Anchor staple cartridge

Abstract

The invention relates to an anchor cartridge. A tube has a distal opening and a proximal end defining a proximal opening. An extracorporeal unit is coupled to the proximal end, defines a deployed position, and includes a track leading to the deployed position. Each cartridge in a series holds a respective tissue anchor and is coupled to the extracorporeal unit at a respective initial position. Each cartridge body is movable along a track from the respective initial position to the deployed position such that the cartridge body retains its tissue anchor opposite the proximal opening. An anchor driver may advance the tissue anchor distally away from its cartridge, through the proximal opening, and through the tube. Each cartridge can then be removed from the deployment location, thereby freeing the deployment location for consecutive cartridges in the series. Other applications are also described.

Description

[0001] This application is a divisional application. The application date of the original application is September 23, 2021, the application number is 2021111138960, and the name of the invention is “Anchor Nail Magazine”. Background Art

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

[0003] This summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any feature included in the examples of this summary is not required by the claims unless the claims clearly state the feature. Moreover, the features, components, steps, concepts, etc. described in the 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 here.

[0004] For some applications, systems, devices and methods are provided for delivering one or more anchors percutaneously (e.g., transcavitary) to tissue of an object and anchoring the anchor to the tissue. For some such applications, the tissue anchor is a component of an implant, which also includes a tether, on which the tissue anchor is pre-threaded. For some such applications, the distal portion of the tether is implanted with the anchor for a long time, and after the anchor (and therefore the implant) is anchored to the tissue, the proximal portion of the tether is removed from the object.

[0005] The methods herein may be performed on a living animal or on a simulation (eg, on a cadaver, a cadaver heart, a simulator (eg, having a body part, tissue, etc. being simulated), etc.).

[0006] Some applications relate to systems, devices, and methods for determining successful (eg, complete) anchoring of one or more tissue anchors to tissue that is not in line of sight, such as during a percutaneous (eg, transluminal) technique.

[0007] In some applications, the tissue anchor includes a tissue engaging element and a head. The tissue engaging element can be or include one or more of hook(s), clip(s), barb(s), barb(s), nail(s), tines(s), needle(s), spiral(s), screw(s), tissue penetrating(s), etc.

[0008] In some applications, the anchor driver can engage the anchor at the head (e.g., reversibly attached to the head) and drive the tissue engaging element into the tissue. Typically, successful anchoring includes the tissue engaging element becoming fully embedded in the tissue, e.g., so that the head abuts the surface of the tissue.

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

[0010] For some applications, the mechanism may include a plurality of detents to control advancement of the anchor beyond the anchor storage area and prevent too many anchors from being advanced out of the anchor storage area at a given time. For some applications, the mechanism may include a dispenser to control advancement of the anchor beyond the anchor storage area and prevent too many anchors from being advanced out of the anchor storage area at a given time. For some applications, the mechanism may include a rotational stop at the extracorporeal unit that controls advancement of the anchor beyond the anchor storage area and prevents too many anchors from being advanced out of the anchor storage area at a given time.

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

[0012] For some applications, a corresponding catheter system is provided that includes a tensioner that applies tension (e.g., a predetermined and / or constant amount of tension) to a tether during implantation, e.g., to reduce the likelihood of inadvertent entanglement or capture. For some such applications, an anchor may be threaded along the tether between the tensioner and a distal end of the tether. For other applications, the tensioner may be disposed along the tether between the anchor and a distal end of the tether. For some applications, the tensioner may be reversibly engaged with the tether, e.g., so that an operator can select when to apply tension to the tether and when not to apply tension to the tether.

[0013] Thus, according to some applications, systems and / or apparatus for use with a subject are provided that include a catheter device, a series of tissue anchors, a series of cartridges, and an anchor driver.

[0014] In some applications, the catheter device includes a tube having a distal opening and a proximal opening, the distal opening being configured to be advanced into the subject.

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

[0016] In some applications, each cartridge body in the series of cartridge bodies 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 corresponding initial position, for example, in a series of initial positions.

[0018] In some applications, each cartridge body in the series can be moved along the track from the corresponding initial position to the deployed position while remaining coupled to the extracorporeal unit such that the cartridge body maintains the corresponding tissue anchor relative to the proximal opening.

[0019] In some applications, each cartridge in the series is removable from the deployed position such that the deployed position is empty for consecutive cartridges in the series.

[0020] In some applications, for each of the anchors, the anchor driver is configured to couple to the anchor when the anchor is held by the corresponding cartridge body relative to the proximal opening, and to advance the anchor distally out of the corresponding cartridge body, through the proximal opening, and through the catheter toward the distal opening.

[0021] In some applications, the catheter device also includes a port at the proximal opening of the tube, the port including a membrane, and the membrane is formed to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole to the second hole.

[0022] In some applications, the first hole is wider in diameter than the second hole.

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

[0024] In some applications, the anchor driver is configured to, for each of the anchors, advance the anchor distally out of the respective cartridge body, through the proximal opening, and through the tube toward the distal opening while the respective cartridge body remains in the deployed position.

[0025] In some applications, wherein, for each cartridge in the series of cartridges, the cartridge is configured such that the cartridge is removable from the deployed position when (i) the cartridge is in the deployed position and (ii) 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 when (i) the cartridge is in the deployed position and (ii) the anchor driver extends distally beyond the cartridge and through the tube toward the distal opening, the anchor driver prevents the cartridge from being removed from the deployed position.

[0027] In 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 hook(s), clip(s), barb(s), barb(s), staple(s), tines(s), needle(s), spiral(s), screw(s), tissue penetrating(s), etc.

[0028] In some applications, the system and / or device further comprises a tether. The tether can be passed through the eyelet of each of the tissue anchors, has a proximal portion including a proximal end of the tether, and has a distal portion including a distal end of the tether. In some applications, the distal end of the tether can be advanced distally through the catheter into the subject, while the proximal end of the tether remains external to the subject.

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

[0030] In some applications, the catheter device further comprises a port at the proximal opening of the tube, the port comprising a membrane. In some applications, the membrane is shaped to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole. In some applications, the port is arranged so that for each of the anchors, the anchor driver is configured to advance the anchor distally away from the corresponding cartridge body and through the membrane, wherein the tissue engaging element passes through the first hole and the tether extends through the second hole.

[0031] In some applications, the ports are arranged such that for each of the anchors, the anchor driver is configured to advance the anchor distally out of the corresponding cartridge body and through the membrane, wherein the tissue engaging element passes through the first hole and the tether extends through the second hole.

[0032] In some applications, the ports are arranged such that for each of the anchors, as the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the first hole widens instantaneously as the tissue engaging element of the anchor passes through the first hole.

[0033] In some applications, the ports are arranged such that, for each of the anchors, after the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the first aperture seals around the anchor driver.

[0034] In some applications, the ports are arranged such that for each of the anchors, as the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the second hole widens instantaneously as the eyelet of the anchor passes through the second hole.

[0035] In some applications, the ports are arranged such that, for each of the anchors, when the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the slit opens momentarily as the anchor passes through the membrane.

[0036] In some applications, the catheter device further comprises a port at the proximal opening of the tube, the port comprising a membrane. In some applications, the membrane is shaped to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole. In some applications, the port is arranged so that the membrane is substantially transverse to the proximal orientation of the tube, and for each of the series of cartridge bodies, when the cartridge body is in the deployed position, the tissue engaging element of the corresponding tissue anchor is aligned with the first hole, thereby defining an anchor advancement axis from the corresponding tissue anchor through the first hole and through the tube.

[0037] In some applications, the port is arranged such that the tether extends through the second aperture when the distal end of the tether is distally advanced through the tube into the subject while the proximal end of the tether remains external to the subject.

[0038] In some applications, the catheter device further includes a spring and a spool coupled to the spring such that rotation of the spool in a first direction applies stress to the spring.

[0039] In some applications, the proximal portion of the tether is wrapped around the spool such that distal advancement of the distal portion of the tether through the catheter causes the spool to rotate in the first direction.

[0040] In some applications, each cartridge in the series of cartridges is configured to lock to 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 a human operator by hand and is configured to be moved along the track by the operator by hand.

[0042] In some applications, each cartridge in the series of cartridges can be removed from the deployed position by being removed from the extracorporeal unit.

[0043] In some applications, each cartridge body in the series of cartridge bodies includes a displaceable barrier that impedes distal advancement of the corresponding anchor out of the cartridge body.

[0044] In some applications, each cartridge body in the series of cartridge bodies includes a displacement mechanism that, when the displacement mechanism is actuated, displaces the barrier such that the barrier ceases to impede distal advancement of the corresponding anchor out of the cartridge body.

[0045] In some applications, the displacement mechanism is configured such that actuation of the displacement mechanism displaces the barrier via linear translation of the barrier.

[0046] In some applications, the displacement mechanism is configured such that actuation of the displacement mechanism displaces the barrier via deflection of the barrier.

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

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

[0049] In some applications, the displacement mechanism is configured to be actuated by the anchor driver pulling the respective anchor proximally.

[0050] In some applications, for each bin in the series of bins, the bin comprises:

[0051] a first component, the first component comprising the barrier, and

[0052] a second component that retains the corresponding anchor;

[0053] The displacement mechanism is constrained by the pawl of the cartridge body, and

[0054] The displacement mechanism is configured to be actuated by the anchor driver pulling the respective anchor proximally with sufficient force that the respective anchor pulls the second member proximally relative to the first member such that the pawl ceases to restrain the displacement mechanism.

[0055] In some applications, the displacement mechanism is defined by the first component.

[0056] In some applications, the first component defines the detent.

[0057] In some applications, the pawl constrains the displacement mechanism by contacting the corresponding anchor.

[0058] In some applications, the corresponding anchor includes a helical tissue engaging element, and the pawl constrains the displacement mechanism by being disposed within the helical tissue engaging element of the corresponding anchor.

[0059] In some applications, the second component defines the detent.

[0060] In some applications, the pawl constrains the displacement mechanism by contacting the engagement mechanism.

[0061] In some applications, the cartridge is coupled to the extracorporeal unit via a coupling between the first component and the extracorporeal unit.

[0062] In some applications, the cartridge is coupled to the extracorporeal unit via a coupling between the second component and the extracorporeal unit.

[0063] In some applications, each of the cartridges includes a first component that connects the cartridge to the extracorporeal unit and retains the respective anchor, and a second component that includes a barrier.

[0064] In some applications, the first component defines a pawl that constrains the displacement mechanism, and the displacement mechanism is configured to be actuated by the anchor driver pulling the corresponding anchor proximally with sufficient force to pull the first component proximally relative to the second component so that the pawl ceases to constrain the displacement mechanism.

[0065] In some applications, the first member slidably couples the cartridge body to the track.

[0066] In some applications, each of the cartridge bodies is configured such that the anchor driver pulls the respective anchor proximally with sufficient force to pull the first component proximally relative to the second component to reconfigure the cartridge body into a removable state that facilitates removal of the cartridge body from the deployment position.

[0067] In some applications, the first component is mounted inside the second component, and the second component is configured to be grasped by a human operator.

[0068] In addition, a system and / or device is provided, including a catheter device, a first cartridge body, a second cartridge body, and an anchor driver. Optionally, the system and / or device may include additional cartridge bodies (e.g., a third cartridge body, a fourth cartridge body, a fifth cartridge body, a sixth cartridge body, and more), which may be the same or similar to the first cartridge body and / or the second cartridge body and include any of the same features.

[0069] In some applications, the catheter device includes a tube having a proximal opening and a controller or handle including a track leading to a deployment position.

[0070] In some applications, the first housing holds the first tissue anchor and is coupled to the controller or handle and can be moved along the track from the first initial position to the deployed position while remaining coupled to the controller or handle such that the first housing holds the first tissue anchor relative to the proximal opening.

[0071] In some applications, the second housing holds a second tissue anchor and is coupled to the controller or handle and can be moved along the track from the second initial position to the deployed position while remaining coupled to the controller or handle such that the second housing holds the second tissue anchor opposite the proximal opening.

[0072] In some applications, the anchor driver can be coupled to the first anchor when the first anchor is held by the first housing relative to the proximal opening and is configured to advance the first anchor distally out of the first housing, through the proximal opening and through the tube, and the anchor driver can be coupled to the second anchor when the second anchor is held by the second housing relative to the proximal opening and is configured to advance the second anchor distally out of the second housing, through the proximal opening and through the tube.

[0073] In some applications, the second tissue anchor includes a second tissue engaging element and a second head including a second eyelet. The tissue engaging element can be or include one or more of hook(s), clip(s), barb(s), barb(s), staple(s), tines(s), needle(s), spiral(s), screw(s), tissue penetrating(s), etc.

[0074] In some applications, the system and / or device further comprises a tether (e.g., a wire, a string, a suture, an elongated member, etc.) threaded through the first eyelet and the second eyelet, the tether having a proximal portion and having a distal portion, the distal portion comprising a distal end of the tether, the distal end of the tether being distally advanceable through the tube into the subject while the proximal end of the tether remains external to the subject. In some applications, with more cartridges and more anchors, the tether is threaded through multiple additional eyelets of additional anchors.

[0075] In some applications, the anchor driver is configured to advance the first anchor distally out of the first cartridge body, through the proximal opening, and through the tube, while the first eyelet of the first anchor remains threaded on the tether. In some applications, the anchor driver is configured to advance the second anchor distally out of the second cartridge body, through the proximal opening, and through the tube, while the second eyelet of the second anchor remains threaded on the tether. In some applications, in the case of an additional anchor, the anchor driver can similarly advance the additional anchor out of the additional cartridge body, through the proximal opening and the tube, while the eyelet of the additional anchor remains threaded on the tether.

[0076] In some applications, the catheter device further comprises a tensioning device configured to apply tension to the tether. The tensioning device can be configured in a variety of ways.

[0077] In some applications, the tensioning device includes a spring and a reel, wherein the reel is coupled to the spring such that rotation of the reel in a first direction applies stress to the spring, and wherein the proximal portion of the tether is wrapped around the reel such that distal advancement of the distal portion of the tether through the tube causes the reel to rotate in the first direction.

[0078] In some applications, each of the first cartridge body and the second cartridge body is configured to lock to the controller or handle when reaching the deployed position.

[0079] In some applications, each of the first and second cartridge bodies is shaped to be grasped by a human operator by hand and is configured to be moved along the track by a human operator by hand.

[0080] In some applications, each of the first cartridge body and the second cartridge body can be removed from the deployed position by removal from the controller or handle.

[0081] In some applications, the first cartridge body includes a first displaceable barrier that prevents the first anchor from being advanced distally out of the first cartridge body. In some applications, the second cartridge body includes a second displaceable barrier that prevents the second anchor from being advanced distally out of the second cartridge body.

[0082] In some applications, the first cartridge body includes a first displacement mechanism that, when the first displacement mechanism is actuated, displaces the first displaceable barrier so that the first displaceable barrier stops obstructing the first anchor from being advanced distally out of the first cartridge body. In some applications, the second cartridge body includes a second displacement mechanism that, when the second displacement mechanism is actuated, displaces the second displaceable barrier so that the second displaceable barrier stops obstructing the second anchor from being advanced distally out of the second cartridge body.

[0083] In some applications, the first displacement mechanism and the second displacement mechanism are both spring loaded.

[0084] In some applications, the first displacement mechanism is configured to be actuated by a force applied to the first anchor, and wherein the second displacement mechanism is configured to be actuated by a force applied to the second anchor.

[0085] In some applications, the first displacement mechanism is configured to be actuated by an anchor driver that pulls the first anchor proximally, and wherein the second displacement mechanism is configured to be actuated by an anchor driver that pulls the second anchor proximally.

[0086] In some applications, the first cartridge body includes a first component and a second component, the first component coupling the first cartridge body to the extracorporeal unit and retaining the first anchor, the second component including the barrier.

[0087] In some applications, the first component defines a pawl that constrains the first displacement mechanism, and wherein the first displacement mechanism is configured to be actuated by the anchor driver pulling the first anchor proximally with sufficient force that the first anchor pulls the first component proximally relative to the second component such that the pawl ceases to constrain the first displacement mechanism.

[0088] In some applications, the first member slidably couples the first bin body to the track.

[0089] In some applications, the first cartridge body is configured such that the anchor driver pulls the first anchor proximally with sufficient force to pull the first component proximally relative to the second component to reconfigure the first cartridge body into a removable state that facilitates removal of the first cartridge body from the deployed position.

[0090] In some applications, the first component is mounted inside the second component, and the second component is shaped to be grasped by a human operator.

[0091] In some applications, the system and / or device also includes a third housing that holds a third tissue anchor and is coupled to the controller or handle and can be moved along the track from a third initial position to the deployed position while remaining coupled to the controller or handle such that the third housing holds the third tissue anchor relative to the proximal opening.

[0092] According to some applications, a catheter system or other systems and / or devices including the catheter system are also provided. The catheter system includes an extracorporeal unit (e.g., a controller and / or a handle) at a proximal portion of the catheter system and a catheter (e.g., a pipe, etc.) that can be propelled through the cavity and extends distally from the controller. For example, when in a straight configuration, the catheter can extend from the controller to the distal opening of the catheter along the longitudinal catheter axis. The catheter includes a passage and a generally tubular wall that defines a lumen along the length of the catheter or along the catheter axis when in a straight configuration.

[0093] In some applications, the tubular wall has a transverse slit at a distal portion of the passage extending along at least a portion of the passage.

[0094] In some applications, the tubular wall has a helical thread that partially overlaps the channel and is operably coupled to the controller such that the thread can be rotated relative to the channel about the catheter axis via operation of the controller.

[0095] In some applications, the catheter has an anchor storage area in which the threads at least partially coincide with the slit in a longitudinal direction, and at least one tissue anchor is disposed or is disposable in the anchor storage area.

[0096] In 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 axis. The anchor head can be coupled to the tissue engaging portion and define a driver interface.

[0097] In some applications, the anchor and / or anchor head includes a protrusion. For example, the protrusion can be coupled to the tissue engaging portion via the anchor head. The protrusion can be configured to protrude laterally relative to the tissue engaging portion so as to extend through the slit and engage the thread.

[0098] The anchor and the slide can be configured to engage with each other such that when the thread is stationary relative to the channel, the tissue anchor is fixed within the anchor storage area, and rotation of the thread relative to the channel about the tissue anchor axis and / or the catheter axis advances the tissue anchor distally until the protrusion leaves the distal exit of the thread.

[0099] In some applications, the slit defines a linear slit disposed parallel to the catheter axis.

[0100] In some applications, the protrusion is rotatably coupled to the tissue engaging portion via the anchor head.

[0101] In some applications, the system and / or device further includes an inner tube surrounding a proximal portion of the channel, and the threads extend from a distal end of the inner tube and over the distal portion of the channel and define a tubular structure.

[0102] In some applications, the at least one tissue anchor includes at least first and second tissue anchors sequentially disposed within the anchor storage area, each of the first and second tissue anchors including a corresponding protrusion.

[0103] In some applications, when the threads are stationary, the first tissue anchor is disposed in a first position distal to the second tissue anchor and the second tissue anchor is disposed in a second position.

[0104] In some applications, rotation of the thread about the catheter axis relative to the channel (a) advances the first tissue anchor distally until the protrusion of the first tissue anchor clears the distal exit of the thread and the first tissue anchor moves distally away from the first position, and (b) advances the second tissue anchor distally away from the second position until the second tissue anchor moves distally into the first position.

[0105] In some applications, the system and / or device further comprises a spring disposed within the catheter proximal to the second tissue anchor, the spring being configured to facilitate distal movement of the first and second tissue anchors.

[0106] In some applications, the systems and / or devices further include an anchor driver including a driver head coupled to the flexible shaft.

[0107] In some applications, the driver head is dimensioned to slide axially within the lumen of the passageway and is actuatable to reversibly engage the driver interface within the anchor storage area.

[0108] In some applications, the anchor driver is configured to advance the anchor distally away from the anchor storage area toward a distal opening of the catheter and drive the tissue engaging portion into the tissue along the tissue anchor axis when the driver head engages the driver interface.

[0109] In some applications, the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during the rotation of the thread about the catheter axis relative to the channel.

[0110] In some applications, the system and / or device includes an outer tube disposed around the passage and the threads with the threads disposed between the outer tube and the passage.

[0111] In some applications, the threads are movable and rotatable relative to the outer tube and relative to the passageway.

[0112] In some applications, the inner surface of the outer tube defines a helical groove that defines the threads in a manner such that rotation of the outer tube facilitates rotation of the threads.

[0113] In 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 tissue of the subject along the tissue anchor axis, and the protrusion extends radially away from the tissue anchor axis.

[0114] In some applications, the anchor head is fixedly coupled to the tissue engaging portion and the protrusion is rotatably coupled to the anchor head.

[0115] In some applications, the anchor head is disposed within the lumen.

[0116] In some applications, the thread defines a plurality of adjacent bands arranged in a spiral arrangement, the protrusion abuts a surface defining the depth of a distal band among the plurality of bands and rests in a spacing between the distal band among the plurality of bands and an adjacent band proximal to the distal band among the plurality of bands, and during rotation of the thread about the catheter axis, the protrusion slides along the surface defining the depth of the distal band among the plurality of bands.

[0117] In 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.

[0118] In some applications, the driver head is dimensioned to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface within the anchor storage area.

[0119] In some applications, the anchor driver is configured to, when the driver head is engaged with the driver interface, advance the anchor distally away from the anchor storage area toward a distal opening of the catheter and drive the tissue engaging portion into the tissue along the anchor axis.

[0120] In some applications, the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during the rotation of the thread about the catheter axis relative to the channel.

[0121] In some applications, the protrusion is shaped so as to define an aperture, the aperture defining a hole.

[0122] In some applications, the system includes a wire slidably coupled to the at least one tissue anchor, and the wire is passed through the hole of the eyelet of the protrusion.

[0123] According to some applications, there is additionally provided a system and / or device including at least one tissue anchor and a catheter system.

[0124] In some applications, the catheter system includes an extracorporeal unit (e.g., a controller and / or a handle) at a proximal portion of the catheter system and a transluminal catheter (e.g., a tube, etc.) extending distally from the controller to a distal opening of the catheter. In some applications, for example, when in a straight configuration, the catheter extends along a longitudinal catheter axis.

[0125] In some applications, the catheter includes a channel, which may include a generally tubular wall defining a lumen along the length of the catheter or along the catheter axis. The anchor may be disposed in the lumen.

[0126] In some applications, in the closed state: (a) the proximal pawl extends into the lumen, hindering the anchor from returning proximally past the proximal pawl and exiting the dispenser, and (b) the distal pawl extends into the lumen, hindering the anchor from moving distally past the distal pawl and exiting the dispenser.

[0127] In some applications, in the dispensing state: (1) the proximal detent extends into the lumen, preventing the anchor from returning proximally past the proximal detent and exiting the dispenser, and (2) the distal detent collapses away from the catheter axis, allowing the anchor to move distally past the distal detent and exit the dispenser.

[0128] In some applications, the system and / or device also includes a tubular structure surrounding at least a portion of the channel, wherein the tubular structure is coupled to the dispenser in such a manner that movement of the tubular structure distally and proximally along the channel facilitates collapse of the proximal and distal pawls and extension of the proximal and distal pawls into the lumen of the channel.

[0129] In some applications, the tubular wall of the channel is shaped so as to define a transverse window exiting the lumen, the window having a proximal edge and a distal edge, and the tubular structure surrounds the at least a portion of the channel at the transverse window.

[0130] In some applications, proximal movement of the tubular structure relative to the transverse window facilitates collapse of the proximal detent against a proximal edge of the window, causing the proximal detent to move away from the catheter axis.

[0131] In some applications, distal movement of the tubular structure relative to the transverse window facilitates collapse of the distal detent against a distal edge of the window, causing the distal detent to move away from the catheter axis.

[0132] In some applications, the system and / or device further comprises an outer tube disposed around the tubular structure in such a manner that the tubular structure is disposed between the outer tube and the passageway.

[0133] In some applications, the at least one tissue anchor defines a first tissue anchor and the system and / or device further comprises at least one additional tissue anchor disposed within the lumen proximal to the dispenser.

[0134] In some applications, after the first tissue anchor moves distally past the distal detent and leaves the dispensing state of the dispenser: the dispenser returns to the receiving state in which the dispenser allows the at least one additional anchor to move distally past the proximal detent and into the dispenser, the dispenser transitions to the closed state in which the dispenser hinders the at least one additional anchor from moving distally past the distal detent and leaving the dispenser, and subsequently, the dispenser transitions to the dispensing state in which the dispenser allows the at least one additional tissue anchor to move distally past the distal detent and leave the dispenser.

[0135] In some applications, the system and / or device includes a spring disposed within the catheter proximal to the at least one additional tissue anchor, the spring configured to facilitate distal movement of the first tissue anchor and the at least one additional tissue anchor.

[0136] In some applications, the at least one tissue anchor includes a tissue engaging portion, and an anchor head and an eyelet. The tissue engaging portion can be disposed within the lumen of the passageway and define a tissue anchor axis. The anchor head can be coupled to the tissue engaging portion and define a driver interface; and the eyelet can define a hole. In some applications, the eyelet protrudes laterally relative to the tissue engaging portion.

[0137] In some applications, the eyelet is rotatably coupled to the tissue engaging portion via the anchor head.

[0138] In some applications, the system and / or device further comprises a wire slidably coupled to the at least one tissue anchor, and the wire is passed through the hole of the eyelet.

[0139] In some applications, the system and / or device further comprises an anchor driver comprising a driver head coupled to a flexible shaft. The driver head can be dimensioned to slide axially within the lumen and actuatable to reversibly engage a driver interface of the at least one tissue anchor. The anchor driver can be configured to, when the driver head engages the driver interface: advance the anchor distally toward the distal opening of the catheter and drive the tissue engaging portion into the tissue along the tissue anchor axis.

[0140] In some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis. The driver head of the anchor driver can be dimensioned to slide axially within the tissue anchor lumen and can be actuatable to reversibly engage the driver interface, and the flexible shaft of the anchor driver can be dimensioned to slide axially within the tissue anchor lumen.

[0141] In some applications, the tubular wall of the channel is shaped so as to define a transverse slit extending along at least a portion of the channel at a distal portion of the channel.

[0142] In some applications, the eyelet projects laterally relative to the tissue engaging portion so as to extend through the transverse slit.

[0143] According to some applications, a system and / or device is also provided, including at least one tissue anchor and a catheter system. The catheter system may include an extracorporeal unit (e.g., a controller and / or a handle) at a proximal portion of the catheter system and a transluminal catheter extending distally from the controller to a distal opening of the catheter.

[0144] The catheter may extend, for example, in a straight configuration along a longitudinal axis of the catheter from the controller to a distal opening of the catheter.

[0145] In some applications, the catheter includes a channel including a generally tubular wall defining a lumen along the catheter axis. The anchor may be disposed in the lumen. The tubular wall may be shaped so as to define at least one detent having a transverse detent slit defining a movable tab. A protrusion may be coupled to an inner surface of the movable tab facing the lumen of the channel.

[0146] In some applications, an outer sleeve is slidably disposed about the passage and operably coupled to the controller so as to be transitionable via operation of the controller such that the pawl is transitionable between the closed state and the open state.

[0147] In some applications, in the closed state: (i) the outer sleeve surrounds the movable tab, (ii) the movable tab is aligned with the tubular wall of the channel, and (iii) the protrusion extends into the lumen of the channel, thereby hindering the anchor from moving distally past the protrusion.

[0148] In some applications, in the open state: (a) the outer sleeve is retracted from the movable tab, and (b) the movable tab is displaceable away from the catheter axis to move the protrusion away from the catheter axis, thereby enabling the anchor to move distally past the protrusion.

[0149] In some applications, the outer sleeve is shaped so as to define a transverse window configured to align with the projection during the open state in a manner that facilitates movement of the projection away from the catheter axis.

[0150] In some applications, the at least one anchor defines a first tissue anchor, and the system and / or device further includes at least one additional tissue anchor disposed within the lumen proximally of the first tissue anchor.

[0151] In some applications, the at least one pawl defines a first pawl, and the tubular wall is shaped so as to define at least one additional pawl having a transverse additional pawl slot defining an additional pawl movable tab.

[0152] In some applications, the system and / or device further comprises an additional detent protrusion coupled to an inner surface of the additional detent movable tab facing the lumen of the channel.

[0153] In some applications, after the first tissue anchor is moved distally past the open state of the first pawl of the protrusion of the first pawl, the outer sleeve can be retracted distally so that at least one additional pawl can be transitioned between the closed state and the open state.

