Annuloplasty implants and systems for use therewith - Patent Application 20070122997

Abstract

The catheter device (300d) includes a flexible tube (310d) and an extracorporeal unit (350d). The tube has a distal opening configured to be advanced transluminally into a subject, and a proximal end. The extracorporeal unit is coupled to the proximal end and includes (i) a body (352) and (ii) a series of cartridges (360d) distributed along the proximal-distal axis of the body, with the most distal cartridge closest to the proximal end of the tube. The series of anchors (120d) includes a leading anchor (120d') and other anchors (120d''), each anchor (i) housed by a corresponding cartridge, the leading anchor being housed by the most distal cartridge, and (ii) coupled to a tether (112) such that the tether extends parallel to the proximal-distal axis along the body. Other embodiments are also described.

Description

[Background technology]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority from the following: U.S. Provisional Patent Application No. 63 / 386,597, filed December 8, 2022, entitled "Annuloplasty implants and systems for use therewith," by Halabi et al.; U.S. Provisional Patent Application No. 63 / 580,700, filed September 5, 2023, entitled "Annuloplasty implants and systems for use therewith," by Halabi et al.; and U.S. Provisional Patent Application No. 63 / 598,509 by Halabi et al., filed November 13, 2023, entitled "Annuloplasty implants and systems for use therewith."

[0002] Each of the above references is incorporated herein by reference in its entirety for all purposes.

[0003] There are various potential methods for repairing heart valves and / or other anatomical structures. Annuloplasty is a repair procedure that involves reshaping / remodeling the tissue of the annulus. This can be done by pulling the tissue around the annulus into a new shape. Anchors can be used to facilitate medical procedures, including annuloplasty, other remodeling of tissue, and securing implants. In some instances, it may be desirable to use anchors for procedures where there is no line of sight to the target. Summary of the Invention

[0004] This 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 features included in an example of the Summary of the Invention are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in the examples in this Summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples outlined here.

[0005] Some of the systems, apparatus, devices, methods, techniques, etc. described herein, and their implementations and applications, include or are configured for use with an implant that includes multiple anchors slidably coupled to a tether (e.g., a line, wire, ribbon, rope, cable, braid, contraction member, contraction member, suture, etc.).

[0006] In some implementations, the implant can be a tissue-adjusting implant that contracts tissue by pulling on a tether. In some implementations, the implant can be usable and / or configured for use in the heart of a subject (e.g., a live subject, a simulation, etc.). For example, the implant can be an annuloplasty implant.

[0007] In some implementations, the implant may be configured and / or used to close another opening (e.g., an opening to an appendage, an opening to a left ventricular appendage, an opening to a passageway, etc.) or to reshape another region of tissue (e.g., ventricular remodeling, atrial remodeling, muscle remodeling, etc.).

[0008] In some implementations, a delivery system is provided for delivering and immobilizing the anchor (e.g., an implant including an anchor with a tether threaded therethrough). In some implementations, the delivery system may include a catheter device and / or an anchor driver.

[0009] In some implementations, the catheter device can include a tube and an extracorporeal unit, e.g., at the proximal end of the tube. Anchors can be mounted inline on the extracorporeal unit. In some implementations, a tether can be threaded through the anchors in this arrangement.

[0010] In some implementations, a series of cartridges (or anchor holders) can be mounted on the extracorporeal unit and can hold a series of anchors. In some implementations, one or more (e.g., one, some, or all) cartridges can be configured to facilitate bringing their corresponding anchors to a proximal opening of a tube for advancement by a driver through the tube to a site where the anchors are to be anchored. In some implementations, the extracorporeal unit and / or cartridges can be configured to facilitate verification of engagement between the driver and anchors prior to advancement.

[0011] As used herein, the term cartridge is interchangeable with the term anchor holder, and cartridges / anchor holders herein can be configured in a variety of ways (e.g., from simple receptacles or holes for holding anchors to more involved or sophisticated configurations and mechanisms).

[0012] In some implementations, the anchor is configured (e.g., shaped) to be slidable along a tether (e.g., a line, wire, contractile member, etc.) both (i) when aligned (i.e., parallel or coaxial) with the tether and (ii) when positioned orthogonally relative to the tether. This, among other things, facilitates (i) advancement of the anchor along the tether while aligned with the tether during transcatheter delivery, and (ii) subsequent sliding of the tether relative to the anchor after implantation, e.g., while the tether is orthogonal to the anchor.

[0013] In some implementations, each anchor can include (i) a tissue-engaging element and (ii) a head disposed at a proximal end of the tissue-engaging element.

[0014] In some implementations, each anchor in a set of anchors is configured identically or similarly, in some implementations some anchors are of a first type or configuration and one or more other anchors are of a second type or configuration, or in some implementations each anchor is different.

[0015] In some implementations, the tissue engaging element may be a threaded tissue engaging element, for example, helical, screw-like, threaded, or the like.

[0016] In some implementations, the tissue engaging element can be comprised of one or more hooks, barbs, darts, staples, clips, protrusions, arms, expandable portions, threaded portions, rivets, pads, combinations of two or more thereof, and the like.

[0017] In some implementations, the head can include or define an interface that an anchor driver can engage and apply an anchor securing force (eg, torque) to the anchor.

[0018] In some implementations, each anchor may include an eyelet coupled to the head of the anchor, or another connector defining an opening therethrough. In some implementations, the anchor is slidably coupled to a tether by threading the tether through the eyelet. In some implementations, the eyelet may be positioned laterally from the axis of the anchor. The eyelets can be configured in a variety of ways.

[0019] In some implementations, the eyelet is flexible in a manner that facilitates smooth sliding along the tether both when the anchor is parallel to the tether (i) and when the anchor is oriented perpendicular to the tether (ii).

[0020] In some implementations, the eyelets include and / or are formed from a fabric such as a thread (eg, a polyfilament structure).

[0021] In some implementations, the eyelet includes and / or is formed from a polymer (eg, a polymer suture, a polymer thread, a polymer filament, etc.).

[0022] In some implementations, the eyelet is pivotable over the anchor head. In some implementations, the eyelet includes and / or is formed from a fabric shaped to allow the eyelet to pivot over the anchor head.

[0023] In some implementations, the eyelet is connected to two locations on the collar in a manner that defines a hinge axis about which the two locations lie, and about which the eyelet can pivot.

[0024] In some implementations, the eyelet includes and / or is formed from a fabric and / or a polymer, the fabric and / or polymer is configured and / or shaped to define a collar that surrounds a portion of the anchor's head and / or a stock region or neck region of the head (or a stock region or neck region proximate to the head), and the eyelet is coupled (directly or indirectly) to the head and / or the stock or neck region of the head (or the stock or neck region proximate to the head) (e.g., directly coupling the eyelet to the head, directly coupling the eyelet to the stock region or neck region of the head and / or a region proximate to the head, coupling the eyelet to a bushing on or associated with the head and / or the stock region or neck region of the head and / or a bushing proximate to the head).

[0025] In some implementations, a collar can be configured to facilitate rotation of the eyelet around the head of the anchor, for example, by the collar rotating around the axis of the anchor, which in some implementations can be extended by a bushing to which the collar can be attached.

[0026] In some implementations, a collar surrounding a portion of the head of the anchor and / or a stock or neck region of the head (or a stock or neck region adjacent to the head) is formed by one or more loops (e.g., one loop, two loops, three loops, etc.) of fabric and / or polymer that loop around a portion of the head of the anchor and / or a stock or neck region of the head (or a stock or neck region adjacent to the head). This configuration can be used whether or not looped over a bushing, e.g., a bushing around the head, stock, neck, etc.

[0027] In some implementations, the eyelet of each anchor is saddle-shaped.

[0028] In some implementations, each anchor includes a spacer that extends away from the anchor head along the tether, e.g., distally toward the preceding anchor in the series, hi some implementations, the spacer can inhibit the proximity of the anchor and the preceding anchor.

[0029] In some implementations, the spacer may be coupled to the head and / or eyelet of the anchor, hi some implementations, the spacer may be integrally formed with the head and / or eyelet of the anchor.

[0030] In some implementations, the spacer may be rotatable about the head and / or about the axis of the anchor, hi some implementations, the spacer may be rotatable relative to the axis of the anchor.

[0031] In some implementations, a dedicated leading anchor is provided that is secured to the tether but nonetheless facilitates deflection of the tether relative to the axis of the leading anchor. For example, the leading anchor (e.g., at its head) can define a socket configured to receive a stopper (e.g., a bead) secured to the end of the tether.

[0032] In some implementations, the tube of the catheter device has one or more resilient ribs, nubs, or knots at its distal end that engage the tissue-engaging element of the anchor in a manner that controls advancement of the anchor distally from the tube. For example, the ribs can allow the anchor to be advanced distally only while the tissue-engaging element is rotated, e.g., can prevent non-rotational axial advancement. However, the ribs can be less inhibitive to non-rotational axial retraction.

[0033] In some implementations, pulling on the tether causes the tether to slide through the eyelets of each anchor, pulling the anchors toward each other, thereby constricting the tissue to which the anchors are anchored, e.g., the annulus of a heart valve. To lock tension into the tether, a lock (which in some implementations may be considered a stopper) advances along the tether and locks onto the tether, e.g., at the most recently anchored anchor.

[0034] In some implementations, the lock is configured such that actuation thereof locks the lock to the tether and cuts (eg, trims) the tether so that excess tether can be withdrawn.

[0035] In some implementations, a lock can be installed on the tether without accessing either end of the tether.

[0036] In some implementations, a tensioner is provided that can engage a mid-region of the tether and apply tension to the tether from there (e.g., without accessing both ends of the tether). In some implementations, the tensioner is mounted or attachable on an extracorporeal unit of the catheter tool, which provides access to the mid-portion of the tether.

[0037] In some implementations, tensioners can be used to assess the condition and / or behavior of the implant during treatment and / or can be used to apply a locked-in tension to the implant, for example, towards the end of treatment.

[0038] According to some implementations, the system and / or device includes an implant including a tether and / or an anchor. In some implementations, the anchor can include an anchor head, a tissue engaging element, and / or a fabric.

[0039] In some implementations, the anchor head may include a stock, which may be configured in various ways, for example, as a core, a rod, a tube, a neck, a winch, a peg, etc.

[0040] In some implementations, a tissue engaging element is coupled to the stock and extends distally away from the anchor head to define an anchor axis of the anchor and is configured to be driven along the anchor axis into tissue of a subject (e.g., a living subject, a simulation, etc.).

[0041] In some implementations, the fabric may be shaped to define a collar and / or eyelets.

[0042] In some implementations, the fabric can include one or more polymers.

[0043] In some implementations, the collar can surround the stock. In some implementations, the collar can be looped around the stock. In some implementations, the collar can surround and / or loop around the stock more than once (e.g., once, twice, three times, etc.).

[0044] In some implementations, a tether may be threaded through the eyelet.

[0045] In some implementations, the eyelet is rotatable about the anchor axis by a collar that rotates about the anchor axis.

[0046] In some implementations, the fabric is or includes a woven fabric.

[0047] In some implementations, the fabric is a substantially flat woven sheet.

[0048] In some implementations, the collar and eyelets are formed by cutting a woven fabric sheet.

[0049] In some implementations, the fabric is a woven fabric that is woven in a manner that integrally defines the collar and eyelets.

[0050] In some implementations, the eyelets have eyelet openings through the woven fabric, the collars have collar openings through the woven fabric, and / or the woven fabric is woven in a manner that provides eyelet openings and collar openings.

[0051] In some implementations, the woven fabric has general warp strands and reinforcing warp strands, the reinforcing warp strands being stronger and less strong than the general warp strands, and the woven fabric is woven such that the reinforcing warp strands pass through the edges of the eyelet openings and collar openings.

[0052] In some implementations, the woven fabric has general weft strands and reinforcing weft strands, the reinforcing weft strands being stronger and less strong than the general weft strands, and the woven fabric is woven such that the reinforcing weft strands pass through the edges of the eyelet openings and collar openings.

[0053] In some implementations, the fabric is further configured to define a spacer through which the tether is threaded, the spacer inhibiting proximity between the anchor and a series of adjacent anchors.

[0054] In some implementations, the fabric includes a fabric tube that is (i) wrapped around the anchor head in a manner that defines a collar, (ii) formed into a loop in a manner that defines an eyelet, and (iii) through which the tether is coaxially threaded in a manner that defines a spacer.

[0055] In some implementations, the implant is sterilized.

[0056] In some implementations, the fabric includes filaments of a synthetic polymer.

[0057] In some implementations, the fabric comprises natural fiber filaments.

[0058] In some implementations, the anchor head includes an interface that is coupled to the tissue engaging element via a stock, and the tissue engaging element is configured to be driven into tissue along the anchor axis by an anchor securing force applied to the interface.

[0059] In some implementations, the collar and eyelets are integrally formed during the formation of the fabric.

[0060] In some implementations, the eyelet is slidable along the tether.

[0061] In some implementations, the anchor is a secondary anchor and the implant further includes a leading anchor coupled to the tether.

[0062] In some implementations, the fabric is a yarn.

[0063] In some implementations, the collar and eyelets are defined by respective loops of fabric and / or thread, hi some implementations, one or more of the collar and / or eyelets are defined by multiple loops of fabric and / or thread.

[0064] In some implementations, the collar and eyelets are integrally formed during the formation of the thread.

[0065] In some implementations, the collar and eyelets are formed by tying threads.

[0066] In some implementations, the collar is formed by securing a thread to a loop. In some implementations, the collar is formed by securing a thread to multiple loops.

[0067] In some implementations, the eyelet is formed by securing a thread to a loop. In some implementations, the eyelet is formed by securing a thread to multiple loops.

[0068] In some implementations, the anchor further includes a bushing concentrically disposed between the eyelet and the stock.

[0069] In some implementations, the bushing is rotatable about the stock.

[0070] In some implementations, the bushing is annular.

[0071] In some implementations, the fabric defines a knot (eg, includes a polyfilament structure) and the bushing defines a recess shaped to receive the knot.

[0072] In some implementations, the recess is defined by a trimmed portion of the bushing, the trimmed portion having a reduced radius from the anchor axis.

[0073] In some implementations, the recess faces laterally away from the anchor axis.

[0074] In some implementations, the recess is a cube defined by a bulge in the bushing, which bulges laterally.

[0075] In some implementations, the recess faces inward toward the anchor shaft.

[0076] In some implementations, the bushing defines a radially facing groove, with the eyelet residing in the groove.

[0077] In some implementations, the bushing is shaped so that a portion of the groove is covered in a manner that secures the eyelet within the groove.

[0078] According to some implementations, a system usable and / or for use in a subject's tissue (e.g., a live subject, a simulation, etc.) may include a catheter device, a tether, and / or a series of anchors.

[0079] In some implementations, the catheter device may include a flexible tube having a proximal end defining a distal opening and / or a proximal opening configured for transluminal advancement toward the tissue. Alternatively or additionally, the catheter device may include an extracorporeal unit coupled to the proximal end of the tube.

[0080] In some implementations, the catheter device may include a body and / or a series of cartridges (or anchor holders). In some implementations, the series of cartridges / anchor holders are distributed along the body in a manner that defines a proximal-distal axis. In some implementations, the most distal cartridge of the series of cartridges may be the anchor positioned closest to the proximal opening. In some implementations, the series of cartridges / anchor holders are distributed along the body in a manner that defines a proximal-distal axis with one row or column of cartridge / anchor holders along the axis, while other arrangements have two or more parallel rows or columns of cartridge / anchor holders. In some implementations, the series of cartridge / anchor holders are distributed along the body in a manner that does not define a proximal-distal axis (e.g., in a curved manner, an angled manner, a zigzag manner, etc.).

[0081] In some implementations, each anchor in the series of anchors can be housed by a corresponding cartridge / anchor holder in the series of cartridge / anchor holders.

[0082] In some implementations, the series of anchors includes a leading anchor and other anchors, hi some implementations, the leading anchor may be housed by the most distal cartridge.

[0083] In some implementations, a series of anchors may be coupled to the tether such that the tether extends along the body, parallel to the proximal-distal axis.

[0084] In some implementations, the cartridges in the series of cartridges are interlocking.

[0085] In some implementations, the anchors in the series of anchors are interlocking.

[0086] In some implementations, the system is sterilized.

[0087] In some implementations, the catheter device is sterilized.

[0088] In some implementations, the flexible tube flares toward the distal opening.

[0089] In some implementations, at least some of the series of anchors each include an anchor head and / or a tissue engaging element extending distally away from the anchor head to define an anchor axis of the anchor. In some implementations, the tissue engaging element can be configured to be driven into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis.

[0090] In some implementations, at least a portion of the series of anchors each include a fabric and / or polymer shaped to define an eyelet through which the tether is threaded in a manner that slidably couples the anchor to the tether. The fabric and / or polymer may be the same as or similar to other fabrics and / or polymers described elsewhere herein. The eyelet may be the same as or similar to eyelets described elsewhere herein.

[0091] In some implementations, the anchor includes an anchor head and / or a helical tissue-engaging element extending away from the anchor head to define an anchor axis of the anchor and configured to be threaded into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis.

[0092] In some implementations, the tube can have a distal portion including a distal opening, and the tube can define a channel along the tube axis through which the anchor is slidable toward the distal opening.

[0093] In some implementations, the tube can alternatively or additionally define a gripping zone at a distal portion, where the tube has a gripping surface that inhibits sliding of the anchor through the gripping zone by gripping a lateral surface of the helical tissue-engaging element. In some implementations, the system further includes an anchor driver configured to slide the anchor distally through the channel to the gripping zone and / or drive the anchor through the gripping zone by threading the tissue-engaging element onto the gripping surface.

[0094] In some implementations, the gripping surface is configured such that when a driver threads the tissue engaging element onto the gripping surface, the tissue engaging element temporarily compresses the portion of the gripping surface that the tissue engaging element contacts.

[0095] In some implementations, the gripping surface includes and / or is formed from a polymer.

[0096] In some implementations, the tube is lined with a polymer.

[0097] In some implementations, the tube includes and / or is formed from a polymer.

[0098] In some implementations, the polymer is a thermoplastic elastomer.

[0099] In some implementations, the polymer is a block copolymer.

[0100] In some implementations, the block copolymer is a polyether block amide.

[0101] In some implementations, the gripping surface is provided by at least one resilient nub that projects inwardly into the channel.

[0102] In some implementations, the gripping surface is provided by at least one resilient rib that projects inwardly into the channel.

[0103] In some implementations, a rib extends inwardly into the channel adjacent the rib in a manner that defines a niche in the gripping zone. In some implementations, the system is configured such that the rib excludes the tissue engaging element from the niche while the anchor driver threads the tissue engaging element onto the gripping surface, and / or the tether extends laterally from the tissue engaging element through the shielded gripping zone into the niche.

[0104] In some implementations, the anchor further includes an eyelet attached to the head so as to be rotatable about the anchor axis, which eyelet may be the same as or similar to the eyelets described elsewhere herein.

[0105] In some implementations, proximally from the rib, the tube may further define an abutment that protrudes inward into the channel in a manner that inhibits rotation of the eyelet about the anchor axis when the anchor driver screws the tissue engaging element onto the gripping surface.

[0106] In some implementations, a single structure defines both the rib and the abutment.

[0107] In some implementations, the ribs project further inward into the channel than the abutment.

[0108] In some implementations, the abutment is longer along the channel than the rib.

[0109] In some implementations, the rib has a proximal surface shaped to define a shoulder.

[0110] In some implementations, the ribs have a tapered distal surface.

[0111] In some implementations, the rib is a first rib of a plurality of ribs defined by a distal portion within the gripping zone.

[0112] In some implementations, the plurality of ribs is exactly two ribs.

[0113] In some implementations, the plurality of ribs is exactly three ribs.

[0114] In some implementations, the plurality of ribs is exactly four ribs.

[0115] In some implementations, the plurality of ribs is exactly five ribs.

[0116] In some implementations, the plurality of ribs is exactly six ribs.

[0117] In some implementations, a plurality of ribs are distributed circumferentially around the tube axis.

[0118] In some implementations, multiple ribs are distributed along the tube axis.

[0119] In some implementations, the rib extends around at least a portion of the tube axis.

[0120] In some implementations, the rib is annular and extends circumferentially around the entire tube axis.

[0121] 35. The system of claim a9a, wherein the ribs extend along the tube axis.

[0122] In some implementations, the ribs are parallel to the tube axis.

[0123] In some implementations, the system further includes a plurality of tubular spacers through which the tether is threaded, each of the spacers being connected to a series of corresponding anchors via corresponding connectors.

[0124] In some implementations, each of the spacers is disposed on a tether such that the spacer tracks the corresponding anchor as the anchor advances distally along the tether toward the proximal opening.

[0125] In some implementations, a first spacer of the spacers is connected to the leading anchor and is axially less compressible than at least another spacer of the spacers.

[0126] In some implementations, each anchor includes an anchor head and / or a tissue-engaging element extending distally away from the anchor head to define an anchor axis of the anchor. The tissue-engaging element can be configured to be driven along the anchor axis into tissue of a subject (e.g., a living subject, a simulation, etc.).

[0127] In some implementations, at least a portion of the series of anchors each include a fabric and / or polymer shaped to define an eyelet through which the tether is threaded in a manner that slidably couples the anchor to the tether. The fabric and / or polymer may be the same as or similar to other fabrics and / or polymers described elsewhere herein. The eyelet may be the same as or similar to eyelets described elsewhere herein.

[0128] In some implementations, the system further includes a plurality of tubular spacers through which the tether is threaded, each of the spacers being connected to a series of corresponding anchors via corresponding connectors.

[0129] In some implementations, each of the connectors is defined by the fabric and / or polymer of the corresponding anchor.

[0130] In some implementations, each of the spacers is disposed on a tether such that the spacer tracks the corresponding anchor as the anchor advances distally along the tether toward the proximal opening.

[0131] In some implementations, the anchor head includes an interface coupled to a tissue engaging element, the tissue engaging element configured to be driven into tissue along the anchor axis by an anchor securing force applied to the interface.

[0132] In some implementations, the fabric and / or polymer is configured or shaped to allow the eyelet to pivot over the anchor head.

[0133] In some implementations, the fabric is or includes a woven fabric.

[0134] In some implementations, the fabric is or includes a polymer.

[0135] In some implementations, the fabric includes filaments of a synthetic polymer.

[0136] In some implementations, the fabric comprises natural fiber filaments.

[0137] In some implementations, the fabric is a yarn.

[0138] In some implementations, the eyelet is formed by securing a fabric and / or thread to a loop. In some implementations, the eyelet is formed by securing a fabric and / or thread to multiple loops.

[0139] In some implementations, the fabric and / or polymer are further configured to define a collar that connects the eyelet to the anchor head, hi some implementations, the fabric and / or polymer are configured as one or more loops (e.g., 1 loop, 2 loops, 3 loops, etc.) that form the collar.

[0140] In some implementations, the fabric is a yarn.

[0141] In some implementations, the collar and eyelets are defined by respective loops of thread.

[0142] In some implementations, the collar and eyelets are integrally formed during the formation of the thread.

[0143] In some implementations, the collar and eyelets are formed by tying threads.

[0144] In some implementations, the collar is formed by securing a thread to a loop.

[0145] In some implementations, the eyelet is formed by securing a thread to a loop.

[0146] In some implementations, the collar and eyelets are integrally formed during the formation of the fabric.

[0147] In some implementations, the eyelet is rotatable about the anchor axis by a collar that rotates about the anchor axis.

[0148] In some implementations, the eyelet is connected to two locations on the collar in a manner that defines a hinge axis about which the two locations lie, and about which the eyelet can pivot.

[0149] In some implementations, the catheter device further includes a deslacker coupled to the tether and configured to eliminate slack in the tether.

[0150] In some implementations, the descracker is located in the proximal portion of the extracorporeal unit.

[0151] In some implementations, the extracorporeal unit defines an opening, and the tether extends from the dessracker through the opening and along the body.

[0152] In some implementations, the opening faces the proximal opening along the length of the cartridge.

[0153] In some implementations, the opening is aligned with the proximal opening.

[0154] In some implementations, the system further includes an anchor driver. In some implementations, the anchor driver includes a flexible shaft and may include a drive head at a distal end of the shaft. In some implementations, the anchor driver is configured, for each anchor in sequence starting with the leading anchor, to (i) engage the drive head with the anchor, (ii) remove the anchor from the corresponding cartridge, and / or (iii) advance the anchor into the proximal opening, through the tube, and toward the tissue while the anchor remains coupled to the tether, to anchor the anchor to the tissue.

[0155] In some implementations, the extracorporeal unit is configured such that, for each anchor, removal of the anchor from the corresponding cartridge by the anchor driver moves the anchor away from the proximal-distal axis.

[0156] In some implementations, the extracorporeal unit is configured such that, for each anchor, removal of the anchor from the corresponding cartridge by the anchor driver pulls a portion of the tether away from the proximal-distal shaft.

[0157] In some implementations, the tether extends along the body in a manner defining a tether axis parallel to the proximal-distal axis, and the extracorporeal unit is configured such that, for each anchor, removal of the anchor from the corresponding cartridge by the anchor driver pulls a portion of the tether away from the tether axis.

[0158] In some implementations, the tether extends along the body such that the tether is straight and the extracorporeal unit is configured, for each anchor, by the anchor driver such that removal of the anchor from the corresponding cartridge reshapes a portion of the tether away from the straight line.

[0159] In some implementations, the tether extends along the body such that the tether is straight and the extracorporeal unit is configured such that, for each of the other anchors, removal of the other anchor from the corresponding cartridge by the anchor driver causes a portion of the tether to form a V-shape.

[0160] In some implementations, the extracorporeal unit is shaped to define a rest against which the shaft can rest while the anchor driver anchors the anchor into tissue.

[0161] In some implementations, the rest is positioned proximally from the series of cartridges.

[0162] In some implementations, the rest is shaped and positioned so that at least a portion of the shaft extends along the tether and along the extracorporeal unit while the anchor driver anchors the anchor into tissue and the shaft is placed in the rest.

[0163] In some implementations, the rest is shaped and positioned such that at least a portion of the shaft extends along the extracorporeal unit along the proximal-distal axis while the anchor driver anchors the anchor into tissue and the shaft is placed in the rest.

[0164] In some implementations, one or more (e.g., one, some, or all) of the cartridges are shaped to define a window through which a drive head is advanceable to engage an anchor housed within and by the cartridge.

[0165] In some implementations, the window has a sloped rim that facilitates translational alignment of the driver head with the anchor.

[0166] In some implementations, the window is shaped to allow the drive head to reach the anchor housed by the cartridge only when the drive head is rotationally aligned with the anchor.

[0167] In some implementations, for each cartridge, the cartridge includes a chassis and a tray. In some implementations, the cartridge can have a closed state in which the cartridge securely houses the corresponding anchor with the corresponding anchor located in the tray. In some implementations, an anchor driver is configured to remove the corresponding anchor from the cartridge by applying a pulling force to the anchor such that the cartridge transitions to an open state with the tray sliding relative to the chassis in a manner exposing the corresponding anchor from the cartridge.

[0168] In some implementations, (i) the system includes a plurality of spacers interleaved with a series of anchors and through which a tether is threaded, such that each of the spacers is positioned adjacent to a series of corresponding cartridges, and / or (ii) for each of the cartridges, (a) the tray is shaped to define a catch that prevents the corresponding spacer from sliding distally away from the cartridge in a closed state of the cartridge, and / or (b) transitioning the cartridge to an open state displaces the catch such that the catch ceases to prevent the corresponding spacer from sliding distally away from the corresponding cartridge.

[0169] In some implementations, the window is defined at least in part by the chassis and at least in part by the tray.

[0170] In some implementations, the cartridge defines a threshold force and is configured to transition to the open state only when the pulling force exceeds the threshold force.

[0171] In some implementations, the cartridge is configured to resist returning from an open state to a closed state.

[0172] In some implementations, the tether has (i) a distal end of the leading anchor and (ii) a proximal end that is secured within the extracorporeal unit and is removable from within the extracorporeal unit so that it can be threaded proximally through the opening in the lock, through the lock and head, and into the shaft of the adjustment tool.

[0173] In some implementations, the adjustment tool includes a capture assembly that includes: (i) a gripper positioned proximally from the lock at the working end of the capture assembly such that, in the received state of the capture assembly, passing the proximal end of the tether proximally into the opening in the lock, through the lock and head, and proximally into the shaft of the adjustment tool causes the working end of the capture assembly to receive the proximal end of the tether; and / or (ii) a knob mounted on the body of the adjustment tool extracorporeal unit and / or operably coupled to a proximal portion of the gripper such that operation of the knob transitions the capture assembly to a gripping state in which the gripper grips the tether.

[0174] In some implementations, the knob can be attached to the adjustment tool extracorporeal unit such that transitioning the capture assembly to the gripping state releases the knob from the adjustment tool extracorporeal unit. In some implementations, once released from the adjustment tool extracorporeal unit, the knob can be detached from the adjustment tool extracorporeal unit in a manner that retracts the working end of the capture assembly proximally through and out of the shaft and adjustment tool extracorporeal unit along the proximal end of the tether, such that the tether is positioned through the lock, head, shaft, and adjustment tool extracorporeal unit.

[0175] In some implementations, the lock is biased to lock, and the adjustment tool includes a cut-off tube extending distally through the shaft and into the head such that a distal portion of the cut-off tube is disposed within the lock in a manner that limits lock unlocking. In some implementations, while the knob of the intake assembly remains attached to the adjustment tool extracorporeal unit, the working end of the intake assembly can be disposed within the cut-off tube such that a tether is positioned through the lock, the head, the cut-off tube within the shaft, and the adjustment tool extracorporeal unit, such that removal of the knob from the adjustment tool extracorporeal unit retracts the working end of the intake assembly proximally through and out of the cut-off tube, along with the proximal end of the tether.

[0176] In some implementations, the lock is biased to lock. In some implementations, the adjustment tool includes a guillotine (or cutting tool) in the tool head and proximal to the lock, and / or a interrupter extending distally through the shaft and guillotine, such that a distal portion of the interrupter is disposed within the lock in a manner that limits unlocking.

[0177] In some implementations, the adjustment tool extracorporeal unit includes a lock-and-cut subassembly including a locking block and / or a lock-and-cut controller coupled to the interrupter.

