 324 where the tissue engagement element can be similar to that of the anchor 330, but its head may not have the locking function of the head 332 (e.g., may not include the locking portion 310). Rather, the leading anchor 324 can be directly coupled to the tether 26 (e.g., as shown in the figure) (not slidably), or can be inhibited from sliding along and / or off the tether by one or more separate locking portions or stoppers such as the locking portion 24 (e.g., as illustrated for the leading anchor 224 of the implant 222). In some implementations, the leading anchor 324 can be as described above for the anchor 30 with the necessary modifications.

[0324] Delivery tool 340 is configured to advance an anchor 330 (and thereby, generally typically an implant 322) trans-luminally to a target heart. The delivery tool 340 can comprise a driver 342. The delivery tool 340 can also comprise a flexible tube (e.g., a catheter) 350 that is trans-luminally advanceable relative to the heart and through which the driver 342 can extend. The tube 350 can be the same as or identical to the tube 250 described above. For each anchor 330, the delivery tool 340 can be configured to continuously anchor the anchor to tissue such that (i) a section of the tether 26 extends from a preceding anchor of the anchors to the anchor (i.e., the last anchor to be anchored), then the tension on the section of the tether is adjusted, and then it extends to the locking portion 310 of the anchor. The implantation of the implant 322 can be broadly similar to the implantation of the implant 222 and / or, with the necessary modifications, can be similar as shown in FIGS. 11A - G.

[0325] In some implementations, the delivery tool 340 is also configured to anchor a 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 implementations, a separate delivery tool is provided and used to anchor the leading anchor 324.

[0326] FIGS. 13A - B show the anchor 330 in longitudinal cross-section, such that for each of these figures, the cross-section of the left frame is orthogonal to the cross-section of the right frame. That is, for each of FIGS. 13A - B, the central longitudinal axis ax2 of the anchor 330 (e.g., defined by the tissue engagement element 34) is placed on the plane of each of the two cross-sections, and 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, FIGS. 13A - B are similar to FIGS. 9A - B, but show the anchor 330 instead of the anchor 230.

[0327] FIG. 9A shows the anchor 330 in its unlocked state, and FIG. 9B shows the anchor in its locked state.

[0328] In some implementations, as shown, the locking portion 310 defines a pressing surface 311 and is configured to lock the head 332 to the tether 26 by pressing the pressing surface against the tether. As shown, the locking portion 310 can include a pressing plate 312 that defines the pressing surface.

[0329] The locking portion 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, such as by biasing the locking portion 310 to lock. In some implementations, 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 engagement element 34. In the illustrated embodiment, the pressing surface 311 is the proximal surface of the pressing plate 312 (e.g., the surface of the pressing plate facing away from the tissue engagement element 34), and the spring 314 is configured to press the pressing surface 311 proximally (e.g., away from the tissue engagement element). For example, the spring 314 can be a compression spring disposed between the pressing plate 312 and the tissue engagement element 34. In the particular illustrated embodiment, 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 engagement element 34.

[0330] In some implementations, as shown, the head 332 (e.g., its locking portion 310) can include or define a circumferential wall 316 that surrounds (e.g., is coaxial with) the central longitudinal axis ax2 and has one or more holes 318 defined therein. In some implementations, the head 332 is slidably coupled to the tether 26 by a tether that extends transversely through the head via the hole 318. In some implementations, the press surface 311 can be disposed inwardly from the circumferential wall 316 (e.g., the circumferential wall surrounds the press plate 312).

[0331] In some implementations where the head 332 includes a wall 316 having the hole 318, the spring 314 can be configured to move the press surface 311 across at least one of the holes 318. Thereby, the head 332 can be locked to the tether 26 by sandwiching the tether between the press surface 311 and the edge of the hole 318.

[0332] The locking portion 310 may be unlocked or its locking may be inhibited by the force applied by the driver 342. For example, the driver 242 may indirectly (e.g., distally) push a surface 313 (e.g., a proximally facing surface) defined by or connected to the press plate 312, thereby pulling the spring 314 (e.g., compressing the spring against the base plate 366) or inhibiting the relaxation of the spring (FIG. 9A). This indirect pressing can be achieved by the driver 242 pressing one or more lateral push buttons 334 that are components of the head 332. In the illustrated embodiment, the push buttons 334 are lateral push buttons, e.g., mounted laterally on the head 332 and optionally protruding laterally from the head casing 337. Thus, the locking portion 310 can be configured to laterally project the push button 334 from the casing 337 by movement when the spring 314 axially (e.g., away from it) moves the press surface 311 relative to the tissue engagement element 34. Pushing the push button 334 inward unlocks the locking portion 310 by axially moving the press surface 311, e.g., relative to the casing and / or relative to the tissue engagement element 34.

[0333] In the illustrated embodiment, this functionality is provided by (i) each push button 334 defining (or being connected to) a respective bearing surface 336, and (ii) the surface 313 (which can also be regarded as a bearing surface) being inclined with respect to the surface 336 such that for each push button 334, pushing the push button inward causes the surface 336 to slide on the surface 313 to axially move the press surface 311. The surface 336 and / or the surface 313 can be inclined with respect to the axis ax2. As shown, each push button 334 can define (or be attachable to) a wedge that defines the surface 336, e.g., the push button can be wedge-shaped.

[0334] In some implementations, as shown, the anchor 330 can include, for example, two push buttons 334 that face each other. In some implementations, as shown, a portion of the two push buttons slides relative to each other when the push buttons are pushed inward. As shown, the two push buttons can be shaped to slide relative to each other when pushed inward.

[0335] In some implementations, as shown, the surface 313 is curved (e.g., convex). For example, as shown, the surface 313 can be shaped as an arch or a dome. In some implementations, as shown, the surface 336 is curved (e.g., convex).

[0336] In some implementations, as shown, the driver 242 can include a shaft 344 that defines (or is coupled to) a chamber 345 at the distal portion of the shaft, and the chamber is sized to receive at least a portion of the head 332. This, and / or one or more control rods 348 that can extend reversibly from the shaft 344 (e.g., inwardly and / or within the chamber 345), can configure the driver 242 to reversibly engage the head 332, e.g., its driver interface 338. In some implementations, the driver 242 (e.g., the shaft 344) is sized such that the placement of the head 332 within the chamber 345 pushes the push buttons 334 inward, thereby maintaining the locking portion 310 in an unlocked state (FIG. 13A). In some implementations, by removing the head 332 from the chamber 345 (e.g., when pulling out the driver 242 after the anchor 330 is anchor-fixed), the spring 214 is allowed to relax (e.g., decompress), and the locking portion 310 can be shifted to its locked state (FIG. 13B).

[0337] In some implementations, the shaft 344 is a tube and the chamber 345 is the distal portion of the lumen of the tube.

[0338] In some implementations, such as some implementations where the tissue engagement element 34 is a helical / screw-in tissue engagement element, the tissue engagement element can be rotatable independently of the circumferential wall 316. That is, the circumferential wall 316 can be rotatable relative to the tissue engagement element 34 and / or the interface 338. Thereby, the tissue engagement element 34 can be screwed into the tissue, for example, while the tether retaining wall 316 remains stationary while the tissue engagement element rotates, without wrapping the tether 26 around the anchor. Driving (e.g., screwing) the tissue engagement 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 that is complementary to the anchor key. Together, the key 339 and the key 346 define a keyed joint that allows the driver 242 to apply torque to the interface 338 of the anchor 330, for example, via rotation of the shaft 344.

[0339] In some implementations, as shown, the anchor 330 (e.g., its head 332) includes a torque assembly 360, and torque is transmitted from the interface 338 to the tissue engagement element 34 therethrough. The torque assembly 360 can be disposed inwardly from the circumferential wall 316 and can include one or more torque shafts extending between the interface 338 and the tissue engagement element 34. These torque shafts can be positioned on a central longitudinal axis ax2. In the illustrated embodiment, the torque assembly 360 includes at least a first torque shaft 362 and a second torque shaft 364, and these torque shafts are operably coupled to each other to transmit torque, for example, by being rotationally locked to each other by their respective shapes. For example, as shown, the non-circular portion and / or protrusion 365 of the torque shaft 364 can cooperate with the non-circular portion and / or recess 363 of the torque shaft 362 to define a keyed joint.

[0340] Accordingly, in some implementations, the head 332 includes a casing that has a proximal portion (including, for example, the interface 238) and a base portion (including, for example, the base plate 266) to which the head is coupled to the tissue engagement element 34. The proximal and distal portions of the head are axially separated in an intermediate section where the circumferential wall 316 is disposed. The proximal portion, the base portion, and the tissue engagement element are locked relative to each other in the rotational direction (and typically axially), but they are rotatably coupled (e.g., collectively) to the circumferential wall 316. The locking portion 310 and / or the circumferential wall 316 can axially traverse the intermediate section.

[0341] In some implementations, as shown, some components of the head 323 can be common to both the torque assembly 360 and the locking portion 310. For example, as shown, a single component 370 can be shaped to define a surface 313, a shaft 362, and a press plate 312 (see FIG. 12C). The component 370 can be shaped and / or keyed to be rotationally locked to the interface 338. For example, as shown, the surface 313 can be non-circular. In some implementations, the shaft 362 also serves to transmit the unlocking force applied to the surface 313 by the push button 334, such that, for example, the shaft presses the press plate 312 against the spring 314, thereby compressing the spring between the press plate and the base plate 366. Accordingly, in some implementations, the component 370 can be regarded as a piston. To provide this functionality, an operable coupling between the shafts 362 and 364 can allow the shaft 362 to axially slide relative to the shaft 364. For example, as shown, the portion 363 can be a groove or slit extending substantially parallel to the axis ax2 and dimensioned such that the portion 365 can axially slide along it.

[0342] In some implementations, the tether 26 extends laterally through the head 332, for example, by making the necessary modifications to pass (i) through the hole 318, (ii) across the press plate 312, and / or past (e.g., at least a portion around) the torque assembly 360 (e.g., the torque shaft 362 and / or the torque shaft 364), and (ii) out of another hole 318, similar to that shown in FIG. 10A for the anchor 230.

[0343] As described above, the driver 342 is reversibly engagable with the interface 338. This engagement can be controlled via one or more control rods 348. For example, as shown, while in the forward position, the control rod can project inwardly into the chamber 345 to prevent axial movement of the anchor 330. In some implementations, as shown, one or more of the control rods 348 project distally from the head 332 to prevent movement of the anchor 330 distally from the chamber 345. In some implementations, as shown, one or more of the control rods 348 project proximally from the head 332 to prevent movement of the anchor 330 proximally within the chamber 345. In some implementations, while the control rod 348 is projecting 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 control rods 348 (e.g., those projecting distally from the head 332) can be pulled proximally, such that they retract, for example, into the wall of the shaft 344.

[0344] In some implementations, the control rods 348 are circumferentially aligned with the drive keys 346. In the illustrated embodiment, the two control rods 348 are disposed opposite each other on the same plane as where the two drive keys 346 are located. Further, in the illustrated embodiment, the control rods 348 extend inwardly from the drive keys 346. However, other alignments and arrangements of the control rods 348 are possible, such as control rods 348 disposed opposite each other on a plane orthogonal to the plane where the drive keys 346 are located.

[0345] In some implementations, as shown, each push button 334 is disposed on a respective anchor key 339 such that a drive key 346, which is complementary to the anchor key, for example, presses / restrains each push button inwardly.

[0346] Figures 14A - B are schematic diagrams of a system 400 according to some implementations. The system 400, unless otherwise noted, can be described as the system 300 with necessary modifications. The difference between the system 400 and the system 300 is its anchor 430, and the anchor 430, unless otherwise specified, can be described as the anchor 330 with necessary modifications.

[0347] The anchor 430 can include a tissue engagement element 34 and also a head 432 coupled to the tissue engagement element (e.g., the proximal end of the tissue engagement element). In some implementations, the anchor (e.g., the head 432) can be slidably coupled to or configured to be slidably coupled to the tether 26, with necessary modifications, similar to the head 332 of the anchor 330, for example. In the illustrated example, the tissue engagement element of the anchor 430 is the tissue engagement element 34 (described above), but the anchor 330 can alternatively or additionally include a different tissue engagement element with necessary modifications. In some implementations, the head 432 includes a locking portion configured to lock the head to the tether 26 upon its locking. In some implementations, this locking portion can share features with the locking portion 210 or the locking portion 310 with necessary modifications.

[0348] Similar to anchor 330, anchor 430 has a circumferential wall 416 that surrounds (e.g., is coaxial with) the central longitudinal axis of the anchor and has one or more holes 418 defined therein. In some implementations, head 432 is slidably coupled to tether 26 by a tether that extends transversely through the head via hole 418. However, while circumferential wall 316 is typically rotatable relative to the tissue engagement element and / or the interface of anchor 330, circumferential wall 416 is typically rotationally locked relative to the tissue engagement element and / or the interface of anchor 430. Thus, for anchor 430, screwing the tissue engagement element 34 into the tissue also wraps tether 26 around circumferential wall 416, thereby applying tension to the tether and contracting the tissue (FIG. 14B).

