Anchor magazines

Abstract

To provide systems, apparatuses and methods for percutaneously delivering one or more anchors to tissue of a subject and anchoring the anchors to the tissue.SOLUTION: A tube 1072 has a distal opening, and a proximal end that defines a proximal opening. An extracorporeal unit is coupled to the proximal end, defines a deployment position, and includes a track that leads to the deployment position. Each cartridge holds a tissue anchor and is coupled to the extracorporeal unit at an initial position. Each cartridge is moveable from the initial position to the deployment position such that the cartridge holds the tissue anchor opposite the proximal opening. The anchor driver can advance the tissue anchor distally out of the cartridge, through the proximal opening, and through the tube. Each cartridge is removable from the deployment position, and thus vacates the deployment position for a series of successive cartridges. Other application examples are also described.SELECTED DRAWING: Figure 17A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 083,571, filed September 25, 2020, entitled "ANCHOR MAGAZINES" by Halabi et al., the contents of which are incorporated herein by reference in their entirety for all purposes. [Background technology]

[0002] Annuloplasty involves remodeling 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 may be used in procedures where there is no line of sight to the target. Summary of the Invention [Means for solving the problem]

[0003] This Summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this Summary are not required by a claim unless the claim explicitly recites those features. Also, features, components, steps, concepts, etc. described in examples in this Summary and elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0004] For some applications, systems, devices, and methods are provided for percutaneously (e.g., transluminally) delivering one or more anchors to tissue of a subject and securing the anchors to the tissue. In some such applications, the tissue anchors are components of an implant that further includes a tether pre-threaded through the tissue anchor. In some such applications, a distal portion of the tether will be implanted long-term with the anchor, and a proximal portion of the tether will be removed from the subject after the anchor (and therefore the implant) has been secured to the tissue.

[0005] The methods herein can be performed on live animals or in simulations, eg, cadavers, cadaver hearts, simulators (eg, simulated body parts, tissues), etc.

[0006] Some applications relate to systems, devices, and methods for achieving successful (e.g., complete) fixation of one or more tissue anchors to tissue that is not within line of sight, for example, during percutaneous (e.g., transluminal) techniques.

[0007] For some applications, the tissue anchor comprises a tissue-engaging element and a head. The tissue-engaging element can be or include one or more of a hook, clip, dart, barb, staple, tine, needle, helical portion, screw, tissue membrane piercer, etc.

[0008] In some applications, the anchor driver can engage the anchor at the head (e.g., be reversibly attached to the head) and drive the tissue engaging element into the tissue. Often, successful anchoring involves the tissue engaging element being fully embedded in the tissue, e.g., the head contacting the surface of the tissue.

[0009] For some applications, a respective catheter system is provided that includes a transluminally advanceable catheter, the respective catheter system including a respective mechanism for controlling advancement of tissue anchors stored within an anchor storage zone of the transluminally advanceable catheter and / or of an extracorporeal unit (e.g., a controller and / or handle) coupled to the catheter. For some applications, the mechanism can include a rotatable helical thread to control advancement of anchors beyond the anchor storage zone and prevent advancement of too many anchors out of the anchor storage zone at a given time.

[0010] For some applications, the mechanism can include a plurality of detents to control advancement of the anchors beyond the anchor storage zone and prevent advancement of too many anchors out of the anchor storage zone at a given time. For some applications, the mechanism can include a dispenser to control advancement of the anchors beyond the anchor storage zone and prevent advancement of too many anchors out of the anchor storage zone at a given time. For some applications, the mechanism can include a rotation stop on the extracorporeal unit to control advancement of the anchors beyond the anchor storage zone and prevent advancement of too many anchors out of the anchor storage zone at a given time.

[0011] For some applications, a respective catheter system is provided that includes a respective anchor driver for reversibly coupling to the tissue anchor and facilitating driving the anchor into tissue.

[0012] In some applications, each catheter system is provided with a tensioner that applies tension (e.g., a predetermined and / or constant amount of tension) to the tether during implantation, e.g., to reduce the likelihood of unintended tangling or entanglement. In some such applications, an anchor can be threaded along the tether between the tensioner and the distal end of the tether. In other applications, the tensioner can be positioned along the tether between the anchor and the distal end of the tether. In some applications, the tensioner can be reversibly engageable with the tether, e.g., allowing an operator to select when and when not to apply tension to the tether.

[0013] Thus, according to some applications, a system and / or device is provided for use on a subject, comprising a catheter device, a series of tissue anchors, a series of cartridges, and an anchor driver.

[0014] For some applications, the catheter device includes a tube having a distal opening and a proximal opening configured for advancement into a subject.

[0015] For some applications, the catheter device includes an extracorporeal unit (eg, a handle, controller, etc.) that defines a deployment location and includes a track that leads to the deployment location.

[0016] For some applications, each cartridge in the series of cartridges holds a respective tissue anchor in the series of tissue anchors.

[0017] In some applications, each cartridge in the series is coupled to the extracorporeal unit at a respective initial position in a series of initial positions, for example.

[0018] In some applications, each cartridge in the series is movable along a track from a respective initial position to a deployed position while remaining connected to the extracorporeal unit, such that the cartridge holds a respective tissue anchor on opposite sides of the proximal opening.

[0019] In some applications, each cartridge in the series can be subsequently removed from the deployment position, leaving the deployment position free for a subsequent cartridge in the series.

[0020] For some applications, the anchor driver is configured to couple to each of the anchors while the anchor is held by a respective cartridge opposite the proximal opening and advance the anchor distally out of the respective cartridge, through the proximal opening, and through the catheter toward the distal opening.

[0021] For some applications, the catheter device further comprises a port at the proximal opening of the tube, the port comprising a membrane shaped to define a first opening therethrough, a second opening therethrough, and a closing slit connecting the first opening with the second opening.

[0022] For some applications, the first opening has a wider diameter than the second opening.

[0023] In some applications, the first opening is 3 to 10 times larger than the second opening.

[0024] For some applications, the anchor driver is configured to advance, for each of the anchors, 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.

[0025] In some applications, for each cartridge in the series of cartridges, the cartridge is configured such that the cartridge is removable 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.

[0026] In some applications, for each cartridge in the series of cartridges, 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.

[0027] For some applications, each of the tissue anchors includes a tissue-engaging element and a head defining an eyelet. The tissue-engaging element can be or include one or more of a hook, clip, dart, barb, staple, tine, needle, helical portion, screw, tissue membrane piercer, etc.

[0028] For some applications, the system and / or device further includes a tether. The tether can be threaded through each eyelet of the tissue anchor, has a proximal portion with a proximal end of the tether, and has a distal portion with a distal end of the tether. For some applications, the distal end of the tether can be advanced distally into the subject through the catheter, while the proximal end of the tether remains outside the subject.

[0029] For some applications, for each anchor, the anchor driver is configured to advance the anchor distally out of the respective cartridge, through the proximal opening, and through the catheter toward the distal opening, while the tether remains threaded through the eyelet of the anchor.

[0030] 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 closure slit connecting the first opening with the second opening. For some applications, the port is positioned such that, for each anchor, the anchor driver is configured to advance the anchor distally out of the respective cartridge and through the membrane, with the tissue engaging element extending through the first opening and the tether extending through the second opening.

[0031] For some applications, the ports are arranged such that, for each anchor, the anchor driver is configured to advance the anchor distally out of the respective cartridge and through the membrane, with the tissue engaging element extending through the first opening and the tether extending through the second opening.

[0032] For some applications, the ports are positioned for each anchor such that when the anchor driver advances the anchor distally out of the respective cartridge and through the membrane, the first opening temporarily widens as the tissue engaging element of the anchor passes through the first opening.

[0033] For some applications, the port is positioned for each anchor such that the first opening seals around the anchor driver after the anchor driver advances the anchor distally out of the respective cartridge and through the membrane.

[0034] For some applications, the port is positioned for each anchor such that when the anchor driver advances the anchor distally out of its respective cartridge and through the membrane, the second opening temporarily widens as the eyelet of the anchor passes through the second opening.

[0035] For some applications, the port is positioned for each anchor such that when the anchor driver advances the anchor distally out of the respective cartridge and through the membrane, a slit temporarily opens as the anchor passes through the membrane.

[0036] 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 the membrane is oriented substantially transverse to the proximal end of the tube, and for each cartridge in the series of cartridges, while the cartridge is in the deployed position, the tissue engaging element of the respective tissue anchor is aligned with the first opening, thereby defining an anchor advancement axis from the respective tissue anchor, through the first opening, and through the tube.

[0037] In some applications, the port is positioned so that the distal end of the tether extends through the second opening when the distal end of the tether is advanced distally through the tube into the subject, while the proximal end of the tether remains outside the subject.

[0038] For some applications, the catheter device further includes a spring and a spool coupled to the spring, wherein rotation of the spool in a first direction stresses the spring.

[0039] For some applications, a proximal portion of the tether is wound around a spool such that distal advancement of the distal portion of the tether through the catheter rotates the spool in a first direction.

[0040] For some applications, each cartridge in the series is configured to lock onto the extracorporeal unit upon reaching the deployed position.

[0041] In some applications, each cartridge in the series of cartridges is shaped to be grasped by hand by a human operator and configured to be moved along the track by the operator.

[0042] For some applications, each cartridge in the series is removable from the deployed location by detaching it from the extracorporeal unit.

[0043] For some applications, each cartridge in the series of cartridges includes a displaceable barrier that prevents the respective anchor from advancing distally out of the cartridge.

[0044] For some applications, each cartridge in the series of cartridges includes a displacement mechanism that displaces the barrier upon actuation of the displacement mechanism, such that the barrier ceases to prevent the respective anchor from advancing distally out of the cartridge.

[0045] For some applications, the displacement mechanism is configured to displace the barrier by linear movement of the barrier upon actuation of the displacement mechanism.

[0046] For some applications, the displacement mechanism is configured to displace the barrier by deflection of the barrier upon actuation of the displacement mechanism.

[0047] In some applications, the displacement mechanism is spring-loaded.

[0048] For some applications, the displacement mechanism is configured to be actuated by a force applied to the respective anchor.

[0049] For some applications, the displacement mechanism is configured to be actuated by an anchor driver that pulls each anchor proximally.

[0050] In some applications, for each cartridge in a series of cartridges, the cartridge: a first component comprising a barrier; a second part for holding each anchor; the displacement mechanism is constrained by a detent on the cartridge; The displacement mechanism is configured to be actuated by the anchor driver pulling each anchor proximally with sufficient force to cause each anchor to pull the second component proximally relative to the first component, such that the detent ceases to constrain the displacement mechanism.

[0051] For some applications, the displacement mechanism is defined by the first component.

[0052] For some applications, the first part defines a detent.

[0053] In some applications, the detents constrain the displacement mechanism by contacting the respective anchors.

[0054] For some applications, each anchor includes a helical tissue-engaging element, and a detent is disposed within the helical tissue-engaging element of each anchor to constrain the displacement mechanism.

[0055] For some applications, the second component defines a detent.

[0056] In some applications, the detent restrains the displacement mechanism by contacting the engagement mechanism.

[0057] For some applications, the cartridge connects to the extracorporeal unit via a connection between the first component and the extracorporeal unit.

[0058] In some applications, the cartridge connects to the extracorporeal unit via a connection between the second component and the extracorporeal unit.

[0059] For some applications, each cartridge includes a first part that couples the cartridge to the extracorporeal unit and holds a respective anchor, and a second part that includes a barrier.

[0060] For some applications, the first component defines a detent that constrains the displacement mechanism, and the displacement mechanism is configured to be actuated by the anchor driver pulling each anchor proximally with sufficient force to pull the first component in a proximal direction relative to the second component, such that the detent ceases to constrain the displacement mechanism.

[0061] For some applications, the first component slidably couples the cartridge to the track.

[0062] For some applications, each of the cartridges is configured such that the anchor driver reconfigures the cartridge to a removable state that facilitates removal of the cartridge from the deployed position by pulling each anchor proximally with sufficient force to cause each anchor to pull the first component proximally relative to the second component.

[0063] In some applications, the first part is mounted inside a second part, and the second part is shaped to be grasped manually by a human operator.

[0064] Further provided are systems and / or devices comprising the catheter device, the first cartridge, the second cartridge, and the anchor driver. Optionally, the systems and / or devices can also comprise additional cartridges (e.g., a third cartridge, a fourth cartridge, a fifth cartridge, a sixth cartridge, etc.), which can be the same as or similar to the first cartridge and / or the second cartridge and include any of the same functionality.

[0065] For some applications, the catheter device includes a controller or handle that includes a tube with a proximal opening and a track that leads to a deployment location.

[0066] For some applications, the first cartridge holds a first tissue anchor, is coupled to the controller or handle, and is movable along a track from a first initial position to a deployed position while coupled to the controller or handle, the first cartridge holding the first tissue anchor opposite the proximal opening.

[0067] For some applications, the second cartridge holds a second tissue anchor, is coupled to the controller or handle, and is movable along a track from a second initial position to a deployed position while coupled to the controller or handle, the second cartridge holding the second tissue anchor on the opposite side of the proximal opening.

[0068] For some applications, the anchor driver is coupleable to a first anchor while the first anchor is held by the first cartridge opposite the proximal opening and configured to advance the first anchor distally out of the first cartridge, through the proximal opening, and through the vessel, and the anchor driver is coupleable to a second anchor while the second anchor is held by the second cartridge opposite the proximal opening and configured to advance the second anchor distally out of the second cartridge, through the proximal opening, and through the vessel.

[0069] For some applications, the first tissue anchor comprises a first head comprising a first tissue-engaging element and a first eyelet. For some applications, the second tissue anchor comprises a second head comprising a second tissue-engaging element and a second eyelet. The tissue-engaging element can be or include one or more of a hook, clip, dart, barb, staple, tine, needle, helical portion, screw, tissue membrane piercer, etc.

[0070] For some applications, the system and / or device further includes a tether (e.g., a wire, line, suture, elongated member, etc.) threaded through the first eyelet and the second eyelet, the tether having a proximal portion comprising a proximal end of the tether and a distal portion comprising 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 is outside the subject. In some applications with more cartridges and more anchors, the tether is threaded through different eyelets of multiple different anchors.

[0071] For some applications, the anchor driver is configured to advance a first anchor distally out of the first cartridge, through the proximal opening, and through the tube while the tether remains threaded through the first eyelet of the first anchor. For some applications, the anchor driver is configured to advance a second anchor distally out of the second cartridge, through the proximal opening, and through the tube while the tether remains threaded through the second eyelet of the second anchor. For some applications using another anchor, the anchor driver can similarly advance another anchor from another cartridge through the proximal opening and the tube while the tether remains threaded through the eyelet of the other anchor.

[0072] For some applications, the catheter device further comprises a tensioning device configured to tension the tether. The tensioning device can be configured in a variety of ways.

[0073] For some applications, the tensioning device includes a spring and a spool, the spool coupled to a screw such that the spool rotates in a first direction to stress the spring, and the proximal portion of the tether is wound around the spool such that advancing the distal portion of the tether distally through the tube rotates the spool in the first direction.

[0074] For some applications, each of the first cartridge and the second cartridge is configured to lock to the controller or handle upon reaching the deployed position.

[0075] For some applications, each of the first cartridge and the second cartridge is shaped to be manually grasped by a human operator and configured to be manually moved along the track by the operator.

[0076] For some applications, each of the first cartridge and second cartridge is removable from the deployed position by detaching it from the controller or handle.

[0077] For some applications, the first cartridge includes a first displaceable barrier that prevents the first anchor from advancing distally out of the first cartridge, and for some applications, the second cartridge includes a second displaceable barrier that prevents the second anchor from advancing distally out of the second cartridge.

[0078] For some applications, the first cartridge includes a first displacement mechanism that, upon actuation of the first displacement mechanism, displaces the first displaceable barrier so that the first displaceable barrier ceases to prevent distal advancement of the first anchor out of the first cartridge. For some applications, the second cartridge includes a second displacement mechanism that, upon actuation of the second displacement mechanism, displaces the second displaceable barrier so that the second displaceable barrier ceases to prevent distal advancement of the second anchor out of the second cartridge.

[0079] For some applications, the first displacement mechanism and the second displacement mechanism are each spring-loaded.

[0080] For some applications, the first displacement mechanism is configured to be actuated by a force applied to the first anchor, and the second displacement mechanism is configured to be actuated by a force applied to the second anchor.

[0081] For some applications, the first displacement mechanism is configured to be actuated by the anchor driver pulling the first anchor proximally, and the second displacement mechanism is configured to be actuated by the anchor driver pulling the second anchor proximally.

[0082] For some applications, the first cartridge includes a first part that couples the first cartridge to the extracorporeal unit and holds the first anchor, and a second part that includes the barrier.

[0083] For some applications, the first component defines a detent that constrains the first displacement mechanism, and the first displacement mechanism is configured to be actuated by the anchor driver pulling the first anchor proximally with sufficient force to pull the first component in a proximal direction relative to the second component, such that the detent ceases to constrain the first displacement mechanism.

[0084] For some applications, the first component slidably couples the first cartridge to the track.

[0085] For some applications, the first cartridge is configured such that the anchor driver reconfigures the first cartridge to a removable state that facilitates removal of the first cartridge from the deployed position by pulling the first anchor proximally with sufficient force to pull the first component in a proximal direction relative to the second component.

[0086] In some applications, the first part is mounted inside a second part, and the second part is shaped to be grasped manually by a human operator.

[0087] For some applications, the system and / or device further includes a third cartridge holding a third tissue anchor and coupled to the controller or handle, and is movable along a track from a third initial position to a deployed position while coupled to the controller or handle, the third cartridge holding the third tissue anchor opposite the proximal opening.

[0088] According to some applications, a catheter system or other system and / or device including a catheter system is also provided. The catheter system includes an extracorporeal unit (e.g., a controller and / or handle) at a proximal portion of the catheter system and a transluminally advanceable catheter (e.g., a tube, etc.) extending distally from the controller. The catheter can extend along its longitudinal axis, for example, when in a straight configuration, from the controller to a distal opening of the catheter. The catheter includes a channel and a generally tubular wall defining a lumen along the length of the catheter or, when in a straight configuration, along the axis of the catheter.

[0089] For some applications, the tubular wall has a side slit at a distal portion thereof that extends along at least a portion of the channel.

[0090] For some applications, the tubular wall has a helical thread, partially overlapping the channel, and is operably coupled to a controller such that manipulation of the controller allows the thread to rotate about the catheter axis relative to the channel.

[0091] For some applications, the catheter has an anchor storage zone whose threads are at least partially longitudinally aligned with the slits, and at least one tissue anchor is disposed or positionable within the anchor storage zone.

[0092] For some applications, the tissue anchor includes a tissue engaging portion and an anchor head. The tissue engaging portion can be disposed within the lumen of the channel and define a tissue anchor shaft. The anchor head can couple to the tissue engaging portion and define a driver interface.

[0093] For some applications, the anchor and / or anchor head include a protrusion. For example, the protrusion can be coupled to the tissue-engaging portion via the anchor head. The protrusion can be configured to extend through the slit and protrude transversely relative to the tissue-engaging portion to engage the thread.

[0094] The anchor and slide are configured to engage with each other so that the tissue anchor is secured within the anchor storage zone while the sled is stationary relative to the channel, and rotation of the sled about the tissue anchor axis and / or the catheter axis relative to the channel advances the tissue anchor distally until the protrusion exits the distal exit of the sled.

[0095] For some applications, the slit defines a linear slit disposed parallel to the catheter axis.

[0096] For some applications, the prongs are rotatably coupled to the tissue engaging portion via the anchor head.

[0097] For some applications, the system and / or device further includes an inner tube surrounding a proximal portion of the channel, with a thread extending from a distal end of the inner tube over the distal end of the channel to define a tubular structure.

[0098] For some applications, the at least one tissue anchor includes at least first and second tissue anchors sequentially positioned within the anchor storage zone, each of the first and second tissue anchors including a respective protrusion.

[0099] For some applications, while the sled is stationary, a first tissue anchor is positioned at a first location distal to a second tissue anchor positioned at a second location;

[0100] In some applications, rotation of the thread about the catheter axis relative to the channel (a) advances the first tissue anchor distally and moves the first tissue anchor distally away from the first position until the prong of the first tissue anchor exits the distal exit of the thread, and (b) advances the second tissue anchor distally away from the second position until the second tissue anchor moves distally to the first position.

[0101] For some applications, the system and / or device further includes a spring positioned within the catheter proximal to the second tissue anchor, the spring configured to facilitate distal movement of the first and second tissue anchors.

[0102] For some applications, the system and / or apparatus further includes an anchor driver including a driver head coupled to the flexible shaft.

[0103] For some applications, a driver head is dimensioned to slide axially within the lumen of the channel and is operable to reversibly engage a driver interface within the anchor storage zone.

[0104] For some applications, the anchor driver is configured to advance the anchor distally, away from the anchor storage zone, toward the distal opening of the catheter while the driver head is engaged with the driver interface, driving the tissue engaging portion into tissue along the tissue anchor axis.

[0105] For some applications, the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during rotation of the sled about the catheter axis relative to the channel.

[0106] For some applications, the system and / or apparatus includes an outer tube disposed around the channel and the thread such that the thread is disposed between the outer tube and the channel.

[0107] In some applications, the thread is movable and rotatable relative to the outer tube and relative to the channel.

[0108] For some applications, the inner surface of the outer tube defines a helical groove that defines the threads, such that rotation of the outer tube facilitates rotation of the threads.

[0109] For some applications, the tissue anchor defines a tissue anchor axis, the tissue engaging element is disposed along the axis and is rotatable about the tissue anchor axis, the tissue engaging element is configured to be driven into subject tissue along the tissue anchor axis, and the protrusion extends radially away from the tissue anchor axis.

[0110] For some applications, the anchor head is fixedly coupled to the tissue engaging portion and the prongs are rotatably coupled to the anchor head.

[0111] For some applications, the anchor head is positioned within the lumen.

[0112] In some applications, the thread defines a plurality of adjacent ribbons arranged in a spiral, the protrusion abuts a surface defining the depth of a distal ribbon of the plurality of ribbons and is within the pitch between the distal ribbon of the plurality of ribbons and an adjacent ribbon proximal to the distal ribbon of the plurality of ribbons, and the protrusion slides along the surface defining the depth of the distal ribbon of the plurality of ribbons during rotation of the thread about the catheter axis.

[0113] For some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, and the system and / or device further includes an anchor driver including a driver head coupled to the flexible shaft.

[0114] For some applications, a driver head is dimensioned to slide axially within the tissue anchor lumen and is operable to reversibly engage a driver interface within the anchor storage zone.

[0115] For some applications, the anchor driver is configured to advance the anchor distally, away from the anchor storage zone, toward the distal opening of the catheter while the driver head is engaged with the driver interface, driving the tissue engaging portion along the anchor axis and into tissue.

[0116] For some applications, the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during rotation of the sled about the catheter axis relative to the channel.

[0117] For some applications, the protrusions are shaped to define eyelets that define the openings.

[0118] For some applications, the system includes a wire slidably coupled to the at least one tissue anchor, the wire being threaded through an opening in the eyelet of the prong.

[0119] According to some applications, there is further provided a system and / or device comprising at least one tissue anchor and a catheter system.

[0120] For some applications, the catheter system includes an extracorporeal unit (e.g., a controller and / or handle) at a proximal portion of the catheter system and a transluminally advanceable catheter (e.g., a tube, etc.) extending distally from the controller to a distal opening of the catheter. For some applications, the catheter extends along a longitudinal axis of the catheter, e.g., when in a straight configuration.

[0121] For some applications, the catheter includes a channel that can include a generally tubular wall that defines a lumen along the length or axis of the catheter. The anchor can be positioned within the lumen.

[0122] In some applications, the dispenser is distal to the anchor, includes a proximal detent and a distal detent, and is operably coupled to the controller so as to be transitionable between an accepting state, a closed state, and a dispensing state by operation of the controller.

[0123] In some applications, in the accepted state, (i) the proximal detent is pushed away from the catheter shaft, allowing the anchor to move distally past the proximal detent into the dispenser, and (ii) the distal detent extends into the lumen, preventing the anchor from moving distally past the distal detent out of the dispenser.

[0124] In some applications, in the closed state, (a) the proximal detent extends into the lumen and prevents the anchor from moving proximally past the proximal detent and out of the dispenser, and (b) the distal detent extends into the lumen and prevents the anchor from moving distally past the distal detent and out of the dispenser.

[0125] In some applications, in the dispensed state, (1) the proximal detent expands into the lumen, preventing the anchor from moving proximally back past the proximal detent and out of the dispenser, and (2) the distal detent is pushed away from the catheter shaft, allowing the anchor to move distally past the distal detent and out of the dispenser.

[0126] In some applications, the system and / or device further includes a tubular structure surrounding at least a portion of the channel, the tubular structure coupled to the dispenser such that longitudinal movement of the tubular structure in distal and proximal directions along the channel easily compresses the proximal and distal detents and easily expands the proximal and distal detents within the lumen of the channel.

[0127] For some applications, the tubular wall of the channel is shaped to define a side window outside the lumen, the window having a proximal end and a distal end, and the tubular structure surrounds at least a portion of the channel at the side window.

[0128] In some applications, moving the tubular structure proximally relative to the side window facilitates compressing the proximal detent against the proximal end of the window, thereby moving the proximal detent away from the catheter shaft.

[0129] In some applications, moving the tubular structure distally relative to the side window facilitates compressing the distal detent against the distal end of the window, thereby moving the distal detent away from the catheter shaft.

[0130] For some applications, the system and / or device further includes an outer tube disposed around the tubular structure such that the tubular structure is disposed between the outer tube and the channel.

[0131] For some applications, the at least one tissue anchor defines a first tissue anchor, and the system and / or device further includes at least one other tissue anchor disposed in the lumen proximal to the dispenser.

[0132] For some applications, following a dispensing state in which a first tissue anchor moves distally past the distal detent and out of the dispenser, the dispenser returns to a receiving state in which the dispenser allows at least one other anchor to move distally into the dispenser past the proximal detent, the dispenser transitions to a closed state in which the dispenser prevents at least one other anchor from moving distally past the distal detent and out of the dispenser, and subsequently the dispenser transitions to a dispensing state in which the dispenser allows at least one other tissue anchor to move distally past the distal detent and out of the dispenser.

