Systems and methods for anchoring medical implants

Abstract

An anchor (120) is addable to a tether (112) that is transluminally implantable at a tissue of a subject. The anchor has a head (122), a tissue-engaging element (130), and an eyelet (126). The tissue-engaging element can be driven into the tissue. The eyelet is mounted on the head is gated to facilitate lateral introduction of an intermediate region of the tether into the eyelet, such that the intermediate region becomes disposed through the eyelet. An anchor-adding device (20) includes a shell (22) in which is situated a cavity (30) that houses the anchor. The shell defines a slot (24) via which the intermediate region of the tether is slidable to the cavity for lateral introduction in the eyelet. Other embodiments are also described.

Description

SYSTEMS AND METHODS FOR ANCHORING MEDICAL IMPLANTSCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to Provisional US Patent Application 63 / 653,842 to Darabian, titled “Systems and methods for anchoring medical implants,” filed on May 30, 2024; and to Provisional US Patent Application 63 / 768,075 to Darabian et al., titled “Systems and methods for anchoring medical implants,” filed on March 6, 2025.

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

[0003] Implants that include anchors threaded on a tether, a cord, a wire, a suture, a filament, or a ribbon, can be used for various treatments, including cardiac repair treatments such as annuloplasty and / or chord repair.SUMMARY

[0004] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0005] Some of the systems, apparatuses, devices, methods, techniques, etc. described herein, and implementations and applications thereof, include or are configured to be used with an implant (which can be the same as or similar to other implants described herein or in the references incorporated herein) that includes multiple anchors slidably coupled to a tether (e.g., a line, wire, ribbon, rope, cable, braid, contraction member, contraction member, suture, etc.). In some implementations, the multiple anchors can include anchors of different sizes and / or configurations.

[0006] In some implementations, the implant can be a tissue-adjustment implant that contracts tissue upon tensioning of the tether.

[0007] In some implementations, the implant can be usable and / or configured for use at a heart of a subject (e.g., a living subject, a simulation, etc.). For example, the implant can be an annuloplasty implant.

[0008] In some implementations, the implant can be configured and / or used to close another opening (e.g., an opening to an appendage, an opening to a left atrial appendage, an opening to a passageway, etc.) or reshape another region of tissue (e.g., ventricular remodeling, atrial remodeling, muscle remodeling, etc.)

[0009] In some implementations, a delivery system is provided for advancement and anchoring of the anchors (e.g., an implant that includes the anchors threaded on the tether).

[0010] In some implementations, the delivery system can include a catheter device and / or an anchor driver.

[0011] In some implementations, the catheter device can include a tube, and an extracorporeal unit, e.g., at a proximal end of the tube.

[0012] In some implementations, the anchors can be mounted, in a series, on the extracorporeal unit.

[0013] In some implementations, the extracorporeal unit can be configured as and / or include an anchor-adding device.

[0014] In some implementations, the tether can be threaded through the anchors (e.g., all, some, or just one of the anchors) in this arrangement.

[0015] In some implementations, the anchors, which the tether is threaded through, include at least one anchor that is a different size and / or configuration from another anchor the tether is threaded through.

[0016] In some implementations, the anchors, which the tether is threaded through, include more than one anchor that is a different size and / or configuration from more than one other anchor the tether is threaded through.

[0017] In some implementations, a series of cartridges (or anchor holders) can be mounted on the extracorporeal unit and can hold the anchors in the series.

[0018] In some implementations, one or more (e.g., one, some, or all) cartridges can be configured to facilitate bringing its corresponding anchor to a proximal opening of the tubefor advancement, by the driver, through the tube to the site at which the anchor is to be anchored.

[0019] In some implementations, the extracorporeal unit and / or the cartridges can be configured to facilitate verification of engagement between the driver and the anchor prior to advancement.

[0020] In some implementations, anchors are configured (e.g., shaped) to be slidable along a tether (e.g., a line, wire, contraction member, etc.) both (i) while aligned (e.g., parallel or coaxial) with the tether, and (ii) while oriented orthogonal to the tether. This can help facilitate, inter alia, (i) advancement of the anchor along the tether while aligned with the tether during transcatheter delivery, and (ii) subsequent sliding of the tether with respect to the anchor after implantation, e.g., while the tether is orthogonal to the anchor.

[0021] In some implementations, each anchor can include (i) a tissue-engaging element, (ii) and a head at a proximal end of the tissue-engaging element.

[0022] In some implementations, the tissue-engaging element can be a screw-in tissueengaging element, e.g., can be helical, screw-like, threaded, etc.

[0023] In some implementations, the tissue-engaging element can include one or more hooks, barbs, darts, staples, clips, protrusions, arms, expandable portions, threaded portions, rivets, pledgets, combinations of two or more of these, etc.

[0024] In some implementations, the head can include or define an interface via which the anchor driver can engage and apply an anchoring force (e.g., torque) to the anchor.

[0025] In some implementations, each anchor can include an eyelet, or any connector / attachment, coupled to the head of the anchor.

[0026] In some implementations, the anchor can be coupled to the tether. For instance, the anchor can be coupled to the tether by the eyelet being threaded onto the tether. In some implementations, the eyelet (or other connector) can be disposed laterally from the axis of the anchor. The eyelet (or other connector) can be configured in a variety of different ways.

[0027] In some implementations, one or more eyelets of one or more anchors is flexible in a manner that facilitates smooth sliding along the tether both (i) when the anchor is parallel with the tether and (ii) when the anchor is in an orthogonal orientation with respect to the tether.

[0028] In some implementations, the eyelet includes and / or is formed from a textile (e.g., a polyfilament structure), such as a yarn.

[0029] In some implementations, one or more eyelets of one or more anchors includes and / or is formed from a polymer (e.g., a polymer suture, a polymer yarn, a polymer filament, etc.).

[0030] In some implementations, the eyelet includes and / or is formed from a textile and / or a polymer, wherein the textile and / or polymer is also configured and / or formed to define a collar that circumscribes part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head), coupling (directly or indirectly) the eyelet to the head and / or a stock or neck region of the head (or stock or neck region proximate the head) (e.g., coupling the eyelet directly to the head, coupling the eyelet directly to a stock or neck region of and / or proximate the head, coupling the eyelet to a bushing on or associated with the head and / or a stock or neck region of and / or proximate the head).

[0031] In some implementations, the collar that circumscribes part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head) can include and / or is formed by one or more loops (e.g., 1 loop, 2 loops, 3 loops, etc.) of the textile and / or polymer that loop around the part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head). This configuration can be used whether or not looped on a bushing, e.g., a bushing around the head, stock, neck, etc.

[0032] In some implementations, each anchor can include a spacer, extending away from the anchor head along the tether, e.g., distally, toward the preceding anchor in the series.

[0033] In some implementations, the spacer is not fixed to the anchor. For example, the spacer can be advanced along the tether by the anchor.

[0034] In some implementations, the spacer can inhibit approximation of the anchor and the preceding anchor.

[0035] In some implementations, the spacer is a fixed length and is incompressible.

[0036] In some implementations, the spacer can be coupled to the head and / or the eyelet of the anchor.

[0037] In some implementations, the spacer can be integrally formed with the head and / or the eyelet of the anchor.

[0038] In some implementations, the spacer can be revolvable around the head and / or around an axis (e.g., central axis, and / or longitudinal axis) of the anchor. In some implementations, the spacer can be rotatable with respect to the axis of the anchor.

[0039] In some implementations, the tube of the catheter device has at its distal end, one or more resilient ribs, nubs, or nodules that engage the tissue-engaging element of the anchor in a manner that controls advancement of the anchor distally out of the tube. For example, the ribs can allow the anchor to be advanced distally only while the tissue-engaging element is being rotated, e.g., can inhibit non-rotational axial advancement.

[0040] In some implementations, the ribs can be less inhibitive of non-rotational axial retraction.

[0041] In some implementations, tensioning of the tether slides the tether through the eyelet (or other connector) of each anchor, drawing the anchors toward each other and thereby contracting the tissue to which the anchors are anchored, e.g., the annulus of a heart valve, etc. In order to lock the tension into the tether, a lock (which may, in some implementations, be considered a stopper) is advanced along the tether and locked to the tether, e.g., at the most recently-anchored anchor.

[0042] In some implementations, the lock is configured such that its actuation both locks the lock to the tether and cuts (e.g., trims) the tether so that excess tether can be withdrawn.

[0043] In some implementations, the lock can be introduced onto the tether without access to either end of the tether.

[0044] In some implementations, a tensioner is provided that can engage an intermediate region of the tether (e.g., without access to either end of the tether), and apply tension to the tether from there.

[0045] In some implementations, the tensioner is mounted or mountable on the extracorporeal unit of the catheter tool, which provides access to the intermediate portion of the tether.

[0046] In accordance with some implementations, a system and / or an apparatus for use in a medical procedure includes a tether (e.g., wire, suture, line, contraction member, braid, rope, etc.) and multiple anchors. In some implementations, the tether (e.g., a portion of the tether, etc.) and the multiple anchors form an implant. The implant can be the same as or similar tothe implants described above or elsewhere herein and can include any of the features and / or components thereof - e.g., spacers, flexible eyelets, one or more locks, etc.

[0047] In some implementations, the tether is transluminally implantable at a tissue of a subject (e.g., a living subject and / or a simulation).

[0048] In some implementations, the multiple anchors include at least two anchors of different sizes and / or configurations.

[0049] In some implementations, the multiple anchors include multiple anchors of multiple different sizes and / or configurations.

[0050] In some implementations, different anchors can be different in length, thickness, pitch, radius of curvature, width, wire diameter, etc.

[0051] In some implementations, the system and / or apparatus is configured for treating a heart transluminally. In some implementations, the system and / or apparatus is configured for treating a heart valve transluminally.

[0052] In some implementations, the system and / or apparatus can optionally be configured for treating one or more tissues, body parts, and / or regions, including those outside the heart or cardiovascular system.

[0053] In some implementations, the system and / or apparatus includes an implant that remains in the body of a subject (e.g., a living subject and / or a simulation).

[0054] In some implementations, the tether (e.g., a portion of the tether, etc.) and the multiple anchors are part of an annuloplasty implant capable of reshaping or reconfiguring an annulus.

[0055] In some implementations, the multiple anchors can be positioned at different locations associated with a heart valve. In some implementations, the tether connects the multiple anchors together (e.g., through eyelets, posts, connectors, or other attachments associated with the multiple anchors.). In some implementations, it may be desirable to have different sized anchors at different locations in the body of the patient (e.g., at different locations around a heart valve). For example, longer anchors may provide increased retention force in tissue, while smaller anchors may be better at avoiding an anatomical feature (e.g., avoiding piercing a nearby blood vessel by not penetrating deeply enough to hit the blood vessel, etc.). Further, thicker anchors can provide added retention in tissue as compared to thinner anchors, while thinner anchors may be easier to insert, etc.

[0056] In some implementations, all, some, or one of the multiple anchors can include an anchoring feature - e.g., a retention feature, a barb, multiple barbs, a helix, multiple helixes, a hook, multiple hooks, a dart, multiple darts, a pin, multiple pins, etc. The anchoring feature can be a tissue-engagement feature as described elsewhere herein and / or be in addition to a tissue-engagement feature described elsewhere herein.

[0057] In some implementations, all of the multiple anchors can be provided pre-attached to the tether.

[0058] In some implementations, different sizes and / or configurations of anchors of the multiple anchors can be configured and / or attached such that desired anchor sizes / configurations will be placed as desired during operation. In some implementations, the anchor size can be indicated on a corresponding cassette, e.g., case housing the anchor.

[0059] In some implementations, some of the multiple anchors can be provided pre-attached to the tether, while others need to be attached to the tether during or before operation. In some implementations, all of the multiple anchors can be provided separate from the tether and need to be attached to the tether during or before operation. In some implementations, being able to attach additional anchors to the tether as desired may be helpful to customize an implant and / or operation as the procedure progresses.

[0060] In some implementations, for example in systems / apparatuses having a tether that is transluminally implantable at a tissue of a subject, the system / apparatus can include an anchor and / or an anchor-adding device (e.g., a cassette, anchor-connection device, clip, cartridge, etc.).

[0061] In some implementations, the anchor can be the same as or similar to other anchors described herein, including any of the multiple anchors above. In some implementations, the anchor can be associated with and / or include a spacer.

[0062] In some implementations, the anchor can include a head and / or a tissue-engaging element. In some implementations, the tissue-engaging element can include one or more of a helix, a screw, a dart, a hook, a barb, an anchoring feature, etc.

[0063] In some implementations, the anchor can include an element (e.g., protrusion) to prevent pull-out and / or back-spinning of the anchor.

[0064] In some implementations, the tissue-engaging element can extend distally away from the head to define an anchor axis of the anchor.

[0065] In some implementations, the tissue-engaging element can be configured to be driven along the anchor axis into the tissue.

[0066] In some implementations, the anchor can be configured to be added to supplement existing anchors (e.g., of an implant) that are already attached to and / or threaded on the tether (e.g., of the implant).

[0067] In some implementations, the anchor can be associated with, include, or be coupled with an optional spacer, and also be configured to be added to supplement existing anchors (e.g., of an implant) that are already attached to and / or threaded on the tether (e.g., of the implant), including with the spacer.

[0068] In some implementations, the anchor, which can be an anchor of or associated with the anchor-adding device, can be considered to be, or referred to, as a supplemental anchor.

[0069] In some implementations, the eyelet can be mounted on the head, and / or can define a gate via which an intermediate region of the tether is laterally introducible into the eyelet to become disposed through the eyelet.

[0070] In some implementations, the anchor-adding device or cassette (e.g., anchorconnection device, clip, cartridge, etc.) can include a shell in which is situated a cavity that houses the anchor.

[0071] In some implementations, the shell can define a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the eyelet.

[0072] In some implementations, the cavity is entirely internal to the anchor-adding device or cassette.

[0073] In some implementations, the shell is shaped such that at least part of the cavity is exposed at a surface of the anchor-adding device or cassette.

[0074] In some implementations, the eyelet protrudes laterally from the head.

[0075] In some implementations, the cavity is dimensioned to house at least part of the anchor snugly.

[0076] In some implementations, the cavity is dimensioned to constrain the anchor in a given rotational orientation about the anchor axis.

[0077] In some implementations, the gate is biased to be closed.

[0078] In some implementations, the slot is positioned with respect to the cavity such that sliding the intermediate region of the tether through the slot to the cavity snaps the intermediate region of the tether through the gate into the eyelet.

[0079] In some implementations, the system and / or apparatus further includes the tether.

[0080] In some implementations, the slot is planar.

[0081] In some implementations, the slot defines a plane, and the cavity houses the anchor with the anchor axis parallel to the plane.

[0082] In some implementations, the slot is configured such that the intermediate region of the tether is, while tensioned, slidable to the cavity via the slot.

[0083] In some implementations, the anchor-adding device or cassette is configured for release of the anchor while the intermediate region of the tether remains disposed through the eyelet.

[0084] In some implementations, the anchor-adding device or cassette is configured for release of the anchor only upon the intermediate region of the tether having been slid through the slot.

[0085] In some implementations, the anchor-adding device or cassette defines a passage, and is configured for release of the anchor by the anchor being pulled out of the anchoradding device or cassette via the passage.

[0086] In some implementations, the anchor-adding device or cassette is configured for release of the anchor by the shell being openable to expose the anchor in the cavity.

[0087] In some implementations, the shell is hinged to be openable in a clamshell manner.

[0088] In some implementations, the anchor-adding device or cassette includes an actuator, manually operable to facilitate lateral introduction of the intermediate region of the tether, at the cavity, into the eyelet.

[0089] In some implementations, the actuator is configured to open the gate while the anchor is housed in the cavity.

[0090] In some implementations, actuator is configured to close the gate while the anchor is housed in the cavity.

[0091] In some implementations, the actuator is configured to force the intermediate region of the tether, at the cavity, through the gate into the eyelet.

[0092] In some implementations, the system / apparatus is further for use with a driver for the anchor.

[0093] In some implementations, the shell can further define a passage via which the driver is insertable to the cavity to engage the head.

[0094] In some implementations, the system and / or apparatus further includes the driver, the driver including a flexible shaft and a drivehead at a distal end of the shaft, the drivehead being insertable via the passage to the cavity, the passage guiding the drivehead into engagement with the head.

[0095] In some implementations, the anchor-adding device or cassette is configured for release of the anchor by the anchor being pulled out of the anchor-adding device or cassette via the passage while the intermediate region of the tether remains disposed through the eyelet.

[0096] In some implementations, the passage is shaped such that, at least upon arrival of the drivehead at the head, the drivehead is rotationally aligned with the head.

[0097] In some implementations, the passage is shaped to accept the drivehead only in rotational alignment with the head.

[0098] In some implementations, the passage is shaped to rotationally align the drivehead with the head as the drivehead is advanced through the passage toward the cavity.

[0099] In some implementations, the slot defines a plane in which the intermediate region of the tether is slidable to the cavity, the passage being parallel to the plane.

[0100] In some implementations, the slot defines a plane in which the intermediate region of the tether is slidable to the cavity, the passage lying on the plane.

[0101] In accordance with some implementations, a system, useable and / or for use with a tissue of a subject (e.g., a living subject and / or a simulation) includes one or more of a catheter device, a tether, a series of system-anchors, a supplemental-anchor, and an anchor adding device (e.g., including one or more of a cassette, anchor-connection device, clip, cartridge, etc.).

[0102] In some implementations, the system includes an anchor-adding device that includes a cassette (or anchor-connection device, clip, cartridge, etc.) with the supplemental-anchor disposed therein.

[0103] In some implementations, the cassette (or anchor-connection device, clip, cartridge, etc.) can include a shell in which is situated a cavity that houses the supplemental-anchor.

[0104] In some implementations, the catheter device can include a flexible tube, and / or an extracorporeal unit. In some implementations, the flexible tube can have a distal opening that is configured to be transluminally advanced toward the tissue, and / or a proximal end that defines a proximal opening.

[0105] In some implementations, the extracorporeal unit can be configured as and / or include an anchor-adding device.

[0106] In some implementations, the extracorporeal unit can be coupled to the proximal end of the tube, and / or can include a body, and / or a series of cartridges, distributed along the body.

[0107] In some implementations, the tether can extend along the body.

[0108] In some implementations, each of the system-anchors can be housed by a corresponding cartridge of the series of cartridges.

[0109] In some implementations, each of the system-anchors can include a system-anchor head.

[0110] In some implementations, each of the system-anchors can include a system-anchor tissue-engaging element, extending from the system-anchor head.

[0111] In some implementations, each of the system-anchors is configured to be driven into the tissue.

[0112] In some implementations, a system-anchor eyelet (or other connection or attachment feature) is mounted on the system-anchor head and / or threaded on the tether of one or more system anchors.

[0113] In some implementations, the supplemental-anchor can include a supplemental- anchor head.

[0114] In some implementations, the supplemental-anchor can include a supplemental- anchor tissue-engaging element, extending from the supplemental-anchor head.

[0115] In some implementations, the supplemental-anchor can be configured to be driven into the tissue.