[0349] In some implementations, except that circumferential wall 416 is rotationally fixed, anchor 430 is not as described for anchor 330 and is as described for anchor 230 except that circumferential wall 416 is rotationally fixed. For example, anchor 430 can have an engagement with the interface and an anchor driver as described for anchor 230, as described herein.

[0350] Figures 15A - C and 16A - D are schematic diagrams of system 500 according to several implementation forms. System 500 includes an implant 522 and a delivery tool 540 for percutaneous (e.g., transfemoral, transluminal, etc.) implantation of the implant. System 500 can be as described for system 200 with necessary modifications, unless otherwise stated. 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 with it are generally similar to those of system 200. For example, system 500 allows applying tension to the tether 26 after anchoring each anchor and fixing that tension, for example, by locking the head of the anchor to the tether, such as by a locking portion of the head. Only a single anchor 530 is shown, but system 500 can include multiple anchors 530, for example, with necessary modifications, as described for systems 200, 300, and 400. In the illustrated embodiment, the tether of implant 222 is tether 26 (described above herein), but implant 522 can alternatively or additionally include another tether with necessary modifications.

[0351] Figure 15A shows a tether 26 separate from the anchor 530 of implant 522, but the implant can include an anchor 530 already connected to the tether with necessary modifications, as described, for example, in International Patent Application No. PCT / IB2021 / 058665 by Halabi et al. published as WO2022 / 064401 and / or International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al. In some implementation forms, implant 522 can include one or more of the anchors 530 that are separated from tether 26 and configured to be connected to the tether.

[0352] Figure 15B shows a cross-section of the anchor 530, and Figure 15C shows an exploded perspective view of the anchor. The anchor 530 can include a tissue engagement element 34 and a head 532 coupled to the tissue engagement element (e.g., the proximal end of the tissue engagement element). In the illustrated embodiment, the tissue engagement element of the anchor 530 is the tissue engagement element 34 (described above), but the anchor 530 can alternatively or additionally include another tissue engagement element with the necessary modifications.

[0353] The head 532 is slidably coupled to the tether 26 or is configured to be slidably coupled. For example, as shown, the head 532 (e.g., the casing of the head) can include or define a circumferential wall 516 that surrounds (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 a tether that extends transversely through the head via the holes 518 (Figures 16A - D).

[0354] The delivery tool 540 is configured to advance the anchor 530 (and thereby, generally typically the implant 522) transapically to the target heart. The delivery tool 540 can include a driver 542. The delivery tool 540 can also include a flexible tube (e.g., a catheter) 550 that is transapically advanceable relative to the heart and through which the driver 542 can extend. For each anchor 530, the delivery tool 540 can be configured to (i) have a section of the tether 26 extend from the preceding anchor among the anchors to the anchor (i.e., the last anchor to be anchored), then adjust the tension on the section of the tether, and then fix the tension by locking the locking portion 510 of the anchor.

[0355] In some implementations, the implant 522 can be provided with a leading anchor, with the necessary modifications, for example, similar to those of other systems described herein. In some implementations, the 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 the anchor 530 described below. In some implementations, a separate driver (e.g., a separate delivery tool) can be provided for the leading anchor.

[0356] The locking property of the anchor 530 is provided by a set screw 513 that is attached (e.g., within the casing of the head 532 that can have complementary internal threads) such that rotation of the set screw moves the press surface 511 (e.g., defined by the set screw) towards the opposing surface 566. In the illustrated embodiment, the opposing surface 566 is internal to the head 532 and can be defined by the base plate of the head, as shown. The tether 26 extends through the head 532, but the tether extends between the press surface 511 and the opposing surface 566 such that movement of the press surface towards the opposing surface clamps the tether therebetween, thereby locking the anchor 530 to the tether. Therefore, the set screw 513, the press surface 511, and the opposing surface 566 can be considered components of the locking portion 510 of the head 532.

[0357] The locking portion 510 can be locked by the force applied by the driver 542. For example, the driver 542 can apply torque to the set screw 513 (e.g., through engagement with a recess / slot of the set screw, e.g., through its inner surface). Similarly, the driver 542 can apply reverse torque to release the locking of the locking portion 510. In the illustrated embodiment, the torque is applied by the control rod 548 of the driver 542. For example, while the driver 542 is engaged with the anchor 530, the keying portion (e.g., protrusion) 549 of the control rod 548 can extend into the recess of the set screw 513 such that rotation of the control rod applies torque to the set screw.

[0358] In some implementations, such as some implementations where the tissue engagement element 34 is a helical / screw-in tissue engagement element, the tissue engagement element can be rotatable independently of the circumferential wall 516. Thereby, the tissue engagement element 34 can be screwed into the tissue without wrapping the tether 26 around the anchor while the tether and / or the driver 542 retaining wall 516 remains stationary, for example, while the tissue engagement element rotates. Driving (e.g., screwing) the tissue engagement element 34 into the tissue can be performed by the driver 542. The driver 542 can include a drive head 546 and a shaft (e.g., a drive shaft) 544 that extends from an external portion (e.g., a control handle) to the drive head. The drive head 546 can be reversibly engagable with the driver interface 538 of the head 532 of the anchor 530 and together can be considered to define a torque assembly. FIG. 16A shows the anchor 530 being brought closer to the tissue 10 by the driver 542.

[0359] In some implementations, as shown (e.g., FIGS. 16A - B), the tether 26 extends laterally through the head 532 by (i) passing through the hole 518, (ii) crossing the press surface 511 and / or the opposing surface 566, and / or passing over (e.g., at least a portion around) the interface 538 and / or the drive head 546, and (ii) emerging from another hole 218.

[0360] FIG. 16B shows the state where the anchor 530 (e.g., its tissue engagement element 34) is screwed into the tissue 10 while the tether 26 extends laterally through the head 532 from the previously fixed anchor without wrapping around the head 532, as the circumferential wall 516 (and thereby the hole 518) remains stationary, for example, during the rotation of the tissue engagement element 34. As described above, the torque for this screwing can be provided by the rotation of the shaft 544 while 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 circumferential wall 516, and the set screw 513 itself can be held from rotating relative to the tissue by the tether 26.

[0361] FIG. 16C shows the locking portion 510 where the control rod 548 locks (e.g., relative to the casing of the head 532, e.g., its circumferential wall 516) by rotating the set screw 513, whereby the tether 26 is clamped between the press surface 511 and the opposing surface 566. This locking can be implemented with the necessary modifications, for example, as described above for other systems, after a desired degree of tension is applied to the tether 26. During this locking, the shaft 544 can hold the interface 538 (and thereby the tissue engagement element 34) from rotating relative to the tissue. Thereafter, the driver 542 can be disengaged from and withdrawn from the anchor 530 (FIG. 16D).

[0362] Note that the interface 538 is disposed distally from the locking portion 510 (i.e., closer to the tissue engaging element 34). Also note that the shaft 544 extends distally beyond the locking portion 510 (e.g., the set screw 513) to 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 channel within the set screw) in a manner that does not engage the set screw so as to apply torque to the tissue engaging element 34 without rotating the set screw.

[0363] Next, referring to FIGS. 17A - E and 18, these are schematic diagrams of a system 600 and techniques for use therewith according to some implementations. The system 600 and techniques for its use share features with the other systems described above (e.g., systems 200, 300, 400, and / or 500). Examples of such shared features can be an iterative process of fixing a section of the implant (e.g., the section extending between two anchors) to the tissue, contracting that section, and then doing the same for subsequent sections. However, rather than providing an implant with anchors threaded onto a tether, the system 600 provides a segmented implant that can extend and contract in a telescoping manner.

[0364] System 600 includes an implant 622 and can also include a delivery tool 640 for percutaneous (e.g., transfemoral, transluminal, etc.) implantation of the implant. The implant 622 is a segmented implant that includes a plurality of segments 624 telescopically coupled to each other in series, and each of the segments includes an anchor 630. The delivery tool 640 is configured to deliver the implant 622 percutaneously to the heart, anchor each of the anchors 630 to heart tissue 10 (e.g., the annulus of a valve such as the tricuspid valve 5 as shown), and contract the tissue by telescopically contracting the implant while each of the anchors remains fixed to the tissue. In some implementations, this is done continuously such that a section 626 of the implant (e.g., extending between two anchors 630 and / or overlapping two segments 624) is anchored to the tissue (e.g., by anchoring both of the two anchors where the section extends), then telescopically contracted, and can be locked before the same is done with successive sections of the implant.

[0365] The first segment 624a of the implant 622 is secured to the tissue 10 by anchoring the anchor 630 of the segment to the tissue (FIG. 17A). In some implementations, the anchor 630 is automatically deployed upon exposure from the delivery tool 640. In some implementations, a separate driver (not shown) can be disposed within the implant 622 that extends within the segment 624 (such as within a lumen defined by the segment), and can control the deployment of the anchor 630 independent of exposure from the delivery tool. For example, the driver can first restrain the anchor 630 and operate to release the anchor at a desired time. That is, the anchor 630 can be biased in a direction assuming an anchoring position, but the delivery tool restrains the anchor in a delivery position during delivery of the implant. In some implementations, each anchor 630 can be restrained in a delivery position by an adjacent segment 624 (such as a previously anchored segment, or a segment to be anchored next). For example, the anchor can be restrained in a delivery position by being disposed within an adjacent segment, and the delivery tool can release the anchor by telescopically extending the segment from the segment that is restraining the anchor.

[0366] Subsequently, the second segment 624b extends telescopically from the segment 624a (FIG. 17B), and its anchor 630 is anchored to the tissue (FIG. 17C). Thus, FIGS. 17A - C show a first section 626a of the implant that is fixed along a portion of the path of the tissue 10. The first section 626a includes a portion of the segment 624a and a portion of the segment 624b. Subsequently, a desired degree of contraction is applied to the portion of the path where the first section 626a is fixed by shortening the length of the section 626a (FIG. 17D). As shown, this can be achieved by telescopically contracting the segment 624b into the segment 624a. By locking the segment 624a to the segment 624b (i.e., fixing the amount of telescoping between the segments), this shortened length (and thereby this desired degree of contraction) is fixed. This locking may be performed as a separate action following the length reduction (e.g., by locking of a locking portion), or may be inherent in the manner of reducing the length. For example, one or both of the segments 624a and 624b include a ratchet and / or threads that prevent passive re - increase of the length.

[0367] In some implementations, the contraction of the section 626a of the implant 622 is performed by one component of the delivery tool 640 pulling on the segment 624b while another component of the delivery tool pushes on the segment 624a. In some implementations, the implant 622 comprises a tether that extends along (e.g., through) the implant and is tensioned each time the section 626 is contracted, with the necessary modifications, as described above herein for other implants.

[0368] These steps are repeatedly iterated for each section 626 of the implant using additional segments 624. FIG. 17E shows an implant 622 having six segments (segment 624a, segment 624b, segment 624c, segment 624d, segment 624e, and segment 624f) that define five sections (section 626a, section 626b, section 626c, section 626d, and section 626e). In the illustrated embodiment, section 626a is secured along a portion 10i of tissue 10 (e.g., along a path through the tissue), sections 626b and 626c are secured along a portion 10j of the tissue, section 626d is secured along a portion 10k of the tissue, and section 626e is secured along a portion 10l of the tissue. Portions 10i and 10l 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 10l (e.g., as not contracted at all), and portion 10j is shown as having contracted to a greater degree than portions 10i and 10l. The particular implantation arrangement of implant 622 and the degrees of contraction of the various portions of the tissue are intended to be illustrative examples and should be understood not to be limiting.

[0369] In some implementations, each segment 624 of implant 622 is coupled in an articulatable manner to its adjacent segment, at least during implantation, thereby allowing the implant to be implanted along a curved path, such as around the circumference of a valve ring, as illustrated.

[0370] Please refer to FIGS. 19A - G, which are schematic diagrams of techniques for applying tension to system 700 and implant 722 of the system according to some implementations. Similar to system 20, system 700 is a tissue conditioning system and can be used to condition the dimensions of tissue 10, such as the tissue of a target heart. In some implementations, system 700 is adapted to allow application of tension to the tether of the implant when the implant is fully embedded within the heart, for example, when all anchors of the implant are anchored to the tissue and / or when the tether is trimmed and locked to the implant (FIG. 19A).

[0371] In some implementations, system 700 may be a valve formation system, and implant 22 may be a valve formation structure (e.g., a semi - formed ring or band) for embedding at the heart valve annulus (e.g., along the valve annulus). Implant 722 can include a plurality of anchors 730 and a tether 26 to which the anchors are slidably coupled, for example, by screwing onto the tether.

[0372] Each anchor 730 includes a head 732 and a tissue engagement element 34 that extends distally away from the head. The tissue engagement element 34 defines the anchor axis of the anchor, i.e., the axis along which the anchor advances during anchoring.

[0373] In some implementations where the tissue engagement element 34 is substantially linear (e.g., dart - like), it may be on the anchor axis. In some implementations where the tissue engagement element 34 is helical, the anchor axis can be, for example, the helical axis of the tissue engagement element as shown.

[0374] In some implementations, tether 26 extends through head 732 and through a horizontal channel 748 defined by the head, which is, for example, transverse to the anchor axis. In some embodiments, tether 26 is slidable through channel 748.

[0375] Similar to systems 200 and 300, in some implementations, each head 732 includes a locking portion 770 configured to lock the head to the tether 26 upon its locking.