[0154] In some applications, in the closed state: (i) the outer sleeve surrounds the additional detent movable tab, (ii) the additional detent movable tab is aligned with the tubular wall of the channel, and (iii) the additional detent protrusion extends into the lumen, thereby hindering the anchor from moving distally past the additional detent protrusion.

[0155] In some applications, in the open state: (i) the outer sleeve is retracted from the additional pawl movable tab, and (ii) the additional pawl movable tab can be displaced away from the catheter axis to move the additional pawl protrusion away from the catheter axis, thereby enabling the anchor to move distally past the additional pawl protrusion.

[0156] In some applications, the first tissue anchor is disposed at a first position relative to the passageway, and the additional tissue anchor is disposed at a second position relative to the passageway proximal to the first position.

[0157] In some applications, the system and / or device also includes an anchor driver configured to (1) engage the first tissue anchor at the first position during the closed state of the first pawl, and (2) engage the additional tissue anchor at the second position during the closed state of the additional pawl.

[0158] In some applications, the at least one tissue anchor comprises a tissue engaging portion and an anchor head. In some applications, the tissue engaging portion is disposed or positionable within the lumen of the passage. In some applications, the tissue engaging portion defines a tissue anchor axis.

[0159] In some applications, the anchor head is coupled to the tissue engaging portion and defines a driver interface. In some applications, the anchor head includes an eyelet defining a hole. In some applications, the eyelet protrudes laterally relative to the tissue engaging portion.

[0160] In some applications, the eyelet is rotatably coupled to the tissue engaging portion via the anchor head.

[0161] In some applications, the tissue engaging portion is shaped so as to define a helical tissue engaging portion, and the protrusion of the pawl is configured to be disposed between adjacent subcomponents of the helical tissue engaging portion in the closed state of the pawl.

[0162] In some applications, the system and / or device further comprises a wire slidably coupled to the at least one tissue anchor, and the wire is passed through the hole of the eyelet.

[0163] In some applications, the systems and / or devices further include an anchor driver including a driver head coupled to the flexible shaft.

[0164] In some applications, the driver head is dimensioned to slide axially within the lumen and is actuatable to reversibly engage the driver interface of the at least one tissue anchor.

[0165] In some applications, the anchor driver is configured to advance the anchor distally toward the distal opening of the catheter and drive the tissue engaging portion into the tissue along the tissue anchor axis when the driver head is engaged with the driver interface.

[0166] In some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, and: the driver head of the anchor driver is sized to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface, and the flexible shaft of the anchor driver is sized to slide axially within the tissue anchor lumen.

[0167] In some applications, the tubular wall of the channel is shaped so as to define a transverse slit extending along at least a portion of the channel at a distal portion of the channel.

[0168] In some applications, the eyelet projects laterally relative to the tissue engaging portion so as to extend through the transverse slit.

[0169] According to some applications, a system and / or device is also provided, including at least first and second tissue anchors and a catheter system. In some applications, the catheter system includes a transluminal catheter extending distally from the controller. The catheter can extend from the controller to the distal opening of the catheter along a longitudinal catheter axis, for example, when in a straight configuration.

[0170] In some applications, the catheter includes a channel and an extracorporeal unit (eg, a controller and / or a handle). In some applications, the channel includes a generally tubular wall defining a lumen along the catheter axis for the first and second tissue anchors to pass therethrough.

[0171] In some applications, the extracorporeal unit is at a proximal portion of the catheter system, and the extracorporeal unit includes a handle.

[0172] In some applications, the handle is shaped so as to define an anchor driver sublumen having an anchor driver sublumen axis aligned with the lumen of the channel of the transluminally advanceable catheter and along the catheter axis.

[0173] In some applications, the handle is shaped to define an anchor storage sublumen offset relative to the lumen of the channel of the transluminal advanceable catheter and relative to the anchor driver sublumen, the anchor storage sublumen defining an anchor storage area for accommodating the first and second tissue anchors.

[0174] In some applications, the handle includes a rotation stop at a distal end of the handle, the rotation stop being shaped so as to define a receiving lumen to receive one of the first and second tissue anchors.

[0175] In some applications, the rotational stop can be rotated about the catheter axis in the following manner: in a receiving state of the rotational stop, the receiving lumen of the rotational stop is aligned with the anchor storage sub-lumen so as to receive one of the first and second tissue anchors from the anchor storage area, and in a loaded state of the rotational stop, the receiving lumen of the rotational stop is aligned with the anchor driver sub-lumen so that one of the first and second tissue anchors can pass through the lumen of the channel of the transluminal catheter.

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

[0177] In some applications, the system and / or device further comprises a spring disposed within the anchor storage sublumen proximal to at least the second tissue anchor, the spring being configured to facilitate distal movement of the first and second tissue anchors.

[0178] In some applications, the anchor storage sub-lumen and the anchor driver sub-lumen are in fluid communication.

[0179] In some applications, each of the first and second tissue anchors includes a corresponding tissue engaging portion, which defines a tissue anchor axis; a corresponding anchor head, which is coupled to the tissue engaging portion and defines a driver interface; and a corresponding eyelet, which defines a hole and protrudes laterally relative to the tissue engaging portion.

[0180] In some applications, each eyelet is rotatably connected to the respective tissue engaging portion via the respective anchor head.

[0181] In some applications, the system and / or device further comprises a wire slidably coupled to the first and second tissue anchors, and the wire is passed through the apertures of the corresponding eyelets of the first and second tissue anchors.

[0182] In some applications, the wire is disposed between the anchor driver sub-lumen and the anchor storage sub-lumen.

[0183] In some applications, the wire extends within the lumen of the channel of the transluminally advanceable catheter.

[0184] In some applications, each of the first and second tissue anchors can be rotated about the wire via the rotation stop.

[0185] In some applications, the system and / or device also includes an anchor driver that can slide partially within the anchor driver sub-lumen and partially within the lumen of the channel of the transluminal catheter, and the anchor driver includes a driver head coupled to the flexible shaft.

[0186] In some applications, the driver head is dimensioned to slide axially within the anchor driver sublumen and partially within the lumen of the channel of the transluminally advanceable catheter and is actuatable to reversibly engage the driver interface of each of the first and second tissue anchors.

[0187] In some applications, the anchor driver is configured to advance the tissue anchor distally toward the distal opening of the catheter and drive the tissue engaging portion into the tissue along the tissue anchor axis when the driver head is engaged with the driver interface.

[0188] In some applications, the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, and the driver head of the anchor driver is sized to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface, and the flexible shaft of the anchor driver is sized to slide axially within the tissue anchor lumen.

[0189] In some applications, the tubular wall of the channel is shaped so as to define a transverse slit extending along at least a portion of the channel at a distal portion of the channel.

[0190] In some applications, each eyelet projects transversely relative to the tissue engaging portion so as to extend through the transverse slit.

[0191] According to some applications, an anchor driver is also provided for use with a tissue anchor shaped so as to define a driver interface having a proximal edge and a recessed portion surrounded by a wall of the tissue anchor extending distally from the proximal edge.

[0192] In some applications, the anchor driver includes a flexible shaft and a driver head coupled to the flexible shaft. In some applications, the driver head is shaped so as to define first and second legs having a rest state, wherein the first and second legs define a first space having a first distance between each other, and wherein the first and second legs do not contact the wall of the tissue anchor surrounding the recessed portion in the rest state.

[0193] In some applications, a connecting rod is at least partially disposed between the first and second legs.

[0194] In some applications, first and second expander elements are slidable relative to the flexible shaft and relative to the first and second legs, and the first and second expander elements are disposed upstream of the connecting rod in the static state of the first and second legs of the anchor driver. In some applications, the first and second expander elements can be configured as or include one or more of wire(s), arm(s), rod(s), latch(s), lever(s), extension(s), expandable ring(s), expandable spiral(s), etc. For example, in some applications, the first and second expander elements include first and second wires.

[0195] In some applications, the first and second expander elements can be advanced around the connecting rod and into the first space between the first and second legs to expand the first and second legs so that the first and second legs are in an engaged state, in which the first and second legs define a second space between each other having a second distance greater than the first distance, and in the engaged state, the first and second legs contact and engage the wall of the tissue anchor surrounding the recessed portion.

[0196] In some applications, in the engaged state of the first and second legs, respective distal surfaces at each end of the first and second expander elements push against a proximal edge of the tissue anchor to facilitate urging the tissue anchor in the engaged state of the first and second legs.

[0197] In some applications, the system and / or device further comprises a propulsion element slidably coupled to the flexible shaft, the propulsion element being coupled to the first and second dilator elements and being slidable relative to the flexible shaft to push the first and second dilator elements distally. In some applications, the propulsion element can be configured as or include one or more of a wire, a rod, a shaft, a hypotube, an extension, etc.

[0198] In some applications, the first and second expander elements expand along a plane that is perpendicular relative to a plane along which the first and second legs expand.

[0199] In 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 selectively and reversibly engage the wall of the tissue anchor surrounding the recessed portion.

[0200] In some applications, the first and second expander elements are sized to (a) assume a collapsed state during the static state of the first and second legs, (b) expand about the connecting rod to transition the first and second legs into the engaged state of the first and second legs, and (c) subsequently retract to return the first and second expander elements to the collapsed state to disengage the anchor driver from the tissue anchor.

[0201] According to some applications, an anchor driver is also provided for use with a tissue anchor shaped so as to define a driver interface having a proximal edge and a recessed portion surrounded by a wall of the tissue anchor extending distally from the proximal edge.

[0202] In some applications, the anchor driver includes a flexible propulsion element and a driver head, the driver head coupled to the flexible propulsion element. In some applications, the propulsion element can be configured as or include one or more of a wire, a rod, a shaft, a hypotube, an extension, etc.

[0203] In some applications, the driver head is formed to define first and second legs having a rest state, in which the first and second legs define a first space having a first distance between each other, and in which the first and second legs do not contact the wall surrounding the recessed portion of the tissue anchor.

[0204] In some applications, the expander element is slidable relative to the flexible propulsion element and between the first and second legs.

[0205] In some applications, the first and second expander elements are disposed at distal surfaces of the first and second legs of the anchor driver in the rest state of the first and second legs.

[0206] In some applications, the first and second expander elements can be advanced proximally and into the first space between the first and second legs to expand the first and second legs so that the first and second legs are in an engaged state, in which the first and second legs define a second space between each other having a second distance greater than the first distance, and in the engaged state, the first and second legs contact and engage the wall surrounding the recessed portion of the tissue anchor.

[0207] In some applications, in the rest state, the first and second legs together present a circular profile, and in the engaged state, the first and second legs together present an elliptical profile.

[0208] In some applications, the expander element includes a circular disk having a diameter larger than the first space between the first and second legs in the static state, so that when the expander element is positioned between the first and second legs, the first and second legs expand to assume the engaged state.

[0209] In some applications, the expander element includes an elliptical disk having a major axis diameter that is larger than the first space between the first and second legs in the static state, such that when the expander element is positioned between the first and second legs, the first and second legs expand to assume the engaged state.

[0210] In some applications, the system and / or device also includes a displacement element slidably coupled to the advancement element, the displacement element being coupled to the dilator element and slidable relative to the advancement element to pull the dilator element proximally into the first space between the first and second legs.

[0211] In some applications, the anchor driver is dimensioned to slide axially through a lumen defined by the tissue anchor and selectively and reversibly engage the wall of the tissue anchor surrounding the recessed portion.

[0212] In some applications, the expander element can be urged distally to return the first and second legs to the resting state, thereby disengaging the anchor driver from the tissue anchor.

[0213] According to some applications, an anchor driver is also provided for use with a tissue anchor shaped so as to define a driver interface having a proximal edge and a recessed portion surrounded by a wall of the tissue anchor extending distally from the proximal edge.

[0214] In some applications, the anchor driver includes a flexible tube and a driver head coupled to the flexible tube.

[0215] In some applications, the driver head is shaped so as to have a deflectable protrusion in a rest state in which the protrusion assumes a collapsed state toward a central axis defined by the flexible tube and does not contact the tissue anchor.

[0216] In some applications, a shaft is disposed within the lumen of the flexible tube and is engageable with the deflectable protrusion such that when the shaft slides alongside the deflectable protrusion, the shaft deflects the deflectable protrusion from the collapsed state away from the central axis and into an engaged state of the deflectable protrusion, wherein the deflectable protrusion engages with the tissue anchor.

[0217] In some applications, the first and second expander elements are coupled to the outer surface of the flexible tube and can be expanded proximally of the tissue anchor, the first and second expander elements have corresponding distal surfaces at each end of the first and second expander elements, and in the engaged state of the deflectable protrusion, the first and second expander elements push against the proximal edge of the tissue anchor to facilitate pushing the tissue anchor.

[0218] In some applications, the anchor driver is dimensioned to slide axially through a lumen defined by the tissue anchor and selectively and reversibly engage the tissue anchor in response to movement of the shaft.

[0219] In some applications, the first and second expander elements can be collapsible when pulled through the lumen of the tissue anchor and can be expanded once exposed from the lumen.

[0220] In some applications, the shaft can be retracted away from the deflectable protrusion to facilitate deflection of the deflectable protrusion from the engaged state toward the central axis and into the collapsed state to disengage the anchor driver from the tissue anchor.

[0221] Additionally provided is a system and / or apparatus for use with a subject that includes a catheter device, a tether, a plurality of tissue anchors, and an anchor driver.

[0222] In some applications, the catheter device includes a distal member or distal portion configured to be advanced into the subject and an extracorporeal proximal unit (eg, a controller, a handle, etc.), the extracorporeal unit including a housing and a tensioner.

[0223] In some applications, the tether has a proximal portion that includes a proximal end of the tether. In some applications, the tether extends distally from the proximal portion through the catheter device to a distal portion of the tether that is disposed distally from the tensioner and includes a distal end of the tether. In some applications, the tensioner is configured to pull the tether proximally.

[0224] In some applications, the plurality of tissue anchors each include a tissue engaging element and a head defining an eyelet that is threaded onto the tether such that the plurality of tissue anchors are distributed in series proximally from the tensioner along the tether.

[0225] In some applications, successively for each of the anchors, the anchor driver is configured to reversibly couple to the anchor and advance the anchor distally along the tether through the tensioner.

[0226] In some applications, the tensioner includes a spring connected to the housing and reversibly locked to the tether such that when the spring is under stress and locked to the tether, the spring causes the tensioner to pull the tether proximally.

[0227] In some applications, the spring is a compression spring configured to be stressed by compression and configured to pull the tether proximally by extending.

[0228] In some applications, the tensioner further comprises a clamp coupled to the spring and reversibly transitionable between an unclamped state and a clamped state, the tether extending distally through the catheter device such that the tether extends through the clamp in a manner that locks the spring to the tether when the clamp is in the clamped state.

[0229] In some applications, the tensioner includes an actuator, actuation of which causes the clamping member to transition between the released state and the clamping state.

[0230] In some applications, the actuator includes a ring surrounding the clamping member, and rotation of the ring causes the clamping member to transition between the unclamped state and the clamped state.

[0231] In some applications, the clamping member is biased toward assuming the unclamped state.

[0232] In some applications, the clamp and the ring together act as a chuck.

[0233] In some applications, the ring has an inner surface and 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 so that axial movement of the ring relative to the clamp presses the clamp toward the clamped state.

[0234] In some applications, the ring has internal threads and the clamp has external threads, so that rotation of the ring threads the ring onto the clamp.

[0235] In some applications, the anchor driver includes a shaft and a driver head at a distal end of the shaft, the driver head reversibly coupled to each of the tissue anchors. In some applications, the tether extends through the tensioner, thereby defining a tether axis, and the catheter device is shaped to provide a non-gripping region laterally from the tether axis, the non-gripping region being shaped and dimensioned to accommodate the shaft being laterally displaced after the driver has advanced a given one of the anchors distally along the tether through the tensioner, such that the shaft extends distally toward the anchor, bypassing the clamp.

[0236] In 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 to provide the non-clamping region by eccentricity of the clamping surfaces relative to the tether axis.

[0237] In some applications, the clamp defines first and second clamping surfaces that are configured to engage the tether when the clamp is in a clamped state, and in the unclamped state, the clamp defines a gap between the first and second clamping surfaces, and each of the tissue anchors is sized to be advanced distally along the tether through the gap by the anchor driver.

[0238] In some applications, the anchor driver includes a shaft and a driver head at a distal end of the shaft, the driver head being reversibly coupled to each of the tissue anchors, and successively for each of the anchors, the anchor driver being sized to advance the anchor along the tether so that the anchor, the driver head, and at least a distal segment of the shaft pass distally through the gap.

[0239] In some applications, the extracorporeal unit is formed to define a non-clamping area laterally from the clamping member, and the non-clamping area is formed and dimensioned to receive the portion of the shaft disposed in the gap when the portion of the shaft is laterally moved out of the gap and into the non-clamping area.

[0240] In 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.

[0241] In some applications, the clamp may be transitioned into the clamped state while the lock remains locked.

[0242] In some applications, the lock is configured to lock the spring in the stressed state when locked by locking the clamp to the housing.

[0243] In some applications, the lock is configured such that, when the clamp is maintained in the clamped state, unlocking of the clamp from the housing triggers the spring to cause the tensioner to pull the tether proximally.

[0244] In some applications, the lock includes a detent and a recess.

[0245] In some applications, the clamp defines the recess and the housing includes the detent.

[0246] In some applications, the clamping member may be transformed into the clamping state by squeezing the clamping member.

[0247] In some applications, the lock is configured such that once the clamp is in the clamped state, further squeezing of the clamp unlocks the clamp from the housing, thereby triggering the spring to cause the tensioner to pull the tether proximally.

[0248] According to some applications, a system and / or apparatus for use with a subject is also provided, comprising: a catheter device, a tether, a plurality of tissue anchors, and an anchor driver.

[0249] In some applications, the catheter device includes a distal member or distal portion and an extracorporeal unit, the distal member or distal portion being configured to be advanced into the object, the extracorporeal unit being at a proximal portion of the catheter device. In some applications, the extracorporeal unit includes a capstan.

[0250] The capstan may be configured to include a spring and a spool coupled to the spring such that rotation of the spool in a first rotational direction applies stress to the spring.

[0251] In some applications, the tether has a distal portion and a proximal portion, the distal portion comprising a distal end of the tether, and the proximal portion comprising a proximal end of the tether. In some applications, the proximal portion is wound around the spool so that the distal portion of the tether is pulled away from the capstan and the tether is released from the spool by rotating the spool in the first rotational direction.

[0252] In some applications, each of the plurality of anchors includes a tissue engaging element and a head. In some applications, the head defines an eyelet.

[0253] In some applications, the eyelets of the plurality of tissue anchors are threaded onto the tether such that the plurality of tissue anchors are distributed in series along the tether, for example between the spool and a distal end of the tether.

[0254] In some applications, successively for each of the anchors, the anchor driver is configured to be reversibly coupled to the anchor and to be used to advance the anchor distally along the tether toward a distal end of the tether.

[0255] In some applications, the capstan is configured to reduce slack in the tether by applying tension to the tether by the spring urging the spool in a second rotational direction opposite the first rotational direction in response to stress applied to the spring.

[0256] In some applications, the winch also includes a reversibly activatable ratchet, which, when activated, allows rotation of the spool in the first rotational direction and prevents rotation of the spool in the second rotational direction, and when deactivated, allows rotation of the spool in both the first rotational direction and the second rotational direction.

[0257] In some applications, the ratchet includes a gear coupled to the reel such that rotation of the reel rotates the gear; a pawl reversibly engageable with the gear such that when the pawl engages with the gear, the ratchet is activated and when the pawl disengages from the gear, the ratchet is deactivated; and a switch configured to switch the ratchet between being activated and deactivated by moving the pawl between engaging with and disengaging from the gear.

[0258] In some applications, the system and / or device also includes a stop fixedly attached to the distal portion of the tether, which stops any anchor in the series from being advanced distally along the tether beyond the stop, such that a first tissue anchor in the series is pushed distally by advancement of the anchor driver distally away from the capstan, and the stop pulls the distal portion of the tether away from the capstan.

[0259] In some applications, the distal member or portion includes a catheter having a proximal opening, having a distal opening configured to be advanced into the subject, and defining a lumen between the proximal opening and the distal opening.

[0260] In some applications, the plurality of tissue anchors are mounted in series on the extracorporeal unit of the catheter device.

[0261] In some applications, the system and / or device also includes a series of bins.

[0262] In some applications, each of the cartridges holds a respective tissue anchor of the plurality of anchors or the series of tissue anchors.

[0263] In some applications, each cartridge body is coupled to the extracorporeal unit at a corresponding initial position in a series of initial positions. In some applications, each cartridge body is movable from the corresponding initial position to a deployed position while remaining coupled to the extracorporeal unit, in which the cartridge body holds the corresponding tissue anchor opposite the proximal opening. In some applications, each cartridge body is subsequently removable from the deployed position such that the deployed position is the same for consecutive cartridge bodies in the series.

[0264] In some applications, for each of the anchors, the anchor driver is configured to couple to the anchor when the anchor is held by the corresponding cartridge body relative to the proximal opening, and to advance the anchor distally out of the corresponding cartridge body, through the proximal opening, and through the catheter toward the distal opening.

[0265] In 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.

[0266] In 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.

[0267] In some applications, the spool surrounds the catheter.

[0268] In some applications, the spool is concentric with the catheter.

[0269] The methods herein or methods using the systems, devices, apparatus, etc. described herein can be performed on a living animal or on a simulation (such as on a cadaver, a cadaver heart, a simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0270] The present invention will be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0271] Figure 1A -B and 2A-B are schematic illustrations of examples of catheter systems including a transluminally advanceable catheter including helical threads for controlling advancement of a tissue anchor according to some applications;

[0272] Figure 3A-B and 4A-B are schematic illustrations of examples of catheter systems according to some applications, the catheter system including a transluminally advanceable catheter including a plurality of detents for controlling advancement of a tissue anchor;

[0273] Figures 5A-5C is a schematic illustration of an example of a catheter system including a transluminally advanceable catheter including a dispenser for controlling advancement of a tissue anchor according to some applications;

[0274] Figures 6A-6E is a schematic illustration of an example of a catheter system according to some applications, the catheter system including a transluminally advanceable catheter including a handle including a rotation stop for controlling advancement of a tissue anchor;

[0275] Figures 7A-7F , 8A-8C and 9A-9B are schematic illustrations of respective examples of catheter systems according to respective applications, the catheter systems comprising a transluminally advanceable catheter, at least one tissue anchor, an implant and respective anchor drivers for implanting the tissue anchor;

[0276] Fig.10 , 11A -B, 12A-B, 13A-E, 14A-E, and 15A-B are schematic illustrations of example systems for use with objects according to some applications;

[0277] Figures 16A-16F is a schematic illustration of another system for use with an object according to some applications;

[0278] Fig.17A -F and 18A-B are schematic illustrations of example systems for use with objects according to some applications;

[0279] Fig.19A - B is a schematic illustration of ports according to some applications; and

[0280] Fig. 20A -H is a schematic illustration of an example system for use with an object according to some applications. DETAILED DESCRIPTION

[0281] refer to Figure 1A -B and 2A-B, Figure 1A2A-B and 2A-B are schematic illustrations of examples of catheter systems 40 and techniques for use therewith, according to some applications, the catheter system 40 including a transluminally advanceable catheter 12, at least one tissue anchor 220, and an implant 210 including the tissue anchor. The system 40 is a tissue adjustment system that can be used to adjust the size of a tissue structure. For example, the system 40 can be an annuloplasty system, and the implant 210 can be an annuloplasty structure.

[0282] The system 40 includes an extracorporeal unit (e.g., a controller and / or handle) 18 at a proximal portion of the system 40. The transluminally propellable catheter 12 is coupled to the extracorporeal unit 18 at a proximal end of the catheter 12 and extends distally therefrom along a longitudinal catheter axis 16 of the catheter 12, from the unit 18 to a distal opening 14 of the catheter 12. The transluminally propellable catheter 12 includes a channel 254, such as 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 so as to define a transverse slit 256 extending along at least a portion of the channel 254 at a distal portion thereof. 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 defining the slit 256, the lumen of the channel 254 at the slit 256 is not closed due to the slit 256.

[0283] The channel 254 is shaped so as to accommodate the implant 210 during delivery to the tissue 10 of the patient. For applications in which the tissue 10 represents the tissue of the annulus of a natural heart valve (such as a mitral valve), the implant 210 is an annuloplasty structure including a wire 212 and a plurality of anchors 220. Each anchor 220 is shaped so as to define a central longitudinal anchor axis ax2. Each anchor 220 includes a tissue engaging element 230 and an anchor head 280. The tissue engaging element 230 has a proximal end 232, a distal end 234, and defines a central longitudinal axis ax2 of the anchor 220. At the distal end 234, the tissue engaging element 230 has a sharp distal tip 238, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 230 is spiral and defines a central lumen 436 along the axis ax2. Alternatively, the tissue engaging element 230 can be another type of tissue engaging element, such as a thorn or a nail.

[0284] The head 280 is coupled to the proximal end 232 of the tissue engaging element 230 and includes a driver interface 282 and an eyelet 240 defining a hole 246 therethrough. The driver interface 282 is configured to be reversibly engaged by the flexible anchor driver 260. In some applications, the eyelet 240 includes a structural element that protrudes laterally relative to the tissue engaging element 230. The driver 260 may include an elongated and 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 282. The driver interface 282 may be rigidly coupled to the tissue engaging element 230.

[0285] For some applications, the driver interface 282 includes a wall that is shaped so as to define a recessed portion surrounded by the wall. For some applications, the wall surrounding the recessed portion is shaped as a circular wall, such as Figure 2B For some applications, the wall surrounding the recessed portion is square.

[0286] In some applications, and as shown, the driver interface 282 is disposed on a central longitudinal axis ax2 and the aperture 240 is disposed transversely from the axis ax2.

[0287] As described in more detail below, the anchor 220 (e.g., its eyelet 240) is configured to facilitate the sliding of the anchor along the wire 212 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 220 along the guidewire. As also described in more detail below, the anchor 220 (e.g., its eyelet 240) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire (i.e., when the axis ax2 is orthogonal to the wire). This is achieved at least in part due to the shape and size of the eyelet 240. This is assumed to be particularly useful for applications (such as annuloplasty) in which the wire is tensioned after implantation to adjust the anatomical size.

[0288] The transluminal catheter 12 includes a helical thread 20 that overlaps (e.g., is coaxial with) a channel 254 and is operably connected to an extracorporeal unit 18 such that the thread 20 can rotate relative to the channel 254 about the catheter axis 16 via operation of the unit 18. The transluminal catheter 12 has an anchor storage area 22 in which the thread 20 at least partially coincides longitudinally with a slit 256 of the channel 254. The coincidence of the thread 20 and the channel 254 defines the anchor storage area 22. In some applications, the thread 20 and the channel 254 are concentrically disposed. A plurality of anchors 220 of an implant 210 are disposed within the anchor storage area 22. For some applications, the transluminal catheter 12 includes an outer tube 252. For applications where the catheter 12 includes an outer tube 252, the outer tube 252 is shaped so as to define a distal linear slit that extends proximally from the opening 14 of the catheter 12 and is aligned with the slit 256 of the channel 254. For 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 in a manner that the rotation of the inner tube causes the thread 20 to rotate. Typically, as shown, the thread 20 defines a tubular structure. For some applications, the thread 20 is generated from the inner tube by cutting a spiral slit in the inner tube. For any application where the thread 20 is coupled to the distal end of the inner tube or is formed by the inner tube, the thread 20 can rotate relative to both the channel 254 and the outer tube 252. For some applications, the catheter 12 does not include an inner tube, but the inner surface of the outer tube 252 defines a spiral groove that defines the thread 20 in a manner that the rotation of the outer tube 252 promotes the rotation of the thread 20 relative to the channel 254. For some applications, the outer tube 252 contains a polymer.

[0289] The anchor storage area 22 has a distal end disposed proximal to the distal opening 14 of the catheter 12. In this manner, the distal portion of the catheter 12 is free of the anchor 220 to enable flexibility and manipulation of the end portion of the catheter 12. The distal end of the anchor storage area 22 may be at a distance of no more than 90 cm (such as no more than 25 cm) from the distal opening 14 to maintain a level of comfort and stability for the user. For some applications, the distal end of the area 22 is at a distance of between 3 cm and 25 cm (such as between 5 cm and 25 cm) from the distal opening 14.

[0290] For some applications, and as shown, the eyelet 240 is mounted to rotate about the axis ax2. For example, the head 280 may include a ring 284 on which the eyelet 240 is mounted. The ring 284 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 230, such as by being rotatably coupled to another component of the head 280 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 282).

[0291] For some applications, and as shown, the eyelet 240 is mounted stationary relative to the axis ax2. For such applications, the head 280 does not include the ring 284, but the eyelet 240 is mounted directly on the head 280.

