Tissue anchors and techniques for their use - Patents.com

Abstract

An extracorporeal unit (1074) coupled to a proximal end of the tube (1072) includes a track (1080) that leads to a deployment position. Each of a series of cartridges (1020) holds a respective anchor (120) and is coupled to the extracorporeal unit at a respective initial position. Each cartridge is movable along the track to the deployment position such that the cartridge holds a respective anchor opposite the proximal opening. An anchor driver (1060) is configured to (i) apply a force to the anchor while each anchor is held opposite the proximal opening by the respective cartridge in the deployment position, and (ii) advance the anchor distally from the respective cartridge and through the proximal opening.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 147,699, filed February 9, 2021, by Shafigh et al., entitled "Tissue anchors and techniques for use therewith," and U.S. Provisional Patent Application No. 63 / 162,443, filed March 17, 2021, by Shafigh et al., entitled "Tissue anchors and techniques for use therewith."

[0002] Each of the above applications is incorporated herein by reference. [Background technology]

[0003] Annuloplasty involves tissue remodeling of the valve annulus. This can be done by pulling the tissue around the annulus into a new shape. Tissue anchors can be used to facilitate medical procedures, including annuloplasty, other tissue remodeling, and securing implants. In some cases, tissue anchors can be used as an alternative to sutures. For example, tissue anchors can be used in procedures where there is no line of sight to the target. Summary of the Invention

[0004] This Summary is intended to provide some examples and is not intended to limit the scope in any way. For example, any features included in an example of this Summary are not required by the claims unless the claims explicitly recite 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 summarized herein.

[0005] Some of the systems, devices, and techniques described herein, and their applications, are used or configured to be used with an implant including multiple tissue anchors slidably coupled to tethers, contraction members, or the like. The implant can be a tissue conditioning implant that contracts tissue through tension, such as with tethers. The implant can be for use in a subject's heart. For example, the implant can be an annuloplasty implant.

[0006] Some applications relate to tissue anchors that are configured (e.g., shaped) to be slidable along a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) (i) while aligned with the tether (i.e., parallel or coaxial) and (ii) while oriented perpendicular to the tether. This would, among other things, facilitate (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 perpendicular to the anchor.

[0007] The tissue anchor may include (i) a tissue-engaging element and (ii) a head at a proximal end of the tissue-engaging element. The head may define an eyelet or other connector that defines an opening therethrough.

[0008] A variety of different tissue-engaging element configurations are possible for any of the various anchors described in this disclosure. For some applications, the tissue-engaging element may be shaped as a helix having an axis, defining a central lumen along the axis, and configured to be threaded into tissue along the axis. For some applications, the tissue-engaging element may be forced axially into tissue and, in some circumstances, may include barbs or barbed portions for retaining the tissue-engaging element within the tissue. For some applications, the tissue-engaging element may include a hook or multiple hooks. For some applications, the tissue-engaging element may include one or more of a clamp, clip, pinching device, dart, staple, tines, or the like. Other tissue-engaging elements or portions of anchors are also possible.

[0009] The eyelet can be positioned laterally from the axis of the tissue anchor. For some applications, the eyelet can be rotatable in a manner that facilitates smooth sliding along the tether (i) when the anchor is parallel to the tether and (ii) when the anchor is in an orthogonal orientation relative to the tether. The rotation of the eyelet allows the eyelet to define a respective clear linear path through the opening of the eyelet for the tether to pass through in each of these orientations of the anchor relative to the tether.

[0010] In some applications, one or more spacers or dividers (e.g., tubes, solid-walled tubes, laser-cut tubes, rod coils, springs, etc.) are threaded on the tether between the anchors. In some such applications, the eyelets define a plane against which the spacers or dividers abut to provide safe and stable spacing of the anchors and / or distribution of forces between the anchors.

[0011] For some applications, the tissue anchor includes a tissue-engaging element and a head. An anchor driver can engage the anchor at the head (e.g., be reversibly attached to the head) and drive the tissue-engaging element into tissue. The tissue-engaging element can be the same as or similar to other tissue-engaging elements described herein.

[0012] In some applications, a catheter device is provided for advancing and securing anchors (e.g., an implant including a tethered anchor). The catheter device can include a tube and an extracorporeal unit, and a series of cartridges mounted on the extracorporeal unit can hold the anchors and facilitate a driver delivering each of the anchors in sequence to a proximal opening of the tube for advancement through the tube. The extracorporeal unit can include, along with the cartridges, a barrier that facilitates verification of engagement between the driver and anchor and can prevent advancement of the anchor in the absence of such verification.

[0013] For some applications, the anchor includes a housing having a tissue-facing opening, and the tissue-engaging element is helical and is retracted within the housing such that rotation of the tissue-engaging element relative to the housing, while the tissue-facing opening faces the tissue, causes the tissue-engaging element to helically thread the housing through the tissue-facing opening and into the tissue. In some such applications, the tissue-engaging element is axially compressed within the housing and axially expands upon exiting the tissue-facing opening.

[0014] For some applications, the tissue anchor includes a sharp distal tip, a hollow body proximal to the tip, and a spring constrained to the hollow body, wherein the tissue anchor is configured to be first driven into the tissue tip to position the hollow body within the tissue, and then the spring is released to push the sharp end laterally out a lateral port in the hollow body to further secure the anchor.

[0015] In some applications, the tissue anchor is delivered using a tool including a tube and a driver, where the tool drives the distal opening of the tube into tissue, and while the opening remains submerged in the tissue, the driver drives the tissue-engaging element of the anchor through the opening and into the tissue.

[0016] For some applications, the tissue anchor has a head and a plurality of tissue-engaging elements configured to move toward one another, move linearly toward the tissue, and press a tissue-facing side of the head against the tissue. The heads can define grips such that movement of the tissue-engaging elements toward one another presses the grips against the tissue. For some such applications, each tissue-engaging element can define a lateral barb, and the barb can be exposed upon movement of the tissue-engaging elements toward one another.

[0017] In some applications, a tether handling device is used, for example, to lock tension in the tether before cutting and removing the excess tether. For example, the tether handling device can include a clamp that clamps onto the tether. The tether handling device can also be configured to manage (e.g., move, contain, cover, and / or shield) residual pieces of tether left behind after cutting, for example, to reduce the likelihood of the cut ends damaging adjacent tissue.

[0018] In some applications, the tether handling device is used as a stopper (or fastener) configured to lock onto a tether of a tissue adjustment implant including multiple anchors near the final tissue anchor of the implant. When locked onto the tether, the tether handling device is configured to limit movement of the tether relative to the final tissue anchor. Thus, after tension is applied to the tether, the tether handling device locks the tension in the tether when locked onto the tether.

[0019] Some application examples relate to tensioners that include a spring and a restraint. The restraint constrains the spring in an elastically deformed (i.e., strained) state but is bioabsorbable at a given rate. Thus, after the restraint degrades within the subject's body (e.g., after a predetermined period of time after implantation), it ceases to constrain the spring, and the spring moves away from its elastically deformed state, e.g., toward its resting state. The spring is coupled to at least one tether between two anchors such that this movement of the spring pulls (e.g., tensions) the tether, drawing the anchors toward each other. This delayed application of tension to the tether is hypothesized to allow physiological processes, such as tissue regrowth and growth, to strengthen anchor fixation while the tether is under a lower amount of tension before increasing the tension to a level that achieves desired tissue adjustment.

[0020] Some applications relate to anchor handling assemblies that can be used to transluminally unlock a tissue anchor from tissue of a subject and remove the anchor from the subject. Each of these anchor handling assemblies can include a sleeve and a tool. The distal end of the sleeve can be advanced over the head of the anchor, and the jaws of the tool can then be advanced within the sleeve and engage the anchor head of the anchor. The inner dimensions of the distal portion of the sleeve can be such that it holds the jaws closed, and the tool can be configured so that the jaws can be locked to an interface of the anchor head during the closed state, e.g., snap-fit. The tool can then unlock the anchor, which is then removed from the subject using the anchor handling assembly.

[0021] Some applications relate to an anchor driver having a driver head that is locked to a driver interface of the anchor, for example, by moving a portion of the driver head laterally into a recess defined by the driver interface. For example, fins can be pushed laterally by a rod extending distally between the fins. Optionally, a cam on the driver head can be coupled to a distal part of a rod that extends through and is eccentric with respect to the shaft of the driver, such that rotation of the shaft causes the cam to rotate and protrude laterally from the shaft.

[0022] For some applications, systems, devices, and techniques are described for use with implants that include multiple anchors threaded with a tether, whereby, after securing the anchors to tissue, the anchors can be added to, secured to, or unlocked from, and removed from the tethers between other anchors. For some applications, a magnet is located in the head of each anchor to facilitate navigation to the anchor. For some applications, the anchor head includes a shackle that facilitates this by allowing the tether to be moved laterally through an opening in the shackle, rather than requiring axial threading of the tether, as would be necessary if the anchor head instead included a typical eyelet.

[0023] According to some applications, a system for use with a subject is provided, including a catheter device including a tube and an extracorporeal unit. The tube may have a distal opening configured for transluminal advancement into the subject and a proximal end defining a proximal opening. The extracorporeal unit may be coupled to the proximal end of the tube and / or may define a deployment position. The extracorporeal unit may include a track leading to the deployment position and / or a barrier movable between (i) a closed state in which the barrier obstructs the proximal opening and (ii) an open state. In some applications, a track is not used, and the cartridge can be moved into position by other means, such as by manual attachment or rotation into position.

[0024] The system may further include a series of anchors.

[0025] For some applications, the system includes a series of cartridges, each holding a respective anchor from the series of anchors, and coupled to the extracorporeal unit at a respective initial position from the series of initial positions. While each of the cartridges remains coupled to the extracorporeal unit, it can be configured such that (i) in the deployed position, the cartridge holds a respective anchor opposite the proximal opening, and (ii) the barrier is in a closed state, the cartridges are movable along a track from their respective initial position to the deployed position (or, if a track is not included, to the deployed position).

[0026] The system may further include, for each of the anchors, an anchor driver configured to (i) engage the anchor while the anchor is held opposite the proximal opening by the respective cartridge in the deployed position, and (ii) while engaged with the anchor, apply a force to the anchor that transitions the barrier to its open state. For each of the anchors, the anchor driver may be configured to advance the anchor distally from the respective cartridge, through the proximal opening, through the tube and to the distal opening while the barrier remains in the open state.

[0027] In some applications, the force is an engagement verification force that challenges engagement of the anchor by the anchor driver.

[0028] For some applications, the barrier is configured to move from its closed state to its open state by pivoting.

[0029] For some applications, the force is a proximal pulling force, and the anchor driver is configured, for each of the anchors, to apply a proximal pulling force to the anchor while engaged with the anchor.

[0030] For some applications, the system is configured to define a threshold force magnitude, and the barrier transitions to an open state in response to the force only when the force exceeds the threshold magnitude.

[0031] For some applications, for each of the cartridges, the cartridge is configured to undergo a conformational change in response to a force, and the anchor driver is configured to transition the barrier to its open state by inducing the conformational change by applying a force to the respective anchor.

[0032] In some applications, the barrier is biased toward an open state.

[0033] For some applications, the extracorporeal unit includes a spring-loaded displacement mechanism configured to transition the barrier to its open state in response to a force applied to the anchor by the anchor driver.

[0034] For some applications, each of the cartridges is configured to lock onto the extracorporeal unit upon reaching the deployed position.

[0035] For some applications, each cartridge is configured to be manually grasped by a human operator and manually moved along the track by the operator.

[0036] For some applications, the catheter device further includes a port at a proximal opening of the tubing. For some applications, the system further includes a flushing adapter including a fluid fitting, a nozzle, and a channel therebetween. For some applications, the flushing adapter is reversibly lockable on the extracorporeal unit in a flushing position where (i) the fluid fitting is accessible from the exterior of the catheter device, and (ii) the nozzle is in fluid communication with the port such that fluid driven through the fluid fitting into the flushing adapter is directed distally through the tubing.

[0037] For some applications, in the flushing position, the barrier is in its open state and the channel extends distally beyond the barrier.

[0038] For some applications, the flushing position substantially coincides with the deployment position.

[0039] For some applications, the fluid fitting is a Luer fitting.

[0040] For some applications, the port includes a sealing membrane and an anchor driver is configured for each of the anchors to advance the anchor distally through the membrane and into the vessel.

[0041] For some applications, in the flushing position, the nozzle seals at a port proximal to the membrane.

[0042] For some applications, the port has a tapered inner wall defining a lumen proximal from the membrane, the lumen of the port tapering distally towards the membrane.

[0043] For some applications, the nozzle is sized so that when the flushing adapter is locked to the extracorporeal unit in the flushing position, the nozzle is sealed against the tapered inner wall proximally from the membrane.

[0044] For some applications, the membrane is shaped to define a first opening through the membrane, a second opening through the membrane, and a closing slit connecting the first opening with the second opening.

[0045] For some applications, the first opening has a wider diameter than the second opening.

[0046] In some applications, the first opening is 3 to 10 times larger than the second opening.

[0047] For some applications, each of the anchors includes a tissue-engaging element. For some applications, each of the anchors includes a head including an eyelet. For some applications, the port is positioned such that, for each of the cartridges, while the cartridge is in the deployed position and positioned to hold a respective anchor opposite the proximal opening, (i) the tissue-engaging element of each tissue anchor is aligned with the first opening, thereby defining an anchor advancement axis from each tissue anchor through the first opening and through the tube, and (ii) the eyelet of each tissue anchor is aligned with the second opening. The tissue-engaging element can be the same as or similar to other tissue-engaging elements described herein.

[0048] For some applications, the system further includes a platform, and the proximal end of the tube defines a longitudinal axis. For some applications, the extracorporeal unit is configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis. For some applications, the extracorporeal unit is rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal axis rotates the tube.

[0049] In some applications, the system defines an array of distinct rotational orientations of the extracorporeal unit about the longitudinal axis, and the extracorporeal unit is configured to be mounted on the platform in a manner that facilitates orientation of the extracorporeal unit in each of the distinct rotational orientations.

[0050] For some applications, the system further includes at least one detent configured to secure the extracorporeal unit in each of the distinct rotational orientations.

[0051] For some applications, at least one detent is configured to secure the extracorporeal unit in each of the distinct rotational orientations by providing a snap fit for the extracorporeal unit in each of the distinct rotational orientations.

[0052] For some applications, the extracorporeal unit defines an array of recesses corresponding to the array of distinct rotational orientations, and for some applications, at least one detent protrudes into a corresponding recess for each distinct rotational orientation, configured to secure the extracorporeal unit in each distinct rotational orientation.

[0053] For some applications, the system further includes a bracket, and the extracorporeal unit is configured to be mounted on the platform via a connection between the bracket and the platform. For some applications, the extracorporeal unit is rotatably coupled to the bracket in a manner that facilitates rotation of the extracorporeal unit about the longitudinal axis. For some applications, the at least one detent is configured to secure the extracorporeal unit in each of the distinct rotational orientations by inhibiting rotation of the extracorporeal unit relative to the bracket while the extracorporeal unit is disposed in one of the distinct rotational orientations.

[0054] For some applications, at least one detent is spring loaded.

[0055] For some applications, for each of the cartridges, the barrier is configured to transition to its closed state in response to movement of the cartridge toward the deployed position.

[0056] For some applications, for each cartridge, the barrier is configured to transition to its closed state in response to the cartridge reaching the deployment position.

[0057] For some applications, for each of the cartridges, the cartridge is configured to push the barrier toward its closed state when the cartridge reaches the deployed position.

[0058] For some applications, for each cartridge, the cartridge includes a first piece and a second piece configured to (i) hold a respective anchor, (ii) define a surface that pushes the barrier toward the closed state when the cartridge reaches the deployed position, and (iii) such that application of a force to the respective anchor while the cartridge remains in the deployed position with the barrier in the closed state displaces the surface such that the barrier responsively transitions to the open state.

[0059] For some applications, the cartridge is configured such that application of a force to each anchor moves the face proximally while the cartridge remains in the deployed position with the barrier in a closed state, hi some applications, the barrier is configured to transition to an open state in response to proximal movement of the face.

[0060] For some applications, the surface is defined by the second piece, and the cartridge is configured such that application of a force to each anchor displaces the surface by sliding the second piece relative to the first piece while the cartridge remains in the deployed position with the barrier in a closed state.

[0061] For some applications, for each cartridge, the cartridge is coupled to the extracorporeal unit via a coupling between the first piece and the extracorporeal unit.

[0062] In some applications, the second piece is attached inside the first piece.

[0063] In some applications, the first piece is configured to be grasped by the hand of a human operator.

[0064] For some applications, each of the cartridges is removable from the deployment position so that the deployment position is emptied for a series of successive cartridges.

[0065] In some applications, each of the cartridges is removable from the deployed position by being detached from the extracorporeal unit.

[0066] For some applications, the anchor driver is configured to, for each of the anchors, advance the anchor distally out of the respective cartridge, through the proximal opening, and through the tube toward the distal opening while the respective cartridge remains in the deployed position.

[0067] For some applications, for each cartridge, the cartridge is configured such that the anchor driver prevents removal of the cartridge from the deployed position (i) while the cartridge is in the deployed position, and (ii) while the anchor driver extends distally beyond the cartridge and through the tube toward the distal opening.

[0068] For some applications, each of the anchors includes a tissue-engaging element and a head including an eyelet. For some applications, the system may further include a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) that passes through each eyelet of the anchors, has a proximal portion including a proximal end of the tether, and has a distal portion including a distal end of the tether. For some applications, the distal end of the tether is advanceable distally through the vessel into the subject, while the proximal end of the tether remains outside the subject. The tissue-engaging element may be the same as or similar to other tissue-engaging elements described herein.

[0069] In some applications, the tube defines a lateral slit extending proximally from the distal end of the tube, the lateral slit being dimensioned to allow a tether, but not an anchor, to exit the tube laterally from the distal end of the tube.

[0070] For some applications, the tube is shaped to define a narrowed entrance within the lateral slit that is configured to inhibit, but not preclude, the tether from distally exiting the lateral slit through the narrowed entrance.

[0071] For some applications, the tube includes a transverse slit and a distal frame that maintains the narrowed entrance.

[0072] In some applications, the tip frame is resilient.

[0073] For some applications, for each anchor, (i) a tissue engaging element defines a central longitudinal axis of the anchor, has a sharp distal tip, and is configured to be driven into target tissue; (ii) a head is coupled to a proximal end of the tissue engaging element, further includes an interface, and is configured to be reversibly engaged by an anchor driver; and (iii) an eyelet is mounted such that it can rotate about the central longitudinal axis of the anchor.

[0074] For some applications, for each of the anchors, an eyelet (i) defines an opening and a sliding axis through the opening, (ii) defines an eyelet axis disposed laterally from a central longitudinal axis of the anchor, thereby orthogonal to the central longitudinal axis, and (iii) is mounted for rotation about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

[0075] For some applications, for each anchor, an eyelet (i) defines an opening and a sliding axis through the opening, (ii) is disposed laterally from a central longitudinal axis of the anchor, and (iii) is mounted such that the sliding axis can rotate about the central longitudinal axis while remaining constrained to be perpendicular to the eyelet axis.

[0076] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0077] For some applications, the tissue engaging element is helical, defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into tissue of a target.

[0078] For some applications, the head includes a collar that surrounds the central longitudinal axis and is rotatably coupled to the tissue engaging element, and the eyelet is attached to the collar and is rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

[0079] For some applications, the system further includes a series of tubular spacers tethered alternately with the anchors.

[0080] For some applications, each of the spacers is resiliently flexible in deflection.

[0081] For some applications, each of the spacers includes a rigid ring at each end of the tubular spacer.

[0082] For some applications, each of the spacers resists axial compression.

[0083] For some applications, each of the spacers is defined by a helical wire configured as a coil.

[0084] For some applications, the anchor driver is configured to, for each anchor, advance the anchor distally out of the respective cartridge, through the proximal opening, and through the tube toward the distal opening, while the eyelet of the anchor remains threaded through the tether.

[0085] For some applications, the catheter device further includes a port at the proximal opening of the tube, the port including a membrane. For some applications, the membrane is shaped to define a first opening therethrough, a second opening therethrough, and a closing slit connecting the first opening with the second opening. For some applications, the port is positioned such that, for each of the anchors, the anchor driver is configured to advance the anchor distally out of the respective cartridge and through the membrane, the tissue engaging element extending through the first opening, and the tether extending through the second opening.

[0086] For some applications, the catheter device further includes a tensioner coupled to a proximal portion of the tether and including a spring-loaded winch configured to maintain tension on the tether.

[0087] According to some applications, a method for use with a catheter device is provided, the method including: (i) transluminally advancing a distal portion of a tube of the catheter device into a subject's heart, the catheter device including an extracorporeal unit coupled to a proximal end of the tube and a cartridge coupled to the extracorporeal unit at an initial position and holding an anchor; and (ii) sliding the cartridge along a track from the initial position to a deployed position where the cartridge holds the anchor opposite a proximal opening of the catheter, the extracorporeal unit including a barrier obstructing the proximal opening. In some applications, a track is not used and the cartridge can be moved into position by other means, such as by manually attaching it, rotating it into position, etc.

[0088] The method may further include then opening the barrier by applying a force to the anchor using an anchor driver that engages the anchor.

[0089] The method may further include, after opening the barrier using the anchor driver, advancing an anchor distally from the cartridge through the proximal opening and through the tube toward a distal portion of the tube.

[0090] According to some applications, a system for use with a subject is provided, including a catheter device including a tube and an extracorporeal unit. The tube can have a proximal opening and a distal opening configured for transluminal advancement into the subject. The extracorporeal unit can include a track leading to a deployment position and / or a barrier movable between (i) a closed state in which the barrier obstructs the proximal opening and (ii) an open state.

[0091] The system may further include a first cartridge that holds the first anchor and is coupled to the extracorporeal unit and that is movable along a track from a first initial position to a deployed position while coupled to the extracorporeal unit such that (i) the first cartridge holds the first anchor opposite the proximal opening and (ii) the barrier is in a closed state.

[0092] The system may further include a second cartridge that holds a second anchor and is coupled to the extracorporeal unit and that, while coupled to the extracorporeal unit, is movable along a track from a second initial position to a deployed position such that (i) the second cartridge holds the second anchor opposite the proximal opening and (ii) the barrier is in a closed state.

[0093] The system may further include an anchor driver configured to (i) couple to a first anchor while the first anchor is held by the first cartridge opposite the proximal opening, and / or (ii) advance the first anchor distally from the first cartridge through the proximal opening and through the tube while the barrier is in its open state. The anchor driver may be subsequently coupleable to a second anchor while the second anchor is held by the second cartridge opposite the proximal opening, and / or advance the second anchor distally from the second cartridge through the proximal opening and through the tube toward the first anchor while the barrier is in its open state.

[0094] For some applications, the driver is configured to advance the first anchor from the first cartridge, through the proximal opening, and distally through the tube while (i) the first cartridge is in the deployed position, (ii) the barrier is in an open state, and (iii) the second cartridge remains in the second initial position.

[0095] For some applications, each of the first cartridge and the second cartridge is configured to lock onto the extracorporeal unit upon reaching the deployment location.

[0096] For some applications, each of the first cartridge and the second cartridge is configured to be manually grasped by a human operator and manually moved along the track by the human operator.

[0097] In some applications, tracks are not used and the cartridge can be moved into position by other means, for example, by being manually attached, rotated into position, etc.

[0098] For some applications, each of the first cartridge and the second cartridge is removable from the deployed position by being detached from the extracorporeal unit.

[0099] For some applications, the system further includes a third cartridge that holds a third anchor, that is coupled to the extracorporeal unit, and that is movable along a track from a third initial position to a deployed position such that the third cartridge holds the third anchor opposite the proximal opening while coupled to the extracorporeal unit.

[0100] For some applications, the first anchor includes a first tissue-engaging element and a first head including a first eyelet, and the second anchor includes a second tissue-engaging element and a second head including a second eyelet. The first and second tissue-engaging elements can be the same as or similar to other tissue-engaging elements described herein.

[0101] For some applications, the system further includes a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) threaded through the first eyelet and the second eyelet, the tether having a proximal portion including a proximal end of the tether and a distal portion including a distal end of the tether, wherein the distal end of the tether is advanceable distally through the tube into the subject while the proximal end of the tether is outside the subject.

[0102] For some applications, the anchor driver is configured to advance the first anchor distally out of the first cartridge, through the proximal opening, and through the tube while the first eyelet of the first anchor remains threaded with the tether, and the anchor driver is configured to advance the second anchor distally out of the second cartridge, through the proximal opening, and through the tube while the second eyelet of the second anchor remains threaded with the tether.

[0103] For some applications, the catheter device further includes a tensioning device configured to maintain tension on the tether during advancement of the first anchor and advancement of the second anchor.

[0104] For some applications, the tensioning device includes a spring and a spool, the spool coupled to the screw such that the spool rotates in a first direction to apply stress to the spring, and a proximal portion of the tether is wound onto the spool such that advancing the distal portion of the tether distally through the tube rotates the spool in the first direction.

[0105] According to some applications, a system for use with a subject is provided, the system including a catheter device including a tube and an extracorporeal unit. The tube can have a distal opening configured for transluminal advancement into tissue of the subject and / or a proximal portion defining a longitudinal tube axis. The extracorporeal unit can be coupled to the proximal portion of the tube.

[0106] The system may further include a series of anchors, each of the anchors including (i) a tissue-engaging element and / or a head coupled to a proximal end of the tissue-engaging element and including an interface and an eyelet. The tissue-engaging element may be the same as or similar to other tissue-engaging elements herein.

[0107] The system may further include a tether (eg, a line, wire, ribbon, rope, braid, contractile member, suture, etc.) threaded through each eyelet of the anchor.

[0108] The system may further include, for each anchor, an anchor driver configured to (i) engage with the interface of the anchor and / or (ii) while engaged with the anchor, advance the anchor distally through the tube toward the distal opening and drive the tissue engaging element into tissue.

[0109] The system may further include a platform. The system may define an array of distinct rotational orientations of the extracorporeal unit about the longitudinal tube axis. The extracorporeal unit may be configured to be mounted on the platform in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis to be oriented in any of the distinct rotational orientations. The extracorporeal unit may be rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

[0110] For some applications, the tether has a proximal end and a distal end that is advanceable distally through a vessel into the subject while the proximal end of the tether remains outside of the subject.

[0111] For some applications, the tube defines a lateral slit extending proximally from the distal end of the tube, hi some applications, the lateral slit is dimensioned to allow a tether, but not an anchor, to exit the tube proximally laterally from the distal end of the tube.

[0112] For some applications, the tube is shaped to define a narrowed entrance within the lateral slit that is configured to inhibit, but not preclude, the tether from distally exiting the lateral slit through the narrowed entrance.

[0113] For some applications, the tube includes a narrowed slit and a tip frame that maintains the narrowed entrance.

[0114] In some applications, the tip frame is resilient.

[0115] For some applications, the system further includes at least one detent configured to secure the extracorporeal unit in each of the distinct rotational orientations.

[0116] For some applications, at least one detent is spring loaded.

[0117] For some applications, at least one detent is configured to secure the extracorporeal unit in each of the distinct rotational orientations by providing a snap fit for the extracorporeal unit in each of the distinct rotational orientations.

[0118] For some applications, the extracorporeal unit defines an array of recesses corresponding to the array of distinct rotational orientations, and for some applications, at least one detent protrudes into a corresponding recess for each distinct rotational orientation, configured to secure the extracorporeal unit in each distinct rotational orientation.

[0119] For some applications, the system further includes a bracket, and the extracorporeal unit is configured to be mounted on the platform via a connection between the bracket and the platform. For some applications, the extracorporeal unit is rotatably coupled to the bracket in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis. For some applications, the at least one detent is configured to secure the extracorporeal unit in each of the distinct rotational orientations by inhibiting rotation of the extracorporeal unit relative to the bracket while the extracorporeal unit is disposed in one of the distinct rotational orientations.

[0120] For some applications, the system further includes a series of tubular spacers tethered alternately with the anchors.

[0121] For some applications, each of the spacers is resiliently flexible in deflection.

[0122] For some applications, each of the spacers includes a rigid ring at each end of the tubular spacer.

[0123] For some applications, each of the spacers resists axial compression.

[0124] For some applications, each of the spacers is defined by a helical wire configured as a coil.

[0125] For some applications, for each anchor, (i) the tissue engaging element defines a central longitudinal anchor axis of the anchor, and (ii) the eyelet is mounted so as to be rotatable about the central longitudinal anchor axis.

[0126] For some applications, for each anchor, an eyelet (i) defines an opening and a sliding axis through the opening, (ii) defines an eyelet axis disposed laterally from the central longitudinal anchor axis, thereby orthogonal to the central longitudinal anchor axis, and (iii) is mounted for rotation about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

[0127] For some applications, for each anchor, an eyelet (i) defines an opening and a sliding axis passing through the opening, (ii) is disposed laterally from the central longitudinal anchor axis, and (iii) is mounted such that the sliding axis can rotate about the central longitudinal anchor axis while remaining constrained to be orthogonal to the eyelet axis.