[0133] For some applications, the systems and devices include a spring positioned within the catheter proximal to the at least one other tissue anchor, the spring configured to facilitate distal movement of the first tissue anchor and the at least one other tissue anchor.

[0134] For some applications, the at least one tissue anchor includes a tissue engaging portion, an anchor head, and an eyelet. The tissue engaging portion can be disposed within the lumen of the channel and define a tissue anchor axis. The anchor head can couple to the tissue engaging portion and define a driver interface, and the eyelet can define an opening. For some applications, the eyelet protrudes laterally relative to the tissue engaging portion.

[0135] For some applications, the eyelet rotatably couples to the tissue engaging portion via the anchor head.

[0136] For some applications, the systems and devices further include a wire slidably coupled to the at least one tissue anchor, the wire being threaded through the opening in the eyelet.

[0137] For some applications, the system and / or device further includes an anchor driver having a driver head coupled to the flexible shaft. The driver head can be dimensioned to slide axially within the lumen and operable to reversibly engage a driver interface of the at least one tissue anchor. The anchor driver can be configured to advance the anchor distally toward the distal opening of the catheter while the driver head is engaged with the driver interface, driving the tissue-engaging portion along the tissue anchor axis and into tissue.

[0138] For some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, a driver head of the anchor driver can be dimensioned to slide axially within the tissue anchor lumen and actuable to reversibly engage the driver interface, and a flexible shaft of the anchor driver can be dimensioned to slide axially within the tissue anchor lumen.

[0139] For some applications, the tubular wall of the channel is shaped to define a side slit at its distal portion that extends along at least a portion of the channel.

[0140] For some applications, the eyelet projects laterally relative to the tissue engaging portion so as to extend through a side slit.

[0141] According to some applications, there is further provided a system and / or device comprising at least one tissue anchor and a catheter system, which can include an extracorporeal unit (e.g., a controller and / or handle) at a proximal portion of the catheter system and a transluminally advanceable catheter extending distally from the controller to a distal opening of the catheter.

[0142] The catheter can extend from the controller to a distal opening of the catheter, for example in a straight configuration, along the longitudinal axis of the catheter.

[0143] For some applications, the catheter includes a channel having a generally tubular wall defining a lumen along the catheter axis. The anchor can be disposed within the lumen. The tubular wall can be shaped to define at least one detent having a side detent slit defining the movable tab. The protrusion can be coupled to an inner surface of the movable tab facing the lumen of the channel.

[0144] In some applications, the overtube is slidably disposed about the channel and operably coupled to the controller such that the overtube is movable by operation of the controller, and the detent is movable between a closed state and an open state.

[0145] In some applications, in the closed state, (i) the overtube surrounds the movable tab, (ii) the movable tab aligns with the tubular wall of the channel, and (iii) the protrusion extends into the lumen of the channel, preventing the anchor from moving distally past the protrusion.

[0146] In some applications, in the open state, (a) the overtube is retracted from the movable tab, and (b) the movable tab is displaceable away from the catheter shaft, moving the protrusion away from the catheter shaft and allowing the anchor to move distally past the protrusion.

[0147] For some applications, the overtube is shaped to define a side window configured to align with the protrusion during the open state in a manner that facilitates movement of the protrusion away from the catheter shaft.

[0148] For some applications, the at least one anchor defines a first tissue anchor, and the system and / or device further includes at least one other tissue anchor disposed in the lumen proximal to the first tissue anchor.

[0149] For some applications, the at least one detent defines a first detent and the tubular wall is shaped to define at least one other detent having another side detent slit defining a second detent movable tab.

[0150] For some applications, the system and / or device further comprises another detent protrusion that couples to an inner surface of the another detent movable tab that faces the lumen of the channel.

[0151] In some applications, following the first detent's open state in which the first tissue anchor is moved distally past the first detent's protrusion, the overtube can be retracted distally, thereby allowing at least one other detent to transition between a closed state and an open state.

[0152] In some applications, in the closed state, (i) the overtube surrounds the other detent movable tab, (ii) the other detent movable tab aligns with the tubular wall of the channel, and (iii) the other detent protrusion extends into the lumen, preventing the anchor from moving distally past the other detent protrusion.

[0153] In some applications, in the open state, (i) the overtube is pulled back from the separate detent movable tab, and (ii) the separate detent movable tab is displaceable away from the catheter shaft, moving the separate detent protrusion away from the catheter shaft and allowing the anchor to move distally past the separate detent protrusion.

[0154] For some applications, a first tissue anchor is positioned at a first position relative to the channel and another tissue anchor is positioned at a second position relative to the channel proximal to the first position.

[0155] For some applications, the system and / or device further includes an anchor driver configured to (1) engage a first tissue anchor at a first position during a closed state of a first detent, and (2) engage another tissue anchor at a second position during a closed state of another detent.

[0156] For some applications, the at least one tissue anchor comprises a tissue engaging portion and an anchor head. For some applications, the tissue engaging portion is disposed or positionable within the lumen of the channel. For some applications, the tissue engaging portion defines a tissue anchor axis.

[0157] For some applications, the anchor head couples to the tissue-engaging portion and defines a driver interface. For some applications, the anchor head includes an eyelet defining an opening. For some applications, the eyelet protrudes laterally relative to the tissue-engaging portion.

[0158] For some applications, the eyelet rotatably couples to the tissue engaging portion via the anchor head.

[0159] In some applications, the tissue-engaging portion is shaped to define a helical tissue-engaging portion, and the protrusions of the detent are configured to be disposed between adjacent sub-components of the helical tissue-engaging portion in the closed state of the detent.

[0160] For some applications, the systems and devices further include a wire slidably coupled to the at least one tissue anchor, the wire being threaded through the opening in the eyelet.

[0161] For some applications, the system and / or apparatus further includes an anchor driver including a driver head coupled to the flexible shaft.

[0162] For some applications, a driver head is dimensioned to slide axially within the lumen and is operable to reversibly engage a driver interface of the at least one tissue anchor.

[0163] For some applications, the anchor driver is configured to advance the anchor distally toward the distal opening of the catheter while the driver head is engaged with the driver interface, driving the tissue engaging portion along the tissue anchor axis and into tissue.

[0164] For some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, a driver head of the anchor driver is dimensioned to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface, and a flexible shaft of the anchor driver is dimensioned to slide axially within the tissue anchor lumen.

[0165] For some applications, the tubular wall of the channel is shaped to define a side slit at its distal portion that extends along at least a portion of the channel.

[0166] For some applications, the eyelet projects laterally relative to the tissue engaging portion so as to extend through a side slit.

[0167] According to some applications, there is further provided a system and / or device including at least first and second tissue anchors and a catheter system. For some applications, the catheter system includes a transluminally advanceable catheter extending distally from the controller. The catheter can extend along a longitudinal axis of the catheter, for example, when in a straight configuration, from the controller to a distal opening of the catheter.

[0168] For some applications, the catheter comprises a channel and an extracorporeal unit (e.g., a controller and / or a handle). For some applications, the channel comprises a generally tubular wall defining a lumen along the catheter shaft for passage of the first and second tissue anchors.

[0169] In some applications, the extracorporeal unit is in the proximal portion of the catheter system, and the extracorporeal unit comprises a handle.

[0170] For some applications, the handle is shaped to define an anchor driver sublumen that aligns with the lumen of the channel of the transluminally advanceable catheter and has an anchor driver sublumen axis along the catheter axis.

[0171] For some applications, the handle is formed to define an anchor storage sublumen that is offset relative to the lumen of the channel of the transluminally advanceable catheter and relative to the anchor driver sublumen, the anchor storage sublumen defining an anchor storage zone that houses the first and second tissue anchors.

[0172] For some applications, the handle includes a rotation stop at a distal end of the handle, the rotation stop being shaped to define a receiving lumen for receiving one of the first and second tissue anchors.

[0173] In some applications, the rotation stop is rotatable about the catheter axis such that, in the rotation stop receiving state, the receiving lumen of the rotation stop is aligned with the anchor storage sub-lumen to receive one of the first and second tissue anchors from the anchor storage zone, and in the rotation stop loading state, the receiving lumen of the rotation stop is aligned with the anchor driver sub-lumen, allowing one of the first and second tissue anchors to pass through the lumen of the channel of the transluminally advanceable catheter.

[0174] In some applications, the anchor storage sublumen and the anchor driver sublumen are parallel.

[0175] For some applications, the system and / or device further includes a spring disposed within the anchor storage sublumen proximal to at least the second tissue anchor, the spring configured to facilitate distal movement of the first and second tissue anchors.

[0176] In some applications, the anchor storage sub-lumen and the anchor driver sub-lumen are in fluid communication.

[0177] For some applications, each of the first and second tissue anchors includes a respective tissue engaging portion defining a tissue anchor shaft, a respective anchor head connecting to the tissue engaging portion and defining a driver interface, and a respective eyelet defining an opening, each eyelet projecting laterally relative to the tissue engaging portion.

[0178] For some applications, each eyelet rotatably couples to a respective tissue-engaging portion via a respective anchor head.

[0179] For some applications, the system and / or device further includes a wire slidably coupled to the first and second tissue anchors, the wire being threaded through an opening in the eyelet of each of the first and second tissue anchors.

[0180] In some applications, the wire is disposed between the anchor driver sub-lumen and the anchor storage sub-lumen.

[0181] For some applications, the wire extends within the lumen of a channel of a transluminally advanceable catheter.

[0182] For some applications, each of the first and second tissue anchors is rotatable about the wire by a rotation stop.

[0183] For some applications, the system and / or device further includes an anchor driver slidable partially within the anchor driver sublumen and partially within the lumen of the channel of the transluminally advanceable catheter, the anchor driver including a driver head coupled to the flexible shaft.

[0184] For some applications, the driver head is dimensioned to slide axially partially within the anchor driver sub-lumen and within the lumen of the channel of the transluminally advanceable catheter, and is operable to reversibly engage the driver interfaces of the respective first and second tissue anchors.

[0185] For some applications, the anchor driver is configured to advance the tissue anchor distally toward the distal opening of the catheter while the driver head is engaged with the driver interface, driving the tissue engaging portion along the tissue anchor axis and into tissue.

[0186] For some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, a driver head of the anchor driver is dimensioned to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface, and a flexible shaft of the anchor driver is dimensioned to slide axially within the tissue anchor lumen.

[0187] For some applications, the tubular wall of the channel is shaped to define a side slit at its distal portion that extends along at least a portion of the channel.

[0188] For some applications, each eyelet projects laterally relative to the tissue engaging portion so as to extend through a side slit.

[0189] According to some applications, there is further provided an anchor driver for use with a tissue anchor that is shaped to define a driver interface having a proximal rim and a recess surrounded by a wall of the tissue anchor extending distally from the proximal rim.

[0190] For some applications, the anchor driver includes a flexible shaft and a driver head coupled to the flexible shaft. For some applications, the driver head is shaped to define the first and second legs defining a first space having a first distance between each other and having a rest state in which the first and second legs do not contact a wall of the tissue anchor surrounding the recess.

[0191] For some applications, the tie bar is disposed at least partially between the first and second legs.

[0192] For some applications, the first and second expandable elements are slidable relative to the flexible shaft and relative to the first and second legs, and the first and second expandable elements are positioned upstream of the tie bar in a stationary state of the first and second legs of the anchor driver. For some applications, the first and second expandable elements can be configured to be or include one or more of a wire, an arm, a rod, a latch, a lever, an extension, an expandable ring, an expandable helix, etc. For example, for some applications, the first and second expandable elements comprise first and second wires.

[0193] For some applications, the first and second expansion elements are advanceable around the connecting bar and into the first space between the first and second legs to spread the first and second legs such that the first and second legs define a second space having a second distance between them that is greater than the first distance, and the first and second legs assume an engaged state in which they contact and engage the wall of the tissue anchor surrounding the recess.

[0194] For some applications, the distal surfaces of the respective ends of the first and second expanding elements press against the proximal rim of the tissue anchor when the first and second legs are engaged, facilitating impaction of the tissue anchor when the first and second legs are engaged.

[0195] For some applications, the system and / or device further includes an advancement element slidably coupled to the flexible shaft, the advancement element coupled to the first and second expandable elements and slidable relative to the flexible shaft to push the first and second expandable elements distally. For some applications, the advancement element can be or be configured to include one or more of a wire, a rod, a shaft, a hypotube, an extension, etc.

[0196] For some applications, the first and second expansion elements extend along a plane that is perpendicular to the plane along which the first and second legs extend.

[0197] For some applications, the anchor driver is dimensioned to slide axially through a lumen defined by the tissue anchor in the resting state of the first and second legs and to selectively and reversibly engage a wall of the tissue anchor surrounding the recess.

[0198] For some applications, the first and second expansion elements are dimensioned to (a) assume a collapsed state between the resting state of the first and second legs, (b) expand around the tie bar to transition the first and second legs to an engaged state of the first and second legs, and (c) thereafter be retractable to return the first and second expansion elements to the collapsed state and release the anchor driver from the tissue anchor.

[0199] According to some applications, there is also provided an anchor driver for use with a tissue anchor that is shaped to define a driver interface having a proximal rim and a recess surrounded by a wall of the tissue anchor extending distally from the proximal rim.

[0200] For some applications, the anchor driver includes a flexible advancement element and a driver head coupled to the flexible advancement element. For some applications, the advancement element can be or be configured to include one or more of a wire, a rod, a shaft, a hypotube, an extension, or the like.

[0201] For some applications, the driver head is shaped to define the first and second legs defining a first space having a first distance between them and having a rest state in which the first and second legs do not contact a wall of the tissue anchor surrounding the recess.

[0202] For some applications, the expansion element is slidable between the first and second legs relative to the flexible advancement element.

[0203] For some applications, the first and second expansion elements are disposed on distal surfaces of the first and second legs of the anchor driver in a resting state of the first and second legs.

[0204] For some applications, the first and second expansion elements are advanceable proximally and into a first space between the first and second legs to spread the first and second legs such that the first and second legs define a second space having a second distance between them that is greater than the first distance, and assume an engaged state in which the first and second legs contact and engage the wall of the tissue anchor surrounding the recess.

[0205] In some applications, in the rest state, the first and second legs together form a circular shape, and in the engaged state, the first and second legs together form an oval shape.

[0206] For some applications, the expansion element comprises a circular disk having a diameter greater than the first space between the first and second legs in a resting state, and when the expansion element is positioned between the first and second legs, the first and second legs expand and assume an engaged state.

[0207] For some applications, the expansion element comprises an oval disk having a major axis diameter greater than the first space between the first and second legs in a resting state, and when the expansion element is positioned between the first and second legs, the first and second legs expand to assume an engaged state.

[0208] For some applications, the system and / or device further includes a displacement element slidably coupled to the advancement element, the displacement element coupled to the expansion element and slidable relative to the advancement element to pull the expansion element proximally into the first space between the first and second legs.

[0209] For some applications, an anchor driver is dimensioned to slide axially through a lumen defined by the tissue anchor and selectively and reversibly engage a wall of the tissue anchor surrounding the recess.

[0210] For some applications, the expander element can be pushed distally to return the first and second legs to a resting position and release the anchor driver from the tissue anchor.

[0211] According to some applications, there is also provided an anchor driver for use with a tissue anchor that is shaped to define a driver interface having a proximal rim and a recess surrounded by a wall of the tissue anchor extending distally from the proximal rim.

[0212] For some applications, the anchor driver includes a flexible tube and a driver head that couples to the flexible tube.

[0213] In some applications, the driver head is shaped so that the deflectable protrusions have a rest state in which the protrusions are pushed toward a central axis defined by the flexible tube and do not contact the tissue anchor.

[0214] For some applications, the shaft is disposed within the lumen of the flexible tube and is engageable with the deflectable protrusions, such that when the shaft slides along the deflectable protrusions, the shaft deflects the deflectable protrusions from a pushed-in state away from the central axis to an engaged state in which the deflectable protrusions engage with the tissue anchor; and

[0215] In some applications, the first and second expanding elements are coupled to the outer surface of the flexible tube and are expandable proximally to the tissue anchor, the first and second expanding elements having respective distal surfaces at respective ends of the first and second expanding elements, and when the deflectable protrusions are engaged, they press against the proximal rim of the tissue anchor to facilitate impaction of the tissue anchor.

[0216] For some applications, the anchor driver is dimensioned to slide axially through a lumen defined by the tissue anchor and to selectively and reversibly engage the tissue anchor in response to movement of the shaft.

[0217] For some applications, the first and second expandable elements are retractable while being pulled through the lumen of the tissue anchor and expandable upon exiting the lumen.

[0218] For some applications, the shaft can be retracted away from the deflectable prongs to facilitate deflection of the deflectable prongs from an engaged state to a depressed state toward the central axis, disengaging the anchor driver from the tissue anchor.

[0219] Further provided is a system and / or device for use in a subject, comprising a catheter device, a tether, a plurality of tissue anchors, and an anchor driver.

[0220] For some applications, the catheter device includes a distal member or section configured for advancement into a subject, and an extracorporeal proximal unit (e.g., controller, handle, etc.) that includes a housing and a tensioner.

[0221] For some applications, the tether has a proximal portion comprising a proximal end of the tether. For some applications, the tether extends distally from the proximal portion through the catheter device to a distal portion of the tether, the distal portion being disposed distally from the tensioner and comprising the distal end of the tether. For some applications, the tensioner is configured to pull the tether proximally.

[0222] In some applications, the multiple tissue anchors each include a tissue engaging element and a head defining an eyelet through which the tether is threaded, and the multiple tissue anchors are positioned one after the other along the tether proximally from the tensioner.

[0223] For some applications, for each of the anchors sequentially, the anchor driver is configured to reversibly couple to the anchor and advance the anchor distally along the tether and past the tensioner.

[0224] For some applications, the tensioner includes a spring coupled to the housing and reversibly lockable to the tether, such that the spring causes the tensioner to pull the tether proximally while the spring is under stress and locked to the tether.

[0225] For some applications, the spring is a compression spring, configured to be stressed by compression and to draw the tether proximally by stretching.

[0226] For some applications, the tensioner further includes a clamp coupled to the spring and reversibly movable between an unclamped state and a clamped state, wherein a tether extends distally through the catheter device such that the spring is locked to the tether when the clamp is in the clamped state.

[0227] In some applications, the tensioner includes an actuator that, when actuated, transitions the clamp between an unclamped state and a clamped state.

[0228] In some applications, the actuator includes a ring that surrounds the clamp, and rotation of the ring transitions the clamp between an unclamped state and a clamped state.

[0229] In some applications, the clamp is biased toward the unclamped state.

[0230] In some applications, the clamp and ring together function as a chuck.

[0231] In some applications, the ring has an inner surface, the clamp has an outer surface, and at least one surface selected from the group consisting of the inner surface of the ring and the outer surface of the clamp is tapered, and axial movement of the ring relative to the clamp urges the clamp toward the clamped state.

[0232] In some applications, the ring has internal threads and the clamp has external threads, and rotation of the ring screws the ring onto the clamp.

[0233] For some applications, the anchor driver includes a shaft and a driver head at a distal end of the shaft, the driver head being reversibly couplable to each of the tissue anchors. For some applications, the tether extends through the tensioner, thereby defining a tether axis, and the catheter device is shaped to provide a non-clamping zone laterally from the tether axis, the non-clamping zone being shaped and dimensioned to accommodate the laterally displaced shaft after the driver advances a given one of the anchors distally along the tether and past the tensioner, such that the shaft bypasses the clamp and extends distally toward the anchor.

[0234] For some applications, the clamp defines a plurality of clamping surfaces configured to engage the tether when the clamp is in a clamped state, and the catheter device is shaped such that non-clamping zones are provided by the clamping surfaces that are eccentric relative to the tether axis.

[0235] For some applications, when the clamp is in a clamped state, the clamp defines first and second clamping surfaces configured to engage the tether, and in an unclamped state, the clamp defines a gap between the first and second clamping surfaces, and each of the tissue anchors is dimensioned to be advanced distally through the gap along the tether by an anchor driver.

[0236] For some applications, the anchor driver includes a shaft and a driver head at a distal end of the shaft, the driver head reversibly coupleable to each of the tissue anchors, and for each of the anchors sequentially, the anchor driver is dimensioned to advance the anchor along the tether, with the anchor, driver head, and at least a distal portion of the shaft passing distally through the gap.

[0237] For some applications, the extracorporeal unit is shaped to define a non-clamping zone laterally from the clamp, the non-clamping zone being shaped and dimensioned to receive a portion of the shaft disposed in the gap when the portion of the shaft is moved laterally out of the gap and into the non-clamping zone.

[0238] For some applications, the extracorporeal unit includes a lock configured to lock the spring in a stressed state in which the spring is under stress when locked.

[0239] In some applications, the clamp can transition to a clamped state while the lock remains locked.

[0240] In some applications, the lock is configured to lock the spring in a stressed state when locked, by locking the clamp to the housing.

[0241] For some applications, the lock is configured to unlock the clamp from the housing while the clamp remains in the clamped state, thereby actuating the spring and causing the tensioner to draw the tether proximally.

[0242] In some applications, the lock includes a detent and a recess.

[0243] For some applications, the clamp defines a recess and the housing includes a detent.

[0244] In some applications, the clamp can be put into the clamped state by compressing the clamp.

[0245] For some applications, the lock is configured so that once the clamp is in the clamped state, further depression of the clamp unlocks the clamp from the housing, thereby actuating the spring and causing the tensioner to pull the tether proximally.

[0246] According to some applications, there is further provided a system and / or device for use on a subject, comprising the catheter device, the tether, the plurality of tissue anchors, and the anchor driver.

[0247] For some applications, the catheter device includes a distal member or portion configured for advancement into a subject and an extracorporeal unit at a proximal portion of the catheter device, hi some applications, the extracorporeal unit includes a winch.

[0248] The winch can be configured with a spring and a spool coupled to the spring, where rotation of the spool in a first rotational direction stresses the spring.

[0249] For some applications, the tether has a distal portion comprising a distal end of the tether and a proximal portion comprising a proximal end of the tether, hi some applications, the proximal portion is wound around a spool, and pulling the distal portion of the tether away from the winch rotates the spool in a first rotational direction, thereby unwinding the tether from the spool.

[0250] For some applications, each of the plurality of tissue anchors includes a tissue engaging element and a head, hi some applications, the head defines an eyelet.

[0251] For some applications, the eyelets of multiple tissue anchors are threaded with the tether, and multiple tissue anchors are positioned one after the other along the tether, for example, between the spool and the distal end of the tether.

[0252] For some applications, the anchor driver is configured to be used sequentially for each of the anchors to reversibly couple to the anchors and advance the anchors distally along the tether toward the distal end of the tether.

[0253] In some applications, the winch is configured to tension the tether by causing the spring to reduce slack in the tether and push the spool in a second rotational direction opposite the first rotational direction in response to stress applied to the spring.

[0254] For some applications, the winch further comprises a reversibly actuable ratchet that, during operation, allows the spool to rotate in a first rotational direction and prevents rotation of the spool in a second rotational direction, and, during stoppage, allows the spool to rotate in both the first and second rotational directions.

[0255] For some applications, the ratchet includes a gear coupled to the spool, where rotation of the spool rotates the gear; a pawl reversibly engageable with the gear, whereby the ratchet is activated when the pawl engages the gear and deactivated when the pawl disengages from the gear; and a switch configured to activate and deactivate the ratchet by moving the pawl between engaging and disengaging with the gear.

[0256] For some applications, the system and / or device further includes a stopper fixedly attached to a distal portion of the tether, the stopper preventing advancement of any anchor in the series distally along the tether beyond the stopper, such that advancement of a first tissue anchor in the series distally away from the winch by the anchor driver pushes the stopper distally and pulls the distal portion of the tether away from the winch.

[0257] In some applications, the distal member or portion comprises a catheter having a proximal opening, a distal opening configured to be advanced into the subject, and defining a lumen between the proximal and distal openings.

[0258] For some applications, multiple tissue anchors are attached in series to the extracorporeal unit of the catheter device.

[0259] For some applications, the system and / or apparatus further comprises a series of cartridges.

[0260] For some applications, each of the cartridges holds a respective tissue anchor of a plurality of anchors or a series of tissue anchors.

[0261] For some applications, each cartridge couples to the extracorporeal unit at a respective initial position in a series of initial positions. For some applications, each cartridge is movable from its respective initial position while remaining coupled to the extracorporeal unit to a deployed position in which the cartridge holds a respective tissue anchor opposite the proximal opening. For some applications, each cartridge can be later removed from the deployed position, leaving the deployed position free for a subsequent cartridge in the series.

[0262] For some applications, the anchor driver is configured to couple to each of the anchors while the anchor is held by a respective cartridge opposite the proximal opening and advance the anchor distally out of the respective cartridge, through the proximal opening, and through the catheter toward the distal opening.

[0263] For some applications, the spool is mounted for rotation about an axis of rotation, the lumen defines a lumen axis, and the axis of rotation is parallel to the lumen axis.

[0264] For some applications, the spool is mounted for rotation about an axis of rotation, the lumen defines a lumen axis, and the axis of rotation is coaxial with the lumen axis.

[0265] In some applications, the spool surrounds the catheter.

[0266] In some applications, the spool is concentric with the catheter.

[0267] The methods herein, or methods using the systems, apparatus, devices, etc. described herein, can be performed on live animals or in simulations, such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues), etc.