[0292] Each tissue anchor 220 includes a protrusion 241 coupled to a tissue engaging element 230 via an anchor head 280. For some applications, the protrusion 241 is coupled to or formed and extends from the eyelet 240 (e.g., from a structural element of the eyelet 240). For some applications, the protrusion 241 is shaped so as to define the eyelet 240, which defines the hole 246. For some applications, the protrusion 241 is rotatably coupled to the tissue engaging element 230, for example, by coupling to the ring 284. For other applications, the head 280 does not include the ring 284, and the protrusion 241 is directly mounted on the head 280. The protrusion 241 projects laterally relative to the tissue engaging element 230 so as to extend through the slit 256 of the channel 254 and engage the thread 20 so that (1) when the thread 20 is stationary relative to the channel 254, the tissue anchor 220 is fixed within the anchor storage area 22, and (2) rotation of the thread 20 relative to the channel 254 about the catheter axis 16 causes the tissue anchor 220 to be advanced distally until the protrusion 241 leaves the distal exit of the thread 20.

[0293] The threads 20 are shaped so as to define a plurality of adjacent bands 24 or coils arranged helically. The plurality of bands have spacing 28 between adjacent bands. Each band 24 has a surface 26 that defines the depth of the band 24. The protrusions 241 of each anchor 220 abut against the respective surface 26 of a given band 24 and rest at spacing 28 between adjacent bands. During rotation of the threads 20 about the catheter axis 16, the protrusions 241 of each anchor 220 slide along the surface 26 of the band 24. As the threads 20 rotate and the protrusions 241 slide along the surface 26, the anchor 220 is linearly advanced distally along the axis 16 of the catheter 12. Figure 1A As shown, before the threads 20 rotate and when the threads 20 are stationary, the first distal-most tissue anchor 220a is positioned distally of the second tissue anchor 220b at a first position 30a relative to the channel 254, and the second tissue anchor 220b is disposed at a second position 30b proximal to the first position 30a.

[0294] like Figure 1BAs shown, rotation of the thread 20 about the catheter axis 16 relative to the channel 254, for example clockwise, (a) advances the first tissue anchor 220a distally until the protrusion 241 of the first tissue anchor 220a leaves the distal exit of the thread 20 and the first tissue anchor 220a moves distally away from the first position 30a and leaves the anchor storage area 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.

[0295] As each anchor moves distally, the protrusion 241 and the eyelet 240 are linearly advanced distally along the slit 256 of the channel 254. Each anchor 220 in the anchor storage area 22 is disposed in such a manner that the protrusion 241 and the eyelet 240 are disposed within the slit 256, and the tissue engaging element 230 and the anchor head 280 are disposed within the lumen of the channel 254. For some applications, the catheter 12 includes a spring (not shown) disposed within the lumen of the catheter 12 proximal to at least the second tissue anchor 220b (e.g., proximal to the plurality of anchors 220). For some applications, the spring is disposed proximal to the anchor storage area 22. The spring is configured to facilitate distal movement of the tissue anchor 220 and is arranged to apply a distally directed force to the most proximal anchor 220 within the anchor storage area 22, thereby retaining the anchor 220 within the storage area 22 and helping to facilitate distal advancement of the remaining anchors 220 as the thread 20 rotates and each anchor 220 is deployed individually.

[0296] It should be noted that rotation of the threads 20 less than a full turn (e.g., 180 degrees) provides the operating physician with an indication of the connection between the driver 260 and the anchor 220. In addition, the interaction between the threads 20 and the anchor 220 acts as a safety mechanism to prevent the anchor 220 from being released prematurely.

[0297] Figure 2A -B shows a system 40, which includes an implant 210 and a delivery tool 250 for percutaneous (e.g., transluminal, such as transfemoral) implantation of the implant. The tool 250 includes a flexible anchor driver 260, which is configured to reversibly engage a driver interface 282 of the anchor 220. Via this engagement, the driver 260 is configured to drive the tissue engagement element 230 into the tissue, for example by rotating (and pushing distally) the anchor 220. In some applications, the tool 250 also includes a flexible tube 252 (e.g., a transluminal catheter), and each anchor 220 engaged with the driver 260 can be advanced to the tissue to which the anchor is to be anchored via the flexible tube 252.

[0298] exist Figure 2AIn FIG. 1 , a plurality of anchors 220 have been anchored to tissue 10. Each anchor 220 is delivered to the tissue in a delivery state in which the wire 212 extends through the hole 246 of the eyelet 240 and is slidable relative to the hole 246 of the eyelet 240 while being substantially parallel to the axis ax2. Figure 2A 2 is an illustration of a currently delivered anchor 220d. It is possible for the wire 212 to take a straight path through the hole 246 of the eyelet 240.

[0299] When a subsequent anchor 220 is anchored to the same tissue, the wire 212 becomes oriented transversely relative to the anchor. Due to the configuration of the eyelet 240, the wire 212 can still take a purely linear path through the hole 246 of the eyelet 240 despite its reorientation.

[0300] After the desired number of anchors 220 have been anchored, an adjustment tool is introduced (e.g., on and along the proximal portion of the wire 212) and used to facilitate tensioning of the wire. Thus, tensioning of the wire 212 pulls the anchors 220 closer together, thereby contracting the tissue to which the anchors are anchored. This is facilitated by the eyelet 240, which provides smooth sliding of the wire 212 through the hole 246 when the wire is orthogonal to the anchor, as described above. A corresponding stop 214 is coupled to the wire 212 to prevent the wire 212 from sliding out of the anchor 220. Figure 2A A stopper is shown distal to the first anchor 220a. The excess wire 212 may then be cut and removed from the patient.

[0301] For simplicity, Figure 2A Implant 210 is shown in a linear configuration. However, for annuloplasty, implant 210 is typically implanted in a curve (or even a full ring) around the annulus so that contraction reduces the size of the annulus, thereby improving coaptation of the valve leaflets.

[0302] As described above, for some applications, the eyelet 240 is mounted to be rotatable about the axis ax2. Thus, this provides independence between the rotational position of the eyelet and the rotational position of the tissue engaging element 230. Assuming that for applications in which the tissue engaging element 230 is spiral, this independence advantageously allows the tissue engaging element to be screwed into the tissue to the extent required for optimal anchoring without requiring the anchor to be completed in a specific rotational orientation. It is further assumed that, regardless of the type of tissue engaging element 230 used, for a given application, this independence allows the eyelet 240 (and the wire 212) to be in an optimal position relative to the axis ax2 of each anchor 220. For example, for applications in which the implant 210 is used for annuloplasty, the anchor 220 is typically anchored in a curve around the valve ring, and the eyelet 240 and the wire 212 can be set on the inside of the curve relative to the axis ax2.

[0303] To anchor anchor 220, the anchor is advanced out of channel 254 and the distal end of tube 252 while driver 260 rotates driver interface 282 (and thus tissue engaging element 230) relative to the tube, while slit 256 may prevent ring 284 from rotating relative to the tube. For some applications, it may be advantageous to place (or even press against) the distal end of tube 252 against tissue 10 during anchoring of the anchor, e.g., as Figure 2A As shown. For applications in which tube 252 is used to implant an implant (such as implant 210) including multiple anchors on a line, interference may occur between the contact between the line and the distal end of the tube and the tissue. For some applications, tube 252 defines a transverse 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 the distal opening 14 of catheter 12. For some applications, the slit is adjacent to the lumen of catheter 12 (e.g., laterally outward from the lumen of catheter 12) and allows wire 212, rather than anchor 220, to laterally exit tube 252 and channel 254 from distal opening 14 to the proximal side. It is believed that this facilitates the implantation of an implant (such as implant 210) including multiple anchors coupled to a line (e.g., threaded on a line).

[0304] Each anchor 220 is shaped so as to define a corresponding tissue anchor lumen extending through the 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., in particular the driver head 264) is dimensioned to slide axially within the lumen of the channel 254 and is actuatable to reversibly engage the driver interface 282 of each tissue anchor within the anchor storage area 22. The anchor driver 260 is configured to advance the anchor 220 distally away from the anchor storage area 22 toward the distal opening 14 of the catheter 12 and drive the tissue engaging element 230 into the tissue 10 along the tissue anchor axis ax2 when the driver head 264 engages with the driver interface 282. The driver 260 advances the tissue anchor 220 distally as the thread 20 rotates. In the absence of rotation of the thread 20, the anchor driver 260 is prevented from advancing the anchor 220 distally.

[0305] Each anchor 220 defines a corresponding tissue-anchor-lumen, and the anchor driver 260 (e.g., particularly the driver head 264) is dimensioned to slide axially within all of the tissue-anchor-lumens of the anchors 220. For example, when the distal-most anchor 220 is engaged by the driver 260, the driver 260 passes through the tissue anchor lumens of all of the anchors 220 until it reaches the anchor head 280 of the distal-most anchor. Once the driver 260 is implanted in the distal-most anchor 220, it is disengaged from the anchor 220 and sequentially retracted through the lumen of the passage 254 and through the tissue-anchor-lumen of the next anchor 220 that is disposed proximally adjacent to the distal-most anchor. To engage the anchor head 280 of the next anchor 220 in sequence, the driver 260 is retracted through the tissue-anchor-lumen of the next anchor 220 in sequence until it aligns with the anchor head 280 to engage the head 280 and thereby the next anchor 220 in sequence.

[0306] refer to Figure 3A -B and 4A-B, Figure 3A 4A-B and 4A-B are schematic illustrations of examples of catheter systems 100 according to some applications, and techniques for use therewith, the catheter system 100 including a transluminally advanceable catheter 112, at least one tissue anchor 320, and an implant 310 including the tissue anchor. The system 100 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, the system 100 can be an annuloplasty system and the implant 310 can be an annuloplasty structure.

[0307] The system 100 includes an extracorporeal unit 318 (e.g., a controller and / or handle) at a proximal portion of the system 100. The transluminally advanceable catheter 112 is coupled to the extracorporeal unit 318 at a proximal end of the catheter 112 and extends distally from the extracorporeal unit 318 along a longitudinal catheter axis 116 of the catheter 112 to a distal opening 114 of the catheter 112. The transluminally advanceable catheter 112 includes a channel 354, such as 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 so as to define a transverse slit 356 extending along at least a portion of the channel 354 at a distal portion thereof. 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 due to the slit 356 .

[0308] The channel 354 is shaped so as to accommodate the implant 310 during delivery to the tissue 10 of the patient. For applications in which the tissue 10 represents the tissue of the annulus of a natural heart valve (such as a mitral valve), the implant 310 is an annuloplasty structure including a wire 312 and a plurality of anchors 320. Each anchor 320 is shaped so as to define a central longitudinal anchor axis ax2. Each anchor 320 includes a tissue engaging element 330 and an anchor head 380. The tissue engaging element 330 has a proximal end 332, a distal end 334, and defines a central longitudinal axis ax2 of the anchor 320. At the distal end 334, the tissue engaging element 330 has a sharp distal tip 338, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 330 is spiral and defines a central lumen 336 along the axis ax2. Alternatively, the tissue engaging element 330 can be another type of tissue engaging element, such as a thorn or a nail. The head 380 is coupled to the proximal end 332 of the tissue engaging element 330 and includes a driver interface 382 and an eyelet 340 that defines a hole 246 therethrough. The driver interface 382 is configured to be reversibly engaged by the flexible anchor driver 260. In 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 and 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.

[0309] For some applications, the driver interface 382 includes a wall that is shaped so as to define a recessed portion surrounded by the wall. For some applications, the wall surrounding the recessed portion is shaped as a circular wall, such as Figure 4B For some applications, the wall surrounding the recessed portion is square.

[0310] In some applications, and as shown, the driver interface 382 is disposed on a central longitudinal axis ax2, and the aperture 340 is disposed transversely from the axis ax2.

[0311] As described in more detail below, the anchor 320 (e.g., its eyelet 340) is configured to facilitate the sliding of the anchor along the wire 312 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 320 along the wire. As also described in more detail below, the anchor 320 (e.g., its eyelet 340) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 340. This is assumed to be particularly useful for applications (such as annuloplasty) in which the wire is tensioned after implantation to adjust the anatomical size.

[0312] The tubular wall of the channel 354 of the transluminal catheter 112 is shaped so as to define at least one detent 360 having a transverse detent slit 366 defining a movable tab 362. In some applications, as shown, the channel 354 of the catheter is shaped so as to define a plurality of detents 360 arranged longitudinally parallel to the axis 116. The transluminal catheter 112 has an anchor storage area 122 in which a plurality of anchors 320 are disposed and held in place by the plurality of detents 360. For some applications, the anchor storage area 122 at least partially coincides longitudinally with the slit 356 of the channel 354. The transluminal catheter 112 includes an outer sleeve 352. In some applications, the outer sleeve 352 is shaped so as to define a distal linear slit extending proximally from the opening 114 of the catheter 112 and aligned with the slit 356 of the channel 354.

[0313] The anchor storage area 122 has a distal end disposed proximal to the distal opening 114 of the catheter 112. In this manner, the distal portion of the catheter 112 is free of the anchor 320 to enable flexibility and manipulation of the end portion of the catheter 112. The distal end of the anchor storage area 122 is typically at a distance of no more than 90 cm (such as no more than 25 cm) from the distal opening 114 to maintain a level of comfort and stability for the user. For some applications, the distal end of the area 122 is at a distance of between 3 cm and 25 cm (such as between 5 cm and 25 cm) from the distal opening 114.

[0314] For some applications, and as shown, the eyelet 340 is mounted to rotate about the axis ax2. For example, the head 380 may include a ring 384 on which the eyelet 340 is mounted. The ring 384 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 330, such as by being rotatably coupled to another component of the head 380 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 382).

[0315] For some applications, and as shown, the eyelet 340 is mounted stationary relative to the axis ax2. For such applications, the head 380 does not include the ring 384, but the eyelet 340 is mounted directly on the head 380.

[0316] As described above, the tubular wall of the channel 354 of the transluminally advanceable catheter 112 is shaped so as to define at least one detent 360 having a transverse detent slit 366 defining a movable tab 362. In some applications, as shown, the channel 354 of the catheter is shaped so as to define a plurality of detents 360 arranged longitudinally parallel to the axis 116. The tab 362 is coupled at its inner surface to a protrusion 364 facing the lumen of the channel 354. For some applications, the tab 362 is shaped at its inner surface to define the protrusion 364. For some applications, the protrusion 364 serves as a baffle and stop that prevents the tissue anchor 320 from linearly moving within the lumen of the channel 354. For some applications, as shown, the protrusion 364 is shaped so as to define a cylinder disposed perpendicularly relative to the axis 116 of the catheter 112. As shown, the protrusion 364 is coupled to the tab 362 at a proximal portion of the tab 362. The projections 364 are shaped so as to fit between adjacent coils of the tissue engaging element 330 of the anchor 320, as shown in FIG. Figure 3B When no force is applied to the protrusion 364, the protrusion 364 remains disposed between adjacent coils of the tissue engaging element 330. Pulling or pushing the anchor 320 facilitates displacement of the protrusion 364 and at least the proximal portion of the tab 362 radially away from the axis 116 of the catheter 112, thereby moving the protrusion 364 out from between the adjacent coils of the tissue engaging element 330, thereby unlocking the anchor 320 from the pawl 360, as described below. In addition, when the sleeve 352 is around the pawl 360, the tab 362 is restricted from moving radially away from the axis 116.

[0317] The outer sleeve 352 is slidably disposed about the channel 354 and is operably coupled to the unit 318 so as to be transformable via operation of the unit 318 so that each pawl 360 can be transformed between (1) a closed state and (2) an open state, in which (i) the outer sleeve 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, thereby hindering the anchor 320 from moving distally past the protrusion 364, and in the open state, (i) the outer sleeve 352 (i.e., the distal end of the outer tube 252) is retracted from the movable tab 362, and (ii) the movable tab 362 can be displaced away from the catheter axis 116 to move the protrusion 364 away from the catheter axis 116, thereby enabling the anchor 320 to move distally past the protrusion 364.

[0318] For some applications (not shown), the outer sleeve 352 is shaped so as to define a transverse window that is configured to align with the protrusion 364 in a manner that facilitates the movement of the protrusion 364 away from the catheter axis during the open state of the pawl 360. For such applications, the distal end of the outer sleeve 352 does not need to be retracted proximally to the pawl 360, but the transverse window of the outer sleeve is aligned with the pawl 360 (particularly, aligned with the portion of the outer sleeve 352 coupled to the protrusion 364) to facilitate the movement of the protrusion 364 radially away from the axis 116. For some applications, the outer sleeve 352 is not retracted, but rotated about the axis 116 to align the transverse window with the pawl 360.

[0319] like Figure 3B As shown, the first distal-most tissue anchor 320a is positioned distally of the second tissue anchor 320b at a first position 370a relative to the channel 354, and the second tissue anchor 320b is disposed at a second position 370b proximal to the first position 370a. In the system 100, each anchor 320 remains in its respective position and is fixed in place as long as the outer sleeve 352 surrounds the detent 360.

[0320] Once each anchor 320 is released from its respective detent 360, the anchor 320 moves distally away from its respective first position 370 and out of the anchor storage area 122. As long as the outer sleeve 352 surrounds the detent 360, the anchor 320 is locked in place in its respective position 370.

[0321] As each anchor 320 moves distally, the eyelet 340 is linearly advanced distally along the slit 356 of the channel 354. Each anchor 320 in the anchor storage area 122 is arranged in a manner that the eyelet 340 is arranged opposite to the pawl 360. The protrusion 364 maintains each anchor 320 fixed in a manner that the eyelet 340 is arranged opposite to the pawl 360 so as to prevent rotation of the anchor 320 and twisting of the wire 312. Therefore, for some applications, the ring 384 is fixed relative to the anchor head 380 and does not rotate about the axis ax2. For some applications, the slit 356 of the channel 354 extends proximally into the anchor storage area 122 so as to keep the eyelet 340 within the slit 356 and thereby prevent rotation of the anchor 320 and entanglement of the wire 312.

[0322] Figure 4A -B shows a system 100, which includes an implant 310 and a delivery tool 350 for percutaneous (e.g., transluminal, such as transfemoral) implantation of the implant. The tool 350 includes a flexible anchor driver 260, which is configured to reversibly engage a driver interface 382 of an anchor 320. Via this engagement, the driver 260 is configured to drive the tissue engagement element 330 into the tissue, for example by rotating (and pushing distally) the anchor 320. In some applications, the tool 350 also includes a flexible outer sleeve 352 (e.g., a transluminal catheter), and each anchor 320 engaged with the driver 260 can be advanced to the tissue to which the anchor is to be anchored via the flexible outer sleeve 352.

[0323] exist Figure 4A In FIG. 1 , a plurality of anchors 320 have been anchored to tissue 10. Each anchor 320 is delivered to the tissue in a delivery state in which the wire 312 extends through the hole 346 of the eyelet 340 and is slidable relative to the hole 346 of the eyelet 340 while being substantially parallel to the axis ax2. Figure 4A 320d is shown as currently delivered. It is possible for the wire 312 to take a straight path through the hole 346 of the eyelet 340.

[0324] When a subsequent anchor 320 is anchored to the same tissue, the wire 312 becomes oriented transversely relative to the anchor. Due to the configuration of the eyelet 340, the wire 312 can still take a purely linear path through the hole 346 of the eyelet 340 despite its reorientation.

[0325] After the desired number of anchors 320 have been anchored, an adjustment tool is actuated (e.g., on and along the proximal portion of the wire 312) and used to facilitate tensioning of the wire. Thus, tensioning of the wire 312 pulls the anchors 320 closer together, thereby contracting the tissue to which the anchors are anchored. This is facilitated by the eyelet 240, which provides for smooth sliding of the wire 312 through the hole 346 when the wire is orthogonal to the anchor, as described above. A corresponding stopper 214 is coupled to the wire 312 to prevent the wire 312 from sliding out of the anchor 320. Figure 4A A stopper is shown distal to the first anchor 320a. The excess wire 312 may then be cut and removed from the patient.

[0326] For simplicity, Figure 4A The implant 310 is shown in a linear configuration. However, for annuloplasty, the implant 310 is typically implanted in a curve (or even a full ring) around the annulus so that contraction reduces the size of the annulus, thereby improving coaptation of the valve leaflets.

[0327] As described above, for some applications, the eyelet 340 is mounted to be rotatable about the axis ax2. Thus, this provides independence between the rotational position of the eyelet and the rotational position of the tissue engaging element 330. Assuming that for applications in which the tissue engaging element 330 is spiral, this independence advantageously allows the tissue engaging element to be screwed into the tissue to the extent required for optimal anchoring without requiring the anchor to be completed in a specific rotational orientation. It is further assumed that, regardless of the type of tissue engaging element 330 used, for a given application, this independence allows the eyelet 340 (and the wire 312) to be in an optimal position relative to the axis ax2 of each anchor 320. For example, for applications in which the implant 310 is used for annuloplasty, the anchor 320 is typically anchored in a curve around the valve ring, and the eyelet 340 and the wire 312 can be set on the inside of the curve relative to the axis ax2.

[0328] To anchor anchor 320, the anchor is advanced out of channel 354 and the distal end of outer cannula 352 while driver 260 rotates driver interface 382 (and thus tissue engaging element 330) relative to the tube, and while slit 356 can prevent ring 384 from rotating relative to the tube. For some applications, it is advantageous that during anchoring of the anchor, the distal end of outer cannula 352 is disposed (or even pressed against) tissue 10, e.g., as Figure 4AAs described above, the slit 356 of the passage 354 is adjacent to (e.g., laterally outward from) the lumen of the catheter 112 and allows the wire 312, rather than the anchor 320, to laterally exit the tube passage 354 proximally from the distal opening 114. It is believed that this facilitates the implantation of an implant (such as the implant 310) that includes multiple anchors coupled to (e.g., threaded on) a wire.

[0329] Each anchor 320 is shaped so as to define a corresponding tissue-anchor-cavity extending from the proximal end of the anchor head 380 through the longitudinal length of the anchor 320 to the distal end of the tissue engaging element 330. The anchor driver 260 (e.g., particularly the driver head 264) is dimensioned to slide axially within the lumen of the channel 354 and is actuatable to reversibly engage the driver interface 382 of each tissue anchor within the anchor storage area 122. The anchor driver 260 is configured to advance the anchor 320 distally away from the anchor storage area 122 toward the distal opening 114 of the catheter 112 and drive the tissue engaging element 330 into the tissue 10 along the tissue anchor axis ax2 when the driver head 264 engages with the driver interface 382. The driver 260 only advances the tissue anchor 320 distally when the distal end of the outer sleeve 352 is proximally retracted to the pawl 360 currently holding the tissue anchor 320. For applications where the outer cannula 352 defines a lateral window, the driver 260 advances the tissue anchor 320 distally only when the lateral window of the outer cannula 352 is aligned with the detent 360 currently holding the tissue anchor 320. If the outer cannula 352 covers the detent 360, the anchor driver 260 is prevented from advancing the anchor 320 distally because the protrusion 364 of the detent 360 remains engaged with the tissue engaging element 330 of the anchor 320.

[0330] Each anchor 320 defines a corresponding tissue-anchor-lumen, and the anchor driver 260 (e.g., particularly the driver head 264) is dimensioned to slide axially within all of the tissue-anchor-lumens of the anchors 320. For example, when the distal-most anchor 320 is engaged by the driver 260, the driver 260 passes through the tissue anchor lumens of all of the anchors 320 until it reaches the anchor head 380 of the distal-most anchor. Once the driver 260 implants the distal-most anchor 320, it is disengaged from the anchor 320 and sequentially retracted through the lumen of the passage 354 and through the tissue-anchor-lumen of the next anchor 320 that is disposed proximally adjacent to the distal-most anchor. To engage the anchor head 380 of the next anchor 320 in sequence, the driver 260 is retracted through the tissue-anchor-lumen of the next anchor 320 in sequence until it aligns with the anchor head 380 to engage the head 380 and thereby the next anchor 320 in sequence.

[0331] like Figure 4A 10. As shown, a series of anchors 320 have been deployed at the tissue 10. In step A, the anchor driver 260 engages the next proximally disposed tissue anchor 320d from its corresponding position 370d in the anchor storage area 122. The anchor 320d is locked in place in the position 370d because the outer sleeve 352 surrounds the pawl 360d in a manner such that the protrusion 364d of the tab 362d of the pawl 360d is disposed between the coils of the tissue engaging element 330. In step B, the outer sleeve 352 is retracted so that its distal end is disposed proximal to the tab 362d, thereby releasing the pawl 360d and allowing the tab 362d to be displaced laterally and radially away from the axis 116 during the anchor driver 260 pushing the anchor 320d distally. This distal push of anchor 320d pushes tissue engaging element 330d and anchor head 380 against protrusion 364d to push protrusion 364d out of the lumen of passage 354. In this way, pawl 360d assumes an open state in which tab 362d is not aligned with the tubular wall of passage 354 and protrusion 364d is displaced away from axis 116. Although anchor 320d moves out of position 370d, the next proximally disposed anchor 320e remains in place in position 370e. Once anchor 320d has moved distally from position 370d, no object and / or force acts on tab 362d, and therefore, tab 362d returns to a position in which tab 362 is aligned with the wall of passage 354, and protrusion 364d again protrudes within the lumen of passage 354. As shown, the anchor 330e remains locked in position 370e because the outer sleeve 352 surrounds the detent 360e.

[0332] exist Figure 4BIn, for some applications, the channel 354 is shaped to control the rotational position of the eyelet 340 relative to the axis ax2 and / or the tissue engaging element 330 during delivery and anchoring. For some such applications, the channel 354 defines a main channel area 354a and a secondary channel area 354b. The main channel area 354a has a larger cross-sectional area than the secondary channel area 354b. The anchor 320 can slide through the channel 354, wherein the tissue engaging element 330 slides (usually tightly) through the main channel area 354a, and the eyelet 340 slides (usually tightly) through the secondary channel area 354b and slides along the line 312. The rotation control of the channel 354 thus controls the position of the eyelet 340, and thus controls the position of the axis ax2 of each anchor. Although the driver interface 382 and the tissue engaging element 330 can rotate in the outer sleeve 352 and in the channel 354, the ring 384 and the eyelet 340 are not. For some applications, and as shown, passage 354 has an orthogonal cross-section that is keyhole-shaped.

[0333] For some applications, eyelet 340 includes or is shaped so as to define the Figure 1A -B and protrusion 241 described in 2A-B.

[0334] refer to Figure 5A -C, Figure 5A -C is a schematic illustration of an example of a catheter system 400 according to some applications, and techniques for use therewith, the catheter system 400 including a transluminally advanceable catheter 402, at least one tissue anchor 420, and an implant 410 including the tissue anchor. System 400 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, system 400 can be an annuloplasty system and implant 410 can be an annuloplasty structure.

[0335] At a proximal portion of the system 400, the system includes an extracorporeal unit (e.g., a controller and / or a handle), which may be similar or identical to the extracorporeal units 18 and / or 318 described above. A transluminally advanceable catheter 402 is coupled to the extracorporeal unit at a proximal end of the catheter 402 and extends distally therefrom along a longitudinal catheter axis 16 of the catheter 402, extending from the extracorporeal unit to a distal opening of the catheter 402. The transluminally advanceable catheter 402 includes a channel 454, such as a flexible tube, having a generally tubular wall defining a lumen along the catheter axis 416. The tubular wall of the channel 454 is shaped so as to define a transverse slit extending along at least a portion of the channel 454 at a distal portion thereof (e.g., as described above with reference to FIG. 1 ). Figure 1A2A-B and 2A-B). The slit defines a linear slit disposed parallel to the axis 416. The tubular wall of the channel 454 defines a longitudinal lumen along the channel 454. For the portion of the tubular wall of the channel 454 that defines the slit, the lumen of the channel 454 at the slit is not closed due to the slit.

[0336] The channel 454 is shaped so as to accommodate the implant 410 during delivery to the tissue 10 of the patient. For applications in which the tissue 10 represents the annulus of a natural heart valve (such as a mitral valve), the implant 410 is an annuloplasty structure including a wire 412 and a plurality of anchors 420. Each anchor 420 is shaped so as to define a central longitudinal anchor axis ax2. Each anchor 420 includes a tissue engaging element 430 and an anchor head 480. The tissue engaging element 430 has a proximal end 432, a distal end 434, and defines a central longitudinal axis ax2 of the anchor 420. At the distal end 434, the tissue engaging element 430 has a sharp distal tip 438, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 430 is spiral and defines a central lumen 436 along the axis ax2. Alternatively, the tissue engaging element 430 can be another type of tissue engaging element, such as a thorn or a nail. The head 480 is coupled to the proximal end 432 of the tissue engaging element 430 and includes a driver interface 482 and an eyelet 440 defining a hole therethrough. The driver interface 482 is configured to be reversibly engaged by the flexible anchor driver 260. In some applications, the eyelet 440 includes a structural element that protrudes laterally relative to the tissue engaging element 430. The driver 260 may include an elongated and 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 may be rigidly coupled to the tissue engaging element 430.

