Valve-spanning tethers

Abstract

A system (100) for use with a valve (7) of a heart of a subject comprises an implant (120) that comprises multiple anchors (122), each anchor comprising an eyelet (128), coupled to a head (123) of the anchor by a cord or other connection (126) extending from the head to the eyelet, the cord or other connection of the anchor being longer than the tissue- engaging element. The implant further comprises a tether (124), threaded through the eyelet of each anchor such that the anchors are arranged in series along the tether. The system comprises a delivery tool (110), adapted to, for each anchor, anchor the anchor adjacent the valve by driving the tissue-engaging element into tissue while the delivery tool is engaged with the head, and, while the anchors remain anchored adjacent the valve, tension the tether such that the eyelets meet to form a node (129).

Description

VALVE-SPANNING TETHERSCROSS-REFERENCES TO RELATED APPLICATIONS

[0001] The present application claims priority to Provisional US Patent Application 63 / 634,856 to Oba et al., titled "Valve-spanning tethers," and filed April 16, 2024.

[0002] The above application is incorporated by reference in its entirety.BACKGROUND

[0003] A function of mammalian hearts is based on heart muscle contracting and creating pressure within ventricles of the heart, causing the blood to flow from the ventricles into arteries. The blood from the body returns to atria of the heart via veins. Valves, between each heart atrium and the corresponding heart ventricle, as well as between the heart ventricles and the corresponding arteries, inhibit backflow from occurring when the heart muscles contract and create pressure in the ventricles. The valves between the atria and the ventricles of the heart are known as the atrioventricular valves. At least in humans, the atrioventricular valve between the left atrium and the left ventricle is known as the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is known as the tricuspid valve. Each of these valves includes of a plurality of leaflets that coapt with each other when the valve is closed, and have a space formed therebetween when the valve is open.

[0004] Proper closing of the mitral and tricuspid valves is critical for proper function of the heart, and many medical conditions, some life threatening, result from improper closing of the valves which creates backflow (regurgitation) from the ventricles into the corresponding atria. Annuloplasty procedures, in which the annulus of the tricuspid or the mitral valve is reshaped, are methodologies of repairing valves that do not close properly.SUMMARY OF THE INVENTION

[0005] 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 andsteps as described elsewhere in this disclosure may be included in the examples summarized here.

[0006] The present disclosure relates, inter alia, to systems and methods of securing (e.g., anchoring) a tether of an implant to different portions or sides of a valve of a heart, such that the tether spans across (e.g., bridges) the valve or a portion thereof (e.g., across a valve orifice of the valve). In some implementations, systems and methods of securing a tether of an implant to different portions or sides of a valve of a heart are configured such that tensioning the tether draws the different portions (e.g., opposite sides, corners, edges, etc.) of the valve closer to each other in order to reduce valve regurgitation.

[0007] In some implementations, multiple tissue anchors, threaded onto the tether, are anchored as a set at a first portion (e.g., a first side, etc.) of the valve. In some implementations, the anchors, and / or their threading onto the tether, are configured to assume a load-sharing arrangement, e.g., responsively to tensioning of the tether.

[0008] In some implementations, each anchor includes a cord or other connection / connector. The cord or other connector can connect the tether to the respective anchor. In some implementations, this is done by the cord / connection / connector extending from an anchor head of the anchor to an eyelet defined by and / or connected to the cord / connection / connector (e.g., at a far end of the cord / connection / connector). In some implementations, the anchors are threaded onto the tether by the tether extending through each eyelet of the anchors.

[0009] In some implementations, while the tether is threaded onto the anchors in such a manner, the anchors can be anchored to the annulus at the first portion (e.g., first side, etc.) of the valve. In some implementations, the anchors can be anchored in an arc around the first portion or first side of the valve. In some implementations, tension can then be applied to the tether. For instance, once the tether has been secured to a second portion (e.g., a second side, etc.) of the valve, tension can be applied to the tether.

[0010] In some implementations, tension can be applied to the tether before the tether has been secured to the second portion of the valve). In some implementations, tension can be applied to the tether in a manner that draws the eyelets of each of the anchors together such that the eyelets converge (e.g., meet) to form a node. For instance, the eyelets can slide along the tether towards each other when tension is applied to the tether.

[0011] In some implementations, the node may be structurally and / or functionally analogous to a "masterpoint" in the field of rock climbing. For instance, during the cardiac cycle, various forces acting on tether 124 may be more equally distributed among anchors.

[0012] In some implementations, tensioning the tether may position the node between the first portion of the valve and the second portion of the valve (e.g., on a point on a longitudinal axis that extends between the two portions). For example, in some implementations, depending on the length of the cords, tensioning the tether can position the node over the valve orifice (e.g., toward the second portion of the valve), and / or over the annulus at the second portion of the valve.

[0013] In some implementations, the tether is additionally secured to the second portion of the valve.

[0014] In some implementations, the node is formed prior to securing the tether to the second portion of the valve. For instance, the tether can be preliminarily tensioned after implanting the anchors to the first portion of the valve (to form the node), and then again subsequently to securing the tether to the second part of the valve (to draw the different portions of the valve towards each other).

[0015] Alternatively or additionally, in some implementations, the tether can be secured to the second portion (e.g., second side, etc.) of the valve prior to drawing the eyelets together to form the node. For instance, the node may be formed once the tether has been secured to both portions of the valve. In this manner, the load-sharing arrangement is formed once all anchors are implanted.

[0016] In some implementations, the operator can tension the tether draw the eyelets together to form the node (e.g., thereby forming the load-sharing arrangement). In some implementations, the operator can tension the tether to reduce the dimension of the valve by drawing the different portions of the valve towards each other (e.g., thereby improving valve regurgitation).

[0017] In some implementations, the tether is secured to the second portion (e.g., second side, etc.) of the valve using a similar technique to that described hereinabove. For example, in some implementations, in addition to the anchors described hereinabove (which can be considered to be a first set of anchors), a second set of anchors can each be similarly threaded onto the tether, by for each anchor of the second set, the tether extending through an eyeletof and / or coupled to a respective cord / connection / connector of the anchor that extends from the anchor head.

[0018] In some implementations, the second set of anchors can be anchored to the annulus at the second portion (e.g., second side, etc.) of the valve while the anchors are threaded onto the tether. In some implementations, the second set of anchors can be anchored to the second portion of the valve in an arc shape.

[0019] In some such applications, the tether is only tensioned once both sets of anchors have been anchored at the valve (e.g., to both portions of the valve). In this manner, the eyelets of the first set of anchors converge to form a first node, and the eyelets of the second set of anchors converge to form a second node.

[0020] In some implementations, a single node is formed (e.g., over the valve orifice, between the different portions of the valve), by the eyelets from both sets of anchors converging at a single point.

[0021] In some implementations, the tether is tensioned once the anchors of the first set have been anchored to the first portion (e.g., first side, etc.) of the valve, but prior to anchoring the second set of anchors to the second portion (e.g., second side, etc.) of the valve. Thus, in some implementations, the first node can be formed prior to the second node (which will only be formed once the second set of anchors have been implanted along the second portion).

[0022] In some implementations, the tether is secured to the second portion of the annulus in a manner that does not include a load-sharing arrangement on the second portion, e.g., using a single anchor and / or using any of the securing methods described hereinbelow.

[0023] In accordance with some implementations, a system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.), the system including an implant that includes: multiple anchors and a tether.

[0024] In some implementations, one or more anchors (e.g., each anchor) includes: a head. In some implementations, each anchor includes a tissue-engaging element. In some implementations, each anchor includes a cord / connection / connector, coupled to the head. In some implementations, each anchor includes an eyelet. The eyelet can be defined by the cord / connection / connector and / or coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to the head by thecord / connection / connector and / or defined by the cord / connection / connector. In some implementations, the cord / connection / connector extends away from the head to the eyelet.

[0025] In some implementations, the tissue-engaging elements extend from the head along an axis of the anchor.

[0026] In some implementations, the tether is threaded through the eyelet of each anchor such that the anchors are arranged in series along the tether.

[0027] In some implementations, for each anchor, the tissue-engaging element of the anchor is a helical tissue-engaging element. In some implementations, for one or more anchors, the tissue-engaging element of the anchor is a helical tissue-engaging element. The tissueengaging element can be adapted to be screwed into tissue of the valve of the heart.

[0028] In some implementations, for each anchor, the tissue-engaging element of the anchor is a longitudinal tissue-engaging element. In some implementations, for one or more anchors, the tissue-engaging element of the anchor is a longitudinal tissue-engaging element. The tissue-engaging element can be adapted to be longitudinally driven into tissue of the valve of the heart.

[0029] In some implementations, for each anchor, the cord or other connection / connector of the anchor has a length of 2-20 mm, such as 4-20 mm e.g. 4-10 mm. In some implementations, for one or more anchors, the cord or other connection / connector of the anchor has a length of 2-20 mm, such as 4-20 mm e.g. 4-10 mm.

[0030] In some implementations, for each anchor, the cord or other connection / connector of the anchor is longer than the tissue-engaging element of the anchor. In some implementations, for one or more anchors, the cord or other connection / connector of the anchor is longer than the tissue-engaging element of the anchor.

[0031] In some implementations, the system includes an adjustment tool. The adjustment tool is adapted to tension the tether such that the eyelets meet to form a node.

[0032] In some implementations, for each anchor, the cord or other connection / connector of the anchor is a thread. In some implementations, for one or more anchor, the cord or other connection / connector of the anchor is a thread.

[0033] In some implementations, for each anchor, the cord or other connection / connector of the anchor is a string. In some implementations, for one or more anchors, the cord or other connection / connector of the anchor is a string.

[0034] In some implementations, for each anchor, the cord or other connection / connector of the anchor is a wire. In some implementations, for one or more anchors, the cord or other connection / connector of the anchor is a wire.

[0035] In some implementations, for each anchor, the eyelet of the anchor is a rigid ring. In some implementations, for one or more anchors, the eyelet of the anchor is a rigid ring.

[0036] In some implementations, for each anchor, the eyelet of the anchor is a grommet. In some implementations, for one or more anchors, the eyelet of the anchor is a grommet.

[0037] In some implementations, for each anchor, the eyelet of the anchor is metallic. In some implementations, for one or more anchors, the eyelet of the anchor is metallic.

[0038] In some implementations, for each anchor, the eyelet of the anchor is polymeric. In some implementations, for one or more anchors, the eyelet of the anchor is polymeric.

[0039] In some implementations, for each anchor, the eyelet of the anchor is made from a textile. In some implementations, for one or more anchors, the eyelet of the anchor is made from a textile.

[0040] In some implementations, for each anchor, the cord or other connection / connector of the anchor is formed into a loop that defines the eyelet of the anchor. In some implementations, for one or more anchors, the cord or other connection / connector of the anchor is formed into a loop that defines the eyelet of the anchor.

[0041] In some implementations, for one or more anchors (e.g., each anchor), the cord or other connection / connector is secured in the loop. For instance, an end portion of the cord or other connection / connector can burrow through a stretch of the cord, such that the stretch squeezes on the end portion therewithin.

[0042] In some implementations, the cord or other connection / connector is secured in the loop via a knot.

[0043] In some implementations, the cord or other connection / connector is secured in the loop via a lock.

[0044] In some implementations, the cord or other connection / connector is coupled to the head by looping around the head to define a collar, and the loop loops through the collar to extend away from the collar to define the eyelet.

[0045] In some implementations, the system includes a delivery tool adapted to, for one or more anchors (e.g., each anchor), anchor the anchor adjacent the valve by driving the tissueengaging element into tissue while the delivery tool is engaged with the head.

[0046] In some implementations, the delivery tool is adapted to anchor the anchors around a first portion (e.g., a first side, etc.) of the valve. In some implementations, the delivery tool is adapted to anchor the anchors in an arc around a first portion (e.g., a first side, etc.) of the valve.

[0047] In some implementations, the delivery tool includes a driver that includes a flexible shaft. In some implementations, the delivery tool includes a drive head. The drive head can be disposed at a distal end of the shaft. The drive head can be is adapted to reversibly engage the head of one or more anchors (e.g., each anchor).