[0116] In some implementations, the supplemental-anchor can include a supplemental- anchor eyelet or other attachment / connection feature.

[0117] The supplemental-anchor eyelet can be mounted on or otherwise connected or coupled to the supplemental-anchor head.

[0118] In some implementations, the supplemental-anchor eyelet defines a gate via which an intermediate region of the tether is laterally introducible into the supplemental-anchor eyelet to become disposed through the supplemental-anchor eyelet.

[0119] In some implementations, the shell of the cassette can define a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the supplemental-anchor eyelet.

[0120] In some implementations, the supplemental-anchor tissue-engaging element is geometrically different from the system-anchor tissue-engaging element.

[0121] In some implementations, the supplemental-anchor tissue-engaging element is wider than the system-anchor tissue-engaging element.

[0122] In some implementations, the supplemental-anchor tissue-engaging element is narrower than the system-anchor tissue-engaging element.

[0123] In some implementations, the supplemental-anchor tissue-engaging element is longer than the system-anchor tissue-engaging element.

[0124] In some implementations, the supplemental-anchor tissue-engaging element is shorter than the system-anchor tissue-engaging element.

[0125] In some implementations, the supplemental-anchor head is substantially identical to the system-anchor head.

[0126] In some implementations, the system further includes a driver that includes a flexible shaft and a drivehead at a distal end of the shaft.

[0127] In some implementations, each of the system-anchor heads defines a system-anchor interface that is engageable by the drivehead.

[0128] In some implementations, the supplemental-anchor head can define a supplemental- anchor interface that is engageable by the drivehead, and that can be identical or substantially identical to the system-anchor interface.

[0129] In some implementations, the shell further defines a passage via which the drivehead is insertable to the cavity such that the passage guides the drivehead into engagement with the system-anchor head.

[0130] In accordance with some implementations, a method is usable and / or for use with a tether that has a first end, a second end, and an intermediate portion therebetween. In some implementations, the method includes, without access to the first end or the second end sliding the intermediate portion laterally through a slot in an anchor-adding device.

[0131] In some implementations, the anchor-adding device includes a case. In some implementations, the case defines a cavity in which an anchor is disposed.

[0132] In some implementations, the method includes within the cavity, coupling the anchor to the tether by laterally introducing the intermediate portion of the tether into an eyelet of the anchor.

[0133] In some implementations, the method includes subsequently, removing the anchoradding device from the tether, leaving the anchor coupled to the tether.

[0134] In some implementations, the anchor-adding device includes a cassette (or other clip, cartridge, etc.) having a case.

[0135] In some implementations, the case of the cassette defines the cavity in which the anchor is disposed.

[0136] In some implementations, the eyelet includes a clip that defines the gate, and the gate is biased closed by a spring element.

[0137] In some implementations, the eyelet includes a shackle that defines the gate. The shackle can include a groove that is configured to be inserted into a latch of the eyelet to lock the gate.

[0138] In some implementations, the eyelet includes two wires that are connected to each other via a tongue that defines the gate.

[0139] In some implementations, the wires are mirror images of each other along a vertical plane that bisects the tongue.

[0140] In some implementations, an end of each wire begins at and extends away from the head and the tongue extends from the wires toward the head to form loops.

[0141] In some implementations, the tongue is configured to receive the tether when the tether is bent.

[0142] In some implementations, the anchor-adding device includes an actuator that is configured to thread the tether into the eyelet, when the tether is present within the slot.

[0143] In some implementations, the actuator is a button that is configured to close the gate when actuated.

[0144] In some implementations, the gate is biased closed. In some implementations, the actuator is a button that is configured to open the gate when actuated. In some implementations, when the gate is opened, the eyelet is configured to receive the tether. In some implementations, releasing the actuator closes the gate.

[0145] In some implementations, the actuator is a finger that is configured to bend the tether and push it over a tongue of the eyelet when actuated.

[0146] There is further provided, in accordance with some implementations, a system for use with a tissue of a subject, the system including, a selection of tissue-engaging elements. The tissue-engaging elements can have a sharp tip and a shank. In some implementations, the system can include a tether configured to be transluminally implantable adjacent the tissue.

[0147] In some implementations, the system can include an anchor head. The anchor head can include (i) an eyelet threaded on the tether, and (ii) a socket. The socket can be configured to be mated with a selected one of the tissue-engaging elements to form an anchor. In some implementations, the anchor is advanceable over and along the tether toward the tissue. The anchor may include a tissue-engaging element that is drivable into the tissue via application of a force to the anchor head.

[0148] In some implementations, the selection of tissue-engaging elements includes multiple first-type tissue-engaging elements, and multiple second-type tissue-engaging elements. In some implementations, the shanks of the second-type tissue-engaging elements are identical to the shanks of the first-type tissue-engaging elements.

[0149] In some implementations, a core of the first-type tissue-engaging elements is different than a core of the second-type tissue-engaging elements. Each core can be disposed between the sharp tip and shank of respective tissue-engaging elements.

[0150] In some implementations, the difference is in a height of each respective core.

[0151] In some implementations, the difference is in a width of each respective core.

[0152] In some implementations, the difference is a shape of each respective core.

[0153] In some implementations, the core of the first-type tissue engaging element includes a first helical coil. In some implementations, the core of the second-type tissue engaging elements includes a second helical coil.

[0154] In some implementations, the first helical coil includes a different pitch than the second helical coil.

[0155] In some implementations, the first helical coil includes a different diameter than the second helical coil.

[0156] In some implementations, the first helical coil includes a different length than the second helical coil.

[0157] In some implementations, the first helical coil includes a different wire diameter than the second helical coil.

[0158] In some implementations, the system further includes a plurality of anchors heads and a series of cartridges.

[0159] In some implementations, the series of cartridges includes a first set of cartridges configured to house the plurality of anchor heads. In some implementations, the series of cartridges includes a second set of cartridges configured to house the first-type tissueengaging elements. In some implementations, the series of cartridges includes and a third set of cartridges configured to house the second-type tissue-engaging elements.

[0160] There is further provided, in accordance with some implementations, a system for use with a tissue of a subject, the system including a driver. In some implementations, the system includes a selection of tissue-engaging elements. In some implementations, each selection of tissue-engaging elements has a sharp tip and a shank. In some implementations, the system includes a tether configured to be transluminally implantable adjacent the tissue. In some implementations, the system includes an anchor head including a socket. The socket can be threaded on the tether. The socket can be implantable in the subject by using the driver, advancing the socket over the shank of a selected one of the tissue-engaging elements to engage the anchor head with the selected tissue-engaging element, and form an anchor. The anchor can be advanced to the tissue. In some implementations, the selected tissueengaging element can be driven into the tissue by applying a force to the anchor head.

[0161] In some implementations, the anchor is releasable from the driver at the tissue.

[0162] In some implementations, the socket locks onto the shank.

[0163] In some implementations, a height of the shank is taller than a height of the socket.

[0164] In some implementations, a height of the shank is shorter than a height of the socket.

[0165] In some implementations, the shank includes a hexagonal cross-section.

[0166] In some implementations, a shape of the socket corresponds to a shape of the shank.

[0167] In some implementations, the socket is press fit with the shank. In some implementations, the socket is threadably connected with the shank.

[0168] In some implementations, the advancing the socket over the shank centers the anchor head with respect to the tissue-engaging element.

[0169] In some implementations, the tissue-engaging element includes a central axis. In some implementations, the central axis of the tissue-engaging element is aligned with a central axis of the shank.

[0170] In some implementations, the socket includes an attachment feature. In some implementations, the shank includes an engagement feature that corresponds to the attachment feature.

[0171] In some implementations, the attachment feature includes clips. In some implementations, the engagement feature includes an edge that corresponds to the clips.

[0172] In some implementations, the edge is a groove on the shank.

[0173] In some implementations, the edge is a lower edge of the shank.

[0174] In some implementations, the attachment feature includes a magnet, and the engagement feature includes a ferromagnetic material.

[0175] In some implementations, the system further includes a plurality of anchor heads.

[0176] In some implementations, each anchor head further includes a rod. In some implementations, each anchor head includes a bushing disposed around an outer surface of the socket. In some implementations, each anchor head includes a wire disposed about the bushing. In some implementations, the wire forms an eyelet that is threaded through the tether.

[0177] In some implementations, the driver is configured to removably connect with the rod.

[0178] In some implementations, a proximal end of the driver clips onto the rod.

[0179] In some implementations, a proximal end of the driver is actuated to grab the rod.

[0180] In some implementations, the driver is configured to sequentially drive each anchor head into distinct locations within the tissue.

[0181] In some implementations, the sequential driving of each anchor head includes, grasping, by the driver, one of the anchor heads. In some implementations, the sequential driving of each anchor head includes withdrawing, using the driver, the one of the anchor heads from a corresponding cartridge. In some implementations, the sequential driving of each anchor head includes advancing, using the driver, the socket of the one of the anchor heads into a selected one of the tissue-engaging elements to form a first anchor. In some implementations, the sequential driving of each anchor head includes advancing, using the driver, the first anchor to the tissue. In some implementations, the sequential driving of each anchor head includes driving, using the driver, the first anchor into the tissue. In some implementations, the sequential driving of each anchor head includes sequentially following steps the steps described in this paragraph for each additional anchor head.

[0182] In some implementations, respective spacers are threaded through the tether between adjacent anchor heads.

[0183] In some implementations, at least one of the plurality of anchor heads is inserted into the body without a corresponding tissue-engaging element.

[0184] In some implementations, the tissue-engaging element includes a helical coil disposed between the sharp tip and the shank.

[0185] In some implementations, each respective helical coil, sharp tip, shank, and socket share a common central axis.

[0186] In accordance with some implementations, a system, useable and / or for use with a tissue of a subject (e.g., a living subject and / or a simulation) includes a catheter device. The catheter device can include a flexible tube that has a distal opening that is configured to be transluminally advanced toward the tissue, and / or a proximal end that defines a proximal opening.

[0187] In some implementations, the system includes an extracorporeal unit. The extracorporeal unit can be coupled to the proximal end of the tube. The extracorporeal unit can include a body. In some implementations, the extracorporeal unit can include a series ofcartridges, distributed along the body. In some implementations, the extracorporeal unit can include a tether. The tether can extend along the body.

[0188] In some implementations, the system can include a selection of tissue-engaging elements. The tissue-engaging elements can have a sharp tip and a shank. The tissue engaging elements can be housed by a corresponding cartridge of the series of cartridges.

[0189] The system can include a plurality of anchor heads. The anchor heads can be housed by corresponding cartridges of the series of cartridges. In some implementations, an anchor head can include an eyelet threaded on the tether. In some implementations, an anchor head can include a socket. In some implementations, an anchor head can be configured to be mated with a selected one of the tissue-engaging elements to form an anchor. The anchor can be advanceable over and / or along the tether toward the tissue. The tissue-engaging element of the anchor can be drivable into the tissue. For instance, an application of a force to the anchor head can be used to drive and / or anchor the anchor into the tissue.

[0190] In accordance with some implementations, a system usable and / or for use at a cardiovascular tissue of a subject includes an implant. In some implementations, the implant includes a tether.

[0191] In some implementations, the system comprises a tool, configured for transluminal implantation of the implant to the tissue. In some implementations, the tool includes an intracorporeal portion, transluminally advanceable toward the tissue. In some implementations, the tool includes an extracorporeal portion.

[0192] In some implementations, the extracorporeal portion includes a clamp. In some implementations, the extracorporeal portion includes a spring -loaded winch, connected to the tether via the clamp to enable the winch to apply tension to the tether. In some implementations, the extracorporeal portion includes a release.

[0193] In some implementations, the release is operable to repeatedly, during the implantation of the implant, open the clamp to disconnect the tether from the winch. In some implementations, the release is operable to repeatedly, during the implantation of the implant, close the clamp to reconnect the tether to the winch.

[0194] In some implementations, the tether has a distal end that is implantable, and a proximal end that is connected to the clamp such that opening of the clamp to disconnect the tether from the winch provides access to the proximal end of the tether.

[0195] In some implementations, disconnecting the tether from the winch exposes a proximal end of the tether.

[0196] In some implementations, the cardiovascular tissue is a heart valve.

[0197] In some implementations, the release is biased closed.

[0198] In some implementations, the extracorporeal portion further includes a spool wire having a distal end connected to the clamp and a proximal end connected to the winch.

[0199] In some implementations, the winch is configured to apply tension to the tether via the spool wire.

[0200] In some implementations, opening the release removes the applied tension to the tether.

[0201] In some implementations, the spool wire is wound around a spool of the winch.

[0202] In some implementations, the clamp is wound around the spool and is configured to be unwound from the spool during the implantation.

[0203] In some implementations, the spool wire is configured to be extendable away from and retractable into the winch.

[0204] In some implementations, the spool wire is connected to the clamp via a set screw.

[0205] In some implementations, the extracorporeal portion further includes a spring which biases the release closed.

[0206] In some implementations, opening the clamp compresses the spring.

[0207] In some implementations, the release includes a lever and the spring biases the lever to press the tether against the clamp.

[0208] In some implementations, the force of the bias from the spring is greater than the applied tension to the tether.

[0209] In some implementations, the tether includes an anchor threaded thereon, the anchor being configured to be implanted into the tissue.

[0210] In some implementations, disconnecting the tether from the winch exposes a proximal end of the tether. In some implementations, supplemental anchors are configured to be threaded onto the exposed proximal end of the tether. In some implementations, reconnecting the tether to the winch retains the supplemental anchors on the tether.

[0211] In some implementations, the supplemental anchors are configured to slide along the tether to the tissue. In some implementations, the supplemental anchors are configured to be implanted at the tissue.

[0212] In accordance with some implementations, a system for use at a cardiovascular tissue of a subject includes an implant. In some implementations, the implant includes a tether.

[0213] In some implementations, the system includes a tool configured for transluminal implantation of the implant to the tissue. In some implementations, the tool includes an intracorporeal portion, transluminally advanceable toward the tissue. In some implementations, the tool includes an extracorporeal portion.

[0214] In some implementations, the extracorporeal portion includes a clamp. In some implementations, the extracorporeal portion includes a spring-loaded winch, configured to apply a tension to a spool wire. In some implementations, the extracorporeal portion includes the spool wire, configured to apply the tension to the tether. In some implementations, the extracorporeal portion includes a release.

[0215] In some implementations, the release is operable to, during the implantation of the implant, open the clamp to remove the applied tension to the tether. In some implementations, the release is operable to, during the implantation of the implant, close the clamp to reapply the tension to the tether.

[0216] In accordance with some implementations, a system includes a tether configured for transluminal implantation at a tissue of a subject. In some implementations, the system includes a spring-loaded winch, capable of applying tension to the tether via a clamp. In some implementations, the system includes the clamp operable to repeatedly open the clamp to disconnect an end of the tether from the winch. In some implementations, the system includes the clamp operable to repeatedly close the clamp to reconnect the end of the tether to the winch. In some implementations, the system includes an anchor.

[0217] In some implementations, the anchor is configured to be threaded onto the disconnected end of the tether. In some implementations, the anchor is configured to be slid along the reconnected tether to the tissue after tension is applied to the tether via the winch.

[0218] In accordance with some implementations, a method for use with a tether includes transluminally implanting an implant connected to the tether to a tissue of a subject. In some implementations, the method includes exposing a clamp, which is coupled to an end of the tether.

[0219] In some implementations, the method includes opening the clamp to release the end of the tether from the clamp. In some implementations, the method includes threading an anchor onto the released end of the tether.

[0220] In some implementations, the method includes closing the clamp to secure the end of the tether to the clamp. In some implementations, the method includes applying a tension to the tether via a spring-loaded winch to tauten the tether. In some implementations, the method includes sliding the anchor to the tissue along the tautened tether.

[0221] In some implementations, the method further includes implanting the anchor at the tissue.

[0222] In some implementations, the opening the clamp further includes opening a release of the clamp.

[0223] In some implementations, the closing the clamp further includes closing the release.

[0224] In some implementations, the clamp and spring-loaded winch are part of an extracorporeal portion.

[0225] In accordance with some implementations, a system usable and / or for use with a tissue of a subject, includes a catheter device. In some implementations, the catheter device includes a flexible tube that has a distal opening that is configured to be transluminally advanced toward the tissue.

[0226] In some implementations, the catheter device is configured to include a proximal end that defines a proximal opening. In some implementations, the catheter device includes an extracorporeal unit, coupled to the proximal end of the tube. In some implementations, the extracorporeal unit includes a body. In some implementations, the extracorporeal unit includes a series of cartridges, distributed along the body.

[0227] In some implementations, the system includes a tether, extending along the body and including a ball at a distal end thereof. In some implementations, the system includes a series of system-anchors.

[0228] In some implementations, each of the system-anchors includes a system-anchor head. In some implementations, a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue.

[0229] In some implementations, the system includes a system-anchor eyelet, mounted on the system-anchor head, and including a slipknot which is threadable over the ball and slidable along the tether.

[0230] In some implementations, the slipknot is self-tightening.

[0231] In some implementations, the system further includes an anchor-adding device including a shell in which is defined a cavity that houses the system-anchor.

[0232] In some implementations, the shell defines an opening through which the selftightening slipknot exits the shell.

[0233] In some implementations, the shell is slidable along the tether to the extracorporeal unit via the self-tightening slipknot. In some implementations, the shell is insertable into the cartridges.

[0234] In some implementations, the shell defines a second opening connected to the opening through which the system-anchor is removable from the shell.

[0235] In some implementations, the system-anchor is removable from the shell via the opening.

[0236] In some implementations, a first system-anchor of the series of system anchors is threaded onto the tether first. In some implementations, a second system-anchor of the series of system anchors is threaded onto the tether last. In some implementations, the second system-anchor is implanted at the tissue first.

[0237] In some implementations, a spring is threaded on the tether between the first systemanchor and the second system-anchor.

[0238] In some implementations, a tension applied to the slipknot between the systemanchor head and the tether maintains the slipknot about the tether.

[0239] In accordance with some implementations, a system useable and / or for use with a tissue of a subject includes a catheter device. In some implementations, the catheter device includes a flexible tube. In some implementations, the flexible tube has a distal opening that is configured to be transluminally advanced toward the tissue. In some implementations, the flexible tube has a proximal end that defines a proximal opening.

[0240] In some implementations, the catheter device includes an extracorporeal unit, coupled to the proximal end of the tube.

[0241] In some implementations, the extracorporeal unit includes a body. In some implementations, the extracorporeal unit includes a series of cartridges, distributed along the body. In some implementations, the system includes a tether, extending along the body.

[0242] In some implementations, the tether includes a ball at a distal end thereof. In some implementations, the system includes a series of system-anchors. In some implementations, each of the system-anchors includes a system-anchor head. In some implementations, each of the system-anchors includes a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue.

[0243] In some implementations, each of the system-anchors includes a system-anchor eyelet, mounted on the system-anchor head. In some implementations, the system-anchor eyelet includes a slipknot which is threadable over the ball and slidable along the tether.

[0244] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human, or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally include computerized and / or physical representations.