[0128] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0129] For some applications, the tissue engaging element is helical and extends helically around and along a central longitudinal anchor axis to define the central longitudinal anchor axis and is configured to be threaded into target tissue.

[0130] According to some applications, a system for use with a subject is provided, the system including a catheter device including a tube and an extracorporeal unit coupled to a proximal portion of the tube. The tube can have a distal opening configured for transluminal advancement into tissue of the subject. The proximal portion of the tube can define a longitudinal tube axis.

[0131] The system may define an array of distinct rotational orientations of the extracorporeal unit about the longitudinal tube axis.

[0132] The system may include a platform configured to be mounted in a manner that facilitates rotation of the extracorporeal unit about the longitudinal tube axis so that the extracorporeal unit may be oriented in any of the distinct rotational orientations.

[0133] The extracorporeal unit may be rotationally fixed to the tube such that rotation of the extracorporeal unit about the longitudinal tube axis rotates the tube.

[0134] For some applications, the system further includes a series of anchors, each of the anchors advanceable through the tube and including a tissue-engaging element and a head coupled to a proximal end of the tissue-engaging element, which may be the same as or similar to other tissue-engaging elements described herein.

[0135] For some applications, the head of each of the anchors includes an interface and an eyelet, and the system further includes a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) threaded through the eyelet of each of the anchors.

[0136] For some applications, the system further includes, for each anchor, an anchor driver configured to engage an interface of the anchor and, while engaged with the anchor, advance the anchor distally through the tube toward the distal opening and drive the tissue engaging element into tissue.

[0137] According to some applications, a method for use on a subject's heart is provided, the method including transluminally advancing a distal portion of a tube of a catheter device of the system into the heart. The catheter device includes an extracorporeal unit coupled to a proximal portion of the tube, the proximal portion of the tube defining a longitudinal tube axis. In some applications, the system further includes a series of anchors, a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) threaded through each eyelet of the anchors, an anchor driver, and a platform.

[0138] For some applications, the extracorporeal units are mounted on the platform in a manner that defines an array of distinct rotational orientations of the extracorporeal units about the longitudinal tube axis.

[0139] For some applications, the method includes, with the extracorporeal unit in a first position at a distinct rotational orientation, using an anchor driver to advance a first anchor of the series of anchors distally through the tube toward the distal opening and secure the first anchor to the first site of cardiac tissue.

[0140] For some applications, the method then includes rotating the tube through a predetermined rotational angle by rotating the extracorporeal unit in a second direction of the separate rotational orientation.

[0141] For some applications, the method then includes, while the extracorporeal unit remains in a second position in the distinct rotational orientation, using an anchor driver to advance a second anchor in the series of anchors distally through the tube and on and along the tether toward the distal opening to secure the second anchor to a second site in the cardiac tissue.

[0142] For some applications, the method further includes then pulling the first anchor and the second anchor toward each other by tensioning the tether.

[0143] According to some applications, a system for use with a subject is provided, the system including a catheter device including a tube and an extracorporeal unit. The tube may have (i) a proximal portion including a proximal end, (ii) a distal portion configured for transluminal advancement into tissue of the subject, and (iii) an intermediate portion extending between the proximal and distal portions. The extracorporeal unit may be coupled to the proximal portion of the tube. The distal portion of the tube may define a lumen, a distal opening, and a transverse slit extending proximally from the distal opening. The distal portion of the tube may be rotatably coupled to the intermediate portion such that the transverse slit is rotatable about the lumen.

[0144] The system may further include a series of anchors, each of the anchors including (i) a tissue engaging element and (ii) a head coupled to a proximal end of the tissue engaging element and including an interface and an eyelet.

[0145] The system may further include a tether (eg, a line, wire, ribbon, rope, braid, contractile member, suture, etc.) threaded through each eyelet of the anchor.

[0146] The system may further include, for each anchor, (i) an anchor driver configured to engage an interface of the anchor and / or while engaged with the anchor, advance the anchor distally through the tube toward the distal portion and drive the tissue engaging element into tissue.

[0147] Each of the anchors can be sized to be advanced distally from the lumen through the distal opening by an anchor driver, and the lateral slit can be sized to allow the tether, but not the anchor, to exit the lumen laterally through the slit.

[0148] For some applications, the distal portion is shaped to define a narrowed entrance within the lateral slit that is configured to inhibit, but not preclude, the tether from distally exiting the lateral slit through the narrowed entrance.

[0149] For some applications, the tether has a proximal end and a distal end that is advanceable distally through a vessel into the subject while the proximal end of the tether remains outside of the subject.

[0150] For some applications, the system further includes a series of tubular spacers tethered alternately with the anchors.

[0151] For some applications, each of the spacers is resiliently flexible in deflection.

[0152] For some applications, each of the spacers includes a rigid ring at each end of the tubular spacer.

[0153] For some applications, each of the spacers resists axial compression.

[0154] For some applications, each of the spacers is defined by a helical wire configured as a coil.

[0155] For some applications, for each anchor, (i) the tissue engaging element defines a central longitudinal anchor axis of the anchor, and (ii) the eyelet is mounted so as to be rotatable about the central longitudinal anchor axis.

[0156] For some applications, for each anchor, an eyelet (i) defines an opening and a sliding axis through the opening, (ii) defines an eyelet axis disposed laterally from the central longitudinal anchor axis, thereby orthogonal to the central longitudinal anchor axis, and (iii) is mounted for rotation about the eyelet axis in a manner that constrains the sliding axis to be orthogonal to the eyelet axis.

[0157] For some applications, for each anchor, an eyelet (i) defines an opening and a sliding axis passing through the opening, (ii) is disposed laterally from the central longitudinal anchor axis, and (iii) is mounted such that the sliding axis can rotate about the central longitudinal anchor axis while remaining constrained to be orthogonal to the eyelet axis.

[0158] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0159] For some applications, the tissue engaging element is helical and extends helically around and along a central longitudinal anchor axis to define the central longitudinal anchor axis and is configured to be threaded into target tissue.

[0160] According to some applications, a system and / or device is provided that includes a tissue anchor, the tissue anchor including a helical tissue-engaging element and a head. The tissue-engaging element can have a proximal turn and a distal turn defining a sharp distal tip. The tissue-engaging element can extend helically around a central anchor axis of the tissue anchor. The head can include a core, a flange, and / or a cap. The core can be disposed on the central longitudinal axis. The flange can be secured to the core and can have a proximal-facing surface. The proximal turn of the tissue-engaging element can be on the proximal-facing surface of the flange. The cap can be secured to the core by sandwiching the proximal turn against the proximal-facing surface of the flange in a manner that secures the tissue-engaging element to the head.

[0161] For some applications, the cap is secured to the core via complementary threads defined by the cap and the core.

[0162] In some applications, the flange is a first flange and the cap is shaped to define a second flange, and the cap is secured to the core in a manner that secures the tissue engaging element to the head by sandwiching the proximal turn between the second flange and a proximal facing surface of the first flange.

[0163] For some applications, the flange is shaped so that the proximal facing surface is angled relative to the central anchor axis.

[0164] For some applications, the flange is shaped so that the proximal facing surface defines a partial helix.

[0165] For some applications, the tissue engaging element has a second turn immediately distal to the proximal turn, with the flange disposed between the proximal turn and the second turn.

[0166] In some applications, the flange projects laterally beyond the core.

[0167] In some applications, the flange projects radially beyond the core.

[0168] For some applications, the device further includes a washer, and the cap is secured to the core in a manner that secures the tissue engaging element to the head by sandwiching the proximal turn between the washer and a proximal facing surface of the flange.

[0169] In some applications, the proximal turn has a notch therein, the washer is shaped to define a spur, and the cap is secured to the core by sandwiching the proximal turn between the washer and the proximal facing surface of the flange, with the spur positioned within the notch, in a manner that secures the tissue engaging element to the head.

[0170] For some applications, the core is shaped as a post and the cap is shaped to define a cavity in which the post is disposed.

[0171] For some applications, the head further includes (i) a collar axially disposed between the flange and the cap, surrounding the post and rotatable about the post, and (ii) an eyelet mounted on the collar and rotatable about the central anchor axis by rotation of the collar about the post.

[0172] For some applications, the cap defines a tubular wall that defines a cavity and is coaxially disposed between the post and the collar.

[0173] For some applications, the cap is secured to the core in a manner that secures the tissue engaging element to the head by sandwiching the proximal turn between the distal end of the tubular wall and the proximal facing surface of the flange.

[0174] According to some applications, a method of manufacturing a tissue anchor including a head and a helical tissue-engaging element is provided, the method including disposing a proximal turn of the helical tissue-engaging element on a proximally-facing surface of a flange of the head. For some applications, the head includes a core disposed on a central anchor shaft of the tissue anchor, and the tissue-engaging element has a distal turn that extends helically around the central anchor shaft and defines a sharp distal tip. For some applications, the method includes clamping the proximal turn against the proximally-facing surface of the flange by securing a cap to the core.

[0175] For some applications, securing the cap to the core includes screwing the cap onto the core.

[0176] For some applications, the flange is a first flange and the cap is shaped to define a second flange, and sandwiching the proximal turn against a proximal facing surface of the flange includes sandwiching the proximal turn between the second flange and the proximal facing surface of the first flange.

[0177] For some applications, pinching the proximal turn against the proximal facing surface of the flange includes pinching the proximal turn between the washer and the proximal facing surface of the flange by securing a cap to the core.

[0178] For some applications, the proximal turn has a notch therein, the washer is shaped to define a spur, and sandwiching the proximal turn between the washer and the proximal-facing surface of the flange includes sandwiching the proximal turn between the washer and the proximal-facing surface of the flange by securing the cap to the core such that the spur is disposed within the notch.

[0179] For some applications, the core is shaped as a post and the cap is shaped to define a cavity, and securing the cap to the core includes positioning the post within the cavity.

[0180] For some applications, the method further includes axially disposing a collar between the flange and the cap such that the collar surrounds the post and is rotatable about the post, the collar having an eyelet mounted thereon such that the eyelet is rotatable about the central anchor axis by rotating about the post.

[0181] For some applications, the cap defines a tubular wall that defines the cavity, and securing the cap to the core includes positioning the tubular wall coaxially between the post and the collar.

[0182] In some applications, sandwiching the proximal turn against the proximal-facing surface of the flange by securing the cap to the core includes sandwiching the proximal turn between the distal end of the tubular wall and the proximal-facing surface of the flange by securing the cap to the core.

[0183] According to some applications, a system for use with a subject is provided, the system including a catheter device including a tube and an extracorporeal unit. The tube can have (i) a proximal portion including a proximal end and (ii) a distal portion configured for transluminal advancement to tissue of the subject. The extracorporeal unit can be coupled to the proximal portion of the tube.

[0184] The system may further include a fluoroscopic guide including a flap having a tip, a root, and an intermediate portion extending between the tip and the root.

[0185] At the root, the flap is pivotally coupled to a distal portion of the canal in such a manner that the flap is flexible relative to the canal between (i) a retracted state in which the flap is substantially parallel to the canal, and (ii) an extended state in which the flap extends laterally from the canal.

[0186] The intermediate portion may be radiopaque and may be flexible such that pressing on the intermediate portion changes the curvature of the intermediate portion.

[0187] The fluoroscopic guide may further include a control rod extending from the distal portion of the tube to the tip of the flap such that (i) advancement of the control rod pushes against the tip of the flap, thereby deflecting the flap toward an extended state, and / or (ii) retraction of the control rod pulls against the tip of the flap, thereby deflecting the flap toward a retracted state.

[0188] For some applications, the fluoroscopic guide is configured such that advancement of the control rod pushes the tip of the flap distally, thereby deflecting the flap toward an extended state.

[0189] For some applications, the fluoroscopic guide is configured such that retraction of the control rod pulls the tip of the flap proximally, thereby deflecting the flap toward an extended state.

[0190] For some applications, the system further includes an anchor and an anchor driver configured to advance the anchor distally through the tube toward the distal portion and drive the anchor into tissue.

[0191] For some applications, a control rod extends from the extracorporeal unit, along the tube, to an exit point where the control rod extends from the tube to the tip of the flap.

[0192] For some applications, in the retracted state, the tip of the flap is positioned against a distal portion of the vessel.

[0193] For some applications, in the retracted state, the tip of the flap is positioned proximally from the base of the flap.

[0194] For some applications, in the extended state, the flap extends distally outward from the tube.

[0195] For some applications, the distal portion of the tube includes a distal end of the tube, and the root of the flap is pivotally coupled to the distal portion of the tube at the distal end of the tube.

[0196] For some applications, the control rod is flexible such that advancement of the control rod deflects the flap toward the extended state, bending the control rod laterally away from the distal portion of the tube.

[0197] For some applications, the flap is pivotally coupled to the distal portion of the tube such that the angular range of the flap between the retracted and extended states is between 80 and 160 degrees.

[0198] For some applications, the flap is pivotally coupled to the distal portion of the tube such that the angular range of the flap between the retracted and extended states is between 90 and 140 degrees.

[0199] For some applications, the flap is pivotally coupled to the distal portion of the tube such that the angular range of the flap between the retracted and extended states is 100-130 degrees.

[0200] In some applications, in the extended state, the flaps are positioned at 80 to 160 degrees relative to the tube.

[0201] In some applications, in the extended state, the flaps are positioned at 90 to 140 degrees relative to the tube.

[0202] In some applications, in the extended state, the flaps are positioned at 100-130 degrees relative to the tube.

[0203] According to some applications, a method is provided that includes transluminally advancing a distal portion of a tube of a catheter device into a subject's heart, the catheter device including a fluoroscopic guide. For some applications, the fluoroscopic guide includes a flap having (i) a tip, (ii) a root at which the flap is pivotally coupled to the distal portion of the tube, and (iii) a flexible intermediate portion extending between the tip and the root. For some applications, the fluoroscopic guide also includes a control rod extending from the distal portion of the tube to the tip of the flap.

[0204] For some applications, the method further includes positioning the distal end of the tube against a cardiac tissue site proximate a cardiac valve. For some applications, the method includes deflecting the flap toward its extended state within the heart by advancing the control rod such that the control rod pushes the tip of the flap away from the tube.

[0205] For some applications, the method includes fluoroscopically observing the curvature of the intermediate portion while the distal end of the tube remains against the tissue site and the flap remains in its extended state.

[0206] For some applications, the method includes determining whether to drive an anchor into the tissue site in response to the observation.

[0207] For some applications, the method includes driving an anchor into the tissue site in response to the determining.

[0208] For some applications, deflecting the flap toward the extended state includes deflecting the flap toward the extended state by advancing the control rod such that the control rod pushes the tip of the flap distally.

[0209] For some applications, fluoroscopically viewing the curvature includes fluoroscopically viewing vibrations of the curvature.

[0210] For some applications, the catheter device includes an extracorporeal unit coupled to a proximal portion of the tube, and a control rod extending from the extracorporeal unit along the tube to an exit point where the control rod extends from the tube to a tip of the flap. For some applications, the method includes deflecting the flap toward an extended state by advancing the control rod, and deflecting the flap toward its extended state by pushing the control rod from the extracorporeal unit.

[0211] In some applications, transluminally advancing the distal portion of the vessel includes transluminally advancing the distal portion of the vessel while the flap is in a retracted state in which a tip of the flap is positioned against the distal portion of the vessel.

[0212] In some applications, transluminally advancing the distal portion of the vessel includes transluminally advancing the distal portion of the vessel while the flap is in a retracted state in which the tip of the flap is positioned proximally from the base of the flap.

[0213] For some applications, in the extended state, the flap extends distally outward from the tube, and deflecting the flap toward the extended state includes deflecting the flap toward the extended state in which the flap extends distally outward from the tube.

[0214] For some applications, the distal portion of the tube includes a distal end of the tube, the root of the flap is pivotally coupled to the distal portion of the tube at a pivot point at the distal end of the tube, and bending the flap toward the extended state includes bending the flap about the pivot point at the distal portion of the tube.

[0215] In some applications, the control rod is flexible, and advancing the control rod includes advancing the control rod such that the control rod deflects laterally away from the distal portion of the tube and pushes the tip of the flap away from the distal portion of the tube.

[0216] For some applications, the method further includes deflecting the flap toward its retracted state by retracting the control rod such that the control rod retracts the tip of the flap toward the tube for subsequent observation.

[0217] In some applications, deflecting the flap toward the retracted state includes deflecting the flap toward the retracted state by retracting the control rod such that the control rod draws the tip of the flap proximally.

[0218] For some applications, the tissue site is a site on a valve annulus, and positioning the distal end of the tube against the tissue site includes positioning the distal end of the tube against a site on the valve annulus.

[0219] For some applications, deflecting the flap toward the extended state includes deflecting the flap toward the extended state such that a middle portion of the flap is pressed against a valve hinge where the valve leaflets connect to the valve annulus.

[0220] For some applications, the method further includes pressing an intermediate portion of the flap against a valve hinge where the valve leaflets are connected to the annulus.

[0221] For some applications, deflecting the flaps toward the extended state includes deflecting the flaps 80 to 160 degrees.

[0222] For some applications, deflecting the flaps toward the extended state includes deflecting the flaps 90 to 140 degrees.

[0223] For some applications, deflecting the flaps toward the extended state includes deflecting the flaps 100 to 130 degrees.

[0224] For some applications, in the extended state, the flap is positioned between 80 and 160 degrees relative to the tube, and deflecting the flap toward the extended state includes deflecting the flap such that the flap is positioned between 80 and 160 degrees relative to the tube.

[0225] For some applications, in the extended state, the flap is positioned at 90 to 140 degrees relative to the tube, and deflecting the flap toward the extended state includes deflecting the flap such that the flap is positioned at 90 to 140 degrees relative to the tube.

[0226] For some applications, in the extended state, the flap is positioned at 100-130 degrees relative to the tube, and deflecting the flap toward the extended state includes deflecting the flap such that the flap is positioned at 100-130 degrees relative to the tube.

[0227] According to some applications, a system and / or device is provided that includes an anchor for use with tissue of a target, the anchor including: a housing having a tissue-facing side defining an opening facing the tissue from inside the housing to outside the housing; and a tissue-engaging element having a plurality of turns about an axis and shaped to define a helix with a distal tip. The tissue-engaging element may be disposed within the housing (and axially compressed) such that rotation of the tissue-engaging element about the axis feeds the helix distally from the tissue-facing opening. The tissue-engaging element may be configured to thread into the tissue to secure the housing to the tissue, the tissue-facing side serving as a head of the anchor.

[0228] In some applications, the distal tip is sharp.

[0229] For some applications, the anchor is configured such that threading the tissue engaging element into tissue presses the tissue opposing side against the tissue.

[0230] For some applications, the housing sides define tissue-facing grips such that threading the tissue-engaging elements into tissue presses the grips against the tissue.

[0231] For some applications, the anchor is configured such that threading the tissue engaging element into tissue moves a proximal part of the tissue engaging element toward the opposing tissue side.

[0232] For some applications, the housing further has a driver side facing the tissue-facing side and defines a driver opening providing access to the interface from outside the housing, and the anchor is configured such that threading the tissue-engaging element into tissue moves a proximal part of the tissue-engaging element away from the driver side.

[0233] For some applications, the housing further has a driver side facing the tissue-facing side and defines a driver opening providing access to the interface from outside the housing, and the housing is configured to automatically contract as the spiral is fed distally from the tissue-facing opening such that the driver side follows the proximal part of the tissue engaging element toward the tissue-facing side.

[0234] For some applications, the anchor is configured such that threading the tissue engaging element into tissue pinches tissue-facing sides between the tissue and a proximal part of the tissue engaging element.

[0235] For some applications, the tissue engaging element is configured such that when the spiral is delivered from the opening facing the tissue, a progressively proximal portion of the spiral expands axially when disposed outside the housing.

[0236] For some applications, while the helix is ​​disposed entirely within the housing, the helix has a compressed pitch, and the portion of the helix disposed outside the housing has an expanded pitch that is at least twice as large as the compressed pitch.

[0237] For some applications, the anchor includes an interface at a proximal part of the tissue engaging element, and the housing further has a driver side defining a driver opening from the inside to the outside of the housing, the driver opening providing access to the interface.

[0238] For some applications, the anchor is configured such that threading the tissue engaging element into tissue moves the interface away from the driver side and toward the tissue-facing side.

[0239] For some applications, the anchor is configured such that threading the tissue engaging element into tissue pinches tissue opposing sides between the tissue and the interface.

[0240] For some applications, the interface is rotationally locked to the helix of the tissue engaging element.

[0241] In some applications, the driver opening is located in front of the interface.

[0242] In some applications, the interface is visible through the driver opening.

[0243] In some applications, the interface includes a bar transverse to the axis and parallel to the driver opening.

[0244] In some applications, the driver side is opposite the tissue-facing side.

[0245] For some applications, the system and / or device further includes a driver having a driver head at a distal portion of the driver, the driver head being dimensioned for external access to the interface through the driver opening and configured to engage the interface and apply a torque to the interface to rotate the tissue engaging element.

[0246] For some applications, the driver head has an introducing state and a locked state, the anchor head is shaped to define a proximal opening through which the interface is accessible by the driver head while the driver head is in the introducing state, and the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to the locked state.

[0247] For some applications, the anchor driver includes a flexible shaft and a rod extending through the shaft, with the anchor head disposed at a distal end of the shaft and the rod configured to apply a force to the driver head to transition the driver head to the locked state.

[0248] For some applications, the driver head includes fins, and the rod is configured to transition the driver head to the locked state by advancing distally between the fins such that the rod pushes the fins radially outward so that the fins lock into the interface.

[0249] For some applications, the fins are configured to lock into the interface via a friction fit when pushed radially outward by the rod.

[0250] For some applications, the driver head includes a cam, the rod is coupled to the cam, and the driver head is configured to transition to the locked state by rotating the cam such that at least a portion of the cam protrudes laterally.

[0251] In some applications, the rod is eccentric relative to the shaft.

[0252] In some applications, the rod is eccentric relative to the cam.

[0253] In some applications, in the installed state, the cam is flush with the shaft.

[0254] For some applications, the anchor driver has a longitudinal axis defined by the shaft, and the shaft and cam are circular in transverse cross section.

[0255] For some applications, the interface is shaped to define a plurality of recesses, each dimensioned to receive a cam when projecting laterally.

[0256] According to some applications, a system and / or device is provided that includes a tissue anchor for use with an anchor driver, the tissue anchor including a tissue engaging element defining a central longitudinal axis of the anchor, having a sharp distal tip, and configured to be driven into target tissue, and an anchor head coupled to a proximal end of the tissue engaging element. The anchor head may include an interface configured to be reversibly engaged by the anchor driver, and an eyelet. The eyelet defines an opening and a sliding axis through the opening, and may be disposed laterally from the central longitudinal axis, thereby defining an eyelet axis perpendicular to the central longitudinal axis. The eyelet may be mounted such that the eyelet is rotatable about the eyelet axis, with the sliding axis constrained to be perpendicular to the eyelet axis.

[0257] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0258] For some applications, the tissue engaging element is helical, defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into tissue of a target.

[0259] For some applications, the eyelet is mounted such that the eyelet is rotatable about the central longitudinal axis while the sliding axis remains constrained to be perpendicular to the eyelet axis.

[0260] For some applications, the anchor head includes a collar that surrounds the central longitudinal axis and is rotatably coupled to the tissue engaging element, and the eyelet is attached to the collar and is rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

[0261] For some applications, the eyelet defines a flange disposed inwardly of the collar and a stem extending laterally across the collar and coupling the flange to the opening.

[0262] For some applications, the collar is a closed collar that defines a recess that supports the stem.

[0263] In some applications, the collar is an open collar with free ends that support the stem together.

[0264] For some applications, the eyelet is shaped to define a first plane and a second plane, with the opening extending through the eyelet from the first plane to the second plane, the second plane being opposite the first plane.

[0265] For some applications, the system and / or device includes an implant that includes an anchor and a tether (eg, a line, wire, ribbon, rope, braid, contraction member, suture, etc.) threaded through the aperture.

[0266] For some applications, the first plane is parallel to the eyelet axis.

[0267] For some applications, the first plane is perpendicular to the sliding axis.

[0268] For some applications, the first plane is parallel to the second plane.

[0269] For some applications, the eyelet has an inner surface that defines an opening between a first plane and a second plane, such that the narrowest portion of the opening is midway between the first plane and the second plane.

[0270] For some applications, the eyelet defines an inner surface of the eyelet as superboloid.

[0271] For some applications, the eyelet defines an inner surface of the eyelet as a catenoid.

[0272] For some applications, the system and / or device includes an implant that includes an anchor and a tether (eg, a line, wire, ribbon, rope, braid, contraction member, suture, etc.) threaded through the aperture.

[0273] In some applications, the anchor is a first anchor of an implant, and the implant may further include a second anchor and a spacer or divider (e.g., a rod, tube, solid-walled tube, laser-cut tube, coil, spring, etc.) that is tubular and has two spacer ends and a lumen therebetween, the spacer having a tether threaded between the first anchor and the second anchor, with the tether passing through the spacer lumen.

[0274] In some applications, the spacer is resiliently flexible in deflection.

[0275] In some applications, the spacer is generally not axially compressible.

[0276] For some applications, the spacer is defined by a helical wire configured as a coil that defines a spacer lumen.

[0277] For some applications, the spacer is configured to limit the proximity between the first anchor and the second anchor.

[0278] For some applications, for each of the anchors, an eyelet is shaped to define two planes, an opening extends through the eyelet between the planes, a spacer is tethered between the first anchor and the second anchor such that one spacer end faces one of the planes of the eyelet of the first anchor and the other spacer end faces one of the planes of the eyelet of the second anchor, and each of the spacer ends is dimensioned to be flush with and abut the facing planes.

[0279] For some applications, the system and / or apparatus further includes an anchor driver.

[0280] For some applications, the anchor driver has a driver head having an introducing state and a locked state, the anchor head is shaped to define a proximal opening through which the interface is accessible by the driver head while the driver head is in the introducing state, and the anchor driver is configured to lock the driver head to the interface by laterally moving a portion of the driver head to transition the driver head to the locked state.

[0281] For some applications, the anchor driver includes a flexible shaft and a rod extending through the shaft, with the anchor head disposed at a distal end of the shaft and the rod configured to apply a force to the driver head to transition the driver head to the locked state.

[0282] For some applications, the driver head includes fins, and the rod is configured to transition the driver head to the locked state by advancing distally between the fins such that the rod pushes the fins radially outward so that the fins lock into the interface.

[0283] For some applications, the fins are configured to lock into the interface via a friction fit when pushed radially outward by the rod.

[0284] For some applications, the driver head includes a cam, the rod is coupled to the cam, and the driver head is configured to transition to the locked state by rotating the cam such that at least a portion of the cam protrudes laterally.

[0285] In some applications, the rod is eccentric relative to the shaft.

[0286] In some applications, the rod is eccentric relative to the cam.

[0287] In some applications, in the installed state, the cam is flush with the shaft.

[0288] For some applications, the anchor driver has a longitudinal axis defined by the shaft, and the shaft and cam are circular in transverse cross section.

[0289] For some applications, the interface is shaped to define a plurality of recesses, each dimensioned to receive a cam when projecting laterally.

[0290] For some applications, the system and / or device includes a delivery tool including an anchor driver and a percutaneously advanceable tube, wherein the anchor driver and anchor are slidable through the tube while the anchor driver is engaged with the anchor.

[0291] In some applications, the tube defines an internal channel having a keyhole-shaped orthogonal cross-section that defines a main channel region and a minor channel region, the main channel region having a larger cross-sectional area than the minor channel region, and the anchor is slidable through the channel, with the tissue engaging element sliding snugly through the main channel region and the eyelet sliding snugly through the minor channel region.

[0292] In some applications, the system and / or device includes an implant including a tether and a tissue anchor, and the eyelet is shaped to facilitate smooth sliding of the eyelet simultaneously (i) through the minor channel region and (ii) over the tether while the tether is positioned within the minor channel region and parallel to the central longitudinal axis.

[0293] In some applications, the anchor is advanceable out of the distal end of the tube, and the tube defines a lateral slit extending proximally from the distal end of the tube, the slit adjacent to the minor channel region, and the slit allows the tether, but not the anchor, to exit the tube laterally from the distal end of the tube.

[0294] In some applications, the system and / or device includes an implant including a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) and a tissue anchor, and the eyelet is shaped to facilitate smooth sliding of the tether through the opening (i) while the tether is parallel to the central longitudinal axis, and (ii) while the tether is oriented perpendicular to the central longitudinal axis.

[0295] For some applications, the tether has a thickness and the narrowest portion of the opening is no more than twice the thickness of the tether.

[0296] For some applications, the narrowest portion of the opening is no more than 50% of the thickness of the tether.

[0297] For some applications, the narrowest portion of the opening is no more than 20% of the thickness of the tether.

[0298] According to some applications, a system and / or device is provided that includes an implant for use in a subject's heart, the implant including a first anchor, a second anchor, at least one tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) connecting the first anchor to the second anchor, and a tensioner connected to the at least one tether between the first anchor and the second anchor.