[0048] In some implementations, the driver is adapted to anchor one or more anchors (e.g., each anchor) adjacent the valve. For instance, the driver can apply an anchoring force to the anchor to drive the tissue-engaging element into the tissue.

[0049] In some implementations, the delivery tool includes a tube. Each anchor can be transluminally advanceable towards the heart by being advanced, while engaged with the driver, through the tube and towards the heart.

[0050] In some implementations, the delivery tool is configured to, while the anchors remain anchored adjacent the valve, tension the tether such that the eyelets converge to form a node.

[0051] In some implementations, the system further includes a covering. In some implementations, the delivery tool is adapted to transluminally advance the covering over and along the tensioned tether to the node such that the covering encases the node.

[0052] In some implementations, the delivery tool is configured to tension the tether such that, for each anchor, the tether pulls the cord or other connection / connector away from its respective anchor. In this manner tensioning the tether causes the corresponding eyelet to become spaced away from the anchor.

[0053] In some implementations, the delivery tool is configured to tension the tether such that for one or more anchors (e.g., each anchor) of a first subset of the anchors, the cord or other connection / connector becomes taut. In some implementations, the delivery tool is configured to tension the tether such that for each anchor of a second subset of the anchors, the cord or other connection / connector does not become taut.

[0054] In some implementations, the first subset of anchors includes two anchors, and the second subset of anchors includes a single anchor.

[0055] In some implementations, the anchors are a set of 2-8 anchors. In some implementations, the delivery tool is adapted to anchor each of the anchors of the set adjacent the valve.

[0056] In some implementations, the set of anchors are a set of 2 anchors.

[0057] In some implementations, the set of anchors are a set of 3 anchors.

[0058] In some implementations, the anchors are a set of anchors.

[0059] In some implementations, the delivery tool is adapted to anchor one or more anchors (e.g., each anchor) of the set adjacent to the valve on a first portion (e.g., first side, etc.) of the valve such that the tether becomes secured to the first portion.

[0060] In some implementations, the delivery tool is adapted to secure the tether to a second portion (e.g., a second side, an opposite side, etc.) of the heart valve, such that the tether spans across the valve. In some implementations, the delivery tool is adapted to secure the tether to a second portion of the heart valve such that tensioning the tether towards a tensioned state draws the first portion and the second portion of the valve toward each other.

[0061] In some implementations, the implant further includes a second- side anchor.

[0062] In some implementations, the second portion is on a second side of the valve, and the delivery tool is configured to secure the tether to the second portion by anchoring the second-side anchor into a wall of an annulus of the valve on the second side.

[0063] In some implementations, the implant further includes a leaflet anchor. In some implementations, the delivery tool is configured to secure the tether to the second portion by anchoring the leaflet anchor into a leaflet of the valve.

[0064] In some implementations, the implant further includes a flexible helical member that defines a plurality of turns, the tether extending through the turns. In some implementations, the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion (e.g., a second side, etc.) of the valve, such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0065] In some implementations, the implant further includes a flexible helical member that defines a plurality of turns, the tether extending through the turns. In some implementations, the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion of the valve, such that the helical member becomes fully submerged within the tissue.

[0066] In some implementations, the implant further includes a stent through which the tether is threaded. In some implementations, the delivery tool is configured to secure the tether to the second portion by implanting the stent in a coronary blood vessel of the heart adjacent the second portion.

[0067] In some implementations, the tether is a first tether. In some implementations, the implant further includes a second tether.

[0068] In some implementations, the delivery tool is adapted to secure the second tether to both the first portion of the valve and the second portion of the valve such that the second tether spans across the valve, independently of the first tether. In some implementations, tensioning the second tether draws the first portion and the second portion of the valve toward each other.

[0069] In some implementations, the delivery tool is configured to secure the tether to the second portion using a single anchor.

[0070] In some implementations, the delivery tool is configured to secure the tether to the second portion using an anchor of the set.

[0071] In some implementations, the implant further includes a second-side anchor that includes a head, a tissue-engaging element, and / or an eyelet, directly or indirectly attached to the head, the tether being threaded through the eyelet.

[0072] In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0073] In some implementations, the delivery tool is configured to secure the tether to the second portion by anchoring the second-side anchor. The delivery tool can secure the tether to the second portion via engagement with the head of the second-side anchor, to tissue of the second side of the heart.

[0074] In some implementations, the implant includes a pledget anchor. In some implementations, the delivery tool is configured to secure the tether to the second portion using the pledget anchor.

[0075] In some implementations, the implant includes a self-expanding anchor. In some implementations, and the delivery tool is configured to secure the tether to the second portion using the self-expanding anchor.

[0076] In some implementations, the implant includes a lock. The lock can be transluminally advanceable over and along the tether to maintain the tether in the tensioned state.

[0077] In some implementations, the lock includes a shock-absorber. In some implementations, the tether is insertable into the lock via the shock-absorber.

[0078] In some implementations, the delivery tool includes a tool adapted to cut excess tether proximal to the lock.

[0079] In some implementations, the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets converge to form a node. The node can be disposed between the first portion and the second portion.

[0080] In some implementations, the valve defines an orifice therethrough. In some implementations, the delivery tool is adapted to anchor one or more anchors (e.g., each anchor) of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the valve orifice.

[0081] In some implementations, the valve defines a plurality of leaflets. In some implementations, delivery tool is adapted to anchor one or more anchors (e.g., each anchor) of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over a leaflet of the plurality.

[0082] In some implementations, the delivery tool is adapted to anchor one or more anchors (e.g., each anchor) of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the first portion.

[0083] In some implementations, the delivery tool is adapted to anchor one or more anchors (e.g., each anchor) of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the second portion.

[0084] In some implementations, the implant includes a toggle anchor. In some implementations, the delivery tool is configured to secure the tether to the second portion using the toggle anchor.

[0085] In some implementations, the toggle anchor includes a self-expanding frame.

[0086] In some implementations, the implant includes an expandable hydrogel bead. In some implementations, the delivery tool is configured to secure the tether to the second portion via the expandable hydrogel bead.

[0087] In some implementations, the delivery tool is configured to implant the hydrogel bead into annular tissue on the second portion of the heart. The hydrogel bead can expand by drawing liquid into itself from the annular tissue.

[0088] In some implementations, the implant includes a second-side anchor.

[0089] In some implementations, the valve has an annulus circumscribing the valve, and the heart has a ventricle downstream of the valve.

[0090] In some implementations, the delivery tool is configured to secure the tether to the second portion by, at the second portion, driving the second-side anchor through the annulus and into the ventricle while the second-side anchor is attached to the tether.

[0091] In some implementations, the second-side anchor has a bulky shape.

[0092] In some implementations, the set of anchors is a first set of anchors. In some implementations, the implant includes a second set of anchors.

[0093] In some implementations, one or more anchors (e.g., each anchor) (of the first set of anchors, or of the second set of anchors, or of both sets of anchors) includes a head and a tissue-engaging element.

[0094] In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0095] In some implementations, one or more anchors (e.g., each anchor) (of the first set of anchors, or of the second set of anchors, or of both sets of anchors) includes a cord or other connection / connector coupled to the head.

[0096] In some implementations, one or more anchors (e.g., each anchor) (of the first set of anchors, or of the second set of anchors, or of both sets of anchors) includes an eyelet.

[0097] In some implementations, all, one, or some of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to the head by the cord or other connection / connector. In some implementations, the cord / connection / connector extends away from the head to the eyelet.

[0098] In some implementations, all, one, or some of the eyelets are defined by the cord or other connection / connector.

[0099] In some implementations, all, one, or some of the eyelets are integrally formed with a head of a respective anchor.

[0100] In some implementations, the tether is threaded through an eyelet of each anchor of the second set such that the anchors of the second set are arranged in series along the tether.

[0101] In some implementations, the delivery tool is adapted to secure the tether to the second portion of the valve by, for one or more anchors (e.g., each anchor) of the second set. For instance the delivery tool can engage with the head, anchoring one or more anchors (e.g., each anchor) of the second set adjacent to the second portion of the valve by, for each anchor, driving the tissue-engaging element into tissue.

[0102] In some implementations, each of the first set of anchors and the second set of anchors include two anchors.

[0103] In some implementations, the valve is a tricuspid valve of the heart. In some implementations, the valve is a mitral valve of the heart.

[0104] In some implementations, the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion. In this manner, the eyelets of the anchors of the first set converge to form a first node, and the eyelets of the anchors of the second set converge to form a second node.

[0105] In some implementations, the implant includes a third set of anchors. In some implementations, one or more anchors (e.g., each anchor) of the third set of anchors includes a head and a tissue-engaging element.

[0106] In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0107] In some implementations, one or more anchors (e.g., each anchor) of the third set of anchors includes a cord or other connection / connector, coupled to the head.

[0108] In some implementations, one or more anchors (e.g., each anchor) of the third set of anchors includes an eyelet.

[0109] In some implementations, all, one, or some of the eyelets are defined by the cord or other connection / connector.

[0110] In some implementations, all, one, or some of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to the head by the cord or other connection / connector. In some implementations, the cord / connection / connector can extend away from the head to the eyelet.

[0111] In some implementations, all, one, or some of the eyelets are integrally formed with a respective head of an anchor.

[0112] In some implementations, the tether is threaded through the eyelet of one or more anchors (e.g., each anchor) of the third set such that the anchors of the third set are arranged in series along the tether.

[0113] In some implementations, the delivery tool is adapted to secure the tether to the first portion of the valve by anchoring the anchors of the first set to a first anchoring site at the first portion of the valve. In some implementations, the delivery tool is adapted to secure the tether to the second portion of the valve by anchoring the anchors of the second set at the second portion of the valve. In some implementations, subsequently to anchoring the first set of anchors to the first anchoring site, and the second set of anchors to the second portion of the valve, the anchors of the third set can be anchored to the first portion at a second anchoring site at the first portion.

[0114] In some implementations, for one or more anchors (e.g., each anchor) of the third set, anchoring occurs by anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue. In some implementations, driving the tissueengaging element into tissue is done via engagement with the head.

[0115] In some implementations, the tether is tensionable, while the anchors of each of the first, second and third sets remain anchored. In this manner, the eyelets of the anchors of the first set can converge to form a first node, the eyelets of the anchors of the second set can converge to form a second node, and the eyelets of the anchors of the third set can converge to form a third node.

[0116] In some implementations, additional sets of anchors can be configured to form additional nodes similar to the first, second, and / or third sets and nodes.

[0117] In some implementations, the implant further includes a fourth set of anchors. In some implementations, each anchor of the fourth set of anchors includes a head and a tissueengaging element.

[0118] In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0119] In some implementations, one or more anchors (e.g., each anchor) of the fourth set of anchors includes a cord, coupled to the head.

[0120] In some implementations, one or more anchors (e.g., each anchor) of the fourth set of anchors includes an eyelet.

[0121] In some implementations, all, one, or some of the eyelets are defined by the cord or other connection / connector.

[0122] In some implementations, all, one, or some of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to the head by the cord or other connection / connector. In some implementations, the cord / connection / connector can extend away from the head to the eyelet.

[0123] In some implementations, all, one, or some of the eyelets are integrally formed with a respective head of an anchor.

[0124] In some implementations, the tether is threaded through the eyelet of one or more anchors (e.g., each anchor) of the fourth set such that the anchors of the fourth set are arranged in series along the tether.

[0125] In some implementations, the delivery tool is adapted to secure the tether to the second portion of the valve by subsequently to anchoring the anchors of the first set to the first anchoring site at the first portion of the valve, anchoring the anchors of the second set to the second portion at a third anchoring site at the second portion. In some implementations, the anchors of the fourth set can be anchored to a fourth anchoring site at the second portion of the valve subsequently to anchoring the anchors of the first set to the first anchoring site at the first portion of the valve and / or subsequently to anchoring the anchors of the second set to the second portion at a third anchoring site at the second portion.

[0126] In some implementations, for one or more anchors (e.g., each anchor) of the fourth set, anchoring occurs by anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue. In some implementations, driving the tissue-engaging element into tissue is done via engagement with the corresponding head.