[0245] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can include (or additional methods include or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0246] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0247] Figs. 1, 2, and 3 are schematic illustrations of a device that includes an anchor-adding device that houses an anchor, in accordance with some implementations; and / or

[0248] Figs. 4A-F and 5A-B are schematic illustrations showing example uses of the device, in accordance with some implementations.

[0249] Fig. 6 is a schematic illustration of an apparatus in accordance with some implementations .

[0250] Figs. 7A-C are schematic illustrations of apparatuses in accordance with some implementations .

[0251] Figs. 8A-C are schematic illustrations showing examples of operation of an apparatus in accordance with some implementations.

[0252] Fig. 9 is a schematic illustration of an apparatus in accordance with some implementations .

[0253] Figs. 10A-B are schematic illustrations showing examples of operation of an apparatus in accordance with some implementations.

[0254] Fig. 11 is a schematic illustration of an apparatus in accordance with some implementations .

[0255] Figs. 12A-C are schematic illustrations showing examples of apparatuses in accordance with some implementations.

[0256] Figs. 13A-B are schematic illustrations showing examples of operation of an apparatus in accordance with some implementations.

[0257] Fig. 14 is a schematic illustration of an apparatus in accordance with some implementations .

[0258] Fig. 15 is a schematic illustration showing an example of operation of an apparatus in accordance with some implementations.

[0259] Figs. 16A-B are schematic illustrations showing different views of an example apparatus in accordance with some implementations.

[0260] Fig. 17 is a schematic illustration of an apparatus in accordance with some implementations .

[0261] Fig. 18 is a schematic illustration of an apparatus in accordance with some implementations .

[0262] Fig. 19 is a schematic illustration of an apparatus in accordance with some implementations .

[0263] Figs. 20A-E are schematic illustrations of apparatuses in accordance with some implementations .

[0264] Figs. 21A-C are schematic illustrations of apparatuses in accordance with some implementations .

[0265] Figs. 22A-B are schematic illustrations of apparatuses in accordance with some implementations .

[0266] Figs. 23A-B are schematic illustrations of apparatuses in accordance with some implementations .

[0267] Figs. 24A-C are schematic illustrations of apparatuses in accordance with some implementations .

[0268] Figs. 25A-B are schematic illustrations of apparatuses in accordance with some implementations .

[0269] Fig. 26 is a schematic illustration of apparatus in accordance with some implementations .

[0270] Figs. 27A-B are schematic illustrations of apparatuses in accordance with some implementations .DETAILED DESCRIPTION OF EMBODIMENTS

[0271] The present disclosure includes different variants of some elements. Variants of a given element can include the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein can include any arrangement in which one variant of an element is substituted with another identically named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants can be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral can be substituted with any other element (e.g., any other variant of the element) having the same reference numeral, independent of any suffix.

[0272] In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements are introduced via one or more drawings and not explicitly identified in every other drawing that contains that element.

[0273] Some of the systems, apparatuses, devices, methods, techniques, etc. described herein, and implementations and applications thereof, include or are configured to be used with an implant (which can be the same as or similar to other implants described herein orin the references incorporated herein) that includes multiple anchors slidably coupled to a tether (e.g., a line, wire, ribbon, rope, cable, braid, contraction member, suture, etc.).

[0274] In some implementations, the multiple anchors can include anchors of different sizes and / or configurations.

[0275] In some implementations, the implant can be a tissue-adjustment implant that contracts tissue upon tensioning of the tether.

[0276] In some implementations, the implant can be usable and / or configured for use at a heart of a subject (e.g., a living subject, a simulation, etc.). For example, the implant can be an annuloplasty implant.

[0277] In some implementations, the implant can be configured and / or used to close another opening (e.g., an opening to an appendage, an opening to a left atrial appendage, an opening to a passageway, etc.) or reshape another region of tissue (e.g., ventricular remodeling, atrial remodeling, muscle remodeling, etc.)

[0278] In some implementations, a delivery system is provided for advancement and anchoring of the anchors (e.g., an implant that includes the anchors threaded on the tether).

[0279] In some implementations, the delivery system can comprise a catheter device and / or an anchor driver.

[0280] In some implementations, the catheter device can include a tube, and an extracorporeal unit, e.g., at a proximal end of the tube. The anchors can be mounted, in a series, on the extracorporeal unit.

[0281] In some implementations, the extracorporeal unit can be configured as and / or include an anchor-adding device.

[0282] In some implementations, the tether can be threaded through the anchors (e.g., all, some, or just one of the anchors) in this arrangement.

[0283] In some implementations, the anchors, which the tether is threaded through, include at least one anchor that is a different size and / or configuration from another anchor the tether is threaded through.

[0284] In some implementations, the anchors, which the tether is threaded through, include more than one anchor that is a different size and / or configuration from more than one other anchor the tether is threaded through.

[0285] In some implementations, a series of cartridges (or anchor holders) can be mounted on the extracorporeal unit, and can hold the anchors in the series.

[0286] In some implementations, one or more (e.g., one, some, or all) cartridges can be configured to facilitate bringing its corresponding anchor to a proximal opening of the tube for advancement, by the driver, through the tube to the site at which the anchor is to be anchored. In some implementations, the extracorporeal unit and / or the cartridges can be configured to facilitate verification of engagement between the driver and the anchor prior to advancement.

[0287] In some implementations, anchors are configured (e.g., shaped) to be slidable along a tether (e.g., a line, wire, contraction member, etc.) both (i) while aligned (e.g., parallel or coaxial) with the tether, and (ii) while oriented orthogonal to the tether. This can help facilitate, inter alia, (i) advancement of the anchor along the tether while aligned with the tether during transcatheter delivery, and (ii) subsequent sliding of the tether with respect to the anchor after implantation, e.g., while the tether is orthogonal to the anchor.

[0288] In some implementations, each anchor can include (i) a tissue-engaging element, (ii) and a head at a proximal end of the tissue-engaging element.

[0289] In some implementations, the tissue-engaging element can be a screw-in tissueengaging element, e.g., can be helical, screw-like, threaded, etc.

[0290] In some implementations, the tissue-engaging element can comprise one or more hooks, barbs, darts, staples, clips, protrusions, arms, expandable portions, threaded portions, rivets, pledgets, combinations of two or more of these, etc.

[0291] In some implementations, the head can comprise or define an interface via which the anchor driver can engage and apply an anchoring force (e.g., torque) to the anchor.

[0292] In some implementations, each anchor can comprise an eyelet, or another connector / attachment, coupled to the head of the anchor.

[0293] In some implementations, the anchor can be slidably coupled to the tether by the eyelet being threaded onto the tether.

[0294] In some implementations, the eyelet (or other connector) can be disposed laterally from the axis of the anchor. The eyelet (or other connector) can be configured in a variety of different ways.

[0295] In some implementations, the eyelet comprises and / or is formed from a textile (e.g., a polyfilament structure), such as a yarn.

[0296] In some implementations, one or more eyelets of one or more anchors comprises and / or is formed from a polymer (e.g., a polymer suture, a polymer yarn, a polymer filament, etc.).

[0297] In some implementations, the eyelet or other connector comprises and / or is formed from a textile and / or a polymer, wherein the textile and / or polymer is also configured and / or formed to define a collar that circumscribes part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head), coupling (directly or indirectly) the eyelet to the head and / or a stock or neck region of the head (or stock or neck region proximate the head) (e.g., coupling the eyelet directly to the head, coupling the eyelet directly to a stock or neck region of and / or proximate the head, coupling the eyelet to a bushing on or associated with the head and / or a stock or neck region of and / or proximate the head).

[0298] In some implementations, the collar that circumscribes part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head) can comprise and / or is formed by one or more loops (e.g., 1 loop, 2 loops, 3 loops, etc.) of the textile and / or polymer that loop around the part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head). This configuration can be used whether or not looped on a bushing, e.g., a bushing around the head, stock, neck, etc.

[0299] In some implementations, each anchor comprises a spacer, extending away from the anchor head along the tether, e.g., distally, toward the preceding anchor in the series. In some implementations, the spacer can inhibit approximation of the anchor and the preceding anchor.

[0300] In some implementations, the spacer can be coupled to the head and / or the eyelet of the anchor.

[0301] In some implementations, the spacer can be integrally formed with the head and / or the eyelet of the anchor.

[0302] In some implementations, the spacer can be revolvable around the head and / or around axis of the anchor.

[0303] In some implementations, the spacer can be rotatable with respect to the axis of the anchor.

[0304] In some implementations, the tube of the catheter device has at its distal end, one or more resilient ribs, nubs, or nodules that engage the tissue-engaging element of the anchor in a manner that controls advancement of the anchor distally out of the tube. For example, the ribs can allow the anchor to be advanced distally only while the tissue-engaging element is being rotated, e.g., can inhibit non-rotational axial advancement. However, the ribs can be less inhibitive of non-rotational axial retraction.

[0305] In some implementations, tensioning of the tether slides the tether through the eyelet (or other connector) of each anchor, drawing the anchors toward each other and thereby contracting the tissue to which the anchors are anchored, e.g., the annulus of a heart valve, etc. In order to lock the tension into the tether, a lock (which may, in some implementations, be considered a stopper) is advanced along the tether and locked to the tether, e.g., at the most recently-anchored anchor.

[0306] In some implementations, the lock is configured such that its actuation both locks the lock to the tether and cuts (e.g., trims) the tether so that excess tether can be withdrawn.

[0307] In some implementations, the lock can be introduced onto the tether without access to either end of the tether.

[0308] In some implementations, a tensioner is provided that can engage an intermediate region of the tether (e.g., without access to either end of the tether), and apply tension to the tether from there.

[0309] In some implementations, the tensioner is mounted or mountable on the extracorporeal unit of the catheter tool, which provides access to the intermediate portion of the tether.

[0310] In some implementations, a system and / or an apparatus for use in a medical procedure includes a tether (e.g., wire, suture, line, contraction member, braid, rope, etc.) and one or more anchors. The tether (e.g., a portion thereof, etc.) and the one or more anchors can collectively form an implant. The implant can be the same as or similar to other implants herein and include any of the features and / or components thereof (e.g., spacers, one or more locks, etc.).

[0311] In some implementations, the one or more anchors comprise at least two anchors of different sizes and / or configurations.

[0312] In some implementations, the one or more anchors comprise one or more anchors of multiple different sizes and / or configurations. In some implementations, different anchors can be different in length, thickness, radius of curvature, width, etc.

[0313] In some implementations, the system and / or apparatus is configured for treating a heart transluminally. In some implementations, the system and / or apparatus is configured for treating a heart valve transluminally.

[0314] In some implementations, the system and / or apparatus can optionally be configured for treating one or more body parts and regions, including outside the heart or cardiovascular system.

[0315] In some implementations, the system and / or apparatus comprises an implant that remains in the body of a subject (e.g., a living subject and / or a simulation).

[0316] In some implementations, the tether and the one or more anchors are part of an annuloplasty implant capable of reshaping or reconfiguring an annulus.

[0317] In some implementations, the one or more anchors can be positioned at different locations associated with a heart valve.

[0318] In some implementations, the tether connects the one or more anchors together (e.g., through eyelets, posts, connectors, or other attachments associated with the one or more anchors.)

[0319] In some implementations, it may be desirable to have different sized anchors at different locations in the body of the patient (e.g., at different locations around a heart valve). For example, longer anchors may provide increased retention force in tissue, while smaller anchors may be better at avoiding an anatomical feature (e.g., avoiding piercing a nearby blood vessel by not penetrating deeply enough to hit the blood vessel, etc.). Further, thicker anchors can provide added retention in tissue as compared to thinner anchors, while thinner anchors may be easier to insert, etc.

[0320] In some implementations, all, some, or one of the one or more anchors can include an anchoring feature - e.g., a retention feature, a barb, multiple barbs, a helix, multiple helixes, a hook, multiple hooks, a dart, multiple darts, a pin, multiple pins, etc. The anchoringfeature can be a tissue-engagement feature as described elsewhere herein and / or be in addition to a tissue-engagement feature described elsewhere herein.

[0321] In some implementations, all of the one or more anchors can be provided preattached to the tether. In some implementations, some (e.g., one or more) of the anchors can be provided pre-attached to the tether.

[0322] In some implementations, different sizes and / or configurations of anchors of the one or more anchors can be configured and / or attached such that desired anchor sizes / configurations will be placed as desired during operation.

[0323] In some implementations, some of the one or more anchors can be provided preattached to the tether, while others need to be attached to the tether during or before operation. In some implementations, all of the one or more anchors can be provided separate from the tether and need to be attached to the tether during or before operation. In some implementations, being able to attach additional anchors to the tether as desired may be helpful to customize an implant and / or operation as the procedure progresses.

[0324] In some implementations, each anchor can comprise an attachment element. The attachment element can be used to attach the anchor to the tether. In some implementations, the attachment element includes the eyelet. In some implementations, the attachment element is separate from the eyelet. In some implementations, the attachment element defines the eyelet.

[0325] In some implementations, the attachment element is connected to the anchor via the eyelet. In some implementations, the attachment element is connected to the anchor via a textile and / or polymer. In some implementations, the textile and / or polymer is comprised and / or is formed to define a collar that circumscribes part of the head of the anchor and / or a stock or neck region of the head (or stock or neck region proximate the head), coupling (directly or indirectly) the attachment element to the head and / or a stock or neck region of the head (or stock or neck region proximate the head) (e.g., coupling the attachment feature directly to the head, coupling the attachment feature directly to a stock or neck region of and / or proximate the head, coupling the attachment feature to a bushing on or associated with the head and / or a stock or neck region of and / or proximate the head).

[0326] In some implementations, the attachment element is coupled to the head of the anchor. In some implementations, the anchor can be slidably coupled to the tether by the attachment element being threaded onto the tether. In some implementations, the attachmentelement can be disposed laterally from the axis of the anchor. The attachment element can be configured in a variety of different ways.

[0327] In some implementations, the attachment element includes one or more of the following: a clip, a snap, a clasp, a shackle, a padlock, a bolt, a hook, a loop, a spring, a bolt snap, a lobster clasp, a carabiner, wires or any other suitable attachment elements.

[0328] In some implementations, the attachment element includes a gate.

[0329] In some implementations, when the gate is open the attachment element can be threadable onto the tether. In some implementations, when the gate is closed the attachment element can be unable to be threaded onto the tether.

[0330] In some implementations, the gate is biased closed. In some implementations, the gate is biased open.

[0331] In some implementations, the gate is a shackle. In some implementations, the gate is a hook. In some implementations, the gate is a tongue.

[0332] In some implementations, the gate is opened and / or closed via the tether (e.g., the tether pushing against a biased closed gate to open it or pushing against a biased open gate to close it). In some implementations, the gate is opened and / or closed via the anchor adding device (e.g., via pressing an actuator on the anchor adding device).

[0333] In some implementations, the anchor adding device includes a button. The button can push a shackle of the attachment element into a latch to close the gate. The button can push open a biased closed gate. The button can push closed a biased open gate. The button can include a finger. The finger can push the tether to thread the tether into the attachment element. The finger can push the tether past the gate. The finger can push the tether through the gate.

[0334] In some implementations, the attachment elements are removable from the tether. In some implementations, the attachment elements are provided already attached to the tether. In some implementations, the attachment elements are attached to the tether based on the needs of the situation. For instance, but not limited to, one or more of a number of anchors attached to the tether, a length of the tether. In some implementations, the number of spacers between anchors may be chosen based on a size of an annulus of a heart where the anchors are to be secured.

[0335] In some implementations, spacers are provided already threaded on the tether. In some implementations, an anchor is attached (via the attachment element) to the tether such that there is a spacer between each anchor. In some implementations, an anchor is attached (via the attachment element) to the tether such that there are multiple spacers between the anchor and an adjacent anchor.

[0336] In some implementation, the number of spacers between anchors may be chosen based on the needs of the situation. For instance, but not limited to, one or more of a number of anchors attached to the tether, a length of the tether. In some implementations, the number of spacers between anchors may be chosen based on a size of an annulus of a heart where the anchors are to be secured.

[0337] In some implementations, anchor heads and spacers are provided pre-attached to the tether.

[0338] In some implementations, there is a spacer between adjacent anchor heads. In some implementations, there are varying spacers between adjacent anchor heads. In some implementations, the anchor heads are separable from tissue engaging elements. In some implementations, the anchor heads are pre-attached on the tether separate from the tissue engaging elements. In some implementations, the anchor heads are connected with tissue engaging elements before being implanted.

[0339] In some implementations, the separate anchor heads can be attached to the tether via an attachment element. In some implementations, a predetermined number of the anchor heads are pre-attached onto the tether. In some implementations, all the anchor heads are connected to tissue engaging elements before implantation. In some implementations, a select number of anchor heads from the predetermined number are connected to tissue engaging elements before implantation.

[0340] In some implementations, different sized tissue engaging elements are provided. In some implementations, the different sizes of tissue engaging elements are disposed in respectively sized cartridges. In some implementations, the cartridges are disposed on the extracorporeal unit. In some implementations, the tissue engaging element cartridges are disposed alongside the anchor head cartridges. In some implementations, each cartridge is marked to identify its contents.

[0341] In some implementations, the anchor head can be attached to the tissue engaging element. The attachment to the tissue engaging element can be via a snap-fit connection,interference fit connection, and the like. The attachment to the tissue engaging element can be via a magnetic connection. The attachment to the tissue engaging element can be via any other suitable connection. A successful attachment to the tissue engaging element can be confirmed by tactile and / or auditory feedback. A successful attachment to the tissue engaging element can allow the tissue engaging element to be removed from its cartridge.

[0342] In some implementations, the anchor driver connects to an anchor head to remove it from its cartridge. In some implementations, the anchor driver advances the anchor head into a selected tissue engaging element cartridge to connect the anchor head to a selected tissue engaging element. In some implementations, the anchor driver advances the combined anchor head and tissue engaging element into the subject for implantation.

[0343] In some implementations, the systems, apparatuses, methods, procedures, etc. herein can be the same as or similar to any of the systems, apparatuses, methods, procedures, etc. described in PCT Application No. PCT / IB2023 / 062298 to Halabi et al. filed December 6, 2023 (now published as WO 2024 / 121770) and / or PCT Application No. PCT / IB 2022 / 051099 (now published as WO2022172149) to Shafigh et al. filed February 8, 2022, each of which is incorporated by reference herein in its entirety for all purposes. In some implementations, the systems, apparatuses, methods, procedures, etc. herein can be used with any of the systems, apparatuses, methods, procedures, etc. described in PCT Application No. PCT / IB2023 / 062298 to Halabi et al. filed December 6, 2023 (now published as WO 2024 / 121770) and / or PCT Application No. PCT / IB 2022 / 051099 (now published as WO2022172149) to Shafigh et al. filed February 8, 2022, each of which is incorporated by reference herein in its entirety for all purposes.

[0344] Reference is made to Figs. 1, 2, and 3, which are schematic illustrations of an anchoradding device 10 comprising, for illustrative purposes, a cassette 20 (or other cartridge, clip, etc.) that houses an anchor 120, in accordance with some implementations. A cassette configuration is not required, other configurations of anchor-adding devices can be used in the various implementations described herein.

[0345] In some implementations, cassette 20 and anchor 120 can be collectively considered to be an anchor-adding device 10.