[0268] The present invention will be more fully understood from the following detailed description taken in conjunction with the drawings, in which: [Brief explanation of the drawings]

[0269] [Figure 1A] 1A-B and 2A-B are schematic diagrams of examples of catheter systems comprising a transluminally advanceable catheter with a helical thread for controlling the advancement of a tissue anchor, according to some applications. [Figure 1B] Same as above. [Figure 2A] Same as above. [Figure 2B] Same as above. [Figure 3A] 3A-B and 4A-B are schematic diagrams of examples of catheter systems comprising a transluminally advanceable catheter with multiple detents for controlling the advancement of tissue anchors, according to some applications. [Figure 3B] Same as above. [Figure 4A] Same as above. [Figure 4B] Same as above. [Figure 5A]5A-C are schematic diagrams of examples of catheter systems comprising a transluminally advanceable catheter with a dispenser for controlling the advancement of tissue anchors, according to some applications. [Figure 5B] Same as above. [Figure 5C] Same as above. [Figure 6A] 6A-E are schematic diagrams of examples of catheter systems comprising a transluminally advanceable catheter with a handle comprising a rotation stop for controlling the advancement of a tissue anchor, according to some applications. [Figure 6B] Same as above. [Figure 6C] Same as above. [Figure 6D] Same as above. [Figure 6E] Same as above. [Figure 7A] 7A-F, 8A-C, and 9A-B are schematic diagrams of respective embodiments of catheter systems including a transluminally advanceable catheter, at least one tissue anchor, an implant, and a respective anchor driver for use in implanting tissue anchors, according to respective applications. [Figure 7B] Same as above. [Figure 7C] Same as above. [Figure 7D] Same as above. [Figure 7E] Same as above. [Figure 7F] Same as above. [Figure 8A] Same as above. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 9A] Same as above. [Figure 9B] Same as above. [Figure 10] 10, 11A-B, 12A-B, 13A-E, 14A-E, and 15A-B are schematic diagrams of exemplary systems for use on a subject, according to several applications. [Figure 11A] Same as above. [Figure 11B] Same as above. [Figure 12A] Same as above. [Figure 12B] Same as above. [Figure 13A] Same as above. [Figure 13B] Same as above. [Figure 13C] Same as above. [Figure 13D] Same as above. [Figure 13E] Same as above. [Figure 14A] Same as above. [Figure 14B] Same as above. [Figure 14C] Same as above. [Figure 14D] Same as above. [Figure 14E] Same as above. [Figure 15A] Same as above. [Figure 15B] Same as above. [Figure 16A] 16A-F are schematic diagrams of another system for use on a subject, according to some applications. [Figure 16B] Same as above. [Figure 16C] Same as above. [Figure 16D] Same as above. [Figure 16E] Same as above. [Figure 16F] Same as above. [Figure 17A] 17A-F and 18A-B are schematic diagrams of exemplary systems for use on a subject, according to several applications. [Figure 17B] Same as above. [Figure 17C] Same as above. [Figure 17D] Same as above. [Figure 17E] Same as above. [Figure 17F] Same as above. [Figure 18A] Same as above. [Figure 18B] Same as above. [Figure 19A] 19A-B are schematic diagrams of ports according to some applications. [Figure 19B] Same as above. [Figure 20A] 20A-H are schematic diagrams of exemplary systems for use on subjects, according to several applications. [Figure 20B] Same as above. [Figure 20C] Same as above. [Figure 20D] Same as above. [Figure 20E] Same as above. [Figure 20F] Same as above. [Figure 20G] Same as above. [Figure 20H] Same as above. DETAILED DESCRIPTION OF THE INVENTION

[0270] 1A-B and 2A-B, which are schematic illustrations of example catheter system 40 including a transluminally advanceable catheter 12, at least one tissue anchor 220, and an implant 210 including the tissue anchor, and techniques for use therewith, according to several application examples. System 40 is a tissue adjustment system and can be used to adjust the dimensions of a tissue structure. For example, system 40 can be an annuloplasty system and implant 210 can be an annuloplasty structure.

[0271] The system 40 includes an extracorporeal unit (e.g., a controller and / or handle) 18 proximal to the system 40. The transluminally advanceable catheter 12 couples to the extracorporeal unit 18 at the proximal end of the catheter 12 and extends distally therefrom along the catheter longitudinal axis 16 of the catheter 12 from the unit 18 to the distal opening 14 of the catheter 12. The transluminally advanceable catheter 12 includes a channel 254, e.g., a flexible tube having a generally tubular wall defining a lumen along the catheter axis 16. The tubular wall of the channel 254 is shaped at its distal portion to define a side slit 256 extending along at least a portion of the channel 254. The slit 256 defines a linear slit disposed parallel to the axis 16. The tubular wall of the channel 254 defines a longitudinal lumen along the channel 254. For the portion of the tubular wall of the channel 254 that defines the slit 256 , the lumen of the channel 254 at the slit 256 is not closed by the slit 256 .

[0272] The channel 254 is shaped to accommodate the implant 210 during delivery into the patient's tissue 10. In applications where the tissue 10 represents tissue of the annulus of a native heart valve, such as the mitral valve, the implant 210 is an annuloplasty structure comprising a wire 212 and a plurality of anchors 220. Each anchor 220 is shaped to define a central longitudinal anchor axis ax2. Each anchor 220 comprises a tissue-engaging element 230 and an anchor head 280. The tissue-engaging element 230 has a proximal end 232 and a distal end 234, defining the central longitudinal axis ax2 of the anchor 220. At the distal end 234, the tissue-engaging element 230 comprises a sharpened distal tip 238, and the tissue-engaging element is configured to be driven (e.g., screwed) into the subject's tissue. In some applications, as shown, tissue engaging element 230 is helical and defines a central lumen 436 along axis ax2. If desired, tissue engaging element 230 can be another type of tissue engaging element, such as a dart or a staple.

[0273] The head 280 couples to the proximal end 232 of the tissue engaging element 230 and includes a driver interface 282 and an eyelet 240 defining an opening 246 therethrough. The driver interface 282 is configured to be reversibly engaged by a flexible anchor driver 260. For some applications, the eyelet 240 comprises a structural element that protrudes laterally relative to the tissue engaging element 230. The driver 260 can include an elongated, flexible shaft 261 and a driver head 264 coupled to a distal end of the shaft. The driver head 264 is the component of the anchor driver 260 that reversibly engages the driver interface 282. The driver interface 282 can be rigidly coupled to the tissue engaging element 230.

[0274] For some applications, driver interface 282 includes walls that are shaped to define a recess surrounded by the walls. For some applications, the walls surrounding the recess are shaped as circular walls, as shown in FIG. 2B. For some applications, the walls surrounding the recess are square.

[0275] In some applications, as shown, driver interface 282 is positioned on central longitudinal axis ax2 and eyelets 240 are positioned laterally from axis ax2.

[0276] As described in more detail below, anchor 220 (e.g., its eyelet 240) is configured to easily slide the anchor along (or slide the wire through) wire 212 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 220 along the wire. Also, as described in more detail below, anchor 220 (e.g., its eyelet 240) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 240. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as annuloplasty.

[0277] The transluminally advanceable catheter 12 includes a helical thread 20 that overlaps, e.g., is coaxial with, the channel 254 and operably couples to the extracorporeal unit 18, such that operation of the unit 18 allows the thread 20 to rotate about the catheter axis 16 relative to the channel 254. The transluminally advanceable catheter 12 has an anchor storage zone 22 in which the thread 20 is at least partially aligned longitudinally with a slit 256 in the channel 254. The alignment of the thread 20 with the channel 254 defines the anchor storage zone 22. For some applications, the thread 20 and the channel 254 are concentrically arranged. A plurality of anchors 220 of the implant 210 are disposed within the anchor storage zone 22. For some applications, the transluminally advanceable catheter 12 includes an outer tube 252. In applications in which the catheter 12 includes an outer tube 252, the outer tube 252 is shaped to define a distal linear slit extending proximally from the opening 14 of the catheter 12 and aligned with the slit 256 in the channel 254. In such applications, the catheter 12 defines an inner tube disposed between the outer tube 252 and the channel 254, and the thread 20 is coupled to the distal end of the inner tube such that rotation of the inner tube rotates the thread 20. In many cases, as shown, the thread 20 defines a tubular structure. In some applications, the thread 20 is created from the inner tube by cutting a helical slit in the inner tube. For any application in which the thread 20 is coupled to or formed from the distal end of the inner tube, the thread 20 is rotatable relative to both the channel 254 and the outer tube 252. For some applications, catheter 12 does not include an inner tube, but rather the inner surface of outer tube 252 defines a helical groove that defines thread 20 such that rotation of outer tube 252 easily rotates thread 20 relative to channel 254. For some applications, outer tube 252 comprises a polymer.

[0278] The anchor storage zone 22 has a distal end that is positioned proximal to the distal opening 14 of the catheter 12. This leaves the distal portion of the catheter 12 free of anchors 220, allowing for flexibility and maneuverability of the end of the catheter 12. The distal end of the anchor storage zone 22 may be 90 cm or less, e.g., 25 cm or less, from the distal opening 14 to maintain a level of user comfort and stability. In some applications, the distal end of the zone 22 is 3 cm to 25 cm, e.g., 5 cm to 25 cm, from the distal opening 14.

[0279] In some applications, as shown, eyelet 240 is mounted so as to be rotatable about axis ax2. For example, head 280 can include a ring 284 to which eyelet 240 is mounted. Ring 284 surrounds and is rotatable about axis ax2, such as by being rotatably coupled to tissue engaging element 230, by being rotatably coupled to another component of head 280 (e.g., driver interface 282), for example, that is fixedly coupled to the tissue engaging element.

[0280] In some applications, the eyelet 240 is mounted so as to be stationary relative to the axis ax2, as shown. In such applications, the head 280 does not include the ring 284; rather, the eyelet 240 is mounted directly to the head 280.

[0281] Each tissue anchor 220 includes a protrusion 241 that couples to tissue-engaging element 230 via anchor head 280. In some applications, protrusion 241 couples to or is molded from and extends from eyelet 240, e.g., a structural element of eyelet 240. In some applications, protrusion 241 is molded to define eyelet 240, which defines opening 246. In some applications, protrusion 241 rotatably couples to tissue-engaging element 230, e.g., by coupling to ring 284. In other applications, head 280 does not include ring 284, but rather, protrusion 241 is attached directly to head 280. The protrusion 241 extends through the slit 256 of the channel 254 and protrudes laterally relative to the tissue engagement element 230 to engage with the thread 20, (1) securing the tissue anchor 220 within the anchor storage zone 22 while the thread 20 is stationary relative to the channel 254, and (2) rotating the thread 20 around the catheter axis 16 relative to the channel 254 advances the tissue anchor 220 distally until the protrusion 241 exits the distal exit of the thread 20.

[0282] The thread 20 is shaped to define a plurality of adjacent ribbons 24, or coils, arranged in a helical configuration. The plurality of ribbons have a pitch 28 between adjacent ribbons. Each ribbon 24 has a surface 26 that defines the depth of the ribbon 24. A protrusion 241 of each anchor 220 abuts the respective surface 26 of a given ribbon 24 and is within the pitch 28 between adjacent ribbons. As the thread 20 rotates about the catheter shaft 16, the protrusion 241 of each anchor 220 slides along the surface 26 of the ribbon 24. As the thread 20 rotates and the protrusions 241 slide along the surface 26, the anchor 220 linearly advances distally along the shaft 16 of the catheter 12. As shown in FIG. 1A, prior to rotation of the thread 20 and while the thread 20 is stationary, the first, most distal tissue anchor 220a is positioned at a first position 30a relative to the channel 254, distal to a second tissue anchor 220b that is positioned at a second position 30b proximal to the first position 30a.

[0283] As shown in FIG. 1B, rotation of the thread 20 around the catheter shaft 16 relative to the channel 254, e.g., clockwise, (a) advances the first tissue anchor 220a distally until the protrusion 241 of the first tissue anchor 220a exits the distal exit of the thread 20, moving the first tissue anchor 220a distally away from the first position 30a and out of the anchor storage zone 22, and (b) advances the second tissue anchor 220b distally away from the second position 30b until the second tissue anchor 220b moves distally into the first position 30a.

[0284] As each anchor is moved distally, protrusion 241 and eyelet 240 linearly advance distally along slit 256 of channel 254. Each anchor 220 in anchor storage zone 22 is positioned such that protrusion 241 and eyelet 240 are disposed within slit 256, while tissue engaging element 230 and anchor head 280 are disposed within the lumen of channel 254. For some applications, catheter 12 includes a spring (not shown) disposed within the lumen of catheter 12 proximal to at least second tissue anchor 220b, e.g., proximal to the plurality of anchors 220. For some applications, the spring is disposed proximal to anchor storage zone 22. The spring is configured to facilitate distal movement of the tissue anchors 220 and is positioned to apply a distal force to the most proximal anchor 220 in the anchor storage zone 22, thereby helping to retain the anchor 220 within the storage zone 22 and facilitate distal advancement of the remaining anchors 220 as the thread 20 rotates to separately deploy each of the anchors 220.

[0285] It should be noted that rotation of the sled 20 less than a full rotation, e.g., less than 180 degrees, provides the surgeon with an indication of interlocking between the driver 260 and the anchor 220. Additionally, the interaction between the sled 20 and the anchor 220 acts as a safety mechanism to prevent premature release of the anchor 220.

[0286] 2A-B show a system 40 including an implant 210 and a delivery tool 250 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. The tool 250 includes a flexible anchor driver 260 configured to reversibly engage with a driver interface 282 of an anchor 220. Upon this engagement, the driver 260 is configured to drive the tissue engaging element 230 into tissue, for example, by rotating (and pushing distally) the anchor 220. For some applications, the tool 250 further includes a flexible tube 252 (e.g., a transluminal catheter) by which each anchor 220 engaged with the driver 260 can be advanced into the tissue where the anchor is to be secured.

[0287] In Figure 2A, multiple anchors 220 are secured to tissue 10. Each anchor 220 has been delivered to the tissue generally parallel to axis ax2 in a delivery state in which wire 212 extends through and is slidable relative to opening 246 of eyelet 240. This is illustrated for anchor 220d, which is shown in Figure 2A as currently being delivered. It is possible for wire 212 to take a straight path through opening 246 of eyelet 240.

[0288] When a subsequent anchor 220 is secured to the same tissue, the wire 212 is oriented laterally relative to the anchor. The structure of the eyelet 240 allows the wire 212 to always follow a well-defined straight path through the opening 246 of the eyelet 240, despite this reorientation of the wire 212.

[0289] After the desired number of anchors 220 have been secured, an adjustment tool is introduced (e.g., over and along the proximal portion of wire 212) and used to facilitate tensioning of the wire. Thus, tensioning wire 212 draws anchors 220 toward one another, thereby contracting the tissue to which they are secured. As described above, this facilitates smooth sliding of wire 212 through opening 246, with eyelets 240 allowing the wire to orthogonally slide relative to the anchors. Each stopper 214 couples to wire 212 and prevents wire 212 from slipping out of anchor 220. FIG. 2A shows a stopper distal to first anchor 220a. Excess wire 212 can then be cut and removed from the patient.

[0290] For simplicity, Figure 2A shows a straight implant 210. However, in annuloplasty, the implant 210 is often implanted in a curved (or even complete circular) shape around the annulus, so that contraction reduces the size of the annulus and improves leaflet coaptation.

[0291] As noted above, in some applications, eyelet 240 is mounted so as to be rotatable about axis ax2. This therefore provides independence between the rotational position of the eyelet and the rotational position of tissue-engaging element 230. In applications where tissue-engaging element 230 is helical, this independence is hypothesized to advantageously allow the tissue-engaging element to be threaded into 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 230 used, this independence is hypothesized to allow eyelet 240 (and wire 212) to be optimally positioned relative to axis ax2 of each anchor 220 for a given application. For example, in applications where implant 210 is used for annuloplasty, anchors 220 are often secured in a curved fashion around the valve annulus, and eyelet 240 and wire 212 can be positioned on the inside of the curve relative to axis ax2.

[0292] To secure anchor 220, driver 260 rotates driver interface 282 (and thereby tissue engaging element 230) relative to the tube, advancing the anchor out of channel 254 and the distal end of tube 252 while slit 256 prevents rotation of ring 284 relative to the tube. In some applications, it is advantageous for the distal end of tube 252 to be positioned (or pressed) against tissue 10 during anchor securement, as shown in FIG. 2A for example. In applications where tube 252 is used to implant an implant comprising multiple anchors on a wire, such as implant 210, interference may occur between the wire and contact between the distal end of the tube and the tissue. In some applications, tube 252 defines a side slit extending proximally from the distal end of tube 252, and channel 254 defines a slit 256 extending proximally from the distal end of channel 254, such that the slit is continuous with distal opening 14 of catheter 12. In some applications, the slits are adjacent (e.g., laterally outward) to the lumen of catheter 12, allowing wire 212, but not anchor 220, to exit tube 252 and channel 254 laterally, proximally from distal opening 14. This is believed to facilitate implantation of an implant, such as implant 210, that includes multiple anchors coupled to (e.g., threaded through) a wire.

[0293] Each anchor 220 is shaped to define a respective tissue anchor lumen extending the entire longitudinal length of the anchor 220, from the proximal end of the anchor head 280 to the distal end of the tissue engaging element 230. The anchor driver 260, e.g., specifically the driver head 264, is dimensioned to slide axially within the lumen of the channel 254 and is operable to reversibly engage a driver interface 282 of each tissue anchor in the anchor storage zone 22. The anchor driver 260 is configured to advance the anchor 220 distally, toward the distal opening 14 of the catheter 12 and away from the anchor storage zone 22, while the driver head 264 is engaged with the driver interface 282, to engage the tissue engaging element 230 within the tissue 10 along the tissue anchor axis ax2. The driver 260 advances the tissue anchor 220 distally with rotation of the sled 20. Absence of rotation of the sled 20 prevents the anchor driver 260 from advancing the anchor 220 distally.

[0294] Each anchor 220 defines a respective tissue anchor lumen, and anchor driver 260, e.g., driver head 264 in particular, is dimensioned to slide axially within all of the tissue anchor lumens of anchors 220. For example, when the distal-most anchor 220 is engaged by driver 260, driver 260 passes through the tissue anchor lumens of all of anchors 220 until it reaches anchor head 280 of the distal-most anchor. Once driver 260 implants the distal-most anchor 220, it is released from anchor 220 and pulled back through the lumen of channel 254 and through the tissue anchor lumen of the next anchor 220, which is disposed proximally adjacent to the distal-most anchor. To sequentially engage anchor head 280 of the next anchor 220, driver 260 is pulled back through the tissue anchor lumen of the next anchor 220 in sequence, aligning with and engaging anchor head 280, thereby sequentially engaging the next anchor 220.

[0295] 3A-B and 4A-B, which are schematic illustrations of example catheter system 100 including a transluminally advanceable catheter 112, at least one tissue anchor 320, and an implant 310 including the tissue anchor, and techniques for use therewith, according to several application examples. System 100 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 100 can be an annuloplasty system and implant 310 can be an annuloplasty structure.

[0296] The system 100 includes an extracorporeal unit 318 (e.g., a controller and / or a handle) proximal to the system 100. The transluminally advanceable catheter 112 couples to the extracorporeal unit 318 at a proximal end of the catheter 112 and extends distally therefrom along a longitudinal catheter axis 116 of the catheter 112 from the unit 318 to a distal opening 114 of the catheter 112. The transluminally advanceable catheter 112 includes a channel 354, e.g., a flexible tube having a generally tubular wall defining a lumen along the catheter axis 116. The tubular wall of the channel 354 is shaped at its distal portion to define a side slit 356 extending along at least a portion of the channel 354. The slit 356 defines a linear slit disposed parallel to the axis 116. The tubular wall of the channel 354 defines a longitudinal lumen along the channel 354. For the portion of the tubular wall of the channel 354 that defines the slit 356 , the lumen of the channel 354 at the slit 356 is not closed by the slit 356 .

[0297] The channel 354 is shaped to accommodate the implant 310 during delivery into the patient's tissue 10. In applications where the tissue 10 represents tissue of the annulus of a native heart valve, such as the mitral valve, the implant 310 is an annuloplasty structure comprising a wire 312 and a plurality of anchors 320. Each anchor 320 is shaped to define a central longitudinal anchor axis ax2. Each anchor 320 comprises a tissue-engaging element 330 and an anchor head 380. The tissue-engaging element 330 has a proximal end 332 and a distal end 334, defining the central longitudinal axis ax2 of the anchor 320. At the distal end 334, the tissue-engaging element 330 comprises a sharpened distal tip 338, and the tissue-engaging element is configured to be driven (e.g., screwed) into the subject's tissue. For some applications, as shown, the tissue engaging element 330 is helical and defines a central lumen 336 along the axis ax2. If desired, the tissue engaging element 330 can be another type of tissue engaging element, such as a dart or a staple. The head 380 couples to the proximal end 332 of the tissue engaging element 330 and includes a driver interface 382 and an eyelet 340 defining an opening 246 therethrough. The driver interface 382 is configured to be reversibly engaged by the flexible anchor driver 260. For some applications, the eyelet 340 includes a structural element that protrudes laterally relative to the tissue engaging element 330. The driver 260 can include an elongated, flexible shaft 261 and a driver head 264 coupled to the distal end of the shaft. The driver head 264 is a component of the anchor driver 260 that reversibly engages the driver interface 382. The driver interface 382 can be rigidly coupled to the tissue engaging element 330.

[0298] For some applications, the driver interface 382 includes walls that are shaped to define a recess surrounded by the walls. For some applications, the walls surrounding the recess are shaped as circular walls, as shown in FIG. 4B. For some applications, the walls surrounding the recess are square.

[0299] In some applications, as shown, driver interface 382 is positioned on central longitudinal axis ax2 and eyelets 340 are positioned laterally from axis ax2.

[0300] As described in more detail below, anchor 320 (e.g., its eyelet 340) is configured to easily slide the anchor along (or slide the wire through) wire 312 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 320 along the wire. Also, as described in more detail below, anchor 320 (e.g., its eyelet 340) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 340. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as annuloplasty.

[0301] The tubular wall of the channel 354 of the transluminally advanceable catheter 112 is shaped to define at least one detent 360 having a side detent slit 366 that defines a movable tab 362. For some applications, the catheter channel 354 is shaped to define multiple detents 360 arranged longitudinally parallel to the axis 116, as shown. The transluminally advanceable catheter 112 has an anchor storage zone 122 in which multiple anchors 320 are disposed and held in place by the multiple detents 360. For some applications, the anchor storage zone 122 is at least partially longitudinally aligned with the slits 356 of the channel 354. The transluminally advanceable catheter 112 includes an overtube 352. For some applications, the overtube 352 is shaped to define a distal linear slit extending proximally from the opening 114 of the catheter 112 and aligned with the slits 356 of the channel 354.

[0302] The anchor storage zone 122 has a distal end that is positioned proximal to the distal opening 114 of the catheter 112. This leaves the distal portion of the catheter 112 free of anchors 320, allowing for flexibility and maneuverability of the end of the catheter 112. The distal end of the anchor storage zone 122 may often be 90 cm or less, e.g., 25 cm or less, from the distal opening 114 to maintain a level of comfort and stability for the user. In some applications, the distal end of the zone 122 is 3 cm to 25 cm, e.g., 5 cm to 25 cm, from the distal opening 114.

[0303] In some applications, as shown, eyelet 340 is mounted so as to be rotatable about axis ax2. For example, head 380 can include a ring 384 to which eyelet 340 is mounted. Ring 384 surrounds and is rotatable about axis ax2, such as by being rotatably coupled to tissue engaging element 330, or by being rotatably coupled to another component of head 380 (e.g., driver interface 382) that is fixedly coupled to the tissue engaging element.

[0304] In some applications, eyelet 340 is mounted so as to be stationary relative to axis ax2, as shown. In such applications, head 380 does not include ring 384; rather, eyelet 340 is mounted directly to head 380.

[0305] As described above, the tubular wall of the channel 354 of the transluminally advanceable catheter 112 is shaped to define at least one detent 360 having a side detent slit 366 that defines a movable tab 362. In some applications, as shown, the catheter channel 354 is shaped to define a plurality of detents 360 that are longitudinally disposed parallel to the axis 116. The tab 362 connects on its inner surface to a protrusion 364 that faces the lumen of the channel 354. In some applications, the tab 362 is molded on its inner surface to define the protrusion 364. In some applications, the protrusion 364 functions as a baffle and stop that prevents linear movement of the tissue anchor 320 within the lumen of the channel 354. In some applications, as shown, the protrusion 364 is shaped to define a cylinder that is disposed perpendicular to the axis 116 of the catheter 112. As shown, protrusion 364 couples to tab 362 at a proximal portion of tab 362. Protrusion 364 is shaped to fit between adjacent coils of tissue-engaging element 330 of anchor 320, as shown in the enlarged image in FIG. 3B. When no force is applied to protrusion 364, protrusion 364 remains disposed between adjacent coils of tissue-engaging element 330. As described below, pulling or pushing anchor 320 encourages protrusion 364 and at least a proximal portion of tab 362 to displace radially away from shaft 116 of catheter 112, moving protrusion 364 out from between adjacent coils of tissue-engaging element 330 and thereby releasing anchor 320 from detent 360. Furthermore, when tubing over 352 surrounds detent 360, it restricts tab 362 from moving radially away from shaft 116.

[0306] The overtube 352 is slidably disposed about the channel 354 and operably coupled to the unit 318 so as to be movable by operation of the unit 318, and each detent 360 is movable between (1) a closed state in which (i) the overtube 352 surrounds the movable tab 362, (ii) the movable tab 362 is aligned with the tubular wall of the channel 354, and (iii) the protrusion 364 extends into the lumen of the channel 354, preventing the anchor 320 from moving distally past the protrusion 364, and (2) an open state in which (i) the overtube 352 (i.e., the distal end of the outer tube 252) is retracted from the movable tab 362, and (ii) the movable tab 362 is displaceable away from the catheter shaft 116 to move the protrusion 364 away from the catheter shaft 116, allowing the anchor 320 to move distally past the protrusion 364.

[0307] In some applications (not shown), overtube 352 is shaped to define a side window configured to align with protrusion 364 so that protrusion 364 can easily move away from the catheter shaft while detent 360 is in an open state. In such applications, the distal end of overtube 352 does not need to be retracted proximally beyond detent 360; rather, the side window of the overtube aligns with detent 360 (particularly the portion of overtube 352 that couples to protrusion 364) to easily move protrusion 364 radially away from shaft 116. In some applications, overtube 352 is not retracted but is rotated about shaft 116 to align the side window with detent 360.