[0299] In some applications, the tensioner includes a spring and a restraint that restrains the spring in an elastically deformed configuration.

[0300] For some applications, the restraint is bioabsorbable such that degradation of the restraint releases the spring from the restraint after implantation of the implant in the heart, and the spring is configured to automatically move away from the elastically deformed state toward the second shape upon release from the restraint.

[0301] For some applications, the coupling of the spring to the at least one tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other via the at least one tether.

[0302] For some applications, the restraint comprises a suture.For some applications, the restraint comprises a band.

[0303] For some applications, the restraint includes a spacer or divider.

[0304] In some applications, a restraint restrains the spring by holding portions of the spring together.

[0305] In some applications, a restraint restrains the spring by holding portions of the spring apart from one another.

[0306] For some applications, the first anchor is a tissue puncture anchor.For some applications, the first anchor is a clip.

[0307] For some applications, the spring is an extension spring. For some applications, the spring has a coiled structure.

[0308] For some applications, the spring defines a cell, and moving the spring away from the elastically deformed state toward the second shape includes the cell becoming smaller in a first dimension and larger in a second dimension.

[0309] For some applications, the spring is a shortening spring, and moving the spring away from the elastically deformed state towards the second shape comprises shortening the spring.

[0310] For some applications, at least one tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) defines a path from the first anchor to the second anchor through the spring, and the coupling of the spring to the at least one tether is such that movement of the spring away from the elastically deformed state toward the second shape causes bending toward the path of the at least one tether, thereby pulling the first anchor and the second anchor toward each other.

[0311] For some applications, the restraint is a first restraint, and the tensioner further includes a second restraint, the second restraint configured to limit movement of the spring away from the elastically deformed state when the spring is released from the first restraint, thereby limiting retraction of the first anchor and the second anchor toward each other.

[0312] For some applications, the second restraint is bioabsorbable such that disassembly of the second restraint releases the spring from the second restraint, thereby allowing the spring to exceed its limit and further withdraw the first anchor and second anchor toward each other.

[0313] For some applications, the first restraint is bioabsorbable at a second rate such that release of the spring from the first restraint occurs after a first period of time after implantation of the implant in the heart, and the second restraint is bioabsorbable at a first rate such that release of the spring from the second restraint occurs after a second period of time after implantation of the implant in the heart, the second period of time being longer than the first period of time.

[0314] For some applications, the first rate is such that the first period is from 1 to 3 months.

[0315] For some applications, the second rate is such that the second period is between 3 months and 1 year.

[0316] For some applications, the implant is an annuloplasty structure, the first anchor and the second anchor are configured to be driven into tissue of an annulus of a heart valve, and the implant is configured to reshape the annulus by pulling the first anchor and the second anchor toward each other.

[0317] For some applications, the at least one tether is a first at least one tether, the tensioner is a first tensioner, and the implant further includes a third anchor, a second at least one tether coupled to the third anchor, and a second tensioner coupled to the second at least one tether.

[0318] For some applications, a second at least one tether couples the third anchor to the second anchor, and a second tensioner is coupled to the second at least one tether between the third anchor and the second anchor.

[0319] For some applications, the at least one tether includes a first tether connecting the first anchor to a first part of the spring and a second tether, separate from the first tether, connecting the second anchor to a second part of the spring, the first and second tethers thereby connecting the first anchor to the second anchor via the spring.

[0320] For some applications, a part-to-part distance between the first part and the second part is smaller in the second state than in the elastically deformed state.

[0321] According to some applications, a system and / or device is provided that includes an anchor for use in a target tissue, the anchor including a sharp distal tip, a hollow body proximal to the distal tip, and a spring. The hollow body can be shaped to define a chamber, a lateral wall around the chamber, and one or more (e.g., two) ports within the lateral wall. The anchor shaft of the anchor can pass through the chamber and the tip. The spring can include an elongated element having one or more (e.g., two) ends and capable of defining a loop therebetween. In many cases, at least the loop is disposed within the chamber. For some applications, the anchor has a first state in which the spring is constrained by the outer lateral wall, and the anchor is transitionable from the first state to a second state in which the spring (e.g., its elongated element) is under less strain relative to the first state, and each of the ends protrudes laterally from the hollow body through a respective one of the ports. In the second state, the ends can be positioned further apart from each other compared to the first state.

[0322] In some applications, the edges are sharp.

[0323] For some applications, in the first state, the end does not protrude laterally from the hollow body.

[0324] For some applications, the anchor is configured such that the loop tightens when the anchor transitions from the first state to the second state.

[0325] For some applications, the anchor is configured such that the loop moves axially within the chamber when the anchor transitions from the first state to the second state.

[0326] For some applications, the anchor further includes a head defining an interface configured to be reversibly engaged by an anchor driver.

[0327] For some applications, the system and / or device further includes a tether (e.g., a line, wire, ribbon, rope, braid, contraction member, suture, etc.), and the head defines an eyelet through which the tether is threaded.

[0328] For some applications, in the first state, the end is disposed distally from the loop.

[0329] For some applications, in the second state, the end is disposed distally from the loop.

[0330] For some applications, in the second state, the end is disposed proximally from the loop.

[0331] For some applications, the system and / or device further includes a retainer, wherein the hollow body is shaped to define at least one window in the outer lateral wall, and the retainer is configured to extend through the window and into the loop to hold the anchor in the first state.

[0332] For some applications, in the first state, each of the ends is disposed in a respective port, and the anchor is configured such that the loop moves axially within the chamber when the anchor transitions from the first state to the second state, and the retainer is configured to hold the anchor in the first state by inhibiting the loop from moving axially within the chamber.

[0333] In some applications, the hollow body is shaped to define two windows in the lateral walls, the two windows facing each other and rotationally offset from the two ports.

[0334] In some applications, the retainer extends through one of the windows, through a loop, and out the other side of the window.

[0335] In some applications, a port axis passes through the two port and anchor axes, and a window axis passes through the two window and anchor axes and is perpendicular to the port axis.

[0336] In some applications, the window is axially offset from the port.

[0337] According to some applications, a system and / or device for use on cardiac tissue of a subject is provided, the system and / or device including a tool and an anchor. The tool may be transluminally advanceable into the heart and may include a tube having a distal end defining an opening and a driver extending through at least a portion of the tube. The anchor may be at least partially disposed within the tube and include a tissue-engaging element, the anchor configured to be secured to the tissue by the tissue-engaging element being driven into the tissue. The driver may extend through at least a portion of the tube with the distal end of the driver reversibly engaged with the anchor within the tube. The tool may be configured to penetrate the distal end of the tube into the tissue such that the opening is immersed in the tissue while the anchor remains at least partially disposed within the tube. The driver may be configured to drive the tissue-engaging element out of the opening and into the tissue while the opening is disposed in the tissue. The tissue-engaging element may be the same as or similar to other tissue-engaging elements described herein.

[0338] For some applications, the distal end is tapered.

[0339] In some applications, the distal end is sharp.

[0340] For some applications, the anchor is placed entirely within the vessel.

[0341] For some applications, the anchor further includes a head, and the driver is reversibly engaged with the anchor by reversibly engaging the head.

[0342] For some applications, the system and / or device further includes a tether (e.g., a line, wire, ribbon, rope, braid, contraction member, suture, etc.), and the anchor further includes a head defining an eyelet through which the tether passes.

[0343] For some applications, at least a portion of the tissue engaging element is constrained by the tube and configured to automatically change shape within the tissue upon exiting the opening.

[0344] For some applications, portions of the tissue engaging elements are tines.

[0345] For some applications, the portion of the tissue engaging element is a flange.

[0346] For some applications, the flange comprises a polymer.

[0347] In some applications, the flange includes a seat and a self-expanding frame that supports the seat.

[0348] In some applications, the distal tip of the tissue engaging element is positioned outside the opening, and the tool is configured to penetrate the distal end of the tube into the tissue such that the opening is immersed in the tissue while the distal tip is positioned outside the opening.

[0349] For some applications, the tissue engaging element is shaped to fit snugly within the opening such that the tissue engaging element blocks the opening while the tool penetrates the distal end of the tube into tissue.

[0350] In some applications, the distal tip is sharp, and the distal tip of the tissue engaging element and the distal end of the tube together define a tapered point, with the distal tip being the distal portion of the tapered point and the distal end of the tube being the proximal portion of the tapered point.

[0351] In some applications, the tube defines a channel having a central channel region and lateral channel regions, and the anchor includes a head and tines, the head being disposed within the central channel region and each of the tines being disposed within a respective lateral channel region such that the anchor is axially slidable within the channel but is constrained from rotation.

[0352] For some applications, the channel is wider in the central channel region than in the lateral channel regions.

[0353] For some applications, the opening is defined by a channel that reaches the distal end of the tube, and the shape of the opening shapes the distal end of the tube to resemble a beak.

[0354] According to some applications, a system and / or device for use on cardiac tissue of a subject is provided, the system and / or device including a tissue anchor including a head and a plurality of tissue-engaging elements. The head may have a tissue-facing side shaped to define a plurality of grips and may have an opposing side defining an eyelet. The tissue-engaging elements may be disposed laterally from the grips. Each of the tissue-engaging elements often has a sharp tip, a delivery state configured so that the tissue-engaging element is driven linearly into the tissue until the grips contact the tissue, and a grasping state. While the tissue-engaging elements are disposed within the tissue with the grips in which the plurality of tissue-engaging elements contact the tissue, transitioning the tissue-engaging elements toward the grasping state may be configured so that the tips move toward each other and press the grips against the tissue. The tissue-engaging elements may be the same as or similar to other tissue-engaging elements described herein.

[0355] For some applications, the plurality of tissue engaging elements are collectively configured such that, while the plurality of tissue engaging elements are positioned within tissue with the grip contacting the tissue, transitioning the tissue engaging elements toward a grasping state forces the tissue between the plurality of tissue engaging elements.

[0356] In some applications, each of the tissue engaging elements has a flexible portion and a static portion connecting the flexible portion to the head, and both the flexible portion and the static portion are configured to be driven linearly into tissue while the tissue engaging element is in the delivery state, and the tissue engaging element is configured such that when the tissue engaging element transitions toward the grasping state, (i) the static portion remains static relative to the head, and (ii) the flexible portion deflects relative to the static portion and relative to the head.

[0357] For some applications, the system and / or device includes an implant that includes a tissue anchor and a tether (eg, a line, wire, ribbon, rope, braid, contractile member, suture, etc.) that is threaded through the eyelet.

[0358] For some applications, in the delivery state, each of the tissue engaging elements has an inner side and a lateral side, the inner side being closer to the other tissue engaging elements than the outer side, and each of the tissue engaging elements being shaped to define a barb on the lateral side.

[0359] For some applications, each of the tissue engaging elements is configured such that the barbs are shielded in the delivery state and exposed in the grasping state.

[0360] In some applications, each of the tissue engaging elements has a flexible portion and a static portion connecting the flexible portion to the head, and both the flexible portion and the static portion are configured to be driven linearly into tissue while the tissue engaging element is in the delivery state, and the tissue engaging element is configured such that when the tissue engaging element transitions toward the grasping state, (i) the static portion remains static relative to the head, and (ii) the flexible portion deflects relative to the static portion and relative to the head.

[0361] For some applications, for each of the tissue engaging elements, the barb is defined by the stationary portion.

[0362] For some applications, for each of the tissue engaging elements, the barb is defined by a flexible portion.

[0363] According to some applications, a system and / or device for use with cardiac tissue of a subject is provided, the system and / or device including an anchor, a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) coupled to the anchor, a tether handling device, and a tool, wherein the anchor is configured to be secured to the tissue with the tether extending proximally from the anchor.

[0364] For some applications, the tether handling device may include a housing that may be shaped to define a passage therethrough, with the tether extending through the passage in a manner that facilitates transluminal sliding of the housing distally over and along the tether to the anchor. The tether handling device may also include a clamp coupled to the housing and biased to clamp onto the tether within the passage in a manner that inhibits sliding of the housing relative to the tether.

[0365] In some applications, the tether handling device may also include an arm that may extend proximally from the housing and that includes a conduit shaped to receive a portion of the tether proximally from the housing, and a lever that connects the conduit to the housing.

[0366] For some applications, the lever is biased to place the conduit in an offset position relative to the passageway.The tool may include a tube.

[0367] For some applications, the system and / or device can have a delivery state in which the tool is coupled to the tether handling device with the tube positioned within the passageway that inhibits the clamp from tightening and within the conduit in a manner that constrains the conduit in an in-line position with the passageway. For some applications, in the delivery state, the tool is configured to transluminally advance the tether handling device distally over and along the tether toward the anchor.

[0368] In some applications, the conduit has open lateral sides.

[0369] For some applications, the tether extends out from the proximal side of the housing and the lever is biased to position the conduit against the proximal side of the housing.

[0370] In some applications, the bias of the clamp is such that, even when no tube is placed in the passageway, the clamp automatically clamps onto the tether in the passageway in a manner that prevents the housing from sliding relative to the tether.

[0371] For some applications, in the delivery state, the tube is positioned within the passageway and within the conduit by extending distally through the conduit and into the passageway.

[0372] For some applications, the system and / or device can transition from the delivery state to the intermediate state by retracting the tube proximally from the passageway, but not from the conduit.

[0373] For some applications, the intermediate state leaves the distal part of the tube disposed within the housing.

[0374] In some applications, the tether has sufficient tensile strength to withstand the bias of the lever, and the lever can inhibit the conduit from moving to the offset position by applying tension to the tether proximally from the clamp, even though the tube is not positioned within the conduit.

[0375] For some applications, the system and / or device further includes a cutter axially movable relative to the vessel, advanceable over and along the tether, and configured to proximally sever the tether from the conduit.

[0376] For some applications, severing the tether proximally from the conduit while the tether is under tension proximally from the clamp triggers a lever to move the conduit to an offset position.

[0377] For some applications, the cutter is configured to sever the tether proximally from the conduit in a manner leaving a residual piece of the tether protruding proximally from the conduit, and the arm is configured to retract the residual piece of the tether into the conduit by the lever moving the conduit to an offset position.

[0378] In some applications, the tube is slidable within the cutter.

[0379] According to some applications, a system and / or device for use with a tether is provided, the system and / or device including a clamp that may include a chuck and a spring. The chuck may include a sleeve and a collet. The chuck may have a longitudinal axis, and the sleeve surrounds the longitudinal axis. The sleeve may have a tapered inner surface. For some applications, a collet is disposed within the sleeve and is dimensioned to receive the tether therethrough. For some applications, a spring can axially urge the collet against the tapered inner surface such that the collet is forced inward by the sleeve.

[0380] In some applications, the sleeve and collet are concentric with the longitudinal axis.

[0381] In some applications, the spring is concentric with the longitudinal axis.

[0382] In some applications, the spring is a compression spring.

[0383] In some applications, the spring is helical.

[0384] For some applications, the clamp is configured to be threaded over the tether such that the spring surrounds the longitudinal axis and the sleeve, collet, and spring surround the tether.

[0385] In some applications, the sleeve has an opposing surface and the spring is maintained under compression between the opposing surface and the collet.

[0386] For some applications, the system and / or device further includes a tether, the clamp configured to receive the tether through the collet and the sleeve, and the spring axially urges the collet against the tapered inner surface by urging the collet in a first axial direction relative to the sleeve such that the collet clamps the tether and thus inhibits sliding of the tether through the collet in at least the first axial direction.

[0387] For some applications, the clamp is configured to facilitate sliding of the tether through the collet in a second axial direction opposite the first axial direction by moving the tether through the sleeve in the second axial direction, which presses the collet axially away from the tapered inner surface, thereby reducing clamping of the tether by the collet.

[0388] In some applications, the sleeve has opposing surfaces against which the spring applies an opposing force while axially pushing the collet.

[0389] For some applications, the system and / or device further includes a tether, the clamp having a proximal end and a distal end, the tapered inner surface tapering toward the distal end, and the chuck facilitating sliding of the clamp along the tether in a distal direction with the distal end leading the proximal end, and the chuck inhibiting sliding of the clamp along the tether in a proximal direction with the proximal end leading the distal end.

[0390] For some applications, the system and / or device further includes a sheath extending proximally from the sleeve and resiliently coupled to the sleeve in a manner such that the sheath is distally retractable onto the sleeve by applying a distally directed force to the sheath and automatically re-expands proximally in response to removal of the distally directed force.

[0391] In some applications, the sheath is rigid.

[0392] For some applications, the system and / or device further includes a tool including a cutter, the tool configured to retract the sheath distally onto the sleeve by applying a distally directed force to the sheath. For some applications, the tool is configured to tension the tether by applying a proximally directed force to the tether such that the tether slides proximally through its collet while maintaining the distally directed force on the sheath. For some applications, the tool is configured to then sever the tether proximally from the sleeve in a manner that removes the distally directed force, leaving a residual piece of tether proximally protruding from the sleeve, and the sheath automatically re-expands proximally, trapping the residual piece of tether.

[0393] For some applications, the tool is configured to sever the tether proximally from the sleeve in a manner that leaves a residual piece of the tether protruding proximally from the chuck.

[0394] For some applications, the spring is a first spring, and the clamp further includes a second spring disposed laterally from the sleeve and providing a resilient coupling of the sheath to the sleeve.

[0395] For some applications, the sleeve defines a flange extending laterally from the sleeve, and the second spring is a compression spring disposed laterally from the sleeve such that application of a distally directed force to the sheath compresses the spring against the flange.

[0396] In some applications, the second spring is a helical spring.

[0397] In some applications, a second spring surrounds the sleeve.

[0398] According to some applications, a system and / or device is provided that includes an implant configured to be implanted into a subject's heart, the implant including a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.), an anchor slidably coupled to the tether and configured to secure the tether to cardiac tissue, a spring, and a restraint. The spring has a resting state and is coupled to the tether in a manner such that movement of the spring toward the resting state tensions the tether. For some applications, the restraint can be coupled to the spring in a manner that inhibits movement of the spring toward the resting state. The restraint can include a material (e.g., a bioabsorbable material) configured to degrade within the heart, and the degradation of the material can be configured to reduce inhibition of the spring by the restraint.

[0399] In some applications, the spring is a helical coil spring.

[0400] For some applications, the restraint is configured such that the restraint no longer inhibits the spring after a threshold amount of degradation of the restraint, and the material is configured to reach the threshold amount of degradation between 1 day and 2 years after implantation of the implant in the heart.

[0401] For some applications, the material is configured to reach a threshold amount of degradation between 15 days and 2 years after implantation of the implant in the heart.

[0402] For some applications, the material is configured to reach a threshold amount of degradation between 15 days and 1 year after implantation of the implant in the heart.

[0403] For some applications, the material is configured to reach a threshold amount of degradation between 6 s and 15 days after implantation of the implant into the heart.

[0404] For some applications, the material is configured to reach a threshold amount of degradation between 1 and 3 months after implantation of the implant in the heart.

[0405] For some applications, the material is configured to reach a threshold amount of degradation within 1-2 months after implantation of the implant in the heart.

[0406] For some applications, the restraint is a first restraint configured to have a first lifespan after implantation of the implant such that upon expiration of the first lifespan, the first restraint no longer inhibits the spring, and the implant further includes a second restraint configured to have a second lifespan after implantation of the implant, the second lifespan being longer than the first lifespan.

[0407] In some applications, the second restraint is coupled to the spring in a manner that inhibits movement of the spring toward the resting state, thereby configuring the system and / or device such that, after implantation, (i) at the expiration of a first lifespan, the spring moves partway toward the resting state but remains inhibited by the second restraint, and (ii) at the expiration of a second lifespan, the second restraint no longer inhibits the spring and the spring moves further toward the resting state.

[0408] For some applications, the spring is a first spring, and the implant further includes a second spring coupled to the tether in a manner having a resting state, such that movement of the second spring to the resting state tensions the tether.

[0409] For some applications, the second restraint is coupled to the second spring in a manner that inhibits movement of the second spring toward a rest state of the second spring, and is configured such that upon expiration of the second life, the second restraint no longer inhibits the second spring.

[0410] For some applications, the first restraint and the second restraint are configured such that the second lifespan is at least twice as long as the first lifespan.

[0411] For some applications, the first restraint and the second restraint are configured such that the second lifespan is at least three times greater than the first lifespan.

[0412] For some applications, the first restraint and the second restraint are configured such that the first life span is between 1 and 3 months and the second life span is between 3 months and 1 year.

[0413] For some applications, the first restraint and the second restraint are configured such that the first lifespan is between 1 and 3 months and the second lifespan is between 3 and 6 months.

[0414] For some applications, the first restraint and the second restraint are configured such that the first life span is between 1 month and 2 months and the second life span is between 3 months and 1 year.

[0415] For some applications, the first restraint and the second restraint are configured such that the first has a lifespan of 1-2 months and the second has a lifespan of 3-6 months.

[0416] In some applications, the restraint is stretch-resistant and is coupled to the spring in a manner that prevents the spring from moving toward a rest state due to the restraint resisting stretch.

[0417] In some applications, the restraint is a tether that connects one portion of the spring to another portion of the spring, thereby preventing the one portion of the spring from separating from the other portion of the spring.

[0418] In some applications, the restraint is a tube in which a spring is disposed.

[0419] In some applications, the restraint is compression resistant and is coupled to the spring in a manner that inhibits the spring from moving toward a rest state by the restraint resisting compression.

[0420] In some applications, the restraint is an obstacle placed between one portion of the spring and another portion of the spring, thereby preventing the one portion of the spring from moving toward the other portion of the spring.

[0421] For some applications, the spring is shaped to define a cell having a first dimension and a second dimension and is configured to move toward a resting state by contracting in the first dimension and expanding in the second dimension.

[0422] In some applications, the spring is longer in the first dimension than in the second dimension, although this is hindered by the restraint.

[0423] For some applications, the cell is a first cell and the spring is configured to further define a second cell.

[0424] According to some applications, a system and / or device for use on cardiac tissue of a subject is provided, the system and / or device including an anchor and an anchor handling assembly. The anchor generally includes a tissue engaging element, which can have a sharp distal tip and can be configured to be driven into the tissue to secure the anchor to the tissue. An anchor head is coupled to the proximal end of the tissue engaging element and includes an interface. The anchor handling assembly can include a sleeve and a tool. The sleeve has a distal portion including the distal end of the sleeve, the distal portion being transluminally advanceable into the anchor secured to the tissue. The distal end can be sized to fit snugly over the anchor head. The tissue engaging element can be the same as or similar to other tissue engaging elements described herein.

[0425] For some applications, the tool includes a flexible shaft and a tool head coupled to a distal end of the flexible shaft. The tool head can include jaws that are biased to assume an open state and can be reversibly forced into a closed state. The tool head can be sized relative to an inner dimension of the distal portion of the sleeve such that placement of the tool head in the distal portion of the sleeve forces the jaws into the closed state.

[0426] For some applications, the tool can be configured to advance the tool head through the sleeve to the distal portion, lock the jaws to the interface while the jaws remain closed, and apply a release force to the anchor head while the jaws remain locked to the interface.

[0427] In some applications, while the tool head is locked to the interface and the distal end of the sleeve is positioned snugly over the anchor head, the jaws can be unlocked from the interface by retracting the sleeve proximally relative to the anchor head and tool head such that the distal portion of the sleeve stops forcing the jaws closed and the jaws automatically separate.

[0428] For some applications, the tool is configured to lock the jaws to the interface by pressing the driver head against the anchor head while the jaws remain closed.

[0429] For some applications, in the closed state, the jaws define a gap therebetween, and while remaining in the closed state, the jaws are configured (i) to be locked to the interface by receiving the interface within the gap in response to the jaws being pushed onto the interface with a distally directed force having a magnitude by the interface deflecting the jaws apart, and (ii) to resist being unlocked from the interface by the interface leaving a gap, such that pulling on the jaws with a proximally directed force having a magnitude is insufficient to pull the jaws from the interface.

[0430] For some applications, the sleeve has an intermediate portion proximal to the distal portion and internally dimensioned such that placement of a tool head in the intermediate portion of the sleeve does not force the jaws closed.

[0431] For some applications, the jaws and the interface are configured to define a snap fit, and the tool is configured to lock the jaws to the interface while the jaws remain in a closed state by snapping the jaws to the interface.

[0432] For some applications, the delocking force is a delocking torque, and the tool is configured to apply the delocking torque to the anchor head while the jaws remain locked to the interface.

[0433] According to some applications, a system and / or device for use with a tether secured along cardiac tissue of a subject is provided, the system and / or device including an anchor and an anchor handling assembly. The anchor includes a tissue-engaging element and a head coupled to a proximal portion of the tissue-engaging element. The head may include a shackle having an opening that can be reversibly opened. The anchor handling assembly is transluminally advanceable into the heart and includes a driver and a linking tool. The driver is configured to secure the tissue-engaging element to the tissue. The linking tool may be configured to temporarily open the opening within the heart and pass the tether laterally through the opening.

[0434] For some applications, a linking tool is configured to slidably couple the anchor to the tether by temporarily opening an opening in the heart and passing the tether laterally through the opening and into the shackle.

[0435] For some applications, the driver is configured to drive the tissue engaging element into tissue by threading the tissue engaging element into the tissue.

[0436] In some applications, the opening includes a shackle that includes a spring-loaded gate.

[0437] In some applications, the spring-loaded gate is a single gate.

[0438] In some applications, the spring-loaded gate is a double gate.

[0439] In some applications, the spring-loaded gate is configured to open inward but not outward.

[0440] For some applications, the linking tool is configured to separate the anchor from the tether by temporarily opening an opening in the heart and passing the tether laterally from the shackle through the opening.

[0441] For some applications, the head further includes a magnet, and the tool is configured to be magnetically attracted to the magnet.

[0442] According to some applications, a method for use on cardiac tissue of a subject is provided, the method including transluminally securing a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) along the tissue by securing a plurality of anchors to respective locations on the tissue such that the tether extends between and along the tissue, each of the plurality of anchors having a respective eyelet through which the tether passes.

[0443] For some applications, the method includes, while the plurality of anchors remain secured to the tissue, (i) slidably coupling an additional anchor to a tether between two of the plurality of anchors, and (ii) securing the additional anchor to the tissue transluminally.

[0444] For some applications, securing the additional anchors to the tissue includes slidably coupling the additional anchors to the tether and then securing the additional anchors to the tissue.

[0445] For some applications, securing the additional anchors to tissue includes securing the additional anchors to tissue before slidably coupling the additional anchors to the tether.

[0446] For some applications, for each of the plurality of anchors, securing the anchor at the respective site of tissue includes driving a tissue engaging element of the anchor into the respective site of tissue.

[0447] For some applications, for each of the plurality of anchors, driving the tissue engaging element of the anchor into the respective portion of the tissue includes threading the tissue engaging element of the anchor into the respective portion of the tissue.

[0448] For some applications, the method further includes contracting the tissue by applying tension to the tether.

[0449] For some applications, tensioning the tether includes tensioning the tether after securing additional anchors to tissue.

[0450] For some applications, tensioning the tether includes tensioning the tether before slidably coupling an additional anchor to the tether.

[0451] For some applications, the method further includes relaxing the tether after tensioning the tether and before slidably coupling additional anchors to the tether.

[0452] For some applications, the method further includes re-tensioning the tether after securing the additional anchors to the tissue.

[0453] For some applications, slidably coupling the additional anchor to the tether includes clipping the additional anchor to the tether.

[0454] For some applications, the additional anchor includes a head that includes a shackle, and clipping the additional anchor to the tether includes transluminally grasping the tether and pushing the tether laterally into the shackle after anchoring the additional anchor to tissue so that the shackle is slidably coupled to the tether.

[0455] For some applications, the shackle is a snap shackle, and pushing the tether laterally into the shackle includes pushing the tether laterally into the snap shackle such that the tether snaps into the snap shackle.

[0456] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0457] According to some applications, a method for use on cardiac tissue of a subject is provided, the method including transluminally securing a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) along the tissue by securing a plurality of anchors at respective locations on the tissue such that the tether extends between and along the tissue, each of the plurality of anchors having a respective eyelet through which the tether passes; and transluminally separating one of the plurality of anchors from the tether from between two other of the plurality of anchors.

[0458] For some applications, the one anchor includes a tissue-engaging element having a sharp distal tip and a head coupled to a proximal portion of the tissue-engaging element, the head including a magnetic element, and the method further includes transluminally advancing a tool into the one anchor, where separating the one anchor from the tether facilitated by magnetic attraction between the tool and the magnetic element includes separating the one anchor from the tether using the tool. The tissue-engaging element can be the same as or similar to other tissue-engaging elements described herein.

[0459] For some applications, the method further includes unlocking one anchor from the tissue while two other anchors of the plurality remain secured to the tissue.

[0460] For some applications, unlocking the one anchor from the tissue includes unlocking the one anchor from the tissue before separating the one anchor from the tether.

[0461] For some applications, unlocking the one anchor from the tissue includes separating the one anchor from the tether and then unlocking the one anchor from the tissue.