[0346] In some implementations, anchor-adding device 10 can be used to add an anchor (e.g., anchor 120) to a tether 112 (e.g., a cord, a wire, a suture, a line, a rope, a braid, a filament, a ribbon, etc.), e.g., such that the anchor becomes threaded on the tether.

[0347] In some implementations, and as described in more detail hereinbelow, anchoradding device 10 can be used to add the anchor to an intermediate portion of the tether without access to either end of the tether.

[0348] In some implementations, and as described in more detail hereinbelow, anchoradding device 10 can be used to add the anchor to an intermediate portion of the tether while the tether (e.g., the intermediate portion thereof) is under tension.

[0349] In some implementations, the added anchor may be considered to be, or referred to, as a supplemental anchor.

[0350] In some implementations, anchor-adding device 10 and / or cassette 20 comprises a shell 22 in which is situated a cavity 30 that houses (e.g., snugly houses) anchor 120. Shell 22 defines a slot 24 via which tether 112 (e.g., an intermediate region thereof) is slidable (e.g., laterally) to the cavity, e.g., as shown in Fig. 2.

[0351] In some implementations, anchor 120 can be a tissue anchor, e.g., for surgical or transluminal implantation. In some implementations, anchor 120 can be for a cardiovascular treatment (e.g., cardiac repair).

[0352] In some implementations, anchor 120 can be configured to be, or to become, a component of a cardiac repair implant, such as an annuloplasty implant. Such an implant can include tether 112.

[0353] In some implementations, the implant can be an implant described in any of the following documents, each of which is incorporated herein by reference:International Patent Application Publication WO 2021 / 084407 to Kasher et al.International Patent Application Publication WO 2022 / 064401 to Halabi et al.International Patent Application Publication WO 2022 / 172149 to Shafigh et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0354] In some implementations, anchor 120 comprises a head 122, a tissue-engaging element 130, and an eyelet 126. In some implementations, tissue-engaging element 130 extends distally away from head 122 to define an anchor axis of the anchor, and is configured to be driven along the anchor axis into the tissue.

[0355] In some implementations, eyelet 126 (or another connection or attachment feature) is coupled to, connected to, integral with, and / or mounted on head 122.

[0356] In some implementations, eyelet 126 (or other connection / attachment feature) can be coupled or mounted such that it extends laterally away from head 122 and / or the anchor axis.

[0357] In some implementations, eyelet 126 (or other connection / attachment feature) can be coupled or mounted such that it can revolve around head 122 and / or the anchor axis.

[0358] In some implementations, eyelet 126 (or other connection / attachment feature) is gated, e.g., it defines a gate, which can be a one-way gate.

[0359] In some implementations, tether 112 (e.g., an intermediate region thereof) is laterally introducible into the eyelet via the gate, such that the tether becomes disposed through the eyelet. For example, eyelet 126 can be snapped onto the tether.

[0360] In the example shown, the eyelet, including its gate, is defined by a loop of a resilient wire or ribbon (e.g., comprising steel or Nitinol). However, it is to be understood that this is not limiting, and that other forms of gated eyelet can be used, including those that are biased to be closed (e.g., such that the tether is snapped into the eyelet) and those that are actively closed (e.g., by a mechanism of device 10 and / or cassette 20).

[0361] In some implementations, anchor-adding device 10 can comprise an actuator (e.g., a button, a thumbwheel, or similar) that is manually operable to facilitate lateral introduction of the intermediate region of the tether, at the cavity, into the eyelet. For example, the actuator can be operatively coupled to an internal component of anchor- adding device 10 (e.g., of cassette 20, etc.) such that operation of the actuator operates (e.g., opens and / or closes) the gate of the eyelet while the anchor is housed in the cavity.

[0362] In some implementations, the actuator is configured to force the tether, at cavity 30, through the gate into eyelet 126.

[0363] Other than the gated nature of eyelet 126, anchor 120 may be as described, mutatis mutandis, for any of the anchors disclosed in the following documents, each of which is incorporated herein by reference:International Patent Application Publication WO 2014 / 064694 to Sheps et al.International Patent Application Publication WO 2016 / 174669 to Iflah et al.International Patent Application Publication WO 2021 / 084407 to Kasher et al.International Patent Application Publication WO 2021 / 255533 to Brauon et al.International Patent Application Publication WO 2022 / 064401 to Halabi et al.International Patent Application Publication WO 2022 / 172149 to Shafigh et al.International Patent Application Publication WO 2023 / 119064 to Herman et al.International Patent Application Publication WO 2024 / 069302 to Peleg et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0364] In some implementations, and as shown, cavity 30 is entirely internal to anchoradding device 10 and / or cassette 20. However, in other implementations, shell 22 can be shaped such that at least part of the cavity is exposed at a surface of the device and / or cassette.

[0365] In some implementations, anchor 120 is configured to be anchored to tissue using a driver 210.

[0366] In some implementations, driver 210 can comprise a flexible shaft 212. In some implementations, at a distal end of the shaft, a drivehead 214 that is configured to engage head 122 of anchor and, via this engagement, to apply an anchoring force (e.g., torque and / or pushing) to drive tissue-engaging element 130 into the tissue.

[0367] Driver 210 may be as described, mutatis mutandis, for any of the drivers or deployment manipulators disclosed in the following documents, each of which is incorporated herein by reference:International Patent Application Publication WO 2014 / 064694 to Sheps et al.International Patent Application Publication WO 2016 / 174669 to Iflah et al.International Patent Application Publication WO 2021 / 084407 to Kasher et al.International Patent Application Publication WO 2021 / 255533 to Brauon et al.International Patent Application Publication WO 2022 / 064401 to Halabi et al.International Patent Application Publication WO 2022 / 172149 to Shafigh et al.International Patent Application Publication WO 2023 / 119064 to Herman et al.International Patent Application Publication WO 2024 / 069302 to Peleg et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0368] In some implementations, device 10 can be configured to facilitate such engagement while anchor 120 remains housed in cavity 30.

[0369] For example, in some implementations, and as shown, device 10 and / or cassette 20 (e.g., shell 22 thereof) can define a passage 26 via which drivehead 214 is insertable to cavity 30 to engage head 122. Fig. 2 shows drivehead 214 poised for entry into passage 26. In some implementations, passage 26 can guide drivehead 214 into engagement with head 122. A cassette configuration is not required, other configurations of anchor-adding devices can be used in the various implementations described herein.

[0370] In some implementations, cavity 30 can be dimensioned to constrain anchor 120, or at least head 122 thereof, in a given rotational orientation about the anchor axis.

[0371] In some implementations, passage 26 is shaped such that, at least upon arrival of drivehead 214 at head 122, the drivehead is rotationally aligned with the head, e.g., is in a rotational position appropriate for engagement with the head. For example, passage 26 can be shaped to accept drivehead 214 only when the drivehead is in rotational alignment with the head. Alternatively or additionally, passage 26 can be shaped to rotationally align drivehead 214 with head 122 (e.g., progressively) as the drivehead is advanced through the passage toward cavity 30.

[0372] In some implementations, slot 24 can be planar, e.g., can define a slot-plane in which tether 112 is slidable to cavity 30. In some implementations, the housing of anchor 120 in cavity 30 can be such that the anchor-axis lies on, or parallel with, the slot-plane. In some implementations, passage 26 lies on, or parallel with, the slot-plane.

[0373] In some implementations, drivehead 214 can be inserted through passage 26 to engage anchor 120 prior to passing tether 112 into eyelet 126, or once the tether has already been passed into the eyelet.

[0374] In order to use anchor 120 once it has been added to tether 112, it is removed from device 10 and / or cassette 20. Therefore, device 10 and / or cassette 20 is configured for release of the anchor while the tether (e.g., the intermediate region thereof) remains disposed through eyelet 126.

[0375] In some implementations, the removal of anchor 120 from the device / cassette is achieved by using driver 210 to pull the anchor out of the device / cassette via passage 26. In such implementations, tether 112 can be concurrently or subsequently pulled laterally out of the device / cassette via slot 24.

[0376] In some implementations, and as shown in Fig. 3, device 10 and / or cassette 20 is configured for release of the anchor by shell 22 being openable to expose anchor 120 incavity 30, e.g., can be hinged to be openable in a clamshell manner. For example, and as shown, a hinge 32 can be disposed opposite slot 24 (e.g., defining a hinge axis that lies on, or parallel with, the slot-plane). In the example shown, this hinging is such that shell 22 opens at slot 24.

[0377] In some implementations, anchor 120 can be released from device 10 and / or cassette 20 irrespective of whether the anchor has been added to the tether. However, in other implementations, device 10 and / or cassette 20 can be configured for release of anchor 120 only upon the tether having been slid through slot 24.

[0378] In some implementations, device 10 and / or cassette 20 can include a latch or switch that is operated by passage of the tether through the slot.

[0379] Reference is now made to Figs. 4A-F and 5A-B, which are schematic illustrations showing example uses of device 10, in accordance with some implementations.

[0380] In the illustrated example, device 10 is used to add an anchor to an implant that comprises a series of anchors threaded onto tether 112, implantation of the implant being facilitated by a delivery tool that includes driver 210 and a catheter device 300. However, it is to be noted that the scope of the present disclosure includes, inter alia, the use of device 10 in other scenarios such as, but not limited to, scenarios in which the ends of tether 112 are not accessible or otherwise threadable into an eyelet of an anchor.

[0381] Catheter device 300, any of its components, and / or its functionality, may be as described for one or more of the catheter devices or delivery tools or systems disclosed in any of the following documents, each of which is incorporated herein by reference:International Patent Application Publication WO 2021 / 084407 to Kasher et al.International Patent Application Publication WO 2022 / 064401 to Halabi et al.International Patent Application Publication WO 2022 / 172149 to Shafigh et al.International Patent Application Publication WO 2024 / 121770 to Halabi et al.

[0382] In some implementations, catheter device 300 comprises a tube 310 that is flexible, and that has a distal opening that is configured to be transluminally advanced toward the tissue to which the anchors of the implant are to be anchored.

[0383] In some implementations, catheter device 300 further comprises an extracorporeal unit 350 that is coupled to a proximal end of tube 310. In some implementations, theextracorporeal unit can be configured as and / or include an anchor-adding device. The extracorporeal unit can be configured to allow anchors to be added to an implant, e.g., advanced along a tether and connected to tissue inside a subject.

[0384] In some implementations, at the proximal end of tube 310 is a proximal opening 320 through which the anchors of the implant are insertable into the tube for advancement to the tissue at the distal end of the tube.

[0385] In some implementations, extracorporeal unit 350 comprises a series of cartridges (or anchor holders) 360, each of which houses a respective anchor of the implant. Thus, the series of cartridges is distributed along the extracorporeal unit (e.g., along a stock or body 352 of the extracorporeal unit) in a manner that supports the arrangement of the series of anchors of the implant.

[0386] In some implementations, tether 112 of the implant extends along extracorporeal unit 350 (e.g., along body 352 thereof), e.g., supported in this position by the series of anchors of the implant, which are housed by cartridges 360.

[0387] Fig. 4A shows an example scenario in which at least the first anchor of the implant has already been advanced through tube 310 and anchored to the tissue, such that tether 112 extends, from the first anchor, proximally through the tube to extracorporeal unit 350. A distal end of tether 112 is thereby inaccessible due to being inside the subject. A proximal end of tether 112 can also be inaccessible, e.g., due to being housed within body 352.

[0388] If it is desired to supplement the implant with an additional (e.g., different) anchor, between pre-existing anchors, this can be done using device 10, e.g., anchor 120 serves as a supplemental anchor for the implant. For example, it may be determined that anchor 120, compared to the anchors that are pre-threaded on tether 112, is more suitable for anchoring to a particular site on the tissue. For example, tissue-engaging element 130 of anchor 120 of device 10 can differ from the tissue-engaging element of the anchors that are pre-threaded on tether 112.

[0389] In some implementations, tissue-engaging element can have a greater length, width, thickness, and / or number of turns (e.g., to take advantage of thick and / or strong tissue), or can have a smaller length, width, thickness, and / or number of turns (e.g., for use in thin or weaker tissue, or close to sensitive anatomy such as a blood vessel or conductive tissue).

[0390] Similarly, in some implementations, anchor 120 can have a different type of tissueengaging element compared to the tissue-engaging element of the anchors that are pre-threaded on tether 112. For example, helical, vs. dart, vs. staple, etc. In some implementations, the anchor can comprise an element (e.g., protrusion) to prevent pull-out and / or back-spinning of the anchor.

[0391] In some implementation, the implant and its delivery tool are provided alongside one or more devices 10 (or even subtypes thereof, with different types of anchor 120), such that the operator can decide on-the-fly whether to supplement the implant with one or more supplemental anchors 120.

[0392] In accordance with some implementations, a system, useable and / or for use with a tissue of a subject (e.g., a living subject and / or a simulation) comprises a catheter device (e.g., catheter device 300), a tether (e.g., tether 112), a series of system-anchors (e.g., those within cartridges 360), a supplemental-anchor (e.g., anchor 120), and an anchor-adding device (e.g., which can optionally comprise cassette 20).

[0393] Figs. 4A-B show a user placing device 10 onto tether 112 (e.g., a medial part of the tether) such that the tether slides laterally through slot 24 to cavity 30, and becomes laterally introduced into eyelet 126 of anchor 120 therein.

[0394] In some implementations, and as shown, extracorporeal unit 350 (e.g., body 352 thereof) is provided with (e.g., shaped to define) a manipulation zone 358 that facilitates this. Body 352 of extracorporeal unit 350 can be shaped such that, at manipulation zone 358, an enlarged space exists between the body and tether 112, thereby providing access to the tether. For example, and as shown, manipulation zone 358 can be defined by a recess in body 352.

[0395] Figs. 4C-D show drivehead 214 of driver 210 subsequently being inserted via passage 26 to cavity 30 to engage head 122 of anchor 120 therein. However, in some implementations, this insertion can be performed prior to the placement of device 10 onto tether 112, e.g., device 10 can be configured for one order of these steps, for the other of these steps, or in a manner that allows the operator to choose the order of these steps, according to preference.

[0396] In some implementations, device 10 and / or cassette 20 (e.g., shell 22 thereof) is then opened to expose and release anchor 120 and tether 112 to which it is now coupled (Fig. 4E).

[0397] In some implementations, driver 210 can then be used to insert anchor 120 through opening 320 (Fig. 4F) for advancement through tube 310 for anchoring to the tissue, ineffectively the same manner as for the anchors of the implant that were pre-threaded on tether 112.

[0398] Figs. 5A-B illustrate a different approach, in which anchor 120 is extracted from device 10 and / or cassette 20 without opening the device or cassette by using driver 210 to pull the anchor out via passage 26. This is shown in Fig. 5A, which may be considered to correspond to, or to be a variant of, the step shown in Fig. 4E. Device 10 and / or cassette 20 can then be withdrawn from tether 112, e.g., with the tether sliding laterally out via slot 24 (Fig. 5B). Driver 210 can then be used to insert anchor 120 through opening 320 (Fig. 4F) for advancement through tube 310 for anchoring to the tissue.

[0399] In some implementations, of this approach, a variant of cassette 20 is used that is not openable. In some implementations, of this approach, cassette 20 is configured to allow for extraction of the anchor both via passage 26, or by opening of the cassette, according to the operator's preference.

[0400] Fig. 6 is a schematic illustration of anchor 600, for illustrative purposes. Anchor 600 can include one or more of the features of anchor 120 discussed above. In some implementations, anchor 600 can replace anchor 120 in cassette 20. In some implementations, cassette 20 is designed to hold anchor 600. In some implementations, anchor 600 fits within cavity 30. In some implementations, anchor 600 is attached to tether 112 via anchor- adding device 10.

[0401] Anchor 600 can include anchor head 602, tissue-engaging element 604, and eyelet 606. Anchor head 602 can include rod 608, and bushing 610. Tissue-engaging element 604 can include shank 612. Tissue-engaging element 604 can include a sharp tip 614. Tissueengaging element 604 can include a helical coil 616. Tissue-engaging element 604 can have a central axis CA (e.g., a longitudinal axis). In some implementations, eyelet 606 can include wire rope 618. Eyelet 606 can include a clip 620. Eyelet 606 can include a gate 622.

[0402] In some implementations, anchor head 602 can include one or more of the features of head 122 as described above. In some implementations, the anchor driver connects to anchor head 602 via rod 608. The anchor driver can removably connect to rod 608. For example, the anchor driver can snap fit around rod 608. The snap fit connection can be strong enough such that the driver is capable of removing anchor 600 from cavity 30 and / or cassette 20. The snap fit connection can be strong enough such that the driver is capable of advancinganchor 600 into the subject, and implanting anchor 600 into the tissue. The anchor driver can be removed from the anchor 600 when anchor 600 is securely implanted into the tissue.

[0403] In some implementations, bushing 610 can be disposed around anchor head 602. In some implementations, bushing 610 can be integral with anchor head 602. In some implementations, bushing 610 can attach to anchor head 602. For example, bushing 610 can attach to anchor head 602 via any mechanical means, such as snap fit, frictional fit, welding, bonding etc. Bushing 610 can be sized to hold wire rope 618. The interface between bushing 610 and wire rope 618 can be smooth such that bushing 610 can rotate relative to wire rope 618. When anchor head 602 is rotated by the anchor driver at the tissue site to implant anchor 600 into the tissue, bushing 610 is rotated relative to wire rope 618 which remains attached to the tether via clip 620.

[0404] In some implementations, tissue-engaging element 604 can include one or more of the features of tissue-engaging element 130 as described above. Shank 612 can be connected at a first end to anchor head 602 and a second end, opposite the first end, to helical coil 616. Shank 612 can include any suitable cross-section (e.g., circular, square, hexagonal etc.). Shank 612 can include a suitable length and thickness to prevent helical coil 616 from snapping off from anchor head 602 during implantation. In some implementations, the shank 612 and the anchor head 602 can be press-fit. In some implementations, the shank 612 and the anchor head 602 can be threadably connected. In some implementations, the anchor head 602 may include a pin such that as the shank 612 is inserted into socket, the pin is pressed thereby securing the shank 612 to the anchor head 602.

[0405] In some implementations, sharp tip 614 can be disposed at an end of helical coil 616 opposite from where shank 612 is disposed. Sharp tip 614 can be sized and shaped such that it will advance easily into the tissue. Sharp tip 614 can be sized and shaped such that it allows helical coil 616 to be advanced into the tissue after it.

[0406] In some implementations, helical coil 616 can include central axis CA. Central axis CA can align with a central axis of shank 612. Central axis CA can align with a central axis of anchor head 602. In some implementations, the central axis of the shank 612 may be the same as the central axis of the anchor head 602. In some implementations, the central axis of the shank 612 can differ from the central axis of the anchor head 602. Helical coil 616 can include a pitch, a length, a diameter, a wire length, etc. The dimensions of helical coil 616 are chosen based on a location in which anchor 600 is intended to be implanted. The dimensions of helical coil 616 may affect the strength of anchor 600. The dimensions ofhelical coil 616 may affect the ability of anchor 600 to be retained within tissue. The dimensions of helical coil 616 may affect how anchors 600 are cinched together by the tether.