[0308] 3B, first, distal-most tissue anchor 320a is positioned at first position 370a relative to channel 354, distal to second tissue anchor 320b, which is positioned at second position 370b proximal to first position 370a. In system 100, each anchor 320 is held in its respective position and locked in place as long as overtube 352 surrounds detent 360.

[0309] As each anchor 320 is released from its respective detent 360, the anchor 320 moves distally away from its first respective position 370 and out of the anchor storage zone 122. As long as the overtube 352 surrounds the detent 360, the anchor 320 is locked in place within its respective position 370.

[0310] As each anchor 320 moves distally, eyelet 340 advances linearly distally along slit 356 of channel 354. Each anchor 320 in anchor storage zone 122 is positioned such that eyelet 340 is positioned opposite detent 360. Protrusion 364 holds each anchor 320 fixed such that eyelet 340 is positioned opposite detent 360 to prevent rotation of anchor 320 and twisting of wire 312. Thus, in some applications, ring 384 is fixed relative to anchor head 380 and does not rotate about axis ax2. In some applications, slit 356 of channel 354 extends proximally into anchor storage zone 122 to hold eyelet 340 within slit 356, thereby preventing rotation of anchor 320 and tangling of wire 312.

[0311] 4A-B show system 100 including implant 310 and a delivery tool 350 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. Tool 350 includes a flexible anchor driver 260 configured to reversibly engage with a driver interface 382 of anchor 320. Upon this engagement, driver 260 is configured to drive tissue engaging element 330 into tissue, for example, by rotating (and pushing distally) anchor 320. For some applications, tool 350 further includes a flexible overtube 352 (e.g., a transluminal catheter) so that each anchor 320 engaged with driver 260 can be advanced into tissue where the anchor is to be secured.

[0312] In Figure 4A, multiple anchors 320 are secured to tissue 10. Each anchor 320 has been delivered to the tissue generally parallel to axis ax2 in a delivery state in which wire 312 extends through and is slidable relative to opening 346 of eyelet 340. This is illustrated for anchor 320d, which is shown in Figure 4A as currently being delivered. Wire 312 can take a straight path through opening 346 of eyelet 340.

[0313] When a subsequent anchor 320 is secured to the same tissue, the wire 312 is oriented laterally relative to the anchor. The structure of the eyelet 340 allows the wire 312 to always follow a well-defined straight path through the opening 346 of the eyelet 340, despite this reorientation of the wire 312.

[0314] After the desired number of anchors 320 have been secured, an adjustment tool is introduced (e.g., over and along the proximal portion of wire 312) and used to facilitate tensioning of the wire. Thus, tensioning wire 312 draws anchors 320 toward one another, thereby contracting the tissue to which they are secured. As described above, this facilitates smooth sliding of wire 312 through opening 346, with eyelets 240 allowing the wire to orthogonally slide relative to the anchors. Each stopper 214 couples to wire 312 and prevents wire 312 from slipping out of anchor 320. FIG. 4A shows a stopper distal to first anchor 320a. Excess wire 312 can then be cut and removed from the patient.

[0315] For simplicity, Figure 4A shows a straight implant 310. However, in annuloplasty, the implant 310 is often implanted in a curved (or even complete circular) shape around the annulus, so that contraction reduces the size of the annulus and improves leaflet coaptation.

[0316] As noted above, in some applications, the eyelet 340 is mounted so as to be rotatable about the axis ax2. This therefore provides independence between the rotational position of the eyelet and the rotational position of the tissue-engaging element 330. In applications where the tissue-engaging element 330 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 330 used, this independence is hypothesized to allow the eyelet 340 (and wire 312) to be optimally positioned relative to the axis ax2 of each anchor 320 for a given application. For example, in applications where the implant 310 is used for annuloplasty, the anchors 320 are often secured in a curved fashion around the valve annulus, and the eyelet 340 and wire 312 can be positioned on the inside of the curve relative to the axis ax2.

[0317] To secure anchor 320, driver 260 rotates driver interface 382 (and thereby tissue engaging element 330) relative to the vessel, advancing the anchor out of channel 354 and the distal end of overtube 352 while slit 356 prevents rotation of ring 384 relative to the vessel. In some applications, it may be advantageous for the distal end of overtube 352 to be positioned (or pressed) against tissue 10 during anchor securement, as shown, for example, in FIG. 4A . As noted above, slit 356 in channel 354 abuts (e.g., laterally outward) the lumen of catheter 112, allowing wire 312, but not anchor 320, to exit vessel channel 354 laterally, proximally from distal opening 114. This may facilitate implantation of an implant, such as implant 310, comprising multiple anchors coupled to (e.g., threaded through) wires.

[0318] Each anchor 320 is shaped to define a respective tissue anchor lumen extending the entire longitudinal length of the anchor 320, from the proximal end of the anchor head 380 to the distal end of the tissue engaging element 330. The anchor driver 260, e.g., specifically the driver head 264, is dimensioned to slide axially within the lumen of the channel 354 and is operable to reversibly engage a driver interface 382 of each tissue anchor in the anchor storage zone 122. The anchor driver 260 is configured to advance the anchor 320 distally toward the distal opening 114 of the catheter 112, away from the anchor storage zone 122, while the driver head 264 is engaged with the driver interface 382, ​​to engage the tissue engaging element 330 within the tissue 10 along the tissue anchor axis ax2. The driver 260 advances the tissue anchor 320 distally only if the distal end of the overtube 352 is pulled back proximally beyond the detent 360 currently holding the tissue anchor 320. For applications in which the overtube 352 defines a side window, the driver 260 will advance the tissue anchor 320 distally only if the side window of the overtube 352 is aligned with the detent 360 currently holding the tissue anchor 320. If the overtube 352 covers the detent 360, the anchor driver 260 will be prevented from advancing the anchor 320 distally because the protrusion 364 of the detent 360 will remain engaged with the tissue engaging element 330 of the anchor 320.

[0319] Each anchor 320 defines a respective tissue anchor lumen, and anchor driver 260, e.g., driver head 264 in particular, is dimensioned to slide axially within all of the tissue anchor lumens of anchors 320. For example, when the distal-most anchor 320 is engaged by driver 260, driver 260 passes through the tissue anchor lumens of all of anchors 320 until it reaches anchor head 380 of the distal-most anchor. Once driver 260 implants the distal-most anchor 320, it is released from anchor 320 and pulled back through the lumen of channel 354 and through the tissue anchor lumen of the next anchor 320, which is positioned proximally adjacent to the distal-most anchor. To sequentially engage anchor head 380 of the next anchor 320, driver 260 is pulled back through the tissue anchor lumen of the next anchor 320 in sequence, aligning with and engaging anchor head 380, thereby sequentially engaging the next anchor 320.

[0320] As shown in FIG. 4A , a series of anchors 320 are deployed in tissue 10. In step A, anchor driver 260 engages the next proximally positioned tissue anchor 320d from its respective position 370d in anchor storage zone 122. Anchor 320d is locked in position 370d because overtube 352 surrounds detent 360d such that protrusion 364d of tab 362d of detent 360d is positioned between the coils of tissue engaging element 330. In step B, overtube 352 is pulled back such that its distal end is positioned proximal to tab 362d, thereby releasing detent 360d and allowing tab 362d to be displaced laterally and radially away from shaft 116 while anchor driver 260 pushes anchor 320d distally. Such distal pushing of anchor 320d pushes tissue engaging element 330d and anchor head 380 against protrusion 364d, forcing protrusion 364d out of the lumen of channel 354. In this manner, detent 360d assumes an open state in which tab 362d is out of alignment with the tubular wall of channel 354, displacing protrusion 364d away from axis 116. Despite anchor 320d moving out from position 370d, the next proximally deployed anchor 320e is held in place at position 370e. Moving anchor 320d distally from position 370d results in no object and / or force acting on tab 362d, and therefore tab 362d returns to a position in which tab 362d is aligned with the wall of channel 354 and protrusion 364d again protrudes into the lumen of channel 354. As shown, overtube 352 surrounds detent 360e so that anchor 330e remains locked in position 370e.

[0321] 4B , for some applications, channel 354 is shaped to control the rotational position of eyelet 340 relative to axis ax2 and / or tissue-engaging element 330 during delivery and fixation. In some such applications, channel 354 defines major channel region 354a and minor channel region 354b. Major channel region 354a has a larger cross-sectional area than minor channel region 354b. Anchor 320 is slidable through channel 354, with tissue-engaging element 330 sliding (often snugly) through primary channel region 354a and eyelet 340 sliding (often snugly) through minor channel region 354b and along wire 312. Rotational control of channel 354 thereby controls the position of eyelet 340, and therefore wire 312, about axis ax2 of each anchor. The driver interface 382 and tissue engaging element 330 are rotatable within the overtube 352, but the ring 384 and eyelet 340 are not rotatable within the channel 354. In some applications, and as shown, the channel 354 has an orthogonal cross-section that is keyhole shaped.

[0322] For some applications, eyelet 340 is shaped to define protrusion 241 as described above with respect to Figures 1A-B and 2A-B.

[0323] 5A-C, which are schematic illustrations of example catheter system 400 including a transluminally advanceable catheter 402, at least one tissue anchor 420, and an implant 410 including the tissue anchor, and techniques for use therewith, according to several applications. System 400 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 400 can be an annuloplasty system, and implant 410 can be an annuloplasty structure.

[0324] At a proximal portion of the system 400, the system includes an extracorporeal unit (e.g., a controller and / or handle) that may be similar or identical to the extracorporeal units 18 and / or 318 described above. The transluminally advanceable catheter 402 couples to the extracorporeal unit at the proximal end of the catheter 402 and extends distally therefrom along the catheter longitudinal axis 16 of the catheter 402 from the extracorporeal unit to a distal opening of the catheter 402. The transluminally advanceable catheter 402 includes a channel 454, e.g., a flexible tube having a generally tubular wall that defines a lumen along the catheter axis 416. The tubular wall of the channel 454 is shaped to define a side slit (e.g., as described above with respect to slit 256 of channel 254 in FIGS. 1A-B and 2A-B) at its distal portion that extends along at least a portion of the channel 454. The slit defines a linear slit that is disposed parallel to the axis 416. The tubular wall of the channel 454 defines a longitudinal lumen along the channel 454. For portions of the tubular wall of the channel 454 that define a slit, the lumen of the channel 454 at the slit is not closed by the slit.

[0325] The channel 454 is shaped to accommodate the implant 410 during delivery of the implant 410 to the patient's tissue 10. In applications where the tissue 10 represents tissue of the annulus of a native heart valve, such as the mitral valve, the implant 410 is an annuloplasty structure comprising a wire 412 and a plurality of anchors 420. Each anchor 420 is shaped to define a central longitudinal anchor axis ax2. Each anchor 420 comprises a tissue-engaging element 430 and an anchor head 480. The tissue-engaging element 430 has a proximal end 432 and a distal end 434, defining the central longitudinal axis ax2 of the anchor 420. At the distal end 434, the tissue-engaging element 430 comprises a sharpened distal tip 438, and the tissue-engaging element is configured to be driven (e.g., screwed) into the subject's tissue. For some applications, as shown, the tissue engaging element 430 is helical and defines a central lumen 436 along the axis ax2. If desired, the tissue engaging element 430 can be another type of tissue engaging element, such as a dart or a staple. The head 480 couples to the proximal end 432 of the tissue engaging element 430 and includes a driver interface 482 and an eyelet 440 defining an opening therethrough. The driver interface 482 is configured to be reversibly engaged by the flexible anchor driver 260. For some applications, the eyelet 440 includes a structural element that protrudes laterally relative to the tissue engaging element 430. The driver 260 can include an elongated, flexible shaft and a driver head 264 coupled to the distal end of the shaft. The driver head 264 is a component of the anchor driver 260 that reversibly engages the driver interface 482. The driver interface 482 can be rigidly coupled to the tissue engaging element 430.

[0326] For some applications, driver interface 482 includes walls that are shaped to define a recess surrounded by the walls. For some applications, the walls surrounding the recess are shaped as circular walls. For some applications, the walls surrounding the recess are square.

[0327] In some applications, as shown, driver interface 482 is positioned on central longitudinal axis ax2 and eyelets 440 are positioned laterally from axis ax2.

[0328] As described in more detail below, anchor 420 (e.g., its eyelet 440) is configured to easily slide the anchor along (or slide the wire through) wire 412 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 420 along the wire. Also, as described in more detail below, anchor 420 (e.g., its eyelet 440) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 440. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as annuloplasty.

[0329] The transluminally advanceable catheter 402 includes a dispenser 460 distal to the distal-most anchor 420a. The dispenser 460 is operably coupled to the extracorporeal unit, e.g., coaxially overlapping the channel 454, such that the dispenser 460 is movable relative to the channel 454 by operation of the extracorporeal unit to easily dispense one anchor 420 at a time. The transluminally advanceable catheter 402 includes an anchor storage zone 422 that includes the dispenser 460 and a plurality of tissue anchors 420. For some applications, the anchor storage zone 422 is at least partially longitudinally aligned with the slits of the channel 454. For some applications, the dispenser 460 and the channel 454 are concentrically arranged. The plurality of anchors 420 of the implant 410 are disposed within the anchor storage zone 422. For some applications, the transluminally advanceable catheter 402 includes an outer tube. In applications where the catheter 402 includes an outer tube, the dispenser is disposed between the outer tube and the channel 454 and is slidable relative thereto.

[0330] The anchor storage zone 422 has a distal end that is positioned proximal to the distal opening of the catheter 402. This leaves the distal portion of the catheter 402 free of anchors 420, allowing for flexibility and maneuverability at the end of the catheter 402. The distal end of the anchor storage zone 422 may often be 90 cm or less, e.g., 25 cm or less, from the distal opening to maintain a level of user comfort and stability. In some applications, the distal end of the zone 422 is 3 cm to 25 cm, e.g., 5 cm to 25 cm, from the distal opening.

[0331] In some applications, as shown, eyelet 440 is mounted so as to be rotatable about axis ax2. For example, head 480 can include a ring 484 to which eyelet 440 is mounted. Ring 284 surrounds and is rotatable about axis ax2, such as by being rotatably coupled to tissue engaging element 430, by being rotatably coupled to another component of head 480 (e.g., driver interface 482), for example, that is fixedly coupled to the tissue engaging element.

[0332] In some applications, the eyelet 440 is mounted so that it is stationary relative to the axis ax2, as shown. In such applications, the head 480 does not include the ring 484; rather, the eyelet 440 is mounted directly to the head 480.

[0333] In some applications, each tissue anchor 420 includes a protrusion 241 (described above with respect to Figures 1A-B and 2A-B) that is coupled to or that is formed from and extends from the eyelet 440, for example, from a structural element of the eyelet 440.

[0334] The dispenser 460 includes a structural element that includes a proximal detent 462 and a distal detent 464. The detents 462 and 464 are transitionable between a state in which they protrude into the lumen of the channel 454 toward the catheter shaft 416 and a state in which they are pushed away from the catheter shaft 426, freeing the lumen of the channel 456 from obstructions. For some applications, a tubular structure 495 surrounds at least a portion of the channel 454 and is slidable relative to the channel 454. The tubular structure 495 couples to the dispenser 460 such that longitudinal movement of the tubular structure 495 distally and proximally along the channel 454 easily pushes the proximal and distal detents 462 and 464 in and expands the proximal and distal detents 462 and 464 into the lumen. The tubular wall of the channel 454 is formed to define a side window 490 outside the lumen. Side window 490 has a proximal edge 491 and a distal edge 493. Tubular structure 495 surrounds at least a portion of channel 454 at side window 490. For some applications, catheter 402 includes an outer tube disposed around tubular structure 495 such that tubular structure 495 is disposed between the outer tube and channel 454.

[0335] The dispenser 460 can be in one of two states: (1) a receiving state in which (i) the proximal detent 462 is pushed in a direction away from the catheter shaft 416, allowing the anchor 420a to move distally past the proximal detent 462 and into the dispenser 460, and (ii) the distal detent 464 is expanded into the lumen, preventing the anchor 420a from moving distally past the distal detent 464 and out of the dispenser 460; and (2) a disengaged state in which (i) the proximal detent 462 is expanded into the lumen, preventing the anchor 420a from moving proximally past the proximal detent 462 and out of the dispenser 460, and (ii) the distal detent 464 is expanded into the lumen. and (3)(i) a dispensing state (FIG. 5C) in which the proximal detent 462 extends into the lumen, preventing the anchor 420a from moving proximally past the proximal detent 462 and out of the dispenser 460, and the distal detent 464 is pressed away from the catheter shaft 416, allowing the anchor 420a to move distally past the distal detent 464 and out of the dispenser 460.

[0336] 5A , anchor 420a has not been moved within dispenser 460. Anchor 420a couples to anchor driver 260 and is movable by driver 260 via sliding movement of driver 260 within the lumen of channel 454. In some applications, anchor 420a is movable distally within dispenser 460 via movement of driver 260 as driver 260 couples to anchor 420a. As anchor 420a moves distally past proximal detent 462, detent 462 is compressed. As anchor 420a moves past detent 464, detent 464 returns to an expanded state within the lumen of channel 454, preventing anchor 420a from retracting proximally. In some applications, the tubular structure 495 is moved proximally relative to the side window 490 of the channel 454 to facilitate pressing the proximal detent 462 against the proximal edge 491 of the window 490, such that the proximal detent 462 moves away from the catheter shaft 416 and retracts or is pressed relative to the shaft 416, such that the detent 462 does not block the lumen of the channel 454, and the anchor 420a is properly positioned within the dispenser 460 in the received state and aligned with the window 490. Once the anchor 420a is positioned within the dispenser 460, the tubular structure 495 is moved distally so that the proximal detent 462 is not pressed against the proximal edge 491 of the window 490, and the detent 462 protrudes and expands into the lumen of the channel 454, as shown in FIG. 5B .

[0337] Distal detent 464 is no longer pressed down by distal edge 493 of window 490, nor does it retract, and it protrudes and expands within the lumen of channel 454, such that dispenser 460 is in a closed state and anchor 420a is prevented from moving distally past distal detent 464 and from moving proximally past proximal detent 462. This allows the surgeon to assess a suitable connection between driver 260 and anchor 420 based on the lack of movement of anchor 420a in response to pulling or pushing on driver 260 in the closed state of dispenser 460. Additionally, when detents 462 and 464 protrude from their pressed-down state, an audible "click" is heard and the surgeon receives tactile feedback from detents 462 and 464 clicking into place.

[0338] As the tubular structure 495 is moved proximally and distally, the proximal handle of the anchor driver 260 moves accordingly, allowing the physician to visualize the movement of the driver 260 .

[0339] 5C , tubular structure 495 is moved distally relative to side window 490, facilitating depressing distal detent 464 against distal edge 493 of window 490, causing dispenser 460 to assume a dispensed state in which distal detent 464 moves away from catheter shaft 416 while proximal detent 462 extends into the lumen of channel 454, preventing anchor 420a from returning proximally past proximal detent 462. Driver 260 moves distally while moving tubular structure 495 distally to distally advance anchor 420a out of dispenser 460 and out of anchor storage zone 422.

[0340] As anchor 420a is moved distally out of dispenser 460, tubular structure 495 is retracted proximally to sequentially position the next anchor 420b within dispenser 460. Dispenser 460 returns to the receiving state, allowing one additional anchor 420b to move distally past proximal detent 462 (because detent 462 is retracted by proximal edge 491). Dispenser 460 then transitions to the closed state, preventing at least one additional anchor 420b from moving distally out of dispenser 460 past distal detent 464. Dispenser 460 then transitions to the dispensing state, allowing at least one additional tissue anchor 420b to move distally out of dispenser 460 past distal detent 464.

[0341] For some applications, catheter 402 includes a spring (not shown) disposed within the lumen of catheter 402 proximal to at least second tissue anchor 420b, e.g., proximal to the plurality of anchors 420. For some applications, the spring is disposed proximal to anchor storage zone 422. The spring is configured to facilitate distal movement of tissue anchors 420 and is positioned to exert a distal force on the proximal-most anchor 420 within anchor storage zone 422, thereby helping to retain anchor 420 within storage zone 422 and facilitate distal advancement of the remaining anchors 420 as each of anchors 420 is separately deployed.

[0342] As each anchor 420 moves distally, eyelet 440 advances linearly distally along the slit of channel 454. Each anchor 420 in anchor storage zone 422 is positioned such that eyelet 440 is disposed in the slit, while tissue engaging element 430 and anchor head 480 are disposed within the lumen of channel 454. In some applications, the slit does not extend into anchor storage zone 422, and anchor 420 is disposed entirely within anchor storage zone 422 and within the lumen of channel 454.

[0343] 5A-C show a system 400 including an implant 410 and a delivery tool 450 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. The tool 450 includes a flexible anchor driver 260 configured to reversibly engage a driver interface 482 of an anchor 420. Upon this engagement, the driver 260 is configured to drive the tissue engaging element 430 into tissue, for example, by rotating (and pushing distally) the anchor 420. For some applications, the tool 450 further includes a flexible tube (e.g., a transluminal catheter) so that each anchor 420 engaged with the driver 260 can be advanced into the tissue where the anchor is to be secured.

[0344] Each anchor 420 is delivered to tissue generally parallel to axis ax2 in a delivery state in which wire 412 extends through the opening of eyelet 440 and is slidable relative to the opening of eyelet 440.

[0345] When a subsequent anchor 420 is secured to the same tissue, the wire 412 is oriented laterally relative to the anchor. The structure of the eyelet 440 allows the wire 412 to always follow a well-defined straight path through the opening 246 of the eyelet 440, despite this reorientation of the wire 412.

[0346] After the desired number of anchors 420 have been secured, an adjustment tool is introduced (e.g., over and along the proximal portion of wire 412) and used to facilitate tensioning of the wire. Thus, tensioning wire 412 draws anchors 420 toward one another, thereby contracting the tissue to which they are secured. As described above, this facilitates smooth sliding of wire 412 through the openings in eyelets 440, with the wire perpendicular to the anchors. Each stopper 214 couples to wire 412 and prevents wire 412 from slipping out of anchor 420. Excess wire 412 can then be cut and removed from the patient.

[0347] As noted above, in some applications, the eyelet 440 is mounted so as to be rotatable about the axis ax2. This therefore provides independence between the rotational position of the eyelet and the rotational position of the tissue-engaging element 430. In applications where the tissue-engaging element 430 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 430 used, this independence is hypothesized to allow the eyelet 440 (and wire 412) to be optimally positioned relative to the axis ax2 of each anchor 420 for a given application. For example, in applications where the implant 410 is used for annuloplasty, the anchors 420 are often secured in a curved fashion around the valve annulus, and the eyelet 440 and wire 412 can be positioned on the inside of the curve relative to the axis ax2.

[0348] To secure anchor 420, driver 260 rotates driver interface 482 (and thereby tissue engaging element 430) relative to the vessel, advancing the anchor out the distal end of channel 454 while the slits in channel 454 prevent rotation of ring 484 relative to the vessel. In some applications, it is advantageous for the distal end of catheter 402 to be positioned (or pressed) against tissue 10 while securing the anchor. A side slit extending proximally from the distal end of catheter 402 allows wire 412, rather than anchor 420, to exit channel 454 laterally and proximally from the distal opening of catheter 402. This is believed to facilitate implantation of an implant, such as implant 410, comprising multiple anchors coupled to (e.g., threaded through) wires.

[0349] Each anchor 420 is shaped to define a respective tissue anchor lumen extending the entire longitudinal length of the anchor 420, from the proximal end of the anchor head 480 to the distal end of the tissue engaging element 430. The anchor driver 260, e.g., specifically the driver head 264, is dimensioned to slide axially within the lumen of the channel 454 and is operable to reversibly engage a driver interface 482 of each tissue anchor within the anchor storage zone 422. The anchor driver 260 is configured to advance the anchor 420 distally, toward the distal opening of the catheter 402 and away from the anchor storage zone 422, while the driver head 264 is engaged with the driver interface 482, to engage the tissue engaging element 430 within the tissue 10 along the tissue anchor axis ax2. The driver 260 advances the tissue anchor 420 distally with rotation of the sled 20. As shown in FIG. 5B, when the dispenser 460 is not in the closed state, the anchor driver 260 is prevented from advancing the anchor 420 distally.

[0350] Each anchor 420 defines a respective tissue anchor lumen, and the anchor driver 260, e.g., driver head 264 in particular, is dimensioned to slide axially within all of the tissue anchor lumens of the anchors 420. For example, when the distal-most anchor 420 is engaged by the driver 260, the driver 260 passes through the tissue anchor lumens of all of the anchors 420 until it reaches the anchor head 480 of the distal-most anchor. Once the driver 260 has implanted the distal-most anchor 420, it is released from the anchor 420 and is pulled back through the lumen of the channel 454 and then through the tissue anchor lumen of the next anchor 420, which is disposed proximally adjacent to the distal-most anchor. To sequentially engage the anchor head 480 of the next anchor 420, the driver 260 is pulled back through the tissue anchor lumen of the next anchor 420 in sequence, aligning with and engaging the anchor head 480, thereby sequentially engaging the next anchor 420.

[0351] As each anchor 420 moves distally, the eyelet 440 advances linearly distally along the slit in the channel 454. Each anchor 420 in the anchor storage zone 422 is positioned such that the eyelet 440 is positioned opposite the dispenser 460. Detents 462 and 464 hold each anchor 420 fixed such that the eyelet 440 is positioned opposite the dispenser 460 to prevent rotation of the anchor 420 and twisting of the wire 312. Thus, in some applications, the ring 484 is fixed relative to the anchor head 480 and does not rotate about axis ax2. In some applications, the slit in the channel 454 extends proximally into the anchor storage zone 422 to retain the eyelet 440 within the slit, thereby preventing rotation of the anchor 420 and tangling of the wire 412.

[0352] 6A-E, which are schematic illustrations of example catheter system 500 including a transluminally advanceable catheter 502, at least one tissue anchor 520, and an implant 510 including the tissue anchor, and techniques for use therewith, according to several applications. System 500 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 500 can be an annuloplasty system and implant 510 can be an annuloplasty structure.