[0127] In some implementations, the tether spans or is configured to span between the third anchoring location and the fourth anchoring location on the second portion of the valve.

[0128] In some implementations, the tether is tensionable, while the anchors of each of the first, second third, and fourth sets remain anchored, such that the eyelets of the anchors of the first set can converge to form the first node, the eyelets of the anchors of the second set can converge to form the second node, the eyelets of the anchors of the third set can converge to form the third node, and the anchors of the fourth set can converge to form a fourth node.

[0129] In some implementations, the implant further includes one or more spacers, threaded along the tether between the second node and the fourth node.

[0130] In some implementations, the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion, such that the eyelets of the anchors of the first set and the eyelets of the anchors of the second set all converge to form a single node.

[0131] In some implementations, the valve is a tricuspid valve of the heart, having a first leaflet adjacent a first portion (e.g., a first side, etc.) of the valve, a second leaflet adjacent a second portion (e.g., a second side, etc.) of the valve, and a third leaflet adjacent a third portion (e.g., a third side, etc.) of the valve. In some implementations, the valve has an annulus that circumscribes the valve.

[0132] In some implementations, the system includes a delivery tool adapted to anchor a first anchor of the anchors into tissue of the annulus at the first portion. In some implementations, the delivery tool is adapted to anchor a second anchor of the anchors into tissue of the annulus at the second portion. In some implementations the delivery tool is adapted to anchor a third anchor of the anchors into tissue of the annulus at the third portion. In this manner, tensioning the tether draws the first portion, the second portion, and the third portion toward each other.

[0133] In some implementations, tensioning the tether causes the eyelets to converge to form a node that is disposed medially between the first portion, the second portion, and the third portion.

[0134] In accordance with some implementations, a method for use with a valve of a heart (e.g., of a real or simulated heart) includes, for each anchor of a set of anchors, sequentially transluminally advancing the anchor towards the heart, and / or anchoring the anchor to tissue (e.g., real or simulated tissue) adjacent the valve.

[0135] In some implementations, one or more anchors (e.g., each anchor) includes an eyelet.

[0136] In some implementations, all, one, or some of the eyelets are defined by a cord or other connection / connector of a respective anchor.

[0137] In some implementations, all, one, or some of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to a head of the anchor via a cord or other connection / connector. In some implementations, the cord / connection / connector extends away from the head to the eyelet.

[0138] In some implementations, all, one, or some of the eyelets are integrally formed with a respective head of an anchor.

[0139] In some implementations, the method further comprises subsequently drawing together the eyelets of the anchors of the set to form a node by tensioning a tether that extends through the eyelets.

[0140] In some implementations, each anchor of the set defines a helical tissue-engaging element, and anchoring one or more anchors (e.g., each anchor) of the set to the tissue includes screwing the helical tissue-engaging element into the tissue.

[0141] In some implementations, one or more anchors (e.g., each anchor) of the set defines a longitudinal tissue-engaging element, and anchoring each anchor of the set to the tissue includes driving the longitudinal tissue-engaging element into the tissue.

[0142] In some implementations, drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set to form the node such that for each anchor of a first subset of the anchors, the cord or other connection / connector becomes taut. In some implementations for one or more anchors (e.g., each anchor) of a second subset of the anchors, the cord or other connection / connector does not become taut.

[0143] In some implementations, anchoring the anchors of the set to the tissue includes anchoring the anchors such that the anchors collectively form an arc around a first portion of the valve.

[0144] In some implementations, the method further includes, subsequently to forming the node, advancing a covering over and along the tether to the node such that the covering encases the node.

[0145] In some implementations, drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set to form the node. In some implementations, this is done such that, for one or more anchors (e.g., each anchor), the tether pulls the cord or other connection / connector away from its respective anchor in a manner that causes the corresponding eyelet to become spaced away from the anchor.

[0146] In some implementations, drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set such that the node is formed between a first portion of the valve and a second portion of the valve.

[0147] In some implementations, the valve defines an orifice therethrough, and drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set such that the node is formed over the valve orifice.

[0148] In some implementations, the valve defines a plurality of leaflets, and drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set such that the node is formed over a leaflet of the plurality.

[0149] In some implementations, anchoring the anchor to tissue adjacent the valve includes anchoring the anchor to tissue adjacent a first portion of the valve. In some implementations, drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set such that the node is formed over the first portion.

[0150] In some implementations, anchoring the anchor to tissue adjacent the valve includes anchoring the anchor to tissue adjacent a first portion of the valve. In some implementations, drawing together the eyelets of the anchors of the set to form the node includes drawing together the eyelets of the anchors of the set such that the node is formed over a second portion (e.g., a second, opposite side, etc.) of the valve.

[0151] In some implementations the node is a first node. In some implementations, anchoring the anchors of the set to the tissue includes anchoring a first subset of the anchors of the set to the tissue in a first set / cluster of anchors, and anchoring a second subset of anchors of the anchors of the set to the tissue in a second set / cluster of anchors, such that the tether spans from the first set / cluster to the second set / cluster.

[0152] In some implementations, tensioning the tether includes tensioning the tether in a manner that: draws together the eyelets of the anchors of the first set / cluster to form a first node. In some implementations, tensioning the tether includes tensioning the tether in a manner that draws together the eyelets of the anchors of the second set / cluster to form a second node. In some implementations, tensioning the tether includes tensioning the tether in a manner that draws the first set / cluster and the second set / cluster toward each other.

[0153] In some implementations, anchoring the first subset of anchors to the tissue includes anchoring the first subset of anchors to the tissue at a first portion of the valve. In some implementations, anchoring the second subset of anchors to the tissue includes anchoring the second subset of anchors to a second portion of the valve, such that tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0154] In some implementations, anchoring the first subset of anchors to the tissue includes anchoring the first subset of anchors to tissue of a fibrous trigone of the heart.

[0155] In some implementations, the valve is a mitral valve of the heart, and anchoring the second subset of anchors to the tissue includes anchoring the second subset of anchors to tissue of an annulus of the mitral valve that is disposed behind a root of a posterior leaflet of the valve.

[0156] In some implementations, the valve is a tricuspid valve of the heart. In some implementations, the tissue is tissue of an annulus of the tricuspid valve. In some implementations, anchoring the first subset of anchors to the tissue includes anchoring the first subset of anchors to the annulus behind a root of a septal leaflet of the tricuspid valve. In some implementations, anchoring the second subset of anchors to the tissue includes anchoring the second subset of anchors to the annulus behind a root of an inferior leaflet of the tricuspid valve.

[0157] In some implementations, the valve is a tricuspid valve of the heart. In some implementations, the tissue is tissue of an annulus of the tricuspid valve. In some implementations, anchoring the first subset of anchors to the tissue includes anchoring thefirst subset of anchors to the annulus behind a root of an inferior leaflet of the tricuspid valve. In some implementations, anchoring the second subset of anchors to the tissue includes anchoring the second subset of anchors to the annulus behind a root of a superior leaflet of the tricuspid valve.

[0158] In some implementations, anchoring the anchors of the set to the tissue includes anchoring a third subset of the anchors of the set to the tissue in a third set / cluster of anchors, such that the tether spans from the second set / cluster to the third set / cluster. In some implementations, tensioning the tether includes tensioning the tether in a manner that draws together the eyelets of the anchors of the third set / cluster to form a third node.

[0159] In some implementations, anchoring the first subset and the third subset of anchors to the tissue includes anchoring the first subset and the third subset of anchors to the tissue at a first portion of the valve. In some implementations, anchoring the second subset of anchors to the tissue includes anchoring the second subset of anchors to a second portion of the valve.

[0160] In some implementations, anchoring is done such that the tether spans, from the first set / cluster at the first portion, across the valve to the second set / cluster at the second portion, and, from the second set / cluster at the second portion, back across the valve to the third set / cluster at the first portion. In some implementations, anchoring is done such that tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0161] In some implementations, anchoring the anchors of the set to the tissue further includes anchoring a fourth subset of the anchors of the set to the tissue in a fourth set / cluster of anchors, such that the tether spans from the third set / cluster to the fourth set / cluster.

[0162] In some implementations, anchoring the first subset and the fourth subset of anchors to the tissue includes anchoring the first subset and the fourth subset of anchors to the tissue at a first portion of the valve. In some implementations, anchoring the second subset and the third subset of anchors to the tissue includes anchoring the second subset and the third subset of anchors to a second portion of the valve.

[0163] In some implementations, anchoring is done such that the tether spans, from the first set / cluster at the first portion, across the valve to the second set / cluster at the second portion, along the second portion of the valve to the third set / cluster, and, from the third set / cluster at the second portion, back across the valve to the fourth set / cluster at the first portion. Insome implementations, anchoring is done such that tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0164] In some implementations, the method includes, subsequently to anchoring the second subset of anchors at the second portion, and prior to anchoring the third subset of anchors at the second portion, transluminally advancing at least one spacer over and along the tether such that, once the third subset is anchored to the tissue, the spacer maintains a spacing between the second set / cluster and the third set / cluster.

[0165] In some implementations, anchoring the anchors of the set to the tissue includes anchoring the anchors along a first portion of the valve such that the tether becomes secured to the first portion.

[0166] In some implementations, the method includes securing the tether to a second, opposite portion of the heart, such that the tether spans across the valve. In some implementations, the method includes tensioning the tether towards a tensioned state to draw the first portion and the second portion of the valve toward each other.

[0167] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart prior to securing the tether to the first portion of the heart.

[0168] In some implementations, the method includes transluminally advancing a lock over and along the tether to the node to lock the tether in the tensioned state.

[0169] In some implementations, the method includes cutting excess tether proximally to the lock.

[0170] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart using a single anchor.

[0171] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart using an anchor that is identical to the anchors of the set.

[0172] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart by anchoring a second-side anchor. The second side anchor can include a head and an eyelet. The eyelet can be directly attached to the head. The second side-anchor can be anchored to tissue of the second portion of the heart while the tether is threaded through the eyelet of the second-side anchor.

[0173] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart using a pledget anchor.

[0174] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart using a self-expanding anchor.

[0175] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart using a toggle anchor.

[0176] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart by implanting an expandable hydrogel bead in tissue of the heart. The bead can expand by drawing liquid into itself from the tissue.

[0177] In some implementations, securing the tether to the second portion of the heart includes anchoring a second-side anchor into a wall of an annulus of the valve on the second portion.

[0178] In some implementations, securing the tether to the second portion of the heart includes securing the tether to the second portion of the heart by anchoring a leaflet anchor to a leaflet of the valve.

[0179] In some implementations, securing the tether to the second portion of the heart includes anchoring a helical member that defines a plurality of turns helically along the second portion of the valve while the tether extends along the turns, such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0180] In some implementations, securing the tether to the second portion of the heart includes implanting a stent in a coronary blood vessel of the heart adjacent the second portion while the tether is coupled to the stent.

[0181] In some implementations, the tether is a first tether, the method includes securing a second tether to both the first portion of the valve and the second portion of the valve such that the second tether spans across the valve, independently of the first tether. In some implementations, the method includes tensioning the second tether to draw the first portion and the second portion of the valve toward each other.

[0182] In some implementations, the valve has an annulus circumscribing the valve In some implementations, the heart has a ventricle downstream of the valve. In someimplementations, securing the tether to the second portion of the heart includes driving a second-side anchor through the annulus and into the ventricle while the second-side anchor is attached to the tether.

[0183] In some implementations, the anchor is preformed to assume a bulky shape, and driving the second-side anchor into the ventricle includes advancing the anchor into the ventricle while the anchor is coupled to the tether, after the anchor has assumed the bulky shape.

[0184] In some implementations, the set of anchors is a first set of anchors. In some implementations, securing the tether to the second portion of the heart includes, for each anchor of a second set of anchors, sequentially: transluminally advancing the anchor towards the heart, and / or anchoring the anchor to tissue adjacent the second portion of the valve.

[0185] In some implementations, one or more anchors (e.g., each anchor) comprises an eyelet.

[0186] In some implementations, all, one, or some of the eyelets are defined by a cord or other connection / connector of a respective anchor.