[0376] In some implementations, the locking portion 770 can include a first locking element 772a and a second locking element 772b, and is 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 various ways. In some implementations, the locking elements can be the same as or similar to one or more of a lever, a ratchet, teeth, a barb, a foot, a pliers, a bead, a crimper, etc.

[0377] In some implementations, the locking portion 770 is biased assuming a locked state in which the locking portion is locked to the tether when the tether is disposed between the locking elements. This biasing can be achieved by biasing the locking elements 772a and 772b to pivot in a manner that reduces the size of the gap therebetween.

[0378] In some implementations, each of the locking elements 772a and 772b has associated springs 774a and 774b, respectively, adapted to bias the locking elements toward the locked state, for example, in the absence of an unlocking force applied to the locking portion.

[0379] In some implementations, each of the locking elements 772a and 772b defines a capture surface 776a and 776b, respectively. In some implementations, the locking elements are biased to pivot in a manner that reduces the size of the gap between the capture surfaces. The capture surfaces may be scored and / or may define a plurality of teeth to facilitate engagement with the tether 26. In some implementations, the locking elements are configured such that, while the locking portion 770 is locked to the tether 26, the locking portion has a ratchet-like property, e.g., to facilitate movement of the tether in only one direction between the locking elements. In some implementations, as shown, the locking portion may even increase its grip on the tether 26 in response to pulling the tether in the other direction (e.g., the direction that would otherwise release the tether from the locking portion). In the illustrated embodiment, this is achieved by the geometry of the locking elements and their respective hinge points 777a and 777b to which they are attached, e.g., the eccentric positioning of the hinge points relative to the position and / or curvature of the capture surfaces.

[0380] In addition to the implant 722, the system 700 can include a tension application tool 740 for applying tension to the implant transcutaneously (e.g., transluminally such as transfemorally). In some implementations, the tool 740 is adapted to advance and engage any anchor 730 of the implant 722 following implantation of the implant into the heart (e.g., when all or at least some of the anchors of the implant are implanted in tissue). Thus, the system 700 advantageously may allow for adjustment (e.g., increase) of the tension of the tether 26 if determined to be desirable following the original locking of the tension of the tether 26.

[0381] In some implementations, the tool 740 comprises a catheter 750 (e.g., a trans-luminal catheter) adapted to engage with the anchor head 732 of the anchor 730 (e.g., as shown in FIG. 19B). The tool 740 can comprise a release device 752 that can comprise a tube. The release device 752 is disposed within the catheter 750 and / or can be advanced through the catheter 750. The release device 752 can be adapted to transition the locking portion 770 to an unlocked state, for example, by applying an unlocking force to the locking portion.

[0382] The tool 740 comprises a gripper 754 (e.g., a hook, a jaw, or a clamp) adapted to increase the tension of the tether 26 by gripping the tether 26 and pulling the tether through the gap between the locking elements 722a and 722b (FIG. 19D). As shown, the gripper 754 can be adapted to advance through the catheter 750 and / or through the release device 752.

[0383] FIGS. 19B-G represent a series of steps that can be performed by an operator to apply tension to the implant 722. FIGS. 19A-G are not intended to precisely define a series of steps of a procedure, but mainly to illustrate the capabilities of the system 700.

[0384] FIG. 19A shows the implant 722 implanted in the heart with the anchor 730 anchored to the tissue 10 (e.g., the annulus of a heart valve). FIG. 19A schematically illustrates the tension on the tether 26 that is insufficient to optimally contract the tissue 10. This insufficiency can occur during or after implantation.

[0385] Following implantation of the implant 722 (e.g., during the same medical procedure or during a subsequent medical procedure), the catheter 750 advances into the heart and engages the anchor head 732 of the implant's anchor 730 (FIG. 19B). The unlocker 752 is then used to move the locking portion 770 towards an unlocked state, for example, by pushing against the locking elements 772a and 772b (e.g., against a lever defined by the locking elements) (FIG. 19C). In some implementations, the unlocker 752 advances to the locking portion 770 through an opening defined by the anchor head 732 that provides access to the locking portion by the unlocker, as shown, for example. In some implementations, the unlocker 752 pivots the locking elements 772a and 772b away from each other to move the locking portion to an unlocked state, and thus, as shown, the size of the gap between them increases. While the locking portion remains in the unlocked state (e.g., while the unlocker 752 remains against the locking portion 770), the gripper 754 advances through the gap between the locking elements and engages the tether 26 within the channel 748, for example, the gripper grips (e.g., catches) the tether (FIG. 19D).

[0386] The gripper 754 is then pulled proximally through the locking portion 770 (e.g., through the gap between the locking elements), and thus can form a loop 28 within the tether (FIG. 19E). As shown in FIG. 19E, this applies tension to the implant 722 and reduces the distance between the anchors 730 (e.g., by the tether pulling the anchors towards each other), causing the heart tissue 10 to contract.

[0387] To lock the tension within the implant, the unlocker 752 can then be retracted (FIG. 19F), whereby, for example, the locking elements 772a and 772b pivot inwardly relative to each other, allowing the locking portion 770 to transition towards the locked state, such as by clamping the tether therebetween. In this state, the tether 26 (e.g., its loop 28) is arranged such that the tether is away from the channel 748, extends through the locking portion 770, and returns to the channel through the locking portion.

[0388] The catheter 750 can then be retracted (FIG. 19G), and the implant 722 remains embedded with tension applied within the tissue 10.

[0389] FIGS. 19A - G show an implant 722 having three anchors, but it should be understood that the implant 722 can have more or fewer anchors. In some implementations, the above-described technique for applying tension to the anchors 730 of the implant 722 is performed as needed, for example, in accordance with intra-procedure imaging. Thus, tension can be applied in this manner to only one or a selected subset of the anchors 730. In some implementations, all of the anchors of the implant can be sequentially tensioned in this manner.

[0390] It should be further noted that the anchors 730 and / or the catheter 750 can be used in combination with other systems and / or implants described in the International Patent Application No. PCT / IB2022 / 051099 by Shafigh et al. filed on February 8, 2022, which is incorporated herein by reference. For example, one or more of the anchors of such implants can be replaced with the anchor 730 to provide the options for post-implant adjustment described herein.

[0391] Next, referring to FIGS. 20A - C, 21, 22A - B, and 23A - E, which are schematic diagrams of devices for use with a tether according to some implementations. FIGS. 20A - C show a cutter 810 for use with a tether according to some implementations. FIGS. 21 and 22A - B show a locking portion 990 for use with a tether according to some implementations. FIGS. 23A - E show a system 1000 including a cutter 810 and a locking portion 990 for use with a tether 26 according to some implementations.

[0392] The locking portion 990 can be a variation of the locking portion 24 described above in this specification or can be used in place thereof. As described with reference to the locking portion 24, the locking portion 990 can lock to a tether of an implant (e.g., any of the tethers 26 of the implants described above in this specification) to maintain the tension of the implant.

[0393] The locking portion 990 includes a tubular wall 992 surrounding a lumen 980 sized to receive a tether (e.g., tether 26) therethrough. A window 994 (e.g., a hole, aperture, or opening) is cut out of the wall and is positioned on the opposite side of the wall from the window, and a tab 996 (having, for example, only a single edge attached to the wall 992) is also cut out of the wall. In some implementations, the tab 996 is biased (e.g., shaped) to deflect across the lumen 980 and project into the window 994 in a manner that locks the locking portion to the tether.

[0394] In some implementations, as shown, the wall 992 defines a plurality of windows 994 cut out of the wall and a plurality of corresponding tabs 996 cut from the wall, each tab facing its respective window and being adapted to deflect into its respective window across the lumen to capture a tether within the locking portion.

[0395] In some implementations, the locking portion 990 is advantageously manufactured by cutting from a single piece of stock tubing (e.g., a nitinol tube) and shaping the tabs 996.

[0396] In some embodiments, the blocking rod 920 is adapted to maintain the locking portion in a released state where the tab is prevented from deflecting into the window across the lumen (FIG. 22A). In some embodiments, in the released state of the locking portion, the rod extends through the lumen along the tether, and thus the tether is shielded from the tab. In some embodiments, pulling the rod out of the locking portion allows the tab to deflect across the lumen and pushes the tether into the window, thereby transitioning the locking portion to the locked state (FIG. 22B).

[0397] Note that the rod 920 can have a circular cross-section, but alternatively can have an elongated (e.g., rectangular) cross-section like a ribbon, or a curved cross-section (e.g., an arc) to facilitate shielding of the tether 26.

[0398] Figs. 20A-20C show the cutting of the implant tether 26 according to some embodiments. In some embodiments, and as described later with reference to FIGS. 23A-D, the cutter 810 can be configured to be used with a locking portion 990, for example, to lock and cut the tether. The cutter 810 includes a cutting element 860 adapted to cut the tether 26. The cutter 810 can include one or more of various cutting elements, such as a blade, knife, scissors, shears, scalpel, edge, sharp edge, cutting edge, etc.

[0399] In some embodiments, the cutter 810 (e.g., its cutting element 860) can define a lumen sized to receive the tether therethrough.

[0400] In some implementations, at the distal end of the cutting element 860, the cutting element defines a pair of facing cutting blades 862 through which the tether 26 can extend therebetween (FIG. 20A). The cutter 810 further includes an overtube 850 that is slidable over and along the cutting element 860 in a manner that biases the cutting blades towards each other and thereby cuts the tether (FIGS. 20B-C).

[0401] In some implementations, the cutting element 860 includes a pair of arms 868, each arm having a proximal portion 864 that extends distally and away from the proximal portion of the other pair of arms, and a distal portion 866 that extends distally from the proximal portion and towards the distal portion of the other pair of arms. In the illustrated embodiment, each arm 868 has an individual 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 individual elbows (e.g., they may describe a continuous curve from the proximal portion to the distal portion).

[0402] The cutting blades 862 can be coupled to or defined by, for example, the distal portions 866 of the arms as shown in FIGS. 20A-C. In some implementations, at rest, the proximal portions 864 extend outwardly such that the arms collectively define a diameter d3 that is wider than the inner diameter of the overtube 850, and when the overtube is slid distally over and along the proximal portions 864, the proximal portions are compressed together, the arms pivot inwards relative to each other, and the cutting blades 862 cut the tether 26 (FIGS. 20B-C). In some implementations, as shown in FIG. 20A, at rest, the angle at which the proximal portions 864 are disposed relative to the central axis of the cutter is shallower than the angle at which the distal portions 866 are disposed relative to the central axis. In some implementations, as illustrated, the proximal portions 864 are longer than the distal portions 866.

[0403] In some implementations, the cutting element 860 is advantageously manufactured only by cutting from a single piece of stock tubing (e.g., a Nitinol tube) and shaping the arms and cutting edges. Similarly, the overtube 850 can be a simple tube. That is, in some implementations, the cutter 810 can consist essentially of two concentric tubes, the inner of which is cut and shaped to define the arms and / or cutting edges. In some implementations, this advantageously allows the cutter 810 to be small enough for transvascular delivery to the heart (e.g., having a diameter small enough to fit through other components of the delivery system). For example, the adjustment tool 60 is shown / described as advancing toward the implant after the tube 50 has been withdrawn from the subject, but the cutter 810 can be advanced through a tube such as the tube 50. In some implementations, this can allow for the subsequent introduction of more anchors. For example, this can facilitate the implantation of multiple implants (e.g., the techniques described with reference to FIGS. 3 and 4) without requiring removal of the tube 50. In another example, the cutter 810 can be used to advance the locking portion 990 after a subset of the anchors have been anchored and before a further subset of the anchors are anchored, using a technique similar to the techniques shown in FIGS. 7A - F. That is, in some implementations and / or for a particular step, the cutter 810 can be used to advance the anchors but not to cut the tether. Such advantages can similarly be provided by making the necessary modifications such that the locking portion 990 is cut from a single piece of stock tubing.

[0404] The cutting element 860 can be advanced over and along the tether 26 (i.e., while the tether 26 extends through the cutting element) to the heart. In some implementations, the cutter 810 advances the cutting element 860 over and along the tether, together with the overtube 850, to the heart without advancing the overtube relative to the cutting element until it is desired to cut the tether.

[0405] Next, reference is made to FIGS. 23A - E, which are schematic views of a system 1000 for locking and cutting the tether 26 of an implant 1022 according to some embodiments. In some implementations, the implant 1022 is a variation of any of the implants described above herein or is substantially identical thereto and includes a plurality of anchors 1030, which may be variations of any of the anchors described above herein. The system 1000 can include a cutter 810 and a locking portion 990 for locking and cutting the tether.

[0406] In some implementations, the cutter 810 is adapted to advance (e.g., press) the locking portion 990 transapically into the implant 1022 implanted in the heart. For example, as shown, the cutter 810 can advance toward 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 locking portion, such that advancing the cutter 810 distally toward the implant 1022 implanted in the heart presses the locking portion 990 distally toward the implant.