[0178] In some implementations, retraction of the working end of the intake assembly proximally through and out of the shaft and adjustment tool extracorporeal unit, along with the proximal end of the tether, leaves the tether positioned through the lock and guillotine (or cutting tool) such that (a) subsequent engagement of the lock locks the lock to the tether, and (b) subsequent actuation of the guillotine (or cutting tool) severs the tether proximally from the lock.

[0179] In some implementations, a lock-and-cut controller is operably coupled to the locking block such that operation of the lock-and-cut controller retracts the locking block proximally, thereby withdrawing the interrupter from the lock and responsively locking the lock to the tether.

[0180] In some implementations, the lock includes a latch that retains the lock in the tool head through engagement with the tool head. In some implementations, the interrupter and lock may be configured such that (i) a distal portion of the interrupter blocks the latch from disengaging from the tool head while the distal portion of the interrupter is disposed in the lock in a manner that constrains lock unlocking, and / or (ii) the lock is deployable from the tool head when the interrupter is withdrawn from the lock.

[0181] In some implementations, the shaft of the adjustment tool is a primary shaft, and / or the adjustment tool further includes a cutter shaft that extends from the adjustment tool extracorporeal unit through the primary shaft to the guillotine (or cutting tool).

[0182] In some implementations, the lock-and-cut subassembly further includes an adapter coupled to the cutter shaft and shaped and positioned relative to the locking block such that (i) operation of the lock-and-cut controller by a first amount retracts the locking block proximally such that the interrupter is withdrawn from the lock and the lock responsively locks to the tether while the guillotine remains deactivated, and / or (ii) further operation of the lock-and-cut controller beyond the first amount engages the locking block with the adapter such that further operation of the lock-and-cut controller actuates the guillotine (or cutting tool) via the locking block, adapter, and cutting shaft.

[0183] In some implementations, the cutter shaft is coupled to the guillotine (or cutting tool) via a swivel connector.

[0184] In some implementations, the adjustment tool extracorporeal unit includes a tension subassembly including a tension block, a clamp attached to the tension block, and / or a tension controller. In some implementations, while the knob of the intake assembly remains mounted on the adjustment tool extracorporeal unit, the gripper can extend distally from the knob, through the clamp and shaft, to the working end.

[0185] In some implementations, retraction of the working end of the intake assembly, along the proximal end of the tether, proximally through and out of the shaft and adjustment tool extracorporeal unit can retract the gripper from the clamp, leaving the tether positioned through the clamp such that subsequent actuation of the clamp locks the tether to the tension block.

[0186] In some implementations, the tension controller can be operably coupled to the tension block such that operation of the tension controller applies tension to the tether by drawing the tension block and tether proximally while the tether remains locked to the tension block.

[0187] In some implementations, the adjustment tool extracorporeal unit includes a distance indicator where the position of the adjustment block relative to the body of the adjustment tool extracorporeal unit indicates the distance operation of the tension controller has pulled the tension block proximally.

[0188] In some implementations, the tension subassembly further includes a spring and a stock driven by the tension controller such that operation of the tension controller causes the stock to urge the adjusting block proximally via the spring, and / or a tension indicator in which the position of the adjusting block relative to the stock indicates the amount of tension applied to the tether by operation of the tension controller.

[0189] In some implementations, the adjustment tool includes an intake assembly including a sleeve extending distally through the shaft and terminating proximally from the lock, a gripper extending distally through the sleeve and having a wider distal portion disposed distally outside the sleeve, the sleeve and gripper shaped and positioned such that threading the proximal end of the tether into the distal-facing opening of the lock, through the lock and head and proximally into the shaft of the adjustment tool advances the proximal end of the tether proximally around the wider distal portion of the gripper and into the sleeve, and / or a knob.

[0190] In some implementations, a knob may be mounted on the adjustment tool extracorporeal unit and / or may be operably coupled to a proximal portion of the sleeve and a proximal portion of the gripper such that operation of the knob causes the capture assembly to transition to a gripping state by retracting a wider distal portion of the gripper proximally into the sleeve, thereby gripping the tether within the sleeve.

[0191] In some implementations, the attachment of the knob to the adjustment tool extracorporeal unit may be such that transitioning of the capture assembly to the gripping state releases the knob from the adjustment tool extracorporeal unit.

[0192] In some implementations, when released from the adjustment tool extracorporeal unit, the knob may be removable from the adjustment tool extracorporeal unit in a manner that pulls the sleeve and gripper proximally along the proximal end of the tether, through the shaft and adjustment tool extracorporeal unit, and out of the adjustment tool so that the tether extends through the lock, head, shaft, and adjustment tool extracorporeal unit.

[0193] In some implementations, the adjustment tool includes a cut-off tube disposed within the lock. The lock can include (i) a housing shaped to define a distal-facing opening through which a tether can be inserted through the lock and into the cut-off tube, and / or (ii) a spring-loaded clamp disposed within the housing and biased to clamp onto the tether within the lock, wherein the presence of the cut-off tube within the lock prevents the clamp from clamping onto the tether within the lock.

[0194] In some implementations, the lock further includes a tubular leader extending from the distally facing opening away from the body, the tether being insertable through the opening via the leader.

[0195] In some implementations, the reader includes a helical coil.

[0196] In some implementations, the leader includes a smooth rim with a protrusion.

[0197] In some implementations, the leader has a flared distal end.

[0198] In some implementations, the leader includes a sleeve.

[0199] In some implementations, the leader is rigid.

[0200] In some implementations, the reader is flexible.

[0201] In some implementations, the reader may include and / or be formed from a metal.

[0202] In some implementations, the leader may include and / or be formed from a polymer.

[0203] In some implementations, each anchor in the series includes a head slidably coupled to the tether and / or a tissue-engaging element extending away from the head to define an anchor axis of the anchor, hi some implementations, each anchor is housed by its corresponding cartridge such that the anchor axis is oriented at an angle relative to the proximal-distal axis.

[0204] In some implementations, for each anchor in the series of anchors, the anchor is oriented with the head proximally from the tissue engaging element.

[0205] In some implementations, for each anchor in the series of anchors, the anchor is oriented with the tissue engaging element closer to the proximal opening than the head.

[0206] In some implementations, the anchor axes of a set of anchors collectively define a common anchor plane on which the anchor axes lie.

[0207] In some implementations, the proximal-distal axis is parallel to a common anchor plane.

[0208] In some implementations, the proximal and distal axes lie in a common anchor plane.

[0209] In some implementations, the tethers extend along the extracorporeal body parallel to the common anchor plane.

[0210] In some implementations, one or more (e.g., one, some, or all) of the cartridges have a closed state in which the cartridge securely receives a corresponding anchor. In some implementations, one or more (e.g., one, some, or all) of the cartridges can define a respective cartridge vector that is angled relative to the proximal-distal axis. In some implementations, one or more (e.g., one, some, or all) of the cartridges can be transitioned to an open state in which a corresponding anchor is removable from the cartridge by sliding at least a portion of the cartridge along the cartridge vector.

[0211] In some implementations, the cartridge defines a threshold force and is configured to transition to the open state only when the pulling force exceeds the threshold force.

[0212] In some implementations, the cartridge is configured to resist returning from an open state to a closed state.

[0213] In some implementations, the cartridge vector is angled relative to the proximal-distal axis.

[0214] In some implementations, the cartridge vectors of a set of cartridges collectively define a common cartridge plane on which the cartridge vectors lie.

[0215] In some implementations, the proximal-distal axis is parallel to a common cartridge plane.

[0216] In some implementations, the proximal and distal axes lie in a common cartridge plane.

[0217] In some implementations, the tether extends along the body parallel to the common cartridge plane.

[0218] According to some implementations, a system and / or device includes an implant including a tether, a first anchor, and / or a second anchor.

[0219] In some implementations, a first anchor may be coupled to the tether and / or may be configured to anchor the tether to tissue of a subject (e.g., a living subject, a simulation, etc.).

[0220] In some implementations, a second anchor can be coupled to the tether, hi some implementations, the second anchor can include an anchor head, a tissue engaging element, and / or a spacer.

[0221] In some implementations, the anchor head may include an interface.

[0222] In some implementations, a tissue engaging element extends distally away from the anchor head to define an anchor axis of the anchor, and the tissue engaging element is configured to be driven into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis by an anchor fixation force applied to the interface.

[0223] In some implementations, a spacer can extend along the tether away from the anchor head toward the first anchor in a manner that inhibits proximity of the second anchor and the first anchor.

[0224] In some implementations, the implant is sterilized.

[0225] In some implementations, the spacer is axially compressible.

[0226] In some implementations, the spacer is longer than the tissue engaging element.

[0227] In some implementations, the second anchor is fixedly coupled to the tether.

[0228] In some implementations, a second anchor is slidably coupled to the tether.

[0229] In some implementations, the implant is configured such that when a first anchor anchors the tether to tissue, a second anchor is advanceable along the tether toward the first anchor while the spacer faces toward the first anchor.

[0230] In some implementations, the implant is configured such that when the tissue engaging element is driven into the tissue, the first anchor is advanceable along the tether toward the second anchor while the spacer faces toward the first anchor.

[0231] In some implementations, the tether has a distal end and a spacer extends along the tether distally away from the anchor head.

[0232] In some implementations, the tether has a distal end and a spacer extends along the tether proximally away from the anchor head.

[0233] In some implementations, the interface is positioned on the anchor axis.

[0234] In some implementations, the tissue engaging element is helical and extends helically around and along the anchor shaft to define the anchor shaft and is configured to be threaded into tissue of a target.

[0235] In some implementations, the spacer resists axial compression.

[0236] In some implementations, the spacer is mounted so as to be rotatable about the anchor axis.

[0237] In some implementations, the anchor includes a collar surrounding the anchor shaft, hi some implementations, a spacer is coupled to the collar.

[0238] In some implementations, the spacer is mounted so as to be rotatable about the anchor axis by rotation of the collar about the anchor axis.

[0239] In some implementations, the anchor head includes a stock that fixedly couples the interface to the tissue engaging element. In some implementations, a collar surrounds and is rotatable about the stock. The stock can be configured in a variety of ways, for example, as a core, a rod, a tube, a neck, a winch, a peg, etc.

[0240] In some implementations, the second anchor is slidable along the tether in a delivery state in which the spacer extends away from the anchor head along the tissue engaging element.

[0241] In some implementations, the tissue engaging element has a sharp point at its distal end and / or the spacer extends beyond the sharp point in the delivery state.

[0242] In some implementations, the tissue engaging element can be comprised of one or more hooks, barbs, darts, staples, clips, prongs, arms, expandable portions, threaded portions, rivets, prongs, helices, screws, threaded portions, combinations of two or more thereof, and the like.

[0243] In some implementations, the spacer is pivotable from a delivery state so as to be substantially perpendicular to the tissue engaging element.

[0244] In some implementations, the spacer is flexible in deflection.

[0245] In some implementations, the spacer is elastic.

[0246] In some implementations, the spacer is tubular.

[0247] In some implementations, the spacer is defined by a coil-shaped helical wire.

[0248] In some implementations, for at least a portion of the spacer, the spacer comprises a substantially helical coil.

[0249] In some implementations, for at least a portion of the spacer, the coil may include and / or be formed from wire bent to define the coil such that a transverse cross section through the turns of the coil is substantially elliptical.

[0250] In some implementations, for at least a portion of the spacer, the coil may include and / or be formed from a tube that has been cut to define the coil such that a transverse cross section through the turns of the coil is substantially quadrilateral.

[0251] In some implementations, for at least some of the spacers, the spacers have a first end, a second end, and an intermediate portion therebetween, the first end and the second end being narrower than the intermediate portion.

[0252] In some implementations, for at least a portion of the spacer, the spacer tapers from its middle towards its ends.

[0253] In some implementations, the taper is shallow enough to prevent adjacent turns of the coil from axially overlapping upon axial compression of the spacer.

[0254] In some implementations, the coil may include and / or be formed from a metal.

[0255] In some implementations, the coil may include and / or be formed from a polymer.

[0256] In some implementations, the anchor further includes a snood that is positioned around the anchor head in a manner that maintains access to the interface.

[0257] In some implementations, the snood is absorbent.

[0258] In some implementations, the snood includes a sponge.

[0259] In some implementations, the snood comprises multiple layers of material.

[0260] In some implementations, the snood comprises a cellulose sheet.

[0261] In some implementations, the snood is impregnated with a substance and configured to gradually release the substance within the subject.

[0262] In some implementations, the substance includes a drug.

[0263] In some implementations, the substance includes a radiopaque dye.

[0264] In some implementations, the system / device further includes a delivery tool including an anchor driver and a tube that can be percutaneously advanced, the anchor driver configured to mate with the interface and to advance a second anchor through the tube and apply an anchor fixation force to the interface, thereby driving the anchor into tissue.

[0265] In some implementations, the anchoring force comprises a torque, and the anchor driver is configured to apply the torque to the interface, thereby driving the anchor into the tissue.

[0266] In some implementations, the tube defines an interior channel having a keyhole-shaped orthogonal cross-section that defines a major channel region and a minor channel region. In some implementations, the cross-sectional area of ​​the major channel region is larger than the cross-sectional area of ​​the minor channel region. In some implementations, the anchor driver is configured to advance the second anchor through the interior channel with the anchor head sliding snugly through the major channel region and the spacer sliding snugly through the minor channel region.

[0267] In some implementations, the spacer is configured to restrain the tether within the small channel region as the second anchor is advanced by the anchor driver through the interior channel.

[0268] According to some implementations, a system and / or device (e.g., for use with tissue, for use with a target tissue, for repair, etc.) includes an implant, an anchor driver, and / or an adjustment tool.

[0269] In some implementations, the implant may include a radiopaque tether that is biased toward assuming a regular wavy shape.

[0270] In some implementations, the implant can include multiple anchors, each including an anchor head and / or tissue-engaging element extending distally from the anchor head, where the head and / or tissue-engaging element can each be of the same or similar configuration as other heads and / or tissue-engaging elements described herein.

[0271] In some implementations, the anchor driver can be configured to anchor the multiple anchors to tissue by (i) driving a tissue engaging element into tissue for each of the multiple anchors through engagement with the anchor head, and / or (ii) threading a tether through the anchor head of each of the multiple anchors and causing the tether to assume its regular wavy shape.

[0272] In some implementations, the adjustment tool can be configured to apply tension to the tether in a manner that straightens the tether, draws multiple anchors toward each other, and / or locks tension in the tether.

[0273] In some implementations, the implant is sterilized.

[0274] In some implementations, the anchor driver is sterilized.

[0275] In some implementations, the adjustment tool is sterilized.

[0276] In some implementations, the tether comprises an elongated filled tube having a radiopaque core.

[0277] In some implementations, the tether comprises a cable that includes radiopaque strands and shape-memory strands.

[0278] In some implementations, the tether comprises a shape memory alloy and is shaped into a regular wave pattern.

[0279] In some implementations, the regular wave shape is sinusoidal and the tether is biased to assume the sinusoidal shape.

[0280] In some implementations, the regular wave shape is zigzag, and the tether is biased to assume the zigzag shape.

[0281] According to some implementations, the system and / or device includes an implant that includes an anchor, a tether, and / or a stopper.

[0282] In some implementations, the anchor can include an anchor head and / or a tissue-engaging element extending distally from the anchor head, where the head and / or tissue-engaging element can be of the same or similar configuration as other heads and / or tissue-engaging elements described herein, respectively.

[0283] In some implementations, the anchor head may include a socket.

[0284] In some implementations, a stopper may be attached to the end of the tether and secured within the socket in a manner that couples the anchor to the end of the tether.

[0285] In some implementations, the implant is sterilized.

[0286] In some implementations, the stopper is bulbous.

[0287] In some implementations, the stopper is substantially spherical.

[0288] In some implementations, the anchor is a leading anchor and the implant further includes one or more consecutive anchors.

[0289] In some implementations, the stopper is rotatable within the socket.

[0290] In some implementations, the stopper snaps into the socket.

[0291] In some implementations, the stopper is a bead.

[0292] In some implementations, the stopper is attached to the end of the tether by a crimp.

[0293] In some implementations, the stopper is attached to the end of the tether by welding.

[0294] In some implementations, the stopper is attached to the end of the tether by brazing.

[0295] In some implementations, the anchor is a fixed anchor and the implant further includes one or more sliding anchors, each of the sliding anchors slidably coupled to a tether.

[0296] In some implementations, each of the one or more sliding anchors includes an eyelet that is slidably coupled to a tether by threading the tether through the eyelet, which may be the same as or similar to other eyelets described elsewhere herein.

[0297] In some implementations, the anchor head includes a casing that defines a socket. In some implementations, the casing further defines a window in the socket. In some implementations, a tether extends from the stopper, through the window, and exits the socket.

[0298] In some implementations, across from the window, the socket has an open side.

[0299] In some implementations, the casing includes a cantilever that prevents the stopper from exiting the socket through the open side.

[0300] In some implementations, the window extends at least one-fifth of the way around the stopper.

[0301] In some implementations, the window curves in an arc around the socket.

[0302] In some implementations, the window is sized and the socket is configured to allow the tether to pivot relative to the anchor head via rotation of a stopper within the socket.

[0303] In some implementations, the window is sized and the socket is configured to allow the tether to pivot relative to the anchor head to rotate the stopper within the socket.

[0304] In some implementations, the tissue engaging element extends distally from the anchor head to define an anchor shaft along which the tissue engaging element is advanceable into tissue of a subject (e.g., a living subject, a simulation, etc.).

[0305] In some implementations, the window is shaped to allow the tether to pivot between (i) an axial state in which the tether extends through the window in a trajectory parallel to the anchor axis, and / or (ii) a lateral state in which the tether extends through the window in a trajectory perpendicular to the anchor axis.

[0306] In some implementations, the end of the tether does not protrude from the stopper.

[0307] In some implementations, the end of the tether is flush with the outer surface of the stopper.

[0308] In some implementations, the end of the tether is disposed within a stopper.

[0309] According to some implementations, a system usable and / or for use in the heart of a subject (e.g., a live subject, a simulation, etc.) includes an implant and a delivery tool.

[0310] In some implementations, the implant can include an anchor having a head and a helical tissue-engaging element extending distally away from the head to define an anchor axis of the anchor. In some implementations, the head can define an interface of the anchor.

[0311] In some implementations, the delivery tool can include a catheter device and / or an anchor driver.

[0312] In some implementations, the catheter device may include an extracorporeal portion at a proximal portion of the catheter device and / or a flexible tube extending distally from the extracorporeal portion.

[0313] In some implementations, the flexible tube can have a distal portion configured for transluminal advancement into the heart, in some implementations, the flexible tube can have a distal portion with a distal opening, in some implementations, the flexible tube can have a distal portion that defines a channel along the tube's luminal axis through which the anchor is slidable toward the distal opening.

[0314] In some implementations, the flexible tube may have a distal portion, proximal to the distal opening, that defines a gripping zone, the distal portion having resilient ribs extending inwardly into the channel in a manner that inhibits sliding of the anchor through the gripping zone by gripping the helical tissue-engaging element.

[0315] In some implementations, the anchor driver can be configured to drive the anchor through the gripping zone by sliding the anchor distally through the channel towards the gripping zone via engagement with the interface and / or by threading the tissue engaging element onto the rib.

[0316] In some implementations, the implant is sterilized.

[0317] In some implementations, the catheter device is sterilized.

[0318] In some implementations, the anchor driver is sterilized.

[0319] In some implementations, the distal opening has a rim and the tube is shaped so that the rim is contoured.

[0320] In some implementations, the distal portion flares toward the distal opening.

[0321] In some implementations, the rib is configured such that when a driver threads the tissue engaging element onto the rib, the tissue engaging element compresses the portion of the rib that it contacts.

[0322] In some implementations, the rib has a proximal surface shaped to define a shoulder.

[0323] In some implementations, the ribs have a tapered distal surface.

[0324] In some implementations, the anchor further includes an eyelet attached to the head so as to be rotatable about the anchor axis, which eyelet may be the same as or similar to the eyelets described elsewhere herein.

[0325] In some implementations, the implant may further include a tether threaded through the eyelet such that the eyelet is slidable along the tether.

[0326] In some implementations, a rib extends inwardly into the channel adjacent the rib in a manner that defines a niche in the gripping zone. In some implementations, the system is configured such that the tissue engaging element is removed from the niche while the anchor driver screws the tissue engaging element onto the rib, and / or a tether extends laterally from the tissue engaging element and through the gripping zone in the niche.

[0327] In some implementations, proximal to the rib, the tube further defines an abutment that protrudes inward into the channel in a manner that inhibits rotation of the eyelet about the anchor axis when the anchor driver screws the tissue engaging element onto the rib.

[0328] In some implementations, a single structure defines both the rib and the abutment.

[0329] In some implementations, the ribs project further inward into the channel than the abutment.

[0330] In some implementations, the abutment is longer along the channel than the rib.

[0331] In some implementations, the ribs include and / or are formed from a polymer.

[0332] In some implementations, the tube is lined with a polymer.

[0333] In some implementations, the tube includes and / or is formed from a polymer.

[0334] In some implementations, the polymer is a thermoplastic elastomer.

[0335] In some implementations, the polymer is a block copolymer.

[0336] In some implementations, the block copolymer is a polyether block amide.

[0337] In some implementations, the rib is a first rib of a plurality of ribs defined by a distal portion within the gripping zone.

[0338] In some implementations, the plurality of ribs is exactly two ribs.

[0339] In some implementations, the plurality of ribs is exactly three ribs.

[0340] In some implementations, the plurality of ribs is exactly four ribs.

[0341] In some implementations, the plurality of ribs is exactly five ribs.

[0342] In some implementations, the plurality of ribs is exactly six ribs.

[0343] In some implementations, a plurality of ribs are distributed circumferentially around the tube axis.

[0344] In some implementations, multiple ribs are distributed along the tube axis.

[0345] In some implementations, the rib extends around at least a portion of the tube axis.

[0346] In some implementations, the rib is annular and extends circumferentially around the entire tube axis.

[0347] In some implementations, the ribs extend along the tube axis.

[0348] In some implementations, the ribs are parallel to the tube axis.

[0349] According to some implementations, a system usable and / or for use in the heart of a subject (e.g., a live subject, a simulation, etc.) includes an implant and a delivery tool.

[0350] In some implementations, the implant can include an anchor having a head and a helical tissue-engaging element extending distally away from the head to define an anchor axis of the anchor. In some implementations, the head can define an interface of the anchor.

[0351] In some implementations, the delivery tool can include a catheter device and / or an anchor driver.

[0352] In some implementations, the catheter device may include an extracorporeal portion at a proximal portion of the catheter device and / or a flexible tube extending distally from the extracorporeal portion.

[0353] In some implementations, the flexible tube can have a distal portion that is (i) configured for transluminal advancement into the heart and (ii) has a distal opening, hi some implementations, the flexible tube can have a distal portion that defines a channel along the tube's luminal axis through which the anchor is slidable toward the distal opening.

[0354] In some implementations, the flexible tube can have a membrane positioned over the distal opening and having one or more slits that divide the membrane into multiple flaps.

[0355] In some implementations, the anchor driver may be configured to slide the anchor distally through the channel via engagement with the interface and distally through the membrane via one or more slits, the membrane configured such that the flaps temporarily separate in response to passage of the anchor through the membrane.

[0356] In some implementations, the implant is sterilized.

[0357] In some implementations, the catheter device is sterilized.

[0358] In some implementations, the anchor driver is sterilized.

[0359] In some implementations, the membrane has multiple slits.

[0360] In some implementations, multiple slits divide the membrane into four flaps.

[0361] In some implementations, multiple slits converge to define a convergence point.

[0362] In some implementations, the membrane has a hole at the convergence point.

[0363] In some implementations, the anchor driver is configured to slide the anchor distally through the channel so that the tissue engaging element is aligned with the hole.

[0364] In some implementations, the membrane defines an eccentrically positioned notch.

[0365] In some implementations, the notch extends laterally from the convergence point.

[0366] In some implementations, a notch is defined in a single one of the flaps.

[0367] In some implementations, the notch is defined partially in one of the flaps and partially in another portion of the flap.

[0368] In some implementations, the head is on the anchor shaft. In some implementations, the anchor includes an eyelet mounted laterally from the anchor shaft. This eyelet can be the same as or similar to eyelets described elsewhere herein.

[0369] In some implementations, the anchor driver is configured to slide the anchor distally through the channel so that the eyelet aligns with the notch.

[0370] According to some implementations, the system and / or device may be configured for use with a tether secured to tissue of a subject (e.g., a live subject, a simulation, etc.). In some implementations, the system / device includes a tool and / or a lock.

[0371] In some implementations, the lock can define a passage therethrough, the passage configured to receive a tether therethrough, hi some implementations, the lock can have an unlocked state in which the lock is transluminally slidable along the tether and into tissue with the tether sliding through the passage.

[0372] In some implementations, the lock can include a clamping surface and a blade, and can further include an interface engageable by a tool in a manner that configures the tool to actuate the lock by applying an actuation force to the interface.

[0373] In some implementations, the lock can be configured such that while the tether is positioned through the passageway, actuation of the lock (i) locks the tether to the lock by clamping a clamping surface onto the tether, and (ii) cuts the tether with a blade.

[0374] In some implementations, the tool is sterilized.

[0375] In some implementations, the lock is sterilized.

[0376] In some implementations, the actuation force is a torque, and the tool is configured to actuate the lock by applying the torque to the interface.

[0377] In some implementations, the lock includes opposing surfaces, and actuation of the lock advances the clamping surface toward the opposing surfaces, thereby locking the tether to the lock.

[0378] In some implementations, the lock is configured such that after tightening of the tether between the clamping surface and the opposing surface, further actuation of the lock causes the clamping surface to push against the opposing surface and move with the clamping surface.

[0379] In some implementations, actuation of the lock clamps the clamping surface to the tether via axial movement of the clamping surface and / or severs the tether via axial movement of the blade.

[0380] In some implementations, actuation of the lock clamps the clamping surface to the tether via planar movement of the clamping surface and / or severs the tether via planar movement of a blade.

[0381] In some implementations, the lock includes a mechanical linkage including a first bar and a second bar, the first bar providing the clamping surface and the second bar providing the blade.

[0382] In some implementations, the mechanical linkage is a planar linkage.

[0383] In some implementations, the first bar is hingedly connected to the second bar.

[0384] In some implementations, the mechanical linkage is configured such that actuation of the lock tightens the tether between the clamping surface and the second bar.

[0385] In some implementations, the lock includes a casing, and the mechanical linkage is configured such that actuation of the lock tightens the tether between the clamping surface and the casing.

[0386] In some implementations, the blade faces away from the first bar.

[0387] In some implementations, the interface is coupled to a threaded rod that cooperates with a mechanical linkage as a linear actuator such that rotation of the interface rotates the threaded rod and pivots the first bar relative to the second bar.

[0388] In some implementations, the lock is configured such that a first amount of actuation clamps the clamping surface to the tether and / or beyond the first amount of actuation, further actuation of the lock is required for the blade to cut the tether, such that actuation of the lock tightens the clamping surface to the tether before the blade cuts the tether.

[0389] In some implementations, the lock is configured such that actuation of the lock clamps the clamping surface onto the tether before the tether is cut by the blade, such that the travel distance of the blade required to cut the tether is greater than the travel distance of the clamping surface required to clamp the clamping surface onto the tether.

[0390] In some implementations, the lock is configured to clamp the clamping surface to the tether before severing the tether with the blade, with the lock including a mechanism that causes the blade to move at a different speed than the clamping surface in response to actuation of the lock.

[0391] In some implementations, the lock includes opposing surfaces, and actuation of the lock locks the tether to the lock by clamping the tether between the clamping surface and the opposing surface.

[0392] In some implementations, the lock includes a spring, and / or further actuation of the lock tensions the spring, which activates the blade.

[0393] In some implementations, the opposing surfaces are supported by compressible members.

[0394] In some implementations, further actuation of the lock drives the clamping surface to compress the compressible member in a manner that maintains the tether secured between the clamping surface and the opposing surface and / or allows movement of the blade to sever the tether.

[0395] In some implementations, the lock extends from the first end of the passage to the second end of the passage, defining a lateral access through which the tether can be introduced laterally into the passage.

[0396] In some implementations, the lock includes a casing at a first end of the passageway that defines an entrance to the passageway, hi some implementations, the lock includes a casing at a second end of the passageway that defines an exit from the passageway.

[0397] In some implementations, the lock includes a casing that connects the inlet to the outlet and defines a lateral slit that provides lateral access.

[0398] In some implementations, actuation of the lock cuts the tether by rotating a blade about an axis.

[0399] In some implementations, actuation of the lock causes the clamping surface to tighten onto the tether by moving the clamping surface along an axis.

[0400] According to some implementations, the system and / or device may be configured for use with a tether fixed to tissue (e.g., of a living subject, a simulation, etc.). In some implementations, the device includes a malleable lock and / or tool.

[0401] In some implementations, the malleable lock may be shaped to define a passageway therethrough.

[0402] In some implementations, the tool may include a shaft, a collet, and a grasper.

[0403] In some implementations, a collet may be housed within the shaft and / or a lock may be held within the collet.

[0404] In some implementations, a grasper can extend distally through the passageway, out of the shaft, and / or can be configured to grasp the slack in the tether and pull the slack proximally into the shaft through the lock, thereby holding the tether as a loop within the shaft.

[0405] In some implementations, the tool may be configured to (i) advance distally within the body along the tether so that incremental regions of the tether are fed around the grasper while the tether remains held as a loop within the shaft, (ii) then engage the lock to the tether by actuating the collet to crimp the lock, (iii) then release the lock from the collet and the tether from the grasper, and / or (iv) then be withdrawn from the subject.

[0406] In some implementations, the tool is sterilized.

[0407] In some implementations, the lock is sterilized.

[0408] In some implementations, the tool is configured to actuate the collet via rotation of the shaft.

[0409] In some implementations, the grasper is a hook.

[0410] In some implementations, the grasper is a snare.

[0411] According to some implementations, a system usable with and / or for use on a subject includes a catheter device, a tether, a series of anchors, an anchor driver, and / or a tensioner.