[0187] In some implementations, all, one, or some of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to a corresponding head of the anchor via a cord or other connection / connector. In some implementations, the cord / connection / connector extends away from the head to the eyelet.

[0188] In some implementations, all, one, or some of the eyelets are integrally formed with a respective head of an anchor.

[0189] In some implementations, the tether is threaded through all, one, or some of the eyelets.

[0190] In some implementations, the node is a first node. In some implementations, drawing together the eyelets of the anchors to form the node by tensioning the tether includes drawing together the eyelets of the anchors to form the first node by tensioning the tether prior to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set converge to form the first node.

[0191] In some implementations, the method includes, subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, tensioning thetether to draw the eyelets of the anchors of the second set together to converge to form a second node.

[0192] In some implementations, the node is a first node. In some implementations, drawing together the eyelets of the anchors to form the node by tensioning the tether includes drawing together the eyelets of the anchors to form the first node by tensioning the tether subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set converge to form the first node, and the eyelets of the anchors of the second set converge to form a second node.

[0193] In some implementations, drawing together the eyelets of the anchors to form the node by tensioning the tether includes drawing together the eyelets of the anchors to form the node by tensioning the tether subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set and the eyelets of the anchors of the second set converge to form the node.

[0194] In some implementations, the valve is a tricuspid valve of the heart, having: (a) a first leaflet adjacent a first portion of the valve, a second leaflet adjacent a second portion of the valve, and a third leaflet adjacent a third portion of the valve, and / or (b) an annulus that circumscribes the valve.

[0195] In some implementations, anchoring the anchors of the set adjacent tissue of the valve includes anchoring a first anchor of the set into tissue of the annulus at the first portion. In some implementations, anchoring the anchors of the set adjacent tissue of the valve includes anchoring a second anchor of the set into tissue of the annulus at the second portion. In some implementations, anchoring the anchors of the set adjacent tissue of the valve includes anchoring a third anchor of the set into tissue of the annulus at the third portion.

[0196] In some implementations, drawing together the eyelets of the anchors to form the node by tensioning the tether includes tensioning the tether such that the first portion, the second portion, and the third portion are drawn toward each other.

[0197] In some implementations, drawing together the eyelets of the anchors to form the node by tensioning the tether includes drawing together the eyelets of the anchors such that the node is disposed medially between the first portion, the second portion, and the third portion.

[0198] In accordance with some implementations, a system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.) includes an implant that includesmultiple anchors and / or a tether. In some implementations, one or more anchors (e.g., each anchor) includes a head. In some implementations, one or more anchors (e.g., each anchor) includes a tissue-engaging element. In some implementations, one or more anchors (e.g., each anchor) includes an eyelet.

[0199] In some implementations, a tether, threaded through the eyelet of one or more anchors (e.g., each anchor) such that the anchors are arranged in series along the tether. In some implementations, responsive to application of tension to the tether, the eyelets slide along the tether to form a node at which the eyelets meet.

[0200] In some implementations, the tissue-engaging element extends away from the head to define an anchor axis of the anchor.

[0201] In some implementations, one, some, or all of the eyelets are coupled (e.g., flexibly coupled, rigidly coupled, securely coupled, permanently coupled, removably coupled, etc.) to the head.

[0202] In some implementations, one, some, or all of the eyelets are defined by a cord / connection / connector extending from the head.

[0203] In some implementations, one, some, or all of the eyelets are formed integrally with the head.

[0204] In some implementations, the implant can be the same as or similar to other implants described above or elsewhere in this application.

[0205] In some implementations, one, some, or all of the anchors can be the same as or similar to one or more other anchors described above or elsewhere in this application.

[0206] In some implementations, the tether can be the same as or similar to other tethers described above or elsewhere in this application.

[0207] In accordance with some implementations, a system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.) includes an implant that includes a hypotube. In some implementations, the implant can include a first anchor. In some implementations, the implant can include a second anchor. In some implementations, the first anchor is connected to a first end of the hypotube, and anchorable into tissue at a first portion of the valve.

[0208] In some implementations, the second anchor is connected to a second end of the hypotube, and anchorable into tissue at a second portion of the valve such that the laser-cut hypotube bridges the valve.

[0209] In some implementations, at least one anchor selected from the group of the first anchor and the second anchor is a pledget anchor.

[0210] In some implementations, at least one anchor selected from the group of the first anchor and the second anchor is a helical anchor adapted to be screwed into tissue of the heart.

[0211] In some implementations, the implant further includes a tether that connects the first anchor to the second anchor.

[0212] In some implementations, the hypotube has a saddle-shape. In some implementations, the hypotube is heat-set to define a saddle-shape.

[0213] In some implementations, the hypotube is a first hypotube. In some implementations, the implant includes a second hypotube. In some implementations, the implant includes a third anchor. The third anchor can be connected to a first end of the second hypotube. In some implementations, the third anchor is anchorable into tissue at the first portion of the valve. In some implementations, the implant can include a fourth anchor. The fourth anchor can be connected to a second end of the second hypotube. In some implementations, the fourth anchor is anchorable into tissue at the second portion of the valve such that the second hypotube bridges the valve.

[0214] In some implementations, the first and second hypotubes collectively define a valve support for receiving a prosthetic valve.

[0215] In some implementations, the implant includes the prosthetic valve.

[0216] In some implementations, the implant can be the same as or similar to other implants described above or elsewhere in this application.

[0217] In some implementations, one, some, or all of the anchors can be the same as or similar to one or more other anchors described above or elsewhere in this application.

[0218] In some implementations, the tether can be the same as or similar to other tethers described above or elsewhere in this application.

[0219] 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 comprise computerized and / or physical representations.

[0220] 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 comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.)

[0221] 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

[0222] Figs. 1A-G, 2A-D, 3A-D, 4A-E, and 5 illustrate various systems and methods for securing a tether to different portions of a valve in order to subsequently draw the different portions of the valve together, thereby reducing valve regurgitation;

[0223] Figs. 6-9 illustrate a variety of anchors, in accordance with some implementations;

[0224] Figs. 10A-B, 11A-B, 12A-B, and 13-14 show different uses and / or variants of implants implanted around an annulus of a heart, in accordance with some applications;

[0225] Figs. 15-16, 17A-B, and 18-22 illustrate various systems, methods and techniques for securing a tether to at least one portion of a valve in order to subsequently draw different portions of the valve together; and

[0226] Figs. 23-25 illustrate various systems, methods, and techniques of bridging a valve of a heart using at least one laser-cut hypo tube.DETAILED DESCRIPTION OF EMBODIMENTS

[0227] The present disclosure relates, inter alia, to systems and methods of securing (e.g., anchoring) a tether of an implant to different portions of a valve (e.g., a mitral valve 7 or a tricuspid valve 17) of a heart. In some implementations, they can be arranged such that the tether spans across (e.g. bridges) the valve or portion thereof (e.g., across a valve orifice ofthe valve). Tensioning the tether draws the different portions of the valve closer to each other in order to reduce valve regurgitation.

[0228] Although the methods and / or systems described herein generally relate to annuloplasty, e.g., reducing a dimension of a valve of the heart, the systems and / or methods described herein could similarly be used, mutatis mutandis, to reduce a dimension of any body orifice of a subject, such as to reduce the size of a ventricle of the heart (e.g., ventriculoplasty).

[0229] Reference is now made to Figs. 1A-G, 2A-D, 3A-D, 4A-E, and 5, which illustrate various example systems and methods for securing a tether 124 to different portions (e.g., opposite sides) of a valve 7 in order to subsequently draw the two portions or sides of the valve together, thereby reducing valve regurgitation. The tether can be secured to at least one portion / side 7a, 7b of the valve via multiple tissue anchors 122 that subsequently assume a load-sharing arrangement.

[0230] Although throughout the figures valve 7 is shown to be a mitral valve for illustrative purposes, with first portion / side 7a illustrated as located adjacent the anterior leaflet of the mitral valve, and second portion / side 7b located adjacent to the posterior leaflet of the valve, it is to be understood that first portion / side 7a could be located adjacent to the posterior leaflet, and second portion / side could be located adjacent to the anterior leaflet. Similarly, the valve being treated could be a tricuspid valve, or any other native valve.

[0231] Figs. 1A-G illustrate a system 100 comprising an implant 120, and a delivery tool 110 adapted to transluminally (e.g. transfemorally, transjugularly, etc.) deliver and implant the implant at the heart of a subject (e.g., a living subject, a simulation, etc.). In some implementations, delivery tool 110 comprises a catheter device that comprises a flexible tube (e.g. a catheter) 114. In some implementations, delivery tool 110 comprises an anchor driver 116. In some implementations, delivery tool 110 also comprises a sheath 112 via which tube 114 is advanceable.

[0232] In some implementations, implant 120 comprises tether 124, as well as multiple tissue anchors 122 threaded onto the tether. Each anchor 122 has a head 123 and a tissueengaging element (not shown) extending from the head (e.g., such as tissue-engaging element 127, illustrated in Figs. 6-9).

[0233] In some implementations, each tissue-engaging element can be helical and / or a screw-in tissue-engaging element, or any other type of tissue-engaging element, e.g. a dart, a staple, or a clip, or a combination of two or more of these. In some implementations, each anchor 122 is anchorable (e.g., screwable) into the tissue until head 123 abuts (e.g., contacts, but does not penetrate) a surface of the tissue. In some implementations, tether 124 can be any of a suture, a wire, a string, a ribbon, a band, a rope and / or a filament.

[0234] In some implementations, each anchor 122 has an eyelet 128 through which the tether extends, the tether thereby being slidably threaded along the eyelets of the anchors.

[0235] In some implementations, one, some, or all of eyelets 128 are attached / coupled to a respective anchor head 123 via a cord / connection / connector 126. In some implementations, one, some, or all of eyelets 128 are defined by a respective cord / connection / connector 126. In some implementations, one, some, or all of the eyelets 128 can be integrally formed with the head of a respective anchor. Any of the eyelets for any of the anchors described anywhere herein can be formed in any of the ways described in this paragraph or elsewhere in this disclosure.

[0236] It is to be noted that the term "cord" (including the specification and the claims) refers to a flexible elongate component having tensile strength, whether formed from multiple strands (e.g. twisted or braided together to form a polyfilament cord), or from a single strand (e.g. a monofilament cord). For example, the cord may comprise (e.g. may be) a thread, a suture, a string, a rope, a wire, a ribbon, or a chain. The cord may be formed from natural fibers, synthetic fibers, a polymer, and / or a metal.

[0237] In some implementations, cords / connections / connectors 126 may space the eyelets from their respective heads, e.g., each cord / connection / connector may have a significant length. For example, cord / connection / connector 126 may have a length that is at least 2 mm (e.g. at least 4 mm, such as at least 6 mm). In some implementations, the length of cord / connection / connector 126 is no greater than 30 mm (e.g. no greater than 20 mm, such as no greater than 15 mm or lOe mm). In some implementations, cord / connection / connector 126 may have a length of 2-20 mmm, e.g. 4-20 mm, such as 4-10 mm. Similarly, cord / connection / connector 126 may attach eyelet 128 to head 123 such that the distance between the eyelet and the head (e.g. measured along the cord) is at least 2 mm (e.g. at least 4 mm, such as at least 6 mm). In some implementations, this distance between the eyelet andthe head is no greater than 30 mm (e.g. no greater than 20 mm, such as no greater than 15 mm or 10 mm). In some implementations, this distance between the eyelet and the head is 2-20 mmm, e.g. 4-20 mm, such as 4-10 mm.

[0238] Each cord / connection / connector 126 can be attached to its respective anchor head 123 by looping around the head to define a collar (e.g., as illustrated in Fig. 6). In some implementations, each cord / connection / connector 126 is attached to its respective head by looping through an aperture in head 123 of the anchor. Various eyelets and cord / connection / connector embodiments are shown in more detail in Figs. 6-9.