[0407] In some embodiments, the locking portion 990 advances into the implant using a blocking rod 920 that extends through the locking portion to maintain the locking portion in a released state (FIG. 23A). In some embodiments, the blocking rod 920 can extend proximally from the locking portion 990 through the cutter 810 (e.g., through the cutting element 860) and outside the subject. In some embodiments, the tether 26 can be tensioned while the tether extends through the locking portion 990 (FIG. 23B), for example, by pulling the tether proximally from outside the subject. The reference force can be provided via the cutter 810 and the locking portion 990 (e.g., by maintaining the state where the locking portion abuts the most proximal anchor 1030).

[0408] Thereafter (e.g., when appropriate tension is applied to the tether 26), the tab 994 deflects into the window 996 across the lumen 980, whereby the blocking rod 920 is withdrawn from the locking portion 990 (e.g., by pulling the rod proximally from outside the subject) to lock the locking portion to the tether 26 (FIG. 23C).

[0409] With the locking portion 990 locked to the tether 26, the tether can then be cut, for example, by sliding the overtube 850 distally over the cutting element 860, thereby moving the cutting blades 862 towards each other to cut the tether (FIG. 23D).

[0410] Next, the cutter 810 is withdrawn from the subject, and the implant 1022 can remain implanted in the heart while the locking portion 990 maintains the tension of the tether 26 (FIG. 23E).

[0411] Next, referring to FIGS. 24A - B, 25, and 26A - B, these figures show various locking portions 1100, 1100a, and 1200 adapted to be clamped to the implant's tether according to several implementation forms. The locking portions 1100, 1100a, and / or 1120 may be, for example, a variation of any of the locking portions described herein, instead of or in place of the above - mentioned locking portions 24 and / or 990. For example, as referred to with respect to the locking portion 24, the locking portions 1100, 1100a, and / or 1120 can be locked onto the implant's tether (e.g., any of the tethers 26 of the implant described hereinabove) to maintain the tension of the implant. Alternatively or additionally, the locking portions 1100, 1100a, and / or 1120 can be used in a surgical procedure, for example, as a suture locking portion used instead of a knot.

[0412] Each of the locking portions 1100, 1100a, and 1200 includes an outer tube and an inner tube coaxially disposed within the outer tube.

[0413] In each of FIGS. 24A, 24B, 26A, and 26B, the central image is a perspective view of each locking portion on the tether 26, the upper image shows the same figure but with the outer tube of the locking portion made transparent to show the inner tube of the locking portion, and the lower image is a longitudinal section taken along A - A. For simplicity, FIG. 25 shows only the cross - section of the locking portion 1100a.

[0414] FIGS. 24A - B schematically illustrate the locking portion 1100 according to several implementation forms. The locking portion 1100 includes an outer tube 1110 and an inner tube 1120 positioned coaxially within the outer tube. The tether 26 extends through the locking portion 1100 via the lumen 1122 defined by the inner tube 1120.

[0415] FIG. 24A shows the locking portion 1100 in the unlocked state, where the tether 26 is slidable through the locking portion (i.e., through its lumen 1122), and FIG. 24B shows the locking portion in the locked state where the locking portion is locked to the tether.

[0416] The inner tube 1120 is fixed to the outer tube 1110 at the attachment point 1112, for example, via welding. In some implementations, as shown, the attachment point 1112 is disposed at the first end 1115 of the locking portion 1100. For example, the base of the inner tube is fixed to the base of the outer tube.

[0417] In some implementations, and as illustrated by the transition between FIGS. 24A and 24B, when the inner tube is further pushed into the outer tube towards the attachment point 1112, a portion of the inner tube (e.g., the central section of the inner tube) bends inwardly (e.g., buckles), thereby clamping onto the tether 26 within the lumen 1122, thereby locking the locking portion to the tether. That is, the inner tube 1120 is axially compressible towards the attachment point 1112 in such a manner that, for example, the diameter of the inner tube is reduced and thus pressed against the tether, thereby clamping the inner tube to the tether 26. This can be achieved by pressing against an end of the inner tube 1120, for example, the end of the inner tube located at the second end 1116 of the locking portion 1100. For example, as shown, in the unlocked state of the locking portion 1100, at the second end 1116, the inner tube 1120 may protrude from the outer tube 1110 (FIG. 24A), and transitioning the locking portion to its locked state is achieved by pushing the end of the inner tube towards the attachment point, thereby reducing (e.g., removing) the amount by which the inner tube protrudes from the outer tube (FIG. 24B). In some implementations, when the inner tube is clamped to the tether 26, the tether 26 is no longer slidable within the locking portion 1100, and thus the locking portion is locked to the tether (e.g., thereby maintaining the tension of the tether).

[0418] In some implementations, to maintain the locking portion 1100 in its locked state (e.g., to prevent axial decompression of the inner tube), the locking portion may define a snap - fit mechanism between the outer tube 1110 and the inner tube 1120 such that when the inner tube is pushed into the outer tube by a predetermined amount, the inner tube snap - fits to the outer tube.

[0419] The snap - fit mechanism can be provided by an inner tube 1120 that defines a first snap - fit component and an outer tube 1110 that defines a second snap - fit component that is complementary to the first snap - fit component. In the illustrated embodiment, 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 by a predetermined amount, the tongue 1114 aligns (e.g., axially aligns) with the window 1124, and in response to this alignment, it automatically protrudes (e.g., snaps) into the window (FIG. 24B). Due to the geometric shape and / or angular arrangement of the tongue 1114 and the window 1124, axial decompression of the inner tube is inhibited.

[0420] In some implementations, as shown, the bending (e.g., buckling) of the inner tube 1120 can result in the inner tube obtaining an overall hourglass shape having a constriction that clamps to the tether (FIG. 24B). In some embodiments, the inner tube 1120 defines, longitudinally, a plurality of struts 1126 that extend, for example, between the ends of the inner tube. Each of the struts 1126 may itself be hourglass - shaped, having, for example, a first spherical portion 1127, a second spherical portion 1129, and a constriction 1128 therebetween. In some implementations, the bending (e.g., buckling) of the inner tube 1120 moves the spherical portion 1127 towards the spherical portion 1129, bending the struts inwards, such that the constrictions 1128 are collectively clamped 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 may be annular, for example, defining a complete ring.

[0421] FIG. 25 illustrates a locking portion 1100a according to some implementations. The locking portion 1100a can be regarded as a variation of the locking portion 1100 described for the locking portion 1100, except that its strut 1126a is preset to bend inward to some extent even in the unlocked state of the locking portion. Therefore, the inner tube 1120a of the locking portion can have an hourglass shape in both the unlocked state and the locked state of the locking portion. In some implementations, when the inner tube 1120a is axially compressed, the constricted portions of the struts 1126a bend further inward, contact the tether 26, and are clamped to the tether 26. This preset hourglass shape of the inner tube 1120 can advantageously reduce the force and / or movement required to clamp the inner tube onto the tether as compared to the locking portion 1100. Alternatively or additionally, this preset hourglass shape can advantageously maintain the tether 26 centered within the lumen 1122a of the locking portion, and thereby maintain it in an appropriate position to be clamped by the struts 1126a.

[0422] FIGS. 26A - B schematically illustrate a locking portion 1200 according to some implementations. The locking portion 1200 can be similar to the locking portion 1100, except that instead of pushing the inner tube towards the attachment point to clamp the inner tube to the tether, the inner tube can be twisted inward towards the attachment point so as to "strangle" the tether within the lumen, thereby clamping the tether.

[0423] The locking portion 1200 includes an outer tube 1210 fixed (e.g., welded) to the inner tube 1220 at an attachment point 1212. The inner tube 1220 has a lumen 1222 and is shaped to define a helix 1240 around the lumen. The helix 1240 has a series of turns and a pitch p1. The helix 1240 can be a single helix or a double helix. The locking portion 1200 is locked to the tether 26 such that by applying torque to the inner tube 1220 (e.g., while providing a reference force to the outer tube 1210), the helix 1240 twists inward to clamp onto the tether within the lumen 1222.

[0424] Torque can be applied to the interface end 1228 of the inner tube 1220, for example, the end facing the attachment point 1212. The interface end 1228 may protrude from the outer tube 1210, for example, as shown. The interface end 1228 (e.g., its outer surface) may be keyed and / or have a notch therein for a tool to apply torque. The outer tube 1210 may similarly be keyed and / or have a notch therein for a tool to apply a reference force thereto.

[0425] It should be noted that the three-dimensional structural change of the helix 1240 caused by the application of torque includes a decrease in pitch p1, thereby including shortening of the tube 1220 (i.e., axial compression).

[0426] In some implementations, similar to what was described above with reference to the locking portion 1100, the locking portion 1200 includes a snap-fit mechanism used to maintain the locking portion 1200 locked to the tether 26 (e.g., to prevent axial decompression of the inner tube 1220 and / or torsion of the helix 1240). In some implementations, rotation of the inner tube 1220 relative to the outer tube 1210 causes rotation of the snap-fit component of the inner tube (e.g., the window 1224) relative to the snap-fit component of the outer tube (e.g., the tongue 1214), and the snap-fit components are aligned and thus automatically snap-fit together. This alignment may include, for example, rotational alignment and / or axial alignment as shown. Thus, with a predetermined amount of axial compression (and / or torsion) of the inner tube, the tongue 1214 moves into rotational and / or axial alignment with the window 1224 and thus automatically protrudes into the window.

[0427] Referring again to FIGS. 24A - 26B. In some implementations, any of the locking portions 1100, 1100a, and / or 1200 can be advanced transapically into the heart by sliding the locking portion on and along the tether 26 while the locking portion is in its unlocked state. Using the rod of the delivery assembly, the locking portion can be pushed distally (e.g., within the catheter of the delivery assembly) on and along the tether towards the heart. Once the locking portion is positioned in the heart and / or once appropriate tension is applied to the tether (e.g., as described with reference to other figures herein), the locking portion is locked to the tether by axially compressing the inner tube towards the attachment point such that the inner tube clamps to the tether within the lumen (e.g., by axially pushing and / or twisting the inner tube). The locking force and / or reference force may be provided, for example, by the delivery assembly (e.g., by its rod) used to push the locking portion towards the heart, such as by pushing distally and / or twisting with respect to the inner tube. As described above, the inner tube may be compressed towards the attachment point until the inner tube snap - fits onto the outer tube, thereby preventing axial decompression of the inner tube.

[0428] In some implementations, any of the locking portions 1100, 1100a, and / or 1200 can have multiple stable (e.g., locked) states, for example, allowing various degrees of clamping of the tether 26. In some implementations, this is provided by a plurality of snap - fit mechanisms arranged in a ratchet - like configuration, for example, by the inner tube defining a plurality of windows along its length, such that when a tongue on the outer tube protrudes into a first window of the mechanism, further axially compressing the inner tube within the outer tube causes the tongue to protrude into a second window that is closer to the attachment point than the first window.

[0429] For example, with regard to manufacturing and / or reliability, it can be particularly advantageous that the locking portions 1100, 1100a, and / or 1200 can be formed (e.g., cut) simply from two stock tubes that are fixed to each other at an attachment point (e.g., one end). In some implementations, the stock tubes can have a wall thickness of at least 75 microns (e.g., at least 100 microns) and / or 600 microns or less (e.g., 400 microns or less), such as 75 - 600 microns (e.g., 100 - 400 microns, such as 75 - 400 microns).

[0430] In some embodiments, the outer tube of the locking portion (e.g., the stock tube from which it is cut) can have an outer diameter of at least 1500 microns (e.g., at least 2000 microns) and / or 6000 microns or less (e.g., 4000 microns or less). For example, the outer diameter of the outer tube can be 1500 - 6000 microns (e.g., 2000 - 4000 microns, such as 1500 - 4000 microns).

[0431] In some implementations, the outer tube of the locking portion can have an inner diameter of at least 1350 microns (e.g., at least 1800 microns) and / or 4800 microns or less (e.g., 3200 microns or less). For example, the inner diameter of the outer tube can be 1350 - 4800 microns (e.g., 1800 - 3200 microns, such as 1350 - 3200 microns).

[0432] In some embodiments, the inner tube of the locking portion (e.g., the stock tube from which it is cut) can have an outer diameter of at least 1350 microns (e.g., at least 1800 microns) and / or 4800 microns or less (e.g., 3200 microns or less). For example, the outer diameter of the inner tube can be 1350 - 4800 microns (e.g., 1800 - 3200 microns, such as 1350 - 3200 microns).

[0433] In some embodiments, the inner tube has an inner diameter of at least 1000 microns (e.g., at least 1600 microns) and / or 3800 microns or less (e.g., 2500 microns or less). For example, the inner diameter of the inner tube may be 1000 to 3800 microns (e.g., 1600 to 2500 microns, such as 1000 to 2500 microns).

[0434] In some embodiments, the ratio of the length (L) of the locking portion to the outer diameter (OD) of the locking portion (i.e., the L:OD ratio) may be 1.6:1 to 2.2:1. In some embodiments, the ratio of OD to the thickness (T) of the stock tube from which the outer tube is cut (i.e., the OD:T ratio) may be 10:1 to 20:1.