[0412] The catheter device can include a tube having a proximal end defining (i) a distal opening configured to be inserted transluminally into a subject, and (ii) a proximal opening.

[0413] In some implementations, the catheter device may include an extracorporeal unit coupled to the proximal end of the tube.

[0414] In some implementations, the tether may have a first end and a second end, the second end being coupled to the extracorporeal unit.

[0415] In some implementations, the series of anchors can include a leading anchor coupled to a distal end of the tether and multiple consecutive anchors slidably coupled to the tether.

[0416] In some implementations, the anchor driver can be configured to (i) advance a leading anchor having a tether distal end through the vessel and anchor the leading anchor to the target tissue, and (ii) then, for each successive anchor, advance the successive anchor along the tether through the vessel.

[0417] In some implementations, the tensioner may be configured to (i) engage an intermediate region of the tether, the intermediate region of the tether being in the extracorporeal unit and between the distal end and the second end, and / or (ii) apply tension to the tether by pulling the intermediate region of the tether.

[0418] In some implementations, the catheter device is sterilized.

[0419] In some implementations, the tether is sterilized.

[0420] In some implementations, the set of anchors is sterilized.

[0421] In some implementations, the anchor driver is sterilized.

[0422] In some implementations, the tensioner is sterilized.

[0423] In some implementations, the tensioner includes a gripper configured to grip the tether in a manner that defines a separation region of the tether between the gripping portion and the second end and isolates the separation region from the tension applied by the tensioner.

[0424] In some implementations, the tensioner includes a sheave and is configured to engage an intermediate region of the tether by engaging the sheave with the tether.

[0425] In some implementations, the tensioner is a component of the extracorporeal unit.

[0426] In some implementations, the tensioner includes a linear actuator.

[0427] In some implementations, the tensioner includes a knob and complementary threads and is actuatable via rotation of the knob.

[0428] In some implementations, the tensioner is configured to apply tension to the tether by pulling laterally on an intermediate region of the tether.

[0429] In some implementations, the tensioner includes a force gauge that indicates the magnitude of the tension.

[0430] In some implementations, the extracorporeal unit includes a winch, and the second end of the tether is operably coupled to the winch.

[0431] In some implementations, the winch is spring loaded in a manner that reduces slack in the tether.

[0432] In some implementations, the death tracker includes a user-operable stop switch to stop the death tracker in a manner that causes slack to be introduced into the tether and not picked up by the winch.

[0433] In some implementations, the anchor is mounted on an extracorporeal unit.

[0434] In some implementations, each of the anchors is stored in a respective cartridge that is mounted on the extracorporeal unit.

[0435] In some implementations, the system further includes a plurality of spacers interleaved with the series of anchors and through which the tether is threaded.

[0436] In some implementations, the system further includes at least one free spacer that is separate from the tether and allows the tether to be manually threaded between the anchors without accessing the ends of the tether.

[0437] In some implementations, each of the spacers is tubular and threaded with a tether that extends through a lumen defined by the spacer.

[0438] In some implementations, the tube is substantially axially incompressible.

[0439] In some implementations, the tube is a flexible sleeve that is substantially axially compressible.

[0440] In some implementations, the tube is a woven tube.

[0441] In some implementations, the tube has a sidewall that is expandable in a manner that adjusts the compressibility of the spacer.

[0442] In some implementations, each of the spacers is a ribbon with the tether threaded by a tether woven along the ribbon.

[0443] In some implementations, each of the spacers is expandable in a manner that adjusts the compressibility of the spacer.

[0444] In some implementations, each spacer has a body and one or more laterally positioned eyelets through which the tether is threaded such that the body is laterally attached from the tether.

[0445] In some implementations, the system further includes a plurality of connectors, each connecting a corresponding one of the spacers to a corresponding set of anchors.

[0446] In some implementations, the system further includes a disconnector housed within and removable from the compartment of the extracorporeal unit and configured to disconnect one or more of the connectors.

[0447] In some implementations, each of the connectors provides a frangible connection between a corresponding spacer and a corresponding anchor.

[0448] In some implementations, the frangible connection is configured to be broken by pulling the connector away from the corresponding spacer.

[0449] In some implementations, each of the spacers includes a helical coil, and the frangible connection is provided by a connector that is inserted between adjacent turns of the helical coil of the corresponding spacer.

[0450] In some implementations, each of the spacers includes a helical coil, and the frangible connection is configured to be broken by rotating the spacer to unwind the helical coil from the corresponding connector.

[0451] In some implementations, each of the spacers is disposed on a tether such that the spacer tracks the corresponding anchor as the anchor advances distally along the tether toward the proximal opening.

[0452] In some implementations, a first spacer of the spacers is connected to the leading anchor and is axially less compressible than at least another spacer of the spacers.

[0453] In some implementations, each of the anchors includes (i) an anchor head; (ii) a tissue-engaging element extending distally away from the anchor head to define an anchor axis of the anchor and / or configured to be driven along the anchor axis into tissue of a subject (e.g., a living subject, a simulation, etc.); and / or (iii) a fabric and / or polymer shaped to define an eyelet, the anchor being coupled to the tether by the eyelet being coupled to the tether. The fabric and / or polymer may be the same as or similar to other fabrics and / or polymers described elsewhere herein. The eyelet may be the same as or similar to eyelets described elsewhere herein.

[0454] In some implementations, for at least a portion of the anchor, the fabric and / or polymer is a single piece of fabric and / or polymer that is further shaped to define a spacer that extends along the tether and away from the anchor head.

[0455] In some implementations, the single piece of fabric is a strip along which the tether is woven.

[0456] In some implementations, the single piece of fabric further defines a collar that rotatably couples the single piece of fabric to the anchor such that the eyelet and spacer are rotatable about the anchor axis.

[0457] In some implementations, the single piece of fabric further defines a narrowed neck between the collar and the spacer that facilitates pivoting of the spacer.

[0458] In some implementations, a spacer extends along the tether from the anchor head to a series of subsequent anchors.

[0459] In some implementations, the tissue engaging element is porous.

[0460] In some implementations, the tissue engaging element is formed to be helical and porous via additive manufacturing.

[0461] In some implementations, the tissue engaging element may include and / or be formed from titanium.

[0462] In some implementations, the tissue engaging element may include and / or be formed from a structural material, with a coating on which the structural material is coated, the coating being (i) a coating of a material other than the structural material, and (ii) etched in a manner that provides the tissue engaging element with a textured surface.

[0463] In some implementations, the coating material is a gold coating.

[0464] In some implementations, the coating is formed by laser etching.

[0465] In some implementations, the coating is ion beam etched.

[0466] In some implementations, the tensioner is configured to (i) apply tension and / or (ii) thereafter maintain tension.

[0467] In some implementations, the tensioner includes a latch and is configured to maintain tension with the latch latched after the tensioner is actuated.

[0468] In some implementations, the tensioner includes a ratchet, which maintains the tension.

[0469] In some implementations, the tensioner is reversibly attachable onto the extracorporeal unit.

[0470] In some implementations, the extracorporeal unit defines an access site where the anchor driver advances a leading anchor having a distal end of a tether through the vessel and secures the leading anchor, with an intermediate region of the tether extending through the access site.

[0471] In some implementations, a tensioner is reversibly attachable to the access site of the extracorporeal unit.

[0472] According to some implementations, the system and / or device includes an anchor that includes an anchor head, a tissue engaging element, and an eyelet, which may be the same as or similar to other heads, tissue engaging elements, and / or eyelets elsewhere herein.

[0473] In some implementations, the anchor head may include a stock, which may be configured in a variety of ways, such as a core, a rod, a tube, a winch, a peg, a neck, etc.

[0474] In some implementations, a tissue engaging element may be coupled to the stock and may extend distally from the anchor head to define an anchor axis of the anchor and / or may be configured to be driven into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis.

[0475] In some implementations, the eyelet may be mounted eccentrically from the stock and may be saddle-shaped.

[0476] In some implementations, the anchor is sterilized.

[0477] In some implementations, the system / device further includes a tether threaded through the eyelet.

[0478] In some implementations, the eyelet is rotatable about the anchor axis.

[0479] In some implementations, the anchor further includes a collar that surrounds the stock, the eyelet being rotatable about the anchor axis by the collar that rotates about the anchor axis.

[0480] According to some implementations, the system and / or device includes an anchor for use with and / or for use with cardiac tissue of a subject (e.g., a live subject, a simulation, etc.), the anchor including an anchor head and a tissue-engaging element, which may be the same as or similar to other anchors, heads, and / or tissue-engaging elements elsewhere herein.

[0481] In some implementations, the anchor head can define the interface and can be formed substantially from a polymer.

[0482] In some implementations, a tissue engaging element can extend distally away from the anchor head to define an anchor axis of the anchor, and can be configured to be driven into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis by an anchor fixation force applied to the interface, and / or can be formed substantially from a polymer.

[0483] In some implementations, the anchor is sterilized.

[0484] In some implementations, the anchor head includes a metal pin that serves as part of the interface.

[0485] In some implementations, the polymer is a polyaryletherketone.

[0486] In some implementations, the polymer is polyetheretherketone.

[0487] In some implementations, at least a portion of the anchor has a radiopaque material mixed with the polymer.

[0488] In some implementations, the radiopaque material is barium sulfate.

[0489] In some implementations, the anchor head includes a stock that fixedly couples the interface to the tissue engaging element, and the anchor further includes a collar and / or eyelet. The stock can be configured in various ways, for example, as a core, a rod, a tube, a neck, a winch, a peg, etc.

[0490] In some implementations, the collar and / or eyelets may be substantially formed from a polymer.

[0491] In some implementations, a collar may be rotatably coupled to the anchor head by surrounding the stock.

[0492] In some implementations, the eyelet may be eccentrically mounted by being coupled to a collar and may be rotatable about the anchor axis by rotation of the collar about the stock.

[0493] In some implementations, the collar and eyelets are formed as a monolithic piece of polymer.

[0494] In some implementations, the tissue engaging element includes a central shaft and an external self-tapping thread that extends helically around and along the central shaft.

[0495] In some implementations, the central shaft defines a distal point and has a tapered region that tapers distally toward the distal point.

[0496] In some implementations, the distal point is on the anchor axis.

[0497] In some implementations, the central shaft tapers more steeply at the distal point compared to the tapered region.

[0498] In some implementations, the threads protrude laterally from the central shaft a distance, and the central shaft has a diameter that is 2 to 4 times larger than the distance.

[0499] In some implementations, the diameter of the central shaft is about three times larger than the distance.

[0500] According to some implementations, the system includes an implant including a tether and / or an anchor. The anchor may include an anchor head, a tissue engaging element, and / or a fabric (and / or polymer).

[0501] In some implementations, the anchor head includes a stock and / or an interface. A tissue engaging element may be coupled to the interface via the stock and may extend distally away from the anchor head to define an anchor axis of the anchor and / or may be configured to be driven into tissue of a subject (e.g., a living subject, a simulation, etc.) along the anchor axis by an anchor fixation force applied to the interface.

[0502] In some implementations, the fabric (and / or polymer) is shaped to define an eyelet through which the tether is threaded. The eyelet may be pivotable on the interface. The fabric (and / or polymer) may be the same as or similar to other fabrics (and / or polymers) described elsewhere herein. The eyelet may be the same as or similar to eyelets described elsewhere herein.

[0503] In some implementations, the fabric is a woven cloth.

[0504] In some implementations, the fabric is a yarn.

[0505] In some implementations, the fabric is elongated, having two ends and slack therebetween, and is shaped to define a loop at each end through which the stock is threaded such that the slack defines an eyelet.

[0506] In some implementations, the anchor further includes a collar that surrounds the stock, and the eyelet is connected to the collar such that the eyelet is rotatable about the anchor axis by the collar rotating about the anchor axis.

[0507] In some implementations, the fabric is elongated and has two ends and a slack therebetween, the ends being connected to the collar such that the slack defines an eyelet.

[0508] In some implementations, the eyelet is pivotable on the interface by extending from two locations on the collar and / or pivoting about a hinge axis across which the two locations lie.

[0509] In some implementations, the color is defined by the fabric.

[0510] In some implementations, the collar is rigid.

[0511] In some implementations, the collar is shaped to define at least one bore through which the fabric passes.

[0512] In some implementations, the collar is shaped to define at least one tab to which the fabric is tied.

[0513] In some implementations, the collar is flexible.

[0514] In some implementations, the collar is defined by a flexible tube. In some implementations, the flexible tube has a lumen along the tube, the lumen having end openings at each end of the tube and / or two transverse channels. Stock can extend transversely through the tube via the transverse channels. In some implementations, a fabric defines a closed loop in which the tube is threaded by the fabric extending through the lumen and out both end openings.

[0515] According to some implementations, a system usable with and / or for use in cardiac tissue of a subject (e.g., a live subject, a simulation, etc.) includes an implant, which may include a tether and / or a plurality of anchors. In some implementations, the tether may have a series of beads fixedly distributed therealong.

[0516] In some implementations, each of the anchors may include a tissue-engaging element and / or a head coupled to the tissue-engaging element, hi some implementations, the tissue-engaging element may define an anchor axis of the anchor.

[0517] In some implementations, the head has a geometry that (i) facilitates sliding of the head over and along the tether while the anchor axis is parallel to the tether by allowing beads to pass through the head, and / or (ii) inhibits sliding of the head over and along the tether while the anchor axis is transverse to the tether by obstructing beads from passing through the head.

[0518] In some implementations, the system further includes, for each of the anchors, an anchor driver configured to implant the implant into the tissue through engagement with the head by (i) transluminally sliding the head over and along the tether into the heart while the anchor axis is parallel to the tether, and (ii) driving the tissue engaging element into the tissue so that the tether is non-parallel to the tissue engaging element of each of the anchors.

[0519] In some implementations, the system further includes an adjustment tool configured to apply tension to the tether after the implant is implanted in the tissue, and the implant is configured such that tension on the tether is obstructed by at least one head of the anchor after the implant is implanted in the tissue.

[0520] In some implementations, each of the beads is oval.

[0521] In some implementations, each of the beads is a prolate spheroid.

[0522] In some implementations, each of the beads is radiopaque.

[0523] In some implementations, each of the beads is echogenic.

[0524] In some implementations, the implant is sterilized.

[0525] In some implementations, the anchor driver is sterilized.

[0526] In some implementations, the adjustment tool is sterilized.

[0527] According to some implementations, a system usable and / or for use in a subject's tissue (e.g., a live subject, a simulation, etc.) includes a catheter device, a tether, and / or a series of anchors. In some implementations, the catheter device may include a tube and / or an extracorporeal unit. In some implementations, the tube may have a distal opening configured for transluminal advancement into the subject, and / or a proximal end defining a proximal opening.

[0528] In some implementations, an extracorporeal unit can be coupled to the proximal end of the tube.

[0529] In some implementations, the extracorporeal unit includes a body and / or a series of cartridges (or anchor holders). In some implementations, the series of cartridges are distributed along the body in a manner defining a proximal-distal axis. In some implementations, the series of cartridges / anchor holders are distributed along the body in a manner defining a proximal-distal axis having one row or column of cartridge / anchor holders along the axis, while other arrangements have two or more parallel rows or columns of cartridge / anchor holders. In some implementations, the series of cartridge / anchor holders are distributed along the body in a manner aligned with the proximal-distal axis (e.g., in a curved manner, an angled manner, a zigzag manner, etc.).

[0530] The cartridge / anchor holders herein can be configured in a variety of ways (eg, from simple receptacles or holes for holding the anchors to more involved or elaborate configurations and mechanisms).

[0531] In some implementations, one or more (e.g., one, some, or all) of the cartridges can define a respective cartridge vector that is angled relative to the proximal-distal axis, has a closed state, and / or is transitionable to an open state by at least a portion of the cartridge being slid along that cartridge vector.

[0532] In some implementations, a tether may extend along the body.

[0533] In some implementations, each anchor in the series of anchors is coupled to a tether and is housed by a corresponding cartridge in the series of cartridges and / or is removable from the corresponding cartridge upon transition of the corresponding cartridge to an open state.

[0534] In some implementations, the cartridge vectors of a set of cartridges collectively define a common cartridge plane on which the cartridge vectors lie.

[0535] In some implementations, the proximal-distal axis is parallel to a common cartridge plane.

[0536] In some implementations, the proximal and distal axes lie in a common cartridge plane.

[0537] In some implementations, the tether extends along the body parallel to the common cartridge plane.

[0538] According to some implementations, a system usable and / or for use in a subject's tissue (e.g., a live subject, a simulation, etc.) includes a catheter device, a tether, and / or a series of anchors.

[0539] In some implementations, the catheter device may include a tube and / or an extracorporeal unit. In some implementations, the tube may have a distal opening configured for transluminal advancement into a subject and / or a proximal end defining a proximal opening. In some implementations, the extracorporeal unit may be coupled to the proximal end of the tube.

[0540] In some implementations, the extracorporeal unit includes a body and / or a series of cartridges (or anchor holders). In some implementations, the series of cartridges can be distributed along the body in a manner that defines a proximal-distal axis.

[0541] In some implementations, a tether may extend along the body.

[0542] In some implementations, each anchor in the series of anchors is coupled to a tether and is received by a corresponding cartridge / anchor holder in the series of cartridge / anchor holders.

[0543] In some implementations, each anchor is removable from the corresponding cartridge by pulling on the anchor such that at least a portion of the corresponding cartridge slides along a respective cartridge vector that is inclined relative to the proximal-distal axis.

[0544] According to some implementations, a system usable and / or for use in a subject's tissue (e.g., a live subject, a simulation, etc.) includes a catheter device, a tether, and / or a series of anchors. In some implementations, the catheter device may include a tube and / or an extracorporeal unit. In some implementations, the tube may have a distal opening configured for transluminal advancement into the subject, and / or a proximal end defining a proximal opening.

[0545] In some implementations, an extracorporeal unit can be coupled to the proximal end of the tube.

[0546] In some implementations, a tether may extend along the extracorporeal unit.

[0547] In some implementations, a series of anchors can be distributed along the body in a manner that defines a proximal-distal axis.

[0548] In some implementations, each anchor in the series of anchors includes a head coupled to the tether and / or a tissue engaging element extending away from the head to define an anchor shaft of the anchor.

[0549] In some implementations, each anchor in the series of anchors is mounted on the extracorporeal unit such that the anchor axis is oriented at an angle relative to the proximal-distal axis.

[0550] In some implementations, a tether extends along the extracorporeal unit along the proximal-distal axis.

[0551] In some implementations, the extracorporeal unit includes a series of cartridges (or anchor holders) distributed along the proximal-distal axis, and / or each of the anchors is mounted on the extracorporeal unit by being housed by a corresponding cartridge in the series of cartridges.

[0552] In some implementations, for each anchor in the series of anchors, the anchor is oriented with the head proximally from the tissue engaging element.

[0553] In some implementations, for each anchor in the series of anchors, the anchor is oriented with the tissue engaging element closer to the proximal opening than the head.

[0554] In some implementations, the anchor axes of a set of anchors collectively define a common anchor plane.

[0555] In some implementations, the proximal-distal axis is parallel to a common anchor plane.

[0556] In some implementations, the proximal and distal axes lie in a common anchor plane.

[0557] In some implementations, the tethers extend along the extracorporeal body parallel to the common anchor plane.

[0558] In some implementations, an anchor usable for and / or for use in cardiac tissue of a subject (e.g., a live subject, a simulation, etc.) includes a head and / or a tissue-engaging element.

[0559] In some implementations, the tissue engaging element may extend away from the head to define an anchor shaft of the anchor configured to drive the tissue engaging element into tissue, and / or may be formed to be porous by additive manufacturing.

[0560] In some implementations, the tissue engaging element is helical and configured to be threaded into tissue along the anchor shaft.

[0561] In some implementations, the tissue engaging elements are darts.

[0562] In some implementations, the tissue engaging elements are staples.

[0563] In some implementations, the tissue engaging element may include and / or be formed from titanium.

[0564] In some implementations, the tissue engaging elements are formed by powder bed fusion.

[0565] In some implementations, the tissue engaging elements may include and / or be formed by electron beam melting.

[0566] In some implementations, the tissue engaging element may include and / or be formed by powder fed directed energy deposition.

[0567] In some implementations, the tissue engaging element may be formed from a structural material and / or may have a coating on which the structural material is coated, where the coating is (i) a coating of a material other than the structural material and / or (ii) etched in a manner that provides the tissue engaging element with a textured surface.

[0568] In some implementations, the tissue engaging element is helical and configured to be threaded into tissue along the anchor shaft.

[0569] In some implementations, the tissue engaging elements are darts.

[0570] In some implementations, the tissue engaging elements are staples.

[0571] In some implementations, the structural material is coated with the coating by electroplating.

[0572] In some implementations, the structural material is steel.

[0573] In some implementations, the coating is gold.

[0574] In some implementations, the tissue engaging elements are etched by laser etching.

[0575] In some implementations, the tissue engaging elements are etched by ion beam etching.

[0576] In some implementations, the tissue engaging element is etched shallowly enough so that the coating is not etched completely through.

[0577] In some implementations, the method includes (i) absorbing a substance into a snood disposed around a head of an anchor, such that the head includes an interface, the anchor includes a tissue-engaging element coupled to the interface, and the snood is disposed around the anchor head in a manner that maintains access to the interface, and (ii) performing a procedure on the subject. In some implementations, the procedure may include (i) transluminally advancing the anchor with the snood carrying the absorbed substance into a heart of the subject, and / or (ii) applying an anchor fixation force to the interface, thereby driving the tissue-engaging element into tissue of the heart.

[0578] In some implementations, the substance includes a drug, and absorbing the substance into the snood includes absorbing the drug into the snood.

[0579] In some implementations, the substance includes a radiopaque dye, and absorbing the substance into the snood includes absorbing the radiopaque dye into the snood.

[0580] In some implementations, the procedure is performed in an operating room, and the absorption step is performed in the operating room.

[0581] In some implementations, the absorption step is performed for 2 hours or less before transluminally advancing the anchor.

[0582] In some implementations, advancing the anchor includes advancing the anchor using a driver engaging with the interface, driving the tissue engaging element includes driving the tissue engaging element by applying an anchor securing force to the interface using the driver, and / or absorbing the substance includes absorbing the substance while the driver is engaged with the interface.

[0583] In some implementations, absorbing the substance includes dipping the anchor into the substance using a driver while the driver is engaged with the interface.

[0584] According to some implementations, the present disclosure relates to methods that include manufacturing a woven fabric component usable in and / or for use with an implantable anchor. In some implementations, the method includes (i) weaving the fabric into an elongated form that includes first and second tubular structures that are connected to one another and parallel, and / or (ii) slicing the elongated form into transverse slices.

[0585] In some implementations, each slice can define a respective woven component including a first ring derived from the first tubular structure and configured to function as a collar of the anchor, and / or a second ring derived from the second tubular structure, connected to the first ring, and configured to function as an eyelet of the anchor.

[0586] In some implementations, weaving the fabric into an elongated form includes weaving the fabric into an elongated form such that the first tubular structure has a larger inner diameter than the second tubular structure.

[0587] In some implementations, weaving the fabric into an elongated form includes weaving the fabric into an elongated form such that the first tubular structure and the second tubular structure extend parallel along a warp axis of the fabric.

[0588] In some implementations, the method further includes, for each of the woven components, rotatably mounting a first ring onto the head of the anchor such that the first ring couples the second ring to the head in a manner that allows the second ring to rotate about the head.

[0589] In some implementations, the method further includes manufacturing a woven component for an implantable anchor by weaving a first elongated form comprising a first tubular structure, weaving a second elongated form comprising a second tubular structure, slicing the first elongated form into first transverse slices, each slice defining a first ring derived from the first tubular structure, slicing the second elongated form into second transverse slices, each slice defining a second ring derived from the second tubular structure, and / or forming the woven component by interlinking one of the first rings with one of the second rings, such that for each of the woven components, the first ring is configured to function as a collar of the anchor and the second ring is configured to function as an eyelet of the anchor.

[0590] In some implementations, weaving the second elongated form includes weaving the second elongated form such that the second tubular structure has a smaller inner diameter than the first tubular structure.

[0591] In some implementations, weaving the first elongated form includes weaving the fabric into the first elongated form such that the first tubular structures extend along a warp axis of the fabric.

[0592] In some implementations, weaving the second elongated form includes weaving the fabric into the second elongated form such that the second tubular structures extend along the warp axis of the fabric.

[0593] In some implementations, the method further includes, for each of the woven components, rotatably mounting a first ring onto the head of the anchor such that the first ring couples the second ring to the head in a manner that allows the second ring to rotate about the head.

[0594] In some implementations, the method includes weaving the fabric into a strip having a first slit and a second slit defined therethrough, and / or rotatably mounting the strip onto a head of an implantable anchor by placing the head through the first slit such that the first slit functions as a collar opening and the second slit functions as an eyelet opening rotatable about the head.

[0595] In some implementations, weaving the fabric includes weaving the fabric such that the first slit is longer than the second slit.

[0596] In some implementations, weaving the fabric includes weaving the fabric such that the first slit and the second slit are collinear with one another.

[0597] In some implementations, the weaving includes weaving the fabric such that the first slit and the second slit are parallel to the warp axis of the fabric.

[0598] In some implementations, a system usable and / or for use in tissue of a subject (e.g., a live subject, a simulation, etc.) includes a catheter device and / or a series of anchors. In some implementations, the catheter device can include a flexible tube and / or an extracorporeal unit. In some implementations, the flexible tube can have a distal opening configured for transluminal advancement toward the tissue and / or a proximal end defining a proximal opening.

[0599] In some implementations, the extracorporeal unit may be coupled to the proximal end of the tube and may include a body and / or a series of cartridges (or anchor holders) mounted in a one-piece fashion on the body, and in some implementations, each anchor in the series may be housed by a corresponding cartridge / anchor holder in the series of cartridge / anchor holders.

[0600] In some implementations, the system further includes a tether threaded through each of the series of anchors.

[0601] In some implementations, a system usable and / or for use in tissue of a subject (e.g., a live subject, a simulation, etc.) includes a catheter device and / or a series of anchors. The catheter device may include a flexible tube and / or an extracorporeal unit. The flexible tube may have a distal opening configured for transluminal advancement toward the tissue. In some implementations, the extracorporeal unit may be coupled to a proximal end of the tube.

[0602] In some implementations, a series of anchors may be mounted on the body or stock in a tile-like fashion.

[0603] In some implementations, the system further includes a tether threaded through each of the series of anchors.

[0604] In some implementations, the implant includes a tether and / or a series of anchors, each of which may include an anchor head, a tissue-engaging element, and / or a fabric through which the tether is threaded in a manner that slidably couples the anchor to the tether.

[0605] In some implementations, a system for treating a subject includes a support assembly, a first catheter, an implant catheter, an implant, and / or an adjustment tool. In some implementations, the support assembly may include a track. In some implementations, the first catheter may include a first catheter flexible tube and / or a first catheter extracorporeal unit coupled to a proximal portion of the first catheter flexible tube and / or slidably mountable on the track such that the first catheter flexible tube extends distally away from the track into the subject.

[0606] In some implementations, the implant catheter may include an implant catheter flexible tube and / or an implant catheter extracorporeal unit coupled to a proximal portion of the implant catheter flexible tube. In some implementations, the implant catheter extracorporeal unit may be slidably mountable on the track proximally from the first catheter extracorporeal unit such that (i) the implant catheter flexible tube extends distally through the first catheter flexible tube, distally away from the track, and / or (ii) the distance along the track between the implant catheter extracorporeal unit and the first catheter extracorporeal unit is adjustable.

[0607] In some implementations, the implant may be mounted on an implant catheter and / or may be transluminally implantable in a subject using an implant catheter.

[0608] In some implementations, the adjustment tool may include a flexible shaft and / or an adjustment tool extracorporeal unit coupled to a proximal portion of the flexible shaft.

[0609] In some implementations, the adjustment tool may be configured to be switched with the implant catheter following implantation such that (i) the adjustment tool extracorporeal unit is slidably mounted on a track proximally from the first catheter extracorporeal unit, (ii) the flexible shaft is positioned through the first catheter flexible tube and extends distally away from the track toward the implant, and / or (iii) the distance along the track between the adjustment tool extracorporeal unit and the first catheter extracorporeal unit is adjustable.

[0610] In some implementations, the system further includes a second catheter including a second catheter flexible tube and / or a second catheter extracorporeal unit coupled to a proximal portion of the second catheter flexible tube, in some implementations the second catheter extracorporeal unit may be slidably mountable on the track proximally from the first catheter extracorporeal unit such that the second catheter flexible tube extends distally away from the track and through the first catheter flexible tube, and / or the distance along the track between the second catheter extracorporeal unit and the first catheter extracorporeal unit is adjustable.

[0611] In some implementations, the implant catheter extracorporeal unit may be slidably mountable on the track proximally from the first catheter extracorporeal unit and the second catheter extracorporeal unit such that (i) the implant catheter flexible tube extends distally from the track within and through the second catheter flexible tube, and / or (ii) the distance along the track between the implant catheter extracorporeal unit and the second catheter extracorporeal unit is adjustable.

[0612] In some implementations, the adjustment tool may be configured to be switched with the implant catheter and the second catheter following implantation of the implant such that (i) the adjustment tool extracorporeal unit is slidably mounted on the track proximally from the first catheter extracorporeal unit, and / or (ii) the flexible shaft is positioned through the first catheter flexible tube and extends distally toward the implant, away from the track, where the second catheter flexible tube is not present.

[0613] In some implementations, the present disclosure is directed to a system including a catheter device, an extracorporeal unit, a tether, and a series of anchors.

[0614] In some implementations, the catheter device may include a flexible tube having a distal opening positioned at a distal end of the flexible tube and a proximal opening positioned at a proximal end of the flexible tube.

[0615] In some implementations, an extracorporeal unit may be coupled to the proximal end of the flexible tube. In some implementations, the extracorporeal unit may include a body and a series of cartridges or anchor holders.

[0616] In some implementations, the series of cartridge / anchor holders are distributed along a proximal-distal axis of the body in a manner that defines a proximal-distal axis, hi some implementations, the most distal cartridge or anchor holder of the series of cartridge / anchor holders is closest to the proximal opening.