[0239] In some implementations, a stopper 125 is fixed to a distal end of tether 124, e.g., to prevent the end of the tether from slipping out of eyelets 128, e.g., by the stopper abutting a first eyelet 128' of the most distal anchor 122' of implant 120. In some implementations, anchor 122' is fixedly attached to the distal end of the tether (e.g., rather than extending through eyelet 128' of the anchor as shown, the tether is affixed to an end of the cord / connection / connector of the anchor). In some such implementations, stopper 125 is not used.

[0240] Figs. 1A-G represent an example series of steps that can be performed by the operator, to reshape (e.g., reduce) a dimension of an annulus 10 of a heart valve, in accordance with some implementations. Although Figs. 1A-G show a sequence of at least some steps in a procedure, and can, in fact, be performed in the order shown, these figures are also intended to illustrate the capability of system 100, independently of any particular sequence of steps.

[0241] While tether 124 is threaded through eyelets 128, the anchors can be anchored to the annulus, e.g., into an atrial-facing surface of the annulus at first portion / side 7a of valve 7. In some implementations, the anchors are anchored into a fibrous trigone of the valve.

[0242] Figs. 1A-D illustrate multiple anchors 122 being anchored, in an arc around the first portion / side 7a of the valve, such that the anchors form a set / cluster of anchors on the first portion / side of the valve. Although the valve shown is a mitral valve, the system and techniques can be used similarly at another valve, such as the tricuspid valve.

[0243] In some implementations, each anchor may be delivered transluminally to the heart via driver 116 (Fig. IB), e.g., while reversibly engaged with the driver. In some implementations, driver 116 is advanced within a tube (e.g., tube 114, Fig. IB).

[0244] In some implementations, driver 116 can comprise a flexible shaft, and a drive head at a distal end of the shaft that is adapted to engage an interface on the head of each anchor. Once driver 116 has anchored the anchor to the tissue (e.g., by screwing the tissue-engaging element into the tissue, or by driving the tissue-engaging element longitudinally into the tissue), the driver can be released from the anchor and withdrawn from the heart. In some implementations, this process can be repeated until sufficient anchors have been anchored around first portion / side 7a of the valve. For example, Fig. ID illustrates three anchors having been anchored around the first portion / side of the valve. However, it is to be noted that 2 (e.g., as shown for each implant 120 in Fig. 10A) 3, 4, 5, 6 or more anchors may be anchored to the first portion / side of the valve, in order to form the load-sharing arrangement as will be explained hereinbelow.

[0245] In some implementations, the tether is then secured to second portion / side 7b of the valve, e.g., via an anchor 147 and / or via any other securing means. Anchor 147 can thus be considered to be a "second-side anchor", i.e., an anchor that anchors the tether to the second portion / side of the valve. In some implementations, anchor 147 is different to anchors 122. In some such implementations, and as illustrated in Fig. IE, anchor 147 defines an eyelet 148 that is attached directly to the anchor, e.g., that is not spaced away from the anchor, through which tether 124 extends.

[0246] In some implementations, anchor 147 is identical, or similar to, anchors 122. In some implementations, the tether is secured to the second portion / side using multiple anchors, e.g., that will subsequently form a second load-sharing arrangement (see Figs. 3A-D hereinbelow). In some implementations, the tether is secured to the second portion / side of the annulus in a manner that does not include a load-sharing arrangement on the second portion / side, e.g., using a single anchor 147 and / or using any of the securing methods described hereinbelow. In some implementations, tether 124 is not secured to second portion / side 7b within the atrium, rather it is attached to the second portion / side within the cardiovascular system and / or within the ventricle downstream of the valve.

[0247] As illustrated in Fig. IF, tension can be applied to tether 124 in a manner that draws eyelets 128 of each of the anchors together such that they converge (e.g., meet) to form a node 129, e.g., by the eyelets sliding along the tether towards each other (illustrated by the transition from Fig. IE to IF). In some implementations, at node 129, each eyelet 128 contacts its neighboring eyelets, e.g., there is no gap between the eyelets at the node. It is tobe noted that even though eyelets 128 can meet and contact each other, heads 123 remain spaced apart from each other, e.g., the heads are not drawn against each other (Fig. 1G).

[0248] In some implementations, the node can be structurally and / or functionally analogous to a "masterpoint" in the field of rock climbing. For example, during the cardiac cycle, various forces acting on tether 124 may be more equally distributed among anchors 122, e.g., as compared to an arrangement in which no node is formed, such as in an implementation in which the tether is coupled directly to the anchors. In some implementations, forming node 129 allows each eyelet 128 to appropriately find an angle that best distributes force between the anchors. For example, node 129 may dynamically find its "happy point", e.g., the load-sharing arrangement may be substantially immune to the subject's anatomy and / or to forces acting on the different anchors during the cardiac cycle.

[0249] Although each of Figs. 1G, 2D, 3D, 4E and 5 show all cords 126 of anchors 122 being taut upon tensioning of tether 124, in some implementations, only a subset (e.g., two of the cords) become taut responsively to tensioning the tether. For example, depending on the angles / position of each of anchors 122 and / or of anchor 147 within the heart, cords 126 may achieve varying degrees of tension responsively to tensioning the tether. In some implementations, at least one cord / connection / connector 126 remains slack, or less taut, than the other cords. This may advantageously allow the implant to dynamically find an optimal force-distributing arrangement e.g., to dynamically spread the forces over a subset of anchors 122 that are best positioned to receive the forces.

[0250] In some implementations, during the cardiac cycle, the cord / connection / connector that remains slacker than the other cords may periodically become tensioned, and may relax responsively to the cardiac cycle. In other implementations, the slacker cord / connection / connector may not become tensioned, leaving the forces distributed more over the other anchors of the set during the entire cardiac cycle.

[0251] In some implementations, and as shown in Figs. 1A-G, tensioning the tether can successively (i) draw the eyelets together to form the node (e.g., thereby forming the loadsharing arrangement), and (ii) reduce the dimension of the valve by drawing the different portions / sides of the valve towards each other (e.g., thereby improving valve regurgitation). That is, node 129 is formed (e.g., by tensioning tether 124) subsequently to securing the tether to second portion / side 7b of the valve.

[0252] In some implementations, node 129 is formed (e.g., by tensioning tether 124) prior to securing the tether to second portion / side 7b of the valve, e.g., the tether is initially tensioned to form the node, prior to the securing of the tether to the second portion / side of the valve, and the tether is then tensioned again once the tether has been secured to the second portion / side of the valve, in order to draw the two portions of the valve together.

[0253] In some implementations, and as shown, tensioning tether 124 positions node 129 between first portion / side 7a of the valve and second portion / side 7b of the valve (e.g., on a point on a longitudinal axis that extends between the two portions). For example, depending on the length of cords 126, tensioning tether 124 may position node 129 over the valve orifice, over the leaflets of the valve (e.g., as shown), and / or over the annulus at the second portion / side of the valve.

[0254] As shown in Figs. 1F-G, the tension in the tether can then be locked, e.g., using a lock 121. In some implementations, application of the tension to tether 124 may be facilitated by an adjustment tool 118 applying a reference force to implant 120, e.g., the adjustment tool may push against anchor 147 and / or lock 121 while pulling tether 124 proximally.

[0255] In some implementations, adjustment tool 118 is also used to deliver lock 121 to the implant, e.g., the adjustment tool is transluminally advanced over and along tether 124 (e.g., as shown in Fig. IF), while pushing the lock distally.

[0256] In some implementations, tether 124 is then cut, e.g., proximally to lock 121. In some implementations, tool 118 comprises a cutter that is configured to cut the tether proximally to the lock. In some implementations, adjustment tool 118 can be a component of delivery tool 110.

[0257] In some implementations, mutatis mutandis, adjustment tool 118 may have one or more of the features of any of the tools having similar function described in the following references, each of which is incorporated herein by reference in its entirety:International Patent Application PCT / IL2019 / 050777 to Brauon et al., filed 11 July 2019, which published as WO 2020 / 012481;International Patent Application PCT / IB 2020 / 060044 to Kasher et al., filed 27 October 2020, which published as WO 2021 / 084407;International Patent Application PCT / IB 2022 / 051099 to Shafigh et al., filed 8 February 2022, which published as WO 2022 / 172149;International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed 6 December 2023, which published as WO 2024 / 121770.

[0258] Fig. 1G illustrates implant 120 in its implanted form along valve 7, after delivery tool 110 has been withdrawn from the heart. As illustrated, implant 120 (e.g., the tensioned state of tether 124) maintains the two portions (e.g., sides, etc.) of the valve 7a and 7b drawn towards each other, such that valve regurgitation is reduced.

[0259] Figs. 2A-D illustrate an implementation which, similarly to Figs. 1A-G, uses a loadsharing arrangement on first portion / side 7a of the valve to evenly-distribute forces among the anchors on the first portion / side, but differs to Figs. 1A-G in that the tether is secured to the second portion / side of the valve using an anchor 122" that is identical to the anchors used to secure the tether to the first portion / side of the valve (e.g., and not via an anchor 147 that has an eyelet 148 that is closely attached to the anchor).

[0260] Figs. 2A-D illustrate a system 100a, which may be a variant of, or substantially identical to, system 100, except when noted otherwise. System 100a comprises an implant 120a, and a delivery tool 110a which can be identical to delivery tool 110, except when noted otherwise. Implant 120a can be identical to implant 120, except that, rather than the implant comprising a specialized anchor 147 for securing tether 124 to second portion / side 7b of the valve, implant 120a comprises a set of identical, or nearly identical anchors 122 that are used on both portion / sides of the valve. This may advantageously allow for the storing of anchors 122 in an anchor magazine having identical cartridges for the anchors, e.g., at an extracorporeal portion of delivery tool 110a and / or can advantageously allow for tether 124 to be secured to second portion / side 7b of the valve using the same anchor driver (e.g., driver 116) to that used for the anchoring of the anchors to first portion / side 7a. Similarly, having a set of identical anchors 122 may allow for an operator (e.g., physician) to interprocedurally determine how many anchors are needed for anchoring to first portion / side 7a of the valve (e.g., in order to form a satisfactory load-sharing arrangement), such that, once it has been determined that enough anchors are anchored to the first portion / side, the operator can simply use the same driver and / or select the next anchor 122" of the set to anchor an identical anchor of the set to the second portion / side of the valve.

[0261] Figs. 2A-D represent a series of steps that can be performed by the operator to reduce the size of an annulus 10 of a heart valve, in accordance with some implementations. Although Figs. 2A-D show a sequence of at least some steps in a procedure, and can, in fact,be performed in the order shown, these figures are also intended to illustrate the capability of system 100a, independently of any particular sequence of steps.

[0262] Fig. 2A illustrates multiple anchors 122 having been anchored to first portion / side 7a of valve 7. As mentioned hereinabove, it is to be noted that 2, 3, 4, 5, 6 or more anchors may be anchored to the first portion / side of the valve, in order to subsequently form the loadsharing arrangement. Once the operator has assessed that a satisfactory number of anchors 122 have been anchored to first portion / side 7a, an anchor 122" is anchored to second portion / side 7b of the valve (Fig. 2B).

[0263] As shown in Fig. 2C, tether 124 can then be tensioned, thereby forming node 129, e.g., as described hereinabove with respect to Figs. 1A-G. In some implementations, tensioning the tether pulls the eyelet 128" of the anchor that is implanted on second portion / side 7b toward, or against, node 129, e.g., such that all eyelets 128 become positioned over the leaflets and / or valve orifice of valve 7. In some implementations, tension is applied to tether 124 to form node 129 prior to implanting anchor 122" on second portion / side 7b of the valve.

[0264] In some implementations, and as shown, tension is applied to tether 124 to form node 129 subsequently to implanting anchor 122" on second portion / side 7b of the valve, e.g., a tensioning tool 118 is used to successively form node 129 and to draw the two portions / sides 7a, 7b of the valve towards each other. In some implementations, applying tension to tether 124 draws eyelet 128" against node 129, e.g., such that all the eyelets of implant 120a converge at the node.

[0265] In some implementations, a lock 121 is then applied to the tether, to maintain the tension in the tether, and delivery tool 110a can then be withdrawn from the heart, leaving implant 120a implanted therein (Fig. 2D).