[0435] In some embodiments, the outer tube of the locking portion has a length of at least 1000 microns (e.g., at least 3000 microns) and / or 10000 microns or less (e.g., 7500 microns or less). For example, the length of the outer tube may be 1000 to 10000 microns (e.g., 3000 to 7500 microns, such as 1000 to 7500 microns). In some embodiments, the inner tube of the locking portion has a length of at least 1000 microns (e.g., at least 3000 microns) and / or 10000 microns or less (e.g., 7500 microns or less). For example, the length of the inner tube may be 1000 to 10000 microns (e.g., 3000 to 7500 microns, such as 1000 to 7500 microns).

[0436] In some implementations, the outer tube of the locking portion (e.g., the stock tube from which it is cut) includes (e.g., is formed from) a metal such as stainless steel, cobalt chrome, titanium, and / or nitinol. In some implementations, the inner tube of the locking portion (e.g., the stock tube from which it is cut) includes (e.g., is formed from) a metal such as stainless steel, cobalt chrome, titanium, and / or nitinol. In some implementations, the outer tube of the locking portion includes (e.g., is formed from, etc.) a polymer. In some implementations, the inner tube of the locking portion includes (e.g., is formed from, etc.) a polymer. In some implementations, the material of the inner tube is the same as the material of the outer tube. In some implementations, the material of the inner tube is different from the material of the outer tube.

[0437] Exemplary implementations (some non-limiting examples of the concepts herein are listed below).

[0438] Example 1. A system and / or device for use in a target heart, the system / device comprising an implant, the implant comprising a tether, and / or a series of anchors, each of the anchors comprising a tissue engagement element, and / or a head coupled to the tissue engagement element and slidably coupled to the tether, the head comprising a locking portion configured to lock the head to the tether upon locking thereof.

[0439] Example 2. The system / device according to Example 1, further comprising a stopper lockable to the tether, the stopper defining (i) a tubular wall surrounding a lumen dimensioned to receive the tether therethrough, (ii) a window cut out of the wall, and / or (iii) a tab cut from the wall, positioned on the opposite side of the window, biased to project into the window in a manner that locks the locking portion to the tether received through the lumen.

[0440] Example 3. The system / apparatus according to Example 1, further comprising a stopper lockable to the tether, the stopper comprising (A) an outer tube and / or (B) an inner tube, the inner tube being (i) coaxially positioned within the outer tube, (ii) fixed to the outer tube at the attachment point, (iii) shaped to define a lumen along the longitudinal axis of the locking portion, the lumen being dimensioned to receive the tether therethrough, and / or (iv) axially compressible toward the attachment point in a manner that clamps the inner tube to the tether within the lumen.

[0441] Example 4. The system / apparatus according to Example 1, further comprising a tension tool, the tension tool comprising a gripper, configured to adjust the tension on the tether by advancing to any one of a series of anchors, gripping the tether at the anchor, and forming a loop in the tether by pulling the tether through the locking portion, the locking portion being configured to lock the head to the loop upon its locking.

[0442] Example 5. The system / apparatus according to Example 4, wherein the gripper is configured to advance through the locking portion and grip the tether.

[0443] Example 6. The system / apparatus according to Example 4, wherein (i) the tension tool comprises a tube and the gripper is configured to extend through the tube, (ii) the gripper is configured to pull the loop into the tube, and / or (iii) the tension tool is configured to release the loop when the locking portion locks the head to the loop.

[0444] Example 7. For each of the anchors, the system / apparatus according to Example 6, wherein (i) the tube is configured to unlock the locking portion by applying an unlocking force to the locking portion, and / or (ii) the locking portion is biased to lock in the absence of an unlocking force.

[0445] Example 8. (i) For each of the anchors, the locking portion includes a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to the head, and / or (ii) the tube is configured to unlock the locking portion by pressing against the locking arms in a manner that pivots each of the locking arms away from each other, a system / apparatus according to Example 7.

[0446] Example 9. A system / apparatus according to Example 7, wherein the locking portion is configured to lock onto the loop upon withdrawal of the tube from the head such that the locking arms pivot towards each other.

[0447] Example 10. A system / apparatus according to Example 1, wherein the implant further comprises a guide anchor fixed to the distal end of the tether.

[0448] Example 11. For each of the anchors, the tissue engagement element is helical and defines the longitudinal axis of the anchor and is configured to be screwed into the heart tissue by rotation of the tissue engagement element about the central longitudinal axis, a system / apparatus according to any one of Examples 1 to 10.

[0449] Example 12. A system / apparatus according to Example 11, wherein for each of the anchors, the head is configured to facilitate screwing of the tissue engagement element into the tissue while remaining slidably coupled to the tether.

[0450] Example 13. For each of the anchors, (i) the head comprises a circumferential wall surrounding the central longitudinal axis and / or (ii) the head is slidably coupled to the tether by a tether extending transversely through the head via a hole defined within the circumferential wall, a system / apparatus according to Example 11.

[0451] Example 14. A system / apparatus according to Example 13, wherein for each of the anchors, the tissue engagement element is rotatable independently of the circumferential wall.

[0452] Example 15. For each of the anchors, the system / apparatus according to Example 13, wherein the tissue engagement element is rotatably locked to the circumferential wall.

[0453] Example 16. For each of the anchors, the system / apparatus according to Example 13, wherein the locking portion is disposed inside from the circumferential wall.

[0454] Example 17. For each of the anchors, the system / apparatus according to any one of Examples 1 to 16, wherein the locking portion defines a pressing surface and is configured to lock the head to the tether by pressing the pressing surface against the tether.

[0455] Example 18. For each of the anchors, the system / apparatus according to Example 17, wherein the locking portion includes a pressing plate that defines the pressing surface.

[0456] Example 19. For each of the anchors, the system / apparatus according to Example 17, wherein the locking portion includes a spring configured to lock the head to the tether by pressing the pressing surface against the tether.

[0457] Example 20. For each of the anchors, the system / apparatus according to Example 19, wherein the spring is configured to press the pressing surface against the tether by axially moving the pressing surface relative to the tissue engagement element.

[0458] Example 21. For each of the anchors, (A) the head includes a casing and a push button, and / or (B) the locking portion is configured such that (i) the spring axially moves the pressing surface relative to the tissue engagement element to project the push button laterally from the casing and / or (ii) pressing the push button axially moves the pressing surface relative to the casing to unlock the locking portion inward.

[0459] Example 22. For each of the anchors, the pressing surface is defined by a piston disposed within the casing, the piston further defines a first bearing surface, the push button defines a second bearing surface inclined with respect to the first bearing surface, whereby, by pressing the push button, the second bearing surface is slid on the first bearing surface to axially move the pressing surface inward with respect to the casing, a system / apparatus according to Example 21.

[0460] Example 23. For each of the anchors, a system / apparatus according to Example 22, wherein the first bearing surface is inclined with respect to the central longitudinal axis of the anchor.

[0461] Example 24. For each of the anchors, a system / apparatus according to Example 22, wherein the second bearing surface is inclined with respect to the central longitudinal axis of the anchor.

[0462] Example 25. For each of the anchors, a system / apparatus according to Example 22, wherein the push button is attached to a wedge defining the second bearing surface.

[0463] Example 26. For each of the anchors, a system / apparatus according to Example 20, wherein a spring is configured to press the pressing surface against the tether by moving the pressing surface axially away from the tissue engagement element.

[0464] Example 27. For each of the anchors, (i) the head defines a circumferential wall surrounding the central longitudinal axis of the anchor, (ii) the head is slidably coupled to the tether by a tether extending transversely through the head via a hole defined within the circumferential wall, (iii) at least the pressing surface of the engagement portion is disposed inwardly from the circumferential wall, and / or (iv) a spring is configured to press the pressing surface against the tether by moving the pressing surface across the hole, a system / apparatus according to Example 20.

[0465] Example 28. For each of the anchors, a system / apparatus according to Example 27, wherein the tissue engagement element is rotatable independently of the circumferential wall.

[0466] Example 29. For each of the anchors, a system / apparatus according to Example 27, wherein the tissue engagement element is rotatably locked to the circumferential wall.

[0467] Example 30. For each of the anchors, (A) the head includes a casing including a proximal portion and a base portion axially separated in an intermediate section where the circumferential wall is disposed, (B) the head is coupled to the tissue engagement element via the base portion, and / or (C) the proximal portion, the base portion, and the tissue engagement element are (i) rotationally and axially locked to each other and / or (ii) rotatably coupled to the circumferential wall, a system / apparatus according to Example 27.

[0468] Example 31. A system / apparatus according to Example 30, wherein the locking portion and the circumferential wall axially traverse the intermediate section.

[0469] Example 32. Further comprising a delivery tool configured to advance the anchor trans-luminally to the heart, the delivery tool comprising a flexible tube that is trans-luminally advanceable relative to the heart, and / or a driver sized to extend through the flexible tube, the delivery tool being configured, for each of the anchors, in order to anchor the anchor to the heart tissue such that a section of the tether extends from a preceding anchor of the anchors to the anchor, then adjust the tension on the section of the tether, and / or then lock the locking portion, a system / apparatus according to any one of Examples 1 to 31.

[0470] Example 33. For each anchor, (i) the locking portion is biased to lock, (ii) the head includes a casing, and the push button is operably coupled to the locking portion such that while the locking portion is unlocked, the push button protrudes laterally from the casing, and / or (iii) the delivery tool is configured to maintain the unlocking of the locking portion by restraining the push button inwardly, a system / apparatus according to Example 32.

[0471] Example 34. For each anchor, the delivery tool is configured such that (i) a flexible tube restrains the push button inwardly to maintain the locking portion in an unlocked state, and / or (ii) the head is deployed from the flexible tube to lock the locking portion, a system / apparatus according to Example 33.

[0472] Example 35. The casing 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 via rotation of the flexible tube, a system / apparatus according to Example 33.

[0473] Example 36. For each anchor, the push button is disposed on the anchor key, a system / apparatus according to Example 35.

[0474] Example 37. For each anchor, the anchor key includes a sunk key, the push button is disposed on the sunk key, and the delivery tool is configured such that the drive key restrains the push button inwardly to maintain the locking portion in an unlocked state, a system / apparatus according to Example 36.

[0475] Example 38. For each anchor, the locking portion is biased to lock, and the delivery tool is configured to restrain the anchor in an unlocked state while adjusting the tension on a section of the tether, a system / apparatus according to Example 32.

[0476] Example 39. A system / apparatus according to Example 38, wherein for each anchor, the delivery tool is configured to restrain the anchor in an unlocked state while advancing the anchor trans-luminally into the heart.

[0477] Example 40. A system / apparatus according to Example 38, wherein for each anchor, the delivery tool is configured to restrain the anchor in an unlocked state while anchoring the anchor to tissue.

[0478] Example 41. A system / apparatus according to Example 32, wherein for each anchor, the delivery tool is configured to advance the anchor trans-luminally into the heart following anchoring of a leading one of the anchors to tissue.

[0479] Example 42. A system / apparatus according to Example 41, wherein for each anchor, the delivery tool is configured to advance the anchor trans-luminally into the heart following locking of a locking portion of a leading one of the anchors.

[0480] Example 43. A system for use in tissue of a subject's heart, the system comprising an implant comprising an elongate member, a plurality of anchors, and / or an implant comprising a plurality of locking portions, and / or a delivery tool, wherein the delivery tool is configured to implant the implant in the tissue by anchoring a first section of the elongate member along a first portion of the path using one or more of the anchors, and / or subsequently anchoring a second section of the elongate member along a second portion of the path using one or more of the anchors, thereby Following anchoring the first section and prior to anchoring the second section, contracting a first portion of the path by reducing the length of the first section, While the first portion of the path remains contracted, fixing the length of the first section using at least a first locking portion of the plurality of locking portions, Following anchoring the second section and while the length of the first section remains fixed, contracting a second portion of the path by reducing the length of the second section, and / or While the second portion of the path remains contracted, fixing the length of the second section using at least a second locking portion of the plurality of locking portions, a system configured to contract.

[0481] Example 44. A system and / or device for use in a target heart, the system / device comprising An implant, A tether, A series of anchors, each anchor comprising A tissue engagement element, and / or A head coupled to the tissue engagement element and slidably coupled to the tether, the implant, A plurality of tension adjusters, and / or A delivery tool, the delivery tool comprising A tube that is advanceable trans-luminally relative to the heart, An anchor driver configured to advance the anchors through the tube and, for each anchor, anchor the anchor in the heart tissue in sequence within the heart by driving the tissue engagement element into the tissue, and / or An applicator configured to connect a plurality of tension adjusters to the implant within the heart, a system and / or device.

[0482] Example 45. The system / device according to Example 44, wherein the applicator is configured to connect the tension adjusters to a series of adjacent anchors within the heart.

[0483] Example 46. A system / apparatus according to Example 44 or 45, wherein the applicator is configured to connect the tension adjuster to the tether intracardially.

[0484] Example 47. A system / apparatus according to Example 46, wherein the applicator is configured to connect the tension adjuster to the tether intracardially between a series of adjacent anchors.

[0485] Example 48. A system / apparatus according to any one of Examples 44 to 47, wherein each of the tension adjusters is a connector configured to connect each pair of a series of adjacent anchors.

[0486] Example 49. A system / apparatus according to Example 48, wherein each of the tension adjusters is configured to pull the respective pair of anchors towards each other.

[0487] Example 50. A system / apparatus according to Example 48, wherein each of the tension adjusters is configured to prevent the respective pair of anchors from moving away from each other.