[0617] In some implementations, the series of cartridge / anchor holders are distributed along the body in a manner that defines a proximal-distal axis with one row or column of cartridge / anchor holders along the axis, while other arrangements have two or more parallel rows or columns of cartridge / anchor holders. In some implementations, the series of cartridge / anchor holders are distributed along the body in a manner that is not aligned with the proximal-distal axis (e.g., in a curved manner, an angled manner, a zigzag manner, etc.).

[0618] In some implementations, the anchors of the series of anchors are housed within cartridges or anchor holders of the series of cartridge / anchor holders and are coupled to tethers such that the tethers extend along the body and parallel to the proximal-distal axis.

[0619] In some implementations, the anchor includes an anchor head and a tissue-engaging element extending distally from the anchor head to define an anchor axis of the anchor, the tissue-engaging element being configured to be driven into tissue along the anchor axis, hi some implementations, the anchor further includes a fabric shaped to define an eyelet through which the tether is threaded in a manner that slidably couples the anchor to the tether.

[0620] In some implementations, the series of anchors includes a leading anchor and one or more trailing anchors, such that the leading anchor is housed within a distal-most cartridge or anchor holder and secured to the tether, hi some implementations, the one or more trailing anchors are configured to be slidably coupled to the tether.

[0621] In some implementations, the anchor includes a head slidably coupled to the tether and a tissue-engaging element extending away from the head to define an anchor axis of the anchor. In some implementations, the anchor is housed within a cartridge or anchor holder such that the anchor axis is obliquely oriented relative to the proximal-distal axis. In some implementations, the anchor is housed within a cartridge or anchor holder such that the anchor axis is perpendicular to the proximal-distal axis.

[0622] In some implementations, the cartridge or anchor holder has a closed state in which the cartridge / anchor holder securely accommodates the anchor. In such implementations, the cartridge / anchor can define a respective cartridge / anchor holder vector that is angled relative to the proximal-distal axis. In some implementations, the cartridge / anchor holder is transitionable to an open state in which the corresponding anchor is removable from the cartridge / anchor holder in response to at least a portion of the cartridge sliding along the cartridge / holder vector.

[0623] In some implementations, the cartridge / anchor holder is associated with a threshold force and is further configured to transition to an open state in response to the anchor being pulled with a force that exceeds the threshold force.

[0624] In some implementations, the tether includes (i) a distal end coupled to the leading anchor and (ii) a proximal end removably secured within the extracorporeal unit.

[0625] In some implementations, the extracorporeal unit includes a dessracker that includes a winch that is spring-loaded in a manner that takes up slack in the tether.

[0626] In some implementations, the dessracker includes a stop switch configured to stop the dessracker in a manner that allows slack to be introduced into the tether and not picked up by the winch.

[0627] In some implementations, the system further includes a plurality of spacers through which the tether is threaded, alternating with the anchors in the series of anchors.

[0628] In some implementations, the spacers of the plurality of spacers are tubular and threaded with a tether extending through a lumen defined by the spacer.

[0629] In some implementations, a spacer is disposed on the tether such that the spacer tracks the anchor as the anchor advances distally along the tether toward the proximal opening.

[0630] In some implementations, a first spacer of the plurality of spacers is connected to a leading anchor of the series of anchors, and the first spacer of the plurality of spacers is axially less compressible than at least another spacer of the plurality of spacers.

[0631] In some implementations, an anchor of the series of anchors includes an anchor head and a helical tissue-engaging element extending away from the anchor head to define an anchor axis of the anchor and configured to be threaded into tissue along the anchor axis.

[0632] In some implementations, the tube can alternatively or additionally define a gripping zone at a distal portion, where the tube has a gripping surface that inhibits sliding of the anchor through the gripping zone by gripping a lateral surface of the helical tissue-engaging element. In some implementations, the system further includes an anchor driver configured to slide the anchor distally through the channel to the gripping zone and / or drive the anchor through the gripping zone by threading the tissue-engaging element onto the gripping surface.

[0633] In some implementations, the system further includes an anchor driver configured to slide the anchor distally through the channel to the gripping zone and / or drive the anchor through the gripping zone by threading the tissue engaging element onto the gripping surface.

[0634] In some implementations, the gripping surface is configured such that when a driver threads the helical tissue engaging element onto the gripping surface, the helical tissue engaging element temporarily compresses the portion of the gripping surface that the helical tissue engaging element contacts.

[0635] In some implementations, the gripping surface includes at least one resilient nub that projects inwardly into the channel. Alternatively, or additionally, in some implementations, the gripping surface includes at least one resilient rib that projects inwardly into the channel.

[0636] In some implementations, the anchor further includes an eyelet mounted to the head such that it is rotatable about the anchor axis. Proximal to the rib, the tube may further define an abutment that protrudes inwardly into the channel in a manner that inhibits rotation of the eyelet about the anchor axis when the anchor driver threads the tissue engaging element onto the gripping surface.

[0637] In some implementations, the anchor includes an anchor head, a tissue-engaging element, and a fabric (and / or polymer). In such implementations, the tissue-engaging element can extend distally from the anchor head to define an anchor axis of the anchor and can be configured to be driven into tissue along the anchor axis. In some implementations, the fabric (and / or polymer) can be shaped to include an eyelet, through which the anchor is coupled to the tether. The fabric (and / or polymer) can be the same as or similar to other fabrics (and / or polymers) described elsewhere herein. The eyelet can be the same as or similar to eyelets described elsewhere herein.

[0638] In some implementations, the anchor head includes an interface coupled to a tissue engaging element, the tissue engaging element configured to be driven into tissue along the anchor axis by an anchor securing force applied to the interface.

[0639] In some implementations, the catheter device further includes a deslacker coupled to the tether and configured to eliminate slack in the tether.

[0640] In some implementations, the system further includes an anchor driver including a flexible shaft and a drive head at a distal end of the shaft. In some implementations, the anchor driver is configured to engage the drive head with the anchor, remove the anchor from the corresponding cartridge, and advance the anchor into the proximal opening, through the flexible tube, and toward the tissue while the anchor remains coupled to the tether, anchoring the anchor to the tissue.

[0641] In some implementations, the anchor driver is configured to remove the anchor from the cartridge / anchor holder by applying a pulling force to the anchor such that the cartridge / anchor holder transitions to the open state.

[0642] In some implementations, the system further includes an elongated adjustment tool and a lock. In some such implementations, the adjustment tool can be configured to advance the lock along the tether into the subject and distally toward tissue, apply tension to the tether, lock the tension on the tether by locking the lock to the tether, sever the tether proximally from the lock, and / or leave the lock locked to the tether within the subject.

[0643] In some implementations, the lock is configured to be placed on and advanced along the tether by an adjustment tool without accessing the end of the tether.

[0644] In some implementations, the lock includes a frame, a first set of hooked fingers, and / or a second set of hooked fingers. In some such implementations, the first set of hooked fingers extend from a first side of the frame toward a second side of the frame, the second side being opposite the first side. In some such implementations, the second set of hooked fingers extend from the second side toward the first side, the fingers of the second set being disposed alternately with the fingers of the first set along the frame.

[0645] In some implementations, the lock can be locked to the tether by (i) having an unlocked state in which the frame is constrained to narrow and the tether is positionable and / or slidable between the first set of fingers and the second set of fingers, and / or (ii) unlocking the frame from expanding such that the first and second sides of the frame responsively move away from each other, pulling on the first and second sets of fingers, respectively.

[0646] In some implementations, the first and second sides of the frame moving away from each other pull on the first and second sets of fingers such that the tether is tightened between the first set of fingers and the second set of fingers.

[0647] In some implementations, the first and second sides of the frame moving away from each other pull the first and second sets of fingers with them such that the tether is forced into a tortuous path.

[0648] In some implementations, the adjustment tool is configured to advance the lock distally along the tether into the heart and toward the tissue of the subject while maintaining the lock in an unlocked state by narrowing and constraining the frame.

[0649] In some implementations, the extracorporeal unit includes a catheter device extracorporeal unit. In some implementations, the adjustment tool includes an adjustment tool extracorporeal unit, a shaft extending distally from the adjustment tool extracorporeal unit, and a tool head at a distal end of the shaft. In some such implementations, the adjustment tool is configured to advance the lock distally along the tether into the subject and toward tissue while the lock is housed within the tool head.

[0650] In some implementations, the tether has (i) a distal end at the leading anchor of the series of anchors, and (ii) a proximal end that is secured within the extracorporeal unit and is removable from within the extracorporeal unit so as to be threaded proximally into the opening in the lock, through the lock, and into the shaft of the adjustment tool.

[0651] In some implementations, the adjustment tool includes a capture assembly and a knob. In some such implementations, the adjustment tool includes a gripper at the working end of the capture assembly, positioned proximally from the lock, such that, in a received state of the capture assembly, threading the proximal end of the tether proximally into the opening in the lock, through the lock and tool head, and into the shaft of the adjustment tool causes the working end of the capture assembly to receive the proximal end of the tether.

[0652] In some implementations, a knob can be mounted on the body of the adjustment tool extracorporeal unit. In some implementations, the knob can be operably coupled to a proximal portion of the gripper such that operation of the knob transitions the capture assembly to a gripping state in which the gripper grips the tether. In some implementations, the knob is mounted on the adjustment tool extracorporeal unit such that transitioning the capture assembly to the gripping state releases the knob from the adjustment tool extracorporeal unit.

[0653] In some implementations, when released from the adjustment tool extracorporeal unit, the knob may be removable from the adjustment tool extracorporeal unit in a manner that retracts the working end of the intake assembly proximally through and out of the shaft and adjustment tool extracorporeal unit along the proximal end of the tether so that the tether is positioned through the lock, tool head, shaft, and adjustment tool extracorporeal unit.

[0654] In some implementations, the lock is biased to lock, and the adjustment tool includes a cut-off tube extending distally through the shaft and into the head such that a distal portion of the cut-off tube is disposed within the lock in a manner that limits lock unlocking. While the knob of the intake assembly remains mounted on the adjustment tool extracorporeal unit, the working end of the intake assembly can be disposed within the cut-off tube such that removal of the knob from the adjustment tool extracorporeal unit retracts the working end of the intake assembly proximally through and out of the cut-off tube, along with the proximal end of the tether, such that the tether is positioned through one or more of the lock, the tool head, the cut-off tube in the shaft, and the adjustment tool extracorporeal unit.

[0655] In some implementations, (i) the lock is biased to lock, and / or (ii) the adjustment tool includes a guillotine / cutting tool in the tool head and proximal to the lock, and / or a cutoff device extending distally through the shaft and guillotine / cutting tool such that a distal portion of the cutoff device is positioned within the lock in a manner that limits unlocking of the lock.

[0656] In some implementations, the adjustment tool extracorporeal unit includes a lock-and-cut subassembly including a locking block and / or a lock-and-cut controller coupled to the interrupter.

[0657] In some implementations, retraction of the working end of the intake assembly, along the proximal end of the tether, through and out of the shaft and adjustment tool extracorporeal unit proximally leaves the tether positioned through the lock and guillotine such that (a) subsequent engagement of the lock locks the lock to the tether, and (b) subsequent actuation of the guillotine severs the tether proximally from the lock.

[0658] In some implementations, a lock-and-cut controller is operably coupled to the locking block such that operation of the lock-and-cut controller retracts the locking block proximally, thereby withdrawing the interrupter from the lock and responsively locking the lock to the tether.

[0659] In some implementations, the adjustment tool extracorporeal unit includes a tension subassembly including a tension block, a clamp attached to the tension block, and / or a tension controller. In some implementations, while the knob of the intake assembly remains mounted on the adjustment tool extracorporeal unit, the gripper can extend distally from the knob, through the clamp and shaft, to the working end.

[0660] In some implementations, retraction of the working end of the intake assembly, along the proximal end of the tether, proximally through and out of the shaft and adjustment tool extracorporeal unit can retract the gripper from the clamp, leaving the tether positioned through the clamp such that subsequent actuation of the clamp locks the tether to the tension block.

[0661] In some implementations, a tension controller is operably coupled to the tension block such that operation of the tension controller applies tension to the tether by drawing the tension block and tether proximally while the tether remains locked to the tension block.

[0662] In some implementations, the adjustment tool includes an intake assembly including: a sleeve extending distally through the shaft and terminating proximally from the lock; a gripper extending distally through the sleeve and having a wider distal portion disposed distally outside the sleeve, wherein the sleeve and gripper are shaped and positioned such that threading the proximal end of the tether proximally into the shaft of the adjustment tool advances the proximal end of the tether proximally into the sleeve, around the wider distal portion of the gripper; and / or a knob.

[0663] In some implementations, a knob may be mounted on the adjustment tool extracorporeal unit and / or may be operably coupled to a proximal portion of the sleeve and a proximal portion of the gripper such that operation of the knob causes the capture assembly to transition to a gripping state by retracting a wider distal portion of the gripper proximally into the sleeve, thereby gripping the tether within the sleeve.

[0664] In some implementations, the attachment of the knob to the adjustment tool extracorporeal unit may be such that transitioning of the capture assembly to the gripping state releases the knob from the adjustment tool extracorporeal unit.

[0665] In some implementations, when released from the adjustment tool extracorporeal unit, the knob may be removable from the adjustment tool extracorporeal unit in a manner that pulls the sleeve and gripper proximally along the proximal end of the tether, through the shaft and adjustment tool extracorporeal unit, and out of the adjustment tool so that the tether extends through the lock, head, shaft, and adjustment tool extracorporeal unit.

[0666] In some implementations, a system usable with and / or for use with a tissue of interest includes a catheter device, a tether, and / or a series of anchors. The catheter device can include a flexible tube and / or an extracorporeal unit. The flexible tube can have a proximal end defining a distal opening and / or a proximal opening configured for transluminal advancement toward the tissue. The extracorporeal unit can be coupled to the proximal end of the tube and / or can include a body and / or a series of cartridges.

[0667] In some implementations, the series of anchors can be coupled to a tether. In some implementations, each anchor in the series of anchors can include an anchor head and a tissue engaging element extending distally away from the anchor head to define an anchor shaft of the anchor, and / or can be housed by a corresponding cartridge in the series of cartridges.

[0668] In some implementations, the set of anchors includes a first subset of anchors and a second subset of anchors.

[0669] In some such implementations, the first subset includes a first 2-6 of the set of anchors. In some implementations, for each of the anchors in the first subset, the tissue engaging element has a first width.

[0670] In some implementations, the second subset may include more (eg, a greater number) anchors than the first subset.

[0671] In some implementations, for each of the anchors in the second subset, the tissue engaging element has a second width that is less than the first width.

[0672] In some implementations, for each of the series of anchors, the tissue engaging element is a helical tissue engaging element that extends helically away from the anchor head and is configured to be threaded into tissue along the anchor shaft.

[0673] In some implementations, the first 2-6 of the set of anchors is the first 4 of the set of anchors, and the second subset includes the set of the first 4 anchors.

[0674] In some implementations, the second subset includes between 4 and 18 of the set of anchors.

[0675] In some implementations, the second subset includes the remainder of the set of anchors.

[0676] In some implementations, the system further includes a flexible shaft and / or an anchor driver including a drive head at a distal end of the shaft. In some implementations, the anchor driver can be configured to, for each of a series of anchors sequentially starting with a first subset of anchors, (i) engage the drive head with the anchor head, (ii) remove the anchor from the corresponding cartridge, and / or (iii) advance the anchor into the proximal opening, through the flexible tube, toward the tissue, and drive the tissue engaging element into the tissue while the anchor remains coupled to the tether.

[0677] In some implementations, a system and / or device for use with and / or for use with tissue of a subject includes an implant and / or anchor driver. The implant may include a tether and / or a series of anchors. The series of anchors may be coupled to the tether. Each anchor in the series of anchors may include (i) an anchor head and / or (ii) a tissue-engaging element extending distally from the anchor head to define an anchor axis of the anchor.

[0678] In some implementations, the set of anchors includes a first subset of the set of anchors, including a first 2-6 of the set of anchors. The tissue engaging element of each anchor in the first subset can have a first width.

[0679] In some implementations, the series of anchors further includes a second subset of the series of anchors, the second set may include more anchors than the first subset, and the tissue engaging element of each anchor in the second subset may have a second width that is smaller than the first width.

[0680] The anchor driver may include a flexible shaft and / or a drive head at a distal end of the shaft, and may be configured to, for each of a series of anchors sequentially beginning with a first subset of anchors, (i) engage the drive head with the anchor head, and / or (ii) transluminally advance the anchor toward the tissue while the anchor remains coupled to the tether, driving the tissue engaging element into the tissue.

[0681] Any of the above systems, assemblies, apparatus, devices, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for patient use, and the methods herein can include (or additional methods can include or consist of) sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, apparatus, components, etc. described herein.

[0682] The above methods and any methods using the systems, assemblies, apparatus, devices, 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, a body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.), and can optionally include computerized and / or physical representations.

[0683] The present invention will be more fully understood from the following detailed description of implementations of the invention taken in conjunction with the drawings. [Brief explanation of the drawings]

[0684] [Figure 1] FIG. 1 is a schematic diagram of a delivery tool for implanting an implant into a subject, including aesthetic features, according to some implementations. [Figure 2A]FIG. 2A is a schematic diagram of a delivery tool for implanting an implant into a subject, including aesthetic features, according to some implementations. [Figure 2B] FIG. 2B is a schematic diagram of a delivery tool for implanting an implant into a subject, including aesthetic features, according to some implementations. [Figure 2C] FIG. 2C is a schematic diagram of a delivery tool for implanting an implant into a subject, including aesthetic features, according to some implementations. [Figure 2D] FIG. 2D is a schematic diagram of a delivery tool for implanting an implant into a subject, including aesthetic features, according to some implementations. [Figure 3A] FIG. 3A is a schematic diagram of a corresponding spacer including anchors and aesthetic features, according to some implementations. [Figure 3B] FIG. 3B is a schematic diagram of a corresponding spacer including anchors and aesthetic features, according to some implementations. [Figure 4A] FIG. 4A is a schematic diagram of a leading anchor including aesthetic features, according to some implementations. [Figure 4B] FIG. 4B is a schematic diagram of a leading anchor including aesthetic features, according to some implementations. [Figure 4C] FIG. 4C is a schematic diagram of a leading anchor including aesthetic features, according to some implementations. [Figure 4D] FIG. 4D is a schematic diagram of a leading anchor including aesthetic features, according to some implementations. [Figure 5A] FIG. 5A is a schematic diagram of an anchor including aesthetic features, according to some implementations. [Figure 5B] FIG. 5B is a schematic diagram of an anchor including aesthetic features, according to some implementations. [Figure 5C] FIG. 5C is a schematic diagram of an anchor including aesthetic features, according to some implementations. [Figure 6A] FIG. 6A is a schematic diagram of an eyelet, according to some implementations. [Figure 6B]FIG. 6B is a schematic diagram of an eyelet, according to some implementations. [Figure 7] FIG. 7 is a schematic diagram of an eyelet according to some implementations. [Figure 8A] FIG. 8A is a schematic diagram of an eyelet, according to some implementations. [Figure 8B] FIG. 8B is a schematic diagram of an eyelet, according to some implementations. [Figure 9] FIG. 9 is a schematic diagram of an eyelet, according to some implementations. [Figure 10] FIG. 10 is a schematic diagram of an eyelet according to some implementations. [Figure 11A] FIG. 11A is a schematic diagram of an eyelet, according to some implementations. [Figure 11B] FIG. 11B is a schematic diagram of an eyelet, according to some implementations. [Figure 11C] FIG. 11C is a schematic diagram of an eyelet, according to some implementations. [Figure 11D] FIG. 11D is a schematic diagram of an eyelet, according to some implementations. [Figure 11E] FIG. 11E is a schematic diagram of an eyelet, according to some implementations. [Figure 11F] FIG. 11F is a schematic diagram of an eyelet, according to some implementations. [Figure 11G] FIG. 11G is a schematic diagram of an eyelet, according to some implementations. [Figure 11H] FIG. 11H is a schematic diagram of an eyelet, according to some implementations. [Figure 11I] FIG. 11I is a schematic diagram of an eyelet, according to some implementations. [Figure 11J] FIG. 11J is a schematic diagram of an eyelet, according to some implementations. [Figure 11K] FIG. 11K is a schematic diagram of an eyelet, according to some implementations. [Figure 12] FIG. 12 shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13A] FIG. 13A shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13B] FIG. 13B shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13C] FIG. 13C shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13D] FIG. 13D shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13E] FIG. 13E shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 13F] FIG. 13F shows a schematic diagram of the distal portion of the flexible tube (including aesthetic features) and examples of its use, according to some implementations. [Figure 14A] FIG. 14A is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 14B] FIG. 14B is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 14C] FIG. 14C is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 14D] FIG. 14D is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 14E] FIG. 14E is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 15A] FIG. 15A is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 15B] FIG. 15B is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 15C]FIG. 15C is a schematic diagram of a flexible tube variation (including aesthetic features) according to some implementations. [Figure 16] FIG. 16 shows a schematic diagram of a system including a membrane with aesthetic features, according to some implementations. [Figure 17A] FIG. 17A is a schematic diagram of an anchor including aesthetic features, according to some implementations. [Figure 17B] FIG. 17B is a schematic diagram of an anchor including aesthetic features, according to some implementations. [Figure 18A] FIG. 18A is a schematic diagram illustrating implantation of an implant including aesthetic features, according to some implementations. [Figure 18B] FIG. 18B is a schematic diagram illustrating implantation of an implant including aesthetic features, according to some implementations. [Figure 19A] FIG. 19A is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19B] FIG. 19B is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19C] FIG. 19C is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19D] FIG. 19D is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19E] FIG. 19E is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19F]FIG. 19F is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 19G] FIG. 19G is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 20A] FIG. 20A is a schematic diagram of a system used to tension and lock the tether of an implant, including tools and locks, including aesthetic features, according to some implementations. [Figure 20B] FIG. 20B is a schematic diagram of a system with tools and locks used to tension and lock the tether of an implant, including aesthetic features, according to some implementations. [Figure 20C] FIG. 20C is a schematic diagram of a system with tools and locks used to tension and lock the tether of an implant, including aesthetic features, according to some implementations. [Figure 21] FIG. 21 is a schematic diagram of various locks or lockers including aesthetic features according to some implementations. [Figure 22A] FIG. 22A is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 22B] FIG. 22B is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 22C] FIG. 22C is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 22D] FIG. 22D is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 22E] FIG. 22E is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 23]FIG. 23 is a schematic diagram of various locks or lockers including aesthetic features according to some implementations. [Figure 24A] FIG. 24A is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 24B] FIG. 24B is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 24C] FIG. 24C is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 24D] FIG. 24D is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 25A] FIG. 25A is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 25B] FIG. 25B is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 25C] FIG. 25C is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 26] FIG. 26 is a schematic diagram of various locks or lockers including aesthetic features according to some implementations. [Figure 27A] FIG. 27A is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 27B] FIG. 27B is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 27C] FIG. 27C is a schematic diagram of various locks or lockers including aesthetic features, according to some implementations. [Figure 28] FIG. 28 is a schematic diagram of a tensioner, including aesthetic features, according to some implementations. [Figure 29A]FIG. 29A is a schematic diagram of a tensioner, including aesthetic features, according to some implementations. [Figure 29B] FIG. 29B is a schematic diagram of a tensioner, including aesthetic features, according to some implementations. [Figure 30] FIG. 30 is a schematic diagram of a tensioner, including aesthetic features, according to some implementations. [Figure 31] FIG. 31 is a schematic diagram of an implant being implanted according to some implementations. [Figure 32A] FIG. 32A is a schematic diagram of an implant being implanted according to some implementations. [Figure 32B] FIG. 32B is a schematic diagram of an implant being implanted according to some implementations. [Figure 33A] FIG. 33A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 33B] FIG. 33B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 34A] FIG. 34A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 34B] FIG. 34B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 34C] FIG. 34C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 34D] FIG. 34D is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 35A] FIG. 35A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 35B]FIG. 35B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 35C] FIG. 35C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 36A] FIG. 36A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 36B] FIG. 36B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 36C] FIG. 36C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37A] FIG. 37A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37B] FIG. 37B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37C] FIG. 37C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37D] FIG. 37D is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37E] FIG. 37E is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37F] FIG. 37F is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 37G] FIG. 37G is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 38A] FIG. 38A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 38B] FIG. 38B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 38C] FIG. 38C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39A] FIG. 39A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39B] FIG. 39B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39C] FIG. 39C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39D] FIG. 39D is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39E] FIG. 39E is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39F] FIG. 39F is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39G] FIG. 39G is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39H] FIG. 39H is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 39I]FIG. 39I is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 40A] FIG. 40A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 40B] FIG. 40B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 40C] FIG. 40C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41A] FIG. 41A is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41B] FIG. 41B is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41C] FIG. 41C is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41D] FIG. 41D is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41E] FIG. 41E is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41F] FIG. 41F is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41G] FIG. 41G is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41H] FIG. 41H is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41I] FIG. 41I is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41J] FIG. 41J is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41K] FIG. 41K is a schematic diagram of a system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 41L] FIG. 41L is a schematic diagram of the system, including its aesthetic features and techniques for use therewith, according to some implementations. [Figure 42A] FIG. 42A is a schematic diagram of a portion of the extracorporeal unit, including its aesthetic features and the technology used therewith, according to some implementations. [Figure 42B] FIG. 42B is a schematic diagram of a portion of the extracorporeal unit, including its aesthetic features and the technology used therewith, according to some implementations. [Figure 43] FIG. 43 is a schematic illustration of a technique for modifying the presence of a spacer between the final anchor and lock of the implant, according to some implementations. [Figure 44A] FIG. 44A is a schematic illustration of a technique for modifying the presence of a spacer between the final anchor and lock of the implant, according to some implementations. [Figure 44B] FIG. 44B is a schematic illustration of a technique for modifying the presence of a spacer between the final anchor and lock of the implant, according to some implementations. [Figure 45A] FIG. 45A is a schematic diagram of the various locks that make up the reader, including their aesthetic features, according to some implementations. [Figure 45B] FIG. 45B is a schematic diagram of the various locks that make up the reader, including their aesthetic features, according to some implementations. [Figure 45C]FIG. 45C is a schematic diagram of the various locks that make up the reader, including their aesthetic features, according to some implementations. [Figure 45D] FIG. 45D is a schematic diagram of the various locks that make up the reader, including their aesthetic features, according to some implementations. [Figure 46] FIG. 46 is a schematic diagram of an anchor-spacer assembly including an anchor and a spacer, including its aesthetic features, according to some implementations. [Figure 47A] FIG. 47A is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47B] FIG. 47B is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47C] FIG. 47C is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47D] FIG. 47D is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47E] FIG. 47E is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47F] FIG. 47F is a schematic diagram of various spacer and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47G] FIG. 47G is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 47H] FIG. 47H is a schematic diagram of various spacers and anchor spacer assemblies, including their aesthetic features, according to some implementations. [Figure 48]FIG. 48 is a schematic diagram of a woven collar and eyelets, such as a woven component including both a collar and eyelets, including its aesthetic features, according to some implementations. [Figure 49] FIG. 49 is a schematic diagram of a woven collar and eyelets, such as a woven component including both a collar and eyelets, including its aesthetic features, according to some implementations. [Figure 50] FIG. 50 is a schematic diagram of a woven collar and eyelets, such as a woven component including both a collar and eyelets, including its aesthetic features, according to some implementations. [Figure 51A] FIG. 51A is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 51B] FIG. 51B is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 51C] FIG. 51C is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 52A] FIG. 52A is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 52B] FIG. 52B is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 52C] FIG. 52C is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 53] FIG. 53 is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 54] FIG. 54 is a schematic diagram of various spacers, including their aesthetic features, according to some implementations. [Figure 55] FIG. 55 is a schematic illustration of an anchor including tissue engaging elements, including aesthetic features thereof, according to some implementations. [Figure 56]FIG. 56 is a flowchart illustrating at least some steps of a technique for manufacturing a tissue engaging element, according to some implementations. [Figure 57] FIG. 57 is a schematic diagram of a catheter device, including its aesthetic features, whose extracorporeal unit includes an integrated tensioner, according to some implementations. [Figure 58] FIG. 58 is a schematic diagram of an implant including its aesthetic features, according to some implementations. [Figure 59] FIG. 59 is a schematic diagram of an implant including its aesthetic features, according to some implementations. DETAILED DESCRIPTION OF THE INVENTION

[0685] In the following description, various aspects of the present disclosure are described. For purposes of explanation, specific structures and details are set forth in order to provide a thorough understanding of various aspects of the present disclosure. However, it will also be apparent to those skilled in the art that the present disclosure can be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure the present disclosure.

[0686] Throughout this specification, the same name is used to indicate different implementations of an element. Unless otherwise stated, implementations and applications of the devices, systems, and technologies described herein may include any variations in which an element is replaced with another element having the same name. Furthermore, throughout the figures, the presence or absence of different suffixes for the same reference number are used to indicate different variations of the same element. Unless otherwise stated, implementations and applications of the devices, systems, and technologies described herein may include any variations in which an element is replaced with another element having the same reference number, regardless of whether it is shown with or without a suffix.

[0687] To avoid undue confusion due to too many reference numbers and leads in a particular drawing, some elements may be introduced through one or more drawings and not be explicitly identified in all subsequent drawings that include that element.

[0688] Reference is now made to Figures 1 and 2A-D, which are schematic illustrations of a delivery tool 200 for implanting an implant 110 in a subject, according to some implementations. The implant 110 and delivery tool 200 may be components of a system 100. Nevertheless, because the implant 110 is loaded into the delivery tool 200 and is therefore largely obscured in Figure 1, reference numeral 110 has been omitted from Figure 1. It should be noted that the tether 112 (described below) of the implant 110 is visible and is therefore labeled in Figure 1.

[0689] In describing system 100, the implant of the system is described and illustrated as implant 110, which will be described in detail below. However, it should be understood that system 100 may, with appropriate modifications, include other implants, e.g., delivery tool 200 may, with appropriate modifications, be used to implant other implants.