[0462] For some applications, for each of the plurality of anchors, securing the anchor at the respective site of tissue includes driving a tissue engaging element of the anchor into the respective site of tissue.

[0463] For some applications, for each of the plurality of anchors, driving the tissue engaging element of the anchor into the respective portion of the tissue includes threading the tissue engaging element of the anchor into the respective portion of the tissue.

[0464] For some applications, the method further includes contracting the tissue by applying tension to the tether.

[0465] For some applications, tensioning the tether includes tensioning the tether after separating one anchor from the tether.

[0466] For some applications, tensioning the tether includes tensioning the tether before detaching one anchor from the tether.

[0467] For some applications, the method further includes relaxing the tether after tensioning the tether and before detaching one anchor from the tether.

[0468] For some applications, the method further includes re-tensioning the tether after separating one anchor from the tether.

[0469] For some applications, separating one anchor from the tether includes unclipping additional anchors from the tether.

[0470] For some applications, one anchor includes a head that includes a shackle, and unclipping the one anchor from the tether includes transluminally opening the shackle.

[0471] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0472] According to some applications, a system and / or device including a tissue anchor is provided. The anchor may include a tissue-engaging element having a sharp distal tip and defining a central longitudinal axis of the anchor configured to be driven into target tissue. The anchor may further include an anchor head coupled to a proximal end of the tissue-engaging element. The anchor head may include a stock, a ball joint, and an eyelet coupled to the stock via the ball joint. The tissue-engaging element may be the same as or similar to other tissue-engaging elements described herein.

[0473] In some applications, a ball joint is located on the central longitudinal axis.

[0474] For some applications, the anchor head defines an eyelet axis through the ball joint and the eyelet, and the ball joint enables the eyelet to be moved to a position where the eyelet axis is perpendicular to the central longitudinal axis.

[0475] For some applications, the pole is fixedly coupled to the tissue engaging element.

[0476] For some applications, the tissue engaging element is helical, defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into tissue of a target.

[0477] For some applications, the eyelets are positioned laterally from the central longitudinal axis.

[0478] In some applications, the ball joint is positioned laterally from the central longitudinal axis.

[0479] In some applications, the anchor head includes a collar that surrounds and is rotatably coupled to the stock, and a ball joint is attached to the collar such that the ball joint is rotatable about the central longitudinal axis by rotating the collar about the stock.

[0480] In some applications, the stock is positioned on the central longitudinal axis.

[0481] For some applications, the ball joint includes a socket and a bearing stud, the bearing stud defining a ball at a first end of the stud, the ball being disposed within the socket, and a second end of the stud defining an eyelet.

[0482] The ball joint can define (i) a spherical sector of deflection in which the ball joint allows the bearing stud to deflect to an angular configuration with respect to the socket, and (ii) a deflection plane in which the ball joint allows the bearing stud to deflect beyond the spherical sector of deflection, and outside the deflection plane, the ball joint prevents the bearing stud from deflecting beyond the spherical sector of deflection.

[0483] In some applications, the spherical sector of deflection has a midpoint and the ball joint is positioned so that the midpoint is on the central longitudinal axis.

[0484] In some applications, a ball joint is located on the central longitudinal axis.

[0485] For some applications, the ball joint defines a spherical sector of deflection having a solid angle of at least 1 steradian.

[0486] For some applications, the ball joint subtends a solid angle that is at least 2 steradians.

[0487] In some applications, the ball joint subtends a solid angle that is between 2 and 5 steradians.

[0488] In some applications, the ball joint subtends a solid angle that is between 3 and 5 steradians.

[0489] In some applications, the ball joint defines a planar arc of deflection of at least 110 degrees on the plane of deflection, and on the plane of deflection, the ball joint allows the bearing stud to deflect beyond the boundaries of only the planar arc of deflection.

[0490] For some applications, the ball joint defines a planar arc of deflection that is at least 120 degrees.

[0491] For some applications, the ball joint defines a planar arc of deflection that is at least 140 degrees.

[0492] For some applications, the ball joint defines a planar arc of deflection that is at least 160 degrees.

[0493] For some applications, the ball joint defines a planar arc of deflection that is at least 180 degrees.

[0494] For some applications, the ball joint defines a planar arc of deflection that is at least 200 degrees.

[0495] In some applications, the ball joint defines a planar arc of deflection that is less than or equal to 180 degrees.

[0496] For some applications, the ball joint defines a planar arc of deflection that is 160 degrees or less.

[0497] For some applications, the ball joint defines a planar arc of deflection that is 140 degrees or less.

[0498] For some applications, the eyelet is shaped to define a first side and a second side opposite the first side, the eyelet having an opening defined by an inner surface of the eyelet, the opening extending between the first side and the second side, and the narrowest portion of the opening being midway between the first side and the second side.

[0499] In some applications, the inner surface of the eyelet is superboloid.

[0500] For some applications, the inner surface of the eyelet is catenoid.

[0501] In some applications, the system / device includes an implant that includes a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) and an anchor, and further includes an eyelet threaded through the tether.

[0502] For some applications, the anchor is a first anchor of an implant, and the implant further includes a second anchor, an eyelet of the second anchor through which the tether is threaded.

[0503] In some applications, the implant further includes a spacer or divider that is tubular and has two spacer ends and a lumen therebetween, the spacer having a tether threaded between the first anchor and the second anchor, the tether passing through the spacer lumen.

[0504] In some applications, the spacer is resiliently flexible in deflection.

[0505] In some applications, the spacer resists axial compression.

[0506] For some applications, the spacer is defined by a helical wire configured as a coil that defines a spacer lumen.

[0507] In some applications, the eyelet defines an opening through which the tether is threaded, and the anchor head is configured to facilitate smooth sliding of the tether through the opening while (i) the tether is parallel to the central longitudinal axis and (ii) the tether is oriented perpendicular to the central longitudinal axis.

[0508] For some applications, the tether has a thickness and the narrowest portion of the opening is no more than twice the thickness of the tether.

[0509] For some applications, the narrowest portion of the opening is no more than 50% of the thickness of the tether.

[0510] For some applications, the narrowest portion of the opening is no more than 20% of the thickness of the tether.

[0511] For some applications, the anchor head further includes a driver interface, and the system / device further includes an anchor driver configured to reversibly engage with the driver interface and, while engaged with the driver interface, configured to (i) transluminally advance the anchor into tissue and (ii) drive the tissue engaging element into tissue.

[0512] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0513] For some applications, the system / device includes a delivery tool including a percutaneously advanceable tube and an anchor driver, configured to transluminally advance the anchor into tissue by sliding the anchor through the tube while the anchor driver is engaged with the driver interface.

[0514] In some applications, the tube defines an internal channel having a cross-section that defines a main channel region and a minor channel region, the main channel region having a larger cross-sectional area than the minor channel region, and the anchor is slidable through the channel, with the tissue engaging element sliding through the main channel region and the eyelet sliding through the minor channel region.

[0515] According to some applications, a system and / or device is provided that includes a tissue anchor, the anchor including a tissue engaging element defining a central longitudinal axis of the anchor, having a sharp distal tip, and configured to be driven into target tissue; and an anchor head. The anchor head may include a stock coupled to a proximal end of the tissue engaging element, a driver interface coupled to the stock, and an eyelet hingedly coupled to the stock such that the eyelet is pivotable on the driver interface. The tissue engaging element may be the same as or similar to other tissue engaging elements described herein.

[0516] For some applications, the stock is fixedly coupled to the proximal end of the tissue engaging element.

[0517] In some applications, the driver interface is fixedly coupled to the stock.

[0518] For some applications, a pole is coupled to the proximal end of the tissue engaging element and the driver interface in a manner that transfers torque from the driver interface to the tissue engaging element.

[0519] In some applications, the eyelet can be located on the central longitudinal axis.

[0520] In some applications, the hinged connection of the eyelet to the stock is such that the eyelet is positioned on a first side of the driver interface and is pivotable onto a second side of the driver interface, the second side being opposite the first side.

[0521] In some applications, the hinge connection of the eyelet to the stock is such that the eyelet can pivot on the driver interface through an arc of more than 180 degrees.

[0522] For some applications, the tissue engaging element is helical, defines a central longitudinal axis by extending helically around and along the central longitudinal axis, and is configured to be threaded into tissue of a target.

[0523] For some applications, the anchor head includes an arch that defines at least a portion of the eyelet, the arch having two base ends, each of the base ends hingedly connected to the stock at a respective hinge point opposite each other.

[0524] In some applications, the anchor head includes a collar that surrounds and is rotatably coupled to the stock, and the eyelets are hinged to the stock by each of the proximal ends being hinged to the collar at a respective one of the hinge points.

[0525] For some applications, at each of the hinge points, the collar defines a respective recess, and the respective proximal ends are hinged to the collar by projecting into the recesses.

[0526] In some applications, the eyelet is centrally located on the arch.

[0527] In some applications, the eyelets are positioned eccentrically on the arch.

[0528] In some applications, the system / device includes an implant that includes a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) and an anchor, and further includes an eyelet threaded through the tether.

[0529] For some applications, the anchor is a first anchor of an implant, and the implant further includes a second anchor, an eyelet of the second anchor through which the tether is threaded.

[0530] In some applications, the implant further includes a spacer or divider that is tubular and has two spacer ends and a lumen therebetween, the spacer having a tether threaded between the first anchor and the second anchor, the tether passing through the spacer lumen.

[0531] In some applications, the spacer is resiliently flexible in deflection.

[0532] In some applications, the spacer resists axial compression.

[0533] For some applications, the spacer is defined by a helical wire configured as a coil that defines a spacer lumen.

[0534] In some applications, the eyelet defines an opening through which the tether is threaded, and the anchor head is configured to facilitate smooth sliding of the tether through the opening while (i) the tether is parallel to the central longitudinal axis and (ii) the tether is oriented perpendicular to the central longitudinal axis.

[0535] For some applications, the system / device further includes an anchor driver configured to reversibly engage with the driver interface and, while engaged with the driver interface, configured to (i) transluminally advance the anchor into tissue and (ii) drive the tissue engaging element into tissue.

[0536] For some applications, the interface is located on the central longitudinal axis of the anchor.

[0537] For some applications, the system / device includes a delivery tool including a percutaneously advanceable tube and an anchor driver, configured to transluminally advance the anchor into tissue by sliding the anchor through the tube while the anchor driver is engaged with the driver interface.

[0538] According to some applications, a method is provided for transluminally advancing an elongated tool including a holder and a cutter to an implant coupled to a subject's heart. The implant may include a tether under tension (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) and a stopper that locks the tension in the tether by being engaged with a first portion of the tether. The method includes securing the stopper to the holder, and while the stopper is secured to the holder and engaged with the first portion of the tether, (i) relieving the tension in the tether by cutting the tether with the cutter, and (ii) removing the tool, stopper, and first portion of the tether from the subject while leaving a second portion of the tether coupled to the heart.

[0539] For some applications, the implant includes an anchor coupled to a tether and secured to the heart, and removing the tool, stopper, and first portion of the tether includes removing the tool, stopper, and first portion of the tether from the subject while leaving the anchor secured to the heart.

[0540] For some applications, the holder includes a chamber and an opening to the chamber, the cutter is disposed in the opening, and securing the stopper includes advancing the stopper into the chamber, past the cutter and the opening.

[0541] For some applications, securing the stopper includes using a cutter to inhibit the stopper from exiting the chamber through the opening.

[0542] For some applications, using a cutter to prevent the stopper from exiting the chamber through the opening includes activating the cutter to obstruct the opening.

[0543] For some applications, actuating the cutter to obstruct the opening includes moving a blade of the cutter to obstruct the opening, and severing the tether includes further moving the blade of the cutter to sever the tether with the blade.

[0544] In some applications, an implant is positioned within the heart, and transluminally advancing the elongated tool into the implant includes transluminally advancing the elongated tool into the implant positioned within the heart.

[0545] In some applications, the implant is an annuloplasty implant coupled to an annulus of a heart valve, and transluminally advancing the elongated tool into the implant includes transluminally advancing the elongated tool into the annuloplasty implant coupled to the annulus.

[0546] For some applications, the method further includes deploying the prosthetic valve within the annulus of the heart after releasing the tension on the tether.

[0547] In some applications, the annuloplasty implant extends a path at least partway around the annulus and is coupled to the annulus at multiple sites along the path, and transluminally advancing the elongated tool into the implant includes transluminally advancing the elongated tool into the annuloplasty implant that extends a path at least partway around the annulus and is coupled to the annulus at multiple sites along the path.

[0548] For some applications, the implant includes an anchor slidably coupled to the tether and secured to the heart, a stopper locking tension in the tether by preventing a first portion of the tether from sliding relative to the anchor, and transluminally advancing the elongated tool into the implant includes transluminally advancing the elongated tool into the implant including an anchor slidably coupled to the tether and secured to the heart, a stopper locking tension in the tether by preventing a first portion of the tether from sliding relative to the anchor.

[0549] In some applications, a stopper abuts against the anchor, thereby preventing the first portion of the tether from sliding relative to the anchor, and advancing the elongated tool transluminally into the implant includes advancing the elongated tool transluminally into the implant, wherein the stopper abuts against the anchor, thereby preventing the first portion of the tether from sliding relative to the anchor.

[0550] For some applications, cutting the tether includes cutting the tether between the stopper and the anchor.

[0551] For some applications, relieving tension on the tether by cutting the tether can include cutting the tether such that cutting forms a first cut end and a second cut end of the tether, and the second portion of the tether pulls the second cut end away from the cutter and passes through the anchor. Removing the first portion of the tether can include removing the first portion of the tether with the first cut end. Leaving the second portion of the tether can include leaving the second portion of the tether with the second cut end.

[0552] For some applications, the anchor is a first anchor, the implant includes a second anchor slidably coupled to the tether and secured to the heart, and cutting the tether includes cutting the tether such that a second portion of the tether pulls a second cut end away from the cutter and passes past the first anchor but not past the second anchor.

[0553] For some applications, cutting the tether such that the second portion of the tether pulls the second cut end away from the cutter and passes through the anchor includes cutting the tether such that the second portion of the tether pulls the second cut end away from the cutter and passes through the anchor, thereby separating the anchor from the tether.

[0554] For some applications, the anchor is slidably coupled to the tether by threading an eyelet of the anchor through the tether, and cutting the tether so that a second portion of the tether separates the anchor from the tether includes cutting the tether so that the second portion of the tether separates the anchor from the tether by pulling the second cut end away from the cutter and through the eyelet.

[0555] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0556] According to some applications, a method is provided that includes transluminally advancing an elongate tool onto a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) under tension and positioned within a heart of a subject. The elongate tool may include a holder and a cutter. The method may further include securing a first portion of the tether to the holder, and while the first portion of the tether remains secured to the holder, (i) relieving tension on the tether by cutting the tether with the cutter, thereby separating the first portion of the tether from the second portion of the tether, and (ii) withdrawing the tool and the first portion of the tether from the subject, while leaving the second portion of the tether coupled to the heart.

[0557] For some applications, the first portion of the tether includes a knot that locks tension in the tether, and removing the first portion of the tether includes removing the knot from the subject.

[0558] For some applications, the first portion of the tether has a stopper secured thereto, the stopper locking tension in the tether, and removing the first portion of the tether includes removing the stopper from the subject.

[0559] For some applications, the tether is coupled to an anchor secured to the heart, and removing the tool and the first portion of the tether includes removing the tool and the first portion of the tether from the subject while leaving the anchor secured to the heart.

[0560] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0561] According to some applications, a system and / or device including a tissue anchor is provided, the anchor including an external rotation joint defining a hinge axis, a first arm, and a second arm. The first arm can define a first coupling and a first hook that curves about and away from the hinge axis and terminates at a first tip, the curvature of the first hook being in a first direction about the hinge axis. The second arm can be hingedly coupled to the first arm via the external rotation joint and can define a second coupling and a second hook that curves about and away from the hinge axis and terminates at a second tip, the curvature of the second hook being in a second direction about the hinge axis, the second direction being opposite the first direction.

[0562] The hinge connection of the second arm to the first arm can be such that the anchor is transitionable between (i) an open state in which the first arm is in a first rotational position about the hinge axis, the first hook and the second hook defining a space therebetween, the first tip and the second tip defining a gap to the space therebetween, and the first coupling and the second coupling disengaging from one another, and (ii) a closed state in which the first arm is in a second rotational position about the hinge axis, the gap is smaller than in the open state, the first coupling and the second coupling engaging with one another, and the engagement between the first coupling and the second coupling inhibits the anchor from transitioning from the closed state.

[0563] For some applications, for each of the first hook and the second hook, the radius of curvature of the hook increases with distance from the external rotation joint.

[0564] For some applications, in the closed state, the first tip and the second tip face away from each other.

[0565] For some applications, the anchor further includes a spring configured to bias the first arm toward a given rotational position about the hinge axis.

[0566] For some applications, a spring is configured to bias the lock toward the closed state.

[0567] In some applications, the spring is a torsion spring.

[0568] For some applications, the external rotation joint includes a pin extending through the first arm and the second arm, with the torsion spring mounted on the pin.

[0569] For some applications, the first arm defines a first beam, the second arm defines a second beam, and external rotation joints are disposed between the first beam and the first hook and between the second beam and the second hook such that the first arm is a Class I lever with its fulcrum at the external rotation joint.

[0570] In some applications, the anchor is a Class I double lever whose fulcrum is an external rotation joint.

[0571] For some applications, the anchor is transitionable from an open state to a closed state by actuating the first beam about the hinge axis.

[0572] For some applications, the anchor can be transitioned from an open state to a closed state by increasing the alignment between the first beam and the second beam.

[0573] For some applications, a first coupling is disposed on the first beam, a second coupling is disposed on the second beam, and the hinge connection of the second arm to the first arm is such that the anchor can be moved to a closed state by aligning the first beam with the second beam such that the first coupling and the second coupling responsively engage with each other.

[0574] For some applications, the first coupling includes a protrusion and the second coupling includes a recess.

[0575] According to some applications, a system and / or device for use with cardiac tissue is provided, the system / device including a tether (e.g., line, wire, ribbon, rope, braid, contractile member, suture, etc.) and a tissue anchor. The tissue anchor may include a stem, an arm, a hinge, and a head. The arm may be coupled to a distal end of the stem via the hinge. The head may be coupled to a proximal part of the stem. The tether may be slidably coupled to the head. The stem may have an intermediate part between the distal end and the proximal part.

[0576] The anchor can be secured within tissue by sequentially advancing the first side of the arm, the hinge, and the intermediate portion of the stem within the tissue such that the stem extends from the distal end of the tissue and the hinge within the tissue to a proximal portion above the tissue. The arms can be pivotable about the hinge within the tissue such that the anchor can transition within the tissue toward a constrained state in which the arms extend laterally across the distal end of the stem. The head can be configured to clamp tissue between the arms and head by moving the head distally along the stem toward the hinge.

[0577] For some applications, the system / device further includes a hollow needle having a sharp tip and configured to penetrate tissue. The arm may be configured to be delivered to the tissue within the needle. The stem may be biased to automatically curve upon deployment from the needle within the tissue. The needle may be configured to inhibit bending of the stem while the stem is disposed within the needle.

[0578] For some applications, the arm has a second side, and a hinge is coupled to the arm between the first side and the second side such that transition of the anchor toward the constrained state causes the arm to pivot relative to the stem within tissue such that the first side of the arm moves proximally relative to the stem and the second side of the arm moves distally relative to the stem.

[0579] For some applications, the anchor is configured to automatically transition toward the constrained state upon application of a proximal pulling force to the stem while the arms are positioned within tissue.

[0580] For some applications, the second side measured between the tip of the second side and the hinge is longer than the first side measured between the tip of the first side and the hinge.

[0581] For some applications, the second side has an eccentric tip.

[0582] In some applications, the eccentric tip is sharp.

[0583] For some applications, the first side has a centralized tip.

[0584] In some applications, the centralized tip is sharp.

[0585] In some applications, the system / device further includes a retrieval line coupled to the second side in a manner that transitions the anchor from a constrained state by pivoting the arm within the tissue and relative to the stem such that pulling the retrieval line proximally moves a first side of the arm distally relative to the stem and a second side of the arm proximally relative to the stem.

[0586] In some applications, the system / device further includes a tube that is distally advanceable over and along the retrieval line and stem, and the anchor is configured to be released from the tissue by retracting the retrieval line, stem, and second side of the arm into the tube.

[0587] In some applications, the retrieval line may be detachable from the anchor intracorporeally.

[0588] According to some applications, a method for implanting an implant into cardiac tissue of a subject is provided, the method including introducing into the subject a tissue anchor including a stem, a head coupled to a proximal portion of the stem, an arm, and a hinge coupling the arm to the stem, the stem having an intermediate portion between a distal end and the proximal portion.

[0589] The method may further include transluminally advancing the anchor along the tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) toward the heart with the head sliding over the tether, and advancing the first side of the arm, the hinge, and the intermediate part of the stem sequentially into the tissue so that the proximal part of the stem extends above the tissue.

[0590] The method may further include transitioning the anchor toward its constrained state within the tissue by pivoting the arms about the hinge so that the arms extend laterally across the distal end of the stem, and then clamping the tissue between the arms and the head by moving the head distally along the stem toward the hinge.

[0591] For some applications, the method further includes advancing a needle having a sharp tip into the tissue, and advancing the first end of the arm, the hinge, and the intermediate part of the stem into the tissue includes advancing the first end of the arm, the hinge, and the intermediate part of the stem sequentially from the needle into the tissue.

[0592] For some applications, advancing the first side of the arm into the tissue includes advancing the first side of the arm into the annulus of an atrioventricular valve of the heart while the arm is generally perpendicular to a coronary artery disposed along the annulus.

[0593] For some applications, pivoting the arm about the hinge includes pivoting the arm about the hinge such that the arm is substantially parallel to the coronary artery.

[0594] For some applications, the arm has a second side, a hinge is coupled to the arm between the first and second sides, and transitioning the anchor toward the holding state includes pivoting the arm relative to the stem within the tissue such that the first side of the arm moves proximally relative to the stem and the second side of the arm moves distally relative to the stem.

[0595] For some applications, pivoting the arm about the hinge includes pivoting the arm about the hinge while a retrieval line is coupled to the second side, and the method further includes thereafter intracorporeally detaching the retrieval line from the anchor.

[0596] For some applications, pivoting the arm relative to the stem includes applying a proximal pulling force to the stem such that the anchor automatically transitions toward the constrained state.

[0597] For some applications, the second side, measured between a tip of the second side and the hinge, is longer than the first side, measured between a tip of the first side and the hinge, and pivoting the arm relative to the stem includes applying a proximal pulling force to the stem such that interaction between the tissue and the longer second side pivots the arm relative to the stem.

[0598] For some applications, the second side has an eccentric tip, and pivoting the arm relative to the stem includes applying a proximal pulling force to the stem such that interaction between the tissue and the eccentric tip side pivots the arm relative to the stem.

[0599] For some applications, the first side of the arm has a centralized tip, and advancing the first side of the arm through tissue includes penetrating the tissue with the centralized tip.

[0600] For some applications, the method further includes (i) pivoting the arm relative to the stem within the tissue by pulling a retrieval line coupled to the second side proximally so that a first side of the arm moves distally relative to the stem and a second side of the arm moves proximally relative to the stem, and (ii) then unlocking the anchor from the tissue by pulling the arm from the tissue, second side first.

[0601] For some applications, the method further includes advancing a tube over and along the retrieval line and stem, and withdrawing the arm from the tissue includes withdrawing the arm second side first into the tube and out of the tissue.

[0602] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0603] According to some applications, a system and / or device for use with cardiac tissue of a subject is provided, the system / device including an implant including a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.), a first anchor, and a second anchor. Each of the first and second anchors can include a head slidably coupled to the tether and a tissue-engaging element configured to secure the anchor and tether to tissue. The tissue-engaging element can be the same as or similar to other tissue-engaging elements described herein.

[0604] For some applications, the system / device further includes a tubular spacer or divider defining a lumen along the spacer axis and having (i) a primary region that is flexible in bending, and (ii) secondary regions at each end of the primary region that are less flexible than the primary region, the lumen passing through the primary region and both secondary regions. The tubular spacer can be tethered between the first anchor and the second anchor by a tether passing through the lumen.

[0605] For some applications, the primary region is elastically flexible in deflection.

[0606] In some applications, the primary region resists axial compression.

[0607] In some applications, each of the secondary regions is more resistant to axial compression than the primary regions.

[0608] For some applications, each of the secondary regions is shorter than the primary region.

[0609] In some applications, the combined length of both secondary regions is shorter than the primary region.

[0610] In some applications, each of the secondary regions is less than 30% as long as the primary region. In some applications, each of the secondary regions is less than 20% as long as the primary region. In some applications, each of the secondary regions is less than 10% as long as the primary region. In some applications, each of the secondary regions is at least 2% as long as the primary region. In some applications, each of the secondary regions is at least 5% as long as the primary region.

[0611] For some applications, the spacer or divider includes a helical coil extending along the primary region.

[0612] For some applications, the helical coil includes a wire coiled to form a helical coil, the wire having a core including a radiopaque material.

[0613] For some applications, the wire comprises cobalt chromium and the core comprises platinum.

[0614] In some applications, the coil extends into the secondary region.

[0615] For some applications, the helical coil includes a wire coiled to form a helical coil, the wire having a wire thickness, and in the rest state of the helical coil, the helical coil has a pitch that is 1.4 to 2 times the wire thickness.

[0616] In some applications, in the quiescent state, the pitch of the helical coil is 1.6 to 1.8 times the thickness of the wire.

[0617] For some applications, the spacer includes a rigid ring coupled to the end of the helical coil at each of the secondary regions.

[0618] For some applications, the helical coil includes a wire coiled to form a helical coil, the wire having a thickness of the wire, and each of the rings having a length along the spacer axis at least twice the thickness of the wire.

[0619] For some applications, each of the rings is disposed at least partially within the helical coil.

[0620] For some applications, each of the rings has a flange disposed on the outside of the helical coil, the flange providing a bearing surface configured to facilitate sliding of the tether.

[0621] According to some applications, a system and / or device for use with a subject is provided, the system and / or device including a delivery tool and a stopper. The delivery tool is percutaneously advanceable into the subject and can have a cavity. The stopper can include a first element including a first plate defining a first passage therethrough, a second element including a second plate defining a second passage therethrough, and a torsion bar.

[0622] In some applications, the torsion bar can connect the first plate to the second plate in a manner such that (i) the torsion bar biases the stopper toward a gripping state in which the first passage and the second passage are offset relative to one another, and (ii) the stopper is dimensioned such that the delivery tool holds the stopper in an open state while the stopper is positioned within the cavity, and the stopper is moveable to the open state by increasing the stress on the torsion bar and alignment between the first passage and the second passage.

[0623] For some applications, both the first passageway and the second passageway are parallel to the torsion bar in both the clamped and open positions.

[0624] In some applications, the cavity is defined by an inner surface of the delivery tool and is dimensioned such that the stopper is disposed within the cavity in a manner such that the first plate and the second plate are disposed within the cavity, with the inner surface pressing against the first plate and the second plate to hold the stopper in an open state.

[0625] For some applications, the stopper is configured to transition toward the gripping state by torsional stress relief of the torsion bar moving the first plate relative to the second plate in response to the stopper being ejected from the cavity, with the inner surface pressing against the first plate and the second state preventing torsional stress relief of the torsion bar.

[0626] For some applications, in the open state of the stopper, the stopper defines a central longitudinal axis passing through a center of the first plate and a center of the second plate, and transitioning of the stopper to the clamped state offsets the center of at least one of the first plate and the second plate relative to the central longitudinal axis.

[0627] For some applications, both the first passageway and the second passageway are parallel to the longitudinal axis in both the open and gripped states.

[0628] For some applications, the first plate is non-axial with the second plate in the clamped state.

[0629] For some applications, the delivery tool is a catheter.

[0630] For some applications, the system / device further includes a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.), and while the stopper is in the open state, alignment between the first passage and the second passage is sufficient to allow the tether to slide through the stopper, and while the tether is positioned through the stopper, transitioning of the stopper to the grasping state grabs the tether within the stopper, thereby preventing the tether from sliding through the stopper.

[0631] In some applications, the system / device includes an implant including a tether, the implant being contractible by applying tension to the tether, and in a gripping state of the stopper, the stopper is configured to grip the tether, thereby locking the tension in the tether.

[0632] For some applications, in the open state of the stopper, the first element and the second element are aligned relative to one another such that the stopper is cylindrical.

[0633] For some applications, in the gripped state, the first element is offset relative to the second element such that the stopper is non-cylindrical.