[0488] Example 51. A system / apparatus according to any one of Examples 44 to 50, wherein each of the tension adjusters is a spacer configured to be connected to the tether between each pair of a series of anchors.

[0489] Example 52. A system / apparatus according to Example 51, wherein each of the spacers is tubular.

[0490] Example 53. For each of the spacers, the applicator is configured to connect the spacer to the tether intracardially while the spacer is constrained in an open state having a substantially C-shaped cross-section. A system / apparatus according to Example 51.

[0491] Example 54. The tube defines a primary lumen, the anchor driver is configured to advance each of the anchors from the primary lumen, and the applicator is configured to advance each of the spacers from the primary lumen to a secondary lumen disposed laterally therefrom. The system / apparatus according to Example 51.

[0492] Example 55. A method for use in a target heart tissue, the method comprising Advancing an elongate implant along the tissue such that the implant defines a path along the tissue, Anchoring a first section of the implant along a first portion of the path and / or Subsequently, anchoring a second section of the implant along a second portion of the path to implant percutaneously, Following anchoring of the first section and prior to anchoring of the second section, Shrinking a first portion of the path by reducing the length of the first section and / or Fixing the length of the first section while the first portion of the path remains shrunk and / or Following anchoring of the second section and while the length of the first section remains fixed, Shrinking a second portion of the path by reducing the length of the second section and / or Fixing the length of the second section while the second portion of the path remains shrunk. A method comprising.

[0493] Example 56. (i) The implant includes a first segment, a second segment, and / or a third segment telescopically coupled in series with each other, (ii) a first section of the implant includes a portion of the first segment and a portion of the second segment, (iii) a second section of the implant includes a portion of the second segment and a portion of the third segment, (iv) contracting a first portion of the path includes decreasing the length of the first section by telescopically contracting the first segment into the second segment, and / or (v) contracting a second portion of the path includes decreasing the length of the second section by telescopically contracting the second segment into the third segment, the method according to Example 55.

[0494] Example 57. (i) Fixing the length of the first section includes locking the first segment to the second segment, and / or (ii) fixing the length of the second section includes locking the second segment to the third segment, the method according to Example 56.

[0495] Example 58. (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) anchor-fixing the first section of the implant includes anchor-fixing the first anchor and the second anchor to tissue, and / or (iii) anchor-fixing the second section of the implant includes fixing the second anchor and the third anchor to tissue, the method according to Example 56.

[0496] Example 59. (i) The implant includes a tether, (ii) contracting a first portion of the path includes applying tension to the tether to reduce the length of a first section and thereby contracting the first portion of the path, and / or (iii) contracting a second portion of the path includes applying tension to the tether to reduce the length of a second section and thereby contracting the second portion of the path, a method according to any one of Examples 55 - 58.

[0497] Example 60. A method according to Example 59, wherein percutaneously implanting the implant along tissue includes implanting the implant along tissue such that the tether defines a path along the tissue.

[0498] Example 61. (i) Fixing the length of a first section includes engaging a first locking portion to the tether, and / or (ii) fixing the length of a second section includes engaging a second locking portion to the tether, a method according to Example 59.

[0499] Example 62. A method according to Example 61, further comprising percutaneously advancing a first locking portion into the heart and subsequently anchoring a first section of the implant along a first portion of the path.

[0500] Example 63. A method according to Example 62, wherein advancing a first locking portion into the heart includes advancing the first locking portion into the heart before anchoring a second section of the implant along a second portion of the path.

[0501] Example 64. A method according to Example 62, wherein percutaneously advancing a first locking portion into the heart includes sliding the locking portion over and along the tether percutaneously.

[0502] Example 65. The implant includes a first locking anchor and a second locking anchor, each including a tissue engagement element, and / or A head that is attached to the tissue engagement element, slidably coupled to the tether, and / or includes a locking portion. Percutaneously implanting the implant along the tissue includes anchoring the first and second locking anchors to the tissue. The first locking portion is the locking portion of the first locking anchor, and fixing the length of the first section includes locking the locking portion of the first locking anchor to the tether, and / or The second locking portion is the locking portion of the second locking anchor, and fixing the length of the second section includes locking the locking portion of the second locking anchor to the tether, according to Example 61.

[0503] Example 66. The method according to Example 65, further comprising sliding each of the first and second locking anchors percutaneously over and along the tether to the heart.

[0504] Example 67. (i) Percutaneously implanting the implant along the tissue includes anchoring the distal portion of the tether to the tissue by anchoring the tissue to the leading anchor coupled to the tether, and / or (ii) sliding each of the first and second locking anchors percutaneously over and along the tether to the heart, followed by fixing the leading anchor to the tissue to fix the distal portion of the tether to the tissue, and sliding each of the first and second locking anchors percutaneously distally over and along the tether toward the leading anchor, according to the method of Example 66.

[0505] Example 68. The method according to Example 65, wherein fixing the first and second locking anchors to the tissue includes anchoring the first and second locking anchors to the tissue using an anchor driver.

[0506] Example 69. For each of the first and second locking anchors, the method according to Example 68, wherein anchoring the locking anchor to the tissue, with the locking portion biased toward locking, includes anchoring the locking anchor to the tissue while the anchor driver holds the locking portion in a released state.

[0507] Example 70. For each of the first and second locking anchors, the method according to Example 69, wherein locking the locking portion to the tether includes releasing the locking portion so that the locking portion locks in response.

[0508] Example 71. For each of the first and second locking anchors, the method according to Example 69, wherein anchoring the locking anchor to the tissue while the anchor driver holds the locking portion in a released state includes anchoring the locking anchor to the tissue by inhibiting the push button of the head from moving laterally outward from the casing of the head while the anchor driver holds the locking portion in a released state.

[0509] Example 72. For each of the first and second locking anchors, the method according to Example 68, wherein locking the locking portion to the tether includes applying a locking force to the locking portion using the anchor driver.

[0510] Example 73. For each of the first and second locking anchors, the method according to Example 72, wherein the locking force is a rotational locking force and / or applying a locking force to the locking portion includes applying a rotational locking force to the locking portion.

[0511] Example 74. A method for use in tissue of a subject's heart, the method comprising: percutaneously anchoring a first anchor of an implant to a first site of the tissue; thereafter, percutaneously anchoring a second anchor of the implant to a second site of the tissue, wherein a first portion of the tissue is disposed between the first site and the second site. Thereafter, by pulling out the first anchor and the second anchor together, contracting a first part of the tissue, while the first part of the tissue remains contracted, fixing the distance between the first anchor and the second anchor, thereafter, by sliding a third anchor relative to the second anchor, transcutaneously varying the distance between the third anchor and the second anchor of the implant, thereafter, transcutaneously anchoring the third anchor to a third site of the tissue, wherein a second part of the tissue is disposed between the second site and the third site, thereafter, while the distance between the first anchor and the second anchor remains fixed, by pulling out the second anchor and the third anchor together, contracting a second part of the tissue, and / or while the second part of the tissue remains contracted, fixing the distance between the second anchor and the third anchor, a method comprising.

[0512] Example 75. the implant includes a tether, transcutaneously anchoring the second anchor includes transcutaneously anchoring the second anchor while the tether is coupled to the first anchor and slidably coupled to the second anchor, pulling out the first anchor and the second anchor together includes sliding the tether relative to the second anchor, fixing the distance between the first anchor and the second anchor includes inhibiting sliding of the tether relative to the second anchor by latching a first latching portion to the tether, pulling out the second anchor and the third anchor together includes sliding the tether relative to the third anchor, and / or fixing the distance between the second anchor and the third anchor includes latching a second latching portion to the tether, a method according to Example 74.

[0513] Example 76. (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 locking portion to the tether includes inhibiting sliding of the tether in a second direction relative to the second anchor by locking the first locking portion 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 locking portion to the tether, the method according to Example 75.

[0514] Example 77. Locking the third locking portion to the tether includes locking the third locking portion to the tether before pulling the second anchor and the third anchor together, the method according to Example 76.

[0515] Example 78. A method for use in tissue of a subject's heart, the method comprising: percutaneously implanting a first section of an implant along a first portion of 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; subsequently, contracting the first portion of the tissue by reducing the length of the first section; fixing the length of the first section while the first portion of the tissue remains contracted; subsequently, percutaneously implanting a second section of the implant along a second portion of the tissue by fixing a third anchor of the implant to a third site of the tissue; subsequently, contracting a second portion of the path by reducing the length of the second section while the length of the first section remains fixed, and / or fixing the length of the second section while the second portion of the tissue remains contracted.

[0516] Example 79. A method according to Example 78, wherein (i) a second portion of the tissue is disposed between a second site and a third site and / or (ii) embedding a second section of the implant along the second portion of the tissue comprises embedding the second section of the implant along the second portion of the tissue disposed between the second site and the third site.

[0517] Example 80. A method according to Example 78, wherein (i) a second portion of the tissue is disposed between a third site and a fourth site and / or (ii) embedding a second section of the implant along the second portion of the tissue comprises embedding the second section of the implant along the second portion of the tissue by anchoring a third anchor of the implant to a third site of the tissue and / or anchoring a fourth anchor of the implant to a fourth site of the tissue.

[0518] Example 81. A system and / or device for use in a subject's heart, the system / device comprising a segmented implant comprising a plurality of segments telescopically coupled to each other in series, each of the segments including an anchor, and / or a delivery tool, the delivery tool being configured to deliver the implant percutaneously to the heart, fix each of the anchors to the heart tissue, and / or contract the tissue by telescopically contracting the implant while each of the anchors remains anchored to the tissue.

[0519] Example 82. A system / device according to Example 81, wherein the delivery tool is configured to telescopically extend the implant into the heart.

[0520] Example 83. A system / apparatus according to Example 81 or 82, wherein each of the segments is articulately connectable to an adjacent one of the segments.

[0521] Example 84. A method according to any one of Examples 81 to 83, wherein each of the segments further comprises a locking portion configured such that locking of the locking portion fixes the amount of expansion and contraction between the segment and an adjacent one of the segments for each of the segments.

[0522] Example 85. A system / apparatus according to any one of Examples 81 to 84, wherein (A) each of the anchors is biased to assume an anchor fixation position, and / or (B) the delivery tool is configured to (i) deliver the implant transcutaneously to the heart while each of the anchors is constrained in a delivery position, and / or (ii) within the heart, release each of the anchors to allow each of the anchors to move responsive towards the anchor fixation position.

[0523] Example 86. A system / apparatus according to Example 85, wherein the implant has a delivery state for each of the segments in which the anchor is constrained in the delivery position by an adjacent one of the segments.

[0524] Example 87. A system / apparatus according to Example 86, wherein 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.

[0525] Example 88. A system / apparatus according to Example 87, wherein for each of the segments, the delivery tool is configured to release the anchor by extending the segment telescopically from an adjacent one of the segments.

[0526] Example 89. The delivery tool is configured to cause the tissue to contract in a first portion of the path by (A) securing a first section of the implant along a first portion of the path along the tissue by (i) securing an anchor of a first segment of a plurality of segments to a first site on the tissue and / or (ii) securing an anchor of a second segment of the plurality of segments to a second site on the tissue, (B) securing a second section of the implant along a second portion of the path along the tissue by securing an anchor of a third segment of the plurality of segments to a third site on the tissue, wherein the first section includes a part of the first segment and a part of the second segment, and the second section includes a part of the second segment and a part of the third segment, (C) contracting the tissue in the first portion of the path by telescopically contracting the first segment into the second segment, and / or (D) contracting the tissue in the second portion of the path by telescopically contracting the second segment into the third segment, independent of contracting the first segment into the second segment, a system / apparatus according to any one of Examples 81-88.

[0527] Example 90. The delivery tool is configured to lock the first segment to the second segment and then telescopically contract the first segment into the second segment, and lock the second segment to the third segment and then telescopically contract the second segment into the third segment, a system / apparatus according to Example 89.

[0528] Example 91. The delivery tool is configured to contract the tissue in the second portion of the path by contracting the second segment into the third segment and then locking the first segment to the second segment, a system / apparatus according to Example 90.

[0529] Example 92. The system / apparatus according to Example 91, wherein the delivery tool is configured to extend the implant telescopically into the heart by (i) telescopically extending the first segment from the second segment before 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 before anchoring the anchor of the third segment.

[0530] Example 93. A method comprising: (i) implanting an implant along the tissue of a subject's heart by anchoring a series of anchors of the implant to the tissue, wherein the anchors are slidably coupled to a tether of the implant; (ii) thereafter applying tension to the tether; and / or (iii) thereafter adjusting the tension by applying a tension adjuster between a pair of adjacent anchors of the series of anchors.

[0531] Example 94. The method according to Example 93, wherein the tension adjuster includes a spacer, and applying the tension adjuster between a pair of adjacent anchors includes biasing the pair of adjacent anchors away from each other by connecting the spacer to the tether between the pair of adjacent anchors.

[0532] Example 95. The method according to Example 93, wherein the tension adjuster includes a connector, and applying the tension adjuster between a pair of adjacent anchors includes pulling the pair of adjacent anchors towards each other by connecting the connector to the anchors of both of the pair of adjacent anchors.