[0690] For example, system 100 can include other implants that include or are secured with multiple anchors, such as (but not limited to) the implants and / or anchors described herein and / or the implants and / or anchors described in WO 2021 / 084407 by Kasher et al. and / or WO 2022 / 172149 by Shafigh et al., each of which is incorporated herein by reference (e.g., an implant including multiple anchors slidably coupled to, e.g., through, a tether). Alternatively, or additionally, delivery tool 200 and / or components thereof can be used, modified as needed, to facilitate implantation of an implant (e.g., an annuloplasty structure) described in International Patent Application Publication No. WO 2014 / 064694 by Sheps et al. and / or International Patent Application Publication No. WO 2016 / 174669 by Iflah et al., each of which is incorporated herein by reference. Furthermore, more generally, system 100 and / or the techniques described for use therewith can be used in combination with one or more of the systems and / or techniques described in the references mentioned in this paragraph.

[0691] In some implementations, the systems, apparatus, devices, implants, etc. herein can be configured and / or used for annuloplasty, e.g., the implant can be an annuloplasty implant. In some implementations, the systems, apparatus, devices, implants, etc. herein can be configured and / or used to close an opening (e.g., an opening to an appendage, an opening to a passageway, etc.) and / or reconstruct another region of tissue (e.g., ventricular remodeling, atrial remodeling, muscle remodeling, etc.).

[0692] 1 shows a schematic diagram of a delivery tool 200 including an anchor driver 210 and a catheter device 300. The catheter device 300 includes a flexible tube 310 (e.g., a catheter) configured to be advanced into a subject and an extracorporeal unit 350 (e.g., an extracorporeal control unit) coupled to the tube 310 and configured to remain outside the subject's body. In some implementations, the extracorporeal unit 350 defines or is coupled to a handle of the device 300. In some implementations, the extracorporeal unit 350 shares one or more features with one or more of the extracorporeal units described in International Patent Application Publication No. WO 2022 / 064401 to Halabi et al. and / or International Patent Application Publication No. WO 2022 / 172149 to Shafigh et al., each of which is incorporated herein by reference. Additionally, the catheter device 300 can be modified and used to facilitate implantation of any of the implants described in U.S. Patent Application Publication No. 2021 / 0145584 to Kasher et al. and / or International Patent Application No. 2022 / 172149 to Shafigh et al., each of which is incorporated by reference herein.

[0693] 2A-D illustrate a delivery tool 200 used to implant an implant 110 into a subject's heart valve 12 (e.g., a live subject, a simulation, etc.). In the illustrated example, the valve 12 is a mitral valve, but it should be understood that the valve may be another atrioventricular valve (e.g., a tricuspid valve, as shown in later figures) or another valve, such as a pulmonary valve, a vena cava valve, and / or other valve. Furthermore, while the illustrated exemplary implant 110 is implanted on the upstream surface of the valve 12 (e.g., along the valve annulus), the scope of the present disclosure includes other implantation sites, such as the downstream surface of the valve (e.g., along the subannular groove). Still further, the implant 110 may be implanted at a site other than a heart valve, such as within the atrium or within a ventricle of the heart, for example, to contract the atrium or ventricle.

[0694] As described above, implant 110 includes a plurality of anchors 120 and a tether 112 through which the anchors are threaded. As described in detail below, upon implantation, only a distal portion of tether 112 is implanted into a subject, while a proximal portion of the tether is removed from the subject using, for example, catheter device 300. However, for simplicity, tether 112 is described herein as a component of implant 110.

[0695] Tether 112 can take a variety of forms, such as, for example, monofilament, polyfilament, line, wire, ribbon, rope, cable, braid, suture, etc. Tether 112 can include metal (e.g., nitinol or surgical steel), synthetic polymer (e.g., nylon, polyester, polypropylene, polybutester), and / or natural fiber (e.g., silk). Tether 112 can be considered a contractile member.

[0696] The anchors 120 are distributed serially along the tether 112, e.g., the tether is threaded through. Additionally, as shown, the catheter device 300 is loaded with the tether 112 and anchors 120, and the tether is threaded through the anchors. When provided in this manner, the series of anchors may be in the extracorporeal unit 350, e.g., mounted on / in the extracorporeal unit.

[0697] In some implementations, each anchor 120 may be disposed within a respective cartridge or anchor holder 360 to facilitate anchor handling, such as engagement of the anchor driver 210 with the anchor and / or proper positioning of the engaged anchor for advancement into the canal 310. This is illustrated in FIG. 1 by bracketing the reference numbers of the anchors within the cartridge 360. In some implementations, once a given anchor is anchored, the cartridge is discarded, for example, by releasing it from the extracorporeal unit 350. Examples of such cartridge-based mounting of anchors are described in WO 2022 / 064401 to Halabi et al. and International Patent Application Publication No. WO 2022 / 172149 to Shafigh et al., each of which is incorporated herein by reference.

[0698] As used herein, the term cartridge is interchangeable with the term anchor holder, and the cartridges / anchor holders herein may be configured in a variety of ways (e.g., from simple receptacles or holes for holding anchors to more involved or sophisticated configurations and mechanisms).

[0699] Using delivery tool 200, implant 110 can be implanted by using anchor driver 210 to engage each of the anchors sequentially (e.g., with extracorporeal unit 350), advance the anchors distally through tube 310 into the subject, and anchor the anchors to internal tissue of the subject, such as tissue 10 of the annulus of valve 12. For example, as shown, implant 110 can be an annuloplasty implant that is implanted with anchors 120 positioned around at least a portion of the annulus of valve 12.

[0700] In some implementations, the distal end of tether 112 is inserted distally into a subject with a first anchor (hereinafter referred to as the "leading anchor"). Meanwhile, successive anchors can be advanced by sliding them distally along the tether toward the leading anchor. The prefix ' is used for leading anchors, and the prefix '' is used for successive anchors. Thus, reference numeral 120 is used when referring generally to anchors, reference numeral 120' is used when referring specifically to the leading anchor, and reference numeral 120'' is used when referring specifically to the successive anchor. In some implementations, leading anchor 120' is identical to successive anchor 120'', while in other implementations, the leading anchor may be specialized and may differ in one or more aspects, for example, as shown in FIG. 4A.

[0701] 2A shows leading anchor 120' anchored to tissue 10, for example, at the annulus near the commissure of valve 12. At this point, tether 112 extends proximally from leading anchor 120' through tube 310 to extracorporeal unit 350, where the tether is threaded to continuous anchor 120''. As described above, this can be accomplished by advancing the distal end of tether 112 along with leading anchor 120'. For example, the distal end of tether 112 can be fixed to (e.g., non-slidable relative to) leading anchor 120'.

[0702] In some implementations, advancement and anchoring of the leading anchor 120′ may be performed through the use of an anchor driver 210. The anchor driver 210 ( FIG. 1 ) is comprised of an elongated, flexible shaft 212 and a driver head 214 coupled to the distal end of the shaft. While the driver head 214 engages the anchor 120, the anchor driver 210 advances to drive the anchor through the canal 310 and into the tissue 10. The anchor driver 210 is then used to apply an anchoring force to the anchor, thereby driving the anchor's tissue-engaging element into the tissue, thereby anchoring the anchor into the tissue 10. For example, in some implementations where the anchor's tissue-engaging element is helical or screw-like, the anchor driver 210 applies a torque to the anchor to screw the anchor into the tissue.

[0703] In some implementations, the tissue engaging element can be comprised of one or more hooks, barbs, darts, staples, clips, prongs, arms, expandable portions, threaded portions, rivets, prongs, helices, screws, threaded portions, combinations of two or more thereof, and the like.

[0704] In some implementations, anchor driver 210 may further include a handle 216 and / or an actuator (e.g., a trigger) 218 ​​operably coupled to drive head 214 to control engagement of the drive head with anchor 120. As shown at 218, actuator 218 may be a component of handle 216. In some implementations, this operable coupling may be provided by a pull rod extending from actuator 218 to drive head 214, the distal end of the pull rod maintaining engagement of the drive head with anchor 120 until actuator 218, and thereby the pull rod, is pulled proximally by an operator to disengage the drive head from the anchor.

[0705] In some implementations, after each anchor 120 is anchored, the anchor driver 210 is withdrawn proximally through the tube 310 (e.g., with the extracorporeal unit 350) so that, upon disengagement from the anchored anchor, the driver head 214 can be engaged with the subsequent anchor for advancing and anchoring the subsequent anchor. FIG. 2B shows four anchors 120 (a leading anchor 120′ and three successive anchors 120″) anchored to the tissue 10 so that the implant 110 begins to lie along a portion of the annulus of the valve 12. The tether 112 can be advanced with the leading anchor 120′ (e.g., pulled by the leading anchor), while the successive anchors 120″ advance distally along the tether toward the leading anchor (e.g., slide along it).

[0706] FIG. 2C shows eight anchors 120 (leading anchor 120′ and seven consecutive anchors 120″) anchored to tissue 10 such that implant 110 is positioned along the posterior annulus of valve 12, approximately from commissure to commissure. It should be understood that this number of anchors and this positioning are merely illustrative examples, and that more or fewer anchors and / or other arrangements are possible on valve 12 and / or elsewhere. FIG. 2C shows tether 112 being tensioned (e.g., by being pulled from outside the subject), thereby drawing anchors 120 toward each other (e.g., shortening the length of implant 110) and contracting the annulus of valve 12, e.g., to improve valve leaflet cohesion. In some implementations, a tool or adjustment tool 400 (e.g., a tensioning / contraction and / or locking tool) can be used to facilitate this tensioning, e.g., by providing a reference force to the most recently anchored anchors. In some implementations, tool 400 can be considered a component of system 100.

[0707] In some implementations, tension applied to tether 112 is then locked, for example, by locking lock 160 (which in some implementations may be considered and / or referred to as a stopper) to the tether ( FIG. 2D ) at the most recent anchor. At this point, tether 112 can be cut, and excess tether (e.g., tether proximal to lock 160) can be removed, as shown. In FIG. 2D , lock 160 is shown as a separate component. However, in some implementations, final anchor 120 can include and / or function as a lock or stopper, i.e., a specialized anchor. Locking lock 160 and / or severing tether 112 can be performed directly or indirectly by tool 400. In some implementations, lock 160 can include a blade that cuts tether 112 when actuated by tool 400, as shown below, for example, with reference to FIGS. 21-27C .

[0708] In some implementations, lock 160 and / or tool 400 are advanced and / or tether 112 is tensioned, for example, as shown, via tube 310. However, in some implementations, tube 310 can first be retracted from the subject.

[0709] In addition to its tissue-engaging element, in some implementations, each anchor 120 may have a head 122 from which the tissue-engaging element may extend distally in a manner that defines an anchor axis ax1 of the anchor. The head 122 may be rigidly attached to the tissue-engaging element. In some implementations, the head 122 may include or define an interface 124 with which the drive head 214 is reversibly engageable, and the anchor driver 210 applies an anchor fixation force (e.g., torque) through this engagement. The interface 124 of the anchor 120 may be fixedly coupled to the tissue-engaging element of the anchor. For example, for implementations in which the tissue-engaging element is a threaded (e.g., helical) tissue-engaging element, the tissue-engaging element may be threaded by application of torque to the interface 124. The interface 124 may be disposed on the anchor axis ax1.

[0710] In some implementations, the tissue engaging element can be comprised of one or more hooks, barbs, darts, staples, clips, prongs, arms, expandable portions, threaded portions, rivets, prongs, helices, screws, threaded portions, combinations of two or more thereof, and the like.

[0711] In some implementations, each anchor in the series of anchors has the same type of head and / or the same type of tissue-engaging element, while in some implementations, some anchors in the series have a different type of head and / or a different type of tissue-engaging element than other anchors in the series (e.g., some have a first type of head and / or tissue-engaging element, while one or more anchors have a different second type of head and / or tissue-engaging element).

[0712] For anchors 120 that are slidably coupled to tether 112 (e.g., continuous anchor 120″), the slidable coupling can be provided by an eyelet 126 on the anchor, through which the tether is threaded. Eyelet 126 can be a component of or coupled to head 122 of the anchor.

[0713] 2A-D, implant 110 can include one or more spacers (or dividers) 150 between anchors 120. For example, as shown, each spacer 150 can be disposed in a respective inter-anchor space between two adjacent anchors 120, e.g., sandwiched between the two adjacent anchors. Spacers 150 can be present in all inter-anchor spaces (e.g., as shown) or in only a subset of the inter-anchor spaces. Tether 112 can be threaded through spacers 150.

[0714] In some implementations, spacer 150 is flexible in flexure, e.g., elastically (e.g., may be resilient) or plastically. As an alternative to this flexibility, spacer 150 may resist axial compression (e.g., may be axially incompressible) or may be axially compressible to some extent. In the example shown, spacer 150 is tubular and defined by a coil. In some implementations, spacer 150 has one or more features of the spacers described in WO 2021 / 084407 by Kasher et al. or WO 2022 / 172149 by Shafigh et al., each of which is incorporated herein by reference.

[0715] During contraction of the implant 110, each spacer 150 can inhibit the approximation of the anchors it sandwiches. In some implementations (e.g., some implementations in which the spacers 150 are axially incompressible), this inhibition can take the form of defining a discrete minimum inter-anchor distance between the sandwiching anchors. In some implementations (e.g., some implementations in which the spacers 150 are axially compressible), this inhibition can be provided across a continuous inter-anchor distance. In some implementations, the spacers 150 can be configured to combine both of these forms of inhibition. The spacers 150 can advantageously distribute contraction and / or force along the implant 110 and / or among the anchors 120.

[0716] The configuration and / or distribution of spacers 150 within implant 110 can be selected according to particular needs. For example, in some implementations, spacers 150 can be configured and / or distributed to achieve greater uniformity of contraction and / or force throughout the implant. In some implementations, the configuration and / or distribution can be selected to concentrate contraction and / or force in one or more regions of the implant and / or tissue.

[0717] In some implementations, spacer 150 is separate from anchor 120. For example, spacer 150 may be threaded over tether 112 separately from anchor 120 and / or may be coupled to the anchor only via the tether.

[0718] Referring again to Figures 1-2D, in some implementations, the catheter device 300 (e.g., its extracorporeal unit 350) includes a de-screw 354 that reduces slack on the tether 112 (e.g., prevents the tether from loosening) and / or generally manages the tether during implantation of the implant 110. It is believed that this structure may advantageously reduce the likelihood of the tether 112 becoming twisted or tangled, or of the tether accidentally contacting an anchor. In some implementations, the de-screw 354 includes a spring-loaded winch. Such a configuration may have the advantage of providing greater control and / or consistency over the amount of tension exerted on the tether compared to a human operator manually pulling on the proximal end of the tether, and may also have the advantage of reducing the number of human operators required.

[0719] In some implementations, desracker 354 may share one or more characteristics with (e.g., may be described as) the “tensioner” described in International Patent Application (PCT) Publication WO 2022 / 064401 by Halabi et al., which is incorporated herein by reference. While desracker 354, at least while servicing this desrack function, may not apply sufficient tension to tether 112 to affect (e.g., contract) the tissue to which anchor 120 is anchored, in some implementations, the desracker may be considered to apply a small amount of tension to the tether, for example, sufficient to reduce / remove slack, but insufficient to substantially affect tissue during implantation. Thus, in some implementations, desracker 354 may be considered a tensioner. However, for clarity, throughout this application, the term tensioner is reserved for tensioners that are actually configured to tension tether 112 sufficiently to contract tissue. Some such tensioners are described below, for example, with reference to FIGS. 28-30 .

[0720] In some implementations, the de-screw 354 can be stopped by an operator so that the de-screw stops reducing slack on the tether 112. In some implementations, the de-screw 354 is configured such that stopping allows the tether 112 to be pulled out of the de-screw without a reaction force from the de-screw.

[0721] In some implementations, as mentioned below, the de-screw 354 can be locked by an operator to prevent such anti-lock tether 112 from being pulled out of the de-screw. In some implementations, such locking stops the de-screw, for example, so that any slack introduced into the tether is not reduced by the de-screw. In some implementations, the catheter device 300 (e.g., its extracorporeal unit 350) can include a similar locking feature separate from the de-screw 354, even in some implementations in which the catheter device does not include a de-screw. Whether or not the locking feature is part of the de-screw can be advantageous, particularly in implementations in which tensioners are used, e.g., as described with reference to FIGS. 28-30 .

[0722] See Figures 3A-B, which are schematic diagrams of anchor 120a and corresponding spacer 150a, according to some implementations. Figure 3A illustrates anchor 120a and spacer 150a through which tether 112 is threaded, according to some implementations, and Figure 3B illustrates a step in implantation of implant 110a including such an anchor and spacer. In some implementations where implant 110 includes a spacer rather than the spacer being separate from the anchor, the spacer is coupled to the anchor, for example, independently of tether 112. Spacer 150a is an example of this, where the spacer is attached (e.g., by welding, brazing, soldering, adhesive, and / or sewing) to anchor 120a, e.g., to head 122a of the anchor, such as eyelet 126a thereof.

[0723] In some implementations, such as the example shown, anchor 120a has a helical tissue-engaging element 130 configured to be threaded into tissue. Tissue-engaging element 130 extends helically around and along the anchor axis, thereby defining anchor axis ax1.

[0724] In the illustrated embodiment, anchor 120a is configured to advance along the tether with spacer 150a leading, e.g., pointing toward the preceding anchor, through which tether 112 is threaded. However, in some implementations, anchor 120a is configured to advance along the tether with spacer 150a trailing, e.g., pointing toward the subsequent anchor (as the subsequent anchor also advances), through which tether 112 is threaded.

[0725] In some implementations, spacer 150a can be considered a component of anchor 120a. For example, spacer 150a can be considered to be a part (e.g., an extension) of eyelet 126a. Similarly, in some implementations, eyelet 126a can be considered to define spacer 150a.

[0726] In some implementations, anchor 120a and spacer 150 can be considered to collectively define anchor-spacer assembly 108. Note that in this context, "assembly" indicates that the system includes these components that are connected to one another and remain connected during their advancement and implantation.

[0727] When implant 110 is implanted, anchor axis ax1 of each anchor 120 may be substantially rotationally offset from tether 112 (e.g., substantially perpendicular to the tether). In FIG. 3B , such offset is observable for the three anchors shown anchored to tissue 10. However, during advancement of each anchor 120 into the heart (e.g., through tube 310), the anchor's anchor axis ax1 may be less offset from tether 112 (e.g., may be substantially parallel to tether 112). In FIG. 3B , this is observable for the anchor shown within tube 310. Thus, eyelet 126 (including variants thereof, such as eyelet 126a) may be configured to permit passage of tether 112 therethrough (and thus sliding of anchor 120 along the tether) both while anchor axis ax1 is substantially parallel to tether 112 (e.g., during advancement through tube 310) and while the anchor axis is substantially perpendicular to the tether (e.g., during anchoring and / or retraction).

[0728] In some implementations, eyelet 126a provides this functionality by being rotatably mounted, such that spacer 150a pivots in response to rotation of the eyelet to which it is coupled. Figure 3A illustrates this rotatable attachment by showing three exemplary rotational orientations. The left-hand example shows eyelet 126a (and spacer 150a) rotationally oriented in a manner that facilitates passage of tether 112 while anchor axis ax1 is substantially parallel to the tether (e.g., the delivery state of anchor 120a), the right-hand example shows a rotational orientation that facilitates passage of the tether while the anchor axis is substantially perpendicular to the tether, and the middle example shows a rotational orientation halfway between the other two orientations, e.g., the anchor axis is offset from the tether but not perpendicular.

[0729] Alternatively, or additionally, eyelet 126 and / or spacer 150 may be mounted so as to be rotatable about anchor axis ax1. This characteristic can advantageously facilitate rotation of interface 124 and tissue-engaging element 130 (to thread the tissue-engaging element into tissue) while tether 112 remains relatively stationary, e.g., without wrapping the tether around anchor 120. In some implementations, as shown in anchor 120a, this feature is achieved by coupling the eyelet and / or spacer (e.g., by coupling it to the eyelet) to a collar 128 that is rotatable about the anchor axis. For example, anchor head 122 (e.g., anchor head 122a) may include a stock 123 that fixedly couples interface 124 to tissue-engaging element 130 (and may be positioned on anchor axis ax1), and collar 128 may surround and be rotatable about the stock. Stocks 123 of different anchors can be seen in FIGS. 4A-D. The stock can be configured in a variety of ways, for example as a core, rod, tube, neck, winch, peg, etc.

[0730] In some implementations, the tissue engaging element can be comprised of one or more hooks, barbs, darts, staples, clips, prongs, arms, expandable portions, threaded portions, rivets, prongs, helices, screws, threaded portions, combinations of two or more thereof, and the like.

[0731] In some implementations, as shown, each anchor 120a is configured to be advanced (e.g., have a delivery state) with spacer 150a extending away from anchor head 122a along tether 112 and / or along tissue engaging element 130. Similarly, in some implementations, as shown, each anchor 120a is advanced with spacer 150a extending away from anchor head 122a and toward the preceding anchor (e.g., distally and / or toward the preceding anchor).

[0732] In some implementations, each anchor 120a can be configured to be advanced (e.g., have a delivery state) with the spacer 150a extending proximally (e.g., along the shaft 212) away from the anchor head 122a, e.g., facing toward the next anchor to be advanced.

[0733] In some implementations, as shown, to accommodate passage of anchor 120a and spacer 150, the interior channel of tube 310 has a keyhole-shaped orthogonal cross-section defining a minor channel region and a main channel region having a larger cross-sectional area than the minor channel region. In some implementations, anchor 120a is advanced through the channel by driver 210, with anchor head 122 and / or tissue engaging element 130 sliding snugly through the main channel region and eyelet 126a and / or spacer 150a sliding snugly through the minor channel region. Spacer 150a may be configured to constrain tether 112 within the minor channel region as anchor 120a advances through the channel. Notably, this may advantageously reduce the likelihood of tissue engaging element 130 undesirably engaging tether 112.

[0734] In some implementations, the spacer 150 may be longer than the tissue engaging element 130 and / or extend beyond the distal end (e.g., sharp point) of the tissue engaging element. See, for example, the left image of FIG. 3A. Notably, this may advantageously further reduce the likelihood of the tissue engaging element 130 undesirably engaging the tether 112.

[0735] Reference is now made to Figures 4A-D, which are schematic illustrations of leading anchor 120' according to some implementations. As mentioned above, in some implementations, leading anchor 120' can be dedicated. Figures 4A-B illustrate an example in which the specialization of leading anchor 120' facilitates securing the leading anchor to tether 112, for example, to the distal end of the tether.

[0736] In some implementations, leading anchor 120′ includes a tissue-engaging element (e.g., tissue-engaging element 130) and an anchor head 122b that includes a socket 132. Stopper 114 is fixedly attached to tether 112, for example, at the distal end of the tether. This fixation can be achieved by compression (e.g., crimping), welding, brazing, soldering, and / or adhesive bonding. Leading anchor 120′ is secured to tether 112 by stopper 114, which is secured within socket 132.

[0737] 4A is a perspective view of leading anchor 120', including a "flip" view showing socket 132 (e.g., its interior) from, for example, the underside of the socket. FIG. 4A includes an inset cross-section through socket 132.

[0738] In some implementations, the socket 132 can be defined by the casing 134, e.g., the socket can be a recess defined by the casing. In some implementations, the casing 134 can be rotatable about the anchor axis of the anchor 120c and / or about the stock of the anchor head 122c, e.g., by being coupled to a rotatably mounted collar 128b. In some implementations, as shown, the casing 134 and collar 128b can be formed from a single, unitary piece of stock material. Such rotatable attachment of the casing 134 via the collar 128b can be as described for the rotatable attachment of the eyelet 126 via the collar 128b, mutatis mutandis. In some implementations, the casing 134 and / or collar 128b can be considered components of the head 122b.

[0739] Figure 4B shows stopper 114 secured to tether 112 installed within socket 132, according to some implementations. Figures 4C-D show stopper 114 secured to tether 112 in different rotational orientations within socket 132, according to some implementations.

[0740] In some implementations, at least one cantilever 136 (e.g., a component of the casing 134) holds the stopper 114 within the socket 132. For example, as shown in FIGS. 4B-C (e.g., the transition therebetween), the stopper 114 can be introduced into the socket 132 through an open side of the socket, and the cantilever 136 can prevent the stopper 114 from exiting the socket through the open side. In some implementations, as shown, the stopper 114 is snap-fit ​​into the socket 132, e.g., the cantilever 136 provides the snap-fit ​​functionality by temporarily moving to accommodate the movement of the stopper into the socket. Thus, the cantilever 136 can be resilient and biased to provide a gap that is narrower than the stopper 114 (e.g., smaller than the diameter of the stopper).

[0741] In some implementations, the stopper 114 is introduced into the socket 132 by pulling the tether 112. For example, the casing 134 can define a window 138 in the socket 132 through which the tether 112 is threaded and pulled, thus pulling the stopper 114 into the socket. Figures 4B-C (e.g., the transitions therebetween) can be considered to represent this. The window 138 can be separate from and extend across from the open side of the socket 132. For example, as shown, at least a portion of the window 138 can be on the opposite side of the socket 132 from the open side. Thus, when the stopper 114 is positioned within the socket 132, the tether 112 extends from the stopper through the window 138 to exit the socket.

[0742] In some implementations, the stopper 114 and socket 132 are shaped and dimensioned so that the stopper can rotate while secured within the socket. For example, the stopper 114 can be bulbous (e.g., beaded and / or substantially spherical), and the stopper and socket can function as a ball-and-socket joint.

[0743] In some implementations, window 138 may be sized and / or shaped to accommodate at least some of such rotation and concomitant pivoting of tether 112 relative to casing 134 (e.g., and generally relative to head 122b). For example, window 138 may extend partway around socket 132 and / or stopper 114 therein, e.g., curved in an arc. For example, window 138 may be elongated and / or extend at least one-fifth of the way around socket 132 and / or stopper 114 therein. This can facilitate pivoting of tether 112 between (i) an axial state ( FIG. 4C ) in which the tether extends through window 138 in a trajectory parallel to the anchor axis, and (ii) a lateral state ( FIG. 4D ) in which the tether extends through window 138 in a trajectory that is rotationally offset (e.g., perpendicular) from the anchor axis. For example, tether 112 may be in an axial state during advancement of the anchor through tube 310 and / or may be in a transverse state after implantation.

[0744] The above-described rotatability of casing 134 and / or collar 128b allows the casing to responsively rotate to face the first continuous anchor of the implant based on tensioning of tether 112. This, combined with the above-described rotatability of stopper 114 and the size and shape of window 138, advantageously allows tether 112 to be in a substantially straight line between stopper 114 and the first continuous anchor of the implant, thereby reducing potentially tether-damaging bending of the tether and allowing the tether to press against the leading anchor component.

[0745] In some implementations, to facilitate the above-mentioned rotation of stopper 114 within socket 132, the end of the tether does not protrude from the stopper. For example, the end of tether 112 may be flush with the outer surface of the stopper. This may be achieved, for example, by cutting and / or grinding off excess tether 112 after the stopper is secured to the tether. In some implementations, the end of tether 112 may be within the stopper.

[0746] See FIGS. 5A-C, which are schematic illustrations of anchor 120c according to some implementations. As discussed above, it may be advantageous for the anchor of implant 110 (or a similar implant) to facilitate the ability of the implant's tether to pivot relative to the anchor between an axial state (e.g., during transcatheter advancement) and a lateral state (e.g., during implantation). It may be advantageous for such an anchor to be slidable along the tether in both the axial and lateral states, particularly if the anchor functions as a continuous anchor for the implant. Anchor 120c provides this feature through eyelet 126c, which is saddle-shaped. Similar to eyelet 126 described above, eyelet 126c may be eccentrically mounted and / or rotatable about the anchor axis and / or stock 123 of the anchor, for example, via rotation of collar 128c.

[0747] Figure 5B shows tether 112 substantially parallel to the anchor axis of anchor 120c (e.g., as might be during advancement of the anchor through tube 310), Figure 5A shows the tether deflected relative to the anchor axis (e.g., as might be the case during implantation of the anchor), and Figure 5C shows the tether deflected in the opposite direction relative to the anchor axis (e.g., the opposite direction from that shown in Figure 5A). In Figures 5A-C, eyelet 126c provides a straight, clear line of sight through the eyelet so that the eyelet can slide smoothly along the tether regardless of the rotational orientation of the tether relative to the anchor axis.

[0748] Anchor 120c can function as a successive anchor (eg, similar to successive anchor 120'') and will be described in this context, although it should be understood that it can also be used as a leading anchor.

[0749] Reference is made to Figures 6A-B, 7, 8A-B, 9, 10, and 11A-K, which are schematic illustrations of exemplary eyelets, eg, eyelets formed from textiles (eg, from polyfilament structures) and / or polymers, according to some implementations.

[0750] Eyelets formed from woven fabric can be flexible and strong, thereby advantageously providing (i) a high degree of freedom of deflection of the anchor shaft relative to the tether 112, (ii) smooth sliding of the eyelet over and along the tether, (iii) low wear on the tether, and / or (iv) long-term durability of the eyelet.

[0751] 6A shows two opposing views of anchor 120d, whose eyelet 126d includes and / or is formed from textile and / or polymer 140. As a result of being formed from textile and / or polymer 140, eyelet 126 can be highly flexible. Furthermore, eyelet 126 can be less abrasive on tether 112 compared to, for example, a metal eyelet. In some implementations, as shown, textile and / or polymer 140 is a thread (e.g., a suture).

[0752] In some implementations, the fabric 140 is a woven fabric (e.g., woven or nonwoven). In some implementations, the fabric 140 can include filaments of natural fibers and / or filaments of synthetic polymers.

[0753] In this disclosure, the term "woven fabric" is used generically, although in some implementations, the polymer may be configured in the same manner as described with respect to various woven fabrics herein, for example, to form eyelets and / or collars, even if the polymer is not configured as a common woven fabric. In some implementations, the polymer may not include any polyfilament structure, any woven fabric, or any weave.

[0754] Additionally (or alternatively), collar 128d of anchor 120d may be formed from fabric 140. Figure 6A shows eyelet 126d and collar 128d both formed from fabric 140, each defined by a respective loop (one or more loops each) to which the fabric is secured.

[0755] In some implementations, the fabric 140 is formed into the eyelet 126d by tying / tie-tying the fabric (e.g., thread). In some implementations, the fabric 140 is formed into the collar 128d by tying / tie-tying the fabric (e.g., thread). In some implementations, the fabric 140 is coupled to the anchor head 122d by tying / tie-tying.