[0407] In some implementations, eyelet 606 can include one or more of the features of eyelet 126 discussed above. Eyelet 606 can include wire rope 618. Wire rope 618 can be formed from textile, polymer or metal materials. Wire rope 618 can be secured around bushing 610 in a suitable manner. Wire rope 618 can be looped around clip 620.

[0408] In some implementations, clip 620 can include gate 622 therein. Gate 622 can be biased closed via a spring (not shown). Gate 622 can open inwardly to prevent tether from pulling gate 622 open during implantation. Clip 620 can be connected to the tether. Clip 620 can attach anchor 600 to the tether.

[0409] In some implementations, anchor 600 is clipped onto the tether separate from the anchor- adding device 10. In some implementations, anchor 600 is clipped onto the tether through the use of anchor-adding device 10. In some implementations, anchor 600 is positioned within anchor-adding device 10 such that gate 622 aligns with slot 24. In some implementations, advancing slot 24 over the tether will force the tether to open gate 622, enter the clip 620, and thereby be attached to anchor 600. In some implementations, anchor 600 can be removable from anchor-adding device 10 through passage 26 while still being attached to the tether via clip 620. In some implementations, cavity 30 is constructed to correspond to anchor 600 and eyelet 606.

[0410] Fig. 7A is a schematic illustration of anchor 700A, for illustrative purposes. In the implementation shown in Fig. 7A shackle 702, and gate 704 have replaced clip 620 and gate 622 of anchor 600 shown in Fig. 6.

[0411] In some implementations, wire rope 618 can be looped around shackle 702. Shackle 702 can include gate 704 therein. Gate 704 can lock on shackle 702. Gate 704 may slide into and out of shackle 702. Gate 704 can include a notch (not shown). The notch can fit into a latch of shackle 702 to lock into shackle 702. Gate 704 can lock into shackle 702 in any other suitable manner. In some implementations, Gate 704 can be provided open. Sliding gate 704 into shackle 702 can close gate 704. The tether can be inserted into shackle 702 while gate 704 is open. Eocking gate 704 after the tether is inserted into shackle 702 can thread anchor 700 A onto the tether.

[0412] In some implementations, anchor 700A is locked onto the tether separate from an anchor-adding device. In some implementations, anchor 700A is locked onto the tether using the anchor-adding device.

[0413] Fig. 7B is a schematic illustration of anchor 700B, for illustrative purposes. In the implementation shown in Fig. 7B clasp 706, gate 708, and latch 710 have replaced clip 620 and gate 622 of anchor 600 shown in Fig. 6.

[0414] Wire rope 618 can be looped around an end of clasp 706. Clasp 706 can include gate 708, and latch 710 therein. Gate 708 can be biased closed via a spring (not shown). Gate 708 can open inwardly to prevent the tether from pulling gate open during implantation. Pulling on latch 710 can open gate 708. Clasp 706 can be connected to the tether. Clasp 706 can attach anchor 700B to the tether.

[0415] In some implementations, anchor 700B is locked onto the tether separate from an anchor-adding device. In some implementations, anchor 700B is locked onto the tether using the anchor-adding device.

[0416] Fig. 7C is a schematic illustration of anchor 700C, for illustrative purposes. In the implementation shown in Fig. 7C ring 712, parallel bars 714, parallel U-bends 716, catch 718, and gate 720 have replaced clip 620 and gate 622 of anchor 600 shown in Fig. 6.

[0417] In some implementations, wire rope 618 can be looped around ring 712. Parallel bars 714 can extend from a first side of ring 712. Parallel bars 714 can include two parallel bars extending from ring 712 with a gap between them. Parallel U-bends 716 can be formed and extend from parallel bars 714. Parallel U-bends 716 can end in catch 718. Catch 718 can include a U-shaped bend perpendicular to bars 714. Gate 720 can extend from a second side of ring 712. In some implementations, ring 712 can act as, or define, a coil spring that biases gate 720 toward being closed. Gate 720 can be integral with the coil spring. Gate 720 can be biased away from parallel bars 714. In some implementations, gate 720 can be biased into a curve of catch 718. Gate 720 can be pushed away from catch 718. Gate 720 can be pushed between parallel bars 714. Pushing gate 720 between parallel bars 714 may allow for tether to be placed within a curve of parallel U-bends 716. Gate 720 can be pushed at any point of its height. Releasing gate 720 can bias gate 720 back into catch 718. The tether can then be locked into anchor 700C. In this manner anchor 700C can be threaded onto the tether.

[0418] In some implementations, anchor 700C is locked onto the tether separate from an anchor-adding device. In some implementations, anchor 700C is locked onto the tether using the anchor-adding device.

[0419] Figs. 8 A, 8B, and 8C are schematic illustrations of anchor-adding device 800. In some implementations, anchor-adding device 800 can be used to add anchor 700A to tether 112. In some implementations, anchor-adding device 800 can be used to add anchor 700B to tether 112. In some implementations, anchor-adding device 800 can be used to add anchor 700C to tether 112. In some implementations, anchor-adding device 800 can be used to add other anchors not shown or described to tether 112. In some implementations, each anchor to be added has its own anchor-adding device 800. In some implementations, one anchoradding device 800 is used to add many anchors.

[0420] Anchor-adding device 800 can include one or more of the following: upper shell 802, lower shell 804, slot 806, knob 808, spring 810, piston 812, and plate 814. In some implementations, anchor- adding device 800 can be formed from upper shell 802 and lower shell 804. Upper shell 802 and lower shell 804 can be attached via a hinge and open and close in a clamshell manner. Upper shell 802 can be opened to place anchor 700A within anchor-adding device 800.

[0421] In some implementations, anchor-adding device 800 can include an interior with a space for housing an anchor. In Fig. 8A, anchor 700A is shown as fitting within the interior such that gate 704 is open towards slot 806. Slot 806 can be suitable for tether 112 to be inserted therein. Fig. 8B shows anchor 700a within anchor-adding device 800 with gate 704 open.

[0422] In some implementations, tether 112 is inserted into slot 806 and past open gate 704. Once tether 112 is within shackle 702 gate 704 can be closed. In some implementations, gate 704 is closed by pressing knob 808 inwards. Pressing knob 808 inwards presses piston 812 against plate 814 to push gate 704 closed. Spring 810 can serve to bias knob 808 and piston 812 away from plate 814 such that unintentional closings may be prevented. In some implementations, other means of closing gate 704 are envisioned. Fig. 8C shows tether 112 inserted into shackle 702 and piston 812 actuated to push plate 814 upwards to close gate 704.

[0423] In some implementations, gate 704 can include a notch at an end thereof. The notch can click into a latch on shackle 702 when gate 704 is closed. Closing gate 704 can lock gate 704.

[0424] In some implementations, gate 704 can be locked when tether 112 is inserted into shackle 702 to thread anchor 700 A onto tether 112.

[0425] In some implementations, anchor 700B is housed within anchor-adding device 800. In some implementations, advancing slot 806 over tether 112 will cause tether 112 to open gate 708, enter clasp 706, and thereby be attached to anchor 700B. In some implementations, gate 708 is opened via pressing knob 808 or actuator. Pressing knob 808 or actuator can push down on latch 710 and open gate 708. When gate 708 is open, the tether can be advanced into clasp 706. Releasing knob 808 or actuator can release latch 710 and the spring bias can close gate 708, thereby threading the tether through clasp 706.

[0426] In some implementations, anchor 700C is housed within anchor-adding device 800. In some implementations, advancing slot 806 over tether 112 will cause tether 112 to open gate 720, enter parallel U-bend 716, and thereby be attached to anchor 700C. In some implementations, gate 720 is opened via pressing knob 808 or actuator. Pressing knob 808 or actuator can push down on gate 720 to open it. When gate 708 is open, the tether can be advanced into parallel U-bend 716. Releasing knob 808 or actuator can release gate 720 and ring 712 can close gate 720, thereby threading the tether through parallel U-bend 716.

[0427] Anchor-adding device 800 can be adapted to house different anchors than those shown. Actuator 808 can be adapted to close and / or open gates different than those shown.

[0428] Fig. 9 is a schematic illustration of an anchor 900, for illustrative purposes. Anchor 900 can include one or more features similar to anchors 120, 600, 700A, 700B, and 700C discussed above. Anchor 900 can include eyelet 902. Eyelet 902 can include wire 904, wire 906 and tongue 908. Anchor 900 can include anchor head 602 and tissue-engaging element 604. Anchor head 602 and tissue-engaging element 604 can be substantially the same and / or similar to anchor head 602 and tissue-engaging element 604 of anchor 600.

[0429] In some implementations, wires 904 and 906 can connect to each other at tongue 908 at one end and around bushing 610 at the other end. Wire 904 can be symmetrical with wire 906. Wire 904 can be a mirror image of wire 906 along a bisector of tongue 908. The bisector can cut tongue into 2 equal halves along a longitudinal plane of anchor 900. Wire 904 can form loop 910. Wire 906 can form loop 912.

[0430] In some implementations, anchor 900 can be threaded onto tether 112. Figs. 10A and 10B show an example of threading anchor 900 onto tether 112. Finger 1002 can push tether 112 up and over tongue 908 such that tether 112 enters into loops 910 and 912. Tether 112 can be bent inward, towards anchor 900, to wrap around tongue 908. Finger 1002 can include notch 1004 to hold tether 112 in place while it is being pushed. Once tether 112 is inserted into loops 910 and 912 it can be straightened out. Straightening out tether 112 can prevent tether 112 from exiting loops 910 and 912.

[0431] Anchors 600, 700A, 700B, 700C, 900, and / or any other suitable anchors can be added to tether 112 on the fly as needed.

[0432] Fig. 11 is a schematic illustration of an anchor head 1100, for illustrative purposes. In some implementations, it may be desirable to have anchors having different sized and / or shaped tissue-engaging elements. The different sizes may be chosen based on a location of implantation within the subject (e.g., when placing an anchor over a blood vessel a shorter length anchor may be desirable). An anatomy scan via CT and / or echocardiogram may be performed to determine features of the tissue (e.g., thickness, size, etc.) prior to selecting the appropriate tissue-engaging elements. In some implementations, anchor head 1100 can be separable from a tissue-engaging element. In some implementations, anchor head 1100 can connect to a tissue-engaging element before implantation. In some implementations, a tissueengaging element can be selected by snapping anchor head 1100 onto a suitable tissueengaging element to form an anchor. The anchor can be implanted within the subject.

[0433] In some implementations, anchor head 1100 can include head 1102. In some implementations, anchor head 1100 can include rod 1104. Anchor head 1100 can include bushing 1106. Anchor head 1100 can include wire rope 1108. In some implementations, anchor head 1100 can include clips 1110. In some implementations, anchor head 1100 can include ledge 1112. In some implementations, anchor head 1100 can include cavity 1114. In some implementations, anchor head 1100 can include slit 1116.

[0434] In some implementations, an anchor driver can connect to rod 1104 to maneuver anchor head 1100. Bushing 1106 can receive wire rope 1108. Clips 1110 can be sized to receive a shank of a tissue-engaging element. In some implementations, clips 1110 may be flexible enough to allow a shank to enter cavity 1114 and get caught by ledge 1112 thereby locking shank within anchor head 1100. Slits 1116 can improve the flexibility of clips 1110.

[0435] Figs. 12A, 12B, and 12C are schematic illustrations of tissue-engaging elements 1200A, 1200B, and 1200C. In some implementations, tissue-engaging elements 1200A, 1200B, and 1200C can be connectable with anchor head 1100. Tissue-engaging elements 1200A, 1200B, and 1200C can include a shank 1202. Tissue-engaging elements 1200A, 1200B, and 1200C can include a stem 1204. Tissue-engaging elements 1200A, 1200B, and 1200C can include a sharp tip 1206.

[0436] In some implementations, tissue-engaging element 1200A can include helical coil 1208. Tissue-engaging element 1200B can include helical coil 1210. Tissue-engaging element 1200C can include helical coil 1212. Helical coils 1208, 1210, and 1212 can vary in pitch, length, diameter, wire length, etc. Tissue-engaging elements with other variances in pitch, length, diameter, wire length, etc. not shown in Figs. 12A-12C can be used as well. A skilled artisan may design the dimensions of helical coil. While the dimensions of helical coils can differ, each shank 1202 can be the same size. Maintaining the same size for each shank allows the different sized tissue engaging elements to fit within cavity 1114 and snap into clips 1110.

[0437] In some implementations, anchor head 1100 can selectively connect to one of tissueengaging elements 1200A, 1200B, or 1200C. In this manner a suitable tissue-engaging element can be selectively chosen. Connecting anchor head 1100 with a tissue-engaging element can form an anchor to be implanted within the subject. Tissue-engaging elements 1200A, 1200B, and 1200C can also be referred to as a core of the anchor.

[0438] Fig. 13A is a schematic illustration of an anchor head 1100 and tissue-engaging element 1200A. Anchor head 1100 is held by anchor driver 210.

[0439] Fig. 13B is a schematic illustration of an anchor head 1100 connecting to tissueengaging element 1200A. In some implementations, anchor driver 210 moves anchor head 1100 over tissue-engaging element 1200A such that shank 1202 aligns with cavity 1114. In some implementations, anchor driver 210 pushes anchor head 1100 onto tissue-engaging element 1200A such that shank 1202 enters cavity 1114 and clicks into place. In this manner, anchor head 1100 can be connected to a selected one of a variety of tissue engaging elements.

[0440] Fig. 14 is a schematic illustration of cartridges 1400. Cartridges 1400 can house anchor heads 1100. Cartridges 1400 can be disposed on catheter device 300. Anchor driver 210 can be inserted into cartridge 1400 to remove one anchor head 1100 at a time. Onceanchor driver 210 implants a first anchor head 1100 (and connected tissue-engaging member), anchor driver 210 can connect to another one of anchor heads 1100.

[0441] Fig. 15 shows a schematic of assembling anchor 1504 and placing it within catheter device 300. Cartridge 1500 is shown as having four compartments. Each compartment includes openings 1502. In some implementations, there are more than four compartments. In some implementations, there are less than four compartments. Each compartment can house a tissue-engaging element. In some implementations, the compartments can house the same type of tissue-engaging elements, e.g., four tissue engaging elements 1200A, four tissue-engaging elements 1200B, four tissue-engaging elements 1200C. In some implementations, the compartments can house a mix of different types of tissue-engaging elements, e.g., a mix of one or more of tissue-engaging elements 1200A, 1200B, and 1200C. Cartridge 1500 can include openings 1502 to allow for the insertion and removal of tissueengaging elements.

[0442] Anchor driver 210 can grab anchor head 1100 from cartridge 1400, in a manner discussed above. Anchor head 1100 can be pre-threaded through tether 112. Anchor driver 210 can insert anchor head 1100 into cartridge 1500. Anchor driver 210 can maneuver anchor head 1100 in cartridge such that cavity 1114 is pushed over shank 1202 connecting anchor head 1100 and a tissue-engaging element (e.g., tissue engaging element 1200A) to form anchor 1504. Anchor driver 210 can then remove anchor 1504 from cartridge 1500. Anchor driver 210 can bring anchor 1504 along tether 112 to catheter device 300 to be inserted and implanted into the subject.

[0443] In this manner selected tissue-engaging elements can be implanted in the subject at desired locations. In some implementations, spacers are positioned between adjacent anchor heads when implanting the multiple anchor heads. In some implementations, the spacers and anchor heads are pre-threaded onto the tether. In some implementations, a pre-threaded anchor head is inserted into the body without an attached tissue-engaging element when less anchors are needed or when more space is needed between anchors than just one spacer.

[0444] Fig. 16A is an orthographic illustration of catheter device 300. Catheter device 300 can include rows of cartridges for storing anchor heads 1100 and tissue-engaging elements 1200A, 1200B, and 1200C to be used during implantation. Each row can contain the same type of element. The rows and / or individual cells in each row can be identified, e.g., labeled to indicate the type of tissue-engaging element.

[0445] Fig. 16B is a top view of catheter device 300.

[0446] Fig. 17 is a schematic illustration of an anchor delivery apparatus 1700, for illustrative purposes. Anchor delivery apparatus 1700 can include a spool 1702 of a spring- loaded winch. Spool wire 1704 can be wound around spool 1702. A distal end of spool wire 1704 can be connected to a proximal end of implant disengagement clamp 1706. A proximal end of implant wire 1708 can be connected to a distal end of implant disengagement clamp 1706. A distal end of the implant wire 1708 can end with stopper 1710 (e.g. a ball). Anchor 1712 can be threaded along implant wire 1708. Spacer 1714 can be threaded along implant wire 1708. Anchor 1712 can include one or more features similar to anchors 120, 600, 700A, 700B, 700C, and 900 discussed above. Anchor 1712 can be advanced to the implantation site using anchor driver 1716.

[0447] In some implementations, implant disengagement clamp 1706 allows spool wire 1704 to be separated from implant wire 1708. Separating spool wire 1704 from implant wire 1708 allows for additional anchors 1712 to be added to implant wire 1708 on the fly (e.g. during implantation). In some implementations, implant disengagement clamp 1706 may reengage spool wire 1704 to implant wire 1708 to tighten implant wire 1708 and allow the additional anchor to be advanced to the implantation site. Implant wire 1708 can be X long. Implant wire 1708 can be spooled around spool 1702.

[0448] Fig. 18 is a schematic illustration of catheter device 300 with anchor delivery apparatus 1700, for illustrative purposes. In some implementations, spool 1702 can be disposed inside catheter device 300. In some implementations, implant disengagement clamp 1706 can be wound around spool 1702.

[0449] In the implementation shown in Fig. 18 catheter device 300 can have a first anchor positioned through tube 310. In some implementations, spool 1702 of spring-loaded winch can be configured to automatically pull on and tighten spool wire 1704. Tightening spool wire 1704 will pull on implant disengagement clamp 1706 and implant wire 1708, thereby tightening them as well.

[0450] In some implementations, deactivation switch 1802 can be used to deactivate the spring-loaded winch. When deactivation switch 1802 is in an up position the spring-loaded winch is active. When deactivation switch 1802 is in a down position the spring-loaded winch is deactivated and spool wire 1704 may be pulled out from catheter device 300, without spool wire 1704 being automatically drawn back around spool 1702 via the spring-loaded winch. In some implementations, a length X of spool wire can be chosen such that implant disengagement clamp 1706 remains within catheter device 300 during active implantation of anchors 1712.

[0451] Fig. 19 is a schematic illustration of pulling implant disengagement clamp 1706 out of catheter device 300. In some implementations, active implantation of the anchors can be suspended to add additional anchors to implant wire 1708. In order to add additional anchors to implant wire 1708 deactivation switch 1802 can be positioned in the down position. In some implementations, positioning deactivation switch 1802 in the down position allows implant wire 1708 to be pulled out by a user, thereby pulling implant disengagement clamp 1706 out of catheter device 300 and unspooling spool wire 1704 from spool 1702. In some implementations, in order to add additional anchors implant disengagement clamp 1706 must be pulled out from catheter device 300 through opening 1902.