[0337] For some applications, the driver interface 482 includes a wall shaped so as to define a recessed portion surrounded by the wall. For some applications, the wall surrounding the recessed portion is shaped as a circular wall. For some applications, the wall surrounding the recessed portion is square.

[0338] In some applications, and as shown, the driver interface 482 is disposed on a central longitudinal axis ax2, and the eyelet 440 is disposed transversely from the axis ax2.

[0339] As described in more detail below, the anchor 420 (e.g., its eyelet 440) is configured to facilitate the sliding of the anchor along the wire 412 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 420 along the wire. As also described in more detail below, the anchor 420 (e.g., its eyelet 440) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 440. This is assumed to be particularly useful for applications (such as annuloplasty) in which the wire is tensioned after implantation to adjust the anatomical size.

[0340] The transluminal catheter 402 includes a dispenser 460 distal to the distal-most anchor 420a. The dispenser 460 overlaps (e.g., coaxially) with the channel 454 and is operably connected to the extracorporeal unit so that the dispenser 460 can be moved relative to the channel 454 via operation of the extracorporeal unit to facilitate dispensing one anchor 420 at a time. The transluminal catheter 402 has an anchor storage area 422 including the dispenser 460 and a plurality of tissue anchors 420. For some applications, the anchor storage area 422 at least partially coincides with the slit of the channel 454 in the longitudinal direction. In some applications, the dispenser 460 and the channel 454 are concentrically arranged. A plurality of anchors 420 of the implant 410 are arranged in the anchor storage area 422. For some applications, the transluminal catheter 402 includes an outer tube. For applications where the catheter 402 includes an outer tube, the dispenser is positioned between the outer tube and the channel 454 and can slide relative to the outer tube and the channel 454.

[0341] The anchor storage area 422 has a distal end disposed proximal to the distal opening of the catheter 402. In this manner, the distal portion of the catheter 402 is free of the anchor 420 to achieve flexibility and manipulation of the end portion of the catheter 402. The distal end of the anchor storage area 422 is typically at a distance of no more than 90 cm (such as no more than 25 cm) from the distal opening to maintain a level of comfort and stability for the user. For some applications, the distal end of the area 422 is at a distance of between 3 cm and 25 cm (e.g., between 5 cm and 25 cm) from the distal opening 14.

[0342] For some applications, and as shown, the eyelet 440 is mounted to rotate about the axis ax2. For example, the head 480 may include a ring 484 on which the eyelet 440 is mounted. The ring 284 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 430, such as by being rotatably coupled to another component of the head 480 that is fixedly coupled to the tissue engaging element (e.g., a driver interface 482).

[0343] For some applications, and as shown, the eyelet 440 is mounted stationary relative to the axis ax2. For such applications, the head 480 does not include the ring 484, but the eyelet 440 is mounted directly on the head 480.

[0344] For some applications, each tissue anchor 420 includes a protrusion 241 (described above with reference to Figure 1A -B and 2A-B), the protrusion 241 is coupled to the eyelet 440 (e.g., a structural element of the eyelet 440), or is formed and extends from the eyelet 440 (e.g., from a structural element of the eyelet 440).

[0345] Distributor 460 includes a structural element including a proximal pawl 462 and a distal pawl 464. Pawls 462 and 464 can be transformed between a state in which they protrude into the lumen of channel 454 toward the catheter axis 416 and a state in which they collapse away from the catheter axis 426 to disengage the lumen of channel 456 from its obstruction. For some applications, a tubular structure 495 surrounds at least a portion of channel 454 and can slide relative to channel 454. Tubular structure 495 is coupled to distributor 460 in such a manner that the movement of tubular structure 495 longitudinally distally and proximally along channel 454 facilitates the collapse of proximal pawls 462 and distal pawls 464 and the extension of proximal pawls 462 and distal pawls 464 into the lumen. The tubular wall of channel 454 is shaped so as to define a transverse window 490 of the lumen. Transverse window 490 has a proximal edge 491 and a distal edge 493. Tubular structure 495 surrounds at least a portion of passage 454 at transverse window 490. For some applications, catheter 402 includes an outer tube disposed around tubular structure 495, wherein tubular structure 495 is disposed between the outer tube and passage 454.

[0346] The dispenser 460 is operably connected to the extracorporeal unit so that it can be switched between (1) a receiving state, (2) a closed state ( Figure 5B ) and the allocation status ( Figure 5C), in a receiving state, (i) the proximal pawl 462 collapses away from the catheter axis 416, allowing the anchor 420a to move distally past the proximal pawl 462 and into the dispenser 460, and (ii) the distal pawl 464 extends into the lumen, preventing the anchor 420a from moving distally past the distal pawl 464 and leaving the dispenser 460, and in a closed state, (i) the proximal pawl 462 extends into the lumen, thereby preventing the anchor 420a from returning proximally past the proximal pawl 462 and leaving the dispenser The dispenser 460, and (ii) the distal pawl 464 extends into the lumen, thereby hindering the anchor 420a from moving distally past the distal pawl 464 and leaving the dispenser 460. In the dispensing state, (i) the proximal pawl 462 extends into the lumen, hindering the anchor 420a from returning proximally past the proximal pawl 462 and leaving the dispenser 460, and the distal pawl 464 collapses away from the catheter axis 416, allowing the anchor 420a to move distally past the distal pawl 464 and leave the dispenser 460.

[0347] exist Figure 5A 4, the anchor 420a has not yet moved into the dispenser 460. The anchor 420a is coupled to the anchor driver 260, and the anchor 420a can be moved by the driver 260 due to the sliding movement of the driver 260 within the lumen of the passage 454. For some applications, when the driver 260 is coupled to the anchor 420, the anchor 420a can be moved within the dispenser 460 by the driver 260 moving distally. The distal movement of the anchor 420a past the proximal detent 462 causes the detent 462 to collapse. Once the anchor 420a has moved past the detent 464, the detent 464 returns to an extended state within the lumen of the passage 454, thereby inhibiting the anchor 420a from retracting proximally. For some applications, tubular structure 495 is moved proximally relative to transverse window 490 of passage 454 to facilitate collapse of proximal detent 462 against proximal edge 491 of window 490, such that proximal detent 462 moves away from catheter axis 416 and retracts or collapses relative to axis 416, such that detent 462 does not obstruct the lumen of passage 454, and anchor 420a is properly positioned within dispenser 460 and aligned with window 490 in a received state. Once anchor 420a is positioned within dispenser 460, tubular structure 495 is moved distally such that proximal detent 462 does not collapse against proximal edge 491 of window 490, and detent 462 protrudes and extends within the lumen of passage 454, as shown. Figure 5B shown.

[0348] The distal detent 464 is no longer collapsed and retracted by the distal edge 493 of the window 490, and also protrudes and extends within the lumen of the channel 454, so that the dispenser 460 is in a closed state, hindering the anchor 420a from moving distally past the distal detent 464 and proximally past the proximal detent 462. In this way, the operating physician can evaluate the proper coupling between the driver 260 and the anchor 420 in response to pulling or pushing the driver 260 without movement of the anchor 420a in the closed state of the dispenser 460. In addition, when the detents 462 and 464 protrude from their collapsed state, they make a "click" sound, and the operating physician receives tactile feedback that the detents 462 and 464 are snapped into place.

[0349] As the tubular structure 495 moves proximally and distally, the proximal handle of the anchor driver 260 moves accordingly, and the physician is able to see the movement of the driver 260 .

[0350] exist Figure 5C 4, the tubular structure 495 moves distally relative to the transverse window 490, facilitating the collapse of the distal pawl 464 against the distal edge 493 of the window 490, causing the dispenser 460 to assume a dispensed state in which the distal pawl 464 moves away from the catheter axis 416 and the proximal pawl 462 extends into the lumen of the passage 454, thereby hindering the anchor 420a from returning proximally past the proximal pawl 462. The driver 260 moves distally in conjunction with the distal movement of the tubular structure 495 to advance the anchor 420a distally out of the dispenser 460 and the anchor storage area 422.

[0351] Once the anchor 420a is distally moved out of the dispenser 460, the tubular structure 495 is proximally retracted to position the next anchor 420b in sequence within the dispenser 460. The dispenser 460 returns to a receiving state in which the dispenser 460 allows one additional anchor 420b to move distally past the proximal detent 462 (as the detent 462 is retracted past the proximal edge 491). The dispenser 460 then transitions to a closed state in which the dispenser 460 blocks at least one additional anchor 420b from moving distally past the distal detent 464 and out of the dispenser 460. Subsequently, the dispenser 460 transitions to a dispensing state in which the dispenser 460 allows at least one additional tissue anchor 420b to move distally past the distal detent 464 and out of the dispenser 460.

[0352] For some applications, the catheter 402 includes a spring (not shown) disposed within the lumen of the catheter 402 proximal to the second tissue anchor 420b (e.g., proximal to the plurality of anchors 420), near at least 1. For some applications, the spring is disposed proximal to the anchor storage area 422. The spring is configured to facilitate distal movement of the tissue anchors 420 and is arranged to apply a distally directed force to the proximal anchor 420 within the anchor storage area 422, thereby retaining the anchor 420 within the storage area 422 and helping to facilitate distal advancement of the remaining anchors 420 as each anchor 420 is individually deployed.

[0353] As each anchor 420 moves distally, the eyelet 440 is linearly advanced distally along the slit of the channel 454. Each anchor 420 in the anchor storage area 422 is disposed in a manner such that the eyelet 440 is disposed within the slit and the tissue engaging element 430 and the anchor head 480 are disposed within the lumen of the channel 454. For some applications, the slit does not extend within the anchor storage area 422, and the entire anchor 420 is disposed within the lumen of the channel 454 while being disposed within the anchor storage area 422.

[0354] Figure 5A -C shows a system 400, which includes an implant 410 and a delivery tool 450 for percutaneous (e.g., transluminal, such as transfemoral) implantation of the implant. The tool 450 includes a flexible anchor driver 260, which is configured to reversibly engage a driver interface 482 of an anchor 420. Via this engagement, the driver 260 is configured to drive the tissue engagement element 430 into the tissue, for example by rotating (and pushing distally) the anchor 420. In some applications, the tool 450 also includes a flexible tube (e.g., a transluminal catheter), and each anchor 420 engaged with the driver 260 can be advanced to the tissue to which the anchor is to be anchored via the flexible tube.

[0355] Each anchor 420 is delivered to tissue in a delivery state in which the wire 412 extends through and is slidable relative to the hole of the eyelet 440 while being generally parallel to the axis ax2.

[0356] When a subsequent anchor 420 is anchored to the same tissue, the wire 412 becomes oriented transversely relative to the anchor. Due to the configuration of the eyelet 440, the wire 412 can still take a purely linear path through the hole 246 of the eyelet 440 despite the reorientation of the wire.

[0357] After the desired number of anchors 420 have been anchored, an adjustment tool is actuated (e.g., on and along the proximal portion of the wire 412) and used to facilitate tensioning of the wire. Thus, tensioning of the wire 412 pulls the anchors 420 closer together, thereby contracting the tissue to which the anchors are anchored. This is facilitated by the eyelet 440, which provides for smooth sliding of the wire 412 through the hole of the eyelet 440 when the wire is orthogonal to the anchor, as described above. A corresponding stopper 214 is coupled to the wire 412 to prevent the wire 412 from sliding out of the anchor 420. Excess wire 412 can then be cut and removed from the patient.

[0358] As described above, for some applications, the eyelet 440 is mounted to be rotatable about the axis ax2. Thus, this provides independence between the rotational position of the eyelet and the rotational position of the tissue engaging element 430. Assuming that for applications in which the tissue engaging element 430 is spiral, this independence advantageously allows the tissue engaging element to be screwed into the tissue to the extent required for optimal anchoring without requiring the anchor to be completed in a specific rotational orientation. It is further assumed that, regardless of the type of tissue engaging element 430 used, for a given application, this independence allows the eyelet 440 (and the wire 412) to be in an optimal position relative to the axis ax2 of each anchor 420. For example, for applications in which the implant 410 is used for annuloplasty, the anchor 420 is typically anchored in a curve around the valve ring, and the eyelet 440 and the wire 412 can be set on the inside of the curve relative to the axis ax2.

[0359] To anchor the anchor 420, the anchor is advanced out of the distal end of the channel 454 when the driver 260 rotates the driver interface 482 (and thus the tissue engaging element 430) relative to the tube, and when the slit of the channel 454 can prevent the ring 484 from rotating relative to the tube. For some applications, it is advantageous to place (or even press against) the distal end of the catheter 402 against the tissue 10 during anchoring of the anchor. The transverse slit extending proximally from the distal end of the catheter 402 allows the wire 412, rather than the anchor 420, to exit the channel 454 laterally proximally from the distal opening of the catheter 402. It is believed that this facilitates the implantation of an implant (such as the implant 410) that includes multiple anchors coupled to a wire (e.g., threaded on a wire).

[0360] Each anchor 420 is shaped so as to define a corresponding tissue anchor lumen extending through the 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., particularly the driver head 264) is dimensioned to slide axially within the lumen of the channel 454 and is actuatable to reversibly engage the driver interface 482 of each tissue anchor within the anchor storage area 422. The anchor driver 260 is configured to advance the anchor 420 distally away from the anchor storage area 422 toward the distal opening of the catheter 402 and drive the tissue engaging element 430 into the tissue 10 along the tissue anchor axis ax2 when the driver head 264 engages with the driver interface 482. The driver 260 advances the tissue anchor 420 distally as the thread 20 rotates. In the absence of Figure 5B In the closed condition of the dispenser 460 shown, the anchor driver 260 is prevented from advancing the anchor 420 distally.

[0361] Each anchor 420 defines a corresponding tissue-anchor-lumen, and the anchor driver 260 (e.g., particularly the driver head 264) 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 implants the distal-most anchor 420, it is disengaged from the anchor 420 and sequentially retracted through the lumen of the passage 454 and 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 sequentially retracts through the tissue anchor lumen of the next anchor 420 until it is aligned with the anchor head 480 to engage the head 480, and thereby sequentially engages the next anchor 420.

[0362] As each anchor 420 moves distally, the eyelet 440 is linearly advanced distally along the slit of the channel 454. Each anchor 420 in the anchor storage area 422 is arranged in a manner that the eyelet 440 is arranged relative to the dispenser 460. The pawls 462 and 464 maintain each anchor 420 fixed in a manner that the eyelet 440 is arranged relative to the dispenser 460 so as to prevent rotation of the anchor 420 and twisting of the wire 312. Therefore, for some applications, the ring 484 is fixed relative to the anchor head 480 and does not rotate about the axis ax2. For some applications, the slit of the channel 454 extends proximally into the anchor storage area 422 so as to keep the eyelet 440 in the slit and thereby prevent rotation of the anchor 420 and entanglement of the wire 412.

[0363] refer to Fig. 6A -E, Fig. 6A -E is a schematic illustration of an example of a catheter system 500 and technology for use therewith, according to some applications, the catheter system 500 including a transluminally advanceable catheter 502, at least one tissue anchor 520, and an implant 510 including the tissue anchor. The system 500 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, the system 500 can be an annuloplasty system and the implant 510 can be an annuloplasty structure.

[0364] The system 500 includes an extracorporeal unit 518 (e.g., a controller and / or handle) at a proximal portion of the system 500. The transluminally propellable catheter 502 is coupled to the extracorporeal unit 518 at a proximal end of the catheter 502 and extends distally therefrom along a longitudinal catheter axis 516 of the catheter 502, extending from the unit 518 to a distal opening of the catheter 502. The transluminally propellable catheter 502 includes a channel 554, such as 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 so as to define a transverse slit extending along at least a portion of the channel 554 at a distal portion thereof. 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 defining the slit, the lumen of the channel 554 at the slit is not closed due to the slit.

[0365] The in vitro unit 518 and the channel 554 are shaped so as to define a corresponding lumen, which accommodates the implant 510 during delivery of the implant 510 to the patient's tissue 10. For applications where the tissue 10 represents the tissue of the annulus of a natural heart valve (such as a mitral valve), the implant 510 is an annuloplasty structure comprising a wire 512 and a plurality of anchors 520. Each anchor 520 is shaped so as 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, a distal end 534, and defines a central longitudinal axis ax2 of the anchor 520. At the distal end 534, the tissue engaging element 530 has a sharp distal tip 538, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 530 is spiral and defines a central lumen 536 along the axis ax2. Alternatively, the tissue engaging element 530 can be another type of tissue engaging element, such as a thorn or a nail. The head 580 is coupled to the proximal end 532 of the tissue engaging element 530 and includes a driver interface 582 and an eyelet 540, which defines a hole 546 therethrough. The driver interface 582 is configured to be reversibly engaged by the flexible anchor driver 260. In 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 and 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.

[0366] For some applications, the driver interface 582 includes a wall shaped so as to define a recessed portion surrounded by the wall. For some applications, the wall surrounding the recessed portion is shaped as a circular wall, as shown. For some applications, the wall surrounding the recessed portion is square.

[0367] In some applications, and as shown, the driver interface 582 is disposed on a central longitudinal axis ax2, and the eyelet 540 is disposed transversely from the axis ax2.

[0368] As described in more detail below, the anchor 520 (e.g., its eyelet 540) is configured to facilitate the sliding of the anchor along the wire 512 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 520 along the wire. As also described in more detail below, the anchor 520 (e.g., its eyelet 540) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 540. This is assumed to be particularly useful for applications (such as annuloplasty) in which the wire is tensioned after implantation to adjust the anatomical size.

[0369] For some applications, and as shown, the eyelet 540 is mounted to rotate about the axis ax2. For example, the head 580 may include a ring 584 on which the eyelet 540 is mounted. The ring 584 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 530, such as by being rotatably coupled to another component of the head 580 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 582).

[0370] For some applications, and as shown, the eyelet 540 is mounted stationary relative to the axis ax2. For such applications, the head 580 does not include the ring 584, but the eyelet 540 is mounted directly on the head 580.

[0371] The handle of the extracorporeal unit 518 is shaped so as to define two sublumens: (1) an anchor driver sublumen 506 and (2) an anchor storage sublumen 504, the anchor driver sublumen 506 having an anchor driver sublumen axis 507 aligned with the lumen of the channel 554 of the transluminally advanceable catheter 502 and along the catheter axis 516, the anchor storage sublumen 504 being 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 fluidly connected and parallel relative to each other. The anchor storage sublumen 504 defines an anchor storage area 522 that accommodates a plurality of tissue anchors 520. The plurality of anchors 520 are sequentially arranged within the area 522. The wire 512 of the anchor 520 and each eyelet 540 are positioned in the space between the anchor storage sublumen 504 and the anchor driver sublumen 506. That is, when the tissue anchor 520 is disposed within the anchor storage area 522 and within the anchor storage sub-lumen 504, the tissue engaging element 530 and the anchor head 580 are disposed within the anchor storage sub-lumen 504, and the eyelet 540 and the wire 512 are disposed in the space between the sub-lumens 504 and 506. The wire 512 extends distally through the lumen of the passage 554 from the anchor driver sub-lumen toward the distal opening of the catheter 502.

[0372] Prior to engaging any anchors 520, the anchor driver 260 is disposed within the anchor driver sublumen 506 and is slidable therein, such as Fig. 6A shown.

[0373] The handle of the extracorporeal unit 518 includes a rotation stop 560 at the distal end of the handle. The rotation stop 560 is shaped so as to define a receiving lumen 562 to receive one tissue anchor 520 at a time. The rotation stop can be rotated about the catheter axis 516 in the following manner: during a first stop state, as shown in FIG. Fig. 6A As shown, the stopper is in a position where the receiving lumen 562 is not aligned with the anchor storage sub-lumen 504, but rather the wall of the stopper 560 blocks the distal end of the sub-lumen 504, thereby preventing any anchor 520 from moving distally.

[0374] like Figure 6BAs shown, the rotation stopper 560 is rotated 180 degrees around the central axis 516 of the catheter 502 and around the wire 512 so as to align the receiving lumen 562 of the rotation stopper 560 with the anchor storage sub-lumen 504 so as to receive the anchor storage area 522 of the first tissue anchor 520a, thereby defining a receiving state of the rotation stopper 560. During the rotation of the stopper 560, the wire 512 remains stationary. The rotation of the stopper 560 around the wire 512 prevents entanglement of the wire 512. The stopper 560 includes a spring 564 disposed within the receiving lumen 562 so as to secure the anchor 520a in place during the rotation of the rotation stopper 560.

[0375] exist Figure 6C 502 so as to bring rotation stop 560 into a loaded state in which receiving lumen 562 of rotation stop 560 is aligned with anchor driver sub-lumen 506 so that tissue anchor 520a can pass through the lumen of passage 554 of transluminally advanceable catheter 502. For some applications, rotation stop 560 is rotated again about central axis 516 of catheter 502 to bring rotation stop 560 into a loaded state in which receiving lumen 562 of rotation stop 560 is aligned with anchor driver sub-lumen 506 to allow tissue anchor 520a to pass through the lumen of passage 554 of transluminally advanceable catheter 502. Figure 6B An additional 180 degrees rotation in the same direction as described, i.e., so that the rotation stop is rotated about the axis 516 from Fig. 6A The stop state shown is Figure 6C The loaded state shown completes a full 360 degree rotation. For some applications, the rotation stop 560 is in the same manner as described above. Figure 6B Rotate 180 degrees in the opposite direction of the description, that is, make the rotation stop at Fig. 6A The stop state shown is the same as Figure 6C The loading states shown switch back and forth 180 degrees.

[0376] Since each anchor 520 is slidably coupled to the wire 512 through the eyelet 540, when the rotation stop is rotated about the axis 516, the tissue anchor 520a disposed within the receiving lumen 562 rotates about the wire 512. Figure 6C As shown, the tissue engaging element 530 and the anchor head 580 are arranged to align with the lumen of the anchor driver sublumen 506 and the channel 554. That is, the central lumen 536 of the tissue engaging element 530 is arranged to align with the lumen of the channel 554 of the transluminally advanceable catheter 502 (a) along the axis ax2 of the anchor 520, (b) along the axis 516 of the catheter 502, and (c) along the anchor driver sublumen axis 507.

[0377] In the loaded state, the wall of the stopper 560 blocks the distal end of the anchor storage sub-lumen 504, thereby preventing any additional anchors 520 from moving distally and providing a safety mechanism for accidental release of the additional anchors. For some applications, the handle of the unit 518 includes a spring (not shown) disposed within the anchor storage sub-lumen 504 proximal to the plurality of tissue anchors 520. For some applications, the spring is disposed proximal to the anchor storage area 522.

[0378] Fig.6D A system 500 is shown, which includes an implant 510 and a delivery tool 550 for percutaneous (e.g., transluminal, such as transfemoral) implantation of the implant. The tool 550 includes a flexible anchor driver 260, which is configured to reversibly engage a driver interface 582 of an anchor 520. Via this engagement, the driver 260 is configured to drive the tissue engagement element 530 into the tissue, for example, by rotating (and pushing distally) the anchor 520. When the anchor 520a is disposed in the receiving lumen 562 and is generally held in place by the force of the spring 564, the anchor driver 260 slides distally in the anchor driver sublumen 506 so that the driver head 264 approaches and engages the interface 582 of the anchor head 580 of the tissue anchor 520a.

[0379] The passage 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 anchoring. For some such applications, the passage 554 defines a main passage area 556a and a secondary passage area 556b. The main passage area 556a has a larger cross-sectional area than the secondary passage area 556b. The anchor 520 can slide through the passage 554, wherein the tissue engaging element 530 slides (usually tightly) through the main passage area 556a, and the eyelet 540 slides (usually tightly) through the secondary passage area 556b and along the line 512. Therefore, the rotation control of the passage 552 controls the position of the eyelet 540, and thus controls the position of the axis ax2 of each anchor. Although the driver interface 582 and the tissue engaging element 530 can rotate in the passage 554, the ring 584 and the eyelet 540 cannot rotate in the passage 554. For some applications, and as shown in the figure, the passage 554 has a keyhole-shaped orthogonal cross section.

[0380] like Fig.6D As shown, an indicator 570 is coupled to each anchor 520. When the anchor 520a is disposed within the receiving lumen 562, the indicator 570 is disposed between the anchor 520 and the spring 564 to help stabilize the anchor 520a. Fig. 6E554 of the catheter 502. In the embodiment of the present invention, the anchor driver 260 is pushed distally to advance the anchor 520a distally beyond the receiving lumen 562 and into the lumen of the passage 554. Due to the curvature of the spring 564, in the absence of the anchor 520a, the spring 564 returns to its resting state, i.e., wherein the spring 564 assumes a bent state. When the anchor 520a is advanced distally and the spring 564 assumes its bent state, the indicator 570 is discharged from the receiving lumen 562, thereby providing an indication that the anchor driver 260 has been successfully coupled to the anchor 520a and has advanced the anchor 520a distally into the lumen of the passage 554 of the catheter 502.

[0381] Once the driver 260 is implanted in the tissue anchor 520a, it is disengaged from the anchor 520a and retracted through the lumen of the passage 554 and through the anchor driver sub-lumen 506. The driver head 264 is disposed within the sub-lumen 506 proximal to the rotation stop 560 until the rotation stop 560 is rotated so that it appears as shown. Figure 6B The receiving state shown in FIG. 5 is to sequentially receive the next anchor 520b disposed adjacent to the most distal anchor 520a. The rotation stopper 560 is then rotated to present a Figure 6C The loaded state shown causes the anchor 550b to align with the anchor driver sub-lumen 506 and the lumen of the channel 554 of the catheter 502. In the loaded state, the anchor driver 260 engages the tissue anchor 520b, as described above with reference to Fig.6D As described above, the anchor driver 260 pushes the anchor 520b distally through the lumen of the channel 554, as shown in FIG. Fig. 6E described.

[0382] After the desired number of anchors 520 have been anchored, an adjustment tool is actuated (e.g., on and along the proximal portion of the wire 512) and used to facilitate tensioning of the wire. Thus, tensioning of the wire 512 pulls the anchors 520 closer together, thereby contracting the tissue to which the anchors are anchored. This is facilitated by the eyelet 240, which provides for smooth sliding of the wire 512 through the hole 546 when the wire is orthogonal to the anchor, as described above. A corresponding stopper is coupled to the wire 512 to prevent the wire 512 from sliding out of the anchor 520. Excess wire 512 can then be cut and removed from the patient.

[0383] As described above, for some applications, the eyelet 540 is mounted to be rotatable about the axis ax2. Therefore, this provides independence between the rotational position of the eyelet and the rotational position of the tissue engaging element 530. Assuming that for applications in which the tissue engaging element 530 is spiral, this independence advantageously allows the tissue engaging element to be screwed into the tissue to the extent required for optimal anchoring without requiring the anchor to be completed in a specific rotational orientation. It is further assumed that, regardless of the type of tissue engaging element 530 used, for a given application, this independence allows the eyelet 540 (and the wire 512) to be in an optimal position relative to the axis ax2 of each anchor 520. For example, for applications in which the implant 510 is used for annuloplasty, the anchor 520 is typically anchored in a curve around the valve ring, and the eyelet 540 and the wire 512 can be set on the inside of the curve relative to the axis ax2.

[0384] To anchor the anchors 520 , each anchor is advanced out of the distal end of the channel 554 while the driver 260 simultaneously rotates the driver interface 582 (and thus the tissue engaging element 530 ) relative to the channel 554 .

[0385] Each anchor 520 defines a corresponding tissue-anchor-cavity extending through the 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., particularly the driver head 264) is dimensioned to slide axially within all of the tissue-anchor-cavities of the anchor 520.

[0386] For some applications, eyelet 540 includes or is shaped so as to define the Figure 1A -B and the protrusion 241 described in 2A-B.

[0387] Reference now Fig. 7A -F, Fig. 7A -F is a schematic illustration of an example of a catheter system 600 and technology for use therewith, the catheter system 600 including a transluminally advanceable catheter 622, at least one tissue anchor 620, and an implant 603 including the tissue anchor, according to some applications. System 600 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, system 600 can be an annuloplasty system and implant 603 can be an annuloplasty structure.