[0634] The present invention will be more fully understood from the following detailed description of the present invention taken together with the drawings. [Brief explanation of the drawings]

[0635] [Figure 1A] 1A-I, 2A-B, 3A-D, and 4A-B are schematic illustrations of example anchors, implants including anchors, systems including implants, and techniques for use therewith, according to several example applications. [Figure 1B] Same as above. [Figure 1C] Same as above. [Figure 1D] Same as above. [Figure 1E] Same as above. [Figure 1F] Same as above. [Figure 1G] Same as above. [Figure 1H] Same as above. [Figure 1I] Same as above. [Figure 2A] Same as above. [Figure 2B] Same as above. [Figure 3A] Same as above. [Figure 3B] Same as above. [Figure 3C] Same as above. [Figure 3D] Same as above. [Figure 4A] Same as above. [Figure 4B] Same as above. [Figure 5A] 5A-D and 6A-C are schematic illustrations of exemplary anchors for use in tissue of a subject, according to some applications. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 5D] Same as above. [Figure 6A] Same as above. [Figure 6B] Same as above. [Figure 6C] Same as above. [Figure 7A] 7A-C and 8A-C are schematic diagrams of exemplary anchors, according to some applications. [Figure 7B] Same as above. [Figure 7C] Same as above. [Figure 8A] Same as above. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 9A]9A-C and 10A-C are schematic diagrams of exemplary anchors, according to some applications. [Figure 9B] Same as above. [Figure 9C] Same as above. [Figure 10A] Same as above. [Figure 10B] Same as above. [Figure 10C] Same as above. [Figure 11A] 11A-D and 12A-E are schematic diagrams of respective exemplary systems according to some applications. [Figure 11B] Same as above. [Figure 11C] Same as above. [Figure 11D] Same as above. [Figure 12A] Same as above. [Figure 12B] Same as above. [Figure 12C] Same as above. [Figure 12D] Same as above. [Figure 12E] Same as above. [Figure 13] 13-17 are schematic diagrams of respective exemplary anchors according to some applications. [Figure 14] Same as above. [Figure 15] Same as above. [Figure 16] Same as above. [Figure 17] Same as above. [Figure 18A] 18A-C, 19A-D, 20A-C, and 21A-E are schematic diagrams of exemplary tether management systems including respective tether management devices, according to some applications. [Figure 18B] Same as above. [Figure 18C] Same as above. [Figure 19A] Same as above. [Figure 19B] Same as above. [Figure 19C] Same as above. [Figure 19D] Same as above. [Figure 20A] Same as above. [Figure 20B] Same as above. [Figure 20C] Same as above. [Figure 21A] Same as above. [Figure 21B] Same as above. [Figure 21C] Same as above. [Figure 21D] Same as above. [Figure 21E] Same as above. [Figure 22A] 22A-B, 23A-B, and 24A are schematic diagrams of various example tensioners according to several applications. [Figure 22B] Same as above. [Figure 23A] Same as above. [Figure 23B] Same as above. [Figure 24A] Same as above. [Figure 24B] Same as above. [Figure 24C] Same as above. [Figure 24D] Same as above. [Figure 25A] 25A-F and 26A-B are schematic diagrams of exemplary anchor handling assemblies, according to some applications. [Figure 25B] Same as above. [Figure 25C] Same as above. [Figure 25D] Same as above. [Figure 25E] Same as above. [Figure 25F] Same as above. [Figure 26A] Same as above. [Figure 26B] Same as above. [Figure 27A] 27A-C and 28A-B are schematic diagrams of exemplary anchor handling assemblies, according to some applications. [Figure 27B] Same as above. [Figure 27C] Same as above. [Figure 28A] Same as above. [Figure 28B] Same as above. [Figure 29A]29A-B and 30A-B are schematic diagrams of respective anchoring systems according to some applications. [Figure 29B] Same as above. [Figure 30A] Same as above. [Figure 30B] Same as above. [Figure 31A] 31A-B, 32A-B, 33A-B, 34A-C, and 35A-C are schematic illustrations of systems, devices, and techniques for adding anchors to and / or removing anchors from implants, according to some applications. [Figure 31B] Same as above. [Figure 32A] Same as above. [Figure 32B] Same as above. [Figure 33A] Same as above. [Figure 33B] Same as above. [Figure 34A] Same as above. [Figure 34B] Same as above. [Figure 34C] Same as above. [Figure 35A] Same as above. [Figure 35B] Same as above. [Figure 35C] Same as above. [Figure 36A] 36A-B, 37A-D, 38A-B, 39A-C, 40A-D, 41, and 42 are schematic illustrations of various tissue anchors and techniques for use therewith, according to several applications. [Figure 36B] Same as above. [Figure 37A] Same as above. [Figure 37B] Same as above. [Figure 37C] Same as above. [Figure 37D] Same as above. [Figure 38A] Same as above. [Figure 38B] Same as above. [Figure 39A] Same as above. [Figure 39B] Same as above. [Figure 39C]Same as above. [Figure 40A] Same as above. [Figure 40B] Same as above. [Figure 40C] Same as above. [Figure 40D] Same as above. [Figure 41] Same as above. [Figure 42] Same as above. [Figure 43A] 43A-C are schematic illustrations of tissue anchors and variations thereof, according to some applications. [Figure 43B] Same as above. [Figure 43C] Same as above. [Figure 44A] 44A-E and 45A-E are schematic illustrations of tissue anchors and techniques for their use, according to some applications. [Figure 44B] Same as above. [Figure 44C] Same as above. [Figure 44D] Same as above. [Figure 44E] Same as above. [Figure 45A] Same as above. [Figure 45B] Same as above. [Figure 45C] Same as above. [Figure 45D] Same as above. [Figure 45E] Same as above. [Figure 46A] 46A-C and 47A-C are schematic diagrams of exemplary spacers, according to some applications. [Figure 46B] Same as above. [Figure 46C] Same as above. [Figure 47A] Same as above. [Figure 47B] Same as above. [Figure 47C] Same as above. [Figure 48A] 48A-E are schematic diagrams of tether handling systems, according to some applications. [Figure 48B] Same as above. [Figure 48C] Same as above. [Figure 48D] Same as above. [Figure 48E] Same as above. [Figure 49A] 49A-D are schematic illustrations of at least some steps in a technique for use in an implant coupled to a subject's heart, according to some applications. [Figure 49B] Same as above. [Figure 49C] Same as above. [Figure 49D] Same as above. [Figure 50] 50, 51, 52A-F, and 53A-E are schematic diagrams of systems for use with subjects, according to several application examples. [Figure 51] Same as above. [Figure 52A] Same as above. [Figure 52B] Same as above. [Figure 52C] Same as above. [Figure 52D] Same as above. [Figure 52E] Same as above. [Figure 52F] Same as above. [Figure 53A] Same as above. [Figure 53B] Same as above. [Figure 53C] Same as above. [Figure 53D] Same as above. [Figure 53E] Same as above. [Figure 54] 54 and 55A-C are schematic diagrams of flexible tubes having rotatable distal portions, according to some applications. [Figure 55A] Same as above. [Figure 55B] Same as above. [Figure 55C] Same as above. [Figure 56A] 56A-B and 57A-B are schematic diagrams of flushing adapters, according to some applications. [Figure 56B] Same as above. [Figure 57A] Same as above. [Figure 57B] Same as above. [Figure 58A] 58A-C are schematic diagrams of fluoroscopic guides according to some applications. [Figure 58B] Same as above. [Figure 58C] Same as above.

[0636] [Figure 59A] 59A-B are schematic diagrams of anchors, according to some applications. [Figure 59B] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0637] In the following description, various aspects of the present disclosure will be 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.

[0638] Throughout this specification, the same name is used to indicate different implementations of an element. Unless otherwise stated, applications of the devices, systems, and technologies described herein may include any variations in which an element is replaced with another identically named element. Furthermore, throughout the figures, the presence or absence of different suffixes for the same reference number is used to indicate different implementations of the same element. Unless otherwise stated, 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, whether shown with or without a suffix. To avoid undue confusion due to an excessive number of reference numbers or leads in a particular drawing, some elements may be introduced through one or more drawings and not explicitly identified in all subsequent drawings that include that element.

[0639] 1A-I, 2A-B, 3A-D, and 4A-B, which are schematic illustrations of example tissue anchors 120, implants 110 including the tissue anchors, systems 100 including the implants, and techniques for use therewith, according to some application examples. System 100 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures (e.g., soft tissue). For example, system 100 can be an annuloplasty system, and implant 110 can be an annuloplasty structure (e.g., an annuloplasty ring, an annuloplasty implant, etc.).

[0640] FIG. 1A shows an isometric view of anchor 120, FIG. 1B shows an exploded view, FIGS. 1C and 1E show side and top-down views, respectively, and FIGS. 1D and 1F show longitudinal and transverse cross sections, respectively.

[0641] The anchor 120 includes a tissue-engaging element 130 and a head 180. The tissue-engaging element can be configured in a variety of ways and can be the same as or similar to other tissue-engaging elements described herein. For some applications, as shown in FIGS. 1A-4F , the tissue-engaging element has a proximal end 132, a distal end 134, and defines a central longitudinal axis ax1 of the anchor 120. At the distal end 134, the tissue-engaging element 130 has a sharp distal tip 138, and the tissue-engaging element is configured to be driven (e.g., screwed, pushed, etc.) into target tissue (e.g., soft tissue). For some applications, as shown, the tissue-engaging element 130 is helical and defines a central lumen along the axis ax1. Optionally, the tissue-engaging element 130 can be a dart, staple, hook, clip, clamp, pinch device, and / or another type of tissue-engaging element, as described below with reference to FIGS. 13-17 . For some applications, the tissue engaging element may be hook-shaped, straight, angled, and / or otherwise configured. For some applications, the tissue engaging element may include barbs or barbed portions that hold the tissue engaging element in the tissue.

[0642] The tissue engaging element 130 has a lateral width d1. In applications in which the tissue engaging element 130 is helical, the width d1 is the outer diameter of the helix. The head 180 couples to the proximal end 132 of the tissue engaging element 130 and includes a driver interface 182 and an eyelet 140 (or other connector) defining an opening 146 therethrough. The driver interface 182 is configured to be reversibly engaged by an anchor driver 160 (FIG. 3A). The driver 160 may include an elongate, flexible shaft 162 and a driver head 164 coupled to the distal end of the shaft. The driver head 164 is a component of the anchor driver 160 that reversibly engages the driver interface 182. The driver interface 182 can be coupled (e.g., fixedly coupled) to the tissue engaging element 130. In some applications, and as shown, the interface 182 includes a bar 183 that is traversable relative to an axis ax1.

[0643] In some applications, as shown, driver interface 182 is disposed on or centered on central longitudinal axis ax1, and eyelet 140 is disposed laterally (e.g., eccentrically) from axis ax1, thereby defining an eyelet axis ax2 that is orthogonal to axis ax1. That is, eyelet axis ax2 is an axis that extends orthogonally from axis ax1 through eyelet 140. Eyelet 140 is shaped to define a sliding axis ax3 along which a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) can slide through opening 146. Often, sliding axis ax3 is transverse to opening 146. Often, sliding axis ax3 is the axis of least resistance through opening 146.

[0644] Figure 1G shows eyelet 140 in different rotational orientations relative to axis ax1. Figure 1H shows eyelet 140 in different positions around axis ax1. Figure 1I shows various views of eyelet 140.

[0645] In some applications, the sliding axis ax3 may be defined relative to an opening plane p1 of the eyelet 140. In such applications, the sliding axis ax3 may be transverse to the sliding axis ax3. The opening plane p1 is a cross-sectional plane through the eyelet 140 in which the opening 146 appears enclosed (see, for example, Frame F of FIG. 1I, which is a cross-section on the opening plane p1). Often, among all possible cross-sectional planes through the eyelet 140 in which the opening 146 appears enclosed, the opening plane p1 is the one in which the opening 146 has the smallest cross-sectional area (see, for example, Frames B and E of FIG. 1I). In some applications, in a cross-section at the opening plane p1, the opening 146 appears circular (see, for example, Frame F of FIG. 1I). In some applications, the opening plane p1 is centrally and angularly disposed relative to the eyelet 140 so as to divide the eyelet into two identical halves. In some applications, and as shown in FIG. 1I, the eyelet axis ax2 lies on the opening plane p1.

[0646] For some applications, eyelet 140 is shaped to define two flat surfaces 148, with opening 146 extending through the eyelet between the surfaces, e.g., one surface at each end of the opening. For some applications, surfaces 148 are parallel to one another. For some applications, at least one of surfaces 148 is orthogonal to sliding axis ax3 and / or parallel to eyelet axis ax2. As described in more detail below, surfaces 148 are shaped to facilitate interaction with a tubular spacer or divider (e.g., a tube, a solid-walled tube, a laser-cut tube, a rod coil, a spring, etc.).

[0647] In some applications, the narrowest portion of aperture 146 is midway between planes 148. In some applications, aperture plane p1 is midway between the planes and parallel to the planes. Frames B and F of FIG. 1I show the narrowest portion of aperture 146 as being midway between planes 148 on plane p1.

[0648] In some applications, the inner surface of eyelet 140 has a catenoid shape. In some applications, the inner surface of eyelet 140 has a superboloid shape. See, for example, frames B and E of FIG. 1I.

[0649] As described in more detail below, eyelet 140 is configured to facilitate sliding of anchor 120 along the tether (or sliding of the tether through the eyelet) while the anchor is aligned with the tether, i.e., while axis ax1 is parallel to the tether. Also, as described in more detail below, eyelet 140 is configured to facilitate sliding of the anchor along the tether (or sliding of the tether through the eyelet) while the anchor is oriented perpendicular to the tether, i.e., while axis ax1 is perpendicular to the tether. This is achieved, for example, by eyelet 140 being at least partially rotatable so that sliding axis ax3 can be oriented parallel to axis ax1, perpendicular to axis ax1, or generally at any orientation therebetween. Eyelet 140 can be rotatably mounted in a manner that constrains sliding axis ax3 to be perpendicular to eyelet axis ax2. The rotatability of eyelet 140 is illustrated by FIG. 1G, in which frames each show the eyelet at a different rotational orientation relative to axis ax1. The left frame shows a rotational orientation in which axis ax3 is parallel to axis ax1.

[0650] In some applications, the attachment of eyelet 140 is also such that the eyelet is rotatable about axis ax1 while axis ax3 remains constrained orthogonal to axis ax2. This is illustrated by FIG. 1H , where each frame shows eyelet 140 at a different position about axis ax1 (interface 182 and tissue engaging element 130 are in the same position in each of the frames). This configuration of anchor 120, which allows rotation and pivoting but not flexing of eyelet 140, is hypothesized to advantageously increase predictability and reduce wear on the tether compared to anchors in which the eyelets are loosely coupled, such as links in a chain.

[0651] In some applications, attachment of the eyelet 140 is achieved by the head 180 including a collar 184 (which may also be referred to as a ring) to which the eyelet is rotatably attached. The collar 184 surrounds and is rotatable about the axis ax1 by being rotatably coupled to the tissue engaging element 130, e.g., by being rotatably coupled to another component of the head 180 that is fixedly coupled to the tissue engaging element. For example, the collar 184 may be rotatably coupled to the stock 128, which is coupled (e.g., fixedly coupled) to the tissue engaging element 130 and couples (e.g., fixedly coupled) the tissue engaging element to the interface 182, e.g., in a manner that transmits torque from the interface 182 to the tissue engaging element 130. The stock 128 may be considered and / or referred to as a mount. The stock 128 may be disposed on the central longitudinal axis ax1.

[0652] As shown, stock 128 may be formed by two components, component 128′ and component 128″, fixedly attached to one another. Component 128″ may be fixedly attached to tissue-engaging element 130 and component 128′. For example, and as shown, component 128″ may be shaped to define a core 129, and component 128″ may function as a cap secured to (e.g., over) the core. Core 129 may be disposed on axis ax1. Component 128′ may also define and / or function as at least a portion of interface 182. Component 128′ may be further away from tissue-engaging element 130 than component 128″.

[0653] The rotatable coupling of the collar 184 to the stock 128 may be facilitated by the collar surrounding the stock and being axially constrained by one or more flanges 122 defined by the stock, e.g., a proximal flange 122′ defined by component 128′ and / or a distal flange 122′ defined by component 128″.

[0654] Alternatively or additionally, rotatable coupling of eyelet 140 to collar 184 can be facilitated by the eyelet defining a flange 142 disposed inwardly of collar 184 and a stem 144 extending laterally through the collar to couple flange 142 to an opening in the eyelet. In some applications, these components thereby form an external rotation joint between eyelet 140 and collar 184. FIGS. 2A-B illustrate two examples of this. FIG. 2A illustrates collar 184 as an open collar 184a, both having free ends 186 that support stem 144 (e.g., the free ends are bearing surfaces). FIG. 2B illustrates collar 184 as a closed collar 184b that defines a recess 188 that supports stem 144 (e.g., the collar defines a bearing surface that describes at least a portion of the recess).

[0655] As described above, anchor 120 (e.g., its eyelet 140) is configured to facilitate sliding of the anchor along (or the tether through) the tether while the anchor is aligned with the tether, e.g., while axis ax1 is parallel to the tether. This is hypothesized to facilitate transcatheter advancement of anchor 120 along the tether. Also, as described above, anchor 120 (e.g., its eyelet 140) is configured to facilitate sliding of the anchor along (or the tether through) the tether while the anchor is oriented perpendicular to the tether, e.g., while axis ax1 is perpendicular to the tether. This is hypothesized to be particularly useful in applications where the tether is tensioned after implantation to adjust anatomical dimensions, such as annuloplasty. 3A-D illustrate such an application in which the tissue 10 represents tissue of the annulus of a native heart valve, such as the mitral or tricuspid valve, and the implant 110 is an annuloplasty structure including a tether 112 (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.) and multiple anchors 120.

[0656] 3A-D show a system 100 including an implant 110 and a delivery tool 150 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. Tool 150 includes a flexible anchor driver 160 configured to reversibly engage with a driver interface 182 of an anchor 120. Through this engagement, driver 160 is configured to drive (e.g., thread) tissue engaging element 130 into tissue 10. For some applications, tool 150 further includes a flexible tube 152 (e.g., a transluminal catheter) by which each anchor 120 engaged with driver 160 can be advanced into tissue where the anchor is to be secured.

[0657] In FIG. 3A, three anchors 120 are already secured to tissue 10, with a fourth anchor located within the distal portion of tube 152. Sliding of tether 112 proximally past the first of the anchors to be secured is inhibited by the presence of stopper 114a engaged with the tether. Each of these anchors has been advanced through tube 152 to a delivery state in which tether 112 extends through opening 146 of eyelet 140 while generally parallel to axis ax1. This is illustrated by insets A and B.

[0658] After a given anchor 120 is anchored in tissue 10, when a subsequent anchor is anchored in the same tissue, tether 112 is oriented perpendicular to the given anchor, e.g., parallel to the tissue. Eyelet 140 rotates in response, allowing tether 112 to still take a clear, straight path along the now-rotating sliding axis ax3 and through eyelet opening 146. This is illustrated in inset C.

[0659] After the desired number of anchors 120 are secured (e.g., as shown in FIG. 3C), adjustment tool 190 is introduced (e.g., over and along the proximal portion of tether 112) and used to facilitate tensioning of the tether. A reference force is provided by the tool and / or by tube 152 (e.g., relative to the last anchor to be secured) while tether 112 is withdrawn proximally. The distal end of tether 112 cannot slide out of (e.g., is secured to) the first anchor, e.g., due to the presence of stopper 114a. Thus, tension in tether 112 draws anchors 120 closer together, thereby contracting the tissue to which they are secured (FIGS. 3C-D). This is facilitated by eyelet 140 providing smooth sliding of tether 112 through opening 146 while the tether is perpendicular to the anchor, as described above. Tension is locked into the implant 110, such as by securing a second stopper 114b to the tether 112 proximal to the last anchor. The excess tether 112 can then be cut and removed from the subject. Figure 3D shows the state of the implant 110 after stopper 114b has been secured to the tether 112, the excess tether has been cut, and the implant 110 has been pulled out of the subject by adjustment tool 190, as shown.

[0660] In some applications, stopper 114b may represent (or be substituted for), mutatis mutandis, a tether handling device, such as tether handling device 410 or 460 described below, and / or a contraction member cover device, such as those described with reference to Figures 35A-46B of WO 2021 / 084407 by Kasher et al., incorporated herein by reference.

[0661] For simplicity, Figures 3A, 3C, and 3D show the implant 110 positioned in a straight configuration. However, in annuloplasty, the implant 110 is often implanted in a curved shape (or a complete ring) around the valve annulus, so that contraction reduces the size of the annulus and improves leaflet coaptation. Figures 4A and 4B show the implant 110 implanted partway around the annulus of the mitral valve 12 (Figure 4A) and the tricuspid valve 14 (Figure 4B), respectively.

[0662] As described above, in some applications, the eyelet 140 is mounted so as to be rotatable about the axis ax1. This therefore provides independence between the rotational position of the eyelet and the rotational position of the tissue-engaging element 130. In applications where the tissue-engaging element 130 is helical, this independence is hypothesized to advantageously allow the tissue-engaging element to be threaded into the tissue to the extent necessary for optimal fixation without requiring the anchor to terminate in a specific rotational orientation. Regardless of the type of tissue-engaging element 130 used, this independence is hypothesized to allow the eyelet 140 (and tether 112) to be optimally positioned relative to the axis ax1 of each anchor 120 for a given application. For example, in applications where the implant 110 is used for annuloplasty, the anchors 120 are often secured to a curve around the valve annulus, and the eyelet 140 and tether 112 are often positioned on the inside of the curve relative to the axis ax1.

[0663] In some applications (e.g., as shown below with reference to FIGS. 29A-30B ), driver head 164 has an introduction state and a locked state, anchor head 180 may be shaped such that interface 182 defines a proximal opening accessible by the driver head while the driver head is in the introduction state (e.g., not the locked state), and anchor driver 160 may be configured to lock driver head 164 to interface 182 by laterally moving a portion of the driver head to transition the driver head to the locked state.

[0664] For some applications, as shown, tube 152 is shaped to control the rotational position of eyelet 140 relative to axis ax1 and / or tissue engaging element 130 during delivery and fixation. In some such applications, tube 152 defines an internal channel (e.g., lumen) 154 that defines a main channel region 154a and a minor channel region 154b ( FIG. 3B ). Main channel region 154a has a larger cross-sectional area than minor channel region 154b. Anchor 120 is slidable through channel 154, with tissue engaging element 130 sliding (typically snugly) through main channel region 154a and eyelet 140 sliding (typically snugly) along tether 112 through minor channel region 154b. Rotational control of tube 152 thereby controls the position of eyelet 140, and therefore tether 112, about axis ax1 of each anchor. The driver interface 182 and tissue engaging element 130 are rotatable within the tube 152 (e.g., while threading the tissue engaging element into tissue 10), yet the collar 184 and eyelet 140 (and thereby the tether 112) are still retained, thereby reducing the likelihood of the tether becoming entangled around the anchor. In some applications, and as shown, the channel 154 has an orthogonal cross-section that is keyhole-shaped.

[0665] To secure the anchor 120, the anchor is advanced from the distal end of the tube 152 while the driver 160 rotates the driver interface 182 (and thus the tissue engaging element 130) relative to the tube, and while the minor channel region 154b often prevents rotation of the collar 184 relative to the tube. In some applications, it is advantageous for the distal end of the tube to be placed (or pressed) against the tissue 10 during anchoring, as shown, for example, in FIG. 3A . In some applications, the tube 152 defines a lateral slit 156 extending proximally from the distal end of the tube such that the slit is contiguous with the distal opening of the tube. In some applications, the slit 156 is adjacent (e.g., laterally outward from) the minor channel region 154b, allowing the tether 112, but not the anchor 120, to exit the tube 152 laterally from the distal end of the tube. This is believed to facilitate implantation of an implant, such as implant 110, that includes multiple anchors coupled to (e.g., threaded through) a tether (e.g., a line, wire, ribbon, rope, braid, contraction member, suture, etc.), for example, by allowing tether 112 to exit tube 152 without pinching against tissue and / or by reducing the likelihood of inadvertently trapping the tether while securing the anchor.

[0666] In some applications, the narrowest portion of aperture 146 is no wider than twice the thickness of tether 112. For example, the narrowest portion of aperture 146 can be no wider than 50% of the thickness of tether 112, e.g., no wider than 20%, e.g., no wider than 5%.

[0667] Note that anchor 120 remains threaded through tether 112 during and after implantation despite changes in the orientation of the tether relative to the anchor during implantation, which is hypothesized to advantageously reduce the likelihood of the anchor embolizing.

[0668] For some applications, implant 110 often includes one or more spacers or dividers 170 threaded on tether 112, with each spacer disposed between two of anchors 120. Each spacer 170 may be tubular, defining two ends and a lumen therebetween. Tether 112 passes through the lumen and the end of the spacer facing planar surface 148 of anchors 120 between which the spacer is disposed.

[0669] Spacer 170 is flexible in deflection, and in some applications, is elastically flexible, meaning that it can deflect laterally upon application of a force and elastically return toward its rest shape upon removal of the force. In some applications, and as shown, the rest shape is that of an open cylinder. Despite being elastically flexible in deflection, spacer 170 resists axial compression. In some applications, spacer 170 is generally not axially compressible, meaning that in its rest shape, the spacer is not axially compressible by forces having the magnitude that would be experienced by the spacer in its normal use.

[0670] For some applications, the spacer 170 includes a wire shaped as a helical coil (e.g., defined by ). In some such applications, the spacer 170 is initially axially compressible (though typically provides some resistance to axial compression) and then generally not further axially compressible once compressed to the extent that adjacent turns of the coil contact each other. In some applications, in the coil's rest state, the coil pitch is small enough that the coil appears substantially closed, e.g., tubular. For example, the coil pitch can be less than twice the wire thickness (e.g., 1.4-2 times the wire thickness, such as 1.6-1.8 times the wire thickness, such as 1.7 times the wire thickness). In some applications, in the coil's rest state, the coil is a closed coil, i.e., each turn of the coil contacts its adjacent coil.

[0671] For some applications, slit 156 is sized to allow spacer 170, threaded on tether 112, to exit tube 152 laterally proximally from the distal end of the tube.

[0672] Spacer 170 is configured to limit the proximity between anchors 120 between which it is disposed, i.e., as tether 112 is under tension and anchors 120 move closer together, the anchors between which spacer 170 is disposed are prevented from moving further closer together once they reach a limit defined by the length of the spacer.

[0673] 3D inset, the end of spacer 170 is sized to be flush and abut flat surface 148 of anchor 120. This is hypothesized to result in a stable configuration when contraction of tether 112 forces flat surface 148 against the end of spacer 170. For example, this flat, flush interface is hypothesized to provide tether 112 with a continuous lumen through spacer 170 and eyelet 140, while reducing the likelihood of tension on the tether causing lateral displacement of the spacer relative to adjacent eyelets.

[0674] In some applications, anchor 120 and / or implant 110 can be used in combination with devices, systems, and / or implants using the methods / techniques described in one or more of the following references, mutatis mutandis, each of which is incorporated herein by reference in its entirety for all purposes: U.S. Patent Application No. 14 / 437,373 (now U.S. Patent No. 9,949,828) by Sheps et al., filed April 21, 2015, published as U.S. Patent Application No. 2015 / 0272734. U.S. Patent Application No. 15 / 782,687 (now U.S. Patent No. 10,765,514) by Iflah et al., filed October 12, 2017, published as U.S. Patent Application No. 2018 / 0049875. U.S. Patent Application No. 16 / 534,875 (now U.S. Patent No. 11,123,191) by Brauon et al., filed August 7, 2019, published as U.S. Patent Application No. 2020 / 0015971. International Patent Application PCT / IL2019 / 050777 by Brauon et al., published as International Patent Application No. 2020 / 012481. · International Patent Application PCT / IB2020 / 060044 by Kasher et al., published as International Patent Application No. 2021 / 084407. · U.S. Patent Application No. 17 / 145,258 by Kasher et al., filed January 8, 2021, published as U.S. Patent Application No. 2021 / 0145584. · International Patent Application No. PCT / IB2021 / 058665 by Halabi et al., filed September 23, 2021.

[0675] Additionally, the techniques, methods, steps, etc. described or suggested by the references incorporated herein that may be used with the applications herein may be performed on living animals or on non-living simulations such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0676] 5A-D and 6A-C, which are schematic illustrations of anchor 220 for use in target tissue (e.g., soft tissue) according to some applications. FIG. 5A shows a cutaway view, FIG. 5B shows a cross-sectional view, FIG. 5C shows an exploded view, and FIG. 5D shows a projection. In some applications, anchor 220 may be used in place of other anchors described herein, with appropriate modifications. For example, in some applications, anchor 220 may be used in place of anchor 120 of implant 110 described hereinabove; for simplicity, anchor 220 is not described as having an eyelet, although an eyelet, such as eyelet 140, may be added to anchor 220 for use with implant 110.

[0677] 7A-C and 8A-C, which are schematic illustrations of anchors 220′ and 220″, which are variations of anchor 220, according to some applications. Mutual mutatis mutandis, these variations can be used as described for anchor 220 and, except where noted, have the same components and functions as anchor 220.

[0678] Anchor 220 includes a housing 222 and a tissue-engaging element 230. Housing 222 has a tissue-facing side 224 that defines an opening 225 that faces the tissue from the inside of the housing to the outside of the housing. For some applications, tissue-engaging element 230 is shaped to define a helix having multiple turns about axis ax4 (e.g., a central longitudinal axis of anchor 220) and having a distal tip 238 that can be sharp.