[0452] Figs. 20A-20E are schematic illustrations of adding an anchor 1712 to implant wire 1708 and advancing it to the implantation site. In the implementation shown in Fig. 20A implant wire 1708 can be removed from implant disengagement clamp 1706. Implant wire 1708 can be removed via actuating implant disengagement clamp 1706. In the implementation shown in Fig. 20B anchor 1712 can be added onto the detached proximal end of implant wire 1708. In some implementations, implant disengagement clamp 1706 can rest on catheter device 300 while anchor 1712 is added. In the implementation shown in Fig. 20C implant wire 1708 can be reengaged with implant disengagement clamp 1706.

[0453] In some implementations, after implant wire 1708 is reengaged with implant disengagement clamp 1706, implant wire 1708 can be tightened such that anchor 1712 can be advanced to the implantation site. In some implementations, deactivation switch 1802 can be moved to the up position and implant wire 1708 may be slowly released by the user as it automatically spools around spool 1702 via the spring -loaded winch. In some implementations, once implant wire 1708 is fully tightened anchor 1712 is ready to be advanced to the implantation site.

[0454] In some implementations, implant disengagement clamp 1706 can be withdrawn into catheter device 300 before advancing anchors 1712. Withdrawing implant disengagement clamp 1706 into catheter device 300 includes activating the spring-loaded winch. In the implementation shown in Fig. 20D anchor 1712 can be advanced to the implantation site. In some implementations, implant disengagement clamp 1706 can be within catheter device 300 and spooled around spool 1702. In some implementations, anchor 1712 can be advancedalong implant wire 1708 using anchor driver 1716. In the implementation shown in Fig. 20E anchor 1712 is advanced further down implant wire 1708.

[0455] Figs. 21A-21C are schematic illustrations of implant disengagement clamp 1706, for illustrative purposes. Fig. 21A shows a view of implant disengagement clamp 1706 in a locked position. Implant disengagement clamp 1706 can include a body 2100. Body 2100 can include lever 2102. Lever 2102 can include grips 2104. Body 2100 can include shaft 2106, spring 2108, bore 2110 and nut 2112.

[0456] In some implementations, lever 2102 can be used to disengage and reengage implant wire 1708 from implant disengagement clamp 1706. In some implementations, lever 2102 can pivot about shaft 2106. In some implementations, lever 2102 can be in an up (e.g. locked) position and a down (e.g. unlocked) position. Spring 2108 may maintain lever 2102 in the locked position. In some implementations, pressing down on lever 2102 compresses spring 2108 and places lever 2102 into the unlocked position, allowing implant wire 1708 to be engaged or disengaged from implant disengagement clamp 1706. Grips 2104 can enhance contact with lever 2102. Nut 2112 can be screwed into bore 2110 to secure spool wire 1704 to implant disengagement clamp 1706.

[0457] Fig. 2 IB shows a view of implant disengagement clamp 1706. Implant disengagement clamp 1706 may include opening 2114 for the placement of spool wire 1704.

[0458] Fig. 21C shows a cross-section of Fig. 21 A taken along the lines of XXIC. In some implementations, bore 2110 can include threads 2116. Nut 2112 can include corresponding threads to threads 2116 to screw into bore 2110. Lever 2102 can include a locking portion. The locking portion can include bulge 2118. In some implementations, while lever 2102 is biased in the locked position by spring 2108, bulge 2118 is biased against body 2100. The bias of bulge 2118 against body 2100 can be strong enough to maintain implant wire 1708 locked within implant disengagement clamp 1706 even when spring-loaded winch is activated.

[0459] Figs. 22A-22B are schematic illustrations of implant disengagement clamp 1706. Fig. 22A shows a view of implant disengagement clamp 1706 in the unlocked position. In some implementations, while implant disengagement clamp 1706 is in the unlocked position spool wire 1704 is still secured to implant disengagement clamp 1706. Implant disengagement clamp 1706 can be moved into the unlocked position by pressing down lever 2102. In some implementations, implant wire 1708 can be engaged and disengaged fromimplant disengagement clamp 1706 while in the unlocked position. In some implementations, disengaging implant wire 1708 from implant disengagement clamp 1706 involves pressing down lever 2102 removing implant wire 1708 from implant disengagement clamp 1706 and releasing lever 2102 (e.g. as partially shown in Fig. 20A). In some implementations, engaging implant wire 1708 with implant disengagement clamp 1706 involves pressing down lever 2102 inserting implant wire 1708 into implant disengagement clamp 1706 and releasing lever 2102 (e.g. as partially shown in Fig. 20C).

[0460] Fig. 22B shows a cross-section of Fig. 22A taken along the lines of XXIIB.

[0461] Figs. 23A-23B are schematic illustrations of implant disengagement clamp 1706. Fig. 23A shows an implementation of implant disengagement clamp 1706. Fig. 23A shows a view of implant disengagement clamp 1706 in a locked position. Implant disengagement clamp 1706 can include a body 2300. Body 2300 can include lever 2302. Lever 2302 can include knob 2304 and grips 2306. In some implementations, body 2300 can include shaft 2308, bore 2310 and nut 2312.

[0462] In some implementations, lever 2302 can be used to disengage and reengage implant wire 1708 from implant disengagement clamp 1706. In some implementations, lever 2302 can pivot about shaft 2308. In some implementations, lever 2302 can be in a down (e.g. locked) position and an up (e.g. unlocked) position. In some implementations, pulling up on lever 2302 via knob 2304 places lever 2302 into the unlocked position, allowing implant wire 1708 to be engaged or disengaged from implant disengagement clamp 1706. Grips 2306 can enhance contact with lever 2302. Nut 2312 can be screwed into bore 2310 to secure spool wire 1704 to implant disengagement clamp 1706.

[0463] Fig. 23B shows a cross-section of Fig. 23 A taken along the lines of XXIIIB. Lever 2302 can include a locking portion. The locking portion can include bulge 2316 and ridge 2318. In some implementations, bulge 2316 passing over ridge 2318 locks lever 2302 in the locked position. When bulge 2316 is passed over ridge 2318 bulge 2316 can be locked due to friction between bulge 2316 and ridge 2318. In some implementations implant wire 1708 contributes to the friction. The friction locking of bulge 2316 against ridge 2318 can be strong enough to maintain implant wire 1708 locked within implant disengagement clamp 1706 even when spring-loaded winch is activated. In some implementations lever 2302 can be maintained in the down (e.g. locked) position by any other suitable means, such as screws, bolts, wires etc.

[0464] Figs. 24A-24B are schematic illustrations of implant disengagement clamp 1706, for illustrative purposes. In the implementations shown in Fig. 24 implant disengagement clamp 1706 is in the unlocked position. In some implementations, while implant disengagement clamp 1706 is in the unlocked position spool wire 1704 is still secured to implant disengagement clamp 1706. Implant disengagement clamp 1706 can be moved into the unlocked position by pulling up knob 2304 of lever 2302. In some implementations, implant wire 1708 can be engaged and disengaged from implant disengagement clamp 1706 while in the unlocked position. In some implementations, disengaging implant wire 1708 from implant disengagement clamp 1706 involves pulling up knob 2304 and removing implant wire 1708 from implant disengagement clamp 1706. In some implementations, engaging implant wire 1708 with implant disengagement clamp 1706 involves inserting implant wire 1708 into implant disengagement clamp 1706 and pushing down lever 2302 such that bulge 2316 travels over ridge 2318 to lock lever 2302 in the locked position.

[0465] Fig. 24B shows a cross-section of Fig. 24A taken along the lines of XXIVB.

[0466] Fig. 24C shows a schematic illustration of implant disengagement clamp 1706, for illustrative purposes. In some implementations, body 2300 of implant disengagement clamp 1706 can be configured such that lever 2302 is lifted when in the unlocked position. Lever 2302 can be lifted when in the unlocked position due to interference between bulge 2316 and ridge 2318, a spring, or any other suitable means. Lever 2302 can be lifted such that it will not pass through opening 1902. Lever 2302 not being able to pass through opening 1902 may prevent spring-loaded winch from pulling an unlocked implant disengagement clamp 1706 into catheter device 300 due to an accidental activation of the spring-loaded winch. When an unlocked implant disengagement clamp 1706 is pulled into catheter device 300 it cannot be removed again easily by for example implant wire 1708.

[0467] Fig. 25A is a schematic illustration of anchor 2500, for illustrative purposes. Anchor 2500 can include anchor head 2502, tissue-engaging element 2504, and eyelet 2506. Eyelet 2506 can include slipknot 2508. In some implementations, one or more of anchor 2500 can be arranged on tether 112. Slipknots 2508 of anchors 2500 can be loosened and advanced over stopper 1710 to arrange anchors 2500 on tether 112. Tether 112 may end at stopper 1710 at a first end and spool 1702 at the other end. Slipknot 2508 can include knot 2510 to prevent slipknot 2508 from pulling through itself. Knot 2510 can be a physical knot, a bead of material or any other suitable means for preventing slipknot 2508 from coming undone.

[0468] Fig. 25B is a schematic illustration of anchor 2500, for illustrative purposes. In some implementations, anchors 2500 can be arranged on tether 112. In some implementations, tether 112 can be customizable. For example, a user can arrange anchors 2500 on tether 112 in a desired order and with a desired number of anchors 2500. In some implementations each anchor 2500 can be customizable as well. For example, a width, height, length etc. can be selected for each anchor, as discussed above regarding Figs. 12A-12C. In the implementation shown in Fig. 25B two anchors 2500 have a greater width than the last anchor 2500.

[0469] In some implementations, slipknot 2508 can self-tighten around tether as it is arranged along tether 112. Slipknot 2508 can be configured to self-tighten due to a weight of anchor 2500. The weight on anchor 2500 can apply a tension to slipknot 2508 which can self-tighten slipknot 2508. Slipknot 2508 can be configured to self-tighten while being advanced along tether 112.

[0470] Fig. 26 is a schematic illustration of cassette 2600, for illustrative purposes. Cassette 2600 can include one or more features similar to cassette 20 and anchor-adding device 800 discussed above. In some implementations, cassette 2600 can be configured to hold anchor 2500 such that slipknot 2508 extends outward from cassette 2600 while anchor 2500 is within closed cassette 2600. In this manner anchor 2500 may be arranged on tether 112 by holding cassette 2600 and maneuvering slipknot 2508 over stopper 1710 to arranged anchor 2500 on tether 112.

[0471] Fig. 27A is a schematic illustration of cassette 2600 being set up on catheter device 300, for illustrative purposes. In some implementations, cassette 2600 and anchor 2500 can be advanced over stopper 1710 as described above. In some implementations, catheter device 300 can include designated areas in which cassettes 2600 can dock. In the implementation shown in Fig. 27A cassettes 2600 are docked in catheter device 300 and the final cassette 2600 is being added to tether 112 to be docked in catheter device 300. Cassette 2600 can include bore 2702 and slot 2704. In some implementations, bore 2702 is sized such that anchor 2500 can be removed from cassette 2600 using an anchor driver. In some implementations, as anchor 2500 is removed from cassette 2600 along bore 2702 slipknot 2508 is removed from cassette 2600 along slot 2704 such that slipknot 2508 remains tightened along tether 112 as anchor 2500 is removed. In some implementations, cassette 2600 is left docked in catheter device 300 as anchor 2500 is removed and advanced toward the implantation site.

[0472] Fig. 27B is a schematic illustration of cassette 2600 docked in catheter device 300, for illustrative purposes. In the implementations shown in Fig. 27B cassettes 2600 are docked in catheter device 300 and are ready for implantation.

[0473] The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub-combinations with one another. The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, apparatuses, devices, methods, etc. require that any one or more specific advantages be present or problems be solved.

[0474] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.)

[0475] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0476] Various implementations of systems, devices, methods, etc. are disclosed herein, and any combination of their features, components, and options can be made unless specifically excluded. For example, various descriptions of implants can be used with any appropriate delivery tools, even if a specific combination is not explicitly described. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0477] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.

[0478] The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub -combinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

[0479] Example Implementations (some non-limiting examples of the concepts herein are recited below):

[0480] Example 1. A system for use with a tether that is transluminally implantable at a tissue of a subject, the system comprising: (a) an anchor, comprising: (i) a head, (ii) a tissueengaging element configured to be driven into the tissue, and / or(iii) an eyelet, mounted on the head, and defining a gate via which an intermediate region of the tether is laterally introducible into the eyelet to become disposed through the eyelet; and / or (b) an anchoradding device comprising a shell in which is situated a cavity that houses the anchor, the shell defining a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the eyelet.

[0481] Example 2. The system according to example 1, wherein the cavity is entirely internal to the anchor-adding device.

[0482] Example 3. The system according to example 1, wherein the shell is shaped such that at least part of the cavity is exposed at a surface of the anchor-adding device.

[0483] Example 4. The system according to any one of examples 1-3, wherein the eyelet extends laterally from the head.

[0484] Example 5. The system according to any one of examples 1-4, wherein the cavity is dimensioned to house at least part of the anchor snugly.

[0485] Example 6. The system according to any one of examples 1-5, wherein the cavity is dimensioned to constrain the anchor in a given rotational orientation about the anchor axis.

[0486] Example 7. The system according to any one of examples 1-6, wherein the gate is biased to be closed.

[0487] Example 8. The system according to any one of examples 1-7, wherein the slot is positioned with respect to the cavity such that sliding the intermediate region of the tether through the slot to the cavity snaps the intermediate region of the tether through the gate into the eyelet.

[0488] Example 9. The system according to any one of examples 1-8, further comprising the tether.

[0489] Example 10. The system according to any one of examples 1-9, wherein the slot is planar.

[0490] Example 11. The system according to any one of examples 1-10, wherein the slot defines a plane, and the cavity houses the anchor with the anchor axis parallel to the plane.

[0491] Example 12. The system according to any one of examples 1-11, wherein the slot is configured such that the intermediate region of the tether is, while tensioned, slidable to the cavity via the slot.

[0492] Example 13. The system according to any one of examples 1-12, wherein the anchor-adding device is configured for release of the anchor while the intermediate region of the tether remains disposed through the eyelet.

[0493] Example 14. The system according to example 13, wherein the anchor-adding device is configured for release of the anchor only upon the intermediate region of the tether having been slid through the slot.

[0494] Example 15. The system according to example 13, wherein the anchor-adding device defines a passage, and is configured for release of the anchor by the anchor being pulled out of the anchor-adding device via the passage.

[0495] Example 16. The system according to example 13, wherein the anchor-adding device is configured for release of the anchor by the shell being openable to expose the anchor in the cavity.

[0496] Example 17. The system according to example 16, wherein the shell is hinged to be openable in a clamshell manner.

[0497] Example 18. The system according to any one of examples 1-17, wherein the anchor-adding device comprises an actuator, manually operable to facilitate lateral introduction of the intermediate region of the tether, at the cavity, into the eyelet.

[0498] Example 19. The system according to example 18, wherein the actuator is configured to open the gate while the anchor is housed in the cavity.

[0499] Example 20. The system according to example 18, wherein the actuator is configured to close the gate while the anchor is housed in the cavity.

[0500] Example 21. The system according to example 18, wherein the actuator is configured to force the intermediate region of the tether, at the cavity, through the gate into the eyelet.

[0501] Example 22. The system according to any one of examples 1-21, wherein: (i) the system is further for use with a driver for the anchor, and / or (ii) the shell further defines a passage via which the driver is insertable to the cavity to engage the head.

[0502] Example 23. The system according to example 22, further comprising the driver, the driver comprising a flexible shaft and a drivehead at a distal end of the shaft, the drivehead being insertable via the passage to the cavity, the passage guiding the drivehead into engagement with the head.

[0503] Example 24. The system according to example 23, wherein the anchor-adding device is configured for release of the anchor by the anchor being pulled out of the anchoradding device via the passage while the intermediate region of the tether remains disposed through the eyelet.

[0504] Example 25. The system according to example 23, wherein the passage is shaped such that, at least upon arrival of the drivehead at the head, the drivehead is rotationally aligned with the head.

[0505] Example 26. The system according to example 25, wherein the passage is shaped to accept the drivehead only in rotational alignment with the head.

[0506] Example 27. The system according to example 25, wherein the passage is shaped to rotationally align the drivehead with the head as the drivehead is advanced through the passage toward the cavity.

[0507] Example 28. The system according to example 22, wherein the slot defines a plane in which the intermediate region of the tether is slidable to the cavity, the passage being parallel to the plane.

[0508] Example 29. The system according to example 22, wherein the slot defines a plane in which the intermediate region of the tether is slidable to the cavity, the passage lying on the plane.

[0509] Example 30. The system according to examples 1-29, wherein the eyelet includes a clip that defines the gate, and the gate is biased closed by a spring element.

[0510] Example 31. The system according to examples 1-29, wherein the eyelet includes a shackle, and the gate includes a groove that is configured to be inserted into a latch of the shackle to lock the gate.

[0511] Example 32. The system according to examples 1-29, wherein the eyelet includes two wires that are connected to each other via a tongue that defines the gate.

[0512] Example 33. The system according to example 32, wherein the wires are mirror images of each other along a vertical plane that bisects the tongue.

[0513] Example 34. The system according to example 32, wherein an end of each wire begins at and extends away from the head and the tongue extends from the wires toward the head to form loops.

[0514] Example 35. The system according to example 34, wherein the tongue is configured to receive the tether when the tether is bent.

[0515] Example 36. The system according to examples 1-29, wherein the gate is biased against a catch, and the eyelet is configured to receive the tether when the gate is pushed away from the catch.

[0516] Example 37. The system according to examples 1-29, wherein the anchor-adding device includes an actuator that is configured to thread the tether into the eyelet, when the tether is present within the slot.

[0517] Example 38. The system according to example 37, wherein the actuator is a button that is configured to close the gate when actuated.

[0518] Example 39. The system according to example 37, wherein: (i) the gate is biased closed; (ii) the actuator is a button that is configured to open the gate when pressed; (iii)when the gate is open, the eyelet is configured to receive the tether; and / or (iv) releasing the button closes the gate.

[0519] Example 40. The system according to example 37, wherein the actuator is a finger that is configured to bend the tether, and push it over a tongue of the eyelet when actuated.

[0520] Example 41. A system, useable and / or for use with a tissue of a subject, the system comprising: (i) a catheter device, comprising: (a) a flexible tube that has: (I) a distal opening that is configured to be transluminally advanced toward the tissue, and / or (II) a proximal end that defines a proximal opening; and / or (b) an extracorporeal unit, coupled to the proximal end of the tube, and comprising: (I) a body, and / or (II) a series of cartridges, distributed along the body; (ii) a tether, extending along the body; (iii) a series of system-anchors, each of the system-anchors housed by a corresponding cartridge of the series of cartridges, and comprising: (a) a system-anchor head, (b) a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue, and / or (c) a system-anchor eyelet, mounted on the system-anchor head, and threaded on the tether; (iv) a supplemental-anchor, comprising: (A) a supplemental-anchor head, (B) a supplemental-anchor tissue-engaging element, extending from the supplemental-anchor head, and configured to be driven into the tissue, and / or (C) a supplemental-anchor eyelet, mounted on the supplemental-anchor head, and defining a gate via which an intermediate region of the tether is laterally introducible into the supplemental-anchor eyelet to become disposed through the supplemental-anchor eyelet; and / or (v) an anchor-adding device comprising a shell in which is situated a cavity that houses the supplemental-anchor, the shell defining a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the supplemental-anchor eyelet.