[0353] The system 500 includes an extracorporeal unit 518 (e.g., a controller and / or a handle) proximal to the system 500. The transluminally advanceable catheter 502 couples to the extracorporeal unit 518 at the proximal end of the catheter 502 and extends distally therefrom along a longitudinal axis 516 of the catheter 502 from the unit 518 to a distal opening of the catheter 502. The transluminally advanceable catheter 502 includes a channel 554, e.g., a flexible tube having a generally tubular wall defining a lumen along the catheter axis 516. The tubular wall of the channel 554 is shaped at its distal portion to define a side slit extending along at least a portion of the channel 554. The slit defines a linear slit disposed parallel to the axis 516. The tubular wall of the channel 554 defines a longitudinal lumen along the channel 554 that is aligned with the catheter axis 516. For the portion of the tubular wall of the channel 554 that defines the slit, the lumen of the channel 554 at the slit is not closed by the slit.

[0354] The extracorporeal unit 518 and the channel 554 are shaped to define respective lumens that accommodate the implant 510 during delivery into the patient's tissue 10. In an application in which the tissue 10 represents tissue of the annulus of a native heart valve, such as the mitral valve, the implant 510 is an annuloplasty structure that includes a wire 512 and a plurality of anchors 520. Each anchor 520 is shaped to define a central longitudinal anchor axis ax2. Each anchor 520 includes a tissue-engaging element 530 and an anchor head 580. The tissue-engaging element 530 has a proximal end 532 and a distal end 534, defining the central longitudinal axis ax2 of the anchor 520. At the distal end 534, the tissue-engaging element 530 includes a sharpened distal tip 538, and the tissue-engaging element is configured to be driven (e.g., screwed) into the subject's tissue. For some applications, as shown, the tissue engaging element 530 is helical and defines a central lumen 536 along the axis ax2. If desired, the tissue engaging element 530 can be another type of tissue engaging element, such as a dart or a staple. The head 580 couples to the proximal end 532 of the tissue engaging element 530 and includes a driver interface 582 and an eyelet 540 defining an opening 546 therethrough. The driver interface 582 is configured to be reversibly engaged by the flexible anchor driver 260. For some applications, the eyelet 540 includes a structural element that protrudes laterally relative to the tissue engaging element 530. The driver 260 can include an elongated, flexible shaft 261 and a driver head 264 coupled to the distal end of the shaft. The driver head 264 is a component of the anchor driver 260 that reversibly engages the driver interface 582. The driver interface 582 can be rigidly coupled to the tissue engaging element 530.

[0355] For some applications, the driver interface 582 includes walls that are shaped to define a recess surrounded by the walls. For some applications, the walls surrounding the recess are shaped as circular walls, as shown. For some applications, the walls surrounding the recess are square.

[0356] In some applications, as shown, driver interface 582 is positioned on central longitudinal axis ax2 and eyelets 540 are positioned laterally from axis ax2.

[0357] As described in more detail below, anchor 520 (e.g., its eyelet 540) is configured to easily slide the anchor along (or slide the wire through) wire 512 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 520 along the wire. Also, as described in more detail below, anchor 520 (e.g., its eyelet 540) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 540. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as annuloplasty.

[0358] In some applications, as shown, eyelet 540 is mounted so as to be rotatable about axis ax2. For example, head 580 can include a ring 584 to which eyelet 540 is mounted. Ring 584 surrounds and is rotatable about axis ax2, such as by being rotatably coupled to tissue engaging element 530, by being rotatably coupled to another component of head 580 (e.g., driver interface 582), for example, that is fixedly coupled to the tissue engaging element.

[0359] In some applications, eyelet 540 is mounted so as to be stationary relative to axis ax2, as shown. In such applications, head 580 does not include ring 584; rather, eyelet 540 is mounted directly to head 580.

[0360] The handle of the extracorporeal unit 518 is shaped to define two sublumens: (1) an anchor driver sublumen 506 that is aligned with the lumen of the channel 554 of the transluminally advanceable catheter 502 and has an anchor driver sublumen axis 507 along the catheter axis 516, and (2) an anchor storage sublumen 504 that is offset relative to the lumen of the channel 554 of the transluminally advanceable catheter 502 and offset relative to the anchor driver sublumen 506. In some applications, the sublumens 504 and 506 are in fluid communication and parallel to each other. The anchor storage sublumen 504 defines an anchor storage zone 522 that houses a plurality of tissue anchors 520. The plurality of anchors 520 are aligned consecutively within the zone 522. The wire 512 and each eyelet 540 of the anchor 520 are disposed in the space between the anchor storage sublumen 504 and the anchor driver sublumen 506. That is, when tissue anchor 520 is disposed within anchor storage zone 522 and anchor storage sub-lumen 504, tissue engaging element 530 and anchor head 580 are disposed within anchor storage sub-lumen 504, and eyelet 540 and wire 512 are disposed in the space between sub-lumens 504 and 506. Wire 512 extends distally from the anchor driver sub-lumen, through the lumen of channel 554, toward the distal opening of catheter 502.

[0361] Prior to engaging any of the anchors 520, the anchor driver 260 is positioned and slidable within the anchor driver sublumen 506, as shown in FIG. 6A.

[0362] The handle of the extracorporeal unit 518 includes a rotation stop 560 at its distal end. The rotation stop 560 is shaped to define a receiving lumen 562 that receives one tissue anchor 520 at a time. The rotation stop is rotatable about the catheter shaft 516 while in a first, rest state, as shown in FIG. 6A , where the stop is in a position such that the receiving lumen 562 is not aligned with the anchor storage sublumen 504, but rather, the wall of the stop 560 blocks the distal end of the sublumen 504, thereby preventing distal movement of any anchors 520.

[0363] As shown in FIG. 6B , rotation stop 560 receives first tissue anchor 520a in anchor storage zone 522, thereby rotating 180 degrees about central axis 516 of catheter 502 and about wire 512 to define a receiving state of rotation stop 560, aligning receiving lumen 562 of rotation stop 560 with anchor storage sub-lumen 504. Wire 512 remains stationary during rotation of stopper 560. Rotation of stopper 560 around wire 512 prevents entanglement of wire 512. Stopper 560 includes a spring 564 disposed within receiving lumen 562 to secure anchor 520a in place during rotation of rotation stopper 560.

[0364] 6C , to place rotation stop 560 in a loaded state, rotation stop 560 is again rotated about central axis 516 of catheter 502, where receiving lumen 562 of rotation stop 560 is aligned with anchor driver sub-lumen 506 such that tissue anchor 520 a can pass through the lumen of channel 554 of transluminally advanceable catheter 502. In some applications, rotation stop 560 is rotated an additional 180 degrees in the same direction as described above with respect to FIG. 6B . That is, the rotation stop rotates a full 360 degrees about axis 516 from the stopped state shown in FIG. 6A to the loaded state shown in FIG. 6C . In some applications, rotation stop 560 is rotated an additional 180 degrees in the opposite direction as described above with respect to FIG. 6B . That is, the rotation stop alternates 180 degrees between the stopped state shown in FIG. 6A and the loaded state shown in FIG. 6C .

[0365] Each anchor 520 is slidably coupled to wire 512 via eyelet 540, such that rotation of the rotation stop about axis 516 rotates tissue anchor 520a disposed within receiving lumen 562 about wire 512. In the loaded state, as shown in FIG. 6C , tissue engaging element 530 and anchor head 580 are aligned with anchor driver sub-lumen 506 and the lumen of channel 554. That is, central lumen 536 of tissue engaging element 530 is (a) aligned along axis ax2 of anchor 520, (b) aligned with the lumen of channel 554 of transluminally advanceable catheter 502 along axis 516 of catheter 502, and (c) aligned with anchor driver sub-lumen 506 along anchor driver sub-lumen axis 507.

[0366] In the loaded state, the wall of stopper 560 blocks the distal end of anchor storage sub-lumen 504, thereby preventing distal movement of any additional anchor 520 and providing a safety mechanism against accidental release of another anchor. For some applications, the handle of unit 518 includes a spring (not shown) disposed within anchor storage sub-lumen 504 proximal to multiple tissue anchors 520. For some applications, the spring is disposed proximal to anchor storage zone 522.

[0367] 6D shows a system 500 including an implant 510 and a delivery tool 550 for percutaneous (e.g., transluminal, e.g., transfemoral) implantation of the implant. The tool 550 includes a flexible anchor driver 260 configured to reversibly engage a driver interface 582 of the anchor 520. Upon this engagement, the driver 260 is configured to drive the tissue engaging element 530 into tissue, for example, by rotating (and pushing distally) the anchor 520. While the anchor 520a is disposed within the receiving lumen 562 and held approximately in place by the force of the spring 564, the anchor driver 260 slides distally within the anchor driver sublumen 506 such that the driver head 264 closely engages the interface 582 of the anchor head 580 of the tissue anchor 520a.

[0368] The channel 554 is shaped to control the rotational position of the eyelet 540 relative to the axis ax2 and / or the tissue-engaging element 530 during delivery and fixation. In some such applications, the channel 554 defines a major channel region 556a and a minor channel region 556b. The major channel region 556a has a larger cross-sectional area than the minor channel region 556b. The anchor 520 is slidable through the channel 554, with the tissue-engaging element 530 sliding (often snugly) through the primary channel region 556a and the eyelet 540 sliding (often snugly) through the minor channel region 556b and along the wire 512. Rotational control of the channel 552 thereby controls the position of the eyelet 540, and therefore the wire 512, about the axis ax2 of each anchor. Within the channel 554, the driver interface 582 and the tissue-engaging element 530 are rotatable, but the ring 584 and the eyelet 540 are not. In some applications, and as shown, the channel 554 has a keyhole-shaped orthogonal cross section.

[0369] As shown in FIG. 6D , an indicator 570 couples to each anchor 520. When anchor 520 a is positioned within receiving lumen 562, indicator 570 is positioned between anchor 520 and spring 564 to help stabilize anchor 520 a. In FIG. 6E , anchor driver 260 is pushed distally to advance anchor 520 a distally beyond receiving lumen 562 and into the lumen of channel 554. Due to the bending of spring 564, in the absence of anchor 520 a, spring 564 returns to its resting state, i.e., spring 564 assumes its curved state. As anchor 520 a is advanced distally and spring 564 assumes its curved state, indicator 570 is ejected from within receiving lumen 562, indicating that anchor driver 260 has successfully coupled to anchor 520 a and advanced anchor 520 a distally into the lumen of channel 554 of catheter 502.

[0370] Once driver 260 has implanted tissue anchor 520a, it is released from anchor 520a and retracted through the lumen of channel 554 and through anchor driver sub-lumen 506. Driver head 264 is positioned proximally within sub-lumen 506 relative to rotation stop 560 until rotation stop 560 is rotated to assume the receiving state shown in FIG. 6B for sequentially receiving the next anchor 520b positioned proximally adjacent to the distal-most anchor 520a. Rotation stop 560 is then rotated to assume the loading state shown in FIG. 6C to align anchor 520b with anchor driver sub-lumen 506 and with the lumen of channel 554 of catheter 502. In the loading state, anchor driver 260 engages tissue anchor 520b, as described above with respect to FIG. 6D, and anchor driver 260 pushes anchor 520b distally through the lumen of channel 554, as illustrated in FIG. 6E.

[0371] After the desired number of anchors 520 have been secured, an adjustment tool is introduced (e.g., over and along the proximal portion of wire 512) and used to facilitate tensioning of the wire. Thus, tensioning wire 512 draws anchors 520 toward one another, thereby contracting the tissue to which they are secured. As described above, this facilitates smooth sliding of wire 512 through opening 546, with eyelets 240 allowing the wire to orthogonally slide relative to the anchors. Respective stops couple to wire 512 and prevent wire 512 from slipping out of anchor 520. Excess wire 512 can then be cut and removed from the patient.

[0372] As noted above, in some applications, the eyelet 540 is mounted so as to be rotatable about the axis ax2. This therefore provides independence between the rotational position of the eyelet and the rotational position of the tissue-engaging element 530. In applications where the tissue-engaging element 530 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 530 used, this independence is hypothesized to allow the eyelet 540 (and wire 512) to be optimally positioned relative to the axis ax2 of each anchor 520 for a given application. For example, in applications where the implant 510 is used for annuloplasty, the anchors 520 are often secured in a curved configuration around the valve annulus, and the eyelet 540 and wire 512 can be positioned on the inside of the curve relative to the axis ax2.

[0373] To secure anchors 520 , each anchor is advanced out the distal end of channel 554 and driver 260 rotates driver interface 582 (and thereby tissue engaging element 530 ) relative to channel 554 .

[0374] Each anchor 520 defines a respective tissue anchor lumen extending the entire longitudinal length of the anchor 520, from the proximal end of the anchor head 580 to the distal end of the tissue engaging element 530, and the anchor driver 260, e.g., specifically the driver head 264, is dimensioned to slide axially within all of the tissue anchor lumens of the anchor 520.

[0375] For some applications, eyelet 540 is shaped to define protrusion 241 as described above with respect to Figures 1A-B and 2A-B.

[0376] Reference is now made to Figures 7A-F, which are schematic illustrations of example catheter system 600 including a transluminally advanceable catheter 622, at least one tissue anchor 620, and an implant 603 including the tissue anchor, and techniques for use therewith, according to several applications. System 600 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 600 can be an annuloplasty system and implant 603 can be an annuloplasty structure.

[0377] The catheter 622 comprises a flexible tube, e.g., a polymer tube, that couples to an extracorporeal unit (e.g., unit 18 shown in FIG. 1A ) at its proximal end and extends distally therefrom along a catheter longitudinal axis 626 of the catheter 622 from the unit to a distal opening of the catheter 622 at its distal end 624. The transluminally advanceable catheter 622 comprises a channel shaped to define a lumen that accommodates the implant 603 during delivery to the patient's tissue 10. In an application in which the tissue 10 represents tissue of a native heart valve, e.g., the annulus of a mitral valve, the implant 603 is an annuloplasty structure comprising the wire 601 and a plurality of anchors 620. Each anchor 620 is shaped to define a central, longitudinal anchor axis ax2. Each anchor 620 comprises a tissue-engaging element 630 and an anchor head 680. The tissue engaging element 630 has a proximal end 632 and a distal end 634 and defines a central longitudinal axis ax2 of the anchor 620. At the distal end 634, the tissue engaging element 630 includes a sharpened distal tip, and the tissue engaging element is configured to be driven (e.g., threaded) into the subject's tissue. In some applications, as shown, the tissue engaging element 630 is helical and defines a central lumen 636 along the axis ax2, which is a portion of the central lumen of the tissue anchor 620 from an opening at the proximal end of the anchor head 680 to the distal end 634 of the tissue engaging element 630. If desired, the tissue engaging element 630 can be another type of tissue engaging element, such as a dart or a staple. The head 680 couples to the proximal end 632 of the tissue engaging element 630 and includes a driver interface 682 and an eyelet 640 defining an opening 646 therethrough. Driver interface 682 is configured to be reversibly engaged by flexible anchor driver 604. For some applications, eyelet 640 comprises a structural element that protrudes laterally relative to tissue engaging element 630.

[0378] System 600 includes an anchor driver 604, which can include an elongated, flexible shaft 606, and a driver head 610 coupled to a distal end of the shaft. Driver head 610 is a component of anchor driver 604 that reversibly engages a driver interface 682 of anchor 620. Driver interface 682 can be rigidly coupled to tissue engaging element 630. For some applications, anchor head 680 (e.g., driver interface 682) includes a proximal rim 686 and a wall extending distally therefrom, and is shaped to define and surround a recess 683 extending distally from rim 686. For some applications, the wall surrounding recess 683 is square, as shown. For some applications, the wall surrounding recess 683 is shaped as a circular wall.

[0379] In some applications, as shown, driver interface 682 is positioned on central longitudinal axis ax2 and eyelets 640 are positioned laterally from axis ax2.

[0380] Anchor 620 (e.g., its eyelet 640) is configured to easily slide the anchor along (or slide the wire through) wire 601 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 620 along the wire. Anchor 620 (e.g., its eyelet 640) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 640. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as in annuloplasty.

[0381] In some applications, as shown, eyelet 640 is mounted so as to be rotatable about axis ax2. For example, head 680 can include a ring 684 to which eyelet 640 is mounted. Ring 684 surrounds and is rotatable about axis ax2, for example, by being rotatably coupled to tissue engaging element 630, for example, by being rotatably coupled to another component of head 680 (e.g., driver interface 682) that is fixedly coupled to the tissue engaging element.

[0382] Each anchor 620 is shaped to define a central lumen extending from the proximal rim 686 to the distal end 634 of the tissue engaging element 630. The flexible shaft 606 and driver head 610 of the driver 604 are dimensioned to be slidable within the respective central lumen of the anchors 620. The anchor driver 604, e.g., particularly the driver head 610, is dimensioned to slide axially within the lumen of the catheter 622 and is operable to reversibly engage the driver interface 682 of each tissue anchor. The anchor driver 604 is configured to advance the anchor 620 distally toward a distal opening in the end 624 of the catheter 622 while the driver head 610 is engaged with the driver interface 682, thereby engaging the tissue engaging element 630 within the tissue 10 along the tissue anchor axis ax2.

[0383] By way of example and not limitation, as shown in FIGS. 7A-B, driver head 610 is positioned distal to the distal-most anchor 620 while shaft 606 is positioned within the central lumen of anchor 620, while in FIGS. 7C-F, the distal end of driver head 610 is positioned within anchor head 680 after driver head 610 is slid proximally through the central lumen of anchor 620 by pulling on shaft 606.

[0384] Reference is now made to FIGS. 7A-B. Note that FIG. 7B is a vertical cross-section of delivery tool 602. Driver head 610 is shaped to define first and second legs 612a, 612b having a rest state (shown in FIGS. 7A-D), in which first and second legs 612a, 612b define a first space S1 having a first distance therebetween, and in which first and second legs 612a, 612b do not contact and / or securely engage the walls of tissue anchor 620 surrounding recess 683. Anchor driver 604 includes connecting bar 614 at least partially disposed between first and second legs 612a, 612b. Legs 612a and 612b are each shaped to define a respective window for connecting each leg 612a, 612b to a respective end of bar 614. The windows in legs 612a and 612b are configured to allow legs 612a and 612b to slide along bar 614 in the expanded state, facilitating expansion of legs 612a and 612b away from central axis 626. A distal portion of each leg 612a and 612b is each shaped to define a respective engagement valve 616a and 616b configured to engage with the wall of recess 683, as described below.

[0385] Anchor driver 604 further includes first and second extending elements 618a and 618b disposed on or coupled to a distal end of advancement element 621 (shown in FIG. 7B ). For some applications, first and second extending elements 618a and 618b are molded from advancement element 621. For some applications, first and second extending elements 618a and 618b comprise respective arms or wires. First and second extending elements 618a and 618b and advancement element 621 are slidable relative to flexible shaft 606 and relative to first and second legs 612a and 612b. First and second extending elements 618a and 618b are advanceable distally in response to pushing advancement element 621 and advanceable proximally in response to pulling advancement element 621. The first and second expansion elements can be configured in a variety of ways including, for example, one or more of a wire, an arm, a rod, a latch, a lever, an extension, an expandable ring, an expandable helix, etc. The advancement element can also be configured in a variety of ways including, for example, one or more of a wire, a rod, a shaft, a hypotube, an extension, etc.

[0386] As shown in FIGS. 7A-D , first and second expansion elements 618a and 618b are positioned upstream of connecting bar 614 in a static, folded state of first and second legs 612a and 612b of anchor driver 604. Thus, driver head 610 remains in a position that does not fixedly engage any portion of anchor 620, and driver head 610 is axially slidable within its central lumen relative to anchor 620. In FIGS. 7A-B , driver head 610 is positioned distal to the distal-most tissue anchor 620. Because legs 612a and 612b are static, anchor driver 604 can be slid proximally, for example, by retracting shaft 606, to properly position driver head 610 relative to anchor 620, as shown in FIGS. 7C-D , so that driver head 610 can engage and maintain connection with anchor head 680. As shown, prior to engagement with anchor head 680, distal portions of legs 612a and 612b are positioned within recess 683 such that engagement valves 616a and 616b of legs 612a and 612b are positioned within recess 683 and in alignment with the wall surrounding recess 683 of driving interface 682.

[0387] 7E-F show first and second legs 612a and 612b of driver head 610 in an engaged state in which engagement bulbs 616a and 616b of legs 612a and 612b securely engage the wall surrounding recess 683 of driving interface 682. To transition legs 612a and 612b to the engaged state, advancement element 621 is pushed distally to spread first extension element 618a and second extension element 618b around connecting bar 614 and away from central axis 626 and advance them into the space between first leg 612a and second leg 612b. As first and second expanding elements 618a and 618b expand within the space between legs 612a and 612b, first and second expanding elements 618a and 618b spread first and second legs 612a and 612b away from central axis 626, such that first and second legs 612a and 612b assume an engaged state in which the first and second legs define a second space S2 having a second distance between them that is greater than the first distance of first space S1 (shown in FIGS. 7A and 7C ). As legs 612a and 612b expand outward, engagement valves 616a and 616b of first and second legs 612a and 612b contact and engage the wall of tissue anchor 620 surrounding recess 683.

[0388] As shown, as the first and second extension elements 618a and 618b extend around the connecting bar 614, the extension elements 618a and 618b extend along a first plane shown at cross section AA, which is at a non-zero angle, e.g., perpendicular, to a second plane shown at cross section BB, and along which the first and second legs 612a and 612b extend, by way of example and not limitation.

[0389] First and second expansion elements 618a and 618b have respective distal surfaces 619a and 619b at the respective ends of each element 618a and 618b. As shown in FIGS. 7E-F , when first and second legs 612a and 612b are engaged, surfaces 619a and 619b engage and push proximal rim 686 of tissue anchor 620 to facilitate pushing tissue anchor 620 distally when first and second legs are engaged. Thus, system 600 is particularly advantageous because expansion elements 618a and 618b facilitate a secure, reversible connection between legs 612a and 612b and tissue anchor 620, as well as the pushing of tissue anchor 620 by expansion elements 618a and 618b. Notably, the expansion and collapse of expansion elements 618a and 618b is controlled by advancement element 621. This allows anchor driver 604 to (1) slide proximally and distally through a series of anchors without firmly engaging any of the anchors during sliding, (2) engage any of the anchors in a controlled manner by controlling the expansion and collapse of expansion elements 618a and 618b, and (3) access any anchor in the series of anchors regardless of whether the anchor is positioned proximal or distal to driver head 610.

[0390] Driver 604 is used to implant tissue anchor 620 by rotating tissue anchor 620 along axis ax2. Expanding elements 618a and 618b prevent legs 612a and 612b from collapsing when torque is applied to anchor 620 by driver 604 while driving anchor 620 into tissue. Additionally, expanding elements 618a and 618b allow legs 612a and 612b to pull anchor 620 proximally as needed.

[0391] Note that system 600 provides reversible engagement between anchor driver 604 and anchors 620. For example, once anchor 620 is implanted in tissue, driver 604 is detached from tissue anchor 620 by proximally drawing advancement element 621, which retracts expansion elements 618a and 618b proximally from bar 614 and causes first and second legs 612a and 612b to fold together into the folded state shown in FIGS. 7A-D , which may assume a resting state in which a first space S1 is defined between legs 612a and 612b. The reversible engagement of driver 604 with any tissue anchor 620, due to the expansion and folding of legs 612a and 612b by expansion elements 618a and 618b, is particularly useful if the surgeon accidentally engages the wrong anchor in a series of anchors 620. In such cases, engagement of the incorrect anchor can be undone by retracting advancement element 621 to retract expansion elements 618a and 618b, thereby retracting anchor driver 604. Anchor driver 604 can then be repositioned to engage the correct anchor in the manner described above.

[0392] Reference is now made to Figures 8A-C, which are schematic illustrations of example catheter system 800 including a transluminally advanceable catheter 722, at least one tissue anchor 720, and an implant 703 including the tissue anchor, and techniques for use therewith, according to several applications. System 700 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 700 can be an annuloplasty system and implant 703 can be an annuloplasty structure.

[0393] The catheter 722 comprises a flexible tube, e.g., a polymer tube, that couples to an extracorporeal unit (e.g., unit 18 shown in FIG. 1A ) at the proximal end of the catheter 722 and extends distally therefrom along a central longitudinal catheter axis 726 of the catheter 722 from the unit to a distal opening of the catheter 722 at the distal end 724 of the catheter 722. The transluminally advanceable catheter 722 comprises a channel shaped to define a lumen that accommodates the implant 703 during delivery into the patient's tissue 10. In applications where the tissue 10 represents tissue of the annulus of a native heart valve, e.g., the mitral valve, the implant 703 is an annuloplasty structure comprising the wire 701 and a plurality of anchors 720.

[0394] For some applications, each anchor 720 is shaped to define a central longitudinal anchor axis ax2. For some applications, each anchor 720 includes a tissue engaging element 730 and an anchor head 780. The tissue engaging element 730 has a proximal end 732 and a distal end 734, defining the central longitudinal axis ax2 of the anchor 720. For some applications, at the distal end 734, the tissue engaging element 730 includes a sharp distal tip, and the tissue engaging element is configured to be driven (e.g., threaded) into tissue of a subject. For some applications, as shown, the tissue engaging element 730 is helical and defines a central lumen 736 along axis ax2, which is the portion of the central lumen of the tissue anchor 720 from an opening at the proximal end of the anchor head 780 to the distal end 734 of the tissue engaging element 730. If desired, the tissue engaging element 730 can be another type of tissue engaging element, such as a dart or a staple. Head 780 couples to proximal end 732 of tissue engaging element 730 and includes a driver interface 782 and an eyelet 740 defining an opening 746 therethrough. Driver interface 782 is configured to be reversibly engaged by flexible anchor driver 704. For some applications, eyelet 740 includes a structural element that protrudes laterally relative to tissue engaging element 730.