[0533] Example 96. (i) Identifying a subject in which an implant is implanted along tissue of a heart of the subject, the implant including a series of anchors slidably coupled to a tether, the implant being implanted by anchoring the series of anchors to the tissue, and / or (ii) adjusting the tension of the tether by applying a tension adjuster between a series of adjacent pairs of anchors in response to the identifying.

[0534] Example 97. The method according to Example 96, wherein the tension adjuster includes a spacer, and applying the tension adjuster between a pair of adjacent anchors includes biasing the pair of adjacent anchors away from each other by connecting the spacer to the tether between the pair of adjacent anchors.

[0535] Example 98. The method according to Example 96, wherein the tension adjuster includes a connector, and applying the tension adjuster between a pair of adjacent anchors includes pulling the pair of adjacent anchors toward each other by connecting the connector to both of the pair of adjacent anchors.

[0536] Example 99. A system and / or apparatus for use with a tether, the system / apparatus including a locking portion, the locking portion including (i) a tubular wall surrounding a lumen sized to receive the tether therethrough, (ii) a window cut out of the wall, and / or (iii) a tab cut from the wall, positioned on an opposite side of the window, biased to project into the window in a manner that deflects across the lumen and locks the locking portion to the tether received through the lumen.

[0537] Example 100. The system / apparatus according to Example 99, wherein (i) the window is a first window of a plurality of windows cut out of the wall, (ii) the tab is a first tab of a plurality of tabs cut out of the wall, and / or (iii) each tab of the plurality of tabs is biased to project into a respective window facing that tab in a manner that deflects across the lumen and locks the locking portion to the tether.

[0538] Example 101. A system / apparatus according to Example 99 or 100, further comprising a cutter, the cutter being (i) a cutting element sized to receive a tether therethrough, a distal portion of the cutting element defining a pair of cutting edges facing each other, and / or (ii) an overtube slidable on and along the cutting element in a manner such that the cutting edges move towards each other, thereby cutting the tether.

[0539] Example 102. A system / apparatus according to Example 101, wherein the cutting element is manufactured from a single piece of stock tubing.

[0540] Example 103. A system / apparatus according to Example 101, wherein the cutter is capable of advancing over and along the tether towards the heart while maintaining the overtube stationary relative to the cutting element.

[0541] Example 104. A system / apparatus according to Example 101, wherein the cutter is adapted to advance a locking portion transvascularly over and along the tether towards the heart of a subject.

[0542] Example 105. A system / apparatus according to Example 104, wherein the cutter is adapted to advance the locking portion transvascularly over and along the tether towards the heart by pressing a distal end of the cutter against a proximal end of the locking portion.

[0543] Example 106. A system / apparatus according to Example 101, wherein the cutting element includes a pair of arms, each arm having (i) a proximal portion extending distally away from a proximal portion of the other arm of the pair, and / or (ii) a distal portion extending distally towards a distal portion of the other arm of the pair.

[0544] Example 107. A system / apparatus according to Example 106, wherein each arm defines an individual elbow between the proximal portion and the distal portion.

[0545] Example 108. A system / apparatus according to Example 106, wherein each arm defines a continuous curve from the proximal portion to the distal portion.

[0546] Example 109. A system / apparatus according to Example 106, wherein for each pair of arms, the cutting blade of one of the pair of cutting blades is defined by the distal portion of the arm.

[0547] Example 110. A system / apparatus according to Example 109, wherein the proximal portion extends outwardly such that the pair of arms collectively define a diameter wider than the inner diameter of the overtube, such that sliding the overtube distally over and along the proximal portion compresses the proximal portions together and pivots the arms inwardly towards each other.

[0548] Example 111. A system / apparatus according to Example 110, wherein for each pair of arms, the angle at which the proximal portion is disposed relative to the central axis of the cutter is shallower than the angle at which the distal portion is disposed relative to the central axis.

[0549] Example 112. A system / apparatus according to Example 106, wherein for each arm of the pair, the proximal portion is longer than the distal portion.

[0550] Example 113. A system / apparatus according to any one of Examples 99 - 112, further comprising a blocking rod adapted to maintain the locking portion in the unlocked state where the tab is prevented from deflecting into the window across the lumen.

[0551] Example 114. A system / apparatus according to Example 113, wherein the rod is adapted to extend through the lumen along the tether and / or by pulling the rod out of the locking portion, the locking portion is shifted towards the locked state where the tab deflects into the window across the lumen.

[0552] Example 115. A method for use with a target heart, comprising: (A) using a cutter to push a locking portion over and along a tether toward the heart in a distal trans-luminal manner, wherein the locking portion comprises (i) a tubular wall surrounding a lumen in which the tether extends, (ii) a window cut from the wall, and / or (iii) a tab cut from the wall and positioned on the opposite side of the window; (B) then pulling out a blocking rod from the locking portion such that the tab deflects responsive-ly into the window across the lumen, thereby locking the locking portion to the tether; (C) then cutting the tether by advancing an over-tube over and along the cutter such that the over-tube compresses a pair of cutting edges defined by the cutter toward each other; and / or (D) then pulling out the cutter from the heart.

[0553] Example 116. The method according to Example 115, wherein pushing the locking portion over and along the tether distally comprises pushing the locking portion over and along the tether while a rod extends through the locking portion.

[0554] Example 117. The method according to Example 116, wherein pushing the locking portion over and along the tether distally comprises pushing the locking portion over and along the tether while the rod extends distally from the cutter through the locking portion.

[0555] Example 118. The method according to Example 117, wherein pulling out the rod from the locking portion comprises pulling the rod proximally into the cutter.

[0556] Example 119. A method comprising: (i) implanting an implant along tissue of a target heart by anchoring a series of anchors of the implant to the tissue, wherein the anchors are slidably coupled to a tether of the implant; (ii) then pulling the tether through locking portions of heads of the series of anchors to form a loop of the tether; and / or (iii) then locking the locking portions to the loop.

[0557] Example 120. A method according to Example 119, comprising pulling the tether loop through the locking portion, which includes gripping the tether and pulling the tether into the locking portion.

[0558] Example 121. A method according to Example 119 or 120, comprising locking the locking portion to the loop, which includes withdrawing the unlocking tool from the locking portion such that the locking portion responds and transitions towards the locked state.

[0559] Example 122. A method according to any one of Examples 119 - 121, further comprising unlocking the locking portion before pulling the tether through the locking portion.

[0560] Example 123. A system for use with a tether, comprising an anchor having an anchor head and a tissue engagement element extending distally from the head so as to define an anchor shaft of the anchor, the anchor head defining a channel extending laterally through the head to the anchor shaft and dimensioned to be screwed onto the tether and slidable thereon and along the tether, a locking portion in communication with the channel, and / or an anchor defining a proximal opening providing access to the channel and the locking portion, and / or a tool comprising a gripper configured to advance into the channel through the opening and the locking portion.

[0561] Example 124. A system according to Example 123, wherein the system comprises a tether screwed through the channel, and the gripper is configured to form the tether into a loop by gripping the tether within the channel and pulling the tether proximally through the locking portion.

[0562] Example 125. A system according to Example 124, wherein the locking portion is configured to lock onto the loop in response to withdrawing the tool from the locking portion.

[0563] Example 126. A system according to Example 125, wherein the tool comprises a tube, the gripper is configured to extend through the tube, the gripper is configured to pull a loop into the tube, and / or the earth auger is configured to release the loop when the locking portion locks into the loop.

[0564] Example 127. A system according to Example 126, wherein (i) the tube is configured to unlock the locking portion by applying an unlocking force to the locking portion, and / or (ii) the locking portion is biased to lock in the absence of an unlocking force.

[0565] Example 128. A system according to Example 127, wherein the tube is configured to access the locking portion through an opening.

[0566] Example 129. A system according to Example 127, wherein (i) the locking portion includes a first locking arm and a second locking arm, each of the locking arms being hingedly coupled to an anchor head, and / or (ii) the tube is configured to unlock the locking portion by pressing against the locking arms in a manner that pivots the locking arms away from each other.

[0567] Example 130. A system according to Example 129, wherein the locking portion is configured to lock onto the loop by the locking arms pivoting towards each other in response to pulling the tube out of the anchor head.

[0568] Example 131. A system and / or device for use with a tether, the system / device comprising a locking portion, the locking portion comprising an outer tube, and / or an inner tube, the inner tube being coaxially positioned within the outer tube, fixed to the outer tube at an attachment point, It is shaped to define a lumen along the longitudinal axis of the retention portion, the lumen being sized to receive a tether through its interior, and / or A system and / or device wherein the inner tube is axially compressible toward an attachment point in a manner that clamps the inner tube to a tether within the lumen.

[0569] Example 132. The system / devices according to Example 131, wherein the inner tube is deformable in a manner that curves the inner tube inwardly with respect to the tether by axially compressing the inner tube toward the attachment point.

[0570] Example 133. The system / devices according to Example 131 or 132, wherein the inner tube has a first end and a second end, and / or the inner tube is axially compressible toward the attachment point by moving the second end toward the first end.

[0571] Example 134. The system / devices according to Example 133, wherein the inner tube is annular at each of its first end and second end.

[0572] Example 135. The system / devices according to Example 133, wherein the attachment point is at the first end.

[0573] Example 136. The system / devices according to Example 133, wherein the inner tube is axially compressible toward the attachment point by applying torque to the second end.

[0574] Example 137. The system / devices according to Example 136, wherein the inner tube defines a helix having a series of turns, and / or upon application of torque, the pitch of the helix decreases.

[0575] Example 138. The system / devices according to Example 137, wherein the helix is a double helix.

[0576] Example 139. The system / devices according to Example 133, wherein the inner tube is axially compressible toward the attachment point by pushing the second end toward the first end.

[0577] Example 140. The system / apparatus according to Example 139, wherein the inner cavity is disposed along the longitudinal axis of the locking portion, and / or the inner tube is axially compressible towards the attachment point by pushing one end of the inner tube along the longitudinal axis towards the other end of the inner tube.

[0578] Example 141. (i) The system / apparatus according to Example 133, wherein the locking portion has an unlocked state in which the locking portion is slidable along the tether, and / or (ii) the locking portion is movable towards the locked state by axially compressing the inner tube.

[0579] Example 142. The system / apparatus according to Example 141, wherein the locking portion is movable towards the locked state by moving the second end into the outer tube.

[0580] Example 143. (i) The system / apparatus according to Example 141, wherein in the unlocked state of the locking portion, the second end is disposed outside the outer tube, and / or (ii) in the locked state of the locking portion, the second end is disposed inside the outer tube.

[0581] Example 144. The system / apparatus according to any one of Examples 131 to 143, wherein the locking portion comprises a snap-fit mechanism between the inner tube and the outer tube, and / or the inner tube is axially compressible towards the attachment point until the inner tube snap-fits onto the outer tube, and the snap-fit prevents axial decompression of the inner tube.

[0582] Example 145. The system / apparatus 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 the inner tube is axially compressible towards the attachment point until the tongue extends into the window.

[0583] Example 146. A system / apparatus according to Example 144, wherein the outer tube defines a window and / or the inner tube defines a tongue adapted to extend within the window, and / or the inner tube is axially compressible toward the attachment point until the tongue extends within the window.

[0584] Example 147. A system / apparatus according to any one of Examples 131 - 146, wherein the inner tube is shaped to define an hourglass configuration having a first spherical portion, a second spherical portion, and / or a constriction therebetween, and / or the inner tube is axially compressible toward the attachment point in a manner that clamps the constriction to the tether.

[0585] Example 148. A system / apparatus according to Example 147, wherein the inner tube is axially compressible toward the attachment point by pushing the first spherical portion toward the second spherical portion.

[0586] Example 149. A system / apparatus according to Example 147, wherein each of the first spherical portion and the second spherical portion is annular.

[0587] Example 150. A method for use with a tether, comprising: (i) advancing a locking portion transvascularly over and along the tether to a target heart, the locking portion comprising an inner tube coaxially positioned within an outer tube and fixed to the outer tube at an attachment point, the tether extending through a lumen defined by the inner tube; and / or (ii) thereafter, locking the locking portion 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.

[0588] Example 151. A method according to Example 150, wherein axially compressing the inner tube toward the attachment point such that the inner tube clamps to the tether comprises axially compressing the inner tube toward the attachment point such that the diameter of the inner tube decreases.

[0589] Example 152. A method according to Example 150 or 151, wherein axially compressing the inner tube toward the attachment point includes pushing the inner tube further into the outer tube.

[0590] Example 153. A system / apparatus according to any one of Examples 150 to 152, wherein the inner tube has a first end and a second end, and / or axially compressing the inner tube toward the attachment point includes axially compressing the inner tube by pushing the second end toward the first end.

[0591] Example 154. A method according to Example 153, wherein the attachment point is disposed at the first end.

[0592] Example 155. (i) A method according to Example 153, wherein advancing the locking portion trans-luminally includes advancing the locking portion trans-luminally 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.

[0593] Example 156. A method according to Example 153, wherein the lumen is disposed along the longitudinal axis of the locking portion, and / or axially compressing the inner tube toward the attachment point includes axially compressing the inner tube by pushing one end of the inner tube toward the other end of the inner tube along the long axis direction.

[0594] 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 is snap-fitted to the outer tube, and the snap fit prevents axial decompression of the inner tube.