[0521] Example 42. The system according to example 41, wherein the supplemental- anchor tissue-engaging element is geometrically different from the system-anchor tissueengaging element.

[0522] Example 43. The system according to any one of examples 41-42, wherein the supplemental-anchor tissue-engaging element is wider than the system-anchor tissueengaging element.

[0523] Example 44. The system according to any one of examples 41-42, wherein the supplemental-anchor tissue-engaging element is narrower than the system-anchor tissueengaging element.

[0524] Example 45. The system according to any one of examples 41-44, wherein the supplemental-anchor tissue-engaging element is longer than the system-anchor tissueengaging element.

[0525] Example 46. The system according to any one of examples 41-44, wherein the supplemental-anchor tissue-engaging element is shorter than the system-anchor tissueengaging element.

[0526] Example 47. The system according to any one of examples 41-46, wherein the supplemental-anchor head is substantially identical to the system-anchor head.

[0527] Example 48. The system according to any one of examples 41-47, further comprising a driver that comprises a flexible shaft and a drivehead at a distal end of the shaft, wherein: (a) each of the system-anchor heads defines a system-anchor interface that is engageable by the drivehead, and / or (b) the supplemental-anchor head defines a supplemental-anchor interface that is engageable by the drivehead, and that is substantially identical to the system-anchor interface.

[0528] Example 49. The system according to example 48, wherein the shell further defines a passage via which the drivehead is insertable to the cavity such that the passage guides the drivehead into engagement with the system-anchor head.

[0529] Example 50. A method for use with a tether that has a first end, a second end, and an intermediate portion therebetween, the method comprising, without access to the first end or the second end: (a) sliding the intermediate portion laterally through a slot in a case of an anchor-adding device that defines a cavity in which an anchor is disposed; (b) within the cavity, coupling the anchor to the tether by laterally introducing the intermediate portion of the tether into an eyelet of the anchor; and / or (c) subsequently, removing the anchor-adding device from the tether, leaving the anchor coupled to the tether.

[0530] Example 51. A system useable with a tissue of a subject, the system comprising: (a) a tether; (b) a series of anchors; and / or (c) an anchor-adding device.

[0531] Example 52. The system according to example 51, further comprising a catheter device, comprising: (a) a flexible tube that has: (i) a distal opening that is configured to be transluminally advanced toward the tissue, and / or (ii) a proximal end that defines a proximal opening; and / or (b) an extracorporeal unit, coupled to the proximal end of the tube, and comprising: (i) a body, and / or (ii) the anchor-adding device, wherein the anchor- adding device comprises a series of cartridges, distributed along or parallel to a proximal-distal axisof the body, with a distalmost cartridge of the series of cartridges being closest to the proximal opening.

[0532] Example 53. The system according to example 41, further comprising a tensioner, configured to engage an intermediate region of the tether, the intermediate region of the tether being at the extracorporeal unit, and apply tension to the tether by pulling on the intermediate region of the tether.

[0533] Example 54. The system according to example 53, wherein the extracorporeal unit houses the tensioner.

[0534] Example 55. The system according to any one of examples 51-54, wherein each anchor of the series comprises a head, coupled or couplable to the tether, and a tissueengaging element, extending away from the head.

[0535] Example 56. The system according to any one of examples 52-55, wherein the tether has (i) a distal end at a leading anchor of the series of anchors, and (ii) a proximal end releasably secured within the extracorporeal unit.

[0536] Example 57. The system according to any one of examples 51-56, further comprising multiple spacers threaded on the tether or otherwise attached or attachable to the tether, such that the multiple spacers alternate with at least some anchors of the series of anchors.

[0537] Example 58. The system according to example 57, further comprising at least one free spacer, separate from the tether, and manually attachable onto the tether between anchors without access to an end of the tether.

[0538] Example 59. The system according to example 57, wherein each of the spacers is tubular, and is movable along the tether with the tether extending through a lumen defined by the spacer.

[0539] Example 60. The system according to any one of examples 51-59, wherein each anchor of the series of anchors comprises: (a) an anchor head; and / or (b) a helical tissueengaging element, extending away from the anchor head to define an anchor axis of the anchor, and configured to be screwed along the anchor axis into the tissue; and wherein the system further comprises: (i) a flexible tube that has a distal portion that includes the distal opening, the flexible tube defining along a tube axis of the flexible tube, a channel through which the anchor is advanceable toward the distal opening, and / or (ii) an anchor driverconfigured to advance the anchor distally through the channel, and drive the anchor into the tissue by screwing the helical tissue-engaging element into the tissue.

[0540] Example 61. The system according to any one of examples 51-60, wherein one or more of the anchors of the series of anchors comprises: (i) an anchor head; (ii) a tissueengaging element: (a) extending distally away from the anchor head, and / or (b) configured to be driven into the tissue; and / or (iii) a textile or polymer, shaped to define an eyelet, the anchor being coupled to the tether by the eyelet being coupled to the tether.

[0541] Example 62. The system according to any one of examples 51-61, further comprising an anchor driver: (i) comprising a flexible shaft, and a drive head at a distal end of the shaft, and / or (ii) configured to, for each of the anchors sequentially: (a) engage the drive head with the anchor, and / or (b) while the anchor remains coupled to the tether, advance the anchor into the proximal opening and through a flexible tube toward the tissue, and drive the anchor into the tissue.

[0542] Example 63. The system according to any one of examples 51-62, further comprising an elongate adjustment tool and a lock, the adjustment tool configured to: (i) advance the lock distally along the tether into a location inside of the subject and toward the tissue, (ii) apply tension to the tether, (iii) lock the tension in the tether by locking the lock to the tether, (iv) cut the tether proximally from the lock, and / or (v) leave the lock at the location locked to the tether.

[0543] Example 64. The system according to example 63, wherein the lock is configured to be placed onto and advanced along the tether by the adjustment tool without access to an end of the tether.

[0544] Example 65. The system according to any one of examples 63-64, wherein: (i) the adjustment tool comprises an obstructor tube disposed within the lock, (ii) the lock comprises: (a) a housing, shaped to define a distal-facing aperture via which the tether is insertable through the lock and into the obstructor tube, and / or (b) a spring-loaded clamp, disposed within the housing, and biased to clamp onto the tether within the lock, the presence of the obstructor tube within the lock obstructing the clamp from clamping onto the tether within the lock.

[0545] Example 66. The system according to any one of examples 51-65, wherein the anchor-adding device comprises a shell in which is situated a cavity that houses the anchor,the shell defining a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into an eyelet or other connector of a supplemental anchor.

[0546] Example 67. The system according to example 66, wherein the cavity is entirely internal to the anchor-adding device.

[0547] Example 68. The system according to example 66, wherein the shell is shaped such that at least part of the cavity is exposed at a surface of the anchor-adding device.

[0548] Example 69. The system according to any one of examples 66-68, wherein the eyelet or other connector extends laterally from the head.

[0549] Example 70. The system according to any one of examples 66-69, wherein the supplemental anchor includes an eyelet having a gate that is biased to be closed.

[0550] Example 71. The system according to example 70, wherein the slot is positioned with respect to the cavity such that sliding the intermediate region of the tether through the slot to the cavity snaps the intermediate region of the tether through the gate into the eyelet.

[0551] Example 72. The system according to any one of examples 51-71, wherein the anchor-adding device holds at least one supplemental anchor and is configured for release of the at least one supplemental anchor while an intermediate region of the tether remains disposed through an eyelet or other connector of the at least one supplemental anchor.

[0552] Example 73. The system according to example 72, wherein the anchor-adding device is configured for release of the supplemental anchor only upon the intermediate region of the tether having been advanced through the slot.

[0553] Example 74. The system according to example 72, wherein the anchor-adding device defines a passage, and is configured for release of the at least one supplemental anchor by the at least one supplemental anchor being pulled out of the anchor-adding device via the passage.

[0554] Example 75. The system according to example 72, wherein the anchor-adding device is configured for release of the at least one supplemental anchor by a shell of the anchor-adding device being openable to expose the at least one supplemental anchor in the cavity.

[0555] Example 76. The system according to example 75, wherein the shell is hinged to be openable in a clamshell manner.

[0556] Example 77. The system according to any one of examples 51-76, wherein the anchor-adding device comprises an actuator, manually operable to facilitate lateral introduction of the intermediate region of the tether into an eyelet or other connector of at least one supplemental anchor.

[0557] Example 78. A system for use with a tissue of a subject, the system comprising: (a) a selection of tissue-engaging elements, each having a sharp tip and a shank; (b) a tether configured to be transluminally implantable adjacent the tissue; and / or (c) an anchor head that comprises (i) an eyelet threaded on the tether, and (ii) a socket, configured to be mated with a selected one of the tissue-engaging elements to form an anchor that is advanceable over and along the tether toward the tissue, and whose tissue-engaging element is drivable into the tissue.

[0558] Example 79. The system according to example 78, wherein the selection of tissueengaging elements includes multiple first-type tissue-engaging elements, and multiple second-type tissue-engaging elements, the shanks of the second-type tissue-engaging elements being identical to the shanks of the first-type tissue-engaging elements.

[0559] Example 80. The system according to example 79, wherein a core of the first-type tissue-engaging elements is different than a core of the second-type tissue-engaging elements, and each core is disposed between the sharp tip and shank of respective tissueengaging elements.

[0560] Example 81. The system according to example 80, wherein the difference is in a height of each respective core.

[0561] Example 82. The system according to example 80, wherein the difference is in a width of each respective core.

[0562] Example 83. The system according to example 80, wherein the difference is a shape of each respective core.

[0563] Example 84. The system according to example 80, wherein the core of the first- type tissue engaging element includes a first helical coil, and the core of the second-type tissue engaging elements includes a second helical coil.

[0564] Example 85. The system according to example 84 wherein the first helical coil includes a different pitch than the second helical coil.

[0565] Example 86. The system according to example 84 wherein the first helical coil includes a different diameter than the second helical coil.

[0566] Example 87. The system according to example 84 wherein the first helical coil includes a different length than the second helical coil.

[0567] Example 88. The system according to example 84 wherein the first helical coil includes a different wire diameter than the second helical coil.

[0568] Example 89. The system according to example 79, wherein the system further includes a plurality of anchor heads and a series of cartridges.

[0569] Example 90. The system according to example 89, wherein the series of cartridges includes a first set of cartridges configured to house the plurality of anchor heads, a second set of cartridges configured to house the first-type tissue-engaging elements, and a third set of cartridges configured to house the second-type tissue-engaging elements.

[0570] Example 91. A system for use with a tissue of a subject, the system comprising: (a) a driver; (b) a selection of tissue-engaging elements, each having a sharp tip and a shank; (c) a tether configured to be transluminally implantable adjacent the tissue; and / or (d) an anchor head including a socket, threaded on the tether, and implantable in the subject by, using the driver: (i) advancing the socket over the shank of a selected one of the tissue-engaging elements to engage the anchor head with the selected tissue-engaging element, and form an anchor; (ii) advancing the anchor to the tissue; and / or (iii) driving the selected tissueengaging element into the tissue by applying a force to the anchor head.

[0571] Example 92. The system according to example 91, wherein the anchor is releasable from the driver at the tissue.

[0572] Example 93. The system according to any one of examples 90-91, wherein the socket locks onto the shank.

[0573] Example 94. The system according to any one of examples 90-92, wherein a height of the shank is taller than a height of the socket.

[0574] Example 95. The system according to any one of examples 90-92, wherein a height of the shank is shorter than a height of the socket.

[0575] Example 96. The system according to any one of examples 90-94, wherein the shank includes a hexagonal cross- section.

[0576] Example 97. The system according to any one of examples 90-95, wherein a shape of the socket corresponds to a shape of the shank.

[0577] Example 98. The system according to any one of examples 90-96, wherein the advancing the socket over the shank centers the anchor head with respect to the tissueengaging element.

[0578] Example 99. The system according to any one of examples 90-97, wherein the tissue-engaging element includes a central axis, and a central axis of the shank is aligned with the central axis.

[0579] Example 100. The system according to any one of examples 90-98, wherein the socket includes an attachment feature, and the shank includes an engagement feature that corresponds to the attachment feature.

[0580] Example 101. The system according to example 100, wherein the attachment feature includes clips and the engagement feature includes an edge that corresponds to the clips.

[0581] Example 102. The system according to example 101, wherein the edge is a groove on the shank.

[0582] Example 103. The system according to example 101, wherein the edge is a lower edge of the shank.

[0583] Example 104. The system according to example 100, wherein the attachment feature includes a magnet with a first polarity and the engagement feature includes a magnet with a second polarity, opposite the first polarity.

[0584] Example 105. The system according to any one of examples 90-103, wherein the system further comprises a plurality of anchor heads.

[0585] Example 106. The system according to example 105, wherein each anchor head further includes: (i) a rod; (ii) a bushing disposed around an outer surface of the socket; and / or (iii) a wire disposed about the bushing and forming an eyelet that is threaded through the tether.

[0586] Example 107. The system according to example 106, wherein the driver is configured to be removably connectable to the rod.

[0587] Example 108. The system according to example 107, wherein a proximal end of the driver is configured to be clipped onto the rod.

[0588] Example 109. The system according to example 107, wherein a proximal end of the driver is configured to be actuated to grab the rod.

[0589] Example 110. The system according to any one of examples 104-108, wherein the driver is configured to sequentially drive each anchor head into distinct locations within the tissue.

[0590] Example 111. The system according to example 110, wherein the sequential driving of each anchor head includes: (i) grasping, by the driver, one of the anchor heads; (ii) withdrawing, using the driver, the one of the anchor heads from a corresponding cartridge; (iii) advancing, using the driver, the socket of the one of the anchor heads over a selected one of the tissue-engaging elements to form a first anchor; (iv) advancing, using the driver, the first anchor to the tissue; (v) driving, using the driver, the first anchor into the tissue; and / or (vi) sequentially following steps (i)-(v) for each anchor head.

[0591] Example 112. The system according to any one of examples 104-110, wherein respective spacers are threaded through the tether between adjacent anchor heads.

[0592] Example 113. The system according to any one of examples 104-111, wherein at least one of the plurality of anchor heads is inserted into the subject without a corresponding tissue-engaging element.

[0593] Example 114. The system according to any one of examples 90-112, wherein the tissue-engaging element includes a helical coil disposed between the sharp tip and the shank.

[0594] Example 115. The system according to example 114, wherein each respective helical coil, sharp tip, shank, and socket share a common central axis.

[0595] Example 116. A system, useable and / or for use with a tissue of a subject, the system comprising: (a) a catheter device, comprising: (i) a flexible tube that has: (A) a distal opening that is configured to be transluminally advanced toward the tissue, and / or (B) a proximal end that defines a proximal opening; and / or (ii) an extracorporeal unit, coupled to the proximal end of the tube, and comprising: (I) a body, and / or (II) a series of cartridges, distributed along the body; (b) a tether, extending along the body; (c) a selection of tissue-engaging elements, each having a sharp tip and a shank, housed by a corresponding cartridge of the series of cartridges; and / or (d) a plurality of anchor heads, housed by corresponding cartridges of the series of cartridges, each anchor head: (I) comprising (i) an eyelet threaded on the tether, and (ii) a socket; and / or (II) being configured to be mated with a selected one of the tissue-engaging elements to form an anchor that is advanceable over and along thetether toward the tissue, and whose tissue-engaging element is drivable into the tissue via application of a force to the anchor head.

[0596] Example 117. A system according to any one of the preceding examples, wherein one or more of the components of the system is sterilized.

[0597] Example 118. A method according to example 50, further comprising sterilizing the case in which the anchor is disposed, prior to the step of sliding.

[0598] Example 119. A system usable with a tissue of a subject, the system comprising: (a) a tether; (b) an anchor comprising: (i) a tissue engaging element for securing the anchor to the tissue; (ii) a head couplable to the tissue engaging element; and / or (iii) an eyelet coupled to the head, the eyelet comprising a gate that allows lateral insertion of the tether into the eyelet.

[0599] Example 120. The system of example 119, further comprising an anchor loading device, comprising: (i) a shell comprising a cavity that is configured to receive at least a portion of the anchor; and / or (ii) a slot that allows the tether to slide into the cavity for lateral insertion of the tether into the eyelet.

[0600] Example 121. A system for use with a tissue of a subject, the system comprising: (i) a plurality of tissue-engaging elements, each having a shank; (ii) a tether; and / or (iii) a plurality of anchor heads, an anchor head comprising: (a) an eyelet threaded on the tether; and / or (b) a socket, configured to be mated with a selected one of the tissue-engaging elements to form an anchor.

[0601] Example 122. The system according to example 78, wherein the plurality of tissueengaging elements includes one or more first-type tissue-engaging elements, and one or more second-type tissue-engaging elements, the shanks of the second-type tissue-engaging elements being identical to the shanks of the first-type tissue-engaging elements.

[0602] Example 123. A system for use with a tissue of a subject, the system comprising: (a) a driver; (b) a selection of tissue-engaging elements, each having a shank; (c) a tether; and / or (d) an anchor head threaded on the tether, the anchor head comprising a socket, and implantable in the subject by, using the driver: (i) advancing the socket over the shank of a selected one of the tissue-engaging elements to engage the anchor head with the selected tissue-engaging element, and form an anchor; (ii) advancing the anchor to the tissue; and / or (iii) driving the selected tissue-engaging element into the tissue by applying a force to the anchor head.

[0603] Example 124. A system for use at a cardiovascular tissue of a subject, the system comprising: (i) an implant, including a tether; and / or (ii) a tool, configured for transluminal implantation of the implant to the tissue, the tool comprising: (a) an intracorporeal portion, transluminally advanceable toward the tissue; and / or (b) an extracorporeal portion, comprising: (i) a clamp; (ii) a spring-loaded winch, connected to the tether via the clamp to enable the winch to apply tension to the tether; and / or (iii) a release, operable to repeatedly, during the implantation of the implant: (A) open the clamp to disconnect the tether from the winch; and / or (B) close the clamp to reconnect the tether to the winch.

[0604] Example 125. The system according to example 124, wherein the tether has a distal end that is implantable, and a proximal end that is connected to the clamp such that opening of the clamp to disconnect the tether from the winch provides access to the proximal end of the tether.

[0605] Example 126. The system according to example 124, wherein disconnecting the tether from the winch exposes a proximal end of the tether.

[0606] Example 127. The system according to any one of examples 124-126, wherein the cardiovascular tissue is a heart valve.

[0607] Example 128. The system according to any one of examples 124-127, wherein the release is biased closed.

[0608] Example 129. The system according to any one of examples 124-128, wherein the extracorporeal portion further includes a spool wire having a distal end connected to the clamp and a proximal end connected to the winch.

[0609] Example 130. The system according to example 129, wherein the winch is configured to apply tension to the tether via the spool wire.

[0610] Example 131. The system according to example 130, wherein opening the release removes the applied tension to the tether.

[0611] Example 132. The system according to any one of examples 129-131, wherein the spool wire is wound around a spool of the winch.