[0388] The catheter 622 comprises a flexible tube (e.g., a polymer tube) and is coupled at the proximal end of the catheter 622 to an extracorporeal unit (e.g., unit 18, e.g., in Figure 1A624 ), and extending distally therefrom along a longitudinal catheter axis 626 of the catheter 622, from the unit to a distal opening of the catheter 622 at a distal end 624 of the catheter 622. The transluminally advanceable catheter 622 includes a channel shaped so as to define a lumen for accommodating the implant 603 during delivery of the implant 603 to the patient's tissue 10. For applications in which the tissue 10 represents tissue of the annulus of a native heart valve (e.g., a mitral valve), the implant 603 is an annuloplasty structure including a wire 601 and a plurality of anchors 620. Each anchor 620 is shaped so as to define a central longitudinal anchor axis ax2. Each anchor 620 includes a tissue engaging element 630 and an anchor head 680. The tissue engaging element 630 has a proximal end 632, 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 has a sharp distal tip, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown in the figure, the tissue engaging element 630 is spiral and defines a central lumen 636 along the axis ax2, which is a part of the distal end 634 of the central lumen of the tissue anchor 620 from the opening at the proximal end of the anchor head 680 to the tissue engaging element 630. Optionally, the tissue engaging element 630 can be another type of tissue engaging element, such as thorns or nails. The head 680 is coupled to the proximal end 632 of the tissue engaging element 630, and includes a driver interface 682 and an eyelet 640, and the eyelet 640 defines a hole 646 therein. The driver interface 682 is configured to be reversibly engaged by the flexible anchor driver 604. In some applications, the eyelet 640 includes a structural element that protrudes laterally relative to the tissue engaging element 630.

[0389] System 600 includes an anchor driver 604, which may include an elongated and flexible shaft 606, and a driver head 610 connected to the distal end of the shaft. The driver head 610 is a component of the driver interface 682 of the anchor driver 604 that reversibly engages the anchor 620. The driver interface 682 can be rigidly coupled to the tissue engagement element 630. For some applications, the anchor head 680 (e.g., the driver interface 682) includes a proximal edge 686 and a wall extending distally therefrom, which is shaped to define and surround a recessed portion 683 extending distally from the edge 686. For some applications, the wall around the recessed portion 683 is square, as shown. For some applications, the wall around the recessed portion 683 is shaped as a circular wall.

[0390] In some applications, and as shown, the driver interface 682 is disposed on a central longitudinal axis ax2, and the aperture 640 is disposed transversely from the axis ax2.

[0391] The anchor 620 (e.g., its eyelet 640) is configured to facilitate the sliding of the anchor along the wire 601 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 620 along the wire. The anchor 620 (e.g., its eyelet 640) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 640. This is assumed to be particularly useful for applications in which the wire is tensioned after implantation to adjust the anatomical size, such as annuloplasty.

[0392] For some applications, and as shown, the eyelet 640 is mounted to rotate about the axis ax2. For example, the head 680 may include a ring 684 on which the eyelet 640 is mounted. The ring 684 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 630, such as by being rotatably coupled to another component of the head 680 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 682).

[0393] Each anchor 620 is shaped so as to define a central lumen extending from the proximal edge 686 of the tissue engaging element 630 to the distal end 634. The flexible shaft 606 and the driver head 610 of the driver 604 are sized to slide within the corresponding central lumens of the anchor 620. The anchor driver 604 (e.g., in particular the driver head 610) is sized to slide axially within the lumen of the catheter 622 and can be actuated to reversibly engage the driver interface 682 of each tissue anchor. The anchor driver 604 is configured to advance the anchor 620 distally toward the distal opening at the end 624 of the catheter 622 when the driver head 610 engages with the driver interface 682, and drives the tissue engaging element 630 into the tissue 10 along the tissue anchor axis ax2.

[0394] like Fig. 7A -B, by way of illustration and not limitation, the driver head 610 is disposed distally of the distal-most anchor 620, and the shaft 606 is disposed within the central lumen of the anchor 620, and Figure 7C -F, after the driver head 610 has been slid proximally through the central lumen of the anchor 620 by pulling the shaft 606, the distal portion of the driver head 610 is positioned within the anchor head 680.

[0395] Reference now Fig. 7A -B. It should be noted that Figure 7B602. The driver head 610 is shaped so as to define a first leg 612a and a second leg 612b having a static state (eg, FIG. 7A to FIG. 7D ), in a static state, the first leg 612a and the second leg 612b define a first space S1 having a first distance therebetween, and in a static state, the first leg 612a and the second leg 612b do not contact and / or firmly engage with a wall surrounding the recessed portion 683 of the tissue anchor 620. The anchor driver 604 includes a connecting rod 614 at least partially disposed between the first leg 612a and the second leg 612b. The legs 612a and 612b are each shaped so as to define a respective window for coupling each leg 612a and 612b to a respective end of the rod 614. The windows of the legs 612a and 612b are configured to enable the legs 612a and 612b to slide along the rod 614 in an expanded state and facilitate the expansion of the legs 612a and 612b away from the central axis 626. The distal portion of each leg 612a and 612b is shaped so as to define a respective engagement ball 616a and 616b that is configured to engage a wall of the recessed portion 683, as described below.

[0396] The anchor driver 604 also includes first and second expander elements 618a and 618b ( Figure 7B 612a and 612b, respectively. The first and second expander elements 618a and 618b are disposed at or coupled to the distal end of the propulsion element 621. For some applications, the first expander element 618a and the second expander element 618b are formed by the propulsion element 621. For some applications, the first expander element 618a and the second expander element 618b include respective arms or wires. The first expander element 618a and the second expander element 618b and the propulsion element 621 can slide relative to the flexible shaft 606 and relative to the first leg 612a and the second leg 612b. The first expander element 618a and the second expander element 618b are advanced distally in response to a push on the propulsion element 621, and can be advanced proximally in response to a pull on the propulsion element 621. The first expander element and the second expander element can be configured in various ways, for example, including one or more of a wire, an arm, a rod, a latch, a lever, an extension, an expandable ring, an expandable spiral, and the like. The propulsion element may also be configured in various ways, such as including one or more of a wire, a rod, a shaft, a hypotube, an extension, and the like.

[0397] like Fig. 7A-D, in the static state of the first and second legs 612a and 612b of the anchor driver 604, the first and second expander elements 618a and 618b are disposed upstream of the connecting rod 614 in a collapsed state. Thus, the driver head 610 remains in a position where it does not fixedly engage any portion of the anchor 620, and the driver head 610 can slide axially relative to the anchor 620 within its central lumen. Fig. 7A -B, the driver head 610 is positioned distal to the distal-most tissue anchor 620. Since the legs 612a and 612b are in a stationary state, the anchor driver 604 can be slid proximally, for example by pulling the shaft 606, to properly position the driver head 610 relative to the anchor 620, such as Figure 7C -D, so that the driver head 610 can engage the anchor head 680 and maintain coupling with the anchor head 680. As shown in the figure, before engaging the anchor head 680, the distal portions of the legs 612a and 612b are disposed in the recessed portion 683 in the following manner: the engagement balls 616a and 616b of the legs 612a and 612b are positioned in the recessed portion 683 and aligned with the wall of the recessed portion 683 surrounding the drive interface 682.

[0398] Fig. 7E -F shows the first leg 612a and the second leg 612b of the driver head 610 in an engaged state, in which the engagement balls 616a and 616b of the legs 612a and 612b are securely engaged with the wall of the recessed portion 683 surrounding the drive interface 682. To transition the legs 612a and 612b to the engaged state, the advancement element 621 is pushed distally to advance the first and second expander elements 618a and 618b expanded around the connecting rod 614 away from the central axis 626 and into the space between the first and second legs 612a and 612b. When the first expander element 618a and the second expander element 618b expand in the space between the legs 612a and 612b, the first expander element 618a and the second expander element 618b expand the first leg 612a and the second leg 612b away from the central axis 626, so that the first leg 612a and the second leg 612b present an engaged state in which the first leg and the second leg define a second space S2 between each other, and the second space S2 has a second distance ( S1 ) greater than the first distance of the first space S1. Fig. 7A and 7C As the legs 612a and 612b expand outward, the engagement balls 616a and 616b of the first leg 612a and the second leg 612b contact and engage the wall of the tissue anchor 620 surrounding the recessed portion 683.

[0399] As shown, by way of illustration and not limitation, when the first and second expander elements 618a and 618b expand around the connecting rod 614, the expander elements 618a and 618b expand along a first plane shown in section AA, which is at a non-zero angle (e.g., perpendicular) relative to a second plane shown in section BB, and the first and second legs 612a and 612b expand along the second plane.

[0400] The first and second expander elements 618a and 618b have respective distal surfaces 619a and 619b at respective ends of each element 618a and 618b. Fig. 7E In the engaged state of the first and second legs 612a and 612b shown in Figure 1-F, the surfaces 619a and 619b engage and push the proximal edge 686 of the tissue anchor 620 to facilitate distally pushing the tissue anchor 620 in the engaged state of the first and second legs. Therefore, the system 600 is particularly advantageous because the expander elements 618a and 618b facilitate the secure and reversible coupling between the legs 612a and 612b and the tissue anchor 620, and the pushing of the tissue anchor 620 by the expander elements 618a and 618b. In particular, the expansion and collapse of the expander elements 618a and 618b are controlled by the pusher element 621. In this way, the anchor driver 604 is able to (1) slide proximally and distally through a series of anchors without securely engaging any of them during sliding, (2) engage any of the anchors in a controlled manner by controlling the expansion and collapse of the expander elements 618a and 618b, and (3) enter any anchor in a series of anchors, regardless of whether the anchor is disposed proximally or distally of the driver head 610.

[0401] Driver 604 is used to implant tissue anchor 620 by rotating tissue anchor 620 along axis ax2. Expander elements 618a and 618b prevent collapse of legs 612a and 612b during driving of anchor 620 into tissue because torque is applied to anchor 620 by driver 604. In addition, expander elements 618a and 618b enable legs 612a and 612b to pull anchor 620 proximally, if desired.

[0402] It should be noted that the system 600 provides for reversible engagement between the anchor driver 604 and the anchor 620. For example, once the anchor 620 is implanted in the tissue, the driver 604 is disconnected from the tissue anchor 620 by pulling the advancement element 621 proximally, causing the expander elements 618a and 618b to retract proximally from the rod 614 and collapse together to the Fig. 7A-D, which allows the first and second legs 612a and 612b to assume their resting state in which the first space S1 is defined between the legs 612a and 612b. If the operating physician mistakenly engages an incorrect anchor in the series of anchors 620, it is particularly useful to reversibly engage the driver 604 with any tissue anchor 620 by expanding and collapsing the legs 612a and 612b with the expander elements 618a and 618b. In this case, by retracting the advancement element 621 to retract the expander elements 618a and 618b, the engagement of the incorrect anchor can be reversed, and the anchor driver 604 can be retracted. The anchor driver 604 can then be repositioned to engage the correct anchor in the manner described above.

[0403] Reference now Fig. 8A -C, Fig. 8A -C is a schematic illustration of an example of a catheter system 800 and technology for use therewith, according to some applications, the catheter system 800 including a transluminally advanceable catheter 722, at least one tissue anchor 720, and an implant 703 including the tissue anchor. The system 700 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, the system 700 can be an annuloplasty system and the implant 703 can be an annuloplasty structure.

[0404] The catheter 722 comprises a flexible tube (e.g., a polymer tube) and is coupled at the proximal end of the catheter 722 to an extracorporeal unit (e.g., unit 18, e.g., in Figure 1A 701 and 702. The implant 703 is a valvular annulus structure including a wire 701 and a plurality of anchors 720. The implant 703 is a valvular annulus structure including a wire 701 and a plurality of anchors 720.

[0405] For some applications, each anchor 720 is shaped so as 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, a distal end 734, and defines a central longitudinal axis ax2 of the anchor 720. For some applications, at the distal end 734, the tissue engaging element 730 has a sharp distal tip, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 730 is spiral and defines a central lumen 736 along the axis ax2, which is a part of the central lumen of the tissue anchor 720 from the opening at the proximal end of the anchor head 780 to the distal end 734 of the tissue engaging element 730. Optionally, the tissue engaging element 730 can be another type of tissue engaging element, such as a thorn or a nail. Head 780 is coupled to proximal end 732 of tissue engaging element 730 and includes driver interface 782 and eyelet 740 defining aperture 746 therethrough. Driver interface 782 is configured to be reversibly engaged by flexible anchor driver 704. In some applications, eyelet 740 includes a structural element that protrudes laterally relative to tissue engaging element 730.

[0406] System 700 includes an anchor driver 704, which may include an elongated and flexible shaft 710 and a driver head 712 connected to the distal end of the shaft. The driver head 712 includes a deflectable protrusion and is a component of a driver interface 782 of the anchor driver 704 that reversibly engages the anchor 720. The driver interface 782 can be rigidly coupled to the tissue engagement element 730 and define its inner surface. In some applications, as shown in the figure, by way of illustration and not limitation, the driver interface 782 includes a portion of the anchor 720 at the junction between the head 780 and the tissue engagement element 730. It should be noted that the driver interface 782 may include any portion of the anchor 720. For some applications, the anchor head 780 includes a proximal edge 786 and a wall extending distally therefrom, which is shaped so as to define and surround a recessed portion 783 extending distally from the edge 786. For some applications, the wall around the recessed portion 783 is square, as shown. For some applications, the wall surrounding recessed portion 783 is shaped as a circular wall.

[0407] In some applications, and as shown, the driver interface 782 is disposed on a central longitudinal axis ax2, and the aperture 740 is disposed transversely from the axis ax2.

[0408] The anchor 720 (e.g., its eyelet 740) is configured to facilitate sliding of the anchor along the wire 701 (or sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate transcatheter advancement of the anchor 720 along the wire. The anchor 720 (e.g., its eyelet 740) is configured to facilitate sliding of the anchor along the wire (or sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 740. This is assumed to be particularly useful for applications in which the wire is tensioned after implantation to adjust for anatomical dimensions, such as annuloplasty.

[0409] For some applications, and as shown, the eyelet 740 is mounted to rotate about the axis ax2. For example, the head 780 may include a ring 784 on which the eyelet 740 is mounted. The ring 784 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 730, such as by being rotatably coupled to another component of the head 780 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 782).

[0410] Each anchor 720 is shaped so as to define a central lumen extending from the proximal edge 786 of the tissue engaging element 730 to the distal end 734. The flexible tube 706 and the driver head 712 of the driver 704 are sized to slide within the corresponding central lumens of the anchor 720. The anchor driver 704 (e.g., in particular the driver head 712) is sized to slide axially within the lumen of the catheter 722 and can be actuated to reversibly engage the driver interface 782 of each tissue anchor. The anchor driver 704 is configured to advance the anchor 720 distally toward the distal opening at the end 724 of the catheter 722 when the driver head 712 engages with the driver interface 782, and drives the tissue engaging element 730 into the tissue 10 along the tissue anchor axis ax2.

[0411] like Fig. 8A As shown, by way of illustration and not limitation, the driver head 712 is disposed distally of the driver interface 782 of the distal-most anchor 720, and the tube 706 is disposed within the central lumen of the anchor 720. Figure 8B 782. In the embodiment of the present invention, driver head 712 is positioned to be securely engaged within driver interface 782 after driver head 712 and shaft 710 have been slid proximally through the central lumen of anchor 720 by pulling shaft 710. For some applications, driver interface 782 defines a groove into which driver head 712 fits tightly to securely engage driver interface 782. For some applications, driver interface 782 defines a wall of anchor 720 surrounding recessed portion 783.

[0412] The anchor driver 704 includes a flexible tube 706 having a central axis defined along a central axis 726 of the catheter 722. The protrusion of the driver head 712 is deflectable from (1) a rest state, in which the protrusion of the head 712 assumes a collapsed state (8C) toward the central axis defined by the flexible tube 706 (i.e., toward the axis 726) and does not contact the tissue anchor (e.g., the wall surrounding the recessed portion 783 of the anchor 720), to (2) an engaged state in which the deflectable protrusion of the head 712 moves away from the central axis defined by the flexible tube 706 (i.e., toward the axis 726) and engages with the tissue anchor 720 at the driver interface 782 (e.g., toward the axis 726). Figure 8B ).

[0413] The anchor driver 704 includes a shaft 708 disposed within the lumen of the flexible tube 706 and slidable relative to the tube 706. The shaft 708 can engage the deflectable protrusion of the driver head 712, so that when the shaft 708 slides beside the deflectable protrusion of the head 712 and the distal end 709 is proximal to the driver head 712, the shaft 708 causes the deflectable protrusion to move from a collapsed state (e.g., Figure 8C 726) and enters an engaged state of the deflectable protrusion of the head 712 where the deflectable protrusion engages with the tissue anchor 720 at the interface 782 (as shown). Figure 8B ). The anchor driver 704 is dimensioned to slide axially through a lumen defined by the tissue anchor 720 and selectively and reversibly engage the tissue anchor 720 in response to movement of the shaft 708. The distal end 709 of the shaft 708 can be retracted away from the deflectable protrusion of the head 712 to facilitate the deflectable protrusion to move from the engaged state ( Figure 8B ) deflects toward the central axis 726 and enters a collapsed state ( Figure 8C ) to disengage the anchor driver 704 from the tissue anchor 720.

[0414] Reference now Fig. 8A -C. It should be noted that Fig. 8A - C is a vertical cross-section of the delivery tool 702.

[0415] The anchor driver 704 also includes first and second expander elements 718a and 718b, which are disposed at the distal end of the tube 706 or coupled to the distal end of the tube 706, for example, at the outer surface of the tube 706. For some applications, the first expander element 718a and the second expander element 718b are formed by the tube 706. For some applications, the first expander element 718a and the second expander element 718b are controlled by a separate mechanism. For some applications, the first expander element 718a and the second expander element 718b include corresponding wires. The first expander element 718a and the second expander element 718b and the tube 706 can slide relative to the flexible shaft 708 and relative to the shaft 710 and the driver head 712. The first expander element 718a and the second expander element 718b are advanced distally in response to a push on the tube 706, and can be advanced proximally in response to a pull on the tube 706.

[0416] like Fig. 8A As shown, the first and second expander elements 718a and 718b are collapsed within the lumen of the anchor 720. For some applications, the first expander element 718a and the second expander element 718b include a shape memory material that enables the first expander element 718a and the second expander element 718b to expand without the application of force, such as Figure 8B As shown, Figure 8B The first and second expander elements 718a, 718b are shown in their expanded states. For some applications, the first and second expander elements 718a, 718b do not include shape memory material, and expansion of the first and second expander elements 718a, 718b is controlled by the tube 706 or by some external mechanism.

[0417] In order to Fig. 8A Transform to Figure 8B ,exist Fig. 8A 720, the driver head 712 is in a position where it does not fixedly engage any portion of the anchor 720, and the shaft 708 is retracted proximally along the shaft 710 to collapse the deflectable protrusion of the driver head 712 toward the axis 726. The shaft 710 and the head 712 and the shaft 708 are retracted proximally to position the driver head 712 at the interface 782. In addition, the tube 706 is retracted proximally to expose the first dilator element 718a and the second dilator element 718b from within the lumen of the anchor 720. For some applications, the movement of the shaft 708 and the tube 706 are coupled so that the movement of the shaft 708 assists the movement of the tube 706. Figure 8B7, the driver head 712 is securely engaged with the driver interface 782 and remains coupled to the anchor 720. During secure coupling, the distal end 709 of the shaft 708 is positioned distal to the driver head 712 so that the distal portion of the shaft 708 applies a force to the driver head 712 outward from the axis 726 to maintain the driver head 712 in a position where it is deflected away from the axis 726, maintaining engagement with the interface 782.

[0418] like Figure 8B As shown, when the first and second expander elements 718a and 718b expand, their respective distal surfaces 719a and 719b engage and push against the proximal edge 786 of the tissue anchor 720 at the respective ends of each element 718a and 718b to facilitate distally pushing the tissue anchor 720 in the engaged state of the deflectable protrusion of the driver head 712. Therefore, the system 700 is particularly advantageous because the driver head 712 facilitates secure and reversible coupling to the tissue anchor 720, and the expander elements 718a and 718b facilitate pushing the tissue anchor 720. In particular, the collapse of the expander elements 718a and 718b is controlled by the tube 706.

[0419] Driver 704 is used to implant tissue anchor 720 by rotating tissue anchor 720 along axis ax2.

[0420] It should be noted that the system 700 provides for reversible engagement between the anchor driver 704 and the anchor 720. For example, once the anchor 720 is implanted in the tissue, the driver 704 is disconnected from the tissue anchor 720 by pulling the shaft 708 proximally, causing the deflectable protrusion of the head 712 to collapse toward the axis 726 ( Figure 8C ), and the tube 706 is pulled proximally so that the expander elements 718a and 718b retract the anchor 720 proximally and the surfaces 719a and 719b do not contact the edge 786. Then, when the driver 704 is retracted through the proximally disposed anchor in the series of anchors 720, the expander elements 718a and 718b can collapse together to a collapsed state. If the operating physician mistakenly engages an incorrect anchor in the series of anchors 720, it is particularly useful for the driver 704 to reversibly engage any tissue anchor 720 by expanding and collapsing the legs 712a and 712b through the expander elements 718a and 718b. In this case, by retracting the shaft 708 to retract the collapse head 712, the engagement of the incorrect anchor can be reversed, and the anchor driver 704 can be retracted. The anchor driver 704 can then be repositioned to engage the correct anchor in the manner described above.

[0421] It should be noted that Figure 8CBy way of illustration and not limitation, the driver 704 is shown detached from the anchor 720 while the anchor 720 is within the lumen of the catheter 722. Once the anchor 720 has been implanted in the tissue 10, the driver 704 can be detached from the anchor 720 in the same manner as described for detaching the driver 704 from the anchor 720 while the anchor 720 is within the lumen of the catheter 722.

[0422] Reference now Fig.9A -B, Fig.9A -B is a schematic illustration of an example of a catheter system 800 and technology for use therewith, according to some applications, the catheter system 800 including a transluminally advanceable catheter 822, at least one tissue anchor 820, and an implant 803 including the tissue anchor. The system 800 is a tissue adjustment system and can be used to adjust the size of a tissue structure. For example, the system 800 can be an annuloplasty system and the implant 803 can be an annuloplasty structure.

[0423] The catheter 822 comprises a flexible tube (e.g., a polymer tube) and is coupled at the proximal end of the catheter 822 to an extracorporeal unit (e.g., unit 18, e.g., in Figure 1A 822 and extends distally therefrom along a longitudinal catheter axis 826 of the catheter 822, extending from the unit to a distal opening of the catheter 822 at a distal end 824 of the catheter 822. The transluminally advanceable catheter 822 includes a channel shaped so as to define a lumen for accommodating the implant 803 during delivery of the implant 803 to the patient's tissue 10. For applications where the tissue 10 represents tissue of the annulus of a native heart valve (e.g., a mitral valve), the implant 803 is an annuloplasty structure including a wire 801 and a plurality of anchors 820.

[0424] For some applications, each anchor 820 is shaped so as 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. The tissue engaging element 830 has a proximal end 832, a distal end 834, and defines a central longitudinal axis ax2 of the anchor 820. For some applications, at the distal end 834, the tissue engaging element 830 has a sharp distal tip, and the tissue engaging element is configured to be driven (e.g., screwed) into the tissue of the object. For some applications, and as shown, the tissue engaging element 830 is spiral and defines a central lumen 836 along the axis ax2, which is a part of the central lumen of the tissue anchor 820 from the opening at the proximal end of the anchor head 880 to the distal end 834 of the tissue engaging element 830. Optionally, the tissue engaging element 830 can be another type of tissue engaging element, such as a thorn or a nail. The head 880 is coupled to the proximal end 832 of the tissue engaging element 830 and includes an actuator interface 882 and an eyelet 840 defining a hole 846 therethrough. The actuator interface 882 is configured to be reversibly engaged by the flexible anchor actuator 804. In some applications, the eyelet 840 includes a structural element that protrudes laterally relative to the tissue engaging element 830.

[0425] The system 800 includes an anchor driver 804, which can include an elongated and flexible propulsion element 806, and a driver head 810 connected to the distal end of the propulsion element 806. The driver head 810 is a component of the anchor driver 804 that reversibly engages a driver interface 882 of the anchor 820. The driver interface 882 can be rigidly coupled to the tissue engaging element 830. For some applications, the anchor head 880 (e.g., the driver interface 882) includes a proximal edge 886 and a wall extending distally therefrom, the wall being shaped so as to define and surround a recessed portion 883 extending distally from the edge 886. For some applications, the wall surrounding the recessed portion 883 is square. For some applications, the wall surrounding the recessed portion 883 is shaped as a circular wall.

[0426] In some applications, and as shown, the driver interface 882 is disposed on a central longitudinal axis ax2, and the eyelet 840 is disposed transversely from the axis ax2.

[0427] The anchor 820 (e.g., its eyelet 840) is configured to facilitate the sliding of the anchor along the wire 801 (or the sliding of the wire through the anchor) when the anchor is aligned with the wire (e.g., when the axis ax2 is parallel to the wire). This is assumed to facilitate the transcatheter advancement of the anchor 820 along the wire. The anchor 820 (e.g., its eyelet 840) is configured to facilitate the sliding of the anchor along the wire (or the sliding of the wire through the anchor) when the anchor is oriented orthogonal to the wire - that is, when the axis ax2 is orthogonal to the wire. This is achieved at least in part due to the shape and size of the eyelet 840. This is assumed to be particularly useful for applications in which the wire is tensioned after implantation to adjust the anatomical size (such as annuloplasty).

[0428] For some applications, and as shown, the eyelet 840 is mounted to rotate about the axis ax2. For example, the head 880 may include a ring 884 on which the eyelet 840 is mounted. The ring 884 surrounds the axis ax2 and can rotate about the axis ax2, for example, by being rotatably coupled to the tissue engaging element 830, such as by being rotatably coupled to another component of the head 880 that is fixedly coupled to the tissue engaging element (e.g., the driver interface 882).

[0429] Each anchor 820 is shaped so as to define a central lumen extending from the proximal edge 886 of the tissue engaging element 830 to the distal end 834. The flexible propulsion element 806 and the driver head 810 of the driver 804 are sized to slide within the corresponding central lumen of the anchor 820 when the driver 804 is in its resting state, such as Fig. 9B As shown. 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 actuatable to reversibly engage the driver interface 882 of each tissue anchor. The anchor driver 804 is configured to advance the anchor 820 distally toward the distal opening at the end 824 of the catheter 822 when the driver head 810 engages with the driver interface 882, and drives the tissue engaging element 830 into the tissue 10 along the tissue anchor axis ax2.

[0430] It should be noted that Fig.9A -B is a vertical cross-section of the delivery tool 802. The driver head 810 is shaped so as to define a static state (eg Fig.9A The first and second legs 812a and 812b of the tissue anchor 820 are configured such that, in a static state, the first and second legs 812a and 812b define a first space S3 having a first distance therebetween, and in a static state, the first and second legs 812a and 812b are not in contact with and / or firmly engaged with the wall surrounding the recessed portion 883 of the tissue anchor 820.

[0431] The anchor driver 804 includes an expander element 818 coupled to a displacement element 821, such as a shaft, rod, wire, hypotube, line, wedge, extension, etc., which facilitates distal and proximal sliding of the expander element 818. The displacement element 821 is disposed within the lumen of the advancement element 806 (which may be the same or similar to other advancement elements herein) and is slidable relative to the advancement element 806, such that the expander element is slidable relative to the advancement element 806 and relative to the legs 812a and 812b. In the static state of the legs 812a and 812b, the expander element 818 is positioned at the distal surface of the legs 812a and 812b, as shown in FIG. Fig.9A In the static state, as shown in view A, the legs 812a and 812b together present a circular profile.

[0432] like Fig. 9B As shown, the expander element 818 is pulled proximally by pulling the displacement element 821, so that the expander element 818 is pulled to a position between the legs 812a and 812b and is tightly fitted in the space between the legs 812a and 812b, so that the legs 812a and 812b are expanded away from the central axis 826 to the engaged state of the legs 812a and 812b ( Fig. 9B ). In the engaged state of the legs 812a and 812b, the legs 812a and 812b define a second space S4 between each other, and the second space S4 has a second distance greater than the first distance of the first space S3. The distal portion of each leg 812a and 812b is shaped so as to define a corresponding engagement ball 816a and 816b, which is configured to engage the wall of the recessed portion 883. For some applications, the wall of the recessed portion 883 is shaped so as to define a groove for close coupling of the balls 816a and 816b in the engaged state of the legs 812a and 812b. In the engaged state, as shown in view B, the legs 812a and 812b collectively present an elliptical profile.