[0395] The system 700 includes an anchor driver 704, which may include an elongated, flexible shaft 710, and a driver head 712 coupled to the distal end of the shaft. The driver head 712 includes deflectable protrusions and is a component of the anchor driver 704 that reversibly engages a driver interface 782 of the anchor 720. The driver interface 782 can rigidly couple to and define an inner surface of the tissue-engaging element 730. In some applications, as shown, the driver interface 782 comprises, by way of example and not limitation, a portion of the anchor 720 at the junction between the head 780 and the tissue-engaging element 730. Note that the driver interface 782 can comprise any portion of the anchor 720. In some applications, the anchor head 780 includes a proximal rim 786 and a wall extending distally therefrom, and is shaped to define and surround a recess 783 extending distally from the rim 786. In some applications, the walls surrounding recess 783 are square, as shown. In some applications, the walls surrounding recess 783 are shaped as circular walls.

[0396] In some applications, as shown, driver interface 782 is positioned on central longitudinal axis ax2 and eyelets 740 are positioned laterally from axis ax2.

[0397] Anchor 720 (e.g., its eyelet 740) is configured to easily slide the anchor along (or slide the wire through) wire 701 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 720 along the wire. Anchor 720 (e.g., its eyelet 740) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 740. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as in annuloplasty.

[0398] In some applications, as shown, eyelet 740 is mounted so as to be rotatable about axis ax2. For example, head 780 can include a ring 784 to which eyelet 740 is mounted. Ring 784 surrounds and is rotatable about axis ax2, e.g., by being rotatably coupled to tissue engaging element 730, e.g., by being rotatably coupled to another component of head 780 (e.g., driver interface 782) that is fixedly coupled to the tissue engaging element.

[0399] Each anchor 720 is shaped to define a central lumen extending from the proximal rim 786 to the distal end 734 of the tissue engaging element 730. The flexible tube 706 and driver head 712 of the driver 704 are dimensioned to be slidable within the respective central lumen of the anchors 720. The anchor driver 704, e.g., particularly the driver head 712, is dimensioned to slide axially within the lumen of the catheter 722 and is operable to reversibly engage the driver interface 782 of each tissue anchor. The anchor driver 704 is configured to advance the anchor 720 distally toward a distal opening in the end 724 of the catheter 722 while the driver head 712 is engaged with the driver interface 782, thereby engaging the tissue engaging element 730 within the tissue 10 along the tissue anchor axis ax2.

[0400] 8A , while tube 706 is positioned within the central lumen of anchor 720, driver head 712 is positioned distally relative to driver interface 782 of the distal-most anchor 720, while in FIG. 8B , driver head 712 is positioned to securely engage within driver interface 782 after driver head 712 and shaft 710 are slid proximally through the central lumen of anchor 720 by retracting shaft 710. In some applications, driver interface 782 defines a groove into which driver head 712 fits snugly to securely engage driver interface 782. In some applications, driver interface 782 defines a wall of anchor 720 surrounding recess 783.

[0401] Anchor driver 704 comprises a flexible tube 706 having a central axis defined along central axis 726 of catheter 722. The prongs of driver head 712 are deflectable from (1) a resting state in which the prongs of head 712 are pushed toward the central axis defined by flexible tube 706 (i.e., toward axis 726) ( FIG. 8C ) and do not contact the walls of the tissue anchor, e.g., anchor 720 surrounding recess 783, to (2) an engaged state in which the deflectable prongs of head 712 move away from the central axis defined by flexible tube 706 (i.e., toward axis 726) and engage tissue anchor 720 at driver interface 782 ( FIG. 8B ).

[0402] Anchor driver 704 is disposed within the lumen of flexible tube 706 and includes a shaft 708 that is slidable relative to tube 706. Shaft 708 is engageable with deflectable protrusions of driver head 712 such that, when shaft 708 slides along the deflectable protrusions of head 712 and distal end 709 is proximal to driver head 712, shaft 708 deflects the deflectable protrusions from a retracted state (as shown in FIG. 8C ) away from the central axis (i.e., axis 726) of tube 706 to an engaged state of the deflectable protrusions of head 712 (as shown in FIG. 8B ) in which the deflectable protrusions engage tissue anchor 720 at interface 782. Anchor driver 704 is dimensioned to slide axially through the lumen defined by tissue anchor 720 and to selectively and reversibly engage tissue anchor 720 in response to movement of shaft 708. The distal end 709 of the shaft 708 can be retracted away from the deflectable protrusions of the head 712, facilitating deflection of the deflectable protrusions from an engaged state (FIG. 8B) to a pushed-in state (FIG. 8C) toward the central axis 726, disengaging the anchor driver 704 from the tissue anchor 720.

[0403] Reference is now made to Figures 8A-C. Note that Figures 8A-C are vertical cross sections of transfer tool 702.

[0404] Anchor driver 704 further includes first and second expanding elements 718a and 718b disposed at or coupled to the distal end of tube 706, e.g., the exterior surface of tube 706. For some applications, first and second expanding elements 718a and 718b are molded from tube 706. For some applications, first and second expanding elements 718a and 718b are controlled by separate mechanisms. For some applications, first and second expanding elements 718a and 718b comprise respective wires. First and second expanding elements 718a and 718b and tube 706 are slidable relative to flexible shaft 708 and relative to shaft 710 and driver head 712. First and second expanding elements 718a and 718b are advanceable distally in response to pushing on tube 706 and advanceable proximally in response to pulling on tube 706.

[0405] As shown in FIG. 8A , first and second expanding elements 718 a and 718 b are pushed into the lumen of anchor 720. For some applications, first and second expanding elements 718 a and 718 b include a shape memory material that allows first and second expanding elements 718 a and 718 b to expand in the absence of a force applied thereto, as shown in FIG. 8B , which shows first and second expanding elements 718 a and 718 b in an expanded state. For some applications, first and second expanding elements 718 a and 718 b do not include a shape memory material, and the expansion of first and second expanding elements 718 a and 718 b is controlled either by tube 706 or some external mechanism.

[0406] 8A to 8B, where the driver head 712 is in a position where it is not fixedly engaged with any portion of the anchor 720, the shaft 708 is retracted proximally along the shaft 710, causing the deflectable protrusion of the driver head 712 to collapse toward the axis 726. The shaft 710 and head 712, as well as the shaft 708, are retracted proximally, positioning the driver head 712 at the interface 782. Additionally, the tube 706 is retracted proximally to eject the first and second dilating elements 718a and 718b from within the lumen of the anchor 720. In some applications, the movement of the shaft 708 and the tube 706 are coupled, such that movement of the shaft 708 facilitates movement of the tube 706. In FIG. 8B, the driver head 712 is securely engaged with the driver interface 782, maintaining the coupling with the anchor 720. During secure coupling, the distal end 709 of the shaft 708 is positioned distal to the driver head 712 such that the distal portion of the shaft 708 exerts a force against the driver head 712 outward from the axis 726, maintaining the driver head 712 in a deflected position away from the axis 726 and remaining engaged with the interface 782.

[0407] 8B , to facilitate pushing tissue anchor 720 distally upon engagement of the deflectable prongs of driver head 712, first and second expanding elements 718a and 718b spread their respective distal surfaces 719a and 719b at the respective ends of each element 718a and 718b to engage and push against proximal rim 786 of tissue anchor 720. Thus, system 700 is particularly advantageous because driver head 712 facilitates secure, reversible coupling to tissue anchor 720, and expanding elements 718a and 718b facilitate pushing tissue anchor 720 distally. Notably, collapse of expanding elements 718a and 718b is controlled by tube 706.

[0408] Driver 704 is used to implant tissue anchor 720 by rotating tissue anchor 720 along axis ax2.

[0409] Note that system 700 provides reversible engagement between anchor driver 704 and anchor 720. For example, once anchor 720 is implanted in tissue, driver 704 can be removed from tissue anchor 720 by pulling shaft 708 proximally, thereby forcing deflectable projections of head 712 toward axis 726 ( FIG. 8C ) and pulling tube 706 proximally, thereby retracting expander elements 718 a and 718 b proximally so that anchor 720 and surfaces 719 a and 719 b do not contact rim 786. Expander elements 718 a and 718 b can then be folded together to a collapsed state when driver 704 is pulled back through a proximally positioned anchor in the series of anchors 720. The reversible engagement of driver 704 with any tissue anchor 720 by expansion and collapse of legs 712a and 712b by expansion elements 718a and 718b is particularly useful if the surgeon mistakenly engages the wrong anchor in a series of anchors 720. In such a case, the engagement of the wrong anchor can be reversed by retracting shaft 708 to retract impactor head 712, thereby retracting anchor driver 704. Anchor driver 704 can then be repositioned to engage the correct anchor in the manner described above.

[0410] 8C illustrates, by way of example and not limitation, disengaging driver 704 from anchor 720 while anchor 720 is within the lumen of catheter 722. In the same manner as described for disengaging driver 704 from anchor 720 while anchor 720 is within the lumen of catheter 722, driver 704 can be removed from anchor 720 once anchor 720 is implanted in tissue 10.

[0411] Reference is now made to Figures 9A-B, which are schematic illustrations of example catheter system 800 including a transluminally advanceable catheter 822, at least one tissue anchor 820, and an implant 803 including the tissue anchor, and techniques for use therewith, according to several application examples. System 800 is a tissue adjustment system and can be used to adjust the dimensions of tissue structures. For example, system 800 can be an annuloplasty system, and implant 803 can be an annuloplasty structure.

[0412] The catheter 822 comprises a flexible tube, e.g., a polymer tube, that couples to an extracorporeal unit (e.g., unit 18 shown in FIG. 1A ) at the proximal end of the catheter 822 and extends distally therefrom along a catheter longitudinal axis 826 of the catheter 822 from the unit to a distal opening of the catheter 822 at the distal end 824 of the catheter 822. The transluminally advanceable catheter 822 comprises a channel shaped to define a lumen that accommodates the implant 803 during delivery into the patient's tissue 10. In applications where the tissue 10 represents tissue of the annulus of a native heart valve, e.g., the mitral valve, the implant 803 is an annuloplasty structure comprising the wire 801 and a plurality of anchors 820.

[0413] For some applications, each anchor 820 is shaped to define a central longitudinal anchor axis ax2. For some applications, each anchor 820 includes a tissue engaging element 830 and an anchor head 880. Tissue engaging element 830 has a proximal end 832, a distal end 834, and defines a central longitudinal axis ax2 of anchor 820. For some applications, at distal end 834, tissue engaging element 830 includes a sharp distal tip, and the tissue engaging element is configured to be driven (e.g., threaded) into tissue of a subject. For some applications, as shown, tissue engaging element 830 is helical and defines a central lumen 836 along axis ax2, which is the portion of the central lumen of tissue anchor 820 from an opening at the proximal end of anchor head 880 to distal end 834 of tissue engaging element 830. If desired, tissue engaging element 830 can be another type of tissue engaging element, such as a dart or a staple. Head 880 couples to proximal end 832 of tissue engaging element 830 and includes a driver interface 882 and an eyelet 840 defining an opening 846 therethrough. Driver interface 882 is configured to be reversibly engaged by flexible anchor driver 804. For some applications, eyelet 840 includes a structural element that protrudes laterally relative to tissue engaging element 830.

[0414] System 800 includes an anchor driver 804, which can include an elongated, flexible advancement element 806, and a driver head 810 that couples to a distal end of advancement element 806. Driver head 810 is a component of anchor driver 804 that reversibly engages a driver interface 882 of anchor 820. Driver interface 882 can be rigidly coupled to tissue engaging element 830. For some applications, anchor head 880 (e.g., driver interface 882) includes a proximal rim 886 and a wall extending distally therefrom, and is shaped to define and surround a recess 883 extending distally from rim 886. For some applications, the wall surrounding recess 883 is square. For some applications, the wall surrounding recess 883 is shaped as a circular wall.

[0415] In some applications, driver interface 882 is positioned on central longitudinal axis ax2 and eyelets 840 are positioned laterally from axis ax2, as shown.

[0416] Anchor 820 (e.g., its eyelet 840) is configured to easily slide the anchor along (or slide the wire through) wire 801 while the anchor is aligned with the wire, e.g., while axis ax2 is parallel to the wire. This is hypothesized to facilitate transcatheter advancement of anchor 820 along the wire. Anchor 820 (e.g., its eyelet 840) is configured to easily slide the anchor along (or slide the wire through) the wire while the anchor is oriented perpendicular to the wire, i.e., while axis ax2 is perpendicular to the wire. This is achieved, at least in part, by the shape and dimensions of eyelet 840. This is hypothesized to be particularly useful in applications where wires are tensioned after implantation to adjust anatomical dimensions, such as annuloplasty.

[0417] In some applications, as shown, eyelet 840 is mounted so as to be rotatable about axis ax2. For example, head 880 can include a ring 884 to which eyelet 840 is mounted. Ring 884 surrounds and is rotatable about axis ax2, e.g., by being rotatably coupled to tissue engaging element 830, e.g., by being rotatably coupled to another component of head 880 (e.g., driver interface 882) that is fixedly coupled to the tissue engaging element.

[0418] Each anchor 820 is shaped to define a central lumen extending from the proximal rim 886 to the distal end 834 of the tissue engaging element 830. The flexible advancement element 806 and driver head 810 of the driver 804 are dimensioned to be slidable within the respective central lumen of the anchors 820 when the driver 804 is in a stationary state, as shown in FIG. 9B . The anchor driver 804, e.g., particularly the driver head 810, is dimensioned to slide axially within the lumen of the catheter 822 and is operable to reversibly engage the driver interface 882 of each tissue anchor. The anchor driver 804 is configured to advance the anchor 820 distally toward a distal opening in the end 824 of the catheter 822 while the driver head 810 is engaged with the driver interface 882, thereby engaging the tissue engaging element 830 within the tissue 10 along the tissue anchor axis ax2.

[0419] 9A-B are vertical cross sections of delivery tool 802. Driver head 810 is shaped to define first leg 812a and second leg 812b having a rest state (shown in FIG. 9A) in which first leg 812a and second leg 812b define a first space S3 having a first distance therebetween, and in which first leg 812a and second leg 812b do not contact and / or firmly engage the walls of tissue anchor 820 surrounding recess 883.

[0420] Anchor driver 804 includes an expansion element 818 coupled to a displacement element 821, e.g., a shaft, rod, wire, hypotube, line, wedge, extension, etc., that facilitates distal and proximal sliding of expansion element 818. Displacement element 821 is disposed within the lumen of advancement element 806 (which may be the same as or similar to another advancement element herein) and is slidable relative to advancement element 806, such that the expansion element is slidable relative to advancement element 806 and relative to legs 812a and 812b. In the resting state of legs 812a and 812b, expansion element 818 is disposed at the distal surface of legs 812a and 812b, as shown in FIG. 9A. In the resting state, legs 812a and 812b together form a circular shape, as shown in FIG. 9A.

[0421] As shown in FIG. 9B , to facilitate spreading of legs 812a and 812b away from central axis 826 to the engaged state of legs 812a and 812b ( FIG. 9B ), extension element 818 is pulled proximally by pulling displacement element 821, resulting in extension element 818 being retracted into a position between legs 812a and 812b and fitting snugly into the space between legs 812a and 812b. In the engaged state of legs 812a and 812b, legs 812a and 812b define a second space S4 between them having a second distance greater than the first distance of first space S3. A distal portion of each leg 812a and 812b is each shaped to define a respective engagement bulb 816a and 816b configured to engage with the wall of recess 883. For some applications, the walls of recess 883 are shaped to define a groove for snugly interlocking with valves 816a and 816b when legs 812a and 812b are engaged, in which case legs 812a and 812b together form an oval shape, as shown in view B.

[0422] In some applications, the expansion element 818 comprises a circular disk having a diameter greater than the first space S3 between the first leg 812a and the second leg 812b in a resting state, as shown, such that the first leg 812a and the second leg 812b expand to assume an engaged state when the expansion element 818 is positioned between the legs 812a and 812b.

[0423] In some applications, the expansion element 818 comprises an oval disk having a major axis diameter greater than the first space S3 between the first leg 812a and the second leg 812b in a resting state, such that the first leg 812a and the second leg 812b expand to assume an engaged state when the expansion element 818 is positioned between the legs 812a and 812b.

[0424] Legs 812a and 812b of advancement element 806 are shaped to define pushing surfaces 819a and 819b that are located proximally relative to proximal rim 868. As shown in FIG. 9B , upon engagement of first and second legs 812a and 812b, surfaces 819a and 819b engage and push against proximal rim 886 of tissue anchor 820 to facilitate pushing tissue anchor 820 distally upon engagement of the first and second legs. Thus, system 800 is particularly advantageous because expansion element 818 facilitates a secure, reversible connection between legs 812a and 812b and tissue anchor 820, as well as the pushing of tissue anchor 820 by legs 812a and 812b against surfaces 819a and 819b. Notably, the expansion and collapse of legs 812a and 812b are controlled by displacement element 821 and expansion element 818. This allows anchor driver 804 to (1) slide proximally and distally through a series of anchors without firmly engaging any of the anchors during sliding, (2) engage any of the anchors in a controlled manner by controlling the movement of expansion element 818, and (3) access any anchor in the series of anchors, regardless of whether the anchor is positioned proximal or distal to driver head 810.

[0425] Driver 804 is used to implant tissue anchor 820 by rotating tissue anchor 820 along axis ax2. Expanding element 818 prevents legs 812a and 812b from collapsing when torque is applied to anchor 820 by driver 804 while driving anchor 820 into tissue. Additionally, expanding element 818 allows legs 812a and 812b to pull anchor 820 proximally as needed.

[0426] Note that system 800 provides reversible engagement between anchor driver 804 and anchor 820. For example, once anchor 820 is implanted in tissue, driver 804 can be detached from tissue anchor 820 by pushing and retracting displacement element 821 distally, thereby pushing expansion element 818 distally and causing first and second legs 812a and 812b to collapse toward axis 826, thereby defining a resting state in which first space S3 is defined between legs 812a and 812b. The reversible engagement of driver 804 with any tissue anchor 820, due to the expansion and collapse of legs 812a and 812b by expansion elements 818a and 818b, is particularly useful if the surgeon accidentally engages the wrong anchor in a series of anchors 820. In such a case, the engagement of the wrong anchor can be reversed by pushing displacement element 821 to displace and move expansion element 818 distally, thereby retracting anchor driver 804. The anchor driver 804 can then be repositioned to engage the correct anchor in the manner described above.

[0427] 7A-F, 8A-C, and 9A-B, it should be noted that any of anchor drivers 604, 704, and 804 can be used to deliver any of tissue anchors 220, 320, 420, and 520 described above with respect to FIGS.

[0428] Reference is made to Figures 10, 11A-B, 12A-B, 13A-E, 14A-E, and 15A-B, which are schematic illustrations of a system 1000 for use in a subject, according to several applications. Figure 10 shows an overview of the system 1000, which includes an implant 1010 and a delivery tool 1050, which includes an anchor driver 1060 and a catheter device 1070. The implant 1010 includes a plurality of tissue anchors 1020 and a tether (e.g., a wire or cord) 1012 threaded through the tissue anchors. As described in more detail below, during implantation, only a distal portion of the tether 1012 remains implanted in the subject, while a proximal portion of the tether remains attached to the delivery tool 1050. Nevertheless, for simplicity, the implant 1010 is described herein as including a tether.

[0429] The tissue anchors 1020 are positioned one after the other along the tether 1012, and the delivery tool 1050 can be used to implant the implant 1010 with the anchor driver 1060 used sequentially for each anchor 1020, advancing the anchor distally into the subject and securing the anchor to the subject's internal tissue. For example, as shown, the implant 1010 can be an annuloplasty implant implanted by positioning the anchors 1020 around at least a portion of the annulus of the subject's native heart valve, e.g., the mitral valve or tricuspid valve. Furthermore, in some applications, the distal end of the tether 1012 can be advanced distally into the subject with a first anchor, and subsequent anchors can be advanced by sliding them distally along the tether. For some applications, system 1000 and / or techniques described for use therewith are used in combination with one or more systems and / or techniques described in U.S. Provisional Patent Application No. 62 / 949,392, filed December 17, 2019, to Kasher et al., entitled "ANNULOPLASTY AND TISSUE ANCHOR TECHNOLOGIES," which is incorporated herein by reference. For example, system 1000 can be used to deliver implant 210 of system 200 or implant 210 of system 600 described in U.S. Provisional Patent Application No. 62 / 949,392, mutatis mutandis. For example, anchor driver 1060 of system 1000 may be (or may be used as) the anchor driver of systems 200 or 600 of U.S. Provisional Patent Application No. 62 / 949,392, mutatis mutandis, and / or catheter 1072 of system 100 may be (or may be used as) the flexible tube of U.S. Provisional Patent Application No. 62 / 949,392.

[0430] The device 1070 includes a distal portion or member, e.g., a catheter 1072, configured to be advanced into the subject. In some applications where the implant 1010 is an annuloplasty implant, the catheter 1072 is a catheter that is transluminally (e.g., transfemorally) advanceable, as shown. The device 1070 further includes an extracorporeal unit (e.g., extracorporeal unit) 1074 configured to remain outside the subject's body. In some applications, the extracorporeal unit 1074 defines or is coupled to a handle of the device 1070.

[0431] The extracorporeal unit 1074 includes a tensioner with a winch 1080 that facilitates reducing slack in the tether 1012 during implantation of the implant 1010, for example, while sliding an anchor distally along the tether. It is hypothesized that reducing slack advantageously reduces the likelihood of the tether 1012 becoming twisted or tangled, or of the tether unintentionally engaging an anchor during delivery. It is further hypothesized that using a winch to reduce slack, rather than having a human operator manually pull on the proximal end of the tether, advantageously provides greater control over the magnitude and consistency of tension applied to the tether, further advantageously reducing the number of human operators required.

[0432] Figures 11A-B show detailed views of the catheter device 1070 (e.g., its extracorporeal unit 1074) without the implant 1010, Figures 12A-B show exploded views of the catheter device, and Figures 13A-E show cross-sectional views of the catheter device. Figures 14A-E show the system 1000 with the implant 1010 attached / loaded into the delivery tool 1050, and the delivery tool in use with the implant. Figure 14A shows a view of the extracorporeal unit 1074 similar to that shown by Figure 11A, but in the presence of the implant 1010.

[0433] Winch 1080 includes a spool 1082 and a spring 1084. Spool 1082 and spring 1084 may be contained within a housing 1081. Spool 1082 is coupled to spring 1084 such that when the spool rotates in a first rotational direction, the spring is stressed and therefore pushed back in a second rotational direction opposite the first rotational direction.

[0434] Tether 1012 has proximal portion 1012p, which includes the proximal end of the tether, and distal portion 1012d, which includes the distal end of the tether. As shown in FIG. 14A , tether 1012 (e.g., proximal portion 1012p) is wound around spool 1082, and pulling on the tether (e.g., distal portion 1012d) away from the winch unwinds the tether from the spool by rotating the spool in a first rotational direction. Such pulling on tether 1012 typically occurs during implantation of implant 1010 as anchor 1020, through which the tether is threaded, continuously advances distally toward the implantation location. The resulting stress on spring 1084 causes the spring to push spool 1082 back in a second rotational direction, causing winch 1080 to pull tether 1012 proximally. The winch 1080 (e.g., its spring 1084) can be configured so that the pulling force applied by the winch to the tether 1012 is great enough to take up slack between the winch and the distal end of the tether, but small enough to allow manipulation of the tether necessary for implantation of the implant 1010, e.g., as described below. For example, the force can be (i) small enough to allow the anchor driver 1060 to advance, position, and secure the anchor 1020 at the target tissue site while the tether 1012 remains threaded through the anchor, but (ii) large enough to take up slack in the tether, thereby reducing the likelihood of the tether becoming tangled or snagged during this advancement, positioning, and securement of the anchor.

[0435] In some applications, spring 1084 is configured to provide a substantially constant force over its operating range (e.g., is a constant force spring), so that the pulling force applied to tether 1012 is substantially constant regardless of how much the tether is pulled from winch 1080.

[0436] In some applications, as shown, spring 1084 is a torsion spring, such as a helical torsion spring. For example, spring 1084 can be a main spring.

[0437] For some applications, each anchor 1020 includes a tissue-engaging element 1022 and a head 1024 defining an eyelet 1026 through which the tether 1012 is threaded. As shown in FIG. 14A , multiple tissue anchors are positioned along the tether 1012, one after the other, between the winch 1080 (e.g., its spool 1082) and the distal end of the tether. For example, as shown, the system 1000 is supplied with the anchors 1020 positioned one after the other on the extracorporeal unit 1074 (e.g., a handle).

[0438] In some applications, as shown (e.g., in FIG. 14A ), the portion of tether 1012 just outside winch 1080 extends proximally relative to device 1070 and then rotates to extend distally relative to device 1070. Despite this arrangement, anchors 1020 are sequentially positioned along tether 1012 between winch 1080 and the distal end of the tether. Note that, that is, anchors are sequentially positioned along the tether between the winch and the distal end of the tether relative to the tether (regardless of the arrangement of the tether relative to device 1070 as a whole).

[0439] In some applications, as shown, this placement is facilitated by the device being an extracorporeal unit 1074 that includes a bearing (e.g., pulley) 1076 (e.g., a proximal bearing) about which the tether 1012 rotates. In some such applications, the device 1070 is provided with the distal end of the tether 1012 already positioned beyond the bearing 1076, i.e., the tether extends proximally from the winch 1080 along the extracorporeal unit 1074 and around the bearing 1076, with the distal end of the tether positioned at least slightly distal to the bearing, e.g., aligned and / or positioned opposite or inside the open proximal end (i.e., proximal opening) of the catheter 1072. In some such applications, the distal end of the tether 1012 is prevented from moving proximally from this position by a stopper 1014 that is fixedly attached to the distal end of the tether. Alternatively, the catheter device 1070 is provided with a "distal end" of the tether 1012, which is the most proximal portion of the tether relative to the catheter device, for example, extending proximally from the winch 1080 and generally terminating at the first anchor 1020f of the implant 1010.

[0440] When device 1070 is configured as described above with tether 1012 extending proximally and distally, it is hypothesized that anchor 1020 will be advantageously positioned proximal to winch 1080, in a location that is particularly accessible to the operator.