[0595] Example 158. A method according to Example 157, wherein the locking portion defines a window and a tongue, and / or axially compressing the inner tube toward the attachment point until the inner tube is snap-fitted to the outer tube includes axially compressing the inner tube toward the attachment point until the tongue protrudes into the window.

[0596] Example 159. The method according to Example 158, comprising axially compressing the inner tube towards the attachment point until the tongue protrudes into the window, including axially compressing the inner tube towards the attachment point until the tongue aligns with the window and, in response to aligning with the window, automatically protrudes into the window.

[0597] Example 160. The method according to Example 159, comprising axially compressing the inner tube towards the attachment point until the tongue aligns with the window, including axially compressing the inner tube towards the attachment point so that the tongue moves axially to align with the window.

[0598] Example 161. The method according to Example 159, comprising axially compressing the inner tube towards the attachment point until the tongue aligns with the window, including twisting the inner tube towards the attachment point until the tongue rotates to align with the window and then axially compressing the inner tube towards the attachment point.

[0599] Example 162. The method according to Example 158, wherein the outer tube defines the tongue and / or the inner tube defines the window, and / or comprising axially compressing the inner tube towards the attachment point until the tongue extends into the window, including axially compressing the inner tube towards the attachment point until the tongue of the outer tube extends into the window of the inner tube.

[0600] Example 163. The method according to any one of Examples 150 - 162, comprising axially compressing the inner tube towards the attachment point so that the inner tube is clamped to the tether, including axially compressing the inner tube towards the attachment point so that a part of the inner tube bends inwardly relative to the tether.

[0601] Example 164. The method according to Example 163, comprising axially compressing the inner tube towards the attachment point so that a part of the inner tube bends inwardly relative to the tether, including axially compressing the inner tube towards the attachment point so that the inner tube acquires an hourglass shape with a constriction for clamping to the tether.

[0602] Example 165. A method according to any one of Examples 150 - 164, wherein the inner tube is shaped to define a plurality of struts having a first end portion and a second end portion and 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 inwardly relative to the tether.

[0603] Example 166. A method according to Example 165, wherein each of the struts has an hourglass shape having a first spherical portion, a second spherical portion, and / or a constriction therebetween, and / or wherein compressing the inner tube axially toward the attachment point such that the struts bend inwardly relative to the tether includes compressing the inner tube axially toward the attachment point such that each constriction of the struts is clamped to the tether.

[0604] Example 167. A method according to Example 166, 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 in a manner such that for each of the struts, the first spherical portion moves toward the second spherical portion.

[0605] Example 168. A method according to any one of Examples 150 - 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 relative to the tether.

[0606] Example 169. A method according to Example 168, wherein the inner tube is shaped to define a helix having a series of turns and pitches, and / or wherein compressing the inner tube axially toward the attachment point such that the inner tube twists inwardly relative to the tether includes decreasing the pitch by twisting the inner tube toward the attachment point.

[0607] Example 170. A method according to Example 169, wherein the helix is a double helix and / or reducing the pitch comprises reducing the pitch of the double helix.

[0608] Example 171. A system according to any one of the above examples of the system, wherein the implant is sterilized.

[0609] Example 172. A system / device according to any one of the above examples of the system / device, wherein the implant is sterilized.

[0610] Example 173. A system / device according to any one of the above examples of the system / device, wherein the delivery tool is sterilized.

[0611] The present invention is not limited to the embodiments specifically illustrated and described heretofore. Rather, the scope of the present invention includes both the various combinations and sub-combinations of the features described above, as well as variations and modifications thereof that would occur to those skilled in the art upon reading the above description and that are not in the prior art. Further, techniques, methods, operations, steps, etc. described or suggested in this specification or in references incorporated herein (including in the above examples) can be performed on a living subject (e.g., a human, another animal, etc.) or on a simulation such as a cadaver, a cadaver heart, a simulator, a virtual person, etc. When performed on a simulation, body parts such as a heart, tissue, valve, etc. can be assumed to be simulated or, optionally, can be referred to as "simulated" (e.g., a simulated heart, simulated tissue, simulated valve, etc.) and can include a computerized and / or physical representation of the body part, tissue, etc.

[0612] Any of the various systems, assemblies, devices, components, instruments, etc. (including those in the examples listed above) in the present disclosure can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the methods described herein can include (or additional methods can include or consist of) sterilization of the related systems, devices, components, instruments, etc. (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

Claims

1. An apparatus for use in a target heart, the apparatus comprising an implant, the implant comprising a tether, and a series of anchors, each of the anchors comprising a tissue engagement element, and a head coupled to the tissue engagement element and slidably coupled to the tether, the head comprising a locking portion configured to lock the head to the tether upon locking thereof.

2. Further comprising a stopper lockable to the tether, the stopper comprising a tubular wall surrounding a lumen dimensioned to receive the tether therethrough, a window cut out from the wall, and a tab cut from the wall, positioned on the opposite side of the window, and biased to deflect across the lumen and project into the window in a manner to lock the locking portion to the tether received through the lumen. The apparatus according to claim 1.

3. Further comprising a stopper lockable to the tether, the stopper comprising an outer tube, and an inner tube, the inner tube being positioned coaxially within the outer tube, fixed to the outer tube at a mounting point, formed to define a lumen along the longitudinal axis of the locking portion, the lumen being dimensioned to receive the tether therethrough, and axially compressible towards the mounting point in a manner that the inner tube is clamped to the tether within the lumen. The apparatus according to claim 1 or 2.

4. Further comprising a tension tool, the tension tool comprising a gripper, configured to advance to an anchor of the series of anchors, grip the tether at the anchor, and form a loop in the tether by pulling the tether through the locking portion, thereby adjusting the tension on the tether, the locking portion being configured to lock the head to the loop upon locking thereof. The apparatus according to any one of claims 1 to 3.

5. The apparatus according to claim 4, wherein the gripper is configured to advance through the locking portion to grip the tether.

6. The tension tool comprises a tube, the gripper being configured to extend through the tube, the gripper being configured to pull the loop into the tube. The apparatus according to claim 4, wherein the tension tool is configured to release the loop when the locking portion locks the head to the loop.

7. For each of the anchors, the tube is configured to unlock the locking portion by applying a unlocking force to the locking portion, the apparatus according to claim 6, wherein the locking portion is biased to lock in the absence of the unlocking force.

8. For each of the anchors, the locking portion includes a first locking arm and a second locking arm, and each of the locking arms is hingedly coupled to the head, the apparatus according to claim 7, wherein the tube is configured to unlock the locking portion by pressing against the locking arms in a manner that pivots the locking arms away from each other.

9. The apparatus according to claim 7, wherein the locking portion is configured to lock onto the loop when the tube is withdrawn from the head such that the locking arms pivot towards each other.

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

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

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

13. For each of the anchors, the head includes a circumferential wall surrounding the central longitudinal axis, the apparatus according to claim 11, wherein the head is slidably coupled to the tether by the tether extending transversely through the head via a hole defined within the circumferential wall.

14. The apparatus according to claim 13, wherein for each of the anchors, the tissue engaging element is rotatable independently of the circumferential wall.

15. The apparatus according to claim 13, wherein for each of the anchors, the tissue engaging element is rotatably locked to the circumferential wall.

16. The apparatus according to claim 13, wherein for each of the anchors, the locking portion is disposed inside from the circumferential wall.

17. The apparatus according to any one of claims 1 to 16, wherein for each of the anchors, the locking portion defines a pressing surface, and the head is configured to be locked 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 locking portion includes a pressing plate that defines the pressing surface.

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

20. The apparatus according to claim 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 with respect to the tissue engaging element.

21. For each of the anchors, the head includes a casing and a push button, the locking portion, the spring axially moving the pressing surface with respect to the tissue engaging element projects the push button laterally from the casing, and pressing the push button is configured to unlock the locking portion inwardly by axially moving the pressing surface with respect to the casing. The apparatus according to claim 20.

22. For each of the anchors, the pressing surface is defined by a piston disposed within the casing, the piston further defines a first bearing surface, the push button defines a second bearing surface inclined with respect to the first bearing surface, whereby pressing the push button slides the second bearing surface onto the first bearing surface to axially move the pressing surface inwardly with respect to the casing. The apparatus according to claim 21.

23. The apparatus according to claim 22, wherein for each of the anchors, the first bearing surface is inclined with respect to the central longitudinal axis of the anchor.

24. The apparatus according to claim 22, wherein for each of the anchors, the second bearing surface is inclined with respect to the central longitudinal axis of the anchor.

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

26. The apparatus according to 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. For each of the anchors, the head defines a circumferential wall surrounding the central longitudinal axis of the anchor, the head is slidably coupled to the tether by the tether extending transversely through the head via a hole defined within the circumferential wall, at least the pressing surface of the locking portion is disposed inwardly from the circumferential wall, The apparatus according to claim 20, wherein the spring is configured to press the pressing surface against the tether by moving the pressing surface across the hole.

28. The apparatus according to claim 27, wherein for each of the anchors, the tissue engaging element is rotatable independently of the circumferential wall.

29. The apparatus according to claim 27, wherein for each of the anchors, the tissue engaging element is rotatably locked to the circumferential wall.

30. For each of the anchors, the head comprises a casing, the casing comprising a proximal portion and a base axially separated in an intermediate section where the circumferential wall is disposed, the head is coupled to the tissue engaging element via the base, the proximal portion, the base, and the tissue engaging element are locked to each other in the rotational and axial directions, and rotatably coupled to the circumferential wall. The apparatus according to claim 27.

31. The apparatus according to claim 30, wherein the locking portion and the circumferential wall axially traverse the intermediate section.

32. The apparatus further comprises a delivery tool configured to advance the anchor transapically to the heart, the delivery tool comprising a flexible tube axially advanceable relative to the heart, and a driver sized to extend through the flexible tube. For each of the anchors, in sequence, the delivery tool anchors the anchor to the heart tissue such that the section of the tether extends from a preceding anchor among the anchors to the anchor then adjusts the tension on the section of the tether then locks the locking portion, the device according to any one of claims 1 to 31, which is configured to **Claim 33** For each of the anchors the locking portion is biased to lock the head includes a casing and a push button, and the push button is operably coupled to the locking portion such that the push button protrudes laterally from the casing while the locking portion is unlocked the delivery tool is configured to maintain the locking portion in an unlocked state by restraining the push button inward, the device according to claim 32 **Claim 34** For each of the anchors, the delivery tool maintains the locking portion in an unlocked state by the flexible tube restraining the push button inward is configured to lock the locking portion by deploying the head from the flexible tube, the device according to claim 33 **Claim 35** The casing 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 via rotation of the flexible tube, the device according to claim 33 **Claim 36** For each anchor, the push button is disposed on the anchor key, the device according to claim 35 **Claim 37** For each anchor, the anchor key includes a sunk key, the push button is disposed on the sunk key, and the delivery tool is configured to maintain the locking portion in an unlocked state by the drive key restraining the push button inward, the device according to claim 36 **Claim 38** For each of the anchors, the locking portion is biased to lock, and the delivery tool is configured to restrain the anchor in an unlocked state while adjusting the tension on the section of the tether, the device according to claim 32 **Claim 39** The device according to claim 38, wherein for each of the anchors, the delivery tool is configured to restrain the anchor in an unlocked state while the delivery tool is advancing the anchor trans-luminally into the heart.

40. The device according to claim 38, wherein for each of the anchors, the delivery tool is configured to restrain the anchor in an unlocked state while the delivery tool is anchoring the anchor to the tissue.

41. The device according to claim 32, wherein for each of the anchors, the delivery tool is configured to advance the anchor trans-luminally into the heart following anchoring of the leading one of the anchors to the tissue.

42. The device according to claim 41, wherein for each of the anchors, the delivery tool is configured to advance the anchor trans-luminally into the heart following locking of the locking portion of the leading one of the anchors.

43. A system for use in tissue of a subject's heart, the system comprising an implant, an elongate member, a plurality of anchors, and a plurality of locking portions, and a delivery tool, wherein the delivery tool is configured to implant the implant in the tissue such that the elongate member defines a path along the tissue, by anchoring a first section of the elongate 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, contracting the first portion of the path by reducing the length of the first section prior to anchoring the second section and after anchoring the first section, fixing the length of the first section using at least a first locking portion of the plurality of locking portions while the first portion of the path remains contracted, contracting the second portion of the path by reducing the length of the second section after anchoring the second section and while the length of the first section remains fixed, and ​ A system configured to contract by fixing the length of the second section using at least a second locking portion of the plurality of locking portions while the second portion of the path remains contracted.

44. An apparatus for use in a target heart, the apparatus comprising: an implant, a tether, a series of anchors, each of the anchors comprising: a tissue engagement element, a head coupled to the tissue engagement element and slidably coupled to the tether; an implant; a plurality of tension adjusters, a delivery tool, the delivery tool comprising: a tube that is trans-luminally advanceable relative to the heart, an anchor driver configured to advance the anchors through the tube and, for each of the anchors, anchor-fix the anchors in the tissue within the heart in sequence by driving the tissue engagement element into the heart tissue; an applicator configured to connect the plurality of tension adjusters to the implant within the heart. An apparatus.

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