[0433] For some applications, the expander element 818 includes a circular disk (as shown) having a diameter that is larger than a first space S3 between the first and second legs 812a and 812b in their resting state, such that the first and second legs 812a and 812b expand to assume an engaged state when the expander element 818 is positioned between the legs 812a and 812b.

[0434] For some applications, the expander element 818 includes an elliptical disk having a major axis diameter that is larger than a first space S3 between the first and second legs 812a and 812b in their resting state, such that the first and second legs 812a and 812b expand to assume an engaged state when the expander element 818 is located between the legs 812a and 812b.

[0435] Legs 812a and 812b of propulsion element 806 are shaped so as to define push surfaces 819a and 819b disposed proximally of proximal edge 868. Fig. 9B In the illustrated engaged state of the first and second legs 812a and 812b, the surfaces 819a and 819b engage and push the proximal edge 886 of the tissue anchor 820 to facilitate distally pushing the tissue anchor 820 in the engaged state of the first and second legs. Therefore, the system 800 is particularly advantageous because the expander element 818 promotes a secure and reversible coupling between the legs 812a and 812b and the tissue anchor 820, and the legs 812a and 812b provide pushing of the tissue anchor 820 by pushing the surfaces 819a and 819b. In particular, the expansion and collapse of the legs 812a and 812b are controlled by the displacement element 821 and the expander element 818. In this way, the anchor driver 804 is able to (1) slide proximally and distally through a series of anchors without securely engaging any of them during sliding, (2) engage any of the anchors in a controlled manner by controlling the movement of the expander element 818, and (3) enter any anchor in a series of anchors, regardless of whether the anchor is disposed proximally or distally of the driver head 810.

[0436] The driver 804 is used to implant the tissue anchor 820 by rotating the tissue anchor 820 along the axis ax2. When torque is applied to the anchor 820 by the driver 804, the expander element 818 prevents the collapse of the legs 812a and 812b during the driving of the anchor 820 into the tissue. In addition, if necessary, the expander element 818 enables the legs 812a and 812b to pull the anchor 820 proximally.

[0437] It should be noted that the system 800 provides for reversible engagement between the anchor driver 804 and the anchor 820. For example, once the anchor 820 is implanted in the tissue, the driver 804 is disconnected from the tissue anchor 820 by pulling the displacement element 821 distally, so that the expander element 818 is pushed distally, which allows the first leg 812a and the second leg 812b to collapse toward the axis 826 and assume its resting state in which the first space S3 is defined between the legs 812a and 812b. If the operating physician mistakenly engages an incorrect anchor in a series of anchors 820, it is particularly useful to reversibly engage the driver 804 with any tissue anchor 820 by expanding and collapsing the legs 812a and 812b by the expander elements 818a and 818b. In this case, by pushing the displacement element 821 to displace and move the expander element 818 distally, the engagement of the incorrect anchor can be reversed, and the anchor driver 804 can be retracted. The anchor driver 804 may then be repositioned to engage the correct anchor in the manner described above.

[0438] Reference now Fig. 7A -F, 8A-C and 9A-B. It should be noted that any of the anchor drivers 604, 704 and 804 can be used to deliver the above referenced Figure 1A -B, 2A-B, 3A-B, 4A-B, 5A-C and 6A-E described any of the tissue anchors 220, 320, 420 and 520.

[0439] refer to Fig.10 , 11A -B, 12A-B, 13A-E, 14A-E and 15A-B, Fig.10 , 11A -B, 12A-B, 13A-E, 14A-E, and 15A-B are schematic illustrations of a system 1000 for use with a subject according to some applications. Fig.10 An overview of a system 1000 is shown, 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 rope) 1012, on which the tissue anchors are threaded. As described in more detail below, during implantation, only the distal portion of the tether 1012 remains implanted in the subject, while the 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.

[0440] The tissue anchors 1020 are distributed in series along the tether 1012, and the delivery tool 1050 can be used to implant the implant 1010 by successively using the anchor driver 1060 for each anchor 1020 to advance the anchor distally into the subject and anchor the anchor to the internal tissue of the subject. For example, and as shown, the implant 1010 can be an annuloplasty implant that is implanted by distributing the anchors 1020 around at least a portion of the annulus of a native heart valve (such as the mitral valve or the tricuspid valve) of the subject. In addition, in some applications, the distal end of the tether 1012 can be advanced distally into the subject together with the first anchor, and subsequent anchors can be advanced by sliding them distally along the tether. For some applications, the system 1000 and / or the techniques described for use therewith are used in conjunction with one or more systems and / or techniques described in U.S. Provisional Patent Application 62 / 949,392, filed by Kasher et al. on December 17, 2019, entitled “ANNULOPLASTY AND TISSUE ANCHOR TECHNOLOGIES,” which is incorporated herein by reference. For example, the system 1000 can be used, mutatis mutandis, to deliver the implant 210 of the system 200 or the implant 210 of the system 600 described in US62 / 949,392. For example, the anchor driver 1060 of the system 1000 can be (or can be used as) the anchor driver of the system 200 or 600 of US62 / 949,392, and / or the catheter 1072 of the system 100 can be (or can be used as) the flexible tube of US62 / 949,392, mutatis mutandis.

[0441] Device 1070 includes a distal portion or distal member (such as catheter 1072) configured to be advanced into a subject. For some applications where implant 1010 is an annuloplasty implant, and as shown, catheter 1072 is a catheter that can be advanced transluminally (e.g., transfemorally). Device 1070 also includes an extracorporeal unit (e.g., an extracorporeal unit) 1074 configured to remain outside the subject's body. For some applications, extracorporeal unit 1074 defines or is coupled to a handle of device 1070.

[0442] The extracorporeal unit 1074 includes a tensioner including a capstan 1080 that helps reduce slack on the tether 1012 during implantation of the implant 1010 (e.g., during distal sliding of the anchor along the tether). It is assumed that reducing slack advantageously reduces the likelihood of the tether 1012 becoming twisted or tangled, or the likelihood of the tether inadvertently engaging with the delivered anchor. It is further assumed that using a capstan rather than manually pulling the proximal end of the tether by a human operator to reduce slack advantageously provides greater control over the amount and consistency of tension applied to the tether, and can further advantageously reduce the number of human operators required.

[0443] Fig.11A -B shows a detailed view of the catheter device 1070 (e.g., the extracorporeal unit 1074 thereof) without the implant 1010, Fig. 12A -B shows an exploded view of the catheter device, and Fig.13A -E shows a cross section of the catheter device. Fig.14A -E shows the system 1000, wherein the implant 1010 is mounted / loaded on the delivery tool 1050, and the delivery tool is used with the implant. Fig.14A Shown with Fig.11A The extracorporeal unit shown is similar to the view of extracorporeal unit 1074 but with implant 1010 present.

[0444] Capstan 1080 includes a spool 1082 and a spring 1084. Spool 1082 and spring 1084 may be housed in housing 1081. Spool 1082 is coupled to spring 1084 such that rotation of the spool in a first rotational direction stresses the spring, which pushes backward in a second rotational direction opposite the first rotational direction.

[0445] The tether 1012 has a proximal portion 1012p including a proximal end of the tether and a distal portion 1012d including a distal end of the tether. Fig.14AAs shown, tether 1012 (for example, proximal portion 1012p) is wound on reel 1082, so that tether (for example, distal portion 1012d) is pulled away from capstan by rotating reel in a first rotation direction and tether is released from reel. This pulling of tether 1012 will usually occur during the implantation of implant 1010, because the anchor 1020 worn on the tether is continuously advanced distally toward the implantation site. Due to the stress generated on spring 1084, the spring pushes reel 1082 backward in the second rotation direction, so that capstan 1080 pulls tether 1012 in the proximal direction. Capstan 1080 (for example, its spring 1084) can be configured to make the pulling force applied by capstan on tether 1012 be large enough to absorb the slack between the distal end of capstan and tether, but small enough to allow the tether required for manipulation of implant 1010, for example, as described below. For example, the force can be (i) small enough to allow the anchor driver 1060 to advance, position, and anchor the anchor 1020 to the target tissue site when the anchor is threaded onto the tether 1012, but (ii) large enough to absorb slack in the tether, thereby reducing the likelihood of the tether becoming entangled or captured during such advancement, positioning, and anchoring of the anchor.

[0446] In some applications, spring 1084 is configured to provide a substantially constant force throughout its range of motion (eg, is a constant force spring) so that the tension applied to tether 1012 is substantially consistent regardless of how much tether has been released from winch 1080 .

[0447] In some applications, and as shown, spring 1084 is a torsion spring, such as a helical torsion spring. For example, spring 1084 can be a main spring.

[0448] In some applications, each anchor 1020 includes a tissue engaging element 1022 and a head 1024 that defines an eyelet 1026 that is threaded onto the tether 1012. Fig.14A As shown, a plurality of tissue anchors are distributed in series along the tether 1012 between the capstan 1080 (e.g., its reel 1082) and the distal end of the tether. For example, and as shown, the system 1000 can be provided with the anchors 1020 distributed in series on an extracorporeal unit 1074 (e.g., a handle).

[0449] For some applications, and as shown (e.g., in Fig.14A1070 ), the portion of the tether 1012 immediately outside of the capstan 1080 extends proximally relative to the device 1070, and then rotates to extend distally relative to the device 1070. It should be noted that despite this arrangement, the anchors 1020 are distributed in series along the tether 1012 between the capstan 1080 and the distal end of the tether - meaning that, relative to the tether (regardless of the overall arrangement of the tether relative to the device 1070), the anchors are distributed in series along the tether between the capstan and the distal end of the tether.

[0450] For some applications, and as shown, such an arrangement is facilitated by the device through an extracorporeal unit 1074 that includes a support (e.g., a pulley) 1076 (e.g., a proximal support) about which the tether 1012 rotates. For some such applications, the device 1070 is provided with the distal end of the tether 1012 already disposed outside the support 1076 - that is, wherein the tether extends proximally from the capstan 1080 along the extracorporeal unit 1074 and around the support 1076, wherein the distal end of the tether is disposed at least slightly distal to the support, e.g., aligned with and / or disposed opposite or within the open proximal end (i.e., the proximal opening) of the catheter 1072. For some such applications, the distal end of the tether 1012 is prevented from moving proximally from this position by a stopper 1014 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 portion of the tether positioned proximally relative to the catheter device, for example, extending proximally from the capstan 1080 and typically terminating at the first anchor 1020f of the implant 1010.

[0451] Assuming that the device 1070 is configured as described above (with the tether 1012 extending proximally and then distally), it is advantageous to position the anchor 1020 at a location proximal to the capstan 1080 that is particularly accessible to an operator.

[0452] To deploy the implant 1010, each anchor 1020 is reversibly coupled in series to an anchor driver that advances the implant to a corresponding site within the body of a subject, such as a corresponding site on the annulus of a heart valve of the subject. Fig. 14B -E shows this being performed for the first anchor 1020f of the implant 1010. The anchor 1020f is advanced along the tether 1012 toward the distal end of the tether. Due to the arrangement of the tether 1012 relative to the device 1070, this movement of the anchor 1020f includes moving the anchor proximally relative to the device 1070 ( Fig. 14B ), moves around support 1076 ( Fig. 14C ), and then moves distally ( Fig.14D ).

[0453] For some applications, and as shown, Figures 14B-14D The steps shown are performed manually by a human operator who manually grasps and moves tissue anchor 1020. For some applications, modifications and / or additions to system 1000 eliminate the need to directly grasp anchor 1020 by hand, mutatis mutandis, for example, as described below with respect to system 1200 and / or system 1400.

[0454] It should be noted that each anchor 1020 is thus initially oriented with its tissue engaging element 1022 pointing proximally relative to the catheter device 1070, and is subsequently oriented with its tissue engaging element pointing distally relative to the catheter device. Once the anchor 1020f is pointing distally (e.g., aligned with and / or disposed opposite or within the open proximal end of the catheter 1072), the anchor driver 1060 is reversibly coupled to the anchor (e.g., coupled to its head 1024) ( Fig.14E ), and is subsequently used to advance the anchor distally through the catheter 1072 and anchor the anchor to the tissue of the subject. The anchor driver 1060 may include an elongated and flexible shaft 1062, and a driver head 1064 coupled to the distal end of the shaft.

[0455] For some applications, advancement of first anchor 1020f also pushes the distal end of tether 1012 through catheter 1072 to the subject's tissue, for example, with the aid of stopper 1014 fixedly attached to the distal end of the tether (at Fig.10 and 15A -B). For each of the subsequent anchors 1020, the same steps are performed, mutatis mutandis, to slide the anchor distally along the tether 1012 toward the distal end of the tether and the first anchor.

[0456] FIG. 15A to FIG. 15B The implantation site is shown after three anchors 1020 of implant 1010 have been anchored to tissue 10 of a subject (eg, tissue of the annulus of a heart valve) and a fourth anchor has been delivered by anchor driver 1060, according to some applications.

[0457] Fig.15A The illustration shows that when implanting an implant substantially similar to implant 1010, without capstan 1080, slack in the implant's tether may present challenges, for example, by increasing the likelihood that the tether will become tangled, captured by another element of the implant and / or delivery system, and / or captured between the anchor and the tissue into which the anchor has been driven. Fig.15A1012, which allows the distal portion 1012d of the tether to (1) form a bend 1013 that may be captured by a previously anchored anchor (e.g., may wrap around a most recently anchored anchor), and (2) drift across the lumen and / or open distal end (indicated by reference numeral 1015) of the catheter 1072 in a manner that increases the risk of the tether being captured by the tissue engaging element 1022 of a currently delivered anchor and / or becoming pinched between the head 1024 of that anchor and tissue.

[0458] Fig. 15B The same procedure is illustrated, but where the winch 1080 maintains tension on the tether 1012 so that slack is reduced (e.g., eliminated), thereby lowering the reference Fig.15A Describe the likelihood of undesirable outcomes.

[0459] For some applications, and as shown, the reel 1082 surrounds the catheter 1072 (e.g., concentric with the catheter). For some applications, and as shown, the reel 1082 is mounted so that at the longitudinal position of the catheter 1072 where the capstan 1080 is disposed, the axis of rotation of the reel is parallel or coaxial with the lumen axis ax1 defined by the lumen of the catheter (which, for some applications, can be considered to be the central longitudinal axis of the device 1070). It is assumed that this configuration of the capstan 1080 advantageously provides an increased weight balance of the device 1070 (e.g., compared to positioning the capstan 1080 transversely to the catheter 1071), thereby facilitating its manipulation and stability.

[0460] For some applications, positioning and orientation of the capstan 1080 (e.g., its spool 1082) is facilitated by one or more supports in addition to the proximal support 1076. For example, and as shown, the tether 1012 is directed laterally away from the spool 1082, and a support (e.g., a pulley) 1077 redirects the tether proximally (and typically also medially). It should be noted that in this context, the terms "laterally," "laterally," "medially," and "medially" refer to positions and directions relative to a central longitudinal axis of the device 1070. For some applications, another support (e.g., another pulley) 1078 redirects the tether to be generally parallel to the catheter 1072 until it reaches the proximal support 1076. Thus, for some applications, the supports 1076 and 1078 together define a region 1079 therebetween in which the tether 1012 is generally parallel to the catheter 1072 (and to the central longitudinal axis of the device 1070). In some applications, and as shown, the tether 1012 is directed laterally away from the spool 1082, and a support (e.g., a pulley) 1077 redirects the tether proximally (and typically also medially). It should be noted that in this context, the terms "laterally," "laterally," "medially," and "medially" refer to positions and directions relative to a central longitudinal axis of the device 1070. For some applications, another support (e.g., another pulley) 1078 redirects the tether to be generally parallel to the catheter 1072 until it reaches the proximal support 1076. Thus, for some applications, the supports 1076 and 1078 together define a region 1079 therebetween in which the tether 1012 is generally parallel to the catheter Fig.14A As shown, system 1000 is provided with anchor 1020 disposed within region 1079 .

[0461] For some applications, the extracorporeal unit 1074 of the catheter device 1070 includes a plurality of dividers 1090 defining anchor storage areas 1092 therebetween, each of which can be sized to store a single anchor 1020. The dividers 1090 allow for storage of anchors 1020 threaded in series on the tether 1012 on the extracorporeal unit 1074. The dividers 1090 can be shaped and / or positioned to obstruct the anchors 1020 without obstructing the tether 1012. For example, and as shown, the tether 1012 can extend through the region 1079 on a given line (e.g., at a given lateral distance from the axis ax1), and the dividers 1090 can be disposed slightly away from the line (e.g., further laterally disposed from the line) such that the anchors 1020 reach the dividers 1090, protruding from the tether on which they are threaded. For applications in which device 1070 includes supports 1076 and 1078, the line along which tether 1012 extends through region 1079 is generally determined by the locations of these supports.

[0462] For some applications, each divider 1090 can define a slot 1094 therein through which the tether 1012 can move. For example, grasping the anchor 1020 and moving the anchor 1020 out of its anchor storage area 1092 can include lifting the anchor above one or more dividers 1090, which can be facilitated by the slot 1094 of one or more dividers, thereby allowing the tether 1012 to move through the slot (e.g., as Fig. 14B For some applications, such lifting of the anchor 1020 along with the tether 1012 it threads thereon is further facilitated by winch 1080 temporarily allowing some of the tether to unwind in response to the tether being pulled and subsequently rewinding the tether.

[0463] For some applications, the capstan 1080 includes a reversibly activated ratchet 1100. When activated (i.e., in an activated state), the ratchet 1100 allows the reel 1082 to rotate in a first rotational direction (e.g., allowing the tether 1012 to be pulled to untie the tether), and prevents the reel from rotating in a second rotational direction (e.g., preventing the spring 1084 from rewinding the tether). When deactivated (i.e., in a deactivated state), the ratchet 1100 allows the reel 1082 to rotate in both the first rotational direction and the second rotational direction. In some applications, the ratchet 1100 includes a gear 1102, a pawl 1104, and a switch 1106. The gear 1102 is coupled to the reel 1082 so that rotation of the reel rotates the gear (e.g., the gear and reel are rotationally locked). The pawl 1104 can be reversibly engaged with the gear 1102 so that when the pawl engages with the gear, the ratchet 1100 is activated, and when the pawl is disengaged from the gear, the ratchet is deactivated. The switch 1106 is configured to switch the ratchet 1100 between being activated and deactivated by moving the pawl 1104 between engagement and disengagement with the gear 1102. For example, and as shown, the switch 1106 may define a cam that pushes the pawl 1104 out of engagement with the gear 1102. For some such applications, the pawl 1104 may be biased toward a position in which it engages with the gear 1102, for example, by a ratchet spring 1108.

[0464] As described above, when activated, the ratchet 1100 allows the operator to cause the unwinding of the tether 1012 (e.g., by advancing the distal end of the tether away from the capstan 1080), but prevents the capstan from rewinding the tether. Thus, activation of the ratchet 1100 somewhat disables the capstan 1080. As described above, during advancement of the first anchor 1020, the first anchor can pull the distal end of the tether 1012 along with it all the way through the catheter 1072. It is assumed that for some applications, activating the ratchet 1100 advantageously facilitates such advancement by allowing the operator to gradually and / or stepwise advance the anchor and tether distally without competing with the capstan 1080 pulling the anchor and tether proximally. Assume further that ratchet 1100 provides the operator with the ability to temporarily introduce slack into tether 1012 if the operator wishes to do so, for example, in order to manually lift a subsequent anchor 1020 and move it into position to engage driver 1060, or to simultaneously make fine adjustments to the position of the distal end of catheter 1072 that may interfere with the tension in tether 1012. Slack may be introduced into the tether by activating ratchet 1100 and then manually pulling tether 1012 to unwind a certain amount of tether from reel 1082. Subsequently, the slack may be removed by deactivating the ratchet.

[0465] It should be noted that capstan 1080 can be configured (e.g., by configuring the spring strength of spring 1084) such that the tension applied by the capstan to tether 1012 is insufficient to cause premature contraction of implant 1010. For example, for applications in which implant 1010 is an annuloplasty implant, spring 1084 may not be strong enough to cause significant contraction of the annulus into which anchor 1020 is driven. For some applications, spring 1084 is only just strong enough to remove slack from tether 1012.

[0466] Fig.15A is described above as resulting from implantation of the implant without capstan 1080. However, it should be noted that Fig.15A The state shown can also be achieved by implanting the implant with the ratchet 1100 activated.

[0467] For some applications, the winch 1080 also includes an indicator 1088, which indicates how much the tether 1012 has been untied from the reel 1082, such as by indicating how much the reel has rotated. For example, and as shown, the indicator 1088 can be fixedly coupled to the reel 1082, and can indicate the rotation / untie through a static window. For some applications, and as shown, the indicator 1088 can indicate the rotation / untie digitally. In some applications, other symbols or representations, such as colors, can be used. As shown, the indicator 1088 can be a ring that is locked to the reel 1082 rotation.

[0468] Reference now Fig.16A -F, Fig.16A -F is a schematic illustration of a system 1200 for use with a subject according to some applications. System 1200 includes implant 1010 and a delivery tool 1250, which includes an anchor driver (e.g., driver 1060) and a catheter device 1270. System 1200 can be the same as system 1000, except for the addition of a series of cartridge bodies 1220 and adaptations of the catheter device (e.g., its in vitro unit) to facilitate use of the cartridge bodies as described herein. Therefore, for some applications, catheter device 1270 (e.g., its in vitro unit 1274) can be the same as catheter device 1070 (e.g., its in vitro unit 1074), except for adaptations for use with cartridge body 1220, such as those described below.

[0469] For some applications, extracorporeal unit 1274 includes a support (eg, a pulley) 1276 (eg, a proximal support) about which tether 1012 rotates. Support 1276 can be similar or identical to support 1076 described above.

[0470] Each cartridge body 1220 holds (e.g., supports) a respective tissue anchor 1020 and, mutatis mutandis, facilitates operator manipulation of the tissue anchors in a manner substantially similar to that described with respect to system 1000. However, it is assumed that for some applications, cartridge bodies 1220 provide increased control and / or safety.

[0471] Fig.16A The initial state of the device 1270 is shown, wherein each housing 1220 is coupled to the external unit 1274 in a corresponding initial position. Fig.14A The state shown for system 1000.

[0472] The extracorporeal unit 1274 includes or defines at least one track 1272 (e.g., a groove (as shown) or a rail) along which each cartridge body 1220 can move (e.g., slide) from a corresponding initial position to a deployed position while remaining coupled to the extracorporeal unit, in which the cartridge body retains its tissue anchor 1020 opposite or within the open proximal end (i.e., the proximal opening) of the guide tube 1072. Fig. 16B An example of such movement is shown in FIG. 1 , for a first cartridge body 1220f (which holds a first anchor 1020f), Fig. 16B An initial position (inset A), an intermediate position (inset B), and a deployed position (inset C and main image) are shown. This can be performed manually by an operator who grasps the cartridge body by hand. It is assumed that the cartridge body 1220 is easier to grasp and manually move than the anchor 1020 alone.

[0473] In some applications, each cartridge body 1220 is configured to lock to the extracorporeal unit 1274 upon reaching the deployed position. Such a configuration can be achieved, for example, using a latch mechanism, for example, where the extracorporeal unit 1274 includes one or more latches 1278, and each cartridge body 1220 is correspondingly shaped to be locked by the one or more latches, for example, by each cartridge body defining a corresponding one or more recesses 1222. The latches 1278 can be resilient or spring-loaded so that they momentarily flex (e.g., outward) in response to the arrival of the cartridge body 1220, and then automatically lock to the recess 1222 when the cartridge body 1220 is fully positioned in the deployed position (e.g., snapped / snaps into place).

[0474] When the cartridge body 1220 is disposed in the deployed position, the anchor driver 1060 is used to advance the anchor 1020 distally out of the cartridge body ( Fig.16E) and through the catheter 1072, for example, to anchor the anchor to the target tissue site. The anchor driver 1060 is then separated from the anchor 1020 and can be withdrawn from the device 1270. The cartridge body 1220 can then be removed from the deployment position (e.g., can be completely removed from the extracorporeal unit 1274), so that the deployment position is empty for the consecutive cartridge bodies in the series ( Fig.16F ). For example, and as shown, the recess 1222 can be open at one end to facilitate sliding out of the cartridge body (e.g., in a downward direction as shown) without requiring flexure of the latch 1278.

[0475] Fig. 16C -D illustrates a test feature of the system 1200 according to some applications. The test feature tests the coupling of the anchor driver 1060 to the anchor 1020 (or facilitates testing of the coupling of the anchor driver 1060 to the anchor 1020), and only allows the anchor to be advanced distally if the test is successful. It is assumed that this advantageously reduces the possibility of inadvertently advancing an anchor that is imperfectly coupled to the anchor driver distally (e.g., only pushing the anchor distally). Such imperfect coupling may result in the anchor being advanced, but the anchor driver being unable to screw the anchor into the tissue or withdraw the anchor proximally.

[0476] For applications where the system 1200 includes this testing feature, each cartridge body 1220 includes a displaceable barrier 1224 that blocks the anchor 1020 from being advanced distally out of the cartridge body until the test is successful ( Fig. 16C ). The cartridge body 1220 may be provided with a barrier 1224 in the obstructing position. For such applications, each cartridge body may also include a displacement mechanism 1226 that, when actuated, displaces the barrier 1224 so that the barrier ceases to obstruct distal advancement of the anchor 1020 out of the cartridge body. Once the driver 1060 has been coupled to the anchor 1020, the coupling is tested by applying a force to the anchor, for example, by an operator pulling the driver 1060 proximally so that the driver pulls the anchor proximally ( Fig.16D ). The cartridge body 1220 is configured such that only if the driver 1060 is properly coupled to the anchor 1020 and can therefore apply sufficient pulling force to the anchor, the pulling will actuate (or allow actuation of) the displacement mechanism 1226. For example, if the coupling is not perfect, the driver 1060 may become separated from the anchor 1020 before sufficient pulling force is applied.

[0477] For some applications, displacement mechanism 1226 is spring loaded, for example, including an elastic element that provides a Fig. 16C ), and the elastic element is released by a force applied to the anchor 1020 ( Fig.16DFor example, the housing 1220 may include one or more pawls 1228 that constrain the displacement mechanism 1226 ( Fig. 16C ), and when sufficient tension is applied to the anchor 1020, the one or more pawls 1228 move away from the displacement mechanism so that they cease to constrain the displacement mechanism, and the displacement mechanism responsively moves the barrier 1224 so that the barrier ceases to impede distal advancement of the anchor out of the cartridge body ( Fig.16D ).

[0478] For some applications, and as shown, each cartridge body 1220 includes a first member 1230 that includes or defines a barrier 1224 and a second member 1232 that holds (e.g., supports) an anchor 1020. For some such applications, the displacement mechanism 1226 is configured to be actuated by an anchor driver 1060 that pulls the anchor 1020 proximally with sufficient force that the anchor pulls the second member 1230 proximally relative to the first member 1232 such that the pawl 1228 stops restraining the displacement mechanism ( Fig.16D ).

[0479] For some applications, and as shown, second component 1232 includes or defines detent 1228 , and first component 1230 includes or defines displacement mechanism 1226 (and optionally also includes barrier 1224 ).

[0480] For some applications, the detent function may alternatively or additionally be provided by a detent 1225 (e.g., a post) that is a component of the first member 1230, e.g., coupled to or defined by the barrier 1224. In the blocking position of the barrier 1224, the detent 1225 extends into the central lumen defined by the helical tissue engaging element of the anchor 1020. When sufficient pulling force is applied to the anchor 1020, the helical tissue engaging element of the anchor slides off the detent 1225, thereby allowing the barrier 1224 to be displaced.

[0481] For some applications, first component 1230 is a first unitary structure made from a single piece of material. For some applications, second component 1232 is a second unitary structure made from a single piece of material.

[0482] For some applications, and as shown, the second component 1232 couples the cartridge body 1220 to the extracorporeal unit 1274, for example, by slidably engaging the track 1272. As shown, for applications where the track 1272 is a groove, the second component 1232 can define a tongue 1234 that couples the first component (and thus the entire cartridge body 1220) to the extracorporeal unit 1274 by engaging the groove. For clarity, Fig. 16C-D The in vitro unit 1274 and track 1272 are not shown.