[0756] Similar to the other collars described herein, collar 128d can be configured to be rotatable about the anchor axis of anchor 120d, eg, about stock 123 of head 122d.

[0757] In some implementations, anchor 120d (e.g., its head 122d) includes an optional bushing 142 disposed inward from collar 128d (e.g., concentrically between the eyelet and stock 123). In some implementations, bushing 142 is configured to facilitate rotation of collar 128d, for example, by allowing the bushing to rotate about stock 123. The bushing can be made from a polymer such as polyetheretherketone (PEEK).

[0758] In some implementations, the bushing 142 may be generally annular. In some implementations, the bushing 142 may define a radially facing (e.g., circumferential) groove 144 in which the eyelet resides, the groove stabilizing the eyelet on the bushing and, for example, preventing the eyelet from slipping from the head of the anchor.

[0759] 6B, snood 129 is disposed around anchor head 122d (e.g., the anchor head is enclosed within the snood) in a manner that maintains access to interface 124. Snood 129 may be sized and positioned so as not to engage or interfere with collar 128d, eyelet 126d, or tether 112.

[0760] In some implementations, snood 129 may include (e.g., be formed from) a fabric (e.g., fabric 140), a sponge, and / or a multi-layer material (e.g., a layered cellulose sheet). The material from which snood 129 is formed may optionally be configured to promote tissue growth thereon.

[0761] In some implementations, the snood 129 can be absorbent (e.g., defining pores or pockets) to carry the substance to the anchor site and then gradually release the substance at the site. In some implementations, the substance is absorbed into the snood in the same facility (e.g., in the same operating room) where the procedure using the anchor is performed. In some implementations, the substance is absorbed into the snood by the person (e.g., a physician) performing the procedure using the anchor. In some implementations, the substance is absorbed into the snood two hours or less (e.g., one hour or less, e.g., ten minutes or less, e.g., two minutes or less) before performing the procedure (e.g., before transluminally advancing the anchor into the subject). In some implementations, the substance is absorbed into the snood while a driver used to advance and / or anchor the driver engages the interface 124, e.g., by dipping the anchor into the substance using the driver.

[0762] In some implementations, the substance comprises a drug. In some implementations, the substance comprises a radiopaque dye.

[0763] Of course, a snood such as snood 129 can be used with the head of any tissue anchor, including but not limited to the other tissue anchors described herein.

[0764] FIG. 7 illustrates at least some steps of a technique for forming a collar 128d and / or eyelets 126d from a fabric 140, according to some implementations. In this example, the fabric 140 is an elongated structure, e.g., a thread such as a suture. A length of the fabric 140 is formed into a closed loop 146 (step 51). This can be achieved by tying the fabric and / or by heating (e.g., melting / fusing). Thus, the loop 146 may have a visible bond 141, such as a knot. For simplicity, the bond 141 is not shown in the remaining steps of FIG. 7. In some implementations, multiple loops may be formed and / or used.

[0765] For implementations in which the anchor has a bushing 142, the loop 146 is then wrapped around the bushing (step 52) and passed over itself (step 54) so ​​that two lengths of polyfilament thread extend parallel around the bushing to form a collar 128d. This step can be considered as connecting the loop to the bushing 142 using a Lark's Head knot. In implementations in which the anchor does not have a bushing, the loop 146 may instead be wrapped around a portion of the anchor's head (e.g., another part), such as around the stock 123. In FIG. 7, the dashed cylinder is intended to represent the bushing 142 and / or a portion of the head (e.g., the stock 123). The portion of the loop 146 extending away from the collar 128d forms an eyelet 126d. This portion of the loop 146 can be passed through the eyelet again (step 56), for example, to prevent unlooping. Before and / or after this second loop, the loop 146 is pulled tight (step 58).

[0766] At the intersection between collar 128d and eyelet 126d (e.g., where loop 146 loops over itself one or more times), fabric 140 (e.g., loop 146) can define a knot (or other bulky feature) 147. FIGS. 8A-B, 9, and 10 are schematic illustrations of bushings shaped to define a recess 143 shaped to receive or otherwise accommodate knot 147 and / or joint 141, e.g., to protect or conceal it from exposure to blood flow. FIG. 8, for example, illustrates bushing 142a having recess 143a defined by a trimmed portion of the bushing having a reduced radius (e.g., from the anchor shaft) compared to other portions of the bushing. While recess 143a faces laterally away from the anchor shaft (when bushing 142a is mounted on the anchor), FIGS. 9 and 10 illustrate bushing 142b defining recess 143b that faces inward toward the anchor shaft. As shown, recess 143b may be a cube defined by a bulge in laterally expanding bushing 142b.

[0767] 9 shows an arrangement in which the knot 147 is placed in the recess 143b and the eyelet 126d extends outside the window of the recess. The joint 141 can be placed in the recess 143b.

[0768] Figure 10 shows an arrangement in which joint 141, rather than knot 147, is located within recess 143. In this arrangement, knot 147 may be located elsewhere in groove 144b of bushing 142b, for example, on the opposite side of the bushing from recess 143. In Figure 10, knot 147 is hidden behind bushing 142b.

[0769] In some implementations, bushing 142 is shaped so that a portion of the groove is covered in a manner that secures collar 128d within the groove. Such a cover 149 is shown for bushing 142a. In some implementations, the lateral bulge that defines recess 143b can be considered to function as a cover for bushing 142b.

[0770] 11A-K show anchors (e.g., variations of anchor 120) in which eyelets are formed from fabric 140, according to some implementations. In some implementations, these anchors may be considered variations of anchor 120d (and their eyelet variations of eyelet 126d). Numeric prefixes are used to identify each such variation.

[0771] 6A-10 show eyelet 126d connected to and extending from a single location on collar 128 for some variations shown in FIGS. 11A-K. The eyelet is connected to and / or extends from two locations 60 on the collar, i.e., a pair of locations. The locations 60 can be circumferentially separated from one another. In some implementations, the locations 60 are on opposite sides of the collar from one another. The pair of locations 60 can, for example, define and / or cover hinge axis ax3 such that the eyelet is pivotable about the hinge axis. In some implementations, this allows the eyelet to pivot on anchor head interface 124. This can advantageously allow the eyelet to orient itself according to the relative position of tether 112. This, in turn, can allow for smoother sliding of the tether through the eyelet, for example, during contraction of the implant.

[0772] An example of this is anchor 120dI (FIG. 11A) with fabric 140 positioned (e.g., wrapped and / or tied) to define eyelet 126dI and collar 128dI. In this example, fabric 140 is a thread with a knot defining location 60 where eyelet 126dI extends from collar 128dI, defining hinge axis a3 therebetween.

[0773] 11B-G show anchors each having a collar that is at least partially defined by a component other than fabric 140. For the anchors shown in FIGS. 11B-F, the collars may have one or more features in common with bushing 142 described herein above.

[0774] In some implementations, the fabric 140 is elongated and has two ends with a slack therebetween, the ends being connected to the collar such that the slack defines an eyelet. Examples of such arrangements are shown in Figures 11B-D and 11F.

[0775] FIG. 11B shows anchor 120dII including flexible eyelet 126dII and rigid collar 128dII defined by textile 140. FIG. 11C shows anchor 120dIII including flexible eyelet 126dIII and rigid collar 128dIII defined by textile 140. Collars 128dII and 128dIII each have two openings defining positions 60 where the corresponding eyelet extends from the collar, with hinge axis a3 defined between them. In these variations, textile 140 may be a thread with knots at each end, which act as stoppers to hold the eyelet attached to the collar.

[0776] For anchor 120dII, the knot may be introduced into the collar from the distal side of the collar and placed in recess 62dII on the distal side of the collar (e.g., facing tissue engaging element 130). Recess 62dII may be distal to interface 124.

[0777] For anchor 120dIII, the knot may be introduced into the collar from the proximal side of the collar and disposed in recess 62dIII on the proximal side of the collar (e.g., facing away from tissue engaging element 130). Interface 124 may be disposed between recesses 62dIII (e.g., as shown) or may be distal to the recesses.

[0778] FIG. 11D shows anchor 120dIV, which is similar to anchors 120dII and 120dIII, except as noted. For anchors 120dII and 120dIII, fabric 140 is shown extending outward (e.g., laterally) from its knotted end, e.g., pulling on the eyelet pulls the knot in the outward direction. For anchor 120dIV, collar 128dIV and fabric 140 may be configured such that the fabric extends inward from its knotted end, e.g., pulling on the eyelet pulls the knot inward. For anchors 120dII and 120dIII, the knot is local to location 60. For anchor 120dIV, the knot is distant from location 60, e.g., such that fabric 140 extends through collar 128dIV (e.g., as a string) between each knot and the corresponding location 60. For example, collar 128dIV may define recesses 62dIV, each on a side of the collar distal from its corresponding location 60, with corresponding bores 64dIV cut through the collar therebetween and fabric 140 extending through the bores. In the embodiment shown, bores 64dIV are parallel to one another on opposite sides of stock 123.

[0779] FIG. 11E shows anchor 120dV having a bore 64dV extending through its collar 128dV, similar to anchor 120dV. However, bore 64dV connects collar recesses 62dV to one another. In this manner, fabric 140 can be arranged (e.g., tied) in a closed loop threaded through bore 64dV. In some implementations, using a knot to tie fabric 140 to itself in this manner may advantageously provide enhanced attachment of the eyelet to the collar compared to using a knot as a stopper. In the illustrated embodiment, a single bore 64dV encircles stock 123 partway. Similar to anchors 120dII and 120dIII, recess 62dV can be local to location 60.

[0780] 11F shows an anchor 120dVI similar to anchors 120dII and 120dIII, except that instead of a recess, collar 128dVI defines one or more tabs 66 to which fabric 140 is coupled to secure eyelet 126dVI (defined by the fabric) to the collar. In one embodiment, a pair of tabs 66 are positioned on opposite sides of the collar such that securing corresponding ends of fabric 140 to the tabs creates slack in the fabric within eyelet 126dVI.

[0781] FIG. 11G shows anchor 120dVII, which is similar to anchor 120dV, except that collar 128dV is rigid and collar 128dVII is flexible. Such flexibility may reduce wear on fabric 140. In the embodiment shown, collar 128dVII is defined by a flexible tube having bores 64dVII along the tube. At each end of the tube is an end opening defining a respective one of positions 60. In some implementations, as shown, fabric 140 defines a closed loop in which the tube is threaded through bores 64dVII with the fabric extending out from both end openings. Collar 128dVII may be secured by stock 123 extending laterally through the flexible tube. For example, the flexible tube may define a transverse channel (e.g., a pair of holes facing each other within the material of the tube), and stock may extend transversely through the tube via the transverse channels. The collar 128dVII may be made from a flexible polymer and / or a woven fabric. For example, the collar 128dVII may include a piece of polymer tubing.

[0782] FIG. 11H shows a woven fabric 140dVIII in which the collar 128dVIII and eyelet 126dVIII are integrally formed during fabric formation, e.g., during weaving, knitting, or braiding of the fabric. For example, as the woven fabric 140dVIII is gradually formed from one end to the other, the weaving / knitting / braiding may separate to form the eyelet 126dVIII, converge to close the eyelet and form a joint 147dVIII (similar to a knot 147), diverge again to form the collar 128dVIII, and converge again at the other end to close the collar. Integral formation of the collar and eyelet may be advantageous for production efficiency and / or consistency. It should be understood that the forming may alternatively be performed in the opposite direction. In some implementations, the collar 128 is mounted on a bushing. In other implementations, the collar 128 is mounted directly on the stock 123.

[0783] In some implementations, the fabric 140dVIII may be formed as a substantially flat sheet (e.g., resembling a ribbon) or may be formed using a tubular weave, e.g., the eyelet 126dVIII and collar 128dVIII are each defined by two tubular components alongside each other, and the joint 147dVIII is generally tubular.

[0784] FIG. 11I illustrates an anchor 120dIX that includes a woven fabric 140dIX. Similar to some of the other woven fabrics described above, the woven fabric 140dIX defines both the anchor eyelet 126dIX and the anchor collar 128dIX. Rather than forming the eyelet and collar by tying an elongated strip of fabric into an array, the eyelet 126dIX and collar 128dIX are formed (e.g., cut) from a sheet (e.g., a woven sheet) of the woven fabric 140dIX. For example, the woven fabric 140dIX can be cut to define a disk having a transverse hole 68, with an arcuate slit 69 extending partway circumferentially around the transverse hole. In the illustrated embodiment, the slit 69 extends substantially all the way circumferentially around the transverse hole 68. The area of ​​the disc lateral from the slit 69 functions as the eyelet 126dIX, and the area of ​​the disc inward from the slit functions as the collar 128dIX, with location 60 at the end of the slit 69. In this manner, a unitary structure including both the eyelet and the collar of the anchor can be formed simply by cutting a fabric sheet. This can facilitate the manufacture of such anchors, for example, by allowing many such unitary structures to be cut from a single sheet and requiring few or no additional manufacturing steps. The collar 128dIX can be attached simply by threading the tissue-engaging element 130 through the hole 68 until the stock 123 is positioned therethrough.

[0785] FIG. 11J shows anchor 120dX, which includes woven fabric 140dX. Similar to some of the other woven fabrics described above, woven fabric 140dX defines both anchor eyelets 126dX and anchor collars 128dX. The woven fabric 140dX is elongated, with loops 70 at each end and slack therebetween. The woven fabric 140dX may be a thread whose ends are looped (e.g., tied) to form the loops 70. Alternatively, as shown, the loops 70 may be integrally formed, for example, during the formation of the woven fabric 140dX (e.g., as described with reference to FIG. 11H, mutatis mutandis) or by being cut from a sheet of fabric (e.g., as described with reference to FIG. 11I, mutatis mutandis). The first image in FIG. 11J shows only woven fabric 140dX. The second and third images show the application of woven fabric 140dX. The tissue-engaging element 130 is threaded through the eye 70, which functions proximally along the tissue-engaging element (second image) until the stock 123 is placed through the eye (third image). Thus, the eyes 70 collectively function as the collar 128dX of the anchor. As the eyes 70 come together, the slack in the fabric becomes looped and functions as the eyelet 126dX of the anchor. The anchor 120dX may have similar manufacturing advantages as those described for the anchor 120dIX.

[0786] FIG. 11K shows anchor 120dXI where, rather than the fabric defining the anchor's eyelets, the fabric serves to connect discrete, rigid eyelets 126dXI to the anchor's collar. Eyelets 126dXI may be metal or polymer rings. In some implementations, such an arrangement can benefit from both the advantages of flexible fabric 140 and rigid eyelets. In the example shown, the collar is collar 128dII, but it should be understood that this is merely an illustrative example and that any of the other anchors described herein may be modified in this manner, with appropriate changes.

[0787] Reference is made to Figures 12 and 13A-F, which are schematic illustrations of a distal portion of flexible tube 310a (e.g., a catheter) and its method of use, according to some implementations. Tube 310a is a component of a catheter device and can be considered a variation of tube 310 described above. Furthermore, tube 310a can be used, mutatis mutandis, in place of tube 310 in catheter device 300 described hereinabove and / or as a tube in any other catheter device, including those described herein, mutatis mutandis. Figure 12 shows an enlarged view of the distal portion of tube 310a, and Figures 13A-F show anchor 120d being delivered and secured through the tube.

[0788] The interior channel of tube 310 may be keyhole-shaped, while tube 310a has an interior channel 311 that may not be keyhole-shaped, e.g., may be circular in cross section. In some implementations, anchor 120d is particularly suited for delivery through tube 310a due, for example, to the flexibility of its eyelet 126d.

[0789] Tube 310a defines a gripping zone 312 at its distal end, e.g., proximal to a distal opening 313 of the tube through which an anchor (e.g., anchor 120d) is ultimately advanced. In gripping zone 312, tube 310a has at least one gripping surface that inhibits sliding of the anchor through the gripping zone by gripping a lateral surface of the anchor's helical tissue-engaging element, e.g., tissue-engaging element 130. This gripping surface may be provided by one or more resilient ribs (or nubs, or nodes) 314 that protrude inwardly into channel 311. In the embodiment shown, gripping zone 312 of tube 310a has six ribs 314. However, it should be understood that gripping zone 312, or variations thereof, may have more or fewer ribs, such as four ribs, three ribs (e.g., as shown for gripping zone 312d), two ribs, or one rib. For implementations in which the gripping zone 312 has multiple ribs, the multiple ribs may be distributed circumferentially around the central tube axis ax2 of the tube 310a. In some implementations, this distribution is uniform (e.g., with equal circumferential spacing between each pair of adjacent ribs). In some implementations, this distribution is non-uniform (e.g., some of the ribs are closer together and some are further apart).

[0790] To implant anchor 120d, an anchor driver, such as driver 210, through engagement with the anchor (e.g., the anchor's interface), slides the anchor distally through channel 311 toward grasping zone 312 (FIG. 13A). When anchor 120d reaches grasping zone 312, ribs 314 grip tissue engaging element 130 (FIG. 13B). This gripping prevents sliding of anchor 120d through grasping zone 312 in the absence of rotation, inhibiting only axial sliding, for example. To further advance anchor 120d distally, thus through grasping zone 312, driver 210 rotates tissue engaging element 130 (e.g., by applying torque to the anchor's interface), causing tissue engaging element 130 to slide helically over ribs 314, which deform (e.g., compress) to accommodate this sliding (FIGS. 13C-D). That is, the driver 210 screws the tissue engaging element onto the ribs 314. The shape, strength, and / or resilience of the ribs 314 may be optimized to resist axial sliding, but to allow helical sliding of the tissue engaging element 130 thereon.

[0791] FIG. 13D shows the tissue engaging element 130 being driven (e.g., threaded) into the tissue 10. In some implementations, as shown, this can occur while a portion of the tissue engaging element remains gripped by the ribs 314. Accordingly, the gripping zone 312 can be sized and / or positioned (e.g., relative to the anchor) such that at least the distal tip of the tissue engaging element 130 can exit the distal opening 313 of the tube 310a while the tissue engaging element remains within the gripping zone (e.g., remains gripped by the ribs 314). In this condition, rotation of the tissue engaging element 130 can extract (e.g., pull) the head of the anchor through the gripping zone 312. As an inherent counterforce, the tissue engaging element thereby pulls the tissue 10 proximally. In some implementations, this mutual tension can be utilized to improve anchoring reliability, for example, as a mechanical / tactile and / or imaging-based anchoring indication. For example, if the tissue engaging element is driven into inappropriately weak tissue (e.g., lobular tissue or diseased tissue), the anchor may not be withdrawn from the vessel. Conversely, complete / successful anchoring into the appropriate tissue may be indicated by (i) arrival of the anchor head at (or exit of the head from) the distal opening of the vessel, and / or (ii) bulging of tissue toward the distal end of the vessel (e.g., being pulled into the distal end of the vessel by the anchor). The operator may disengage from the anchor only when one or more indicators of complete / successful anchoring are observed.

[0792] For implementations in which the anchor is coupled to the tether (e.g., implementations in which the anchor and tether are components of the implant and / or implementations in which the tether is threaded through the anchor), the tissue-engaging element 130 may be disposed within the gripping zone (e.g., gripped by ribs 314) while the tether is disposed within a niche 315 defined adjacent to (e.g., between) the ribs. For example, as shown, while driver 210 threads tissue-engaging element 130 onto ribs 314, the tissue-engaging element can be displaced from niche 315 (e.g., due to interaction with at least one rib), while tether 112 extends laterally from the tissue-engaging element through the shielded gripping zone within the niche, as shown, for example, in the inset of FIG. 13D . This may advantageously prevent the tether from being engaged by the tissue-engaging element and / or maintain slidability of the tether through the gripping zone even as the anchor passes through the gripping zone.

[0793] 13E shows tissue engaging element 130 fully anchored within tissue 10, with the head of anchor 120d disposed within grasping zone 312. In some implementations, ribs 314 may be shaped and / or dimensioned to interact with (e.g., engage and / or grasp) the head of the anchor.

[0794] In some implementations, as shown, the head of the anchor passes through gripping zone 312 substantially unobstructed by gripping zone 312, for example, without contacting ribs 314. As shown, eyelet 126d can pass through gripping zone 312 between ribs 314. Figure 13F shows tube 310 retracting from anchor 120d after the anchor has been anchored.

[0795] In some implementations, the ribs 314 are formed from a polymer. In some implementations, the tube 310a includes the same polymer, e.g., is formed from a polymer and / or is lined with a polymer. Thus, the ribs 314 can be integrally formed with the tube 310a, which can be advantageous for manufacturing. The polymer can be a thermoplastic elastomer. The polymer can be a block copolymer, such as a polyether block amide.

[0796] In some implementations, as shown, one or more of the ribs 314 have a proximal surface 316 shaped to define a shoulder. This can facilitate inhibition of anchor 120d through grasping zone 312 in the absence of rotation, for example, by tissue engaging element 130 abutting the shoulder (see, e.g., FIG. 13B ). In some implementations, one or more of the ribs 314 have a tapered distal surface 318. This can facilitate retraction of anchor 120d through grasping zone 312 and into vessel 310, for example, if such retraction is determined to be necessary. For example, with respect to vessel axis ax2, proximal surface 316 can be disposed at a steeper angle than distal surface 318. In some implementations, proximal surface 316 can be disposed at an angle of at least 75 degrees and / or no more than 90 degrees relative to axis ax2 (e.g., can be substantially perpendicular to axis ax2). In some implementations, the distal surface 318 is disposed at an angle of at least 20 degrees (eg, at least 40 degrees) and / or no greater than 70 degrees (eg, no greater than 60 degrees) relative to the axis ax2.

[0797] Reference is made to Figures 14A-E and 15A-C, which are schematic illustrations of variations of tube 310 or tube 310a, according to some implementations.

[0798] As described herein above, the gripping zone of a tube may have only one rib. FIG. 14A shows a distal portion of tube 310b, which may be as described for tube 310a, except that its gripping zone 312b has only one rib 314b. In some implementations, rib 314b may be identical to or similar to rib 314, as described above. In some implementations, rib 314b may differ from rib 314 to accommodate the absence of any other (e.g., opposing) rib; for example, rib 314 may protrude further into the channel of the tube.

[0799] 14B shows a distal portion of tube 310c, which may be as described for tube 310b, except that ribs 314 and 314b extend along (e.g., parallel to) tube axis ax2, and ribs 314c of gripping zone 312c of tube 310c extend around at least a portion of the tube axis. For example, as shown, ribs 314c may extend circumferentially around the entire tube axis, e.g., may be annular.

[0800] In the illustrated embodiment, gripping zone 312c of tube 310c has one rib 314c. However, it should be understood that gripping zone 312c or variations thereof can have more ribs, such as two ribs, three ribs, four ribs, or more. For implementations in which gripping zone 312c has multiple ribs, the multiple ribs can be distributed along tube axis ax2 of tube 310c. In some implementations, this distribution is uniform (e.g., with equal axial spacing between each pair of adjacent ribs). In some implementations, this distribution is non-uniform (e.g., some of the ribs are closer together and some are further apart).

[0801] Although circumferential rather than axial, the ribs 314c can have proximal faces defining shoulders and / or tapered distal faces, for example, as described for ribs 314, mutatis mutandis. In some implementations where the gripping zone 312c has multiple ribs 314c, only a subset of the ribs (e.g., only the most proximal ribs) can have proximal faces defining shoulders. In some implementations where the gripping zone 312c has multiple ribs 314c, only a subset of the ribs (e.g., only the most distal ribs) can have tapered distal faces.

[0802] The ribs 314 (e.g., rib 314b) may be elongated as shown, but may be longer or shorter than shown. Additionally, they may be short enough to resemble nodes, as shown, for example, for rib 314d. Similarly, each rib 314c may include one or more sub-ribs (e.g., nodes), each of which does not entirely surround the tube axis. For example, multiple sub-ribs may be distributed around the tube axis.

[0803] 14C-D show a distal portion of a tube 310d having a gripping zone 312d including one or more ribs 314d, according to some implementations. In addition to the ribs, the gripping zone 312d further includes at least one abutment 317, designated abutment 317d in the illustrated embodiment. The abutment 317 protrudes inward into the channel 311 of the tube 310d but is smaller than the rib 314d, i.e., the height h2 of the abutment is smaller than the height h1 of the rib 314d. This difference allows the abutment 317 to interact less with the tissue-engaging element 130 than the rib 314d. For example, the abutment 317 may not obstruct or grip the tissue-engaging element 130 (e.g., may not inhibit axial sliding of the tissue-engaging element). The abutment 317 functions to inhibit rotation of the eyelet 126d about the anchor axis as the anchor is threaded into tissue.

[0804] 14D shows anchor 120d being threaded into tissue (e.g., FIGS. 13C-E). Interface 124 and tissue engaging element 130 rotate as the tissue engaging element is threaded through grasping zone 312d into tissue 10, but any associated rotation of eyelet 126d is constrained as the eyelet abuts against abutment 317. As tissue engaging element 130 moves helically distally, eyelet 126d slides linearly along abutment 317.

[0805] As shown, the abutment 317 can be positioned proximally from the rib 314d so as to interact with the eyelet of the anchor, for example, while the rib interacts with the tissue-engaging element of the anchor. In some implementations, as shown in abutment 317d, the abutment can be longer than the rib (i.e., extend further along the axis of the tube), i.e., the length d4 of the abutment is greater than the length d3 of the rib 314d. This can allow the eyelet to remain positioned relative to the abutment as the increasingly proximal portion of the tissue-engaging element reaches and passes the rib.

[0806] In some implementations, each abutment may extend from a respective rib, as shown in abutment 317d, for example, the abutments and ribs may be defined by a single structure. Alternatively, abutments 317 may be separate structures.

[0807] Although abutments 317 (eg, abutment 317d) are shown in combination with ribs 314d, it should be understood that gripping zones having other ribs 314 may also utilize such abutments.

[0808] Tubes 310a, 310b, 310c, and 310d are shown as flaring toward their respective distal openings. This optional feature may similarly be applied to other tubes, such as tube 310, e.g., tubes that may not include a gripping zone. Such a flare may advantageously provide the tube with atraumatic properties, e.g., compared to a tube with a straight end. Alternatively, or additionally, such a flare may advantageously reduce the pressure of the end of the tube on tether 112, as shown, e.g., in FIG. 15A for tube 310d. Alternatively, or additionally, such a flare may facilitate sliding of tether 112 over the rim of the distal opening (e.g., reducing grip of the tether by the rim of the distal opening), thereby advantageously reducing the likelihood of tube migration, which may adversely pull tight on tether 112 and previously secured anchors. Alternatively, or additionally, such a flare may advantageously facilitate retraction of the anchor into the tube when the anchor is needed.

[0809] In some implementations, the distal end of the tube (e.g., the distal end of the gripping zone) can be more flexible than the more proximal region of the tube. Similar to the flaring, this can provide atraumatic properties to the tube. This can facilitate retraction of the anchor into the tube if needed. Figure 14E shows this example in which the distal end of tube 310d (e.g., the distal end of gripping zone 312d) plastically deforms at 309 to accommodate re-entry of the anchor, for example, when the tube is imperfectly aligned with the anchor.

[0810] In some implementations, in addition to and / or as an alternative to flaring, the tube may be shaped so that the rim of the tube's distal opening is contoured. Figures 15B and 15C show an example of this, where tube 310f (Figure 15C) has more of these contours than tube 310e (Figure 15B). Like a flare, the contours may advantageously reduce pressure of the end of the tube on tether 112. Whether provided by a flare or contours, this reduced pressure may facilitate de-slackening 354, particularly on the region of the tether beyond tube 310 (e.g., maintaining minimal tension).

[0811] Referring again to gripping zone 312 and variations thereof, in some implementations, gripping zone (e.g., its ribs) is configured to substantially prevent distal advancement of tissue engaging element 130 in the absence of rotation. In some implementations, gripping zone (e.g., its ribs) is primarily configured to provide tactile feedback, e.g., to resist distal advancement in the absence of rotation, should sufficient axial (pushing) force be applied to allow such non-rotational distal advancement. In either case, the presence of gripping zone 312 may advantageously reduce the likelihood of premature and / or inadvertent advancement of the anchor out of the vessel into which it was delivered.

[0812] It should be noted that gripping zone 312 may have advantages over other components or features intended to similarly facilitate controlled advancement of the anchor out of the distal end of the delivery tube or to maintain separation between the tissue engaging element of the anchor and the tether through which the anchor is threaded. For example, a protrusion (which may be relatively rigid) intended to facilitate controlled advancement of the anchor out of the distal end of the delivery tube may require a particular rotational orientation of the anchor (or portion thereof) relative to the delivery tube and / or may prevent retraction of the anchor into the delivery tube if such retraction is deemed necessary.

[0813] Similarly, a keyhole-shaped channel in the delivery tube intended to maintain separation between the tissue engaging element of the anchor and the tether through which the anchor is threaded may require a particular rotational orientation of the delivery tube relative to the tissue and / or the previously secured anchor, and / or may prevent retraction of the anchor into the delivery tube, for example, by requiring rotational alignment between the anchor and the keyhole-shaped lumen.

[0814] While gripping zone 312 is described and shown for tubes whose channels are substantially circular in cross-section, it should be understood that in some implementations gripping zone 312, or a similar gripping zone, may be provided on other tubes, including those having non-circular (e.g., keyhole-shaped) channels. Similarly, while gripping zone 312 is described and shown to facilitate delivery of anchor 120d, it should be understood that in some implementations gripping zone 312, or a similar gripping zone, may be used to facilitate delivery of other anchors, such as, but not limited to, other anchors described herein.

[0815] 15A-C illustrate anchor 120d implanted as a component of an implant further including tether 112. One anchor 120d is shown functioning as leading anchor 120d', and another (identical) anchor is shown functioning as continuing anchor 120d''. Stopper 114d is shown secured to the distal end of tether 112 to maintain the tether coupled to anchor 120d', for example, by preventing the tether from sliding out of eyelet 126d. However, other means of maintaining this coupling can be used. For example, tether 112 can be looped through eyelet 126d and back onto itself, with the loop closed by a knot, crimp, or another suitable means.