[0266] Figs. 3A-D illustrate an implementation in which, in addition to forming a loadsharing arrangement on first portion / side 7a of the valve (e.g., as described hereinabove with reference to implants 120 and 120a), a second load-sharing arrangement is similarly formed on second portion / side 7b of the valve, e.g., using a similar technique to that described with respect to the first portion / side. That is, a first set or cluster of anchors are anchored to the first portion / side such that the first set / cluster forms a first load-sharing arrangement, and a second set or cluster of anchors are anchored to the second portion / side of the valve, such that the second set or set / cluster form a second load-sharing arrangement.

[0267] Figs. 3A-D illustrate an example system 100b which can be a variant of, or substantially identical to, systems 100 and / or 100a, except when noted otherwise. In some implementations, system 100b comprises an implant 120b, and a delivery tool 110b which can be identical to delivery tool 110a, except when noted otherwise. In some implementations, implant 120b can be identical to implant 120a, except that, rather than comprising only a single anchor 122" for securing to second portion / side 7b of the valve, implant 120b comprises multiple anchors 122" that are anchored to the second portion / side.

[0268] In some implementations, each anchor 122" is threaded onto tether 124 via eyelets 128", e.g., as described with reference to anchors 122.

[0269] As will be described hereinbelow, in some implementations, anchors 122" are then drawn into a second load-sharing arrangement, e.g., such that eyelets 128" of the anchors converge to form a second node 129".

[0270] As described hereinabove with reference to implant 120a, having similar or nearly identical anchors for securing to both portions / sides of the valve may advantageously allow for a simpler delivery tool and / or a single set of anchors that can allow an operator to use the same driver and / or to anchor as many anchors as required to the first portion / side of the valve, and then to simply anchor the next anchors of the set to the second portion / side of the valve.

[0271] Figs. 3A-D represent a series of steps that can be performed by the operator, to circumferentially reduce the size of an annulus 10 of a heart valve, in accordance with some implementations. Although Figs. 3A-D show a sequence of at least some steps in a procedure, and can, in fact, be performed in the order shown, these figures are also intended to illustrate the capability of system 100b, independently of any particular sequence of steps.

[0272] Fig. 3A illustrates multiple anchors 122 having been anchored to first portion / side 7a of valve 7. As mentioned hereinabove, it is to be noted that 2 (e.g., as shown for each implant 120 in Fig. 10A), 3, 4, 5, 6 or more anchors may be anchored to the first portion / side of the valve, in order to subsequently form the load-sharing arrangement. Once the operator has assessed that a satisfactory number of anchors 122 have been anchored to first portion / side 7a, multiple anchors 122" are then anchored to second portion / side 7b of the valve (Fig. 3B).

[0273] As shown in Fig. 3C, tether 124 can then be tensioned, thereby forming a first node 129, e.g., as described hereinabove with respect to Figs. 1A-G, and second node 129". In some implementations, tensioning the tether pulls first node 129 and second node 129"toward, or against each other e.g., such that all eyelets 128 become positioned over the leaflets and / or valve orifice of valve 7, and optionally form a single node (not shown).

[0274] In some implementations, tension is applied to tether 124 to form node 129 prior to implanting anchors 122" on second portion / side 7b of the valve (e.g., prior to forming node 129"). In some implementations, tension is applied to tether 124 to form node 129 subsequently to implanting anchors 122" on second portion / side 7b of the valve, e.g., a tensioning tool 118 is used to successively form nodes 129 and 129", and to draw the two portions / sides 7a, 7b of the valve towards each other.

[0275] In some implementations, a lock 121 is then applied to the tether, to maintain the tension in the tether, and delivery tool 110a can then be withdrawn from the heart, leaving implant 120a implanted therein (Fig. 3D).

[0276] Figs. 4A-E illustrate an example system 100c which can be a variant of, or substantially identical to any of the systems mentioned hereinabove, except when noted otherwise. In some implementations, system 100c comprises an implant 120c, and a delivery tool 110c which can be identical to delivery tool 110, except when noted otherwise. In some implementations, implant 120c can be identical to implant 120, except that it additionally comprises a covering 184 for covering node 129 e.g., in order to maintain eyelets 128 in their converged state and / or to facilitate the even distribution of forces among anchors 122.

[0277] Covering 184 can be incorporated into any of the other systems described herein, and are not limited to use with system 100 and / or 100c.

[0278] Figs. 4A-E represent an example series of steps that can be performed by the operator, to circumferentially reduce the size of an annulus 10 of a heart valve, in accordance with some implementations. Although Figs. 4A-E show a sequence of at least some steps in a procedure, and can, in fact, be performed in the order shown, these figures are also intended to illustrate the capability of system 100c, independently of any particular sequence of steps.

[0279] Fig. 4A illustrates multiple anchors 122 having been anchored to first portion / side 7a of valve 7. As mentioned hereinabove, it is to be noted that 2 (e.g., as shown for each implant 120 in Fig. 10A), 3, 4, 5, 6 or more anchors may be anchored to the first portion / side of the valve, in order to subsequently form the load-sharing arrangement.

[0280] Once the operator has assessed that a satisfactory number of anchors 122 have been anchored to first portion / side 7a, in some implementations, covering 184 is slid over and along tether 124 (e.g., via an advancement tool 182), towards eyelets 128, such that thecovering encases (e.g., encloses) the eyelets (Fig. 4B). In some implementations, covering 184 may facilitate the formation of node 129, e.g., by drawing the eyelets towards each other.

[0281] In some implementations, node 129 can be formed by applying tension to the tether, such that covering 184 is not used to form the node. As described hereinabove, covering 184 may advantageously maintain eyelets 128 in their converged state and / or facilitate the even distribution of forces among anchors 122.

[0282] In some implementations, tether 124 can be secured to the second portion / side 7b of the valve, e.g., via an anchor 147 (e.g., as shown in Fig. 4C), or via an anchor 122" e.g., an anchor that is identical, or similar to, anchors 122, or via any other securing means.

[0283] As shown in Fig. 4D, tether 124 can then be tensioned, thereby drawing the two different portions of the valve towards each other. In some implementations, this additionally forms node 129, e.g., as described hereinabove with respect to Figs. 1A-G. For example, covering 184 may be slid over eyelets 128 such that the eyelets are encased, but do not yet converge. In some implementations, tensioning the tether may then subsequently draw the eyelets together such that they contact (e.g., meet) each other. In some such implementations, and as shown, tension is applied to tether 124 to form node 129 subsequently to implanting anchor 147 on second portion / side 7b of the valve, e.g., a tensioning tool 118 is used to successively form node 129 and to draw the two portions / sides 7a, 7b of the valve towards each other.

[0284] In some implementations, a lock 121 is then applied to the tether, to maintain the tension on the tether, and delivery tool 110c can then be withdrawn from the heart, leaving implant 120c implanted therein (Fig. 4E).

[0285] Fig. 5 illustrates an implementation in which a load-sharing arrangement is formed on a second portion / side 7b of a valve (e.g., subsequently to securing the tether to a first portion / side 7a of the valve), in accordance with some implementations.

[0286] Fig. 5 illustrates an implant 120d that comprises a tether 124 that is securable to a first portion / side 7a of the valve via a specialized anchor 147', and to a second portion / side 7b via multiple anchors 122" that form a load-sharing arrangement on the second portion / side of the valve.

[0287] Although anchor 147' is illustrated as an anchor that is anchored into tissue of the annulus, it is to be understood that, similarly, to anchor 147, anchor 147' can be embodiedby any other securing means that can be used to secure tether 124 to the first portion / side of the heart, e.g., using any of the securing techniques mentioned hereinbelow.

[0288] In some implementations, anchors 122" can be identical to any of anchors 122 and / or 122" described hereinabove. For example, once anchor 147' has been anchored to first portion / side 7a, anchors 122" can be iteratively anchored into tissue of the annulus along second portion / side 7b, e.g., such that the anchors form an arc along the tissue on the second portion / side. Tension is then applied to tether 124, such that eyelets 128 of anchors 122" converge to form a node 129".

[0289] In some implementations, enough tension can be applied to concurrently draw different portions 7a and 7b towards each other, e.g., in order to reduce valve regurgitation. In some implementations, a lock 121 can then be applied to tether 124, e.g., in order to maintain the tether in its tensioned state.

[0290] Reference is now made to Figs. 6-9, which illustrate anchors having a variety of cords and / or eyelets, in accordance with some implementations. Each of the anchors illustrated in Figs. 6-9 can be used with any of the implants mentioned hereinabove, and can be understood as being variants of, or substantially identical to, anchors 122.

[0291] Figs. 6-9 illustrate various example anchors 122a, 122b, 122c, and 122d, each having an anchor head 123, and a tissue-engaging element 127 extending away from the head. In some implementations, the tissue-engaging element extends such that the tissue-engaging element defines an anchor axis AX1 of the anchor. As mentioned hereinabove, although throughout Figs. 6-9 tissue-engaging element 127 is illustrated as a helical, screw-in tissueengaging element, it is to be understood that any other tissue-engaging elements could be used, e.g., a dart, a staple and / or a clip.

[0292] Fig. 6 illustrates an example anchor 122a having an eyelet 128a that is in the form of a ring, e.g., such as a rigid ring, a grommet, and / or constructed from a polymer and / or metal.

[0293] In some implementations, eyelet 128a can be a discrete component with respect to cord / connection / connector 126a, e.g., it may be looped onto or otherwise attached to the cord / connection / connector that connects the eyelet to anchor head 123. In some implementations, cord / connection / connector 126a is looped around head 123 (e.g., around a bushing 1231 thereof), or is connected to the head via a bead, a knot or by looping through an aperture in the head of the anchor. In some implementations, an eyelet can be defined by the cord / connection / connector.

[0294] Fig. 7 illustrates an example anchor 122b having an example eyelet 128b that is formed by wrapping an elongate member that is in the form of a closed loop around head 123 (e.g., around a bushing 1231 thereof), and inserting the loop through itself to form the eyelet. In some implementations, the elongate member is a textile, a woven material, a cord, a fabric, a string, a wire and / or a ribbon.

[0295] In some implementations, eyelet 128b can be a variant of (e.g., formed in a similar manner to) eyelet 126d described in international application PCT / IB2023 / 062298 to Halabi, which published as WO 2024 / 121770, which is incorporated herein by reference. However, while eyelet 126d of the aforementioned application maintains the tether close to the anchor head, eyelet 128b is enlarged (e.g., the tether lies loosely within the eyelet) thus allowing for spacing of tether 124 away from head 123 in order to form node 129. In such implementations, the part of the elongate member that is furthest away from head 123 can be considered eyelet 128b, and the part of the elongate member that extends from the head to the eyelet can be considered the cord / connection / connector 126b (e.g., the eyelet can be considered a continuation of the cord).

[0296] Fig. 8 illustrates an example anchor 122c having an example eyelet 128c that is a continuation of a cord / connection / connector 126c, e.g., cord / connection / connector 126c and eyelet 128c are both formed from a single elongate member. In some implementations, the elongate member is a textile, a cord, a woven material, a fabric, a string, a wire and / or a ribbon. As shown, the elongate member may be attached to head 123 (e.g., via looping, knotting, or via any other attachment means), and, from the head, the elongate member extends away from the head to define cord / connection / connector 126c. At an end portion of the cord, the elongate member can be affixed in a loop, e.g., by tying an end of the elongate member about itself (e.g., as shown), and / or can be secured in a loop via any other securing methods, e.g., via a bead and / or a crimp. Other eyelet configurations are also possible.

[0297] Fig. 9 illustrates an example anchor 122d that, similarly, to anchor 122c, has an example eyelet 128d and a cord / connection / connector 126d that are formed from the same elongate member. However, Fig. 9 illustrates an implementation in which eyelet 128d is formed by passing (e.g., burrowing) the elongate member through itself in order to form the eyelet. This can be achieved using the technique described in International Patent Publication 2023 / 218368 to Pesach, e.g., referred to in Figs. 37A-C in the aforementioned application. Rather than necessitating knots and / or coupling elements for forming the eyelet and / or for attaching the eyelet to the cord, the above-described technique (e.g. of burrowing theelongate member through itself) may advantageously provide a smooth and non-abrasive loop and / or connection to cord / connection / connector 126d, e.g., thereby minimizing a risk of emboli forming thereon. Other eyelet configurations are also possible.