[0483] For some applications, cartridge body 1220 is configured such that proximal movement of second member 1232 relative to first member 1230 reconfigures the cartridge body into a removable state that facilitates removal of the cartridge body from the deployed position. Fig. 16C As shown, before pulling, the position of the tongue 1234 relative to the first member 1232 is such that the first member blocks the tongue from disengaging from the track 1272. In the example shown, each track 1272 is disposed inboard from its corresponding tongue 1234, and disengagement will include lateral outward movement of the tongue. Fig.16D As shown, pulling repositions the tongue 1234 so that the first component no longer impedes such movement. For example, and as shown, pulling can align the tongue 1234 (or the portion of the first component 1230 supporting the tongue) with the lumen 1236 defined by the first component 1230 ( Fig.16D Once so aligned, the cartridge body 1220 can be moved away from the track 1272 by pulling the cartridge body away from the track (e.g., by an operator grasping the cartridge body by hand) because such alignment allows the tongue 1234 to deflect outwardly (e.g., momentarily) in response to the pull and thereby disengage from the track ( Fig.16F ). Thus, the deployment location becomes empty for the successive bins to be used.

[0484] It should be noted that, as described above, for some applications, the cartridge body 1220 is configured such that successful verification of coupling between the anchor driver 1060 and the anchor 1020 reconfigures the cartridge body to allow (i) the anchor to be advanced distally out of the cartridge body into the catheter 1072, and (ii) removal of the cartridge body to free up a deployment location for a subsequent cartridge body.

[0485] For some applications, cartridge body 1220 is configured to be removed while driver 1060 remains extended into catheter 1072. For some applications, cartridge body 1220 is configured to be removed only after driver 1060 has been withdrawn from catheter 1072.

[0486] Reference now Fig.17A -F and 18A-B, Fig.17A-F and 18A-B are schematic illustrations of an example system 1400 for use with a subject according to some applications. System 1400 includes implant 1010 and a delivery tool 1450, which includes an anchor driver (e.g., driver 1060) and a catheter device 1470. After necessary modifications, system 1400 can be the same as system 1000, except for the addition of a series of cartridge bodies 1220 and the adaptation of the catheter device (e.g., an in vitro unit thereof) to facilitate the use of the cartridge bodies as described herein. For some applications, system 1400 can be as described for system 1200, except that cartridge body 1420 is used instead of cartridge body 1220, and the corresponding adaptation of the catheter device (e.g., an in vitro unit thereof). Thus, for some applications, catheter device 1470 (e.g., extracorporeal unit 1474 thereof) can be identical to catheter device 1070 (e.g., extracorporeal unit 1074 thereof) and / or catheter device 1270 (e.g., extracorporeal unit 1274 thereof), except for adaptations for use with cartridge body 1420, such as those described below.

[0487] Although the tensioner (eg, capstan) 1080 is illustrated differently in the system 1400 , it may have the same or similar components and functionality as described above.

[0488] For some applications, extracorporeal unit 1474 includes a support (eg, pulley) 1476 (eg, a proximal support) about which tether 1012 rotates. Support 1476 can be similar or identical to supports 1076 and / or 1276 described above.

[0489] Each cartridge body 1420 holds (eg, supports) a respective tissue anchor 1020 and, mutatis mutandis, facilitates manipulation of the tissue anchor by an operator in a manner substantially similar to that described with respect to system 1200 .

[0490] Fig.17A The initial state of the device 1470 is shown, wherein each housing 1420 is coupled to the external unit 1474 in a corresponding initial position. Fig.16A The status shown for system 1200.

[0491] In some applications, the extracorporeal unit 1474 includes or defines at least one track 1472 (e.g., a groove (as shown) or a rail) along which each cartridge body 1420 can be moved (e.g., slidably) from a corresponding initial position to a deployed position while remaining coupled to the extracorporeal unit, in which the cartridge body retains its tissue anchor 1020 opposite or within the open proximal end (i.e., the proximal opening) 1073 of the guide tube 1072. Fig. 17BAn example of such movement is shown in FIG. 14, wherein the curved arrow indicates movement of the first cartridge body 1420f (which holds the first anchor 1020f) from its initial position to its deployed position, for example, similar to that of reference 1420f, mutatis mutandis. Fig. 16B As described for cartridge body 1220. This can be performed manually by an operator who grasps the cartridge body by hand. It is assumed that cartridge body 1420 is easier to grasp and manually move than anchor 1020 alone.

[0492] In some applications, each cartridge body 1420 is configured to lock to the extracorporeal unit 1474 when it reaches the deployed position. Such a configuration can be achieved, for example, using a latch mechanism, for example, where the extracorporeal unit 1474 includes one or more latches 1478, and each cartridge body 1420 is correspondingly shaped to be locked by the one or more latches. The latches 1478 can be resilient or spring-loaded so that they momentarily flex (e.g., upward) in response to the arrival of the cartridge body 1420, and then automatically lock to the cartridge body when the cartridge body is fully positioned in the deployed position (e.g., snapped / snaps into place).

[0493] In some applications, when the cartridge body 1420 is disposed in the deployed position, the anchor driver 1060 is used to advance the anchor 1020 distally out of the cartridge body ( Fig.17E ) and through the catheter 1072, for example, to anchor the anchor to the target tissue site. The anchor driver 1060 is then separated from the anchor 1020 and can be withdrawn from the device 1470. The cartridge 1420 can then be removed from the deployment site (e.g., can be removed from the extracorporeal unit 1474), so that the deployment site is empty for consecutive cartridges in the series ( Fig.17F ). For example, and as shown, the cartridge body 1420 can be shaped to facilitate sliding out of the cartridge body (e.g., in a downward direction as shown) without requiring flexure of the latch 1478.

[0494] Fig. 17C -D illustrates an example test feature of the system 1400 according to some applications. The test feature tests the coupling of the anchor driver 1060 to the anchor 1020 (or facilitates testing of the coupling of the anchor driver 1060 to the anchor 1020) and allows the anchor to be advanced distally only if the test is successful. It is assumed that this advantageously reduces the likelihood of inadvertently advancing an anchor that is imperfectly coupled to the anchor driver distally (e.g., only pushing the anchor distally). Such imperfect coupling may result in the anchor being advanced, but the anchor driver being unable to screw the anchor into the tissue or withdraw the anchor proximally.

[0495] For applications where the system 1400 includes this testing feature, each cartridge body 1420 includes a displaceable barrier 1424 that blocks the anchor 1020 from being advanced distally out of the cartridge body until the test is successful ( Fig. 17C ). The housing 1420 may be provided with a barrier 1424 ( Fig. 17C For such applications, each cartridge body can also include a displacement mechanism 1426 that, when actuated, displaces the barrier 1424 so that the barrier ceases to impede distal advancement of the anchor 1020 out of the cartridge body. Once the driver 1060 has been coupled to the anchor 1020, the coupling is tested by applying a force to the anchor, for example, by an operator pulling the driver 1060 proximally so that the driver pulls the anchor proximally ( Fig.17D ). The cartridge body 1220 is configured such that only if the driver 1060 is properly coupled to the anchor 1020 and can therefore apply sufficient pulling force to the anchor, the pulling will actuate (or allow actuation of) the displacement mechanism 1426. For example, if the coupling is not perfect, the driver 1060 may become separated from the anchor 1020 before sufficient pulling force is applied.

[0496] For the cartridge body 1220 described above, the displacement mechanism 1226 can displace the barrier 1224 by linear displacement of the barrier. In contrast, for the cartridge body 1420, the displacement mechanism 1426 can displace the barrier 1424 by deflection of the barrier. For example, and as shown, the displacement mechanism 1426 can include a hinge about which the barrier 1424 deflects. For some applications, and as shown, displacement of the barrier 1424 can involve the barrier being separated into (e.g., two) barrier subassemblies 1424a and 1424b, which deflect away from each other in different directions.

[0497] The cartridge body 1420 may include one or more detents 1425 that prevent (eg, constrain) the displacement mechanism 1426 from moving the barrier 1424 ( Fig. 17C ), and when sufficient tension is applied to the anchor 1020, one or more pawls 1425 are moved apart so that they cease to block (e.g., constrain) the displacement mechanism, thereby allowing (or triggering) actuation of the displacement mechanism.

[0498] For some applications, and as shown, detents 1425 are coupled to or defined by barrier 1424. In the obstructing position of barrier 1424, detents 1425 extend into a central lumen defined by the helical tissue engaging element of anchor 1020. When sufficient pulling force is applied to anchor 1020, the helical tissue engaging element of the anchor slides off detents 1425, thereby allowing barrier 1424 to be displaced.

[0499] For some applications, and as shown, each barrier subassembly can have its own detent 1425, e.g., barrier subassembly 1424a has detent 1425a, and barrier subassembly 1424b has detent 1425b, both of which extend into a central lumen defined by the helical tissue-engaging element of anchor 1020 when in the blocking position. For some such applications, anchor 1020 itself (e.g., its tissue-engaging element) thereby prevents deflection of barrier subassemblies 1424a and 1424b away from each other.

[0500] For some applications, and as shown, in the blocking position of barrier 1424, multiple detents 1425 can collectively define a column. For example, for applications in which barrier 1424 has two barrier subassemblies, each detent can be semi-cylindrical so that the two detents collectively form a cylindrical column (see Fig. 17C ).

[0501] For some applications, the displacement mechanism 1426 is spring-loaded, for example, comprising an elastic element, such as a spring, which is provided in a constrained state and which is released by a force applied to the anchor 1020. For applications in which the displacement mechanism 1426 is spring-loaded, the displacement mechanism automatically moves the barrier 1424 in response to movement away from the pawl 1425 so that the barrier ceases to impede distal advancement of the anchor out of the cartridge body ( Fig.17D ).

[0502] For some applications, and as shown, each cartridge body 1420 includes a first member 1430 including or defining a barrier 1424 and a second member 1432 that holds (e.g., supports) the anchor 1020. For some such applications, the displacement mechanism 1426 is configured to be actuated (or allowed to be actuated) by the anchor driver 1060 pulling the anchor 1020 proximally with sufficient force that the anchor pulls the second member 1432 proximally relative to the first member 1430, such that the pawl 1425 ceases to prevent (e.g., constrain) the displacement mechanism ( Fig.16D ).

[0503] For some applications, and as shown, first component 1430 includes or defines a pawl 1425 and a displacement mechanism 1426. For some such applications, and as shown, first component 1430 includes two subassemblies 1430a and 1430b hingedly coupled to each other by displacement mechanism 1426, and each subassembly includes a corresponding barrier subassembly and a corresponding pawl 1425.

[0504] For some applications, each of subcomponents 1430a and 1430b is a unitary structure made from a single piece of material.For some applications, second component 1432 is a unitary structure made from a single piece of material.

[0505] For some applications, first component 1430 couples cartridge body 1420 to extracorporeal unit 1474, for example, by slidably engaging rail 1472. For example, and as shown, first component 1430 can define at least one tongue 1434 (e.g., one tongue for each subassembly 1430a and 1430b) that couples the first component (and thus the entire cartridge body 1420) to extracorporeal unit 1474 by slidably engaging rail 1472. For clarity, Fig. 17C -D The in vitro unit 1474 and track 1472 are not shown.

[0506] For some applications, and as shown, the cartridge body 1420 is configured to be locked by the latch 1478 by latching onto the tongue 1434. That is, for such applications, the tongue 1434 (i) slidably couples the cartridge body 1420 to the track 1472, and (ii) facilitates locking the cartridge body in the deployed position.

[0507] For some applications, cartridge body 1420 is configured such that proximal movement of second component 1432 relative to first component 1430 reconfigures the cartridge body (or allows the cartridge body to be reconfigured) to a removable state that facilitates removal of the cartridge body from the deployed position. Fig. 17C As shown, before pulling, each tongue 1434 is positioned to slidably engage the track 1472, thereby preventing the cartridge body 1420 from being disengaged from the track 1472. Fig.16D As shown, pulling the second component 1432 proximally disengages each tongue 1434 from the track 1472 (or allows the tongue to disengage), such as by lateral movement of the tongue, thereby allowing the cartridge body to be pulled away from the track and, in some applications, pulled away from the extracorporeal unit 1474 as a whole ( Fig.17F ). Thus, the deployment location becomes empty for the successive bins to be used.

[0508] For some applications, and as shown, the same deflection between subassemblies 1430a and 1430b is (i) to displace barrier 1424 by deflecting barrier subassemblies 1424a and 1424b relative to each other, and (ii) to disengage tongue 1434 from track 1472. For such applications, both such displacement and such disengagement are thus facilitated (or triggered) by driver 1060 pulling anchor 1020 proximally with sufficient pulling force.

[0509] Thus, it should be noted that, as described above, for some applications, the cartridge body 1420 is configured such that successful verification of coupling between the anchor driver 1060 and the anchor 1020 reconfigures the cartridge body to allow (i) the anchor to be advanced distally out of the cartridge body into the catheter 1072, and (ii) removal of the cartridge body to free up a deployment location for a successive cartridge body.

[0510] For some applications, cartridge body 1420 is configured such that even if tongue 1434 disengages from track 1472, the cartridge body remains in place until manually removed, such as by grasping and pulling by an operator.

[0511] For some applications, cartridge body 1420 is configured to be removed while driver 1060 remains extended into catheter 1072. For some applications, cartridge body 1420 is configured to be removed only after driver 1060 has been withdrawn from catheter 1072.

[0512] Fig.18A -B shows the system 1400 after (i) the anchor 1020 of the first cartridge body 1420f (i.e., the first anchor) has been advanced (with the tether 1012 coupled thereto) through the catheter 1072 and anchored to the tissue, (ii) the driver 1060 has been withdrawn, (iii) the first cartridge body has been removed, and (iv) the subsequent cartridge body 1420 has been moved to the deployed position. The tether 1012 extends proximally from the first anchor, back through the catheter 1072. Thus, when the subsequent anchor is advanced through the catheter 1072, it will slide over and along the tether 1012.

[0513] Reference again Figures 16A-19B As described above, for some applications, each of cartridge bodies 1220 and 1420 can include (i) a first component that defines a barrier for the cartridge body and (ii) a second component that retains anchor 1020 and can be pulled proximally relative to the first component to move the barrier to allow the anchor to be subsequently advanced into tube 1072. It should be noted that in system 1200, cartridge body 1220 is slidably coupled to the track of the proximal unit via the first component (i.e., the component that retains the anchor), while in system 1400, cartridge body 1420 is slidably coupled to the track of the proximal unit via the second component (i.e., the component that defines the barrier).

[0514] It should be noted that while systems 1200 and 1400 are shown above as including a tensioner (e.g., a winch) 1080, aspects of these systems—particularly the use of cartridges 1220 and 1420—can be used independently of tensioner 1080 (or any tensioner). Thus, the scope of the present disclosure includes variations of systems 1200 and 1400 that do not include tensioner 1080 and may not include any tensioner.

[0515] Reference again Figures 17A-18B , and further reference Fig.19A -B, Fig.19A -B is a schematic illustration of a port 1480 according to some applications. For some applications, the port 1480 is disposed at the proximal opening 1073 of the catheter 1072. Although this is shown as a component of the system 1400, the port 1480 can be used in other systems described herein, mutatis mutandis. The port 1480 can have a tapered lumen that facilitates smooth advancement of the anchor 1020 into the catheter 1072.

[0516] Port 1480 can include a membrane 1482 that provides a hemostatic seal during the implantation procedure. The membrane 1482 can be formed of silicone. The material (e.g., silicone) forming the membrane 1482 can have a hardness of 38-42 (e.g., 40) Shore A. The membrane 1482 can be about 1 mm thick. The membrane 1482 can be oriented substantially transversely to the proximal end of the tube 1072.

[0517] The membrane 1482 can be formed to define two holes 1484 therethrough (e.g., a first hole 1484a and a second hole 1484b), which are connected by a closed slit 1486. ​​In some applications, the first hole 1484a is larger in diameter than the second hole 1484b (e.g., at least twice as large, such as at least three times as large, such as 3-10 times as large, such as at least 4 times as large). For example, the first hole 1484a can be 1.5-2.5 mm in diameter (e.g., 1.7-2.2 mm, such as 1.8-2.0 mm, such as 1.9 mm), while the second hole 1484b can be 0.2-0.7 mm in diameter (e.g., 0.2-0.6 mm, such as 0.3-0.5 mm, such as 0.4 mm).

[0518] As shown, the port 1480 (e.g., its membrane 1482) can be oriented so that the first hole 1484a is located on the axis along which the tissue engagement element of the driver 1060 and the anchor 1020 is advanced. This "anchor advancement axis" is represented by a dashed line. When the cartridge body 1420 is in the deployed position, the tissue engagement element of its tissue anchor 1020 can be aligned with the first orifice 1484a, thereby defining an anchor advancement axis from the tissue anchor through the first orifice and through the tube 1072.

[0519] As also shown, the second hole 1484b is generally located on the axis along which the tether 1012 is advanced. Each anchor can be advanced through the membrane 1482 with (i) its central longitudinal axis and / or tissue engaging element aligned with the first hole 1484a, and (ii) its eyelet threaded onto the tether 1012 aligned with the second hole 1484b.

[0520] It should be noted that typically neither the hole 1484a (and thus the anchor advancement axis) nor the hole 1484b are aligned centrally relative to the catheter 1072. Alternatively, the center of the first hole 1484a is disposed on one side of the central axis of the catheter, and the center of the second hole 1484b is disposed on the opposite side of the central axis of the catheter. However, for applications where the first hole 1484a is sufficiently large, the first hole may overlap with the central axis of the catheter (although still not centered on the central axis of the catheter).

[0521] As the anchor passes distally through the membrane 1482, the aperture 1484 and slit 1486 responsively open or widen momentarily and then close or re-narrow behind the anchor.

[0522] In some applications, the hole 1484a is sized to seal around the driver 1060 (e.g., its shaft), which can be narrower than the head of the anchor 1020. For example, for some applications, the diameter of the hole 1484a is 80-120% (e.g., 90-110%) of the thickness of the driver 1060 shaft.

[0523] In some applications, hole 1484b is sized to seal around tether 1012, which is narrower than the eyelet of anchor 1020. For example, for some applications, the diameter of hole 1484b is 50-200% (e.g., 80-120%, such as 90-110%) of the thickness of tether 1012.

[0524] As the driver 1060 is withdrawn proximally through the membrane 1482, the tether 1012 remains extended through the second aperture 1484b.

[0525] It is assumed that the dual-hole configuration of the membrane 1482 advantageously provides a better hemostatic seal for the implantation procedure than other configurations (such as a single larger hole or slit). For example, during the anchoring of the anchor 1012, when the tether 1012 and the driver 1060 extend through the membrane 1482, the slit 1486 is usually closed.

[0526] refer to Fig. 20A -H, Fig. 20A-H is a schematic illustration of a system 1300 for use with a subject according to some applications. System 1300 includes a catheter device 1370 including a distal portion or distal member, such as catheter 1072, and an extracorporeal unit 1374 including a housing 1375 and a tensioner 1380. System 1300 also includes an implant (such as implant 1010) and an anchor driver (such as anchor driver 1060). Catheter device 1370 can be similar to catheter device 1070 and / or catheter device 1270, mutatis mutandis, except that tensioner 1380 is present (e.g., in place of tensioner / capstan 1080).

[0527] In 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 includes a distal end of the tether. As described in more detail below, tensioner 1380 is configured to pull tether 1012 proximally. Although the manner in which this proximal pull is achieved is different from that described for system 1000, the supposed advantage is similar - reducing slack on tether 1012 during implantation (or at least during certain steps of implantation).

[0528] In some applications, in systems 1000 and 1200, the anchor 1020 of the implant 1010 is threaded distally from the tensioner (capstan) onto the tether 1012, i.e., the anchor is threaded onto the tether between the tensioner and the distal end of the tether. Thus, in order to absorb slack at the distal portion of the tether, the tension applied by the tensioner must pass through the portion of the tether on which the unused anchor is threaded, allowing the slack to slide through the unused anchor. In contrast, in system 1300, the anchor 1020 is threaded proximally from the tensioner 1380 onto the tether 1012. It is assumed that, at least for some applications, such a configuration provides certain advantages, such as enabling these unused anchors to be stored in an arrangement that is convenient or ergonomic but less conducive to the tether 1012 sliding through them. For example, while the unused anchors of systems 1000 and 1200 are stored in a linear arrangement, those of system 1300 can be stored in a non-linear arrangement (e.g., in a loop).

[0529] The anchor driver 1060 is configured to sequentially reversibly couple to each anchor and advance the current anchor distally along the tether past (eg, through) the tensioner 1380 . Fig. 20A-H illustrates at least some steps in the advancement of one of the anchors. As described below, the system 1300 has certain features that help position the tensioner 1380 between a stored, unused anchor and the distal end of the tether. These features help the anchor driver 1060 advance the anchor 1020 distally past (e.g., through) the tensioner 1380 without the tensioner blocking or blocking the anchor or driver (e.g., its shaft 1062).

[0530] Tensioner 1380 can include a spring 1382 coupled to housing 1375 and reversibly locked to tether 1012 such that when the spring is under stress and locked to the tether, the spring causes the tensioner to pull the tether proximally. For some applications, and as shown, spring 1382 is a compression spring configured to be stressed due to compression and configured to pull the tether proximally by extension. Alternatively, spring 1382 can be an extension spring or another suitable type of spring.

[0531] The tensioner 1380 may also include a clamp 1384, which is coupled to the spring 1382 and can be in an unclamped state ( Fig. 20A -C) and clamping state ( Fig.20D -F). The tether 1012 extends distally through the catheter device 1370 such that the tether extends through the clamp 1384 in a manner that the spring 1382 locks to the tether when the clamp is in the clamped state. For example, and as shown, the tether axis ax2 along which the tether 1012 extends through the tensioner 1380 can pass between the jaws 1390 of the clamp 1384.

[0532] The tensioner 1380 may also include an actuator 1386, actuation of which causes the clamp 1384 to transition between an unclamped state and a clamped state. For some applications, and as shown, the actuator 1386 includes a ring 1388 surrounding the clamp, rotation of which causes the clamp to transition between an unclamped state and a clamped state. For example, the clamp 1384 and the ring 1388 may be used together as a chuck, for example, where the clamp is biased toward assuming its unclamped state, and rotation of the ring squeezes the clamp closed. For example, an internal thread 1389 defined by an inner surface of the ring 1388 and a complementary external thread 1385 defined by an outer surface of the clamp 1384 may interact so that rotation of the ring screws the ring onto the clamp. For some applications, the inner surface of ring 1388 and / or the outer surface of clamp 1384 are tapered so that axial movement of the ring relative to the clamp (e.g., screwing of the ring on the clamp) squeezes the clamp toward its clamped state. In some applications, ring 1388 is configured to be grasped and rotated by hand.

[0533] In some applications, the clamp 1384 defines first and second clamping surfaces 1392 that are configured to engage the tether 1012 when the clamp is in its clamped state. For example, the clamp 1384 can include first and second clamping jaws 1390, each of which defines a corresponding clamping surface 1392 and can be deflected by, for example, squeezing of the actuator 1386. In the unclamped state, the clamp 1384 defines a gap 1394 between the clamping surfaces 1392, and the tissue anchor 1020 is dimensioned to be advanced distally along the tether 1012 through the gap by the anchor driver 1060. For example, the maximum transverse width of each anchor 1020 (measured transverse to the longitudinal axis of the anchor along which the anchor is driven into the tissue) can be smaller than the gap 1394. In some applications, the anchor driver 1060 (e.g., the driver head 1064 and the shaft 1062) is also narrower than the gap 1394.

[0534] Fig. 20A A tensioner 1380 is shown with a tether 1012 extending therethrough, passing through (e.g., through) the tensioner from a proximal side (right side of the figure) to a distal side of the tensioner, for example, after a first tissue anchor has been anchored to tissue and before a second tissue anchor is advanced, extending through and out of the catheter 1072. Fig. 20B An anchor driver 1060 is shown, wherein a driver head 1064 reversibly coupled to the anchor 1020 has been used to advance the anchor distally past (eg, through) the tensioner 1380 . Fig. 20B The inset cross-section of shows that both the tether 1012 and the shaft 1062 of the driver 1060 are disposed in the gap 1394 between the clamping surfaces 1392 of the jaws 1390 .

[0535] Prior to transitioning the clamp 1384 to its clamped state, at least a portion of the shaft 1062 of the driver 1060 is laterally displaced from the tether axis ax2 (and therefore from the tether 1012) into a non-clamped region 1396 defined by the catheter device 1370 (e.g., by the extracorporeal unit 1374 thereof). Fig. 20C ). This is performed while the driver head 1064 remains coupled to the anchor 1020, which itself remains threaded on the tether 1012, and thus generally involves some degree of deflection and / or bending of the shaft 1062. This is most clearly illustrated in the inset cross section, the plane of which is at the gap 1394, where the shaft 1062 is laterally disposed from the gap 1394 within the non-clamping region 1396. This is also represented in the main longitudinal cross section by the shaft 1062 coming out of the plane of the cross section and thus being "cut" by the cross section at a point away from the clamping surface 1392.

[0536] Thus, the non-clamped region 1396 is shaped and dimensioned to accommodate the laterally displaced shaft 1062 after the driver 1060 has advanced the anchor 1020 along the tether 1012, distally past the tensioner 1380, such that the shaft extends distally toward the anchor, bypassing the clamp 1384.

[0537] For some applications, catheter device 1370 (e.g., extracorporeal unit 1374 thereof) provides a non-clamping region 1396 via a clamping surface 1392 that is eccentric relative to tether axis ax2, for example, as shown in the inset cross-section.

[0538] When the shaft 1062 is maintained in the non-clamping region 1396, the actuator 1386 is actuated (e.g., the ring 1388 is rotated), thereby transforming the clamp 1384 into a clamping state, so that the clamp clamps the tether 1012 between the clamping surfaces 1392 of the jaws 1390, thereby locking the clamp (and therefore the spring 1382) to the tether ( Fig.20D ). It should be noted that, as described above, the location of shaft 1062 in non-clamping region 1396 allows clamp 1384 to clamp tether 1012 without clamping shaft 1062, and the shaft does not hinder the clamping of the tether.

[0539] For some applications, and as shown, at least one of the jaws 1390 is formed to define one or more protrusions 1393 that limit the proximity of the clamping surfaces 1392 to each other in the clamped state, for example, to reduce the likelihood that the clamp 1384 will damage and / or cut the tether 1012 due to excessive clamping.

[0540] exist Fig. 20A -D, spring 1382 is in a stressed state, wherein the spring is under stress and locked in that state. In some applications, the locking is provided by lock 1360, which may be a component of the extracorporeal unit 1374. FIG. 20C to FIG. 20D As shown in the transition between , the clamping member 1384 can be transformed into its clamping state while the lock 1360 remains locked.

[0541] For some applications, and as shown, lock 1360 locks spring 1382 in its stressed state by locking clamp 1384 to housing 1375. For some applications, and as shown, lock 1360 includes pawl 1362 and recess 1364, and projection of the pawl into the recess locks the lock. For some such applications, and as shown, clamp 1384 defines recess 1364, and housing 1375 includes the pawl.

[0542] When the clamp 1384 remains clamped to the tether 1012, the lock 1360 is unlocked, thereby triggering the spring 1382 to cause the tensioner 1380 to pull the tether proximally, for example by the spring pressing the clamp proximally ( Fig.20E ).

[0543] For some applications, and as shown, extracorporeal unit 1374 (e.g., lock 1360 thereof) is configured such that after clamp 1384 has been squeezed into its clamped state, further squeezing of the clamp unlocks the clamp from housing 1375 by unlocking the lock, thereby triggering spring 1382 to cause tensioner 1380 to pull the tether proximally. For example, once actuator 1386 has been sufficiently actuated (e.g., once ring 1388 has been sufficiently rotated) to transform clamp 1384 into its clamped state, further actuation of the actuator (e.g., further rotation of the actuator) unlocks the clamp from housing 1375 by unlocking lock 1360. This is achieved by Fig.20D and 20E The transition diagram shows that the ring 1388 has been further threaded onto the jaws 1390, squeezing the jaws sufficiently so that the recess 1364 is retracted from the pawl 1362, triggering the spring 1382 to push the clamp 1384 (and the ring 1388) proximally, thereby pulling the tether 1012 proximally, thereby reducing the slack in the tether.

[0544] Subsequently, while tensioner 1380 continues to maintain tension on tether 1012, driver 1060 is used to advance anchor 1020 further through catheter device 1370 along the tether toward the tissue to which the anchor is to be anchored ( Fig.20F ), for example, similar to that described for system 1000, mutatis mutandis.

[0545] After the anchor 1020 has been anchored, the clamp 1384 is released from the tether 1012 (e.g., by actuating the actuator 1386 in the reverse direction, such as by unscrewing the ring 1388), and the driver 1060 is withdrawn proximally ( Figure 20G ).