[0679] Anchor 220 can provide tissue-engaging element 230 disposed within housing 222 and positioned such that rotation of the tissue-engaging element about axis ax4 spirals distally out of opening 225. Tissue-engaging element 230 is configured to thread into tissue to secure housing 222 to the tissue, with tissue-facing side 224 serving as the head of anchor 220. Figures 6A-C show examples of securement of anchor 220 to tissue 10, according to some applications. It is hypothesized that anchor 220 advantageously conceals tissue-engaging element 230 until the anchor is secured, thereby reducing the likelihood of inadvertently and / or prematurely engaging tissue or a device, for example, during advancement and / or positioning of the anchor.

[0680] In some applications, and as shown, tissue-engaging element 230 is axially compressed within housing 222. In such applications, as the helix is ​​delivered through tissue-facing opening 225, progressively proximal portions of the helix automatically (e.g., elastically) axially expand as they are disposed outside housing 222 ( FIGS. 6A-C ). For example, tissue-engaging element 230 is a compression spring. In some such applications, the portion of the helix disposed outside the housing has an expanded pitch that is at least twice as large as the original compressed pitch of the helix when the helix is ​​fully disposed within the housing. It is hypothesized that this configuration of tissue-engaging element 230 advantageously (i) facilitates storing a greater number of helical turns within a given size of housing 222 than would be possible with a rigid tissue-engaging element, and / or (ii) facilitates exit of distal tip 238 from tissue-facing opening 225 upon rotation of the tissue-engaging element.

[0681] As shown in FIG. 6A , the tissue-facing side 224 can be positioned against the tissue before rotation of the tissue-engaging element 230. In some applications, this positioning facilitates threading of the tissue-engaging element 230 into the tissue due to contact between the tissue and the housing 222 inhibiting rotation relative to the tissue, such that rotation of the tissue-engaging element (e.g., relative to the tissue) is also rotation relative to the housing. Threading the tissue-engaging element 230 into the tissue further presses the tissue-facing side 224 against the tissue. An alternative anchor 220′ has a housing 222′ defining a grip 226 on the tissue-facing side 224′ of the housing, which, when pressed against the tissue, further inhibits rotation of the housing relative to the tissue, thereby facilitating threading of the tissue-engaging element 230 into the tissue.

[0682] The anchor 220 includes a driver interface 228 on a proximal portion of the tissue-engaging element 230. By interfacing with the interface 228, the anchor driver 210 (either the same as or different from the driver 160) can rotate the tissue-engaging element 230 and drive the tissue-engaging element into tissue. In some applications, and as shown, the interface 228 is rotationally locked with the helix of the tissue-engaging element 230. In the example shown, the interface 228 includes a bar that can be transverse to the axis ax4 and defined by the proximal portion of the tissue-engaging element 230. For example, a single piece of stock (e.g., a wire) can be shaped to define both the helix of the tissue-engaging element 230 and the interface 228. However, other configurations of the driver and driver interface can be used, including those described elsewhere herein.

[0683] Housing 222, in some applications, may have a driver side 234 that defines a driver opening 236 from the inside to the outside of the housing, thereby providing access to interface 228. In some applications, and as shown, driver opening 236 is located in front of interface 228 and / or the interface is visible through the driver opening. In applications where interface 228 includes a bar, the bar may be parallel to driver opening 236 (i.e., relative to the plane in which the opening lies).

[0684] In some applications, and as shown, driver side 234 is opposite (eg, parallel to) tissue-facing side 224.

[0685] At a distal portion of anchor driver 210, the driver has a driver head 214 configured to engage interface 228 and apply a torque to the interface to rotate the tissue engaging element, for example, as described for anchor 120, mutatis mutandis. For some applications, driver head 214 is dimensioned to access interface 228 from outer housing 222 through driver opening 236.

[0686] As shown, anchor 220 may be configured such that threading tissue-engaging element 230 into tissue causes interface 228 and / or the proximal portion of the tissue-engaging element to move toward tissue-facing side 224. As shown, this may ultimately result in pinching of tissue-facing side 224 between the tissue and the interface / proximal portion of the tissue-engaging element. In some applications, and as shown, this movement of interface 228 and / or the proximal portion of the tissue-engaging element is also movement away from driver side 234. However, in a modified anchor 220'', as shown in FIGS. 8A-C , anchor housing 222'' is resilient and configured to automatically contract as the helix is ​​fed distally from tissue-facing opening 225 such that driver side 234 follows the interface / proximal portion of the tissue-engaging element toward tissue-facing side 224.

[0687] 9A-C and 10A-C, which are schematic illustrations of tissue anchor 240, according to some applications. In some applications, anchor 240 may be used as a component of an implant, such as an implant including multiple anchors connected by a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.). For example, anchor 240 may be used in implant 110 in place of anchor 120, with appropriate modifications. For this reason, anchor 240 is shown as including eyelet 242, which in some applications may be similar (or identical) to eyelet 140 described above or to the eyelet described in WO 2021 / 084407 by Kasher et al., incorporated herein by reference, with appropriate modifications. In some applications, anchor 240 may be used for other purposes and may not include an eyelet.

[0688] Anchor 240 includes a tissue-engaging element 241 having a sharp distal tip 244 and a hollow body 246 proximal to tip 244. Hollow body 246 is shaped to define a chamber 254 and a lateral wall 256 about the chamber. A central longitudinal axis ax5 of anchor 240 generally passes through chamber 254 and tip 244. One or more (e.g., two) ports 258 are defined in lateral wall 256.

[0689] Anchor 240 (e.g., its tissue engaging element 241) further includes a spring 260, which often includes an elongated element 261 having two ends 262 and defining a loop 264 therebetween. Loop 264 may be disposed within chamber 254. In some applications, spring 260 is a helical torsion spring. In some applications, and as shown, end 262 is sharpened, for example, to facilitate puncturing tissue 10.

[0690] In a first state of anchor 240, spring 260 is constrained (e.g., inwardly) by lateral walls 256, as shown, for example, in FIGS. 9A, 9C, 10A, and 10B. As described in more detail below, anchor 240 is transitionable from the first state to a second state in which spring 260 (e.g., its elongated elements 261) is under less strain and ends 262 are positioned further apart from one another (e.g., as shown in FIG. 10C) relative to the first state. In the second state, each of ends 262 protrudes laterally from hollow body 246 through a respective port 258. Often, in the first state, the ends do not protrude laterally from the hollow body.

[0691] For some applications, anchor 240 has an anchor head 250 that can include a driver interface 252 configured to be reversibly engaged by an anchor driver 280. For some applications, driver 280 can be identical to driver 160 described above herein, mutatis mutandis.

[0692] 10A-C illustrate a typical use of anchor 240. Anchor 240 may be delivered into a subject while the anchor is in its first state (FIG. 10A) and advanced distally into tissue 10, often with tip 244 piercing the tissue (FIG. 10B). This advancement may be primarily axial, for example, with little or no rotation. Once hollow body 246 (or at least port 258) is positioned within tissue 10, the anchor is transitioned to its second state (FIG. 10C) such that end 262 protrudes laterally from hollow body 246 through port 258 and into tissue 10, thereby securing the anchor within the tissue.

[0693] Due to the nature of spring 260, in some applications, loop 264 becomes smaller as anchor 240 transitions from its first state to its second state.

[0694] In some applications, when anchor 240 transitions from its first state to its second state, loop 264 moves axially (e.g., distally) within chamber 254, as shown, for example, by the transition from FIG. 10B to FIG. 10C.

[0695] In some applications, and as shown, in the first state, end 262 is disposed distally from loop 264. Optionally, end 262 can be disposed proximally from loop 264 in the first state. In some applications, and as shown, in the second state, end 262 is disposed proximally from loop 264 (but outside of body 246). Optionally, end 262 can be disposed distally from loop 264 in the second state.

[0696] In some applications, and as shown, spring 260 is biased to automatically transition the anchor to the second state. In such applications, retainer 282 can be used to hold anchor 240 in its first state (e.g., for transluminal delivery and / or insertion into tissue). Retainer 282 can be coupled to spring 260 in a manner that inhibits movement of spring 260. In the example shown, to transition anchor 240 from its first state to its second state, loop 264 moves distally within chamber 254. Retainer 282 holds anchor 240 in its first state by preventing spring 260 (e.g., its loop 264) from moving distally within the chamber, thereby preventing end 262 from sliding out of port 258.

[0697] For some applications, at least one window 266 is defined in lateral wall 256, and retainer 282 is configured to hold anchor 240 in the first state by extending through the window and into loop 264. For example, and as shown, two windows 266 may be defined in lateral wall 256, and a retainer can extend through one of the windows, through the loop, and out the other of the windows. In some such applications, the two windows may be opposite each other and rotationally offset from the two ports 258. For example, port axis ax6 passing through port 258 may be orthogonal to window axis ax7 passing through window 266. Axis ax6 and / or axis ax7 may intersect axis ax5. For some applications, and as shown, window 266 is axially offset from port 258.

[0698] 11A-D and 12A-E, which are schematic diagrams of systems 300 and 320, respectively, according to some applications. System 300 includes tissue anchor 302 and tool 310, and system 320 includes tissue anchor 322 and tool 330. In some applications, anchor 302 and / or anchor 322 can each be used as a component of an implant, such as an implant including multiple anchors connected by a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.). For example, anchor 302 and / or anchor 322 can be used in implant 110 instead of anchor 120, with appropriate modifications. In such a case, anchor 302 and / or anchor 322 (e.g., its head) can include an eyelet. Anchor 302 is shown with head 303 including eyelet 304, and anchor 322 is shown without the eyelet. For some applications, anchor 302 and / or anchor 322 may have eyelets similar to (or identical to) eyelets 140 described above or those described in WO 2021 / 084407 by Kasher et al., incorporated herein by reference, mutatis mutandis. Optionally, anchor 240 may be used for other purposes and may not include an eyelet, as shown.

[0699] Tool 310 is advanceable to the heart and includes a tube 312 and a driver 314 extending through at least a portion of the tube. Driver 314 reversibly engages head 303 of anchor 302. For simplicity, this engagement is not described in detail herein, but in some applications may be as described for one or more of the other anchors and drivers described herein. Tube 312 has a distal end defining opening 316. Anchor 302 includes tissue-engaging element 306 and is configured to be secured to tissue 10 by the tissue-engaging element being driven into the tissue.

[0700] Tool 330 is advanceable into the heart and includes a tube 332 and a driver 334. Driver 334 reversibly engages head 323 of anchor 322. For brevity, this engagement is not described in detail herein, but in some applications may be as described for one or more of the other anchors and drivers described herein. Tube 332 has a distal end defining an opening 336. Anchor 322 includes tissue-engaging element 326 and is configured to be secured to tissue 10 by the tissue-engaging element being driven into the tissue.

[0701] For each of systems 300 and 320, the anchor is at least partially positioned within the vessel during transluminal advancement and / or immediately prior to securing the anchor. As shown, system 300 anchor 302 may be fully positioned within vessel 312, while for system 320, at least the distal tip of anchor 322 (e.g., of tissue engaging element 326) may be exposed from opening 336.

[0702] Each of tools 310 and 330 is configured to penetrate the distal end of its respective tube into tissue 10 such that the opening is immersed in the tissue while the respective anchor remains at least partially disposed within the respective tube (FIGS. 11C and 12C).

[0703] Each of drivers 314 and 334 extends through at least a portion of its respective tube, with the distal end of the driver reversibly engaged with a respective anchor within the tube, and is configured to drive the tissue engaging element of the respective anchor from the opening in the respective tube and into tissue 10 while the opening remains disposed within the tissue.

[0704] In some applications, and as shown, the distal ends of tubes 312 and 332 are tapered and / or sharpened.

[0705] For some applications, for each of systems 300 and 320, at least a portion of the tissue-engaging element is constrained by the tube (e.g., during transluminal advancement and / or immediately prior to securing the anchor) and is configured to automatically change shape within the tissue upon exiting the opening. For example, tissue-engaging element 306 of anchor 302 includes one or more tines 308 that facilitate automatic deflection and / or bending (e.g., laterally) upon exiting opening 316, and tissue-engaging element 326 of anchor 322 includes one or more flanges that automatically deflect, expand, and / or bend (e.g., laterally) upon exiting opening 336.

[0706] In some applications, the tines 308 are metallic and include a superelastic and / or shape memory material, such as, for example, Nitinol. In some applications, the flange 328 includes a sheet and a self-expanding frame that supports the sheet. In some applications, the flange 328 (e.g., the sheet) includes a polymer.

[0707] In some applications, and as shown (e.g., FIGS. 11A-B), tube 312 defines channel 313 having central channel region 313a and lateral channel regions 313b to accommodate anchor 302, with the anchor's head (in the illustrated example, the anchor's head includes eyelet 304) disposed within the central channel region and each of tines 308 disposed in a respective one of the lateral channel regions such that the anchor is axially slidable but not rotational within the channel. This is posited to provide advantages similar to those described as provided by the channel configuration of system 100, mutatis mutandis.

[0708] In some applications, and as shown, the channel 313 is wider in the central channel region 313a than in the lateral channel regions 313b.

[0709] Opening 316 may be defined by channel 313 that reaches the distal end of tube 312. In some applications, and as shown, the shape of opening 316 (e.g., in conjunction with the tapering of the distal end of tube 312) shapes the distal end of tube 312 to resemble a beak.

[0710] For some applications, system 320 is configured such that during transluminal advancement and / or immediately prior to anchoring, distal tip 329 of tissue engaging element 326 of anchor 322 is positioned outside (e.g., distal to) opening 336, and tool 330 penetrates the distal end of tube 332 into tissue 10 such that the opening is immersed in tissue while the distal tip is positioned outside the opening ( FIG. 12C ). In such applications, anchor 322 (e.g., its tissue engaging element 326) is shaped to fit snugly within opening 336 such that the anchor (e.g., its tissue engaging element) blocks the opening while tool 330 penetrates the distal end of tube 332 into tissue 10. This configuration is hypothesized to advantageously facilitate tissue puncture without tissue 10 entering tube 332. For some such applications, and as shown, distal tip 329 and the distal end of tube 332 together define a tapered point, with the distal tip being the distal portion of the tapered point and the distal end of the tube being the proximal portion of the tapered point. This configuration is hypothesized to advantageously facilitate smooth penetration into tissue 10.

[0711] See FIGS. 13-17, which are schematic illustrations of respective tissue anchors according to some applications. In some applications, each of these anchors can be used as a component of an implant, such as an implant including multiple anchors connected by a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.). For example, these anchors can be used in implant 110 instead of anchor 120, with appropriate modifications. Each of these anchors is shown as a simple ring in FIGS. 13-17, but optionally includes an eyelet, which can be similar (or identical) to eyelet 140 described above or to the eyelet described in WO 2021 / 084407 by Kasher et al., incorporated herein by reference for all purposes, with appropriate modifications. Optionally, these anchors can be used for other purposes and may not include an eyelet, as shown.

[0712] 13 shows a tissue anchor 350 including a head 351 and a plurality of tissue-engaging elements 352. The head 351 has a tissue-facing side 353 and an opposing side 354 defining an eyelet 355. The tissue-engaging elements 352 are disposed laterally from the head 351 and each have a sharp tip. In the delivery state of the anchor 350 (left frame), the tissue-engaging elements 352 are configured to be linearly driven into the tissue 10 (middle frame). While the tissue-engaging elements 352 are being positioned within the tissue, transitioning the anchor 350 (e.g., its tissue-engaging elements) toward a grasping state causes the tips to move toward each other and press the tissue-facing side 353 of the head 351 against the tissue (right frame).

[0713] 14-17 each show a respective tissue anchor similar to anchor 350, with additional features on the tissue-facing side of the anchor's head defining a grip. For these tissue anchors, transitioning the anchor to a grasping state forces the grip against the tissue.

[0714] 14 shows a tissue anchor 360 including a head 361 and a tissue-engaging element 362. The head 361 has a tissue-facing side 363 shaped to define a grip 366 and an opposing side 364 defining an eyelet 365. The tissue-engaging elements 362 are disposed laterally from the head 361 and each have a sharp tip. In the delivery state of the anchor 360 (left frame), the tissue-engaging elements 362 are configured to be driven linearly into the tissue 10, e.g., such that the grip 366 contacts the tissue (middle frame). Transitioning the anchor 360 (e.g., its tissue-engaging element) toward the grasping state while the tissue-engaging element 362 is positioned within the tissue causes the tips to move toward each other and press the grip 366 against the tissue (right frame).

[0715] 15 shows a tissue anchor 370 including a head 371 and a tissue-engaging element 372. The head 371 has a tissue-facing side 373 shaped to define a grip 376 and an opposing side 374 defining an eyelet 375. The tissue-engaging elements 372 are disposed laterally from the head 371 and each have a sharp tip. In the delivery state of the anchor 370 (left frame), the tissue-engaging elements 372 are configured to be driven linearly into the tissue 10, e.g., such that the grip 376 contacts the tissue (middle frame). While the tissue-engaging elements 372 are positioned within the tissue, transitioning the anchor 370 (e.g., its tissue-engaging element) toward the grasping state causes the tips to move toward each other and press the grip 376 against the tissue (right frame).

[0716] 16 shows a tissue anchor 380 including a head 381 and a tissue-engaging element 382. The head 381 has a tissue-facing side 383 shaped to define a grip 386 and an opposing side 384 defining an eyelet 385. The tissue-engaging elements 382 are disposed laterally from the head 381 and each have a sharp tip. In the delivery state of the anchor 380 (left frame), the tissue-engaging elements 382 are configured to be driven linearly into the tissue 10, e.g., such that the grip 386 contacts the tissue (middle frame). Transitioning the anchor 380 (e.g., its tissue-engaging element) toward the grasping state while the tissue-engaging element 382 is positioned within the tissue causes the tips to move toward each other and press the grip 386 against the tissue (right frame).

[0717] 17 shows a tissue anchor 390 including a head 391 and a tissue-engaging element 392. The head 391 has a tissue-facing side 393 shaped to define a grip 396 and an opposing side 394 defining an eyelet 395. The tissue-engaging elements 392 are disposed laterally from the head 391 and each have a sharp tip. In the delivery state of the anchor 390 (left frame), the tissue-engaging elements 392 are configured to be driven linearly into the tissue 10, e.g., such that the grip 396 contacts the tissue (middle frame). While the tissue-engaging elements 392 are positioned within the tissue, transitioning the anchor 390 (e.g., its tissue-engaging element) toward the grasping state causes the tips to move toward each other and press the grip 396 against the tissue (right frame).

[0718] Referring again to Figures 13-17, in some applications, tissue is forced between multiple tissue engaging elements by transitioning the tissue engaging elements towards the grasping state.

[0719] 13-17. In some applications (e.g., as shown in anchor 380), each of the tissue engaging elements has both a flexible portion and a static portion connecting the flexible portion to the head, the static portion configured to be linearly driven into tissue while the flexible portion and the tissue engaging element are in the delivery state. In such applications, the tissue engaging element may be configured such that as the tissue engaging element transitions toward the grasping state, (i) the static portion remains stationary relative to the head, and (ii) the flexible portion deflects relative to the static portion and relative to the head.

[0720] Referring again to Figures 13-17, in some applications (e.g., as shown in anchors 360, 370, and 380), each of the tissue-engaging elements has an inner side and a lateral side, the inner side being closer to the other tissue-engaging elements (at least in the delivery state) than the lateral side, and each of the tissue-engaging elements is shaped to define a barb (367, 377, 387) on the lateral side. In some such applications (e.g., as shown in anchor 360), in the delivery state, the barb is shielded (e.g., by another portion of the tissue-engaging element) and in the grasping state, the barb is exposed. Furthermore, in some such applications where the tissue-engaging element has a static portion and a flexible portion, the barb may be defined by the static portion. In other such applications, the barb may be defined by the flexible portion.

[0721] See FIGS. 18A-C, 19A-D, 20A-C, and 21A-E, which are schematic illustrations of tether handling systems 400 and 450, each including a respective tether handling device 410, 460, according to several applications. Tethers are used in a variety of medical procedures, including as components of sutures and / or implants. It is generally necessary to lock or secure such tethers at specific points in the procedure. In the above example of tether 112 of implant 110, a stopper (e.g., stopper 114b) is used for this purpose. Each of tether handling devices 410 and 460 can be used to secure a tether, such as tether 112, for example, in place of stopper 114b and / or for similar purposes in the implants described in WO 2021 / 084407 by Kasher et al., incorporated herein by reference for all purposes.

[0722] Additionally, each of tether handling devices 410 and 460 may also be useful in applications where the tether is cut (e.g., as described in system 100) by being configured to manage residual pieces of the tether, for example, by moving, confining, covering, and / or shielding the tether. This is hypothesized to be particularly advantageous in applications where the cut end of the tether is hard and / or sharp, to reduce the likelihood of the hard and / or sharp cut end damaging adjacent tissue.

[0723] In some applications, for system 100 described above (and other similar systems), this locking and handling of tether 112 occurs after the final anchor of the implant is implanted. In Figures 19A-D and 21A-E, this final anchor is represented by a block designated by reference numeral 120f. The block may generally represent the head of the final anchor or a component of the head, such as an eyelet.

[0724] 18A-C and 19A-D show a system 400 including a tether management device 410, for example, for use in system 100 in place of stopper 114b. FIG. 18A shows an isometric view, FIG. 18B shows an exploded view, and FIG. 18C shows a cross section.

[0725] Device 410 includes a housing 412 shaped to define a passageway 414 therethrough. Device 410 further includes a clamp 416 coupled to housing 412 and biased to clamp onto tether 112 within passageway 414 in a manner that inhibits sliding of the housing (and locking device as a whole) relative to the tether.

[0726] For some applications, device 410 further includes an arm 420 extending proximally from housing 412. Arm 420 may include a conduit 422 shaped to proximally receive a portion of the tether from the housing. Conduit 422 may be circumferentially closed or, as shown, may have open lateral sides. Arm 420 also includes a lever 424 that couples conduit 422 to housing 412 and is biased to place the conduit in an offset position relative to passageway 414. An example of this offset position is shown in FIG. 19D, described below.

[0727] System 400 further includes a tool 430 that includes a tube 432. Figures 18A and 19A show a delivery state of system 400, with tool 430 coupled to apparatus 410. In the delivery state, tube 432 is (i) positioned within passageway 414 in a manner that inhibits clamp 416 from tightening, and (ii) positioned within conduit 422 in a manner that constrains the conduit in an in-line position with respect to the passageway (i.e., despite the bias of lever 424). For example, and as shown, tube 432 can extend distally through conduit 422 and into passageway 414.

[0728] It should be noted that in this context, the term "in-line" (including the specification and claims) means that the tether 112 may extend between the passageway 414 and the conduit 422 while remaining substantially straight.

[0729] After final anchor 120f is secured, tether 112 continues to extend proximally from the final anchor. In the delivery state, device 410 is slid distally transluminally over and along tether 112 toward anchor 120f, with the tether extending through passage 414 (FIG. 19A). In some applications, after final anchor 120f is implanted, tether 112 is threaded through passage 414 and the anchor driver used to secure it to the final anchor is removed. In some applications, tool 430 includes an advancement member (e.g., pusher) 438 that reversibly engages device 410 (e.g., its housing 412) and is used to transluminally slide device 410 over and along tether 112 toward anchor 120f. Tube 432 can be positioned laterally from advancement member 438 or through the advancement member (as shown).

[0730] In some applications, once device 410 is positioned on anchor 120f, tension can be applied to tether 112 by pulling on the tether (e.g., from outside the subject) to contract the tissue to which implant 110 is secured, while device 410 provides a reference force against anchor 120f (e.g., by advancement member 438 pushing device 410 against anchor 120f). The tension is then locked into implant 110 by securing device 410 to tether 112 by withdrawing tube 432 from passageway 414 until it no longer inhibits clamp 416, thereby automatically securing the clamp onto the tether (FIG. 19B).

[0731] Once tube 432 is sufficiently retracted (e.g., out of conduit 422), often to a position proximal to conduit 422, tether 112 is severed (FIG. 19C). The resulting release of arm 420 triggers lever 424 to move conduit 422 to an offset position relative to passageway 414 (FIGS. 19C-D). Note that in this context, the term "offset" (including in the specification and claims) means that tether 112 must bend in order for it to extend between passageway 414 and conduit 422. In some applications, and as shown, lever 424 is biased to position conduit 422 against the proximal side of housing 412.

[0732] Cutting tether 112 can be performed using cutter 434, which can be a component of tool 430. Cutter 434 is advanceable over and along tether 112 and axially movable relative to (e.g., advanceable over and along) tube 432, e.g., the tube can slide within the cutter. Although advancement member 438 is shown as being detached before advancement of cutter 434 (or at least before severing tether 112), in some applications, cutter 434 can be advanced through advancement member 438.

[0733] For some applications, system 400 is configured to have an intermediate state in which tube 432 is retracted from passageway 414 but not from conduit 422. For some such applications, in the intermediate state, a distal portion of tube 432 remains disposed within housing 412, e.g., proximal from passageway 414 and / or clamp 416. In the intermediate state, tube 432 no longer obstructs clamp 416, causing the clamp to automatically clamp onto tether 112. FIG. 19B shows an example of such an intermediate state.

[0734] In some applications, tether 112 has sufficient tensile strength against the bias of lever 424 that tension on tether 112 proximally from clamp 416 may prevent the lever from moving conduit 422 to the offset position, even in the absence of tube 432. Nevertheless, this tension is eliminated upon severing of tether 112, triggering lever 424 to move conduit 422 to the offset position as described above.

[0735] Cutting tether 112 can often leave behind a residual piece of tether. For example, and as shown, cutting tether 112 proximally from conduit 422 can leave behind a residual piece of tether protruding proximally from the conduit. Arm 420 is configured such that movement of conduit 422 to the offset position moves the residual piece of tether 112 toward housing 412, e.g., trapping the residual piece closer to the housing. In some applications, the resulting curved shape of the residual piece of tether 112 means that the residual piece is drawn into conduit 422 such that the end of the tether is within the conduit.

[0736] 20A-C and 21A-E show system 450 including tether handling device 460, for use in system 100, e.g., in place of stopper 114b. System 450 can be used for purposes similar to system 400, with appropriate modifications. FIG. 20A shows a perspective view of device 460, FIG. 20B shows an exploded view, and FIG. 20C shows a cross section. System 450 often further includes tool 480, described below.

[0737] Apparatus 460 includes clamp 462, which includes chuck 464 and spring 472. Chuck 464 has a longitudinal axis ax8 and includes sleeve 466 and collet 470. Sleeve 466 is shown as including two separate subcomponents secured together. These subcomponents are labeled 466a and 466b singly in FIG. 20B . In some applications, the entire sleeve 466 is fabricated from a single, integral member, e.g., a single piece of stock. Collet 470 is shown as including two separate subcomponents. However, in some cases, collet 470 may comprise three or more subcomponents. Furthermore, the subcomponents of collet 470 do not have to be discrete; for example, they may be movable (e.g., flexible) parts integrated into a unitary member, e.g., fabricated from a single piece of stock.

[0738] For some applications, sleeve 466 surrounds axis ax8 (e.g., thereby defining axis ax8 as the longitudinal axis of chuck 464) and has a tapered inner surface 468. Collet 470 may be disposed within sleeve 466 and is dimensioned to receive a tether, such as tether 112, therethrough (e.g., dimensioned to define a passage therethrough). Spring 472 axially urges collet 470 against surface 468 such that collet 470 is forced inward by sleeve 466 (e.g., by its surface 468). When tether 112 is present within collet 470, this urging of the collet clamps the collet onto the tether, thereby inhibiting sliding of the tether through the collet in at least one axial direction. This axial direction may be distal (in FIGS. 21A-E , this is to the right relative to collet 470). In many cases, this axial direction is the same axial direction that spring 472 urges collet 470 axially against surface 468 (in Figures 21A-E, this is to the right relative to sleeve 466).

[0739] For some applications, the inner surface of collet 470 is roughened or knurled to facilitate gripping of tether 112 .

[0740] In some applications, and as shown, sleeve 466 and collet 470 are concentric with axis ax8. As shown, spring 472 may also be concentric with axis ax8.

[0741] For some applications, as shown, spring 472 is a compression spring, such as a helical compression spring. For some such applications, as shown, spring 472 surrounds axis ax8, and device 460 is configured such that the tether is threaded over sleeve 466, collet 470, and spring surround the tether.

[0742] In some applications, as shown, sleeve 466 has an opposing surface 469, and spring 472 is maintained under compression between the opposing surface and collet 470 (e.g., in the spring's relaxed state, the spring is longer than the distance between the opposing surface and the collet). That is, in such applications, spring 472 applies an opposing force against surface 469 while urging collet 470 axially against surface 468.