[0441] To deploy implant 1010, each anchor 1020 is sequentially reversibly coupled to an anchor driver that advances the implant to a respective site within the subject, e.g., on the annulus of the subject heart valve. Figures 14B-E show this being performed for first anchor 1020f of implant 1010. Anchor 1020f advances along tether 1012 toward the distal end of the tether. Due to the placement of tether 1012 relative to device 1070, this movement of anchor 1020f involves moving the anchor proximally relative to device 1070 (Figure 14B), around bearing 1076 (Figure 14C), and distally (Figure 14D).

[0442] 14B-D are performed manually by a human operator who manually grasps and moves tissue anchor 1020. In some applications, modifications and / or additions to system 1000 eliminate the need to directly grasp anchor 1020 by hand, for example, as described mutatis mutandis for system 1200 and / or system 1400 below.

[0443] Thus, it should be noted that each anchor 1020 is initially oriented with its tissue-engaging element 1022 facing proximally relative to the catheter device 1070, and then oriented with its tissue-engaging element facing distally relative to the catheter device. Once the anchor 1020f is facing distally (e.g., aligned and / or positioned opposite or inside the open proximal end of the catheter 1072), an anchor driver 1060 is reversibly coupled to the anchor (e.g., to its head 1024) (FIG. 14E) and then used to advance the anchor distally through the catheter 1072 and secure the anchor to the subject's tissue. The anchor driver 1060 can include an elongate, flexible shaft 1062 and a driver head 1064 coupled to the distal end of the shaft.

[0444] In some applications, advancement of the first anchor 1020f also presses the distal end of the tether 1012 through the catheter 1072 and against the subject's tissue, for example, by a stopper 1014 (seen in FIGS. 10 and 15A-B) fixedly attached to the distal end of the tether. For each subsequent anchor 1020, the same process is performed mutatis mutandis to slide the anchor distally along the tether 1012 toward the distal end of the tether and the first anchor.

[0445] 15A-B show an implantation site after three anchors 1020 of an implant 1010 have already been secured to the subject's tissue 10 (e.g., the tissue of a heart valve annulus) in some applications, and a fourth anchor being delivered by an anchor driver 1060.

[0446] 15A illustrates that when implanting an implant similar to implant 1010 without winch 1080, slack in the implant's tether can present challenges, for example, by increasing the likelihood of the tether becoming tangled, entangled with the implant and / or other elements of the delivery system, and / or getting caught between the anchor and the tissue in which it is placed. This is illustrated in FIG. 15A , where slack in tether 1012 allows distal portion 1012d of the tether to (1) form a bend 1013 that can become entangled with a previously secured anchor (e.g., wrap around the last secured anchor), and (2) drift across the lumen and / or open distal end of catheter 1072 (denoted by reference numeral 1015) in a manner that increases the risk of the tether becoming entangled with tissue engaging element 1022 of the currently delivered anchor and / or getting caught between the head 1024 of that anchor and the tissue.

[0447] FIG. 15B illustrates the same procedure, but with winch 1080 maintaining tension on tether 1012 such that slack is reduced (e.g., removed), thereby reducing the likelihood of the undesirable results described with reference to FIG. 15A.

[0448] In some applications, as shown, the spool 1082 surrounds (e.g., is concentric with) the catheter 1072. In some applications, as shown, the spool 1082 is attached to the longitudinal portion of the catheter 1072 where the winch 1080 is disposed so that the axis of rotation of the spool is parallel to or coaxial with a lumen axis ax1 defined by the lumen of the catheter (which in some applications may be considered the central longitudinal axis of the device 1070). Such a configuration of the winch 1080 is hypothesized to advantageously improve the weight balance of the device 1070 (e.g., compared to a winch 1080 disposed laterally relative to the catheter 1071), thereby promoting its maneuverability and stability.

[0449] In some applications, the position and orientation of winch 1080 (e.g., its spool 1082) is facilitated by one or more bearings in addition to proximal bearing 1076. For example, as shown, tether 1012 moves laterally off spool 1082, and bearing (e.g., pulley) 1077 redirects the tether proximally (and often inwardly as well). Note that in this context, the terms “laterally,” “laterally,” “inwardly,” and “inwardly” refer to position and direction relative to the central longitudinal axis of device 1070. In some applications, another bearing (e.g., another pulley) 1078 redirects the tether to be approximately parallel to catheter 1072 until the tether reaches proximal bearing 1076. Thus, for some applications, bearings 1076 and 1078 together define a region 1079 therebetween in which tether 1012 is generally parallel to catheter 1072 (and the central longitudinal axis of device 1070). For some applications, as shown in FIG. 14A, system 1000 includes an anchor 1020 disposed within region 1079.

[0450] For some applications, the extracorporeal unit 1074 of the catheter device 1070 includes multiple separators 1090 defining anchor storage zones 1092 therebetween, each of which can be sized to store a single anchor 1020. The separators 1090 allow for the storage of consecutive anchors 1020 threaded with tethers 1012 on the extracorporeal unit 1074. The separators 1090 can be shaped and / or positioned to interfere with the anchors 1020 without interfering with the tethers 1012. For example, as shown, the tether 1012 can extend through region 1079 on a predetermined line (e.g., at a predetermined lateral distance from axis ax1), and the separator 1090 can be positioned slightly away from that line (e.g., further to the side), such that the anchors 1020 protrude from the tether threaded therethrough and reach the separator 1090. In applications where device 1070 includes bearings 1076 and 1078, the line that tether 1012 extends through region 1079 is often determined by the location of these bearings.

[0451] In some applications, each separator 1090 can define a slot 1094 therein through which the tether 1012 can be moved. For example, grasping and moving an anchor 1020 out of its anchor storage zone 1092 can include lifting the anchor onto one or more separators 1090, which can be facilitated by a slot 1094 in one or more separators that allows the tether 1012 to move through the slot (e.g., as shown in FIG. 14B ). In some applications, this lifting of the anchor 1020 and the tether 1012 threaded therethrough is further facilitated by a winch 1080 that temporarily detaches a portion of the tether from the spool in response to tensioning the tether, and subsequently allows the tether to be rewound.

[0452] For some applications, the winch 1080 includes a reversibly actuable ratchet 1100. During actuation (i.e., in an actuated state), the ratchet 1100 allows the spool 1082 to rotate in a first rotational direction (e.g., pulling on the tether 1012 to remove the tether from the spool) and prevents the spool from rotating in a second rotational direction (e.g., the spring 1084 prevents the tether from rewinding). During deactivation (i.e., in a deactivated state), the ratchet 1100 allows the spool 1082 to rotate in both the first and second rotational directions. For some applications, the ratchet 1100 includes a gear 1102, a pawl 1104, and a switch 1106. The gear 1102 couples to the spool 1082 such that rotation of the spool rotates the gear (e.g., the gear and spool are rotationally locked). The pawl 1104 is reversibly engageable with the gear 1102, such that when the pawl engages the gear, the ratchet 1100 is activated and when the pawl disengages the gear, the ratchet is deactivated. The switch 1106 is configured to activate and deactivate the ratchet 1100 by moving the pawl 1104 between engaging and disengaging with the gear 1102. For example, as shown, the switch 1106 can define a cam that pushes the pawl 1104 out of engagement with the gear 1102. In some such applications, the pawl 1104 can be biased toward a position in engagement with the gear 1102, for example, by a latch spring 1108.

[0453] As noted above, during actuation, ratchet 1100 allows the operator to remove tether 1012 from the spool (e.g., by advancing the distal end of the tether away from winch 1080), but prevents the winch from rewinding the tether. Thus, actuating ratchet 1100 somewhat disables winch 1080. As noted above, during advancement of first anchor 1020, the first anchor can pull the distal end of tether 1012 all the way through catheter 1072. It is hypothesized that, in some applications, actuating ratchet 1100 advantageously facilitates this advancement by allowing the operator to gradually and / or stepwise advance the anchor and tether distally without competing with winch 1080, which pulls the anchor and tether proximally. It is further envisioned that ratchet 1100 provides the operator with the ability to temporarily introduce slack into tether 1012 if desired, for example, to manually lift and move a subsequent anchor 1020 into position for engagement with driver 1060, or while fine-tuning the position of the distal end of catheter 1072 where tension in tether 1012 may interfere. Slack can be introduced into the tether by actuating ratchet 1100 and then manually pulling on tether 1012 to remove a certain amount of tether from spool 1082. The slack can then be removed by disabling the ratchet.

[0454] It should be noted that winch 1080 can be configured (e.g., by setting the spring strength of spring 1084) so ​​that the tension it applies to tether 1012 is insufficient to cause premature contraction of implant 1010. For example, in applications where implant 1010 is an annuloplasty implant, spring 1084 may not be strong enough to significantly contract the valve annulus into which anchor 1020 is placed. In some applications, spring 1084 is just strong enough to remove slack from tether 1012.

[0455] Figure 15A is described above as resulting from implanting the implant without the winch 1080. However, it should be noted that the condition shown in Figure 15A also results from actuating the ratchet 1100 to implant the implant.

[0456] In some applications, the winch 1080 further includes an indicator 1088 that indicates how much the tether 1012 has been removed from the spool 1082, for example, by indicating how much the spool has rotated. For example, as shown, the indicator 1088 can be fixedly coupled to the spool 1082 and can indicate rotation / removal from the spool through a fixed opening. In some applications, as shown, the indicator 1088 can indicate rotation / removal from the spool numerically. In some applications, other symbols or representations, such as colors, can be used. As shown, the indicator 1088 can be a ring that rotates and locks with the spool 1082.

[0457] Reference is now made to Figures 16A-F, which are schematic illustrations of a system 1200 for use in a subject, according to some applications. System 1200 includes implant 1010 and a delivery tool 1250 including an anchor driver (e.g., driver 1060) and a catheter device 1270. System 1200 may be identical to system 1000, except for the addition of a series of cartridges 1220 and adaptations of the catheter device (e.g., of its extracorporeal unit) to facilitate use of the cartridges described herein. Thus, in some applications, catheter device 1270 (e.g., its extracorporeal unit 1274) may be identical to catheter device 1070 (e.g., its extracorporeal unit 1074), except for adaptations for use with cartridges 1220, such as those described below.

[0458] For some applications, the extracorporeal unit 1274 includes a bearing (e.g., a pulley) 1276 (e.g., a proximal bearing) about which the tether 1012 rotates. The bearing 1276 may be similar to or identical to the bearing 1076 described herein.

[0459] Each cartridge 1220 holds (e.g., cradles) a respective tissue anchor 1020 and, mutatis mutandis, facilitates an operator's manipulation of the tissue anchors in a manner generally similar to that described in system 1000. However, in some applications, cartridges 1220 are postulated to provide improved control and / or safety.

[0460] Figure 16A shows an initial state of device 1270, with each cartridge 1220 connected to its extracorporeal unit 1274 in its initial position, similar to the state shown in Figure 14A for system 1000.

[0461] The extracorporeal unit 1274 includes or defines at least one track 1272 (e.g., a groove or rail as shown), along which each cartridge 1220 is movable (e.g., slidable) while coupled to the extracorporeal unit from its initial position to a deployed position in which the cartridge holds its tissue anchor 1020 opposite or within the open proximal end of the catheter 1072. An example of such movement is shown in FIG. 16B , which shows the initial position (inset A), intermediate position (inset B), and deployed position (inset C and main image) for the first cartridge 1220f (holding the first anchor 1020f). This can be performed manually by an operator grasping the cartridge by hand. It is assumed that the cartridge 1220 is easier to grasp and move manually than the anchor 1020 alone.

[0462] In some applications, each cartridge 1220 is configured to lock into the extracorporeal unit 1274 upon reaching the deployed position. Such configuration can be achieved, for example, using a latching mechanism in which the extracorporeal unit 1274 includes one or more latches 1278, and each cartridge 1220 is correspondingly shaped to be locked by the one or more latches, e.g., each cartridge defining one or more corresponding recesses 1222. The latches 1278 can be resilient or spring-loaded such that they temporarily flex (e.g., outward) in response to the arrival of the cartridge 1220, and then automatically lock into the recesses 1222 once the cartridge 1220 is fully positioned in the deployed position (e.g., snapping / clicking into place).

[0463] While the cartridge 1220 is in the deployed position, the anchor driver 1060 is used to advance the anchor 1020 distally out of the cartridge and through the catheter 1072, e.g., to secure the anchor at the target tissue site (FIG. 16E). The anchor driver 1060 can then be separated from the anchor 1020 and withdrawn from the device 1270. The cartridge 1220 can then be removed from the deployed position (e.g., completely removed from the extracorporeal unit 1274), leaving the series of successive cartridge deployment positions empty (FIG. 16F). For example, as shown, the recess 1222 can be open at one end to facilitate sliding out of the cartridge (e.g., downward as shown) without requiring flexing of the latch 1278.

[0464] 16C-D illustrate a testing mechanism for system 1200, according to some applications. This testing mechanism tests (or facilitates) the coupling of anchor driver 1060 to anchor 1020 and allows distal advancement of the anchor only if this test is successful. This is hypothesized to advantageously reduce the likelihood of unintentionally distally advancing an anchor that is incompletely coupled to the anchor driver (e.g., simply pushing the anchor distally). Such an incomplete coupling could result in the anchor being advanced but the anchor driver being unable to thread the anchor into tissue or withdraw the anchor proximally.

[0465] In applications in which the system 1200 includes this testing mechanism, each cartridge 1220 includes a displaceable barrier 1224 that prevents distal advancement of the anchor 1020 out of the cartridge until the test is successful ( FIG. 16C ). The cartridge 1220 can include the barrier 1224 in this blocking position. In such applications, each cartridge can further include a displacement mechanism 1226 that, upon actuation of the displacement mechanism, displaces the barrier 1224 so that the barrier no longer prevents distal advancement of the anchor 1020 out of the cartridge. Once the driver 1060 couples to the anchor 1020, the coupling is tested by applying a force to the anchor, for example, by the operator pulling the driver 1060 proximally, causing the driver to pull the anchor proximally ( FIG. 16D ). The cartridge 1220 is configured such that only if the driver 1060 is properly coupled to the anchor 1020 and thus able to apply sufficient pulling force to the anchor will this pulling actuate (or allow actuation of) the displacement mechanism 1226. For example, if the coupling is imperfect, the driver 1060 may become separated from the anchor 1020 before sufficient pulling force has been applied.

[0466] For some applications, the displacement mechanism 1226 is spring-loaded, e.g., comprises a resilient element that is provided in a constrained state ( FIG. 16C ) and released ( FIG. 16D ) by a force applied to the anchor 1020. For example, the cartridge 1220 can include one or more detents 1228 that constrain the displacement mechanism 1226 ( FIG. 16C ) and move away from the displacement mechanism when sufficient pulling force is applied to the anchor 1020, such that the detents unconstrain the displacement mechanism, which in response moves the barrier 1224, and the barrier no longer prevents the anchor from advancing distally out of the cartridge ( FIG. 16D ).

[0467] In some applications, as shown, each cartridge 1220 includes a first part 1230 that includes or defines a barrier 1224 and a second part 1232 that holds (e.g., cradles) an anchor 1020. In some such applications, the displacement mechanism 1226 is configured to be actuated by the anchor driver 1060 pulling the anchor 1020 proximally with sufficient force to pull the second part 1230 proximally relative to the first part 1232, causing the detent 1228 to cease constraining the displacement mechanism ( FIG. 16D ).

[0468] In some applications, as shown, second part 1232 includes or defines one or more detents 1228, and first part 1230 includes or defines displacement mechanism 1226 (and optionally barrier 1224).

[0469] In some applications, the detent function can alternatively or additionally be provided by a detent 1225 (e.g., a post) that is a component of first part 1230, for example, coupled to or defined by barrier 1224. In the blocking position of barrier 1224, detent 1225 extends into a central lumen defined by the helical tissue-engaging element of anchor 1020. Applying sufficient pulling force to anchor 1020 disengages the anchor's helical tissue-engaging element from detent 1225, allowing barrier 1224 to be displaced.

[0470] In some applications, first component 1230 is a first monolithic structure fabricated from a single piece of material, hi some applications, second component 1232 is a second monolithic structure fabricated from a single piece of material.

[0471] In some applications, as shown, the second part 1232 couples the cartridge 1220 to the extracorporeal unit 1274, for example, by slidably engaging the track 1272. In applications where the track 1272 is a groove, as shown, the second part 1232 can define a tang 1234 that engages the groove to couple the first part (and thereby the entire cartridge 1220) to the extracorporeal unit 1274. For clarity, the extracorporeal unit 1274 and track 1272 are not shown in FIGS. 16C-D.

[0472] For some applications, cartridge 1220 is configured to reconfigure the cartridge to a removable state that facilitates removal of the cartridge from the deployed position by proximal movement of second part 1232 relative to first part 1230. For example, as shown in FIG. 16C , prior to pulling, the position of tongue 1234 relative to first part 1232 is such that the first part prevents the tongue from disengaging from track 1272. In the illustrated example, each track 1272 is positioned inward from the respective tongue 1234, and disengagement involves the tongue moving laterally outward. As shown in FIG. 16D , pulling repositions tongue 1234 so that the first part no longer prevents such movement. For example, as shown, pulling can align tongue 1234 (or a portion of first part 1230 that supports the tongue) with cavity 1236 defined by first part 1230 ( FIG. 16D ). This alignment allows tongue 1234 to flex outward (e.g., temporarily) in response to a pull, thereby disengaging from the track, so that cartridge 1220 can be moved away from track 1272 by pulling the cartridge away from the track (e.g., by an operator manually grasping the cartridge) ( FIG. 16F ), thereby clearing the deployment position for the next cartridge to be used.

[0473] As noted above, in some applications, the cartridge 1220 is configured such that successful verification of the connection between the anchor driver 1060 and the anchor 1020 reconfigures the cartridge, allowing both (i) the anchor to be advanced distally out of the cartridge and into the catheter 1072, and (ii) the cartridge to be removed to free a deployment position for a subsequent cartridge.

[0474] For some applications, the cartridge 1220 is configured to be removed while the driver 1060 remains extended within the catheter 1072. For some applications, the cartridge 1220 is configured to be removed only after the driver 1060 has been withdrawn from the catheter 1072.

[0475] Reference is now made to FIGS. 17A-F and 18A-B, which are schematic illustrations of an exemplary system 1400 for use in a subject, according to some applications. System 1400 comprises implant 1010 and a delivery tool 1450 comprising an anchor driver (e.g., driver 1060) and a catheter device 1470. System 1400 may be identical to system 1000, mutatis mutandis, except for the addition of a series of cartridges 1220 and the adaptation of the catheter device (e.g., of its extracorporeal unit) to facilitate use of the cartridges described herein. In some applications, system 1400 can be as described for system 1200, except for the use of cartridge 1420 instead of cartridge 1220 and the corresponding adaptation of the catheter device (e.g., of its extracorporeal unit). Thus, in some applications, catheter device 1470 (e.g., its extracorporeal unit 1474) may be identical to catheter device 1070 (e.g., its extracorporeal unit 1074) and / or catheter device 1270 (e.g., its extracorporeal unit 1274), except for adaptation for use with cartridge 1420, such as those described below.

[0476] Tensioner (eg, winch) 1080, although illustrated differently in system 1400, can have the same or similar components and functions as described above.

[0477] For some applications, the extracorporeal unit 1474 includes a bearing (e.g., a pulley) 1476 (e.g., a proximal bearing) about which the tether 1012 rotates. The bearing 1476 may be similar to or identical to the bearings 1076 and / or 1276 described above.

[0478] Each cartridge 1420 holds (e.g., rests on) a respective tissue anchor 1020 and facilitates the operator's manipulation of the tissue anchors in a manner generally similar to that described in system 1200, mutatis mutandis.

[0479] Figure 17A shows an initial state of device 1470, with each cartridge 1420 connected to its extracorporeal unit 1474 in its initial position, similar to the state shown in Figure 16A for system 1200.

[0480] In some applications, the extracorporeal unit 1474 includes or defines at least one track 1472 (e.g., a groove or rail as shown), along which each cartridge 1420 is movable (e.g., slidable) from its initial position to a deployed position in which the cartridge holds its tissue anchor 1020 opposite or within the open proximal end (i.e., proximal opening) 1073 of the catheter 1072 while still coupled to the extracorporeal unit. An example of such movement is shown in FIG. 17B , where a curved arrow indicates movement of a first cartridge 1420f (holding a first anchor 1020f) from its initial position to a deployed position, similar to that described for cartridge 1220 with reference to FIG. 16B , for example, mutatis mutandis. This can be performed manually by an operator grasping the cartridge by hand. It is assumed that the cartridge 1420 is easier to grasp and manually move than the anchor 1020 alone.

[0481] In some applications, each cartridge 1420 is configured to lock onto the extracorporeal unit 1474 upon reaching the deployed position. Such configuration can be achieved, for example, using a latching mechanism in which the extracorporeal unit 1474 includes one or more latches 1478, and each cartridge 1420 is correspondingly shaped to be locked by the one or more latches. The latches 1478 can be resilient or spring-loaded such that they temporarily bend (e.g., upward) in response to the arrival of the cartridge 1420, and then automatically lock onto the cartridge once the cartridge is fully positioned (e.g., snaps / clicks into place) in the deployed position.

[0482] In some applications, while the cartridge 1420 is in the deployed position, the anchor 1020 is advanced distally out of the cartridge through the catheter 1072 using the anchor driver 1060, e.g., to secure the anchor at the target tissue site (FIG. 17E). The anchor driver 1060 can then be separated from the anchor 1020 and withdrawn from the device 1470. The cartridge 1420 can then be removed from the deployed position (e.g., completely removed from the extracorporeal unit 1474), leaving the series of successive cartridge deployment positions empty (FIG. 17F). For example, as shown, the cartridge 1420 may be shaped to facilitate sliding out of the cartridge (e.g., downward as shown) without requiring flexing of the latch 1478.

[0483] 17C-D illustrate an exemplary testing mechanism for system 1400, according to some applications. This testing mechanism tests (or facilitates) the coupling of anchor driver 1060 to anchor 1020 and allows distal advancement of the anchor only if this test is successful. This is hypothesized to advantageously reduce the likelihood of unintentionally distally advancing an anchor that is incompletely coupled to the anchor driver (e.g., simply pushing the anchor distally). Such an incomplete coupling could result in the anchor being advanced but the anchor driver being unable to thread the anchor into tissue or withdraw the anchor proximally.

[0484] In applications in which the system 1400 includes this testing mechanism, each cartridge 1420 includes a displaceable barrier 1424 that prevents distal advancement of the anchor 1020 out of the cartridge until the test is successful (FIG. 17C). The cartridge 1420 can be provided with the barrier 1424 in this blocking position (FIG. 17C). In such applications, each cartridge can further include a displacement mechanism 1426 that, upon actuation of the displacement mechanism, displaces the barrier 1424 so that it no longer prevents distal advancement of the anchor 1020 out of the cartridge. Once the driver 1060 couples to the anchor 1020, the coupling is tested by applying a force to the anchor, for example, by the operator pulling the driver 1060 proximally, causing the driver to pull the anchor proximally (FIG. 17D). The cartridge 1220 is configured such that only if the driver 1060 is properly coupled to the anchor 1020 and thus able to apply sufficient pulling force to the anchor will this pulling actuate (or allow actuation of) the displacement mechanism 1426. For example, if the coupling is imperfect, the driver 1060 may become separated from the anchor 1020 before sufficient pulling force has been applied.

[0485] In the case of cartridge 1220 described above, displacement mechanism 1226 can displace barrier 1224 through linear displacement of the barrier. In contrast, in the case of cartridge 1420, displacement mechanism 1426 can displace barrier 1424 through deflection of the barrier. For example, as shown, displacement mechanism 1426 can include a hinge about which barrier 1424 deflects. In some applications, as shown, displacement of barrier 1424 can include separating the barrier into (e.g., two) barrier subcomponents 1424a and 1424b that deflect in different directions away from each other.

[0486] The cartridge 1420 includes one or more detents 1425 that prevent (e.g., constrain) the displacement mechanism 1426 from moving the barrier 1424 (FIG. 17C) and are moved away when sufficient pulling force is applied to the anchor 1020 so that they no longer prevent (e.g., constrain) the displacement mechanism, thereby allowing (or enabling) actuation of the displacement mechanism.

[0487] In some applications, as shown, detent 1425 is coupled to or defined by barrier 1424. In the blocking position of barrier 1424, detent 1425 extends into a central lumen defined by the helical tissue-engaging element of anchor 1020. Upon application of sufficient pulling force to anchor 1020, the helical tissue-engaging element of the anchor disengages from detent 1425, allowing barrier 1424 to be displaced.

[0488] In some applications, as shown, each barrier sub-component can have its own detent 1425, for example, barrier sub-component 1424a has detent 1425a and barrier sub-component 1424b has detent 1425b, both of which extend into a central lumen defined by the helical tissue-engaging element of anchor 1020 while in the blocking position. In some such applications, anchor 1020 itself (e.g., its tissue-engaging element) thereby prevents deflection of barrier sub-components 1424a and 1424b away from each other.

[0489] In some applications, as shown, in the blocking position of the barrier 1424, the multiple detents 1425 can collectively define a post, for example in applications where the barrier 1424 has two barrier subcomponents, and each detent can be semi-cylindrical such that when the two detents come together they form a cylindrical post (see inset in Figure 17C).

[0490] In some applications, the displacement mechanism 1426 is spring-loaded, e.g., comprises a resilient element, e.g., a spring, that is constrained and released by a force applied to the anchor 1020. In applications in which the displacement mechanism 1426 is spring-loaded, the displacement mechanism automatically moves the barrier 1424 away from the detent 1425 in response to movement, and the barrier ceases to prevent the anchor from advancing distally out of the cartridge (FIG. 17D).

[0491] In some applications, as shown, each cartridge 1420 includes a first part 1430 that includes or defines a barrier 1424 and a second part 1432 that holds (e.g., cradles) an anchor 1020. In some such applications, the displacement mechanism 1426 is configured to be actuated (or enabled to be actuated) by the anchor driver 1060 pulling the anchor 1020 proximally with sufficient force to pull the second part 1432 proximally relative to the first part 1430, causing the detent 1425 to cease obstructing (unbinding) the displacement mechanism ( FIG. 16D ).