[0546] The tensioner 1380 then returns to its initial position, with the spring 1382 locked in its stressed state ( Fig. 20H). For example, and as shown, the clamp 1384 can be linearly slid distally by sliding the actuator 1386 linearly distally, e.g., without actuating the actuator (e.g., without rotating the ring 1388), until the lock 1360 locks, e.g., until the pawl 1362 re-enters the recess 1364. For some applications in which the clamp 1384 is biased toward assuming its unclamped state (e.g., due to spring loading or shape setting), the lock 1360 automatically locks (e.g., snap locks) when the clamp reaches the appropriate axial position, e.g., where the bias of the clamp causes the pawl 1362 to enter the recess 1364. At this point, the tensioner 1380 and catheter device 1370 as a whole are ready for advancement of the next anchor.

[0547] Reference now Figure 1A-20H For some applications, tissue anchors 220, 320, 420, 520, 620, 720, 820, 1020 may be interchangeable with one another mutatis mutandis. For some applications, components of systems 1000, 1200, and 1400 may be interchangeable with one another mutatis mutandis. For some applications, techniques described with reference to one of systems 1000, 1200, and 1400 may be used mutatis mutandis with another of these systems.

[0548] For 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 conjunction with devices, systems, and / or implanted using methods / techniques described in one or more of the following references, mutatis mutandis, including but not limited to, by replacing corresponding components. Each of the following references is incorporated herein by reference in its entirety:

[0549] Sheps et al., U.S. Patent Application 14 / 437,373, published as US2015 / 0272634 (now U.S. Patent 9,949,828)

[0550] Iflah et al., U.S. Patent Application 15 / 782,687, published as US2018 / 0049875

[0551] Brauon et al., U.S. Patent Application 16 / 534,875, published as US2020 / 0015971

[0552] U.S. Patent Application 17 / 145,258 to Kasher et al., published as US2021 / 0145584

[0553] U.S. Provisional Patent Application 63 / 162,443 to Shafigh et al.

[0554] Similarly, the tissue anchors, implants, delivery tools, systems, and components thereof described in the above references may be used in conjunction with the devices, systems, and / or methods / techniques described herein, including (but not limited to) by replacing corresponding components.

[0555] 1. A system for use with a subject, the system comprising:

[0556] A catheter device, comprising:

[0557] A tube having:

[0558] a distal opening configured to be advanced into the subject, and

[0559] a proximal end defining a proximal opening, and

[0560] an extracorporeal unit coupled to the proximal end of the tube, defining a deployment position,

[0561] and including a track leading to said deployment location;

[0562] a range of tissue anchors; and

[0563] A series of bins, each of the bins:

[0564] retaining a corresponding tissue anchor from the series of tissue anchors,

[0565] coupled to the extracorporeal unit at respective initial positions in a series of initial positions,

[0566] while remaining coupled to the extracorporeal unit, movable along the track from the respective initial position to the deployed position such that in the deployed position the cartridge body holds the respective tissue anchor opposite the proximal opening, and

[0567] It can then be removed from the deployed position, leaving the deployed position empty for consecutive cartridges in the series.

[0568] 2. A system according to clause 1, wherein:

[0569] The catheter device also includes a port at the proximal opening of the tube, the port including a membrane, and

[0570] The membrane is formed to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole.

[0571] 3. The system of clause 2, wherein the first hole is wider in diameter than the second hole.

[0572] 4. The system according to claim 1 further includes an anchor driver, which, for each of the anchors, is configured to couple to the anchor when the anchor is held by the corresponding cartridge body relative to the proximal opening in the deployed position, and to advance the anchor distally out of the corresponding cartridge body, through the proximal opening, and through the tube toward the distal opening.

[0573] 5. A system according to claim 4, wherein the anchor driver is configured to, for each of the anchors, advance the anchor distally out of the corresponding cartridge body, through the proximal opening and through the tube toward the distal opening while the corresponding cartridge body remains in the deployed position.

[0574] 6. A system according to claim 5, wherein, for each of the cartridge bodies, the cartridge body is configured such that the cartridge body can be removed from the deployed position when (i) the cartridge body is in the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening.

[0575] 7. A system according to claim 5, wherein, for each of the cartridge bodies, the cartridge body is configured such that when (i) the cartridge body is in the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening, the anchor driver prevents the cartridge body from being removed from the deployed position.

[0576] 8. A system according to clause 1, wherein:

[0577] Each of the tissue anchors includes a tissue engaging element and a head defining an eyelet, and

[0578] The system also includes a tether:

[0579] passing through the eyelet of each of the tissue anchors,

[0580] having a proximal portion including a proximal end of the tether, and

[0581] There is a distal portion including a distal end of the tether, the distal end of the tether being advanceable distally through the tube into the subject while the proximal end of the tether remains external to the subject.

[0582] 9. A system according to claim 8, wherein for each of the anchors, the anchor driver is configured to advance the anchor distally out of the corresponding housing, through the proximal opening and through the tube toward the distal opening while the eyelet of the anchor remains threaded on the tether.

[0583] 10. A system according to clause 9, wherein:

[0584] The catheter device also includes a port at the proximal opening of the tube, the port including a membrane,

[0585] The membrane is shaped to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole, and

[0586] The ports are arranged such that, for each of the anchors, the anchor driver is configured to advance the anchor distally out of the respective cartridge body and through the membrane, with the tissue engaging element passing through the first aperture and the tether extending through the second aperture.

[0587] 11. A system according to claim 10, wherein the ports are arranged so that for each of the anchors, the anchor driver is configured to advance the anchor distally out of the corresponding housing and through the membrane, wherein the tissue engaging element passes through the first hole and the tether extends through the second hole.

[0588] 12. A system according to claim 11, wherein the port is arranged so that for each of the anchors, when the anchor driver advances the anchor distally out of the corresponding housing and through the membrane, the first hole widens instantaneously as the tissue engaging element of the anchor passes through the first hole.

[0589] 13. A system according to clause 12, wherein the port is arranged so that for each of the anchors, after the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the first hole seals around the anchor driver.

[0590] 14. A system according to claim 11, wherein the port is arranged so that for each of the anchors, when the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the second hole widens instantaneously as the eyelet of the anchor passes through the second hole.

[0591] 15. A system according to clause 11, wherein the ports are arranged so that for each of the anchors, when the anchor driver advances the anchor distally out of the corresponding cartridge body and through the membrane, the slit opens instantaneously as the anchor passes through the membrane.

[0592] 16. A system according to clause 9, wherein:

[0593] The catheter device also includes a port at the proximal opening of the tube, the port including a membrane,

[0594] The membrane is shaped to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole, and

[0595] The ports are arranged such that:

[0596] The membrane is oriented substantially transversely to the proximal end of the tube, and

[0597] For each of the cartridge bodies, when the cartridge body is in the deployed position, the tissue engaging element of the respective tissue anchor is aligned with the first aperture, thereby defining an anchor advancement axis from the respective tissue anchor through the first aperture and through the tube.

[0598] 17. The system of clause 16, wherein the port is arranged such that the tether extends through the second aperture when the distal end of the tether is advanced distally through the tube into the subject while the proximal end of the tether remains external to the subject.

[0599] 18. A system according to clause 8, wherein:

[0600] The catheter device further comprises:

[0601] Springs; and

[0602] a spool coupled to the spring such that rotation of the spool in a first direction applies stress to the spring, and

[0603] The proximal portion of the tether is wrapped around the spool such that distal advancement of the distal portion of the tether through the tube rotates the spool in the first direction.

[0604] 19. The system of any of clauses 1-18, wherein each of the cartridges is configured to lock to the extracorporeal unit upon reaching the deployed position.

[0605] 20. The system of any of clauses 1-18, wherein each of the bins is shaped to be grasped by a human operator by hand and is configured to be moved along the track by the operator by hand.

[0606] 21. A system according to any of clauses 1-18, wherein each of the cartridges is removable from the deployed position by being removed from the extracorporeal unit.

[0607] 22. The system of any of clauses 1-18, wherein each of the cartridge bodies comprises a displaceable barrier that impedes distal advancement of the respective anchor out of the cartridge body.

[0608] 23. The system of clause 22, wherein each of the cartridge bodies comprises a displacement mechanism that, when the displacement mechanism is actuated, displaces the barrier such that the barrier stops to impede distal advancement of the corresponding anchor out of the cartridge body.

[0609] 24. The system of clause 23, wherein the displacement mechanism is configured such that actuation of the displacement mechanism displaces the barrier by linear translation of the barrier.

[0610] 25. The system of clause 23, wherein the displacement mechanism is configured such that actuation of the displacement mechanism displaces the barrier via deflection of the barrier.

[0611] 26. The system of clause 23, wherein the displacement mechanism is spring loaded.

[0612] 27. The system of clause 23, wherein the displacement mechanism is configured to be actuated by a force applied to the respective anchor.

[0613] 28. The system of clause 27, wherein the displacement mechanism is configured to be actuated by an anchor driver that pulls the respective anchor proximally.

[0614] 29. The system of clause 28, wherein for each of the bins:

[0615] The warehouse body comprises:

[0616] a first component, the first component comprising the barrier, and

[0617] a second component that retains the corresponding anchor;

[0618] The displacement mechanism is constrained by the pawl of the cartridge body, and

[0619] The displacement mechanism is configured to be actuated by the anchor driver pulling the respective anchor proximally with sufficient force that the respective anchor pulls the second member proximally relative to the first member such that the pawl stops to restrain the displacement mechanism.

[0620] 30. The system of clause 29, wherein the displacement mechanism is defined by the first component.

[0621] 31. The system of clause 29, wherein the first component defines the pawl.

[0622] 32. The system of clause 31, wherein the pawl constrains the displacement mechanism by contacting the corresponding anchor.

[0623] 33. The system of clause 32, wherein the respective anchor comprises a helical tissue engaging element, and wherein the pawl constrains the displacement mechanism by being disposed within the helical tissue engaging element of the respective anchor.

[0624] 34. The system of clause 29, wherein the second component defines the pawl.

[0625] 35. The system of clause 34, wherein the pawl constrains the displacement mechanism by contacting the engagement mechanism.

[0626] 36. The system of clause 29, wherein the cartridge is coupled to the extracorporeal unit via a coupling between the first component and the extracorporeal unit.

[0627] 37. The system of clause 29, wherein the cartridge is coupled to the extracorporeal unit via a coupling between the second component and the extracorporeal unit.

[0628] 38. A system according to claim 29, wherein each of the cartridge bodies is configured such that the anchor driver pulls the corresponding anchor proximally with sufficient force for the corresponding anchor to pull the second component proximally relative to the first component to reconfigure the cartridge body into a removable state that facilitates removal of the cartridge body from the deployment position.

[0629] 39. The system of clause 29, wherein the second component is mounted within the first component, and the first component is configured to be grasped by a human operator.

[0630] 40. A system for use with a subject, the system comprising:

[0631] A catheter device, comprising:

[0632] a tube having a proximal opening, and

[0633] a controller including a track leading to a deployment position;

[0634] a first cartridge body that retains a first tissue anchor and is coupled to the controller and that is movable along the track from a first initial position to the deployed position while remaining coupled to the controller such that the first cartridge body retains the first tissue anchor opposite the proximal opening; and

[0635] A second housing holds a second tissue anchor and is coupled to the controller and is capable of moving along the track from a second initial position to the deployed position while remaining coupled to the controller such that the second housing holds the second tissue anchor relative to the proximal opening.

[0636] 41. The system of clause 40, wherein the first tissue anchor comprises a first tissue engaging element and a first head comprising a first eyelet, and the second tissue anchor comprises a second tissue engaging element and a second head comprising a second eyelet.

[0637] 42. The system of clause 41 further comprises a tether passing through the first eyelet and the second eyelet, the tether having a proximal portion and a distal portion, the proximal portion comprising a proximal end of the tether, the distal portion comprising a distal end of the tether, the distal end of the tether being capable of being advanced distally through the tube into the object while the proximal end of the tether remains outside the object.

[0638] 43. A system as described in claim 42, wherein the anchor driver is configured to advance the first anchor distally out of the first housing, through the proximal opening, and through the tube, while the first eyelet of the first anchor remains threaded on the tether, and wherein the anchor driver is configured to advance the second anchor distally out of the second housing, through the proximal opening, and through the tube, while the second eyelet of the second anchor remains threaded on the tether.

[0639] 44. A system according to clause 42, wherein the catheter device further comprises a tensioning device configured to apply tension to the tether.

[0640] 45. A system according to claim 44, wherein the tensioning device includes a spring and a reel, the reel being coupled to the spring so that rotation of the reel in a first direction applies stress to the spring, and wherein the proximal portion of the tether is wrapped around the reel so that the distal portion of the tether is advanced distally through the tube causing the reel to rotate in the first direction.

[0641] 46. ​​The system of any of clauses 40-45, wherein each of the first and second cartridges is configured to lock to the controller upon reaching the deployed position.

[0642] 47. The system of any one of clauses 40-45 further comprises an anchor driver capable of coupling to the first anchor when the first anchor is held by the first housing relative to the proximal opening and configured to advance the first anchor distally out of the first housing, through the proximal opening and through the tube, the anchor driver capable of coupling to the second anchor when the second anchor is held by the second housing relative to the proximal opening and configured to advance the second anchor distally out of the second housing, through the proximal opening and through the tube.

[0643] 48. The system of any of clauses 40-45, wherein each of the first and second cartridges is removable from the deployed position by removal from the controller.

[0644] 49. A system according to any of clauses 40-45, wherein the first housing includes a first displaceable barrier that prevents the first anchor from being advanced distally out of the first housing, and wherein the second housing includes a second displaceable barrier that prevents the second anchor from being advanced distally out of the second housing.

[0645] 50. A system according to claim 49, wherein the first housing includes a first displacement mechanism, which displaces the first displaceable barrier when the first displacement mechanism is actuated, so that the first displaceable barrier stops to hinder the first anchor from being advanced distally out of the first housing, and wherein the second housing includes a second displacement mechanism, which displaces the second displaceable barrier when the second displacement mechanism is actuated, so that the second displaceable barrier stops to hinder the second anchor from being advanced distally out of the second housing.

[0646] 51. The system of clause 50, wherein the first displacement mechanism and the second displacement mechanism are both spring loaded.

[0647] 52. The system of clause 50, wherein the first displacement mechanism is configured to be actuated by a force applied to the first anchor, and wherein the second displacement mechanism is configured to be actuated by a force applied to the second anchor.

[0648] 53. The system of clause 52, wherein the first displacement mechanism is configured to be actuated by an anchor driver that pulls the first anchor proximally, and wherein the second displacement mechanism is configured to be actuated by an anchor driver that pulls the second anchor proximally.

[0649] 54. The system of clause 53, wherein the first cartridge body comprises a first component and a second component, the first component comprising the barrier, the second component coupling the first cartridge body to the extracorporeal unit and retaining the first anchor.

[0650] 55. A system according to claim 54, wherein the second component defines a pawl that constrains the first displacement mechanism, and wherein the first displacement mechanism is configured to be actuated by the anchor driver by pulling the first anchor proximally with sufficient force for the first anchor to pull the second component proximally relative to the first component, so that the pawl stops to constrain the first displacement mechanism.

[0651] 56. The system of clause 55, wherein the second component slidably couples the first bin to the track.

[0652] 57. A system according to claim 56, wherein the first cartridge body is configured such that the anchor driver pulls the first anchor proximally with sufficient force that the first anchor pulls the second component proximally relative to the first component to reconfigure the first cartridge body into a removable state that facilitates removal of the first cartridge body from the deployment position.

[0653] 58. The system of clause 54, wherein the second component is mounted within the first component, and the first component is configured to be grasped by a human operator.

[0654] 59. The system according to any one of clauses 40-45 further includes a third housing, which holds a third tissue anchor and is coupled to the controller, and while remaining coupled to the controller, is capable of moving along the track from a third initial position to the deployed position, so that the third housing holds the third tissue anchor relative to the proximal opening.

[0655] 60. An apparatus comprising:

[0656] A catheter system comprising an in vitro controller and a transluminally advanceable catheter, wherein the in vitro controller is at a proximal portion of the catheter system, the transluminally advanceable catheter extending distally from the controller along a longitudinal catheter axis to a distal opening of the catheter, the catheter comprising:

[0657] a channel including a generally tubular wall defining a lumen along the catheter axis, the tubular wall having a transverse slit extending along at least a portion of the channel at a distal portion of the channel; and

[0658] a helical thread partially overlapping the channel and operably coupled to the controller such that the thread is rotatable relative to the channel about the catheter axis via operation of the controller, the catheter having an anchor storage area in which the thread at least partially longitudinally coincides with the slit,

[0659] and;

[0660] at least one tissue anchor disposed within the anchor storage area and comprising:

[0661] a tissue engaging portion disposed within the lumen of the passageway and defining a tissue anchor axis;

[0662] an anchor head coupled to the tissue engaging portion and defining a driver interface; and

[0663] a projection coupled to the tissue engaging portion via the anchor head and projecting laterally relative to the tissue engaging portion so as to extend through the slit and engage the

[0664] The thread is such that:

[0665] When the threads are stationary relative to the channel, the tissue anchor is secured within the anchor storage region, and

[0666] Rotation of the threads about the tissue anchor axis relative to the channel advances the tissue anchor distally until the protrusion clears the distal exit of the threads.

[0667] 61. The apparatus of clause 60, wherein the slit defines a linear slit disposed parallel to the catheter axis.

[0668] 62. The apparatus of clause 60, wherein the protrusion is rotatably coupled to the tissue engaging portion via the anchor head.

[0669] 63. The apparatus of clause 60, further comprising an inner tube surrounding a proximal portion of the channel, and wherein the threads extend from a distal end of the inner tube and over a distal portion of the channel and define a tubular structure.

[0670] 64. Apparatus according to any of clauses 60-63, wherein:

[0671] The at least one tissue anchor includes at least a first tissue anchor and a second tissue anchor sequentially disposed within the anchor storage area, each of the first tissue anchor and the second tissue anchor including a respective protrusion,

[0672] When the threads are stationary, the first tissue anchor is disposed in a first position distal to the second tissue anchor, the second tissue anchor is disposed in a second position, and

[0673] Rotation of the thread about the catheter axis relative to the channel (a) advances the first tissue anchor distally until the protrusion of the first tissue anchor clears the distal exit of the thread and the first tissue anchor moves distally away from the first position, and (b) advances the second tissue anchor distally away from the second position until the second tissue anchor moves distally into the first position.

[0674] 65. The apparatus of clause 64, further comprising a spring disposed within the catheter proximal to the second tissue anchor, the spring configured to facilitate distal movement of the first and second tissue anchors.

[0675] 66. The apparatus of any of clauses 60-63, further comprising an anchor driver comprising a driver head coupled to the flexible shaft, wherein:

[0676] The driver head is dimensioned to slide axially within the lumen of the passageway and is actuatable to reversibly engage the driver interface within the anchor storage area, and

[0677] The anchor driver is configured such that when the driver head is engaged with the driver interface:

[0678] advancing the anchor distally away from the anchor storage area toward the distal opening of the catheter, and

[0679] The tissue engaging portion is driven into the tissue along the tissue anchor axis.

[0680] 67. Apparatus according to clause 66, wherein the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during the rotation of the thread about the catheter axis relative to the channel.

[0681] 68. The apparatus of any of clauses 60-63, further comprising an outer tube disposed around the passage and the threads in such a manner that the threads are disposed between the outer tube and the passage.

[0682] 69. Apparatus according to clause 68, wherein the threads are movable and rotatable relative to the outer tube and relative to the passageway.

[0683] 70. The apparatus of clause 68, wherein an inner surface of the outer tube defines a helical groove that defines the threads in a manner such that rotation of the outer tube facilitates rotation of the threads.

[0684] 71. Apparatus according to any of clauses 60 to 63, wherein:

[0685] The tissue anchor defines a tissue anchor axis,

[0686] The tissue engaging element is disposed along the axis and is rotatable about the tissue anchor axis,

[0687] The tissue engaging element is configured to be driven into tissue of a subject along the tissue anchor axis, and

[0688] The protrusion extends radially away from the tissue anchor axis.

[0689] 72. The apparatus of clause 71, wherein the anchor head is fixedly coupled to the tissue engaging portion, and wherein the protrusion is rotatably coupled to the anchor head.

[0690] 73. The apparatus of clause 71, wherein the anchor head is disposed within the lumen.

[0691] 74. The apparatus of clause 71, wherein:

[0692] The thread defines a plurality of adjacent bands arranged helically,

[0693] The protrusion is disposed against a surface defining a depth of a distal band of the plurality of bands and has a spacing between the distal band of the plurality of bands and an adjacent band of the plurality of bands proximal to the distal band, and

[0694] During rotation of the threads about the catheter axis, the protrusion slides along the surface defining the depth of the distal band of the plurality of bands.

[0695] 75. The apparatus of clause 71, wherein the tissue anchor defines a tissue anchor lumen along the tissue anchor axis, and wherein the apparatus further comprises an anchor driver comprising a driver head coupled to a flexible shaft, wherein:

[0696] The driver head is dimensioned to slide axially within the tissue anchor lumen and is actuatable to reversibly engage the driver interface within the anchor storage region, and

[0697] The anchor driver is configured such that when the driver head is engaged with the driver interface:

[0698] advancing the anchor distally away from the anchor storage area toward the distal opening of the catheter, and

[0699] The tissue engaging portion is driven into the tissue along the anchor axis.

[0700] 76. The apparatus of clause 75, wherein the catheter system is arranged such that the anchor driver is configured to advance the anchor distally during the rotation of the thread about the catheter axis relative to the channel.

[0701] 77. Apparatus according to any of clauses 60 to 76, wherein the protrusion is shaped so as to define an eyelet, the eyelet defining a hole.

[0702] 78. The apparatus of clause 77, further comprising a wire slidably coupled to the at least one tissue anchor, and wherein the wire is passed through the hole of the eyelet of the protrusion.

[0703] 79. An apparatus comprising:

[0704] at least one tissue anchor; and

[0705] A catheter system comprising an in vitro controller and a transluminally advanceable catheter, wherein the in vitro controller is at a proximal portion of the catheter system, the transluminally advanceable catheter extending distally from the controller along a longitudinal catheter axis to a distal opening of the catheter, the catheter comprising:

[0706] a channel including a generally tubular wall defining a lumen along the catheter axis, the anchor being disposed in the lumen; and

[0707] a dispenser distal to the anchor and including a proximal pawl and a distal pawl and operably coupled to the controller so as to be transitionable between a receiving state, a closed state, and a dispensing state via operation of the controller:

[0708] In the receiving state, wherein (i) the proximal detent collapses away from the catheter axis, allowing the anchor to move distally past the proximal detent and into the dispenser, and (ii) the distal detent extends into the lumen, hindering the anchor from moving distally past the distal detent and out of the dispenser;

[0709] In the closed state, (a) the proximal detent extends into the lumen, hindering the anchor from returning proximally past the proximal detent and out of the dispenser, and (b) the distal detent extends into the lumen, hindering the anchor from moving distally past the distal detent and out of the dispenser; and

[0710] In the dispensed state, (1) the proximal detent extends into the lumen, preventing the anchor from returning proximally past the proximal detent and exiting the dispenser, and (2) the distal detent collapses away from the catheter axis, allowing the anchor to move distally past the distal detent and exit the dispenser.

[0711] 80. The device according to clause 79 further includes a tubular structure surrounding at least a portion of the channel, wherein the tubular structure is coupled to the dispenser in such a manner that movement of the tubular structure distally and proximally along the channel facilitates collapse of the proximal and distal pawls and extension of the proximal and distal pawls into the lumen of the channel.

[0712] 81. The apparatus of clause 80, wherein the tubular wall of the passageway is shaped so as to define a transverse window exiting the lumen, the window having a proximal edge and a distal edge, and wherein:

[0713] the tubular structure surrounding the at least a portion of the passage at the transverse window,

[0714] Proximal movement of the tubular structure relative to the transverse window facilitates collapse of the proximal detent against a proximal edge of the window, causing the proximal detent to move away from the catheter axis, and

[0715] Distal movement of the tubular structure relative to the transverse window facilitates collapse of the distal detent against a distal edge of the window, causing the distal detent to move away from the catheter axis.

[0716] 82. The apparatus of clause 80, further comprising an outer tube disposed around the tubular structure in such a manner that the tubular structure is disposed between the outer tube and the passage.

[0717] 83. Apparatus according to any of clauses 79 to 82, wherein:

[0718] The at least one tissue anchor defines a first tissue anchor,

[0719] The device further comprises at least one additional tissue anchor disposed within the lumen proximal to the dispenser,

[0720] After the first tissue anchor moves distally past the distal detent and leaves the dispensed state of the dispenser:

[0721] the dispenser returns to the receiving state in which the dispenser allows the at least one additional anchor to move distally past the proximal detent and into the dispenser,

[0722] the dispenser transitions to the closed state in which the dispenser blocks the at least one additional anchor from moving distally past the distal detent and out of the dispenser, and

[0723] Subsequently, the dispenser transitions to the dispensing state in which the dispenser allows the at least one additional tissue anchor to move distally past the distal detent and out of the dispenser.

[0724] 84. The apparatus of clause 83, further comprising a spring disposed within the catheter proximal to the at least one additional tissue anchor, the spring configured to facilitate distal movement of the first tissue anchor and the at least one additional tissue anchor.

[0725] 85. The device of any of clauses 79-82, wherein the at least one tissue anchor comprises:

[0726] a tissue engaging portion disposed within the lumen of the passageway and defining a tissue anchor axis;

[0727] an anchor head coupled to the tissue engaging portion and defining a driver interface; and

[0728] An eyelet defines a hole, the eyelet projecting laterally relative to the tissue engaging portion.

[0729] 86. The apparatus of clause 85, wherein the eyelet is rotatably coupled to the tissue engaging portion via the anchor head.

[0730] 87. The apparatus of clause 85, further comprising a wire slidably coupled to the at least one tissue anchor, and wherein the wire passes through the hole...

Claims

1. A system for use with a subject, the system comprising: A catheter device, comprising: A tube having: a distal opening configured to be advanced into the subject, and a proximal end defining a proximal opening, and an extracorporeal unit coupled to the proximal end of the tube, defining a deployment location, and including a track leading to the deployment location; a range of tissue anchors; and A series of bins, each of the bins: retaining a corresponding tissue anchor from the series of tissue anchors, coupled to the extracorporeal unit at respective initial positions in a series of initial positions, while remaining coupled to the extracorporeal unit, movable along the track from the respective initial position to the deployed position such that in the deployed position the cartridge body holds the respective tissue anchor opposite the proximal opening, and It can then be removed from the deployed position, leaving the deployed position empty for consecutive cartridges in the series.

2. The system of claim 1, wherein: The catheter device also includes a port at the proximal opening of the tube, the port including a membrane, and The membrane is formed to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole.

3. The system of claim 2, wherein the first hole is wider in diameter than the second hole.

4. The system according to claim 1 further includes an anchor driver, which, for each of the anchors, is configured to couple to the anchor when the anchor is held by the corresponding cartridge body relative to the proximal opening in the deployed position, and to advance the anchor distally out of the corresponding cartridge body, through the proximal opening, and through the tube toward the distal opening.

5. A system according to claim 4, wherein the anchor driver is configured to, for each of the anchors, advance the anchor distally out of the corresponding cartridge body, through the proximal opening and through the tube toward the distal opening while the corresponding cartridge body remains in the deployed position.

6. The system according to claim 5, wherein: For each of the cartridge bodies, the cartridge body is configured such that the cartridge body is removable from the deployed position when (i) the cartridge body is in the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening.

7. The system according to claim 5, wherein: For each of the cartridge bodies, the cartridge body is configured such that when (i) the cartridge body is in the deployed position and (ii) the anchor driver extends distally beyond the cartridge body and through the tube toward the distal opening, the anchor driver prevents the cartridge body from being removed from the deployed position.

8. The system of claim 1, wherein: Each of the tissue anchors includes a tissue engaging element and a head defining an eyelet, and The system also includes a tether: passing through the eyelet of each of the tissue anchors, having a proximal portion including a proximal end of the tether, and There is a distal portion including a distal end of the tether, the distal end of the tether being advanceable distally through the tube into the subject while the proximal end of the tether remains external to the subject.

9. A system according to claim 8, wherein for each of the anchors, the anchor driver is configured to advance the anchor distally out of the corresponding cartridge body, through the proximal opening and through the tube toward the distal opening while the eyelet of the anchor remains threaded on the tether.

10. The system of claim 9, wherein: The catheter device also includes a port at the proximal opening of the tube, the port including a membrane, The membrane is shaped to define a first hole through the membrane, a second hole through the membrane, and a closed slit connecting the first hole with the second hole, and The ports are arranged such that, for each of the anchors, the anchor driver is configured to advance the anchor distally out of the respective cartridge body and through the membrane, with the tissue engaging element passing through the first aperture and the tether extending through the second aperture.

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