[0816] Reference is made to FIG. 16 , which is a schematic diagram of membrane 330 according to some implementations. While membrane 330 is shown as being disposed over the distal opening of flexible tube 310g, it should be understood that the membrane may be used with any of the tubes described herein, with appropriate modifications. Membrane 330 has one or more slits 332 (e.g., multiple slits) that divide the membrane into multiple flaps 334. In the embodiment shown, membrane 330 has four slits 332, but variations of membrane 330 can have one, two, three, five, six, or more slits. In the embodiment shown, membrane 330 is divided into four flaps 334, but variations of membrane 330 can have two, three, five, six, or more flaps.

[0817] In some implementations, the slits 332 converge to define a convergence point, as shown, hi some implementations, the membrane 330 may have a hole 336 at the convergence point.

[0818] In some implementations, to deliver and anchor anchor 120, driver 210 slides the anchor distally through a channel in tube 310g and distally through membrane 330 via one or more slits, with flaps 334 temporarily separating in response to passage of the anchor through the membrane. Tube 310g, membrane 330, anchor 120, and / or driver 210 can be configured (e.g., shaped and / or sized) so that tissue engaging element 130 aligns with hole 336.

[0819] In some implementations, membrane 330 defines a notch 338 that is eccentrically disposed and positioned to substantially align with eyelet 126 of the anchor. Notch 338 may or may not begin at the convergence point of slits 332 or holes 336 (e.g., extend laterally therefrom). Notch 338 may be present regardless of the convergence (or non-convergence) of slits 332. In some implementations, notch 338 is defined in a single one of flaps 334. In some implementations, as shown, notch 338 may be partially defined in one of the flaps and partially defined in another one of the flaps, e.g., the notch may at least partially coincide with one or more of slits 332.

[0820] Membrane 330 can advantageously enhance control over the position of tether 112. Membrane 330 can advantageously reduce the likelihood of tether 112 kinking and / or entangling with anchor 120. Membrane 330 can be radiolucent or echogenic to advantageously improve visualization of the implantation procedure, e.g., to visually verify that the distal end of tube 310 is positioned against tissue 10 and / or to identify the position of anchor 120 relative to the distal opening of the tube. Membrane 330 can advantageously facilitate detachment and / or retraction of anchor 120 by impeding the drawing of tissue 10 into tube 310, e.g., by wiping tissue from tissue engaging element 130.

[0821] 17A-B, which are schematic illustrations of anchor 120e, according to some implementations. FIG. 17A is a perspective view, and FIG. 17B is a cross-sectional view. Anchor 120e includes head 122e and tissue-engaging element 130e. While the head and / or tissue-engaging element of other anchors 120 described herein may be substantially formed from a metal, such as stainless steel, head 122e and tissue-engaging element 130e are substantially formed from a polymer, e.g., a hard polymer.

[0822] Head 122e defines interface 124e, which can be as described for interface 124, except that head 122e is substantially formed from a polymer. In some implementations, interface 124 and / or interface 124e include a pin, e.g., perpendicular to the anchor axis and grasped by the anchor driver. For interface 124e, this pin can be a metal pin 125, e.g., the interface, except for the pin, is substantially formed from a polymer.

[0823] In some implementations, anchor 120e includes eyelet 126e that is rotatable about the anchor axis of the anchor, for example, by being attached to a rotatably mounted collar 128e. In some implementations, anchor 120e may include stock 123e that fixedly couples interface 124e to tissue engaging element 130e (and may be positioned on the anchor axis), and collar 128e may surround and be rotatable about the stock. In some implementations, eyelet 126e, collar 128e, and / or stock 123e are also substantially formed from a polymer. As shown, collar 128e and eyelet 126e may be formed as a monolithic piece of polymer.

[0824] In some implementations, eyelets and / or collars formed from fabric are used instead of eyelets 126e and / or collars 128e. For example, eyelets 126d and / or collars 128d (described hereinabove) may be used in combination with tissue engaging element 130e and / or head 122e, mutatis mutandis.

[0825] In some implementations, the polymer from which the components of anchor 120e are formed is a polyaryletherketone, such as polyetheretherketone (PEEK). In some implementations, one or more of the components of anchor 120e (or the entire anchor) are formed via molding. In some implementations, one or more of the components of anchor 120e (or the anchor as a whole) are formed via additive manufacturing, e.g., 3D printing.

[0826] In some implementations, in one or more of the parts (e.g., components) of anchor 120e, a radiopaque material such as barium sulfate is mixed with a polymer to improve the visibility of the anchor in fluoroscopic images.

[0827] In some implementations, the tissue-engaging element 130e is shaped to be suitable for being formed from a polymer. For example, rather than being helical (e.g., like a cork screw), the tissue-engaging element 130e may include a central shaft 171 having an external self-tapping thread 172 helically extending therearound and therealong, as shown. In some implementations, as shown, the central shaft 171 has a tapered region 174 that tapers to a distal point 176 that may be located on an anchor shaft. As shown, the taper of the shaft 171 may be steeper at the distal point 176 than at the tapered region 174.

[0828] In some implementations, threads 172 protrude laterally from shaft 171 a distance d2 that is 2 to 4 times (e.g., about 3 times) the shaft diameter d1. d1 may be the diameter of shaft 171 at its thickest portion. d2 may be the maximum distance that threads 172 protrude laterally from the shaft.

[0829] Reference is made to FIGS. 18A-B, which are schematic diagrams illustrating implantation of implant 110b according to some implementations. Implant 110b can be considered a variation of implant 110 and, for example, can be as described for implant 110 except where noted. In particular, implant 110b includes tether 112b, which can be considered a variation of tether 112. Tether 112b is radiopaque and biased to assume a wave shape, e.g., a regular wave shape such as a sinusoidal wave or a zigzag wave. For example, tether 112b can include a shape memory alloy such as Nitinol that is shape-set into a wave shape. In some implementations, the radiopacity and shape-bias joint properties are provided by tether 112b having a radiopaque material along with the shape memory material. For example, in some implementations, tether 112b can include a cable including at least one radiopaque strand and at least one shape memory strand. In some implementations, the tether 112b may comprise an elongated filled tube having a radiopaque core, for example, an outer sheath comprising nitinol.

[0830] Implant 110b may be implanted as described for implant 110 and / or using delivery tool 200, with appropriate modifications. However, the undulations of tether 112b can facilitate implantation by providing a scale indication on fluoroscopic images. For example, if the wavelength of the undulations is known, it can be used to measure distance along tissue, e.g., like a ruler. Alternatively, or additionally, anchors can be positioned according to the number of waves between an anchor and the preceding anchor. In the example shown, each successive anchor is positioned one full wavelength after the preceding anchor (FIG. 18A).

[0831] In some implementations, the bias (e.g., shape setting) of tether 112b is (i) strong enough to provide reliable fluoroscopic guidance, but (ii) weak enough (e.g., the tether is sufficiently flexible) that its undulation does not substantially inhibit subsequent tensioning of the tether to draw the anchors together and contract the tissue (FIG. 18B). As shown in FIG. 18B, tether 112b can straighten (e.g., partially or completely) in response to tension.

[0832] For implementations in which implant 110b is implanted using catheter device 300, de-scratcher 354 can reduce (e.g., eliminate) slack without substantially reducing rippling of tether 112b. This can be achieved, for example, by configuring tether 112b with a sufficiently strong bias and / or by configuring de-scratcher 354 to pull harder than tether 112b.

[0833] 19A-G, which are schematic illustrations of a tool 400a (e.g., a contraction and / or locking tool) and lock 160a used to apply tension to and / or lock tether 112, according to some implementations. Tool 400a and lock 160a may be the same as or similar to (e.g., variations of) tool 400 and lock 160.

[0834] It should be noted that tool 400a and lock 160a can advantageously be used without accessing the proximal end of tether 112, e.g., while the proximal end of the tether remains within and / or engaged with the catheter tool's extracorporeal unit (e.g., its descratcher 354). This may confer certain advantages, such as being able to apply the lock prior to any cutting of tether 112 and / or while catheter device 300 (e.g., its tube 310) remains in place. In some implementations, this may allow for the application of multiple lockers along the implant, rather than just at the proximal end of the implant.

[0835] Thus, in some implementations, tool 400a and / or lock 160a may be used in combination with and / or to facilitate systems and / or techniques described in U.S. Provisional Patent Application No. 63 / 370,609 by Biran et al., filed August 5, 2022, entitled "Variable Tissue Retraction," and / or International Patent Application No. PCT / IB2023 / 055323 by Guerrero et al., filed May 24, 2023, entitled "Variable Tissue Retraction," each of which is incorporated herein by reference.

[0836] FIG. 19A shows tool 400a grasping tether 112 without accessing the proximal end of the tether. This is referred to herein as grasping the slack 112′ of the tether, i.e., the portion between the proximal and distal ends, regardless of whether that portion is curved. In the illustrated embodiment, slack 112′ resides in extracorporeal unit 350, e.g., proximal to proximal opening 320 of tube 310, through which tether 112 and anchors 120 are advanced into the tube. It should be understood that the state shown in FIG. 19A is after at least one anchor 120, and typically multiple anchors, have been advanced and secured to tissue.

[0837] Tool 400a includes a shaft 402 and a collet 410. Tool 400a includes a grasper 416, such as, for example, a hook or snare. Collet 410 is housed within shaft 402. Lock 160a is malleable and shaped to define a passage therethrough. During use, lock 160a may be retained within collet 410, for example, as shown. Tool 400 may include lock 160a already retained within collet 410 and / or may be configured to engage and / or accept a lock during use.

[0838] A grasper 416 can extend distally through (e.g., through a passageway in) lock 160a and out of shaft 402 (FIG. 19A) so that it can grasp tether 112. Tool 400 can be provided with grasper 416 already extending through lock 160a, or grasper 416 can extend through the lock during use.

[0839] The grasper 416 can then draw the tether 112 (e.g., slack 112′) proximally through the lock 160a (e.g., through its passage) and into the shaft 402, thereby forming and / or retaining the tether (e.g., slack) in / as a loop 111 within the shaft (FIG. 19B).

[0840] While tether 112 is held as a loop 111 within shaft 402, tool 400 can be advanced distally into the body (e.g., through tube 310) along tether 112 such that incremental regions of tether are fed around grasper 416 (FIG. 19C). Thus, incremental regions of tether 112 are fed through loop 111, i.e., become part of the loop as tool 400 arrives, and then cease to be part of the loop as tool 400 progresses distally beyond the loop. In FIG. 19C, this is represented by the arrows showing the feeding of tether 112 into the tool (arrow a1), around grasper 416 (arrow a2), and out of the tool (arrow a3) as tool 400 advances distally (arrow a4). As shown, the portion of the tether emerging from lock 160a and / or tool 400 (near arrow a3) passes proximally through the lock / tool ​​and curves toward the extracorporeal portion of the delivery tool (e.g., toward extracorporeal unit 350). Thus, during advancement of lock 160a, tether 112 is formed into an S-shape at and / or by the lock and / or delivery tool 400.

[0841] At this point, typically, once tool 400a reaches the most recently anchored anchor, tether 112 is tensioned to draw anchors 120 toward each other and contract the anchored tissue. In some implementations, this can be accomplished by grasper 416 being pulled proximally relative to shaft 402 and / or shaft 404 (FIG. 19D). In some implementations, this can be achieved by pulling the proximal end of tether 112 (e.g., with an external controller), for example, by using a tensioner as described below. The tensioning of tether 112 can coincide with (e.g., be facilitated by) the distal end of tool 400 abutting lock 160 and / or a portion of the implant of which the tether is a component, e.g., abutting eyelet 126 thereof, against the most recently anchored anchor 120. This abutment can provide a reference force for tension. The tensioning of tether 112 may coincide with (e.g., be facilitated by) the distal end of lock 160 and / or tool 400 being positioned at or beyond distal opening 313 of tube 310, for example, to facilitate their engagement with anchor 120.

[0842] In some implementations, tool 400a can lock lock 160a to tether 112, for example, to lock in tension applied to tether 112. This can be accomplished by actuating collet 410 to crimp (e.g., crush) lock 160a ( FIG. 19E ). In some implementations, as shown, collet 410 is actuated by relative movement of two other components of tool 400a. For example, as shown, shaft 402 can be a first shaft, and tool 400a can further include second shaft 404, with relative movement (e.g., axial movement) between the two shafts actuating the collet. As shown, such relative movement can include, for example, rotation with shafts 402 and 404 having complementary threads 406 such that relative rotation translates into axial movement that actuates the collet. In the particular embodiment shown, shaft 402 is an outer shaft and has internal threads, shaft 404 is an inner shaft and has external threads, and rotation of shaft 404 within shaft 402 drives shaft 404 distally in a manner that compresses the collet.

[0843] In some implementations, once lock 160a is locked to tether 112, tool 400a can release the lock from collet 410, release tether 112 from grasper 416, and then withdraw from the subject ( FIG. 19F ). At this point, additional anchors 120 can be advanced and anchored, if desired. If no additional anchors are advanced and anchored, excess tether 112 can be trimmed (e.g., cut). This trimming is shown, for example, in FIG. 19G following withdrawal of tool 400a. This can represent trimming performed using a tool other than tool 400a. However, in some implementations, trimming is performed using tool 400a, which may include a blade, for example.

[0844] See Figures 20A-C, which are schematic illustrations of a tool 400k and lock 160k used to tension or lock an implant's tether, according to some implementations. Like tool 400a and lock 160a, tool 400k and lock 160k can advantageously be used without accessing the proximal end of tether 112, e.g., while the proximal end of the tether remains within and / or engaged by the extracorporeal unit of the catheter tool. This may confer certain advantages, such as being able to apply the lock prior to any severing of tether 112 and / or while catheter device 300 (e.g., its tube 310) remains in place. In some implementations, this may allow for the application of multiple lockers along the implant, rather than just at the proximal end of the implant. Thus, in some implementations, tool 400k and / or lock 160k can be used in combination with and / or to facilitate systems and / or techniques described in U.S. Provisional Patent Application No. 63 / 370,609 by Biran et al., filed August 5, 2022, entitled "Variable tissue contraction," and / or PCT Publication No. 2023 / 228098 by Guerrero et al., filed May 24, 2023, entitled "Variable tissue contraction," each of which is incorporated herein by reference.

[0845] In some implementations, lock 160k includes a casing 580 (e.g., a body of a frame) that is biased to a wide state (FIG. 20C) but is compressible to a narrow state (FIGS. 20A-B) in which opposing sides 582′ and 582″ of the casing are closer to each other than in the wide state. A plurality (e.g., two to four) of extensions or fingers 584′ extend from side 582′ toward side 582″, and a plurality (e.g., two to four) of extensions or fingers 584″ extend from side 582″ toward side 582′. Fingers 584′ and 584″ may be alternately positioned along the longitudinal axis of lock 160k.

[0846] In some implementations, one or more extensions or fingers 584' are hooked, e.g., each finger has (e.g., terminates in) a hook 586'. One or more fingers 584'' are hooked, e.g., each finger has (e.g., terminates in) a hook 586''.

[0847] In some implementations, in the narrowed state of casing 580 shown in FIGS. 20A-B, hooks 586' can be laterally spaced apart from hooks 586'' to thereby define an unobstructed passageway through lock 160k. That is, hooks 586' are distributed along one side of the passageway and hooks 586'' are disposed along the other side of the passageway.

[0848] In some implementations, hooks 586′ and 586″ may face substantially the same direction, e.g., toward the open face of lock 160k. This orientation of 586′ and 586″ may provide lateral access through which tether 112 may be disposed laterally within the passage of the lock, i.e., between hooks 586′ and 586″ ( FIG. 20B ). In some implementations, tool 400k may provide lateral access (e.g., may define a lateral opening along a substantial percentage of its length).

[0849] In some implementations, tool 400k is configured to constrain casing 580 in its narrowed state (FIG. 20A). For example, as shown, at the distal end of tool 400k, the tool may define a chamber sized according to the narrowed state of casing 580. When casing 580 is in this narrowed state, lock 160k is in an unlocked state, and tool 400k can be used to laterally position the lock onto tether 112 and transluminally advance the lock, for example, through tube 310 to currently anchored anchor 120, along the tether (FIG. 20B).

[0850] Once lock 160k is positioned at a desired location along tether 112 and / or a desired tension is applied to the tether, lock 160k is deployed from tool 400k (e.g., ejected from the tool's chamber), thereby unconstraining casing 580, which responds by expanding toward its widened state ( FIG. 20C ). As casing 580 moves away from one another via sides 582′ and 582″, the sides pull respective fingers 584 with them, reducing (e.g., removing and / or blocking) the lateral spacing (i.e., passage) between hooks 586′ and 586″. Reducing (e.g., removing and / or blocking) the passage can prevent sliding of tether 112 through lock 160k by forcing tether 112 into a tortuous path and / or pinching the tether between the hooks. Therefore, in the widened state of casing 580, lock 160k may be considered to be in a locked state.

[0851] In some implementations, the bias of the casing 580 to its wide state may be provided by a resilient end 588 of the casing. In some implementations, the resilient end 588 of the casing may be deformed by compressing the casing to its narrowed state. In some implementations, the end 588 may be shaped to define an entrance to and an exit from the passage of the lock.

[0852] It should be noted that lock 160k may be monolithic, eg, manufactured (eg, cut and formed) from a single piece of stock material.

[0853] 21, 22A-E, 23, 24A-D, 25A-C, 26, and 27A-C, which are schematic illustrations of locks according to some implementations. In addition to functioning as a lock by locking to a tether, each of these locks includes a blade that cuts the tether to trim excess tether. In particular, each of these locks is configured to be used with a corresponding tool (e.g., a retraction and / or locking tool) configured to actuate the lock in a manner that locks the lock to the tether and cuts the tether with the blade.

[0854] In some implementations, the lock defines a passageway therethrough, the passageway being configured to receive a tether (eg, tether 112) therethrough.

[0855] In some implementations, the lock has an unlocked state in which the lock is transluminally slidable along the tether and into tissue by the tether sliding through the passageway.

[0856] In some implementations, the lock includes a clamping surface, a blade, and / or an interface, hi some implementations, the interface is engagable by a tool in a manner that configures the tool to actuate the lock by applying an actuation force to the interface.

[0857] In some implementations, the interface is configured such that while the tether is placed through the passageway, actuation of the lock (i) locks the tether to the lock by clamping the clamping surface against the tether, and (ii) cuts the tether with the blade.

[0858] In some implementations, as shown, the lock is actuated, for example, via application of torque to its interface. This torque can be translated into axial movement of the clamping face, for example, via a screw. However, as described in more detail below, the clamping face and its movement, as well as the blade and its movement, can differ between these various locks.

[0859] 21 and 22A-E are schematic diagrams of lock 160b (which in some implementations may be considered a stopper) and tool 400b usable with and / or for use according to some implementations. The main image of FIG. 21 shows components of lock 160b and tool 400b. Inset A shows a cross section through casing 500 of lock 160b. Insets B, C, and D show a perspective view, a top view, and a close-up side view, respectively, of inner subassembly 504 of lock 160b, including blade 510 and clamping surface 520. FIGS. 22A-E illustrate at least some steps in the use of tool 400b and lock 160b according to some implementations.

[0860] To use lock 160b, the lock is slidably connected to tether 112. This can be accomplished by positioning the slack tether as loop 111 around retainer 506 of inner subassembly 504 inside casing 500 (FIGS. 22A-B). In some implementations, this is accomplished by advancing loop 111b through window 502 in casing 500 and then hooking retainer 506 through the loop. For example, as shown, loop 111 can be advanced completely through casing 500, with the hook being performed on the outside of the casing before the loop hooked to retainer 506 returns with the retainer into the casing. However, it should be understood that this technique can be performed in a different sequence of steps and / or other techniques can be used to arrive at an arrangement in which loop 111 is disposed around retainer 506 inside casing 500.

[0861] As shown, retainer 506 may be shaped as or to define a hook. Note that blade 510 is functionally concealed (e.g., covered) by (e.g., within) retainer 506. As shown, blade 510 may be hook-shaped, for example, corresponding to the shape of retainer 506. Because of this arrangement, the position of loop 111 around retainer 506 (e.g., the hook of the loop) can be seen, at least for some implementations, as positioning the loop around blade 510 (e.g., hooking the loop onto and / or around it). However, due to the concealment of the blade, tether 112 is not severed in this state of lock 160b.

[0862] In some implementations, inner subassembly 504 includes spring 512 that maintains functional shielding / covering of blade 510. In the example shown, spring 512 is a tension spring, although it should be understood that other spring types may be used, with appropriate modifications. In some implementations, as shown, blade 510 and spring 512 may be formed from a single stock material, such as cut from a single sheet of metal.

[0863] As described for lock 160a, coupling of lock 160b to tether 112 can be performed at the extracorporeal portion of the delivery tool (e.g., the extracorporeal unit of the catheter device) and / or without access to the proximal end of the tether. In this state, lock 160b can be advanced through tube 310 into proximal opening 320. FIG. 22B depicts such sliding, although it does not show tube 310. FIG. 22B can be considered similar to FIG. 19C. Note that the arrangement of tether 112 in FIG. 22B is similar to that of FIG. 19C, in that the portion of the tether forward of lock 160b (e.g., not yet entering the lock) is substantially straight, and the tether curves as it exits the lock, proximally past the lock and tool 400b, and toward the extracorporeal portion of the delivery tool (e.g., toward the extracorporeal unit 350). Thus, during advancement of lock 160b, tether 112 is formed into an S-shape at and / or by lock and / or delivery tool 400b.

[0864] It should be noted that window 502 may provide and / or function as an entrance and / or exit to passage through lock 160b through which tether 112 slides.

[0865] Then, when appropriate tension is applied to tether 112 (e.g., as described above), lock 160b is actuated, locking it to the tether and severing it (FIG. 22C). This can be accomplished by manipulating tool 400b to apply an actuation force to locker interface 508. Actuation of lock 160b can include relative axial movement between inner subassembly 504 and casing 500, e.g., movement of inner subassembly distal to the casing. In the illustrated embodiment, casing 500 and inner subassembly 504 have complementary threads, the actuation force is a torque that rotates inner subassembly 504 relative to the casing, and the complementary threads translate the relative rotation into axial movement.

[0866] In some implementations, axial movement of inner subassembly 504 relative to casing 500 (i) locks lock 160b to tether 112 by tightening clamping surface 520 against the tether, and (ii) cuts the tether with blade 510. In some implementations, locking may occur when axial movement closes a gap between clamping surface 520 and opposing surface 522, which may be provided by casing 500 (e.g., a rim of window 502). For example, as shown, clamping surface 520 may be provided by a plug or protrusion (e.g., a conical or frusto-conical structure) that tightens tether 112 by protruding through window 502 in a manner that substantially blocks the opening.

[0867] In some implementations, cutting is facilitated by an axially moving functionalized blade 510, for example, by exposing / unsheathing the blade from the grasper 506. This functionalization can occur by one or more tabs 514 that prevent the blade from moving axially, for example, the blade can be left behind as the component on which it is sheathed (e.g., the grasper 506) moves axially. For implementations in which the inner subassembly 504 has a spring 512, this inhibition of axial movement of the blade is sufficient to overcome the retaining force provided by the spring, i.e., the spring is deformed. It should be understood that in some implementations, a plastically deformable component can be used in place of the spring 512.

[0868] In some implementations, the tabs 514 are defined by or coupled to the blades 510 and are closed after the inner subassembly 504 has moved axially a predetermined distance. In the example shown, the casing 500 defines one or more grooves 516 in which the tabs 514 are slidable up to a predetermined axial distance, at which point the tabs reach the end of the groove and the blades 510 no longer move axially, even as the gripper 506 (and the rest of the inner subassembly 504) continues to move axially.

[0869] In some implementations, simply exposing / functionalizing blade 510 is sufficient to sever tether 112. In some implementations, additional operations such as tagging on tether 112 and / or tool 400b may be required.

[0870] In some implementations, lock 160b can be configured such that its actuation locks onto tether 112 before severing the tether. For example, a first amount of actuation can clamp the clamping surface onto the tether, and additional actuation beyond the first amount of actuation can be required for the blade to sever the tether. Such a configuration can be provided, for example, by the shape (e.g., tapering), compressibility, and / or resilience of clamping surface 520.

[0871] In some implementations, tool 400b can then be disengaged from lock 160b (e.g., from its interface 508) and withdrawn. In the example shown, this is accomplished by retracting locking rod 412 of tool 400b (FIG. 22D), which allows transverse locking bar 414 of tool 400b to exit angled slot 518 of lock 160b at its interface 508 (FIG. 22E), for example. FIG. 22E shows the trimmed proximal portion of tether 112 being withdrawn, with lock 160b remaining locked to the distal portion of the tether that remains a component of the implant.

[0872] Although lock 160b is shown as having a particular interface 508, in some implementations, the lock's interface can be compatible (e.g., engagable) with the drive head 214 of the anchor driver 210. For example, the lock's interface can share features with (e.g., be identical and / or similar to) the interfaces of any of the anchors described herein. Thus, in some implementations, the driver 210 can function as a tool for advancing and locking (e.g., actuating) the lock 160. While lock 160c, described below, is shown as having an interface compatible with such an anchor driver, it should be understood that other locks can be adapted to have such an interface.

[0873] FIGS. 23 and 24A-D show lock (which in some implementations may be considered a stopper) 160c, FIGS. 25A-C show lock (which in some implementations may be considered a stopper) 160f, and FIGS. 26 and 27A-C show lock (which in some implementations may be considered a stopper) 160e. Actuation of lock 160b moves its blade axially; e.g., the clamping surface and blade can move simultaneously and coaxially. In contrast, actuation of lock 160c moves its blade axially, but in the illustrated embodiment, the clamping surface and blade of lock 160c do not move coaxially; instead, the axis along which the blade moves moves parallel to the axis along which the clamping surface moves. Lock 160f is configured so that its blade has planar movement, e.g., deflection and / or translation in a plane that lies on the axis of movement of its clamping surface. Lock 160e is configured so that its blade rotates about the axis of movement of its clamping surface.

[0874] FIG. 23 shows an exploded view of lock 160c, and FIGS. 24A-D show at least some steps in using the lock. For simplicity, the tool with which lock 160c is used is not shown. However, as described above, anchor driver 210 can serve as this tool. Lock 160c includes a casing 500c and an inner subassembly 504c that includes a blade 510c and a clamping face 520c.

[0875] To use lock 160c, the lock is slidably connected to tether 112 such that the tether can slide through a passage defined therethrough (FIG. 24A). This can be accomplished by laterally introducing tether 112 into the lock; for example, lock 160c can define a lateral access through which the tether can be laterally introduced into the passage of the lock. For example, as shown, lock 160c (e.g., its casing 500c) can define a lateral slit 530 that provides such lateral access. As with several other locks described herein, this can advantageously allow lock 160c to be used without accessing the proximal end of tether 112, for example, while the proximal end of the tether remains within and / or engages the extracorporeal unit of the catheter tool.

[0876] In some implementations, as shown, inner subassembly 504c is introduced into casing 500c following introduction of tether 112 (FIG. 24B). However, in some implementations, inner subassembly 504c can be at least partially coupled to (e.g., disposed within) casing 500c before introduction of tether 112. A passageway through lock 160c has entrance 502c at one end and exit 503c at the other end. As lock 160c advances along tether 112 and tension is applied to the tether, the tether slides into entrance 502c and exits exit 503c (FIG. 24C).

[0877] In some implementations, when sufficient tension is applied to tether 112, lock 160c is actuated such that (i) clamping surface 520c clamps to the tether and (ii) blade 510c cuts the tether (FIG. 24D). Similar to lock 160b, this actuation can be achieved, for example, by applying torque to interface 508c, such that complementary threads between inner subassembly 504c and casing 500c translate the torque into axial movement of both clamping surface 520c and blade 510c. Clamping surface 520c can rotate while advancing, and blade 510c can be eccentrically mounted, but the blade can move simply axially, for example, by being rotationally mounted (e.g., via a collar, as shown).

[0878] In some implementations, lock 160c can be configured to lock onto tether 112 before its actuation severs the tether. For example, a first amount of actuation can clamp the clamping surface onto the tether, and additional actuation beyond the first amount of actuation can be required for the blade to sever the tether. Such a configuration can be provided, for example, by the shape (e.g., curvature), compressibility, and / or resilience of opposing surface 522c. For example, compressible member 524 can support (or define) opposing surface 522c to maintain tether 112 clamped between clamping surface 520 and the opposing surface when an additional amount of actuation presses the clamping surface to move with the clamping surface in a manner that allows blade 510c to move and sever the tether. That is, lock 160c may lock onto tether 112 when clamping surface 520c reaches opposing surface 522c (condition not shown), but only upon further actuation of the lock, and thereby compression of compressible member 524, will blade 510c move sufficiently to sever the tether (FIG. 24D).

[0879] In some implementations, the compressible member can include one or more polymers, fabrics, shape memory materials, foams, elastic portions, balloons, bladders, seals, stents, springs, combinations of two or more of these, and the like.

[0880] 25A-C illustrate a lock 160f including a mechanical linkage 540 including a first bar 542 and a second bar 544. In some implementations, as shown, the mechanical linkage 540 is a planar linkage. The blade 510d and / or clamping surface 520d of the lock 160f are provided (e.g., defined) by the bars of the mechanical linkage. In the example shown, the first bar 542 defines the clamping surface 520d, and the second bar 544 defines the blade 510d. The bar 542 can be hingedly connected to the bar 544, for example, as can be seen from the transition from FIG. 25A to FIG. 25B.

[0881] For other locks, this actuation occurs when sufficient tension is applied to tether 112 (FIG. 25B). Actuation of lock 160f can be achieved by applying torque to interface 508d of the lock. Again, threads can be utilized to translate the torque into axial movement. For example, as shown, interface 508d can be coupled to threaded rod 546 that cooperates with mechanical linkage 540 as a linear actuator, such that rotation of the interface rotates the threaded rod, pivoting bar 542 relative to bar 544. The external threads of rod 546 can be complementary to the internal threads of casing 500d.

[0882] FIG. 25A, for example, shows lock 160f through which tether 112 is threaded, with the tether passing between bars 542 and 544 (and optionally rod 546), looping back through a passageway through casing 500d, and exiting the casing at exit 503d. In this arrangement, lock 160f advances to anchor 120 (e.g., as described for other locks, mutatis mutandis). Tether 112 is tensioned, and then lock 160f is actuated (FIGS. 25B-C). FIG. 25C shows that this actuation clamps clamping surface 520d against tether 112, thereby locking tether 112 to lock 160f and severing the tether with blade 510d.