[0743] 21A-E show steps of an exemplary procedure using system 450, according to some applications. Device 460 is threaded onto tether 112 (FIG. 21A). This can be performed after final anchor 120f has been secured to tissue. Tool 480 (e.g., its tubular member 482) is used to push device 460 distally onto and along tether 112 toward final anchor 120f (FIGS. 21B-C). Once device 460 contacts final anchor 120f, tool 480 provides a reference force against the final anchor via device 460, facilitating tensioning of tether 112 as the tether is pulled proximally (FIG. 21C). Once the desired degree of tension (or desired degree of tissue contraction) is achieved, cutter 484 is used to proximally sever tether 112 from clamp 462, and tool 480 is removed from the subject (FIGS. 21D-E). Clamp 462 maintains tension on tether 112 by preventing movement of the tether relative to the clamp. Cutter 484 can be a component of tool 480, for example, disposed within tubular member 482. Cutter 484 can be axially fixedly positioned relative to tubular member 482 (e.g., as shown) or axially movable within the tubular member.

[0744] For some applications, and as shown, clamp 462 is configured to prevent tether 112 from sliding through collet 470 in only a first axial direction and facilitate sliding of the tether through collet 470 in a second, opposite axial direction (to the left in FIGS. 21A-E ). This is hypothesized to advantageously obviate the need for clamp 462 to be actively unlocked and / or locked. For example, and as shown in FIGS. 21B-C , pushing clamp 462 distally along tether 112 moves the tether proximally through the clamp (e.g., through its sleeve 466), causing the tether to push collet 470 axially away from surface 468 (and against spring 472), thereby releasing / reducing the collet's grip on the tether and allowing the tether to slide proximally through the clamp. This extrusion of collet 470 is represented by the small gap between the collet and surface 468 in the inset of FIG. 21C, in which tether 112 has moved proximally relative to clamp 462 (e.g., compared to the inset of FIG. 21A, in which the tether is fixed relative to the clamp).

[0745] As described above, clamp 462 (e.g., its chuck 464) encourages sliding of device 460 along tether 112 in one direction. To facilitate the techniques described above, device 460 may be threaded onto tether 112 in an orientation such that this one direction is distal, i.e., clamp 462 (e.g., the entire device 460) is slidable distally along the tether but prohibited from sliding proximally along the tether. This orientation thereby defines clamp 462 having proximal end 463p and distal end 463d, such that the clamp is slidable distally along tether 112 with the distal end leading the proximal end. Surface 468 often tapers toward distal end 463d.

[0746] Mutually appropriate, cutting tether 112, as described with reference to system 400, can leave, for example, a residual piece of tether protruding proximally from chuck 464. As discussed above, it is assumed that it may be advantageous to displace, contain, cover, and / or shield the residual piece of tether. In some applications, device 460 includes a sheath 474 that is elastically coupled to sleeve 466. In a resting state, sheath 474 extends proximally from sleeve 466 ( FIG. 21A ). The elastic coupling of sheath 474 to sleeve 466 is such that (i) the sheath is distally retractable over the sleeve by application of a distally directed force to the sheath, and (ii) the sheath automatically re-expands proximally in response to removal of the distally directed force. In some applications, the sheath is at least rigid with respect to flexure.

[0747] For some applications, tool 480 is configured to provide this distally directed force, for example, when pushing device 460 distally along tether 112. For example, at least a distal part of tool 480 (e.g., its tubular member 482) can be dimensioned so that pushing of device 460 by the tool contacts sheath 474 in a manner that retracts the sheath distally ( FIGS. 21B-C ). For some such applications, and as shown, sheath 474 is retracted sufficiently that tool 480 (e.g., its tubular member 482) contacts sleeve 466.

[0748] In some applications, and as shown, cutter 484 severs tether 112 while sheath 474 is distally retracted (FIG. 23D). As a result, upon removal of tool 480 (thereby removing the distally directed force that the tool applies to the sheath), the sheath automatically re-expands proximally, trapping the remaining piece of tether (FIG. 23E).

[0749] In some applications, resilient coupling of sheath 474 to sleeve 466 is provided by spring 476; for example, spring 472 is a collet spring and spring 476 is a sheath spring. Spring 476 may be disposed laterally from sleeve 466, e.g., surrounding the sleeve. As shown, spring 476 may be a helical spring. Spring 476 may be a compression spring mounted such that when a distally directed force is applied to sheath 474 and the sheath contracts in response onto sleeve 466, spring 476 is compressed against flange 478 extending laterally from sleeve 466.

[0750] As shown, spring 476 is sufficiently weak (e.g., has a sufficiently low spring constant) relative to spring 472 so that sheath 474 fully retracts (e.g., tool 480 contacts sleeve 466) while pushing device 460 distally along tether 112. Optionally, spring 476 is sufficiently strong (e.g., has a sufficiently high spring constant) relative to spring 472 so that device 460 can be pushed along tether 112 without sheath 474 fully retracting. For example, sheath 474 can further retract when anchor 120f resists further distal advancement of device 460.

[0751] 22A-B, 23A-B, and 24A-D, which are schematic diagrams of various tensioners according to several applications. FIGS. 22A-B show tensioner 500, FIGS. 23A-B show tensioner 530, and FIGS. 24A-D show tensioner 560.

[0752] A tissue adjusting implant (such as implant 110 described above) including a tether (e.g., a line, wire, ribbon, rope, braid, contraction member, suture, etc.) whose tension causes tissue contraction can apply a force to tissue at the site where the tether is secured to the tissue, e.g., the site where the tissue anchor is secured. In some applications, it is hypothesized that it may be advantageous to delay the application of at least a portion of the tension to the tether, e.g., so that post-securation tissue healing and / or growth can enhance the anchoring action, thereby reducing the likelihood of release or another adverse event occurring before (or after) the desired final amount of tether tension and tissue contraction is achieved.

[0753] It should be noted that while tensioners 500, 530, and 560 are described herein for use with implant 110, the scope of the present disclosure includes, mutatis mutandis, the use of these tensioners with other tissue adjusting implants and in other situations. Similarly, it should be noted that while the tensioners are shown as being used with anchor 120, which is a tissue piercing anchor, the tensioners may alternatively or additionally, mutatis mutandis, be used with clips or other types of anchors.

[0754] Each of tensioners 500, 530, and 560 is configured to be coupled to at least one tether (e.g., tether 112) between two anchors (e.g., anchor 120) and includes a spring and a restraint that restrains the spring in an elastically deformed configuration. The restraint is bioabsorbable so that degradation of the restraint releases the spring from the restraint after implantation of the implant in the heart. The spring is configured to automatically move away from the elastically deformed state toward a second shape (e.g., a relaxed or resting shape) upon release from the restraint. The coupling of the spring to the tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the two anchors toward each other via the tether. That is, degradation of the restraint causes the spring to apply tension to the tether, thereby retracting the anchors toward each other. Thus, tensioners 500, 530, and 560 may be considered delayed tensioning devices. In many cases, a constant tension is applied to the tether when the implant is implanted (e.g., during the same procedure), and additional tension is applied by the spring upon degradation of the restraint. Note that the tension on the tether 112 prevents the spring from actually reaching its second shape.

[0755] According to some applications, an implant is provided that includes a first anchor, a second anchor, and at least one tether connecting the first anchor to the second anchor. A tensioner may also be coupled to the at least one tether between the first anchor and the second anchor, and may include a spring and a restraint that restrains the spring in an elastically deformed spring configuration.

[0756] For some applications, the restraint is bioabsorbable such that degradation of the restraint releases the spring from the restraint after implantation of the implant in the heart. For some applications, the spring is configured to automatically move away from the elastically deformed state toward the second shape upon release from the restraint. For some applications, the coupling of the spring to the at least one tether is such that movement of the spring away from the elastically deformed state toward the second shape pulls the first anchor and the second anchor toward each other via the at least one tether.

[0757] For some applications, an implant is provided that includes a tether, an anchor slidably coupled to the tether and configured to secure the tether to cardiac tissue, and a spring and restraint coupled to the tether in a manner that has a resting state and in which movement of the spring toward the resting state tensions the tether.

[0758] For some applications, the restraint is coupled to the spring in a manner that inhibits movement of the spring toward a resting state. For some applications, the restraint includes a material configured to degrade within the heart, and the degradation of the material configured to reduce inhibition of the spring by the restraint.

[0759] 22A-B show an example tensioner in the form of tensioner 500, according to some applications. Tensioner 500 is shown as a component of modified implant 110, assigned reference numeral 110'. Tensioner 500 includes spring 510 and restraint 520. FIG. 22A shows implant 110' immediately after implantation, with spring 510 in its elastically deformed state. FIG. 22B shows implant 110' after disassembly of restraint 520 and movement of spring 510 to a second shape.

[0760] Spring 510 is a shortening spring and can have a cellular structure, i.e., define one or more cells 512. As spring 510 moves from its elastically deformed state toward its second shape (i.e., shortens), cells 512 shrink in a first dimension (horizontal in FIGS. 22A-B ) and expand in a second direction (vertical in FIGS. 22A-B ). In some applications, while in its elastically deformed state, spring 510 is longer in the first dimension than in the second dimension. In some such applications, in its second state, spring 510 is shorter in the first dimension than in the second dimension. Note that spring 510 is (or acts as) an extension spring.

[0761] 22A-B, tether 112 is shown as actually including multiple separate tethers connected to one another via tensioners 500. For each tensioner 500, one of these separate tethers is coupled to a first part 516′ of spring 510, and another of these separate tethers is coupled to a second part 516″ of the spring. The inter-part distance d2 between first part 516′ and second part 516″ is smaller in the second state than in the elastically deformed state. Thus, in some applications, a first tether connects a first anchor to a first part of the spring, and a second tether, separate from the first tether, connects a second anchor to a second part of the spring, such that the first and second tethers connect the first anchor to the second anchor via the spring.

[0762] In some applications, restraint 520 restrains spring 510 by holding portions of the spring together. Note that in this context, the term “together” (including in the specification and claims) means inhibiting portions of the spring from moving apart, including variations in which the portions of the spring are in contact with one another and variations in which they are held together but not in contact with one another. Restraint 520 may be stretch-resistant and may include a tether (e.g., a line, wire, ribbon, rope, braid, contractile member, suture, etc.), a band, or a ring, e.g., an element having tensile strength. In some applications, and as shown, spring 510 may have eyelet 514 or other similar features, such as a notch, through which restraint 520 is coupled to the spring and / or inhibited from moving relative to the spring. For example, and as shown, restraint 520 may thread through eyelet 514. Other eyelets or similar features may be present on parts 516′ and 516″ to facilitate coupling of tether 112 thereto.

[0763] 23A-B show an example tensioner in the form of tensioner 530, according to some applications. Tensioner 530 includes spring 540 and restraint 550. FIG. 23A shows tensioner 530 with spring 540 in its elastically deformed state. FIG. 23B shows tensioner 530 after disassembly of restraint 550 and movement of spring 540 to a second shape.

[0764] Spring 540 is similar to spring 510, but often defines at least two cells 542, such as three or more cells.

[0765] In some applications, restraint 550 restrains spring 540 by holding portions of the spring together. For example, and as shown, restraint 520 may include a tube. However, restraint 550 may optionally include a suture, band, or ring, for example, as described for tensioner 500.

[0766] In Figures 23A-B, tether 112 is shown as actually comprising multiple separate tethers connected to respective portions of spring 540, for example, as described herein above for tensioner 500, mutatis mutandis.

[0767] 24A-B show an example tensioner in the form of tensioner 560, according to some applications. Tensioner 560 includes spring 570 and multiple restraints 580a, 580b, and 580c. FIG. 24A shows tensioner 560 with spring 570 in its elastically deformed state. FIGS. 24B-C show tensioner 560 moving progressively toward its second shape after sequential disassembly of restraints 580a, 580b, and 580c.

[0768] Spring 570 can be an extension spring. For example, and as shown, spring 570 can have a coiled structure, such as a helical coil.

[0769] In some applications, the restraints 580 restrain the spring 570 by holding portions of the spring apart. For example, and as shown, each of the restraints 580 can include one or more spacers or dividers 582. Each spacer 582 can be compression resistant and can hold adjacent portions (e.g., turns) of the spring 570 apart from one another. The restraints 580 are shown as having a comb-like structure, with the spacers 582 connected to one another in series. However, the restraints 580 and / or the spacers 582 can be shaped differently depending on, for example, the shape and type of the spring 570, with appropriate modifications.

[0770] For each of the intentioners 500, 530, and 560, the lifespan of at least one of the tensioner's restraints (depending on the rate of biological absorption / degradation of the restraint) is between 1 day and 2 years (e.g., between 15 days and 2 years, e.g., between 15 days and 1 year, e.g., between 15 days and 6 months, e.g., between 1 month and 3 months, e.g., between 1 month and 2 months) after implantation into the heart of the plant.

[0771] For each of tensioners 500, 530, and 560, the lifespan of at least one of the tensioner restraints can be between 1 day and 2 years (e.g., between 15 days and 2 years, e.g., between 15 days and 1 year, e.g., between 15 days and 6 months, e.g., between 1 month and 3 months, e.g., between 1 month and 2 months) after implantation into the heart of the plant.

[0772] Each of the restraints 580 is configured to reach a threshold amount of degradation after a respective period of time after implantation into the heart, after which the restraint no longer inhibits its respective spring. This is effectively the lifespan of the given restraint. The restraints 580 may be configured to have different lifespans to gradually release the springs 570 (e.g., alternately release different portions of the springs), thereby gradually (e.g., alternately) increasing the tension on the tether over time. That is, at the end of each lifespan, the springs 570 move partway toward a resting state but remain inhibited by the remaining restraints 580. This is shown in FIGS. 24A-D as restraint 580a having the shortest lifespan (whose expiration is depicted in FIG. 24B), restraint 580b having the next shortest lifespan (whose expiration is depicted in FIG. 24C), and restraint 580c having the longest lifespan (whose expiration is depicted in FIG. 24D).

[0773] A similar effect can be achieved, mutatis mutandis, by using multiple tensioners 500 or 530. For example, the restraints of each tensioner 500 or 530 used may have different life spans. Alternatively or additionally, a given tensioner may have multiple restraints, each with a different life span. For example, tensioner 530 may include one restraint 550 per cell 542 of spring 540, or tensioners 500 and 530 may include multiple restraints per cell.

[0774] For a tensioner with multiple restraints, the restraint with the shortest lifespan may be referred to as the first restraint of the tensioner, and the restraint with the longer lifespan may be referred to as the second restraint of the tensioner. In some applications, the second restraint has a lifespan that is at least twice (e.g., at least three times) the lifespan of the first restraint. In some applications, the first restraint has a lifespan that is between 1 and 3 months (e.g., between 1 and 2 months), and the second restraint has a lifespan that is between 3 months and 1 year (e.g., between 3 and 6 months).

[0775] As noted above, each of tensioners 500, 530, and 560 is described as being used with a tether that actually includes multiple separate tethers connected to one another via the tensioners. However, optionally, in some applications, each tensioner can be used with an unbroken, continuous tether. In such applications, the tensioner is coupled to the tether such that movement of the spring away from the elastically deformed state toward the second shape induces a bend in the path taken by the tether. In some such applications, the tether can be threaded partially through the tensioner. It is hypothesized that such a configuration may advantageously facilitate sliding of the tensioner along the tether, for example, during implantation and / or initial contraction of the implant.

[0776] For some applications, one or more of the tensioners described herein are mounted on the head of the tissue anchor.

[0777] 25A-F and 26A-B, which are schematic illustrations of anchor handling assembly 600, according to some applications. Assembly 600 may be used, among other things, to unlock and remove anchor 120 during implantation of implant 110, for example, upon identifying that a given anchor is not optimally secured. Note that while assembly 600 is described as being used with anchor 120 of implant 110, the scope includes, mutatis mutandis, the use of assembly 600 with other anchors.

[0778] Anchor handling assembly 600 includes a sleeve 610 and a tool 620. Sleeve 610 has a distal portion 612 that includes a distal end 614 of the sleeve.

[0779] Figure 25A shows the implant 110 during its implantation, with three anchors 120 anchored in tissue 10. If it is determined that the leftmost anchor (which is the most recently anchored anchor) should be unlocked and removed, the distal portion 612 of the sleeve 610 is transluminally advanced against the anchors and over the anchor head 180 of the anchor (Figures 25B-C). The distal end 614 of the sleeve 610 can be sized to fit snugly over the anchor head 180.

[0780] Tool 620 includes a flexible shaft 622 and a tool head 624 coupled to the distal end of the shaft and including jaws 626. Jaws 626 are biased to assume an open state and are reversibly compressible to a closed state.

[0781] While distal end 614 remains disposed over anchor head 180, tool head 624 is advanced distally through sleeve 610 to distal portion 612 (FIG. 25D). Jaws 626 are sized relative to the interior dimensions of distal portion 612 of sleeve 610 such that placement of tool head 624 in the distal portion of the sleeve forces the jaws closed. While jaws 626 remain closed, they are locked to interface 182 (e.g., its bar 183), e.g., by further advancing tool head 624 distally, thereby pressing tool head 624 against anchor head 180 (FIG. 25E), e.g., so that the interface (e.g., its bar 183) is received within the gap between the jaws.

[0782] For some applications, the jaws 626 and the interface 182 are configured to define a snap fit, and the assembly 600 (e.g., its tool 620) is configured to lock the jaws to the interface while in the closed state by snapping the jaws to the interface.

[0783] For some applications, assembly 600 is configured to resist jaws 626 from unlocking from interface 182 while tool head 624 is disposed in distal portion 612, e.g., so that the pulling force required to remove the driver head from the interface is greater than the pushing force required to lock the jaws to the interface (e.g., so that the jaws can unlock from the interface). That is, while remaining in a closed state, the jaws are configured to (i) be locked to the interface by receiving the interface within a gap in response to the jaws being pushed onto the interface with a distally-directed force having a magnitude by the interface deflecting the jaws apart (e.g., transiently), and (ii) resist unlocking from the interface by the interface leaving a gap such that pulling on the jaws with a proximally-directed force having a magnitude is insufficient to pull the jaws from the interface.

[0784] While jaws 626 are locked to interface 182, tool 620 is used to apply a de-anchor force to anchor head 180, e.g., a torque in the opposite rotational direction to that previously used to implant the anchor (FIG. 25F). In some applications, and as shown, anchor 120 becomes de-anchor tool 620, and sleeve 610 is cooperatively retracted proximally, thereby closing jaws 626.

[0785] The tool 620 (e.g., its jaws 626) can be unlocked from the interface 182 by retracting the sleeve 610 proximally relative to the anchor head 180 and the tool head 624, causing the distal portion of the sleeve to stop forcing the jaws closed and the jaws (which may be exposed from the sleeve) to automatically separate ( FIG. 26A ). The tool 620 (or the entire assembly 600) can then be retracted ( FIG. 26B ). In some applications, this unlocking may be performed upon determining that the anchor should not actually be unlocked or that suboptimal conditions for unlocking exist. In some applications, unlocking may be performed when the assembly 600 is used for initial anchor locking rather than for anchor unlocking.

[0786] For some applications, sleeve 610 has an intermediate portion 618 that is proximal from distal portion 612 and is internally dimensioned such that placement of tool head 624 therein does not force jaws 626 into a closed state. Thus, for some applications, jaws 626 are forced into their closed state by distally advancing tool head 624 from intermediate portion 618 to distal portion 612.

[0787] Reference is now made to FIGS. 27A-C and 28A-B, which are schematic illustrations of anchor handling assembly 600′, according to some applications. Anchor handling assembly 600′ includes similar corresponding components as assembly 600 and has the same overall functionality, but has a slightly different structure. For example, jaws 626′ of assembly 600′ may be longer, curved, and more flexible than jaws 626 of assembly 600. FIGS. 27A-C illustrate steps in using assembly 600′ equivalent to those shown in FIGS. 25D-F of assembly 600, mutatis mutandis. FIGS. 28A-B illustrate steps in using assembly 600′ equivalent to those shown in FIGS. 26A-B of assembly 600, mutatis mutandis.

[0788] Reference is made to Figures 29A-B and 30A-B, which are schematic illustrations of anchor systems 630 and 660, according to some applications. Figures 29A-B illustrate anchor system 630, including tissue anchor 640 and anchor driver 650 for use therewith, and Figures 30A-B illustrate anchor system 660, including tissue anchor 670 and anchor driver 680 for use therewith. Systems 630 and 660 can be used with systems, devices, and techniques described elsewhere herein, for example, by substituting the anchor (or anchor head) and anchor driver (or driver head), mutatis mutandis. For example, anchor drivers 650 and 680 can be used to unlock and remove anchors 640 and 670, and / or deliver and secure the anchors, respectively.

[0789] Anchor 640 includes a tissue-engaging element 642 and an anchor head 644. Anchor driver 650 includes a flexible shaft 652 and a driver head 654 disposed at the distal end of the shaft. Anchor 670 includes a tissue-engaging element 672 and an anchor head 674. Anchor driver 680 includes a flexible shaft 682 and a driver head 684 disposed at the distal end of the shaft.

[0790] In some applications, for systems 630 and 660, respectively, the anchor head has a driver interface 646 or 676, the driver head has an introduction state (FIGS. 29A and 30A) and a locked state (FIGS. 29B and 30B), the anchor head is shaped such that the driver interface defines a proximal opening 645 or 675 accessible by the driver head while the driver head is in the introduction state, and the anchor driver is configured to lock the driver head to the interface by moving a portion of the driver head laterally to transition the driver head to the locked state.

[0791] In some applications, for each of systems 630 and 660, the anchor driver includes a rod 656 or 686 extending through the shaft, the rod configured to apply a force to the driver head, thereby transitioning the driver head to the locked state.

[0792] For system 630, driver head 654 includes a cam 658 coupled to a rod 656, the rod configured to transition driver head 654 to its locked state by rotating the cam such that at least a portion of the cam protrudes laterally. In some applications, and as shown, this is achieved by rod 656 being eccentric relative to shaft 652 and / or relative to cam 658.

[0793] In some applications, the cam 658 does not protrude laterally at all in the installed state (eg, the cam is flush with the shaft 652).

[0794] In some applications, in a cross section transverse to the longitudinal axis of shaft 652, shaft 652 and / or cam 658 are circular.

[0795] For some applications, and as shown, interface 646 is shaped to define a plurality of recesses 648, each dimensioned to receive a laterally protruding cam 658. This allows driver 650 to engage anchor 640 at multiple rotational orientations of the driver relative to the anchor.

[0796] For system 660, driver head 684 includes fins 688, and rod 686 is configured to transition driver head 684 to its locked state by advancing distally between the fins such that the rod pushes the fins radially outward so that the fins lock into interface 676. Fins 688 may be configured to lock into interface 676 via a friction fit when pushed radially outward by rod 686. In some applications, and as shown, interface 676 may be shaped to define a frusto-conical chamber 678 (e.g., having a wider base than a narrower base from opening 675). Driver 680 can generally engage anchor 670 at any rotational orientation of the driver relative to the anchor.

[0797] See Figures 31A-B, 32A-B, 33A-B, 34A-C, and 35A-C, which are schematic illustrations of systems, devices, and techniques for use with heart valves, according to some applications. Described herein above (e.g., in Figures 25A-27C) is the unlocking / removal of anchors. Note that for tissue-adjusting implants including multiple anchors coupled to (e.g., threaded through) a tether, such as implant 110, only the most recently secured anchor may be unlocked / removed. For example, if it is desired to leave the most recently secured anchor in place, the most recently secured anchor may prevent the unlocking anchor (e.g., a more distal anchor) from being removed (e.g., sliding proximally along the tether). Similar challenges may exist when delivering / securing additional anchors. That is, the nature of such implants may limit the addition of anchors in a distal-to-proximal order and / or the subtraction of anchors in a proximal-to-distal order.

[0798] Figure 31A illustrates a scenario in which five anchors 120 of implant 110 are secured to tissue 10 of the annulus of mitral valve 12, but tension in tethers 112 reshapes the annulus, leaving suboptimal regurgitation sites 16 where the valve leaflets do not coapt. Figure 31B illustrates additional anchors 120x coupled (e.g., slidably coupled) to tethers 112 between previously secured anchors and secured to tissue, further deforming the annulus such that the regurgitation sites are reduced (e.g., eliminated). That is, Figures 31A-B illustrate the addition of anchors 120x independently of the distal-to-proximal order.

[0799] Figure 32A illustrates a scenario in which several anchors 120 of implant 110 are anchored to tissue 10 of the annulus of mitral valve 12, but tension on tether 112 reshapes the annulus in a manner that results in undesired deformation of the valve. Figure 32B illustrates one of these anchors (labeled 120y in Figure 32A) being unanchored and separated from tether 112 from between the previously anchored anchors, thereby relaxing (e.g., removing) the deformation. That is, Figures 32A-B illustrate the subtraction of anchor 120y independently of the proximal-to-distal order.

[0800] FIGS. 33A-B, 34A-C, and 35A-C illustrate systems and / or devices configured to facilitate such order-independent techniques. One of the challenges in adding or subtracting anchors in an order-independent manner is navigating a tool to the correct location. For example, to access the most recently secured anchor, it is possible to advance a tool along tether 112, as shown in FIGS. 25A-F. However, using such a technique to access more distal anchors can be difficult, for example, because the most recently secured anchor blocks the advancement of the tool along the tether. Each of the anchors described with reference to FIGS. 31A-32B, with appropriate modifications, can be used in place of one or more of the anchors shown in FIGS. 33A-35C.

[0801] 33A and 33B show implementations 700a and 700b, respectively, of tissue anchors 700 having anchor heads 702 including one or more magnets 704. The anchor head 702a of anchor 700a includes multiple magnets 704a, e.g., distributed circumferentially around the anchor head. The anchor head 702b of anchor 700b includes a magnet 704b, which can be centrally located and, e.g., disk- or ring-shaped. The anchor 700 is configured to facilitate navigation of a tool to an anchor (e.g., an anchor other than the most recent anchor) without advancing the tool along the tether. The magnets 704 can reduce the required navigation precision, e.g., by retracting 704 the tool toward engagement with the anchor 702 once the tool is navigated within threshold proximity of the anchor.

[0802] 34A-C illustrate a system 710 including a tissue anchor 712 and an anchor handling assembly 730, according to some applications. The anchor 712 has an anchor head 714 that includes a shackle 716, according to some applications. The shackle 716 has a reversibly openable opening 718 through which a tether (e.g., tether 112) can be passed laterally by temporarily opening the opening (FIGS. 34A-B), e.g., to slidably couple the anchor to the tether (FIG. 34C). Alternatively, or additionally, the shackle 716 can be modified and configured to facilitate detachment of the tether from the anchor. Note that in this context, the term “lateral” (including in the specification and claims) is intended to distinguish between passing a tether through a shackle (which can often occur without access to the end of the tether) and threading a tether through a conventional eyelet, which may be considered axial movement.

[0803] In some applications, at opening 718, shackle 716 includes a spring-loaded gate 720 (e.g., shackle 716 is a snap shackle). Gate 720 is shown as a single gate, but may optionally be a double gate. In some applications, gate 720 is configured to open inward but not outward.

[0804] The anchor handling assembly 730 often further includes a link tool 732 .

[0805] For some applications, tool 732 temporarily opens opening 718 within the heart and passes tether 112 laterally through the opening and into shackle 716, thereby slidably coupling tether 112 to anchor 712 (e.g., to achieve the results described with reference to FIGS. 31A-B ). For example, tool 732 may include (i) actuator 734 configured to actuate gate 720 to open it (e.g., by pushing against the gate) and / or (ii) limb 736 configured to move tether 112 through open gate 720 and into shackle 716. For some applications, anchor handling assembly 730 also includes driver 740 configured to secure the anchor by, for example, applying a torque to head 714 (e.g., to shackle 716) to drive a tissue-engaging element into tissue. 34A-C do not show tissue but are depicted as if anchor 712 had just been secured, i.e., coupling of tether 112 to the anchor is performed immediately after the anchor has been secured. However, it should be understood that the scope includes coupling of tether 112 to the anchor prior to securing the anchor, subject to appropriate modifications. Additionally, while driver 740 is shown as coaxial with link tool 732, the driver and link tool may be parallel to one another or independent of one another.

[0806] For some applications, tool 732 temporarily opens opening 718 within the heart and passes tether 112 laterally through the opening in shackle 716, thereby separating tether 112 from anchor 712 (e.g., to achieve the results described with reference to FIGS. 32A-B ). For example, limb 736 may be configured to move tether 112 through open gate 718 and out of shackle 716. For some applications, driver 740 is configured to unlock (e.g., unscrew) the anchor, for example, by applying torque to head 714 (e.g., shackle 716). It should be understood that the scope includes separating tether 112 to detach the anchor before or after unlocking the anchor, modified accordingly.

[0807] Note that for clarity, Figures 34A-B and 35A-B show tether 112 as a single dot resembling a cross section through the tether.

[0808] According to some applications, a method is provided that includes: (i) transluminally anchoring a tether along tissue by securing a plurality of anchors at respective locations in the tissue such that the tether extends between the anchors in the tissue and along the tissue, each of the plurality of anchors having a respective eyelet through which the tether passes; and (ii) while the plurality of anchors remain secured to the tissue, transluminally slidably coupling an additional anchor to the tether between two of the plurality of anchors and securing the additional anchor to the tissue.