[0298] Reference is now made to Figs. 10A-B, 11A-B, 12A-B, and 13-14 which show different example uses and / or example variants of implant 120 implanted around an annulus 10 of a heart, in accordance with some applications. Each of the implants shown in these figures may be adapted for use with delivery tool 110, e.g., may be deliverable via the delivery tool (or a variant thereof). In some applications, the implants shown are contracted using the same general technique as described with reference to Figs. 1A-G, e.g., via application of tension to tether 124, and the implant is then locked in a tensioned state by locking tension within tether(s) of the implant. The implants described here can incorporate the same or similar features to other implants described elsewhere herein (e.g., similar anchors, eyelets, tethers, cords / connectors, etc. to other examples herein).

[0299] Fig. 10A shows an example implant arrangement 120e comprising multiple implants 120, 120'. Although implant arrangement 120e is shown as comprising two implants, it is to be understood that the implant arrangement could comprise three, four, five, or more implants 120. Similarly, although implant arrangement 120e is shown as comprising implants 120, it is to be understood that the implant arrangement could comprise multiple implants 120a, 120b, 120c, and / or 120d, or any combination thereof. Similarly, although each implant 120 of implant arrangement 120e is shown as comprising two anchors 122, it is to be understood that each implant could comprise 3, 4, 5, 6 or more anchors.

[0300] As described hereinabove, in some applications, each implant 120, 120' of implant arrangement 120e comprises multiple anchors 122, and a tether 124 that is threaded onto the anchors via eyelets 128 that are spaced away from the head of the anchors via cords / connections / connectors 126.

[0301] In some applications, each implant 120 and 120' of implant arrangement 120e can be anchored and / or contracted as described hereinabove with reference to Figs. 1A-G, mutatis mutandis. For example, tether 124 of each implant is tensionable to form a node 129, and to draw the two different portions / sides towards each other, and the tension in the tether can then be locked using a lock 121.

[0302] In some applications, each implant 120 of implant arrangement 120e may be anchored and / or tensioned independently of the other(s), e.g., the implants of the implant arrangement may be anchored and / or tensioned sequentially.

[0303] In some applications, each implant 120 is contracted immediately following its implantation and prior to the implantation of the next implant of the implant arrangement. In some applications, multiple (e.g., both, or all) of the implants of the implant arrangement are anchored, and then subsequently contracted in concert, e.g., such that the contraction of each of the implants may be adjusted in coordination with the contraction of other implants of the implant arrangement.

[0304] Although Fig. 10A illustrates an implant arrangement in which two implants are not connected to each other, it is to be understood that other implants / implant arrangements could be used. For example, a tether (e.g., tether 124) could extend between anchors 147 of each implant. Similarly, a single anchor 147 could be used to anchor to second portion / side 7b, e.g., such that the tether forms a "V" shape, with two load sharing arrangements on first portion / side 7 a being connected by a single tether 124.

[0305] Fig. 10B illustrates an example implant arrangement 120f comprising multiple implants 120b', 120b". Implant arrangement can be considered to be a variant of implant arrangement 120e, except that each implant 120b of implant arrangement 120f has a loadsharing arrangement (i.e. a set / cluster of anchors) on each side or different portions of the valve. In some implementations, each of implants 120b', 120b" can be a variant of, or substantively identical to, implant 120. Although implant arrangement 120f is shown as comprising two implants 120b, it is to be understood that the implant arrangement could comprise three, four, five, or more implants 120b. Similarly, although implant arrangement 120f is shown as comprising implants 120b, it is to be understood that the implant arrangement could comprise multiple implants 120, 120a, 120c, and / or 120d, or any combination thereof. Similarly, although each implant 120b of implant arrangement 120f is shown as comprising two anchors 122, it is to be understood that each implant could comprise 3, 4, 5, 6 or more anchors.

[0306] As described hereinabove with reference to implant 120b of Figs. 3A-D, in some applications, each implant 120b of implant arrangement 120f comprises two load-sharing arrangements (i.e. sets or clusters of anchors) on different portions of the valve. For example, for each implant 120b of implant arrangement 120f, a first set or cluster (in this case a pair) of anchors 122 is shown anchored to first portion / side 7a, and a second set or cluster (in thiscase a pair) of anchors 122 is shown anchored to second portion / side 7b, such that tensioning tether 124 forms two separate nodes 129 on either portion / side of the valve, by the respective eyelets of the anchors sliding along the tether towards each other. In some implementations, at the anterior side of the valve (shown as side 7a) each of the fibrous trigones 13 A, 13B of the heart may receive a respective set / cluster of anchors 122. As explained hereinabove, the more fibrous tissue of the trigones may advantageously enhance retention of the anchors within the tissue.

[0307] Figs. 11A and 11B show implant 120b' implanted at different example locations within a tricuspid valve 17 of the heart.

[0308] Fig. 11A illustrates an arrangement in which a first cluster (e.g., a first pair) of anchors 122 are anchored behind the root of the septal leaflet of tricuspid valve 17 (e.g., anchored to a right fibrous trigone 13B of the heart), and a second cluster of anchors (e.g., a second pair of anchors) anchored behind the root of the inferior leaflet of tricuspid valve 17.

[0309] Fig. 11B illustrates an example first set or cluster (e.g., a first pair) of anchors 122 anchored behind the root of the inferior leaflet of tricuspid valve 17, and a second set or cluster of anchors (e.g., a second pair of anchors) anchored behind the root of the superior leaflet of tricuspid valve 17.

[0310] Although Figs. 11A-B illustrate implant 120b' implanted at specific locations within a tricuspid valve, it is to be understood that implant 120b', or any other implants described herein, could be implanted at any other locations, e.g., at any location within the tricuspid and / or mitral valve. Similarly, multiple implants could be implanted within the tricuspid and / or mitral valve, e.g., using a combination of the arrangements shown.

[0311] Fig. 12A illustrates an implant 120g that comprises three sets or clusters of anchors 1221, 1222, and 1223. Each set / cluster can comprise 2, 3, 4, 5 or more anchors 122 that are anchored in a set / cluster (e.g., at a single fibrous trigone, or adjacent each other). The sets / clusters are joined together via tether 124 (e.g., that is spaced away from each of the anchor heads 123 via cords 126), such that tensioning tether 124 forms three separate nodes 129 - i.e. for each set / cluster, one node is formed by the eyelets of that set / cluster. Fig. 12A shows tether 124 assuming a "V-shape", extending from the node of first set / cluster 1221 anchored to the anterior side of the annulus, to the node of second set / cluster 1222 on the posterior side, and then back across the valve to the node of third set / cluster 1223 on the anterior side. (It is to be understood that the sets / clusters would be anchored in this sameorder.) However, it is to be understood that the tether could assume any other shape, depending on the positions of each set / cluster within the heart.

[0312] Fig. 12B illustrates a similar implementation to implant 120g, with an implant 120h comprising four anchor sets / clusters 1224, 1225, 1226, and 1227 implanted at various sites along the annulus, all connected via tether 124, such that the tether forms a "U-shape". As illustrated, in some implementations, one or more spacers 132 can be threaded along tether 124 to maintain sets / clusters 1225 and 1226 (e.g., and their respective nodes) spaced away from each other. For example, as shown, spacers 132 are positioned along the tether between two sets / clusters 1225 and 1226 that are anchored to the same side 7b of the valve, with tether 124 extending directly from the node of set / cluster 1225 to the node of set / cluster 1226.

[0313] In some implementations, spacers 132 may also help to distribute forces more evenly between the sets / clusters. In some implementations, spacers 132 comprise an elastic helical or helicoidal coil, which can be formed from a metal such as nitinol. Spacers 132 can act like a compression spring and / or shock absorber, thereby moderating forces between the nodes 129 of the sets / clusters. In some implementations, spacers 132 are variants of, or substantially identical to, the spacers described in International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed 6 December 2023, which published as WO 2024 / 121770, which is incorporated herein by reference.

[0314] One or more spacers 132 can be incorporated into any of the implants described herein, and could be used to space any set or cluster of anchors, or single anchor, away from any other set or cluster of anchors.

[0315] Fig. 13 illustrates an implant 120i comprising a shock-absorber 130 that can be attached to, or positioned just distally along the tether to, lock 121. In some implementations, shock-absorber 130 comprises an elastic helical or helicoidal coil, which can be formed from a metal such as nitinol. In some implementations, shock-absorber 130 can act like a compression spring and / or shock absorber, thereby moderating forces between lock 121 and node 129. In some implementations, shock-absorber 130 is flared at its distal end.

[0316] In some implementations, shock-absorber 130 can be a variant of, or substantially identical to, leader 190g described in International Patent Application PCT / IB2023 / 062298 to Halabi et al., filed 6 December 2023, which published as WO 2024 / 121770, which is incorporated herein by reference.

[0317] In some implementations, tether 124 is insertable into the lock via the shock-absorber 130, e.g., the shock-absorber and the lock form a continuous passage for the tether.

[0318] In implementations in which lock 121 is positioned against anchor 147 (e.g., as shown for implants 120 and 120c), shock-absorber 130 can be positioned between anchor 147 and the lock.

[0319] One or more shock-absorbers can be incorporated into any of the implants and / or used with any of the anchors described herein.

[0320] Fig. 14 illustrates an implant 120j that can be anchored at a tricuspid valve 17 of the heart (e.g., between the right atrium and the right ventricle). Implant 120j can comprise all the components of implant 120a described hereinabove. One or more anchors 122 are anchored into tissue of the annulus adjacent to each leaflet of the valve, such that tensioning the tether causes eyelets 128 to converge in the middle of the valve (e.g., over the valve orifice) to form a node 129, and to draw the three portions / sides of the valve towards each other. The tension can then be locked, e.g., using lock 121.

[0321] Reference is again made to Figs. 1A-14. It is to be noted that the lengths shown for cords 126 are illustrative and are not intended to be limiting. For example, in some implementations, the cords may be shorter than shown. In some implementations, the cords must be merely sufficiently long to allow the formation of the nodes upon tensioning of the tether - i.e. for the eyelets attached to the cords to reach each other.

[0322] Reference is now made to Figs. 15-16, 17A-B, and 18-22, which illustrate various example systems, methods and techniques for securing tether 124 to at least one portion / side 7a, 7b of a valve in order to subsequently draw the two portions / sides of the valve together, thereby reducing valve regurgitation. In some implementations, the tether can be secured to at least one portion / side of a valve (e.g., first portion / side 7a, or second portion / side 7b) via any of the techniques and / or securing methods shown in Figs. 15-22.

[0323] The securing methods shown can be used to secure a tether to the portion / side of a mitral valve adjacent a posterior leaflet of the valve, or to a portion / side of the valve adjacent to the anterior leaflet of the valve. Similarly, these techniques could be used to secure a tether adjacent to any of the leaflets of a tricuspid valve.

[0324] Any of the example anchors and / or example securing methods illustrated in Figs. 15-22 could be incorporated into any of the above-mentioned implants. For example, the belowmentioned anchors could replace anchor 147 in implants 120, 120c, 120d, and / or 120e, e.g., the below-mentioned techniques could be used to secure tether 124 to the portion / side of the valve that does not have a load-sharing arrangement in the aforementioned implants. Therefore, any of the anchors illustrated in Figs. 15-22 can be considered to be "second-side anchors". Alternatively and / or additionally, in some implementations, any of the below described anchors could replace anchors 122, e.g., any of the anchors described in Figs. 15- 22 could be used to form a load-sharing arrangement. For example, multiple anchors of any of the types of anchors shown in Figs. 15-22 could be anchored, in series, along a portion / side of the heart while coupled to the tether, such that the tether is then tensioned to form a load-sharing arrangement as described hereinabove.