[0883] In some implementations, as shown, mechanical linkage 540 is configured such that actuation of lock 160f tightens tether 112 between clamping surface 520d (e.g., bar 542) and bar 544. In some implementations, bar 544 thereby provides (e.g., defines) opposing surface 522d of lock 160f. In some implementations, mechanical linkage 540 is configured such that actuation of lock 160f tightens tether 112 between clamping surface 520d (e.g., bar 542) and casing 500d of the lock.

[0884] In some implementations, as shown, blade 510d faces away from bar 542.

[0885] Lock 160f can be configured to lock onto tether 112 before its actuation severs the tether. For example, a first amount of actuation can tighten the clamping surface on the tether, and additional actuation beyond the first amount of actuation can be required for the blade to cut the tether. Such behavior can be provided by mechanical linkage 540 configured so that the distance of blade travel required to cut the tether is greater than the distance of clamping surface travel required to tighten the clamping surface on the tether. Alternatively or additionally, mechanical linkage 540 can be configured to move the blade at a different speed than the clamping surface.

[0886] 26 and 27A-C show a lock 160e in which actuation of the lock causes a blade 510e of the lock to rotate about an axis, thereby cutting the tether 112. In some implementations, that axis is an axis along which a clamping surface 520e of the lock moves when the lock is actuated. That is, in some implementations, actuation of the lock 160e (i) causes the clamping surface 520e to clamp to the tether 112 by moving the clamping surface along the axis, and (ii) causes the blade to cut the tether by rotating the blade about its axis.

[0887] Similar to the previously described locks, lock 160e can be actuated by applying torque to the lock's interface 508e. In some implementations, as shown, interface 508e is fixed to interface 508e such that rotation of the interface rotates the blade about the interface's axis of rotation. Also similar to the previously described locks, axial movement of clamping surface 520e is achieved by threads that convert torque to axial movement. In the case of lock 160e, the lock includes a threaded rod 548 whose external threads complement the internal threads of the lock's casing 500e. The operable coupling between interface 508e and rod 548 transfers torque from the interface to the rod.

[0888] In some implementations, as shown, threaded rod 548 can provide (e.g., define) clamping surface 520e of lock 160e. In some implementations, the threaded rod can be operably coupled to another component that provides (e.g., defines) the clamping surface. As with the other locks described herein, casing 500e can provide opposing surface 522e against which clamping surface 520e clamps tether 112.

[0889] The rod 548 and / or the blade 510e may be considered components of an inner subassembly 504e of the lock 160e.

[0890] Figure 27A, for example, shows lock 160e with tether 112 threaded into entrance 502e, along a passageway within the lock, and out exit 503e. In this configuration, lock 160e is advanced to anchor 120 (e.g., as described for other locks, mutatis mutandis). Tether 112 is tensioned and then lock 160e is actuated (Figures 27B-C).

[0891] Lock 160e can be configured such that its actuation locks onto tether 112 before severing the tether. For example, a first amount of actuation can clamp the clamping surface onto the tether ( FIG. 27B ), and additional actuation beyond the first amount of actuation can be required for the blade to sever the tether ( FIG. 27C ). In some implementations, such a configuration can be provided by an operable coupling between interface 508e and rod 548 being via a sliding mechanism. For example, lock 160e can lock onto tether 112 when clamping surface 520e reaches opposing surface 522e ( FIG. 27B ), at which point the opposing surface resists further advancement, and thus rotation, of rod 548. Due to this resistance, upon further actuation of lock 160e (e.g., upon application of additional torque to interface 508e), the sliding mechanism is overcome, resulting in rotation of interface 508e and rotation of blade 510e while rod 548 remains stationary ( FIG. 27C ).

[0892] In some embodiments, as shown, the sliding mechanism of lock 160e includes a spring-loaded detent 532 that protrudes into a notch 534, e.g., a detent and / or a notch with a beveled edge. In this embodiment, overcoming the sliding mechanism causes detent 532 to slide out of notch 534 (e.g., as the detent spring is compressed), allowing interface 508e to rotate without transmitting torque to rod 548. While detent 532 is shown as attached to interface 508e and notch 534 is shown as defined in rod 548, it should be understood that reversed and other arrangements are possible, with appropriate modifications.

[0893] During the first amount of actuation, blade 510e rotates as rod 548 advances axially, but the blade cannot cut tether 112 until sufficient actuation brings the blade into the proper axial position for passage of tether 112 through the lock.

[0894] In some implementations, the sliding mechanism provides some functional flexibility to lock 160e. For example, regardless of the rotational position of blade 510e at the moment clamping surface 520e reaches opposing surface 522e and thus rod 548 no longer rotates, application of further torque to interface 508e can still rotate the blade through tether 112. The sliding mechanism can provide reliability to lock 160e because blade 510e can repeatedly rotate to ensure severing of tether 112 without affecting the locking of the lock to the tether.

[0895] It should be noted that the various locking features described herein may be combined and / or substituted for one another.

[0896] 28, 29A-B, and 30, which are schematic illustrations of tensioners according to some implementations. In some implementations, these tensioners are configured to engage an intermediate region or slack in tether 112 (e.g., without requiring access to the ends of the tether) and apply tension to the tether by pulling on the intermediate region or slack. The tensioners may be mounted on or reversibly attachable to an extracorporeal unit of a catheter device, such as catheter device 300. In some implementations, the tensioners may be components of the extracorporeal unit. The tensioners may advantageously be used to evaluate implant 110 (or variations thereof) during its implantation. For example, tensioning of tether 112 between anchoring of one anchor and anchoring of another anchor of implant 110 while imaging a heart valve in which the implant is implanted can provide useful information regarding implant and valve behavior. Such information can be used to direct subsequent portions of the procedure, such as determining whether to add another anchor and, if so, identifying the optimal anchoring site for it. These advantages may be further extended for implementations in which the tensioner includes means for indicating and / or controlling the magnitude of the applied tension.

[0897] 28 and 29A-B show a tensioner 550 mounted on the catheter device 300, according to some implementations. Through engagement with the tether 112, the tensioner 550 can be operated to apply tension to the mid-section of the tether without accessing either end of the tether. The tensioner 550 can engage a segment of the tether exposed at the extracorporeal unit 350. Thus, the extracorporeal unit 350 can define an access site where the tether 112 is exposed. In the illustrated embodiment, this exposed tether segment 112 is just outside the de-scratcher 354, for example, between the de-scratcher and the anchor 120 (see also FIG. 1).

[0898] In some implementations, engagement of tensioner 550 can be provided by looping the tether around a bearing of the tensioner, which is movable (e.g., linearly) to tension the tether. Tensioning the tether can essentially urge the tether to slide over the bearing, and thus, in some implementations, the bearing includes a sheave 552 or other rotating bearing that facilitates such sliding. Figure 29B shows tensioner 550 operating to apply tension to tether 112 by moving sheave 552, for example, linearly, so that the sheave tensions the tether.

[0899] In some implementations, as shown, tensioner 550 includes a gripper 554 configured to grasp tether 112, e.g., on one side of sheave 552. This grasping isolates a region of the tether beyond the gripper, e.g., defining separation region 112″ of the tether, from the tension applied by tensioner 550. This can be particularly advantageous in implementations in which the catheter device includes a de-scratcher 354, because separating the de-scratcher from tensioner 550 can prevent the de-scratcher from unwinding from tether 112 in response to pulling by the tensioner. That is, the tether 112 tensioned by tensioner 550 is taken from a distal portion of the tether, allowing for accurate measurement of the tension and / or length of the tensioned tether, as well as accurate assessment of its effectiveness. In some implementations, a similar separation effect can be achieved by having gripper 554 lock the de-scratcher rather than separating it. For example, as described herein above, the de-screw 354 may include a lock, the activation of which locks the de-screw's winch, i.e., does not allow the tether to be pulled out of the de-screw.

[0900] Movement (e.g., linear movement) of sheave 552 can be achieved by various means. In the embodiment shown, tensioner 550 includes a linear actuator 556, e.g., rotation of knob 558 is converted into linear movement by a complementary screw thread 560. The use of a linear actuator 556 advantageously means that tensioner 550 automatically maintains the applied tension; for example, it requires active reversal to release tension on the tether.

[0901] In some implementations, tensioner 550 may further include a force gauge 562 that indicates the magnitude of the applied tension. Force gauge 562 may be, for example, a spring-based mechanical force gauge in which spring 564 is deformed to a known extent by the tension on tether 112.

[0902] FIG. 30 shows tensioner 550a, which may be considered a variation of tensioner 550. Like tensioner 550, tensioner 550a may have a rotating bearing, such as a sheave 552a, that is moved (e.g., linearly) to apply tension to tether 112 looped around the rotating bearing. Tensioner 550a may be as described for tensioner 550, except that (i) tension is applied by pulling the engagement region of the tether laterally (e.g., upward in the figure, away from the overall axis of the catheter device), and (ii) tension is applied by an operator applying a linear force, for example, by grasping and moving peg 566. Peg 566, in cooperation with another component of tensioner 550a, such as its housing, may function as a latch or ratchet that has one or more stable positions in which the tensioner maintains an applied tension. For example, as shown, the housing of tensioner 550a may be shaped to define a row of teeth 568 within which peg 566 may rest.

[0903] It should be noted that while tensioners 550 and 550a are described as being available for use during a procedure, in some implementations they or similar devices can be used to apply tension to tether 112 that is locked into the tether (e.g., by lock 160 or a variation thereof), i.e., tension that remains in implant 110. This locking may be performed toward the end of the procedure, but tensioners can likewise be used for implementations in which tension is applied and locked (e.g., between anchors) midway through a procedure.

[0904] In some implementations, once all anchors 120 are anchored, tether 112 can be tensioned, locked, and trimmed while catheter device 300 remains in place. That is, in some implementations, catheter device 300 can provide transluminal access for advancing and anchoring anchors 120, tensioning tether 112, advancing lock 160 and locking it to the tether, and trimming the tether.

[0905] 31 and 32A-B, which are schematic illustrations of an implant 110f implanted according to some implementations. Implant 110f is a variation of implant 110 that includes a series of beads 116 distributed along and secured to its tether 112f. In some implementations, beads 116 can be considered to be components of tether 112f; for example, the tether can be manufactured (e.g., extruded, molded, spun, or woven) to include the beads. In some implementations, beads 116 can be considered to be attached to tether 112f by, for example, threads, tying, gluing, welding, soldering, etc.

[0906] In some implementations, implant 110c includes multiple anchors 120f. Anchors 120f are variations of anchor 120 in which heads 122f have a geometry that provides specific interaction with beads 116. Heads 122f (e.g., their eyelets) are configured to have a geometry that (i) facilitates sliding of the heads over and along the tether while the anchor axis is parallel to the tether by allowing beads to pass through them, and (ii) inhibits sliding of the heads over and along the tether while the anchor axis is transverse to the tether by obstructing beads from passing through them. This geometry can be provided, at least in part, by beads 116 that are ellipsoidal or prolate spheroidal, as shown, for example.

[0907] Although the eyelet of head 122f is typically rotatable about the anchor axis of anchor 120f, the eyelet need not be rotatably mounted in a manner that allows it to rotate relative to the anchor axis. For example, the eyelet may be fixedly mounted on a collar that is rotatable about the anchor axis.

[0908] As described above, each anchor (except the first anchor) is advanced onto and along tether 112 toward tissue 10. FIG. 31 shows three anchors 120f already anchored to tissue 10, one anchor 120f being advanced onto and along tether 112f toward tissue 10 within tube 310 while the anchor axis is parallel to the tether, with bead 116 passing through head 122f (e.g., eyelet of the head). For purposes of this illustration, the "first" anchor is at the far right of the illustration, the "second" anchor is the anchor immediately to the left of that, the "third" anchor is the anchor immediately to the left of the second anchor, and the "fourth" anchor (which is the final anchor in this particular illustration) is at the far left and within tube 310. Similarly, the first three beads 116 are numbered (116i, 116ii, and 116iii) to facilitate the following description.

[0909] In some implementations, the beads 116 may be radiopaque and / or echogenic and thus may serve as measurement guides during implantation, such as for spacing between anchors, as described, mutatis mutandis, for wavy tether 112b.

[0910] In some implementations, bead 116 can additionally or alternatively affect the force experienced by the implant's anchors in response to tension on the implant's tether, e.g., in a manner similar or identical to spacer 150. For example, the position of anchor 120f along the tether relative to bead 116 can affect whether that anchor is tensioned more or less than other anchors on the implant. FIGS. 32A-B illustrate this. FIG. 32A shows a slight tension being applied to tether 112f, removing slack in the tether and drawing bead 116i into contact with the head of the second anchor. This tension draws bead 116ii toward the head of the third anchor, but because the initial spacing between bead 116ii and the third anchor was greater than the spacing between bead 116i and the second anchor (see FIG. 31), bead 116ii does not reach the head of the third anchor.

[0911] FIG. 32B shows that additional tension has been applied, locking the tether 112f. As described above, the geometry of the head 122f prevents the bead 116 from passing through the head while the anchor axis is transverse to the tether 112f. Thus, the bead 116i abuts the head of the second anchor, and the pulling force that would otherwise be experienced only by the first anchor is shared by the second anchor, as shown by the first and second anchors tilted leftward together. This may advantageously strengthen the anchoring of the end of the tether 112f, for example, reducing the likelihood that the first anchor will be pulled out of the tissue by tether tension. In the example shown, the bead 116f does not reach the third anchor, and therefore the third anchor remains upright. However, it should be understood that many configurations of the implant 110f are possible, allowing the force distribution to be tailored to specific situations, for example, by varying the initial spacing between each anchor and its immediately distal bead.

[0912] Although exactly one bead 116 is shown between each anchor and the next, it should be noted that this is merely exemplary and that, for example, a more or less dense distribution of beads could be used.

[0913] Note that while the distribution of beads 116 is shown as homogeneous along tether 112f, this is merely illustrative. In some implementations, a denser distribution of beads may be present along certain regions of the tether (e.g., toward one or both ends of the tether), while a less dense distribution of beads (perhaps no beads) may be present along other regions of the tether (e.g., toward the center of the tether).

[0914] Reference is now made to Figures 33A-B, 34A-D, 35A-C, 36A-C, 37A-G, 38A-C, 39A...

Claims

1. 1. A system for use in and / or with a subject organization, comprising: A flexible tube, a distal opening configured to transluminally advance toward the tissue; and a flexible tube having a proximal end defining a proximal opening; coupled to the proximal end of the tube; The main body and a catheter device including an extracorporeal unit including a series of cartridges distributed along or parallel to a proximal-distal axis of the body, the most distal cartridge of the series being closest to the proximal opening; and Tether and A series of anchors including a leading anchor and other anchors, each anchor of the series of anchors comprising: each of the cartridges is housed by a corresponding cartridge in the series of cartridges, the leading anchor being housed by the distal-most cartridge; a series of anchors coupled to the tether such that the tether extends along the body parallel to the proximal-distal axis.

2. 10. The system of claim 1, wherein the cartridges in the series of cartridges are interlocking.

3. The system of any one of claims 1 to 2, wherein the anchors in the series of anchors are interlocking.

4. The system of any one of claims 1 to 3, wherein the catheter device includes a membrane positioned over the distal opening and having one or more slits dividing the membrane into multiple flaps.

5. The system of any one of claims 1 to 4, wherein the flexible tube flares toward the distal opening.

6. engages an intermediate region of the tether, the intermediate region of the tether being on the extracorporeal unit; The system of any one of claims 1 to 5, further comprising a tensioner configured to tension the tether by pulling on the intermediate region of the tether.

7. The system of claim 6 , wherein the tensioner is housed by the extracorporeal unit.

8. The system of claim 6 , wherein the tensioner is mountable on the extracorporeal unit.

9. Each of the cartridges comprises: the cartridge has a closed state in which the corresponding anchor is securely received; defining respective cartridge vectors that are inclined relative to the proximal-distal axis; The system of any one of claims 1 to 8, wherein at least a portion of the cartridge is movable along the cartridge vector to an open state in which the corresponding anchor is removable from the cartridge.

10. The system of claim 9 , wherein the cartridge defines a threshold force, and the anchor is configured to transition to the open state when pulled with a pulling force that exceeds the threshold force.

11. The system of claim 9 , wherein the cartridge is configured to resist returning from the open state to the closed state.

12. The system of claim 9 , wherein the cartridge vector is oblique to the proximal-distal axis.

13. 10. The system of claim 9, wherein the cartridge vectors of the series of cartridges collectively define a common cartridge plane in which the cartridge vectors lie.

14. The system of claim 13 , wherein the proximal-distal axis is parallel to the common cartridge plane.

15. The system of claim 13 , wherein the proximal-distal axis lies in the common cartridge plane.

16. The system of claim 13 , wherein the tether extends along the body parallel to the common cartridge plane.

17. each anchor in the series: a head portion coupled to the tether; a tissue engaging element extending away from the head to define an anchor shaft of the anchor; The system according to any one of claims 1 to 16, wherein the anchor axis is housed by a corresponding cartridge so as to be positioned at an angle relative to the proximal-distal axis.

18. The system of any one of claims 1 to 17, wherein the tether has (i) a distal end at the leading anchor and (ii) a proximal end that is removably secured within the extracorporeal unit.

19. 20. The system of claim 18, wherein the extracorporeal unit includes a descracker including a winch that is spring loaded in a manner to take up slack in the tether.

20. 20. The system of claim 19, wherein the descratcher includes a stop switch operable by a user to stop the descratcher in a manner that allows slack to be introduced into the tether and not taken up by the winch.

21. The system of any one of claims 1 to 20, further comprising a plurality of spacers interleaved with the series of anchors and through which the tether is threaded.

22. 22. The system of claim 21, further comprising at least one free spacer separate from the tether that allows for manual threading of the tether between anchors without accessing the ends of the tether.

23. 22. The system of claim 21, wherein each of the spacers is tubular and the tether is threaded by extending through a lumen defined by the spacer.

24. The system of claim 23 , wherein the spacer comprises a woven tube.

25. 24. The system of claim 23, wherein the spacer has sidewalls that are expandable in a manner to adjust the compressibility of the spacer.

26. 22. The system of claim 21, wherein each of the spacers is a ribbon and the tether is threaded by weaving the tether along the ribbon.

27. 22. The system of claim 21, further comprising a plurality of connectors, each connecting a corresponding one of the spacers to a corresponding set of anchors.

28. 28. The system of claim 27, further comprising a disconnector housed within and removable from a compartment of the extracorporeal unit and configured to disconnect one or more of the connectors.

29. 22. The system of claim 21, wherein each of the connectors provides a frangible connection between the corresponding spacer and the corresponding anchor.

30. 30. The system of claim 29, wherein the frangible connection is configured to be broken by pulling the connector away from the corresponding spacer.

31. 28. The system of claim 27, wherein each of the spacers is positioned on the tether such that the spacer follows the corresponding anchor as the anchor advances distally along the tether toward the proximal opening.

32. 32. The system of claim 31, wherein a first one of the spacers is connected to the leading anchor and is axially less compressible than at least another one of the spacers.

33. each anchor in the series: An anchor head; a helical tissue-engaging element extending away from the anchor head to define an anchor shaft of the anchor and configured to be threaded into the tissue along the anchor shaft; The flexible tube has a distal portion including the distal opening, the flexible tube comprising: a channel through which the anchor is slidable along the axis of the flexible tube toward the distal opening; and at the distal portion, the flexible tube defines a gripping zone having a gripping surface that grips a lateral surface of the helical tissue-engaging element to inhibit sliding of the anchor therethrough; The system comprises: sliding the anchor distally through the channel to the grasping zone; 33. The system of any one of claims 1-32, further comprising an anchor driver configured to drive the anchor through the grasping zone by threading the helical tissue engaging element onto the grasping surface.

34. 34. The system of claim 33, wherein the gripping surface is configured such that when the driver threads the helical tissue-engaging element onto the gripping surface, the helical tissue-engaging element temporarily compresses the portion of the gripping surface that is in contact with the helical tissue-engaging element.

35. 34. The system of claim 33, wherein the gripping surface comprises and / or is formed from a polymer.

36. 34. The system of claim 33, wherein the gripping surface is provided by at least one resilient rib projecting inwardly into the channel.

37. the rib extends inwardly into the channel in a manner that defines a niche in the gripping zone adjacent the rib; The system includes: the anchor driver threading the helical tissue engaging element onto the gripping surface; the rib excludes the helical tissue-engaging element from the niche; 37. The system of claim 36, wherein the tether is configured to extend laterally from the helical tissue engaging element through the gripping zone shielded within the niche.

38. the anchor further includes an eyelet mounted on the anchor head so as to be rotatable about the anchor axis; 38. The system of claim 37, wherein proximal from the rib, the flexible tube further defines an abutment that projects inwardly into the channel in a manner that inhibits rotation of the eyelet about the anchor axis when the anchor driver threads the tissue engaging element onto the gripping surface.

39. 37. The system of claim 36, wherein the rib has a proximal surface shaped to define a shoulder.

40. 37. The system of claim 36, wherein the rib has a tapered distal surface.

41. 37. The system of claim 36, wherein the ribs extend along the tube axis.

42. 42. The system of claim 41, wherein the ribs are parallel to the tube axis.

43. Each of the anchors is An anchor head; a tissue engaging element, extending distally away from the anchor head to define an anchor shaft of the anchor; and a tissue engaging element configured to be driven along the anchor shaft and into the tissue; 43. The system of any one of claims 1 to 42, comprising: a woven fabric shaped to define an eyelet, the anchor being coupled to the tether by the eyelet being coupled to the tether.

44. 44. The system of claim 43, wherein for at least some of the anchors, the fabric is a single piece of fabric further shaped to define a spacer that extends along the tether and away from the anchor head.

45. 45. The system of claim 44, wherein the single piece of fabric is a strip along which the tether is woven.

46. 46. ​​The system of claim 45, wherein the single piece of fabric further defines a collar rotatably coupling the single piece of fabric to the anchor such that the eyelet and the spacer are rotatable about the anchor axis.

47. 45. The system of claim 44, wherein the tissue engaging element is porous.

48. 44. The system of claim 43, further comprising a plurality of spacers through which the tether is threaded, each of the spacers connected to a corresponding anchor in the series via a corresponding connector.

49. 49. The system of claim 48, wherein for at least a portion of the spacers, the spacers are woven spacers.

50. 49. The system of claim 48, wherein for at least a portion of the spacer, the spacer comprises a coil, the coil being substantially helical and comprising and / or formed from a tube cut to define the coil such that a transverse cross section through a turn of the coil is substantially quadrilateral.

51. 49. The system of claim 48, wherein for at least a portion of the spacer, the spacer comprises a coil that is substantially helical and tapered from its middle toward its ends.

52. 49. The system of claim 48, wherein for each of the anchors, the fabric also defines at least a portion of the corresponding connector.

53. 53. The system of claim 52, wherein for each of the anchors, the fabric also defines at least a portion of the corresponding spacer.

54. 49. The system of claim 48, wherein each of the spacers is positioned on the tether such that the spacer follows the corresponding anchor as the anchor advances distally along the tether toward the proximal opening.

55. 44. The system of claim 43, wherein the anchor head includes an interface coupled to the tissue engaging element, the tissue engaging element configured to be driven along the anchor shaft into the tissue by a securing force applied to the interface.

56. 56. The system of claim 55, wherein the anchor further comprises a snood positioned around the anchor head in a manner that maintains access to the interface.

57. 44. The system of claim 43, wherein for each of the anchors, the fabric is further configured to define a collar connecting the eyelet to the anchor head.

58. 58. The system of claim 57, wherein the fabric is a woven fabric woven in a manner that integrally defines the collar and the eyelets.

59. the eyelet has an eyelet opening through the woven fabric; the collar having a collar opening through the fabric; 59. The system of claim 58, wherein the woven fabric is woven in a manner that provides the eyelet openings and the collar openings.

60. 60. The system of claim 59, wherein the woven fabric has general warp strands and reinforcing warp strands, the reinforcing warp strands being stronger and less strong than the general warp strands, and the woven fabric is woven such that the reinforcing warp strands pass through the edges of the eyelet opening and the collar opening.

61. 61. The system of claim 60, wherein the woven fabric has general weft strands and reinforcing weft strands, the reinforcing weft strands being stronger and less strong than the general weft strands, and the woven fabric is woven such that the reinforcing weft strands pass through the edges of the eyelet opening and the collar opening.

62. 58. The system of claim 57, wherein the fabric is further configured to define a spacer through which the tether is threaded, the spacer inhibiting proximity between the anchor and an adjacent anchor in the series.

63. 58. The system of claim 57, wherein the fabric comprises a woven tube (i) wrapped around the anchor head in a manner that defines the collar, (ii) formed into a loop in a manner that defines the eyelet, and (iii) through which the tether is coaxially threaded in a manner that defines the spacer.

64. 58. The system of claim 57, wherein the fabric is a yarn.

65. 65. The system of claim 64, wherein the collar and the eyelet are defined by respective loops of the thread.

66. 65. The system of claim 64, wherein the collar and the eyelet are integrally formed during formation of the thread.

67. 65. The system of claim 64, wherein the collar and the eyelet are formed by tying the thread.

68. 58. The system of claim 57, wherein the collar and the eyelets are integrally formed during formation of the fabric.

69. 58. The system of claim 57, wherein the eyelet is rotatable about the anchor axis by the collar rotating about the anchor axis.

70. 58. The system of claim 57, wherein the eyelet is connected to two locations on the collar in a manner that defines a hinge axis about which the two locations are located, and the eyelet is pivotable about the hinge axis.

71. a flexible shaft and a drive head at a distal end of the shaft; For each of the anchors consecutively starting with the leading anchor, engaging the drive head with the anchor; removing the anchor from the corresponding cartridge; 71. The system of any one of claims 1-70, further comprising an anchor driver configured to advance the anchor into the proximal opening and through the flexible tube toward the tissue to anchor the anchor to the tissue while the anchor remains coupled to the tether.

72. and a lock, the adjustment tool including: advancing the lock distally along the tether into the subject's heart toward the tissue; applying tension to the tether; By locking the lock to the tether, tension in the tether is locked; severing the tether proximally from the lock; and 72. The system of claim 71, configured to keep the lock in the heart locked to a tether.

73. 73. The system of claim 72, wherein the lock is configured to be placed on and advanced along the tether by the adjustment tool without accessing an end of the tether.

74. The lock is The frame and a first set of hooked fingers extending from a first side of the frame toward a second side of the frame, the second side being opposite the first side; a second set of hooked fingers extending from the second side toward the first side, the fingers of the second set being disposed along the frame alternating with the fingers of the first set; The lock is an unlocked state in which the frame is constrained narrowly and the tether is positionable and slidable between the first set of fingers and the second set of fingers; 74. The system of claim 73, wherein the first and second sides of the frame are lockable to the tether by pulling the first and second sets of fingers, respectively, to unconstrain the frame from expanding so that they move away from one another in response.

75. the adjustment tool includes a shut-off tube disposed within the lock; The lock is a housing shaped to define a distally facing opening through which the tether is insertable into the isolation tube through the lock; 73. The system of claim 72, comprising: a spring-loaded clamp disposed within the housing and biased to clamp onto the tether within the lock, wherein the presence of the shut-off tube within the lock prevents the clamp from clamping onto the tether within the lock.

76. 76. The system of claim 75, wherein the lock further comprises a tubular leader extending from the distally facing opening away from the body, the tether being insertable through the opening via the tubular leader.

77. 77. The system of claim 76, wherein the tubular leader comprises a helical coil.

78. 77. The system of claim 76, wherein the tubular leader includes a smooth rim with projections.

79. 72. The system of claim 71, wherein the extracorporeal unit is shaped to define a rest at which the shaft can rest while the anchor driver anchors the anchor into the tissue.

80. 80. The system of claim 79, wherein the rest is positioned proximally from the series of cartridges.

81. 1. A device comprising an implant, the implant comprising: An anchor, an anchor head including a socket; a tissue engaging element extending distally from the anchor head; Tether and a stopper attached to an end of the tether and secured within the socket in a manner coupling the anchor to the end of the tether.

82. 82. The device of claim 81, wherein the stopper is substantially spherical.

83. 83. The device of any one of claims 81 to 82, wherein the stopper is rotatable within the socket.

84. 1. A system usable with and / or for use with a tether secured to tissue of a subject, comprising: a malleable lock shaped to define a passageway; A tool, A shaft, a collet housed within the shaft, the lock being retained within the collet; a tool including a grasper extendable distally through the passage and out of the shaft and configured to grasp slack in the tether and draw the slack proximally into the shaft through the lock, thereby retaining the tether as a loop within the shaft; While the tool is holding the tether as the loop within the shaft, advancing distally into the body along the tether such that a gradual region of the tether is fed around the grasper; Thereafter, actuating the collet to crimp the lock, thereby locking the lock to the tether; Thereafter, releasing the lock from the collet and the tether from the grasper; The system is configured to be subsequently withdrawn from said subject.

85. 1. A method comprising: weaving the fabric into an elongated form comprising first and second tubular structures connected and parallel to one another; and slicing the elongated form into transverse slices, each slice comprising: a first ring extending from the first tubular structure and configured to function as a collar for the anchor; a second ring derived from the second tubular structure, connected to the first ring and configured to function as an eyelet for the anchor.

86. 1. A method comprising: weaving a first elongated form comprising a first tubular structure; weaving a second elongated form comprising a second tubular structure; slicing the first elongated form into first transverse slices, each slice defining a first ring derived from the first tubular structure; slicing the second elongated form into second transverse slices, each slice defining a second ring derived from the second tubular structure; and forming the woven component by interlinking one of the first rings with one of the second rings such that, for each of the woven components, the first ring is configured to function as a collar of the anchor and the second ring is configured to function as an eyelet of the anchor.

87. 1. A method comprising: weaving a fabric into a strip having a first slit and a second slit defined therethrough; and rotatably mounting the strip onto a head of an implantable anchor by positioning the head through the first slit so that the first slit functions as a collar opening and the second slit functions as an eyelet opening rotatable about the head.

Images