[0809] Therefore, according to some applications, a method is provided that includes: (i) transluminally anchoring a tether along tissue by securing a plurality of anchors at respective locations in the tissue such that the tether extends between the plurality of anchors and along the tissue, each anchor having a respective eyelet through which the tether passes; and (ii) transluminally separating one anchor of the plurality of anchors from the tether from between two other anchors of the plurality of anchors.

[0810] The above methods and steps can be performed on a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, heart, tissue, etc.).

[0811] 35A-C show a system 750 including a tissue anchor 752 and an anchor handling assembly 770, according to some applications. The anchor 752 has an anchor head 754 that includes a shackle 756, according to some applications. The shackle 756 has a reversibly openable opening 758 through which a tether (e.g., tether 112) can pass laterally by temporarily opening the opening (FIGS. 34A-B), e.g., to slidably couple the anchor to the tether (FIG. 34C). Alternatively, or additionally, the shackle 756 can be modified and configured to facilitate detachment of the tether from the anchor.

[0812] In some applications, shackle 756 is configured to facilitate clipping of the tether into and / or out of the shackle. For example, shackle 756 may be a snap shackle that temporarily opens when the tether is pushed laterally and passes through opening 758, thereby snapping into the shackle.

[0813] The anchor handling assembly 770 often further includes a link tool 772 .

[0814] In some applications, tool 772 temporarily opens opening 758 within the heart and passes tether 112 laterally through the opening and into shackle 756, thereby slidably coupling tether 112 to anchor 752 (e.g., to achieve the results described with reference to FIGS. 31A-B ). For example, and as shown, tool 772 can push tether 112 laterally into and through opening 758, the opening temporarily opening as the tether passes. In some applications, anchor handling assembly 770 also includes driver 780 configured to secure the anchor by, for example, applying torque to head 754 (e.g., into shackle 756) to drive the tissue engaging element into tissue. For simplicity, FIGS. 35A-C do not show tissue but are depicted as if anchor 712 had just been secured, i.e., coupling of tether 112 to the anchor is performed immediately after the anchor has been secured. However, it should be understood that the range includes coupling of tether 112 to the anchor prior to securing the anchor, modified accordingly. Additionally, although driver 780 is shown as coaxial with link tool 772, the driver and link tool may be parallel to one another or independent of one another.

[0815] For some applications, tool 772 temporarily opens opening 758 within the heart and passes tether 112 laterally through the opening and out of shackle 756, thereby separating tether 112 from anchor 752 (e.g., to achieve the results described with reference to FIGS. 32A-B ). For example, with the opening temporarily open as the tether passes on its way out of shackle 756, tool 772 can pull tether 112 laterally into and through opening 758. For some applications, driver 780 is configured to unlock (e.g., unscrew) the anchor, for example, by applying torque to head 754 (e.g., shackle 756). It should be understood that the scope includes separating tether 112 to detach the anchor before or after unlocking the anchor, modified accordingly.

[0816] 31A-B. In some applications, for example, the need for additional anchors is identified only by the tension in the tether, so that tether 112 is tensioned before adding additional anchors 120x. In some such applications, tether 112 is relaxed after tensioning (e.g., after identifying the need for additional anchors) and before anchors 120x are added. Tether 112 can then be tensioned again after the additional anchors are added.

[0817] 32A-B. In some applications, for example, the need to remove the anchor is identified only by the tension in the tether, so that tether 112 is tensioned before anchor 120y is removed. In some such applications, tether 112 is relaxed after tensioning (e.g., after identifying the need to remove the anchor) and before anchor 120y is removed. Tether 112 can then be re-tensioned after anchor 120y is removed.

[0818] See Figures 36A-B, 37A-D, 38A-B, 39A-C, 40A-D, 41, and 42, which are schematic illustrations of various tissue anchors and techniques for use therewith, according to several applications. Unless otherwise indicated, each of these anchors and their components can be as described for anchor 120 and its similarly named components, mutatis mutandis. Furthermore, each of these anchors can be used, mutatis mutandis, as a component of an implant that further includes a tether, for example, as described above. For example, each of these anchors can include a tissue-engaging element, a head including an eyelet, and a driver interface coupled (e.g., fixedly coupled) to the tissue-engaging element. The tissue-engaging element can be the same as or similar to other tissue-engaging elements described herein.

[0819] Similar to anchor 120, each of these anchors can be configured to facilitate smooth sliding of the tether through the opening in the eyelet (i) while the tether is parallel to the central longitudinal axis of the anchor (e.g., during delivery to the heart) and (ii) while the tether is oriented perpendicular to the central longitudinal axis (e.g., after the anchor is secured to the heart tissue). In some applications, for example, similar to that described for anchor 120, mutatis mutandis, the eyelet is pivotable or rotatable about the central longitudinal axis of the anchor, for example, by being mounted on a rotatable collar. As described in more detail below, the eyelet is flexible relative to the central longitudinal axis of the anchor.

[0820] For each of these anchors, the head of the anchor may include a driver interface configured to be reversibly engaged by an anchor driver that advances and secures the anchor, for example, as described herein above for other anchors. The driver interface may be disposed on or concentric with the central longitudinal axis of the anchor.

[0821] 36A-B show tissue anchor 800 including anchor head 802 that includes eyelet 810 that is disposed laterally, or eccentrically, from central longitudinal axis ax9 of anchor 800, similar to eyelet 140 of anchor 120. However, whereas eyelet 140 of anchor 120 is rotatably coupled only to collar 184 (e.g., by an external rotation joint therebetween), eyelet 810 is coupled to collar 808 of anchor 800 via ball joint 812. In addition to allowing rotation of eyelet 810 (e.g., similar to an external rotation joint between eyelet 140 and collar 184), ball joint 812 allows for flexure of the eyelet relative to collar 808 and relative to axis ax9 of the anchor. It is hypothesized that the extra degree of freedom this configuration adds to eyelet 810 advantageously allows the eyelet to assume an optimal orientation, for example, due to tension in tether 112, according to the relative positions of other anchors in the implant, thereby facilitating smooth sliding of the tether through the eyelet. Additionally, it is hypothesized that this configuration increases the predictability of the implant and reduces wear on the tether, compared to anchors where the eyelet is loosely coupled, for example, like links in a chain.

[0822] 37A-D show tissue anchor 820, which, like anchor 800, includes anchor head 822 including eyelet 830 coupled via ball joint 832. However, whereas ball joint 812 of anchor 800 is disposed laterally (i.e., eccentrically) from the central longitudinal axis of the anchor, ball joint 832 (e.g., its ball 835) is disposed on central longitudinal axis ax10 of anchor 820. FIGS. 38A-B show anchor 820 for use as a component of an implant, for example, similar to that described herein with reference to FIGS. 3A-D for anchor 120 of implant 110, mutatis mutandis.

[0823] Anchor 800 is shown as including tissue engaging element 130 as described hereinabove, and anchor 820 is shown as including tissue engaging element 241 as described hereinabove. However, it should be understood that other combinations of anchor heads and tissue engaging elements are possible and contemplated throughout this patent application. For example, tissue engaging element 130 of anchor 800 could be replaced with tissue engaging element 241, mutatis mutandis.

[0824] Thus, each of anchors 800 and 820 includes (i) a tissue-engaging element having a sharp distal tip and defining a central longitudinal axis of the anchor configured to be driven into target tissue, and (ii) an anchor head coupled to a proximal end of the tissue-engaging element, the anchor head including a stock (e.g., stock 804 of anchor 800 and stock 824 of anchor 820, each of which is as described for other anchors herein, mutatis mutandis), a ball joint, and an eyelet coupled to the stock via the ball joint.

[0825] For each anchor head of anchors 800 and 820, the eyelet axis (eyelet axis 811 of head 802 of anchor 800 and eyelet axis 831 of head 822 of anchor 820) passes through the center of the ball of the ball joint and the center of the eyelet, and the ball joint generally allows the eyelet to move laterally from the central longitudinal axis of the anchor, e.g., to a position where the eyelet axis is perpendicular to the central longitudinal axis, e.g., for transluminal delivery. For example, in such a configuration, the anchor can be advanced through tube 152, e.g., as described herein above for anchor 120, mutatis mutandis, with the anchor's tissue engaging element sliding through main channel region 154a and the anchor's eyelet sliding through minor channel region 154b.

[0826] Ball joint 812 includes a socket 814 and a bearing stud 816 defining a ball 815 at a first end of the bearing stud, with the ball disposed within the socket. The other end of bearing stud 816 defines (or is coupled to) eyelet 810. Similarly, ball joint 832 includes a socket 834 and a bearing stud 836 defining a ball 835 at a first end of the bearing stud, with the ball disposed within the socket. The other end of bearing stud 836 defines (or is coupled to) eyelet 830.

[0827] Similar to ball joints known in the art, each of ball joints 812 and 832 allows the bearing stud to deflect to any angular configuration within a predetermined spherical sector of deflection. The spherical sector of deflection may be bounded, for example, by the bearing stud being obstructed by the edge of the socket at a given magnitude of angular deflection from the midpoint of the spherical sector of deflection. In some applications, the spherical sector of deflection has a solid angle of at least 1 steradian (e.g., at least two steradians, e.g., 2-5 steradians, such as 3-5 steradians). In some applications, the socket is larger than hemispherical to retain the ball within the socket, so the solid angle of the spherical sector of deflection is less than 2π steradians (e.g., less than 6 steradians, such as less than 5 steradians).

[0828] 37B and 37D show spherical sector surface 839 of deflection of ball joint 832. In some applications, and as shown, the midpoint of spherical sector of deflection 839 lies on central longitudinal axis ax10 of anchor 820.

[0829] In some applications, and as shown, ball joint 832 (e.g., its socket 834) allows deflection of bearing stud 836 beyond the limits of the spherical sector of deflection 839 (e.g., to a greater angular deflection from the midpoint of the spherical sector of deflection 839) on a particular deflection plane 838. This may be provided by an edge of socket 834 defining a notch 837 through which bearing stud 836 may pass. On deflection plane 838, ball joint 832 defines a planar angular arc of deflection 821 by which bearing stud 836 deflects in a plane and extends beyond the limits of the spherical sector of deflection. In some applications, planar angular arc of deflection 821 is at least 110 degrees (e.g., at least 120 degrees, e.g., at least 140 degrees, e.g., at least 160 degrees, e.g., at least 180 degrees, such as at least 200 degrees). For some applications, the planar arc of flexure 821 is 200 degrees or less (eg, 180 degrees or less, such as 140 degrees or less, eg, 160 degrees or less).

[0830] Similar to the above description for eyelet 140, the narrowest portion of the opening of eyelet 810 and / or eyelet 830 can be midway between the opposing faces of the eyelet. In some applications, the inner surface of eyelet 810 and / or eyelet 830 is superboloid shaped. In some applications, the inner surface of eyelet 810 and / or eyelet 830 is catenoid shaped.

[0831] 38A-B show steps in implanting an implant including multiple tissue anchors 820 slidably coupled to (e.g., threaded through) tether 112, according to some applications. This implant is similar to implant 110 described herein above, but includes multiple anchors 820 instead of anchor 120, and FIGS. 40A-B are similar to FIGS. 3A-B, mutatis mutandis. FIGS. 38A-B show the implant without spacers threaded through tether 112 between anchors 820, although spacers or dividers as described elsewhere herein can be used. Anchor 800 can be used in the same manner, mutatis mutandis.

[0832] 38A-B, the eyelet is deflectable laterally from axis ax10 such that anchor 820 is advanceable transluminally along tether 112, for example, through a tube such as tube 152. For example, eyelet axis 831 can be orthogonal to axis ax10.

[0833] In some applications, the openings of eyelets 810 and 830, similar to the openings of eyelets 140 of anchor 120, may be no more than twice the thickness of the tether (e.g., no more than 50% of the thickness of the tether, such as no more than 20% of the thickness of the tether).

[0834] 39A-C show various views of tissue anchor 840, and FIGS. 40A-D show at least some steps in implanting an implant including a plurality of such tissue anchors slidably coupled to (e.g., threaded through) tether 112, according to some applications. This implant is similar to implant 110 described above, but includes a plurality of anchors 840 instead of anchor 120, and FIGS. 40A-D are similar to FIGS. 3A-D, mutatis mutandis. Anchor 840 includes an anchor head 842 including a stock 844, a driver interface 843, and an eyelet 850. Stock 844 is coupled (e.g., fixedly coupled) to a proximal end of a tissue-engaging element (in the illustrated example, tissue-engaging element 130) of anchor 840 and is coupled (e.g., fixedly coupled) to driver interface 843 in a manner that transmits torque, e.g., from interface 843 to the tissue-engaging element.

[0835] Eyelet 850 is hinged to stock 844 such that the eyelet is positioned on a first side of the driver interface and pivotable on interface 843, for example, so that the eyelet is positioned on a first side of the driver interface and pivotable above the driver interface on a second, opposite side of the driver interface, the second side being opposite the first side. The pivoting also allows eyelet 850 to be positioned on central longitudinal axis ax11 of anchor 840. The pivoting of eyelet 850 is shown in FIGS. 39B-C. While FIGS. 39B-C show a pivoting of approximately 100 degrees, the hinged connection can allow eyelet 850 to pivot through an arc of up to or greater than 180 degrees.

[0836] In some applications, the eyelet 850 is rotatably coupled to the stock 844, for example, by the eyelet being coupled to a collar 848 of the head 842, and the collar being rotatably coupled to the stock, thereby allowing it to rotate about axis ax11.

[0837] In some applications, and as shown, head 842 includes an arch 851 and has two base ends 855. In some such applications, arch 851 defines at least a portion of eyelet 850. Hinging of eyelet 850 to stock 844 can be achieved by base ends 855 being hinged to stock 844 at respective opposing hinge points. In applications, and as shown, where head 842 includes collar 808, hinging of eyelet 850 to stock 844 can be achieved by base ends 855 being hinged to collar 844 at hinge points. For example, and as shown, collar 808 can define recesses at each of the hinge points, with each base end hinged to the collar by protruding into the recesses.

[0838] Thus, the coupling of eyelet 850 allows the eyelet to both (i) flex relative to axis ax11 and (ii) rotate / pivot about axis ax11.

[0839] Anchor 840 is shown with most of arch 851 being part of eyelet 850 such that interface 843 is disposed within eyelet 850 in at least some orientations of the eyelet. FIGS. 41 and 42 show variations of anchor 840 in which eyelet 850 is disposed on the arch in a manner that spaces the eyelet from the anchor interface of the anchor. FIG. 41 shows, for example, variation 840' of anchor 840 including eyelet 850' that is centrally disposed on arch 851' such that in at least one orientation, the eyelet is positioned on the central longitudinal axis of the anchor. FIG. 42 shows, for example, variation 840'' of anchor 840 including eyelet 850'' that is eccentrically disposed on arch 851'' such that in any possible orientation of the eyelet, the eyelet is laterally disposed from the central longitudinal axis of the anchor.

[0840] 40A-B, eyelet 850 is deflectable laterally from axis ax11 such that anchor 840 is advanceable transluminally along tether 112 through tube 852, such as by using driver 160 or other driver. For example, arch 851 may be orthogonal to axis ax11 and / or an eyelet axis passing through eyelet 850, and the hinge point may be orthogonal to axis ax11. Tube 852 may be similar to or identical to tube 152 described above.

[0841] Figure 40C shows five anchors 840 secured, with tether 112 extending through eyelets 850 of each anchor and proximally from the subject. Figure 40D shows tether 112 under tension, with stopper 114b advanced and locked to the tether to lock the tension in the tether, for example, as described for implant 110, mutatis mutandis.

[0842] Head 842 allows the eyelet to be moved laterally from the central longitudinal axis of the anchor, e.g., to a position where the eyelet axis is perpendicular to the central longitudinal axis, such as for transluminal delivery. For example, in such a configuration, the anchor can be advanced through tube 852, e.g., similar to that described herein above for anchor 120, mutatis mutandis, with the tissue engaging element of the anchor sliding through the main channel region of the tube and the eyelet of the anchor sliding through the minor channel region of the tube.

[0843] 40A-D show that an implant can be used that does not include spacers threaded on tethers 112 between anchors 840, although spacers or dividers as described elsewhere herein can be used.

[0844] 43A-C, which are schematic illustrations of tissue anchor 870 and its variation 870', according to some applications. Anchor 870 can be used, for example, with appropriate modifications, as an anchor for an implant that includes a tether, as described for other anchors hereinabove. Alternatively, anchor 870 can be used in other ways.

[0845] Similar to the other anchors described herein, anchor 870 is transluminally deliverable, for example, to a subject's heart. Anchor 870 includes two arms 872 (e.g., first arm 872a and second arm 872b) hinged to one another at an external rotation joint 874 that defines a hinge axis ax12. External rotation joint 874 often includes a pin 875 extending through each arm 872. Each of arms 872 can be rigid. Each arm 872 defines a coupling 876 and a hook 878; for example, arm 872a defines a first coupling 876a and a first hook 878a, and arm 872b defines a second coupling 876b and a second hook 878b. Each hook 878 curves away from the hinge axis ax12 and terminates in a respective tip 879 (i.e., a first tip 879a and a second tip 879b), which may be sharp. The hooks 878 curve in opposite directions about the hinge axis ax12. In some applications, the hooks 878 lie on respective planes that are parallel to each other and perpendicular to the hinge axis ax12.

[0846] The anchor 870 is transitionable between an open state (e.g., as shown in FIG. 43A ) and a closed state (e.g., as shown in FIG. 43B ). In the open state, the arm 872 a is in a first rotational position about the hinge axis ax12, the hooks 878 a and 878 b define a space 880 therebetween, and the tips 879 a and 879 b define a gap 882 therebetween within the space. For example, the hooks 878 may define the space 880 including their respective recesses facing each other, both recesses. In the closed state, the arm 872 a is in a second rotational position about the hinge axis ax12, and the gap 882 is smaller than in the open state. For example, and as shown in FIG. 43B , there may be substantially no gap between the hooks 878 within the space 880, thereby forming the space 880 within the opening of the eyelet defined by the hooks 878.

[0847] The preceding paragraphs describe the open and closed states with respect to the rotational position of arm 872a about hinge axis ax12, but these positions are relative to arm 872b. That is, in the open state, arms 872a and 872b are in a first rotational juxtaposition about hinge axis ax12, and in the closed state, arms 872a and 872b are in a second rotational juxtaposition about the hinge axis. In some applications, transitioning anchor 870 to the closed state involves rotating both arms 872 about hinge axis ax12 (e.g., relative to another component, such as an anchor driver used to advance and actuate the anchor). However, in some applications, transitioning anchor 870 to the closed state involves rotating only one of arms 872.

[0848] In the open state, tips 879 may generally face in the same direction as one another, for example, to facilitate penetration of hooks 878 into tissue. Anchor 870 may transition toward a closed state after tips 879 have penetrated tissue, which transition typically advances hooks 878 further into tissue. Collectively, hooks 878 thereby serve as tissue-engaging elements 871 of anchor 870.

[0849] In some applications, and as shown, in the closed state, the tips 879 face away from each other.

[0850] In the open state, couplings 876a and 876b disengage from one another, while in the closed state, the couplings engage with one another. The engagement prevents anchor 870 from transitioning from the closed state, thereby inhibiting the anchor from being released from the tissue. For some applications, one of couplings 876 (coupling 876b in the illustrated example) includes a protrusion and the other (coupling 876a in the illustrated example) includes a recess, and the couplings engage with one another by the protrusion projecting into the recess. For some applications, couplings 876 are configured to automatically engage with one another when aligned with one another. For example, and as shown, arms 872 can be sufficiently close to one another along axis ax12 that the protrusion of coupling 876b snaps into the recess of coupling 876a when the couplings are aligned.

[0851] In some applications, each arm 872 defines a respective beam 884 (e.g., arm 872a defines beam 884a, and arm 872b defines beam 884b). For some such applications, and as shown, external rotation joint 874 is disposed between the beam and hook of each arm 872 such that each arm is a class I lever whose fulcrum is its external rotation joint, and thus anchor 870 is a class I double lever whose fulcrum is its external rotation joint (e.g., pin 875 extends through each arm between the beam and hook). In some such applications, anchor 870 can be transitioned from an open state to a closed state by driving one or both beams 884 about hinge axis ax12. That is, in some such applications, anchor 870 can be actuated by applying a force to one or both beams 884 (e.g., by an anchor driver engaging beams 884).

[0852] In applications where each arm 872 defines a respective beam 884, transitioning anchor 870 toward its closed state can be achieved by increasing the alignment between the beams. For example, and as shown, coupling 876 may be disposed on beam 884, and a hinge connection between arms 872 can enable anchor 870 to be transitioned to the closed state by aligning the beams with one another such that the coupling responsively engages.

[0853] In some applications, and as shown, the radius of curvature of each hook 878 increases with distance from the external rotation joint 874. Thus, in some applications, the curvature of each hook 878 can be considered generally helical, despite being less than one turn (e.g., less than half a turn). It is hypothesized that such a shape is advantageous compared to hooks having a more circular curve by improving anchoring, such as by reducing the conversion of tension forces applied to the anchor into rotation of the arm 872 about the external rotation joint 874.

[0854] Variation 870′ (FIG. 43C) may be identical to anchor 870 unless otherwise noted. Compared to anchor 870, variation 870′ further includes a spring 886 configured to bias at least one of arms 872 toward a respective given rotational position about hinge axis ax12. In the example shown, spring 886 is configured to bias the anchor toward a closed state. In some applications, spring 886 and coupling 876 create a synergistic effect such that sufficient force must be applied to overcome the engagement of both the spring and the coupling to return the anchor to its open state. Spring 886 may be coupled to both arms 872, with each end of the spring connected to a respective one of the arms, for example, by protruding through a hole in the arm, as shown. In some applications, and as shown, spring 886 is connected to a hook 878 on each arm, for example, as shown. Optionally, spring 886 may be connected to beam 884 on each arm.

[0855] In some applications, spring 886 is a torsion spring. As shown, in some such applications, spring 886 is mounted on pin 875′, which may be identical to pin 875 except that pin 875′ accommodates the spring, e.g., is longer and / or includes an additional flange for retaining the spring.

[0856] 44A-E and 45A-E are schematic illustrations of tissue anchors 900 and 920 and their use techniques, according to some applications. Each of tissue anchors 900 and 920 includes a stem (902 for anchor 900, 922 for anchor 920), an arm (904 for anchor 900, 924 for anchor 920), and a hinge (906 for anchor 900, 926 for anchor 920) through which the arm is coupled to the stem, often at a distal portion (e.g., the distal end) of the stem. The stem also has a proximal portion and an intermediate portion between the proximal and distal portions. Each of arms 904 and 924 has a first side (904a for arm 904, 924a for arm 924) and a second side (904b for arm 904, 924b for arm 924). The arm can be coupled to the hinge such that the hinge is between a first side and a second side of the arm, for example, such that the position of the hinge defines the first and second sides of the arm.

[0857] For anchors 900 and 920, respectively, the anchor can be secured within tissue (e.g., tissue 10) by advancing sequentially into the tissue a first side of the arm (i.e., the first side of the arm acting as the leading arm), the hinge, and an intermediate portion of the stem, such that the stem extends from the distal end of the stem and hinge (within the tissue) to a proximal portion of the stem above the tissue, as shown, for example, in FIG. 44A (for anchor 900) and FIG. 45A (for anchor 920). Anchor 920 (e.g., its arm 924) can be advanced into tissue within a hollow needle 930 having a sharp tip configured to penetrate into the tissue. Anchor 900 (e.g., its arm 904) can be configured to be driven directly into tissue, e.g., exposed, without a hollow needle. To facilitate this, the first side 904a of arm 904 can thus have a sharp tip 908. The tip 908 can be centralized to facilitate linear advancement of the arm 904 through tissue. In some applications, the second side 904b can be longer than the first side 904a (e.g., 5-50% longer...

Claims

1. A system for use on a target, comprising:

1. A catheter device comprising: A tube, a distal opening configured for transluminal advancement into the subject; and a tube having a proximal end defining a proximal opening; an extracorporeal unit coupled to the proximal end of the tube; a catheter device comprising: A series of anchors and a series of cartridges arranged along the extracorporeal unit, each cartridge comprising: the cartridge having an initial position for holding each anchor in the series of anchors; and is movable from the initial position to a deployed position while being connected to the extracorporeal unit. A series of cartridges; An anchor driver, for each anchor in turn engages with the anchor; while each cartridge is in a deployed position, moving the anchor out of the respective cartridge, through the proximal opening, and through the tube toward the distal opening; An anchor driver configured as follows: A system comprising:

2. The proximal end of the tube defines a tube axis; The system of claim 1 , wherein the series of cartridges are arranged in a row defining a cartridge axis, the cartridge axis being parallel to the tube axis.

3. For each of the anchors, each cartridge configured to capture the anchor therein; the anchor driver is configured to apply a proximal pulling force to the anchor while engaged with the anchor; 2. The system of claim 1, wherein the respective cartridges are configured to undergo a conformational change in response to the proximal pulling force exceeding a threshold, allowing the anchor driver to displace the anchor from the respective cartridge.

4. For each anchor, each cartridge comprising a first piece and a second piece; the anchor driver is configured to apply a proximal pulling force to the anchor while engaged with the anchor; 2. The system of claim 1, wherein the respective cartridges are configured such that, when the proximal pulling force exceeds a threshold, the second piece slides relative to the first piece in response, allowing the anchor driver to move the anchor from the respective cartridge.

5. The catheter device further comprising a port at the proximal opening of the tube; The system comprises a flushing adapter, including the fluid fitting, the nozzle, and the channel therebetween; and the fluid fitting is accessible from the exterior of the catheter device; and 10. The system of claim 1, further comprising a flushing adapter reversibly lockable to the extracorporeal unit in a flushing position, with the nozzle in fluid communication with the port, such that fluid driven into the flushing adapter through the fluid fitting is directed distally through the tube.

6. The system described in claim 5, wherein the fluid fitting is a luer fitting.

7. The system described in claim 5, wherein the port includes a sealing membrane and the anchor driver is configured for each of the anchors to advance the anchor distally through the membrane into the tube.

8. The system described in claim 7, wherein in the flushing position, the nozzle seals with the port proximal to the membrane.

9. The system described in claim 8, wherein the port has a tapered inner wall defining a lumen proximally from the membrane, and the lumen of the port tapers distally toward the membrane.

10. The system described in claim 1, wherein each cartridge is removable from the extracorporeal unit.

11. The system described in claim 1, wherein the anchor driver is configured to, for each anchor, move the anchor from the respective cartridge through the proximal opening, through the tube and toward the distal opening while the respective cartridge remains in the deployed position.

12. The anchors, each including a tissue-engaging element and a head including an eyelet; The system is a tether, threaded through the eyelets of each of the anchors; a proximal portion including a proximal end of the tether; 10. The system of claim 1, further comprising a tether having a distal portion including a distal end of the tether, the distal end of the tether being advanceable distally through the tube into the subject while the proximal end of the tether remains outside the subject.

13. For each of the anchors: the tissue engaging element defines a central longitudinal axis of the anchor, has a sharp distal tip, and is configured to be driven into the target tissue; the head further includes an interface coupled to a proximal end of the tissue engaging element and configured to be reversibly engaged by the anchor driver; The system of claim 12 , wherein the eyelet is mounted for rotation relative to the interface about the central longitudinal axis of the anchor.

14. The system described in claim 13, wherein the eyelet is pivotally mounted relative to the longitudinal axis of the anchor.

15. The system described in claim 14, wherein the eyelet is pivotally mounted on the interface.

16. The system described in claim 13, wherein the interface is positioned on the central longitudinal axis of the anchor.

17. The system described in claim 13, wherein the tissue engaging element defines the central longitudinal axis by extending helically around and along the central longitudinal axis and is configured to be screwed into the tissue of the subject.

18. The system described in claim 17, wherein the tissue engaging element is configured to be screwed into the tissue so that a distal portion of the helix enters the tissue before a proximal portion of the helix, the distal portion having a greater pitch than the proximal portion.

19. The head includes a collar surrounding the central longitudinal axis and rotatably coupled to the interface; The system of claim 13 , wherein the eyelet is attached to the collar and is rotatable about the central longitudinal axis by rotation of the collar about the central longitudinal axis.

20. The system described in claim 12, further comprising a series of tubular spacers threaded through the tether alternating with the anchors.

21. The system described in claim 20, wherein each of the spacers is elastically flexible in bending.

22. The system of claim 20, wherein each of the spacers resists axial compression.

23. The system described in claim 20, wherein each of the spacers is defined by a spiral wire shaped as a coil.

24. The system of claim 12, wherein the anchor driver is configured to, for each of the anchors, move the anchor out of the respective cartridge, through the proximal opening, and through the tube toward the distal opening while the eyelet of the anchor remains threaded through the tether.

25. The system of claim 12, wherein the catheter device further comprises a tensioner coupled to the proximal portion of the tether and comprising a spring-loaded winch configured to maintain tension on the tether.

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