[0612] Example 133. The system according to any one of examples 124-132, wherein the clamp is wound around the spool and is configured to be unwound from the spool during the implantation.

[0613] Example 134. The system according to any one of examples 129-133, wherein the spool wire is configured to be extendable away from and retractable into the winch.

[0614] Example 135. The system according to any one of examples 129-134, wherein the spool wire is connected to the clamp via a set screw.

[0615] Example 136. The system according to any one of examples 124-135, wherein the extracorporeal portion further includes a spring which biases the release closed.

[0616] Example 137. The system according to example 136, wherein opening the clamp compresses the spring.

[0617] Example 138. The system according to any one of examples 136-137, wherein the release comprises a lever and the spring biases the lever to press the tether against the clamp.

[0618] Example 139. The system according to example 138, wherein the force of the bias from the spring is greater than the applied tension to the tether.

[0619] Example 140. The system according to any one of examples 124-139, wherein the tether includes an anchor threaded thereon, the anchor being configured to be implanted into the tissue.

[0620] Example 141. The system according to any one of examples 124-140, wherein: (i) disconnecting the tether from the winch exposes a proximal end of the tether; (ii) supplemental anchors are configured to be threaded onto the exposed proximal end of the tether; and / or (iii) reconnecting the tether to the winch retains the supplemental anchors on the tether.

[0621] Example 142. The system according to example 141, wherein the supplemental anchors are configured to: (i) slide along the tether to the tissue; and / or (ii) be implanted at the tissue.

[0622] Example 143. A system for use at a cardiovascular tissue of a subject, the system comprising: (a) an implant, including a tether; and / or (b) a tool, configured for transluminal implantation of the implant to the tissue, the tool comprising: (i) an intracorporeal portion, transluminally advanceable toward the tissue; and / or (ii) an extracorporeal portion, comprising: (A) a clamp; (B) a spring-loaded winch, configured to apply a tension to a spool wire; (C) the spool wire, configured to apply the tension to the tether; and / or (D) a release, operable to during the implantation of the implant: (I) open the clamp to remove the applied tension to the tether; and / or (II) close the clamp to reapply the tension to the tether.

[0623] Example 144. A system comprising: (i) a tether configured for transluminal implantation at a tissue of a subject; (ii) a spring-loaded winch, capable of applying tension to the tether via a clamp, the clamp operable to repeatedly: (a) open the clamp to disconnect an end of the tether from the winch; and / or (b) close the clamp to reconnect the end of the tether to the winch; and / or (iii) an anchor configured to be: (I) threaded onto the disconnected end of the tether; and / or (II) slid along the reconnected tether to the tissue after tension is applied to the tether via the winch.

[0624] Example 145. A method for use with a tether, the method comprising: (i) transluminally implanting an implant connected to the tether to a tissue of a subject; (ii) exposing a clamp, which is coupled to an end of the tether; (iii) opening the clamp to release the end of the tether from the clamp; (iv) threading an anchor onto the released end of the tether; (v) closing the clamp to secure the end of the tether to the clamp; (vi) applying a tension to the tether via a spring-loaded winch to tauten the tether; and / or (vii) sliding the anchor to the tissue along the tautened tether.

[0625] Example 146. The method according to example 145, further comprising implanting the anchor at the tissue.

[0626] Example 147. The method according to any one of examples 145-146, wherein: (i) the opening the clamp further includes opening a release of the clamp; and / or (ii) the closing the clamp further includes closing the release.

[0627] Example 148. The method according to any one of examples 145-147, wherein the clamp and spring-loaded winch are part of an extracorporeal portion.

[0628] Example 149. A system useable and / or for use with a tissue of a subject, the system comprising: (i) a catheter device, comprising: (a) a flexible tube that has: (I) a distal opening that is configured to be transluminally advanced toward the tissue, and / or (II) a proximal end that defines a proximal opening; and / or (b) an extracorporeal unit, coupled to the proximal end of the tube, and comprising: (A) a body, and / or (B) a series of cartridges, distributed along the body; (ii) a tether, extending along the body and including a ball at a distal end thereof; and / or (iii) a series of system-anchors, each of the system-anchors comprising: (A) a system-anchor head; (B) a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue; and / or (C) a system-anchor eyelet, mounted on the system-anchor head, and including a slipknot which is threadable over the ball and slidable along the tether.

[0629] Example 150. The system according to example 149, wherein the slipknot is selftightening.

[0630] Example 151. The system according to any one of examples 149-150, further comprising an anchor-adding device including a shell in which is defined a cavity that houses the system-anchor.

[0631] Example 152. The system according to any one of examples 149-151, wherein the shell defines an opening through which the self -tightening slipknot exits the shell.

[0632] Example 153. The system according to any one of examples 151-152, wherein the shell is: (i) slidable along the tether to the extracorporeal unit via the self-tightening slipknot; and / or (ii) insertable into the cartridges.

[0633] Example 154. The system according to any one of examples 152-153, wherein the shell defines a second opening, connected to the opening, through which the system-anchor is removable from the shell.

[0634] Example 155. The system according to any one of examples 152-154, wherein the system-anchor is removable from the shell via the opening.

[0635] Example 156. The system according to any one of examples 149-155, wherein: (i) a first system-anchor of the series of system anchors is threaded onto the tether first; (ii) a second system-anchor of the series of system anchors is threaded onto the tether last; and / or (iii) the second system-anchor is implanted at the tissue first.

[0636] Example 157. The system according to example 156, wherein a spring is threaded on the tether between the first system-anchor and the second system-anchor.

[0637] Example 158. The system according to any one of examples 149-157, wherein a tension applied to the slipknot between the system-anchor head and the tether maintains the slipknot about the tether.

[0638] Example 159. A system comprising: (i) an implant, including a tether; and / or (ii) a tool including: (a) a clamp; (b) a spring-loaded winch, connected to the tether via the clamp; and / or (c) a release, operable to: (I) open the clamp to disconnect the tether from the winch; and / or (II) close the clamp to reconnect the tether to the winch.

[0639] Example 160. The system according to example 159, wherein the system is usable at a cardiovascular tissue of a subject.

[0640] Example 161. The system according to example 159, wherein the tool is configured for transluminal implantation of the implant to the tissue.

[0641] Example 162. The system according to example 159, wherein the clamp, spring- loaded winch, and release are part of an extracorporeal portion of the tool.

[0642] Example 163. The system according to example 159, wherein the tool further include an intracorporeal portion, transluminally advanceable toward the tissue.

[0643] Example 164. The system according to example 159, wherein the release is operable to open and close the clamp repeatedly during the implantation of the implant.

[0644] Example 165. The system according to example 159, wherein the spring-loaded winch is configured to enable the winch to apply tension to the tether.

[0645] Example 166. The system according to example 159, wherein the spring-loaded winch is configured to apply tension to a spool wire of the tool.

[0646] Example 167. The system according to example 166, wherein: (i) the spool wire applies the tension to the tether; (ii) opening the clamp removes the applied tension; and / or (iii) closing the clamp reapplies the tension to the tether.

[0647] Example 168. A system comprising: (i) a tether, extending along the body and including a ball at a distal end thereof; and / or (ii) a series of system-anchors, each of the system-anchors comprising: (a) a system-anchor head; (b) a system-anchor tissue-engaging element; and / or (c) a system-anchor eyelet including a slipknot which is threadable over the ball and slidable along the tether.

[0648] Example 169. The system according to example 168, wherein the system is usable and / or for use with a tissue of a subject.

[0649] Example 170. The system according to example 168, further comprising a catheter device, including: (i) a flexible tube that has: (a) a distal opening that is configured to be transluminally advanced toward the tissue; and / or (b) a proximal end that defines a proximal opening; and / or (ii) an extracorporeal unit, coupled to the proximal end of the tube, and comprising: (A) a body; and / or (B) a series of cartridges, distributed along the body.

[0650] Example 171. The system according to example 168, wherein the system anchor tissue-engaging element extends from the system-anchor head, and is configured to be driven into tissue of a subject.

[0651] Example 172. The system according to example 168, wherein the system-anchor eyelet is mounted on the system-anchor head.

[0652] Example 173. A method for use with a tissue of a subject, the method comprising: (i) selecting one of a selection of tissue-engaging elements, each having a sharp tip and a shank; (ii) advancing a socket of an anchor head over the shank of the selected one of the tissue-engaging elements to engage the anchor head with the selected tissue-engaging element and form an anchor, the anchor head being threaded on a tether configured to be transluminally implantable adjacent the tissue; (iii) advancing the anchor to the tissue; and / or (iv) driving the selected tissue-engaging element into the tissue by applying a force to the anchor head with a driver.

[0653] Example 174. A method usable with a tether, the method comprising: (i) advancing the tether into a gate of an eyelet of an anchor, the anchor further comprising a tissue engaging element for securing the anchor to tissue of a subject, and a head couplable to the tissue engaging element and the eyelet; and / or (ii) subsequently locking the gate to couple the anchor to the tether.

Claims

CLAIMSWhat is claimed is:

1. A system for use with a tether that is transluminally implantable at a tissue of a subject, the system comprising: an anchor, comprising: a head, a tissue-engaging element configured to be driven into the tissue, and an eyelet, mounted on the head, and defining a gate via which an intermediate region of the tether is laterally introducible into the eyelet to become disposed through the eyelet; and an anchor-adding device comprising a shell in which is situated a cavity that houses the anchor, the shell defining a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the eyelet.

2. The system according to claim 1, wherein the eyelet includes a clip that defines the gate, and the gate is biased closed by a spring element.

3. The system according to claim 1, wherein the eyelet includes a shackle, and the gate includes a groove that is configured to be inserted into a latch of the shackle to lock the gate.

4. The system according to any one of claims 1-3, wherein the anchor includes a catch, the gate is biased against the catch, and the eyelet is configured to receive the tether when the gate is pushed away from the catch.

5. The system according to any one of claims 1-4, wherein the cavity is entirely internal to the anchor-adding device.

6. The system according to claim 1, wherein the shell is shaped such that at least part of the cavity is exposed at a surface of the anchor-adding device.

7. The system according to any one of claims 1-6, wherein the cavity is dimensioned to house at least part of the anchor snugly.

8. The system according to any one of claims 1-7, wherein the cavity is dimensioned to constrain the anchor in a given rotational orientation about the anchor axis.

9. The system according to any one of claims 1-8, wherein the gate is biased to be closed.

10. The system according to any one of claims 1-9, wherein the slot is positioned with respect to the cavity such that sliding the intermediate region of the tether through the slot to the cavity snaps the intermediate region of the tether through the gate into the eyelet.

11. The system according to any one of claims 1-10, further comprising the tether.

12. The system according to any one of claims 1-11, wherein the slot defines a plane, and the cavity houses the anchor with the anchor axis parallel to the plane.

13. The system according to any one of claims 1-12, wherein the slot is configured such that the intermediate region of the tether is, while tensioned, slidable to the cavity via the slot.

14. The system according to any one of claims 1-13, wherein the anchor-adding device is configured for release of the anchor while the intermediate region of the tether remains disposed through the eyelet.

15. The system according to claim 14, wherein the anchor-adding device is configured for release of the anchor only upon the intermediate region of the tether having been slid through the slot.

16. The system according to claim 14, wherein the anchor-adding device defines a passage, and is configured for release of the anchor by the anchor being pulled out of the anchor-adding device via the passage.

17. The system according to claim 14, wherein the anchor-adding device is configured for release of the anchor by the shell being openable to expose the anchor in the cavity.

18. The system according to claim 17, wherein the shell is hinged to be openable in a clamshell manner.

19. The system according to any one of claims 1-18, wherein the anchor-adding device comprises an actuator, manually operable to facilitate lateral introduction of the intermediate region of the tether, at the cavity, into the eyelet.

20. The system according to claim 19, wherein the actuator is configured to open the gate while the anchor is housed in the cavity.

21. The system according to claim 19, wherein the actuator is configured to close the gate while the anchor is housed in the cavity.

22. The system according to claim 19, wherein the actuator is configured to force the intermediate region of the tether, at the cavity, through the gate into the eyelet.

23. The system according to any one of claims 1-22, wherein: the system is further for use with a driver for the anchor, and the shell further defines a passage via which the driver is insertable to the cavity to engage the head.

24. The system according to claim 23, further comprising the driver, the driver comprising a flexible shaft and a drivehead at a distal end of the shaft, the drivehead being insertable via the passage to the cavity, the passage guiding the drivehead into engagement with the head.

25. The system according to claim 24, wherein the passage is shaped to rotationally align the drivehead with the head as the drivehead is advanced through the passage toward the cavity.

26. The system according to claim 23, wherein the slot defines a plane in which the intermediate region of the tether is slidable to the cavity, the passage lying on the plane.

27. The system according to any one of claims 1-26, wherein the eyelet includes two wires that are connected to each other via a tongue that defines the gate.

28. The system according to claim 27, wherein the wires are mirror images of each other along a vertical plane that bisects the tongue.

29. The system according to claim 27, wherein an end of each wire begins at and extends away from the head and the tongue extends from the wires toward the head to form loops.

30. The system according to claim 29, wherein the tongue is configured to receive the tether when the tether is bent.

31. The system according to any one of claims 1-30, wherein the anchor-adding device includes an actuator that is configured to thread the tether into the eyelet, when the tether is present within the slot.

32. The system according to claim 31, wherein: the gate is biased closed; the actuator is a button that is configured to open the gate when pressed; when the gate is open, the eyelet is configured to receive the tether; and releasing the button closes the gate.

33. The system according to claim 31, wherein the actuator is a finger that is configured to bend the tether, and push it over a tongue of the eyelet when actuated.

34. A system, useable and / or for use with a tissue of a subject, the system comprising: a catheter device, comprising: a flexible tube that has: a distal opening that is configured to be transluminally advanced toward the tissue, and a proximal end that defines a proximal opening; and an extracorporeal unit, coupled to the proximal end of the tube, and comprising: a body, and a series of cartridges, distributed along the body; a tether, extending along the body; a series of system-anchors, each of the system-anchors housed by a corresponding cartridge of the series of cartridges, and comprising: a system-anchor head, a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue, and a system-anchor eyelet, mounted on the system-anchor head, and threaded on the tether; a supplemental-anchor, comprising: a supplemental-anchor head, a supplemental-anchor tissue-engaging element, extending from the supplemental-anchor head, and configured to be driven into the tissue, and a supplemental-anchor eyelet, mounted on the supplemental-anchor head, and defining a gate via which an intermediate region of the tether is laterally introducible into the supplemental-anchor eyelet to become disposed through the supplemental-anchor eyelet; and an anchor-adding device comprising a shell in which is situated a cavity that houses the supplemental-anchor, the shell defining a slot via which the intermediate region of the tether is slidable to the cavity for lateral introduction into the supplemental-anchor eyelet.

35. The system according to claim 34, wherein the supplemental-anchor tissue-engaging element is geometrically different from the system-anchor tissue-engaging element.

36. A method for use with a tether that has a first end, a second end, and an intermediate portion therebetween, the method comprising, without access to the first end or the second end: sliding the intermediate portion laterally through a slot in a case of an anchor-adding device that defines a cavity in which an anchor is disposed; within the cavity, coupling the anchor to the tether by laterally introducing the intermediate portion of the tether into an eyelet of the anchor; and subsequently, removing the anchor-adding device from the tether, leaving the anchor coupled to the tether.

37. A system for use with a tissue of a subject, the system comprising: a selection of tissue-engaging elements, each having a sharp tip and a shank; a tether configured to be transluminally implantable adjacent the tissue; and an anchor head that comprises (i) an eyelet threaded on the tether, and (ii) a socket, configured to be mated with a selected one of the tissue-engaging elements to form an anchor that is advanceable over and along the tether toward the tissue, and whose tissue-engaging element is drivable into the tissue.

38. The system according to claim 37, wherein the selection of tissue-engaging elements includes multiple first-type tissue-engaging elements, and multiple second-type tissueengaging elements, the shanks of the second-type tissue-engaging elements being identical to the shanks of the first-type tissue-engaging elements.

39. The system according to claim 38, wherein a core of the first-type tissue-engaging elements is different than a core of the second-type tissue-engaging elements, and each core is disposed between the sharp tip and shank of respective tissue-engaging elements.

40. A system, useable and / or for use with a tissue of a subject, the system comprising: a catheter device, comprising: a flexible tube that has: a distal opening that is configured to be transluminally advanced toward the tissue, and a proximal end that defines a proximal opening; and an extracorporeal unit, coupled to the proximal end of the tube, and comprising:a body, and a series of cartridges, distributed along the body; a tether, extending along the body; a selection of tissue-engaging elements, each having a sharp tip and a shank, housed by a corresponding cartridge of the series of cartridges; and a plurality of anchor heads, housed by corresponding cartridges of the series of cartridges, each anchor head: comprising (i) an eyelet threaded on the tether, and (ii) a socket; and being configured to be mated with a selected one of the tissue-engaging elements to form an anchor that is advanceable over and along the tether toward the tissue, and whose tissue-engaging element is drivable into the tissue via application of a force to the anchor head.

41. A system for use at a cardiovascular tissue of a subject, the system comprising: an implant, including a tether; and a tool, configured for transluminal implantation of the implant to the tissue, the tool comprising: an intracorporeal portion, transluminally advanceable toward the tissue; and an extracorporeal portion, comprising: a clamp; a spring-loaded winch, connected to the tether via the clamp to enable the winch to apply tension to the tether; and a release, operable to repeatedly, during the implantation of the implant: open the clamp to disconnect the tether from the winch; and close the clamp to reconnect the tether to the winch.

42. The system according to claim 41, wherein the tether has a distal end that is implantable, and a proximal end that is connected to the clamp such that opening of the clamp to disconnect the tether from the winch provides access to the proximal end of the tether.

43. The system according to any one of claims 41-42, wherein the extracorporeal portion further includes a spool wire having a distal end connected to the clamp and a proximal end connected to the winch.

44. The system according to claim 43, wherein the winch is configured to apply tension to the tether via the spool wire.

45. The system according to any one of claims 41-44, wherein: disconnecting the tether from the winch exposes a proximal end of the tether; supplemental anchors are configured to be threaded onto the exposed proximal end of the tether; and reconnecting the tether to the winch retains the supplemental anchors on the tether.

46. The system according to claim 45, wherein the supplemental anchors are configured to: slide along the tether to the tissue; and be implanted at the tissue.

47. A system useable and / or for use with a tissue of a subject, the system comprising: a catheter device, comprising: a flexible tube that has: a distal opening that is configured to be transluminally advanced toward the tissue, and a proximal end that defines a proximal opening; and an extracorporeal unit, coupled to the proximal end of the tube, and comprising: a body, and a series of cartridges, distributed along the body; a tether, extending along the body and including a ball at a distal end thereof; and a series of system-anchors, each of the system-anchors comprising: a system-anchor head; a system-anchor tissue-engaging element, extending from the system-anchor head, and configured to be driven into the tissue; and a system-anchor eyelet, mounted on the system-anchor head, and including a slipknot which is threadable over the ball and slidable along the tether.

48. The system according to claim 47, wherein the slipknot is self-tightening.

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