[0492] In some applications, as shown, first part 1430 includes or defines detent 1425 and displacement mechanism 1426. In some such applications, as shown, first part 1430 includes two sub-parts 1430a and 1430b hinged to one another by displacement mechanism 1426, each sub-part including a respective barrier sub-component and a respective detent 1425.

[0493] In some applications, each of sub-components 1430a and 1430b is a monolithic structure fabricated from a single piece of material. In some applications, second component 1432 is a monolithic structure fabricated from a single piece of material.

[0494] In some applications, the first part 1430 couples the cartridge 1420 to the extracorporeal unit 1474, for example, by slidably engaging the track 1472. For example, as shown, the first part 1430 can define at least one tang 1434 (e.g., one tang per part 1430a and 1430b) that slidably engages the track 1472 to couple the first part (and thereby the entire cartridge 1420) to the extracorporeal unit 1474. For clarity, the extracorporeal unit 1474 and the track 1472 are not shown in FIGS. 17C-D.

[0495] In some applications, as shown, cartridge 1420 is shaped to be locked by latch 1478 with a latch engaging tang 1434. That is, in such applications, tang 1434 both (i) slidably couples cartridge 1420 to track 1472 and (ii) facilitates locking of the cartridge in the deployed position.

[0496] For some applications, the cartridge 1420 is configured such that proximal movement of the second piece 1432 relative to the first piece 1430 reconfigures (or allows for reconfiguration of) the cartridge to a removable state that facilitates removal of the cartridge from the deployed position. For example, as shown in FIG. 17C , prior to pulling, the tongues 1434 are positioned to slidably engage the tracks 1472, preventing the cartridge 1420 from disengaging from the tracks 1472. As shown in FIG. 16D , pulling the second piece 1432 proximally releases (or allows for the tongues to be released from) each tongue 1434 from the tracks 1472, e.g., by moving the tongues laterally, thereby allowing the cartridge to be pulled from the tracks, and in some applications, away from the entire extracorporeal unit 1474 ( FIG. 17F ). This clears the deployed position for the next cartridge to be used.

[0497] In some applications, as shown, it is the same deflection between sub-components 1430a and 1430b that both (i) displaces barrier 1424 by deflecting barrier sub-components 1424a and 1424b relative to one another and (ii) releases tongue 1434 from track 1472. In such applications, therefore, both this displacement and this release are facilitated (or actuated) by pulling anchor 1020 proximally with sufficient pulling force by driver 1060.

[0498] Thus, as noted above, in some applications, it is noted that the cartridge 1420 is configured such that successful verification of the connection between the anchor driver 1060 and the anchor 1020 reconfigures the cartridge, allowing both (i) the anchor to be advanced distally out of the cartridge and into the catheter 1072, and (ii) the cartridge to be removed to free a deployment position for a subsequent cartridge.

[0499] In some applications, cartridge 1420 is configured such that even if tongue 1434 disengages from track 1472, the cartridge will remain in place until manually removed, for example, by an operator grabbing and pulling.

[0500] For some applications, the cartridge 1420 is configured to be removed while the driver 1060 remains extended within the catheter 1072. For some applications, the cartridge 1420 is configured to be removed only after the driver 1060 has been withdrawn from the catheter 1072.

[0501] 18A-B show system 1400 after (i) anchor 1020 of first cartridge 1420f (i.e., the first anchor) has been advanced through catheter 1072 (with tether 1012 coupled thereto) and secured to tissue, (ii) driver 1060 has been withdrawn, (iii) the first cartridge has been removed, and (iv) the subsequent cartridge 1420 has been moved into the deployed position. Tether 1012 extends proximally from the first anchor and back through catheter 1072. Thus, as the subsequent anchor advances through catheter 1072, it slides over and along tether 1012.

[0502] 16A-19B. As noted above, in some applications, each of cartridges 1220 and 1420 can include (i) a first part that defines a barrier for the cartridge, and (ii) a second part that holds anchor 1020 and can then be pulled proximally relative to the first part to move the barrier to allow the anchor to be advanced into tube 1072. Note that in system 1200, cartridge 1220 slidably couples to the track of the proximal unit by the first part (i.e., the part that holds the anchor), while in system 1400, cartridge 1420 slidably couples to the track of the proximal unit by the second part (i.e., the part that defines the barrier).

[0503] While systems 1200 and 1400 are shown above as including tensioner (e.g., winch) 1080, it should be noted that aspects of these systems, particularly the use of cartridges 1220 and 1420, can be used independently of tensioner 1080 (or any tensioner). Accordingly, the scope of the present disclosure includes variations of systems 1200 and 1400 that do not include tensioner 1080, and that may not include a tensioner at all.

[0504] 17A-18B, and further reference is made to FIGS. 19A-B, which are schematic illustrations of port 1480 according to some applications. In some applications, port 1480 is disposed at a proximal opening 1073 of catheter 1072. While shown as a component of system 1400, port 1480 can be used, mutatis mutandis, in the other systems described herein. Port 1480 can have a tapered lumen that facilitates smooth advancement of anchor 1020 into catheter 1072.

[0505] The port 1480 can include a membrane 1482 that provides hemostatic sealing during the implantation procedure. The membrane 1482 can be molded from silicone. The material (e.g., silicone) from which the membrane 1482 is molded can have a Shore A hardness of 38 to 42 (e.g., 40). The membrane 1482 can be approximately 1 mm thick. The membrane 1482 can be oriented substantially transverse to the proximal end of the tube 1072.

[0506] The membrane 1482 can be shaped to define two openings 1484 (e.g., first opening 1484a and second opening 1484b) therethrough, connected by a closed slit 1486. ​​In some applications, the first opening 1484a is larger in diameter than the second opening 1484b (e.g., at least two times larger, e.g., at least three times larger, e.g., 3 to 10 times larger, e.g., at least four times larger). For example, the first opening 1484a can be 1.5 to 2.5 mm in diameter (e.g., 1.7 to 2.2 mm, e.g., 1.8 to 2.0 mm, e.g., 1.9 mm), and the second opening 1484b can be 0.2 to 0.7 mm in diameter (e.g., 0.2 to 0.6 mm, e.g., 0.3 to 0.5 mm, e.g., 0.4 mm).

[0507] As shown, the port 1480 (e.g., its membrane 1482) can be oriented such that the first opening 1484a is along the axis along which the driver 1060 and tissue engaging elements of the anchor 1020 advance. This "anchor advancement axis" is indicated by a dashed line. While the cartridge 1420 is in the deployed position, the tissue engaging elements of its tissue anchor 1020 may be aligned with the first opening 1484a, thereby defining the anchor advancement axis from the tissue anchor, through the first opening, and through the tube 1072.

[0508] As also shown, second opening 1484b is generally on the axis along which tether 1012 is advanced. Each anchor can be advanced through membrane 1482 with (i) its central longitudinal axis and / or tissue engaging element aligned with first opening 1484a, and (ii) its eyelet, through which tether 1012 is threaded, aligned with second opening 1484b.

[0509] Note that typically, neither opening 1484a (and thus the anchor advancement axis) nor opening 1484b are centrally aligned with respect to catheter 1072. Rather, the center of first opening 1484a is located on one side of the central axis of the catheter, and the center of second opening 1484b is located on the opposite side of the central axis of the catheter. However, in applications where first opening 1484a is sufficiently large, the first opening may overlap with the central axis of the catheter (although not centered on the central axis of the catheter).

[0510] As the anchor passes distally through membrane 1482, opening 1484 and slit 1486 respond by briefly opening or widening, and then closing or narrowing again behind the anchor.

[0511] For some applications, opening 1484a is sized to seal around driver 1060 (e.g., its shaft), which can be narrower than the head of anchor 1020. For example, for some applications, the diameter of opening 1484a is 80 to 120 percent (e.g., 90 to 110 percent) of the thickness of the shaft of driver 1060.

[0512] For some applications, opening 1484b is sized to seal around tether 1012 and is narrower than the eyelet of anchor 1020. For example, for some applications, the diameter of opening 1484b is between 50 and 200 (e.g., between 80 and 120 percent, e.g., between 90 and 110 percent) the thickness of tether 1012.

[0513] When driver 1060 is withdrawn proximally through membrane 1482, tether 1012 remains extended through second opening 1484b.

[0514] The dual aperture structure of membrane 1482 is hypothesized to advantageously provide better hemostatic sealing for the implantation procedure compared to other structures, such as a single larger aperture or slit. For example, during fixation of anchor 1012, slit 1486 is normally closed when tether 1012 and driver 1060 extend through membrane 1482.

[0515] 20A-H, which are schematic illustrations of a system 1300 for use in a subject, according to some applications. System 1300 includes a catheter device 1370 having a distal portion or member, e.g., catheter 1072, and an extracorporeal unit 1374 having a housing 1375 and a tensioner 1380. System 1300 also includes an implant, e.g., implant 1010, and an anchor driver, e.g., anchor driver 1060. Catheter device 1370 can be similar to catheter device 1070 and / or catheter device 1270, mutatis mutandis, except for the presence of tensioner 1380 (e.g., instead of tensioner / winch 1080).

[0516] For some applications, as described above, implant 1010 includes tether 1012 and anchor 1020. Tether 1012 extends distally from extracorporeal unit 1374 through catheter device 1370 to a distal portion of the tether, which is disposed distally from a tensioner and comprises the distal end of the tether. As described in more detail below, tensioner 1380 is configured to pull tether 1012 proximally. While the manner in which this proximal tension is achieved differs from that described for system 1000, the postulated advantage is similar: reducing slack in tether 1012 during implantation (or at least during certain steps of implantation).

[0517] For some applications, systems 1000 and 1200 thread the tether 1012 distally from the tensioner (winch) through the anchor 1020 of implant 1010. That is, the tether is threaded through the anchor between the tensioner and the distal end of the tether. Thus, to take up slack in the distal portion of the tether, tension applied by the tensioner is transferred to the portion of the tether that is threaded through the unused anchor, causing the slack to slide through the unused anchor. In contrast, in system 1300, tether 1012 is threaded proximally from tensioner 1380 through anchor 1020. It is hypothesized that, for at least some applications, such a configuration provides several advantages, such as allowing these unused anchors to be stored in a convenient or ergonomic arrangement that is less likely to cause the tether 1012 to slide therethrough. For example, the unused anchors of systems 1000 and 1200 are stored in a linear arrangement, while the anchors of system 1300 may be stored in a non-linear arrangement, such as a ring.

[0518] The anchor driver 1060 is configured to reversibly couple to each of the anchors in succession and advance the current anchor distally along the tether and past (e.g., through) the tensioner 1380. Figures 20A-H illustrate at least some steps of the advancement of one of the anchors. As described below, the system 1300 has several mechanisms that facilitate placement of the tensioner 1380 between a stored, unused anchor and the distal end of the tether. These mechanisms facilitate the anchor driver 1060 advancing the anchor 1020 distally past (e.g., through) the tensioner 1380 without the anchor or driver (e.g., its shaft 1062) interfering with or being interfered with by the tensioner.

[0519] Tensioner 1380 can include a spring 1382 coupled to housing 1375 and reversibly lockable to tether 1012, causing the tensioner to pull the tether proximally while the spring is stressed and locked to the tether. In some applications, as shown, spring 1382 is a compression spring, configured to be stressed by compression and configured to pull the tether proximally by extension. If desired, spring 1382 can be a tension spring or another suitable type of spring.

[0520] Tensioner 1380 can further include a clamp 1384 coupled to spring 1382 and reversibly transitionable between an unclamped state (FIGS. 20A-C) and a clamped state (FIGS. 20D-F). Tether 1012 extends distally through catheter device 1370 such that, when the clamp is in the clamped state, the tether extends through clamp 1384 to lock spring 1382 to the tether. For example, as shown, tether axis ax2 can extend along which tether 1012 extends through tensioner 1380 and passes between jaws 1390 of clamp 1384.

[0521] The tensioner 1380 can further include an actuator 1386, the actuation of which transitions the clamp 1384 between an unclamped state and a clamped state. In some applications, as shown, the actuator 1386 includes a ring 1388 surrounding the clamp, with rotation of the ring transitioning the clamp between the unclamped state and the clamped state. For example, the clamp 1384 and ring 1388 together can function as a chuck, e.g., by applying a force to the clamp toward an unclamped state and rotation of the ring compressing the clamp closed. For example, an internal thread 1389 defined by the inner surface of the ring 1388 and an opposing external thread 1385 defined by the outer surface of the clamp 1384 can act to rotate the ring and thread it onto the clamp. In some applications, the inner surface of the ring 1388 and / or the outer surface of the clamp 1384 are tapered, such that axially moving the ring relative to the clamp (e.g., threading the ring onto the clamp) compresses the clamp toward its clamped state. In some applications, the ring 1388 is configured to be grasped and rotated by hand.

[0522] For some applications, clamp 1384 defines first and second clamping surfaces 1392 configured to engage tether 1012 when clamp is in its clamped state. For example, clamp 1384 can include first and second clamping jaws 1390, each of the clamping jaws defining a respective clamping surface 1392 and deflectable, for example, by being depressed by actuator 1386. In the unclamped state, clamp 1384 defines a gap 1394 between clamping surfaces 1392, and tissue anchor 1020 is dimensioned to be advanced distally through the gap along tether 1012 by anchor driver 1060. For example, the maximum lateral width of each anchor 1020 (measured transverse to the longitudinal axis of the anchor along which the anchor is driven into tissue) can be smaller than gap 1394. For some applications, anchor driver 1060 (e.g., driver head 1064 and shaft 1062) is also narrower than gap 1394.

[0523] FIG. 20A shows tensioner 1380 with tether 1012 passing therethrough, extending distally from the proximal side of the tensioner (right side of the figure) past (e.g., through) the tensioner, and extending outwardly, e.g., through catheter 1072, e.g., after a first tissue anchor has already been secured to tissue but before a second tissue anchor is advanced. FIG. 20B shows anchor driver 1060 having a driver head 1064 that reversibly couples to anchor 1020 and is used to advance the anchor distally past (e.g., through) tensioner 1380. The inset cross-sectional view of FIG. 20B shows that both tether 1012 and shaft 1062 of driver 1060 are disposed in gap 1394 between clamping faces 1392 of jaws 1390.

[0524] Prior to transitioning clamp 1384 to its clamped state, at least a portion of shaft 1062 of driver 1060 is shifted laterally away from tether axis ax2 (and thus from tether 1012) into a no-clamping zone 1396 defined by catheter device 1370 (e.g., by its extracorporeal unit 1374) ( FIG. 20C ). This is performed while driver head 1064 remains coupled to anchor 1020, which itself remains threaded with tether 1012, and thus likely involves some degree of flexing and / or bending of shaft 1062. This is most clearly shown in an inset transverse cross-sectional view, the plane of which is at gap 1394, where shaft 1062 is positioned laterally from gap 1394 within no-clamping zone 1396. This is also represented in primary longitudinal section by shaft 1062 emerging from the cross-sectional plane, and thus being “cut” by the cross-section at a point distal to clamping plane 1392.

[0525] Thus, after the driver 1060 advances the anchor 1020 distally along the tether 1012 and past the tensioner 1380, the non-clamping zone 1396 is shaped and dimensioned to accommodate the laterally offset shaft 1062, which extends distally toward the anchor, bypassing the clamp 1384.

[0526] For some applications, the catheter device 1370 (eg, its extracorporeal unit 1374) comprises a non-clamping zone 1396 by having the clamping surface 1392 eccentric relative to the tether axis ax2, for example as shown in the inset cross-sectional view.

[0527] While shaft 1062 remains in non-clamping zone 1396, actuator 1386 is actuated (e.g., ring 1388 is rotated), thereby transitioning clamp 1384 to a clamping state such that the clamp clamps tether 1012 between clamping surfaces 1392 of jaws 1390, thereby locking the clamp (and thus spring 1382) to the tether ( FIG. 20D ). Note that, as noted above, the position of shaft 1062 within non-clamping zone 1396 allows clamp 1384 to clamp tether 1012 without clamping shaft 1062 and without the shaft interfering with clamping of the tether.

[0528] In some applications, as shown, for example, to reduce the likelihood that clamp 1384 will clamp tether 1012 too tightly, thereby damaging and / or severing it, at least one of jaws 1390 is shaped to define one or more bulges 1393 that limit the proximity of clamping surfaces 1392 to one another in a clamped state.

[0529] 20A-D, spring 1382 is in a stressed state in which the spring is under stress and locked in that state. In some applications, this locking is provided by lock 1360, which can be a component of extracorporeal unit 1374. As shown in the transition from FIG. 20C to FIG. 20D, clamp 1384 can be transitionable to its clamped state while lock 1360 remains locked.

[0530] In some applications, as shown, lock 1360 locks spring 1382 in a stressed state by locking clamp 1384 to housing 1375. In some applications, as shown, lock 1360 includes detents 1362 and recesses 1364, with the detents projecting into the recesses to secure the lock. In some such applications, as shown, clamp 1384 defines recess 1364 and housing 1375 includes detents.

[0531] While clamp 1384 remains clamped on tether 1012, lock 1360 is released, thereby actuating spring 1382, causing tensioner 1380 to pull the tether proximally, e.g., by the spring urging the clamp proximally (FIG. 20E).

[0532] In some applications, as shown, the extracorporeal unit 1374 (e.g., its lock 1360) is configured such that after the clamp 1384 is compressed into a clamped state, further compression of the clamp releases the lock and releases the clamp from the housing 1375, thereby actuating the spring 1382 and causing the tensioner 1380 to draw the tether proximally. For example, once sufficient actuation of the actuator 1386 (e.g., sufficient rotation of the ring 1388) transitions the clamp 1384 into its clamped state, further actuation of the actuator (e.g., further rotation of the actuator) releases the lock 1360 and releases the clamp from the housing 1375. This is illustrated by the transition between Figures 20D and 20E, which shows ring 1388 being threaded further onto jaw 1390, compressing the jaw sufficiently so that recess 1364 is retracted from detent 1362, actuating spring 1382 to push clamp 1384 (and ring 1388) proximally, thereby pulling tether 1012 proximally, thereby reducing tether slack.

[0533] Thereafter, for example, as described for system 1000, mutatis mutandis, while tensioner 1380 continues to maintain tension on tether 1012, driver 1060 is used to further advance anchor 1020 through catheter device 1370, along the tether, and toward the tissue where the anchor is to be secured (FIG. 20F).

[0534] After anchor 1020 is secured, clamp 1384 unclamps tether 1012 (by deactivating actuator 1386, e.g., by unscrewing ring 1388), and driver 1060 is withdrawn proximally (Figure 20G).

[0535] The tensioner 1380 is then returned to its initial tensioner position, where the spring 1382 is locked under its stress ( FIG. 20H ). For example, as shown, the clamp 1384 can be linearly slid distally, e.g., by linearly sliding the actuator 1386 distally without actuating the actuator (e.g., without rotating the ring 1388), until the lock 1360 is locked, e.g., until the detent 1362 re-enters the recess 1364. In some applications where the clamp 1384 is biased toward the unclamped state (e.g., by a spring or shape setting), the lock 1360 automatically locks (e.g., clicks into place) when the clamp reaches a preferred axial position, e.g., when the bias of the clamp causes the detent 1362 to enter the recess 1364. At this point, the tensioner 1380 and the entire catheter device 1370 are ready to advance the next anchor.

[0536] 1A-20H. In some applications, tissue anchors 220, 320, 420, 520, 620, 720, 820, 1020 may be interchangeable with one another, mutatis mutandis. In some applications, components of systems 1000, 1200, and 1400 may be interchangeable with one another, mutatis mutandis. In some applications, techniques described with reference to one of systems 1000, 1200, and 1400 may be used with another of these systems, mutatis mutandis.

[0537] In some applications, tissue anchors 220, 320, 420, 520, 620, 720, 820, 1020, implants 210, 310, 410, 510, 603, 703, 803, 1010, and / or systems 1000, 1200, 1300, 1400 can be used in combination with devices, systems, and / or implanted using, mutatis mutandis, methods / techniques described in one or more of the following references, including, but not limited to, substituting corresponding components: each of the following references is incorporated herein by reference in its entirety: U.S. Patent Application No. 14 / 437,373 (now U.S. Patent No. 9,949,828) by Sheps et al., published as U.S. Patent No. 2015 / 0272634. U.S. Patent Application No. 15 / 782,687 by Iflah et al., published as U.S. 2018 / 0049875. U.S. Patent Application No. 16 / 534,875 by Brauon et al., published as U.S. 2020 / 0015971. U.S. Patent Application No. 17 / 145,258 by Kasher et al., published as U.S. 2021 / 0145584. U.S. Provisional Patent Application No. 63 / 162,443 by Shafigh et al.

[0538] Similarly, the tissue anchors, implants, delivery tools, systems, and components thereof described in the above references can be used in combination with the devices, systems, and / or methods / techniques described herein, including (but not limited to) replacing corresponding components.

[0539] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art and that would occur to one skilled in the art upon reading the above description. Furthermore, the treatment techniques, methods, acts, steps, etc. described or suggested herein can be performed in live animals or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

Claims

1. 1. A system for use on tissue of a subject, the system comprising:

1. A catheter device comprising: A tube, a distal opening configured to transluminally advance into the tissue; a proximal end defining a proximal opening; Tube and an extracorporeal unit coupled to the proximal end of the tube; a catheter device comprising: An implant, a series of anchors disposed along the extracorporeal unit, the series including a first anchor and other anchors, each anchor comprising: a tissue engaging element; and Head defining the eyelet a series of anchors comprising: a tether extending along the extracorporeal unit and through the eyelets of each of the other anchors to the first anchor, whereby the first anchor is advanceable by a distal end of the tether distally into the proximal opening, through the vessel, and toward the tissue; The other anchor is then slidable distally onto and along the tether into the proximal opening and through the tube toward the first anchor. Tether and an implant comprising: A system comprising:

2. The system of claim 1 , wherein the catheter device comprises a series of cartridges arranged along the extracorporeal unit, each of the cartridges carrying a corresponding anchor in the series of anchors.

3. Each of the cartridges comprises: the cartridge has an initial position that prevents the corresponding anchor from sliding relative to the extracorporeal unit; The system of claim 2 , operable to release the corresponding anchor from the cartridge while still coupled to the extracorporeal unit.

4. 4. The system of claim 3, wherein for each of the cartridges, while the cartridge is in the initial position, the cartridge prevents the corresponding anchor from sliding distally along the tether and through the proximal opening into the tube.

5. The system of claim 3 , wherein for each of the cartridges, the cartridge is actuable by pulling the corresponding anchor proximally.

6. The system of claim 1 , wherein the extracorporeal unit comprises a tensioner comprising a spring and configured to reduce slack in the tether.

7. 2. The system of claim 1, wherein the system is configured such that the first anchor is advanceable by the distal end of the tether distally into the proximal opening and through the tube toward the tissue, while the other anchor remains positioned along the extracorporeal unit.

8. 2. The system of claim 1, wherein the system is configured such that the first anchor is advanceable by the distal end of the tether distally into the proximal opening and through the vessel toward the tissue, while the tether for each of the other anchors remains threaded through the eyelet.

9. 2. The system of claim 1, wherein the system is configured such that the first anchor is advanceable by the distal end of the tether distally to the proximal opening and through the vessel toward the tissue, while the proximal end of the tether remains coupled to the extracorporeal unit.

10. 10. The system of claim 1, further comprising an anchor driver configured to engage the head of each of the anchors in turn and advance the anchor distally into the proximal opening and through the vessel.

11. the catheter device further comprising a port at the proximal opening of the tube, the port comprising a membrane; 10. The system of claim 1, wherein the membrane is shaped to define a first opening therethrough, a second opening therethrough, and a closed slit connecting the first opening and the second opening.

12. A system for use on cardiac tissue of a subject, the system comprising: a catheter device; a series of tissue anchors; a series of cartridges; an anchor driver; and a tether; The catheter device a tube (a) configured for transluminal advancement to the tissue, the tube having (i) a distal opening and (ii) a proximal opening, and (b) defining a longitudinal axis of the catheter device; An extracorporeal unit; Including, each cartridge in the series of cartridges holds a respective tissue anchor in the series of tissue anchors, the series of cartridges being mounted axially along the extracorporeal unit; the series of tissue anchors includes (i) a first tissue anchor, and (ii) another tissue anchor; the tether is threaded through the series of anchors, with an end of the tether located in the first tissue anchor; the anchor driver removes the first tissue anchor from its respective cartridge; then advancing the first tissue anchor into the proximal opening and through the tube toward the distal opening, thereby forcing the end of the tether into the proximal opening, through the tube and into the tissue; Then, for each of the other tissue anchors, in turn: removing said other tissue anchors from their respective cartridges; The system then advances the other tissue anchor over and along the tether, into the proximal opening, through the tube toward the end of the tether and into the tissue.

13. Each of the cartridges comprises: the cartridge has an initial position that prevents the corresponding anchor from sliding relative to the extracorporeal unit; The system of claim 12 , operable to release the corresponding anchor from the cartridge while coupled to the extracorporeal unit.

14. 14. The system of claim 13, wherein for each of the cartridges, while the cartridge is in the initial position, the cartridge prevents the corresponding anchor from sliding distally along the tether and through the proximal opening into the tube.

15. The system of claim 13 , wherein for each of the cartridges, the cartridge is actuable by pulling the corresponding anchor proximally.

16. The system of claim 12 , wherein the extracorporeal unit comprises a tensioner comprising a spring and configured to reduce slack in the tether.

17. 13. The system of claim 12, wherein the system is configured such that the first anchor is advanceable by the distal end of the tether distally into the proximal opening and through the vessel toward the tissue, while the other anchor remains positioned along the extracorporeal unit.

18. 13. The system of claim 12, wherein the system is configured such that the first anchor is advanceable by the distal end of the tether distally to the proximal opening and through the vessel toward the tissue, while the proximal end of the tether remains coupled to the extracorporeal unit.

19. the catheter device further comprising a port at the proximal opening of the tube, the port comprising a membrane; 13. The system of claim 12, wherein the membrane is shaped to define a first opening therethrough, a second opening therethrough, and a closed slit connecting the first opening and the second opening.

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