[0325] Figs. 15-17B and 19 illustrate various example anchors that are anchored into a ventricle 8 that is downstream of the valve being treated, e.g., in order to secure the tether to a second portion / side 7b of the valve. In some implementations, and as illustrated in Fig. 17A, the anchor is advanced into the ventricle via a needle 149 (e.g., while housed within the needle). For example, the anchors can be advanced, from an atrial surface of the annulus, through the annulus, and into the ventricle. In some such implementations, once implanted at the valve, tether 124 extends within the atrium from a first portion / side of the valve (not shown), across the valve, to second portion / side 7b, where the tether extends through annulus 10 on the second portion / side and into the ventricle.

[0326] As shown in Fig. 17B, in some implementations, needle 149 remains implanted within the tissue, with tether 124 extending therethrough e.g., the needle can be considered part of the implant. This can prevent tether 124 from cheese-wiring through the tissue. In some such implementations, needle 149 can have a straightened configuration to assist with puncturing the tissue (Fig. 17A) and be heat-set to assume a more curved configuration once within the tissue (Fig. 14B), e.g., once released from out of a delivery sheath. Although Figs. 15-16, and 18-19 do not show needle 149, it is to be understood that a similar needle could be used for a similar purpose mutatis mutandis.

[0327] Fig. 15 illustrates one such anchor 1471, the anchor being configured to assume a preformed shape (e.g., responsively to being released from a delivery tube). Anchor 1471 can comprise a knot and / or a bulky (e.g., figure-of-eight) shape in its deployed state. For example, anchor 1471 can be delivered in a straightened configuration, and, once releasedinto ventricle 8, can assume its preformed bulky shape, to prevent withdrawal back through the annulus.

[0328] Figs. 17A-B illustrate a self-expanding anchor 1473 that is advanceable, in a constrained state, over and along tether 124, through the annulus (e.g., while housed within needle 149, Fig. 17A), and into ventricle 8, where the anchor is released such that it expands to prevent withdrawal back through the annulus (Fig. 17B). It is to be noted that although anchor 1473 is shown having a flower-shape, the anchor can have a frame that expands to define any other shape (e.g., a star, a web-like structure, etc.)

[0329] Fig. 19 illustrates an example toggle anchor 1475 which can have a sharpened distal tip (e.g., to pierce the tissue of the annulus).

[0330] Fig. 18 illustrates an implementation in which an expandable hydrogel bead 1474 is implanted within tissue of annulus 10 on second portion / side 7b of the valve, while attached to tether 124, in order to secure the tether to the second portion / side of the valve. Hydrogel bead 1474 is adapted to expand within the tissue by drawing fluid into itself from the annular tissue, e.g., such that it becomes anchored within the tissue.

[0331] Fig. 16 illustrates another such anchor 1472, in which the anchor is a pledget anchor. Anchor 1472 may be a variant, or substantially identical to any of the pledget anchors described in US 10,918,374 to Groothius. Anchor 1472 can have a single pledget 1482 that is positionable against the ventricular surface of the annulus, or may additionally have a pledget 1480 that is positionable against the atrial-facing surface of the annulus (e.g., as shown). In some implementations, pledget 1482 is advanced over and along tether 124, through annulus 10 (e.g., within a needle), and into ventricle 8. In implementations in which pledget 1480 is used, pledget 1480 can then be advanced over and along tether 124 and against the atrial-facing surface of the annulus.

[0332] Fig. 20 illustrates an implementation in which an anchor 1476 is anchored to a leaflet 16b of the valve, in order to secure tether 124 to a portion / side 7b of the valve. In some implementations, anchor 1476 can be identical, or a variant of, anchor 1472, e.g., a pledget anchor comprising at least one pledget 1486, and / or a second pledget 1487. Alternatively, anchor 1476 can be any other type of leaflet anchor, e.g., a leaflet clip, a leaflet patch etc.

[0333] Fig. 21 illustrates a flexible helical member 1478 that defines a plurality of turns 1477, the helical member being anchorable helically along the annulus 10 on second portion / side 7b of the valve. In some implementations, helical member 1478 is anchored such that part of each turn 1477 of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue. In some implementations, helical member 1478 is anchored such that it is fully submerged within the tissue. As shown, tether 124 can extend through the turns, such that anchoring the helical member along the annulus in this way secures the tether to portion / side 7b of the valve. In some implementations, helical member 1478 can be a metallic coil defining a sharpened distal tip, e.g., in order to penetrate the tissue of the annulus.

[0334] Fig. 22 illustrates an implementation in which a stent 1479 is secured within a coronary blood vessel 19 (e.g., the coronary sinus) of the heart, on second portion / side 7b. In some implementations, tether 124 can extend through the stent, or be otherwise attached to the stent, such that the tether extends through the wall of the blood vessel and into the heart, where the tether spans across the valve to first portion / side 7a (not shown) where the tether is secured to the annulus. In some such implementations, and as shown, at least two lengths of tether 124 span the valve.

[0335] Reference is again made to Figs. 15-22. Any of the second-side anchors described with reference to these figures may be replaced with, or modified to include features of, any of the "patch anchors" described in the following publications, each of which is incorporated herein by reference:International Patent Application PCT / IB2021 / 060436 to Tennenbaum et al., filed November 11, 2021, which published as WO 2022 / 101817; andInternational Patent Application PCT / IB2023 / 054824 to Pesach et al., filed May 10, 2023, which published as WO 2023 / 218368;

[0336] Reference is now made to Figs. 23-25, which illustrate various systems, methods, and techniques of bridging a valve of a heart using at least one laser-cut hypotube.

[0337] Fig. 23 illustrates an example implant 150 comprising a hypotube 152, a first anchor 154, connected to a first end of the hypotube, and a second anchor 156, connected to a second end of the hypotube. In some implementations, implant 150 is implantable at the valve by anchoring anchor 154 into tissue (e.g., of the annulus) at a first portion / side of the valve 7a,and anchoring anchor 156 into tissue (e.g., of the annulus) at the second portion / side of the valve 7b, such that hypotube 152 bridges the valve.

[0338] Hypotube 152 may advantageously draw the two portions / sides of the valve together (e.g., thereby reducing valve regurgitation) without applying significant pull-out force on the anchors. For example, the orientation and / or rigid coupling of anchors 154, 156 via hypotube 152 may advantageously prevent the hypotube from wrenching and / or pivoting the anchors out of the tissue, e.g., as compared to an anchor arrangement in which the anchors are flexibly coupled thereto (e.g., via a tether).

[0339] In some implementations, and as shown, the radius of curvature of hypotube 152 is biased to become smaller, such that the forces applied to the anchors by the hypotube is a translating force that biases the anchors towards each other, rather than wrenching the anchors out of the tissue.

[0340] In some implementations, hypotube 152 is a laser-cut hypotube. In some implementations, hypotube 152 defines an arc once implanted at the valve, e.g. the hypotube arcs across the atrium 6 upstream of the valve. In some implementations, hypotube 152 is heat set to define a saddle-shape (e.g., as illustrated in Fig. 24).

[0341] In some implementations, and as shown in Fig. 24, each anchor has a head 153, and a helical tissue-engagement element 158 that extends away from the head and is screwable into the tissue. In some such implementations, hypotube 152 can define an opening 1523 (e.g., a port) at one or both ends, to allow for a driver 116a to advance the anchor through the hypotube and into the tissue (e.g., at a distal end of the hypotube). In such implementations, applying torque to the head of the anchor, via the driver, can advantageously be done independently of hypotube 152, e.g., without rotating the hypotube and / or the other, already-anchored, anchor.

[0342] In some implementations, at least one of anchors 154 and / or 156 are pledget anchors. In some such implementations, the pledget anchor can be implanted into ventricle 8 downstream of the valve, e.g., the anchor(s) can be a variant of anchor 1472.

[0343] In some implementations, a tether (not shown) extends alongside, or within, hypotube 152, e.g., the tether connects the anchors to each other, in addition to the hypotube. The tether could be contracted such that the tether compresses and / or assists in the curving of the hypotube in order to form the arc, e.g., by pressing against an inner circumference of an inner wall of the hypotube.

[0344] Fig. 24 illustrates an implant arrangement 1500 comprising a pair of implants 150a, that, when the implant arrangement is implanted, each span across valve 7. In some implementations, each of implants 150a are a variant of, or substantially identical to, implant 150, e.g., each implant 150a comprising a hypotube 152a (e.g., hypotube 152, or a variant thereof), and a pair of anchors at either end to secure the hypotube to different portions (e.g., different sides, opposite sides, etc.) of the valve. Although hypotubes 152a are illustrated as being saddle-shaped, it is to be understood that hypotubes assuming any other shape could be used.

[0345] In some implementations, and as shown in Fig. 25, implant arrangement 1500, or a variant thereof, can collectively define a valve support for receiving a prosthetic valve 159. For example, prosthetic valve 159 can be wedged, and / or docked, between the two hypotubes 152, such that the prosthetic valve is secured in place. It is to be noted that although, for the sake of clarity, valve 159 is shown as an empty frame, it is to be understood that the prosthetic valve can include prosthetic leaflets and / or a lining.

[0346] The present disclosure includes different variants of some elements. Variants of a given element typically have 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 may 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 may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (i.e. any other variant of the element) having the same reference numeral, independent of any suffix.

[0347] 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.

[0348] 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.

[0349] 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.). Furthermore, the scope of the present disclosure includes, for some applications, sterilizing one or more of any of the various systems, devices, apparatuses, etc. in this disclosure.

[0350] 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.

[0351] 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 anchors, eyelets, or cords / connections / connectors, can be used with any appropriate implantation technique or arrangement described herein. Likewise, the different constructions and features of devices and systems can be mixed and matched, such as by combining any of the anchor heads, cords / connections / connectors, eyelets, or tissue-engaging elements with each other, even if not explicitly disclosed. In short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0352] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that thismanner 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.

[0353] Example Implementations (some non-limiting examples of the concepts herein are recited below):

[0354] Example 1. A system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.), the system comprising an implant that comprises: (i) multiple anchors, each anchor comprising: (a) a head; (b) a tissue-engaging element; and / or (c) an eyelet, coupled to the head by a cord or other connection extending from the head to the eyelet; and / or (ii) a tether, threaded through the eyelet of each anchor such that the anchors are arranged in series along the tether.

[0355] Example 2. The system according to example 1, wherein, for each anchor, the tissue-engaging element of the anchor is a helical tissue-engaging element adapted to be screwed into tissue of the valve of the heart.

[0356] Example 3. The system according to any one of examples 1-2, wherein, for each anchor, the tissue-engaging element of the anchor is a longitudinal tissue-engaging element adapted to be longitudinally driven into tissue of the valve of the heart.

[0357] Example 4. The system according to any one of examples 1-3, wherein, for each anchor, the cord or other connection of the anchor has a length of at least 4 mm.

[0358] Example 5. The system according to any one of examples 1-4, wherein, for each anchor, the cord or other connection of the anchor is longer than the tissue-engaging element of the anchor.

[0359] Example 6. The system according to any one of examples 1-5, wherein the system further comprises an adjustment tool, adapted to tension the tether such that the eyelets meet to form a node.

[0360] Example 7. The system according to any one of examples 1-6, wherein, for each anchor, the cord or other connection of the anchor is flexible.

[0361] Example 8. The system according to any one of examples 1-7, wherein, for each anchor, the cord or other connection of the anchor is at least one of a string, thread, or suture.

[0362] Example 9. The system according to any one of examples 1-8, wherein, for each anchor, the cord or other connection of the anchor is a wire.

[0363] Example 10. The system according to any one of examples 1-9, wherein, for each anchor, the eyelet of the anchor is a rigid ring.

[0364] Example 11. The system according to any one of examples 1-10, wherein, for each anchor, the eyelet of the anchor is a grommet.

[0365] Example 12. The system according to any one of examples 1-11, wherein, for each anchor, the eyelet of the anchor is metallic.

[0366] Example 13. The system according to any one of examples 1-12, wherein, for each anchor, the eyelet of the anchor is polymeric.

[0367] Example 14. The system according to any one of examples 1-13, wherein, for each anchor, the eyelet of the anchor is made from a textile.

[0368] Example 15. The system according to any one of examples 1-14, wherein, for each anchor, the cord / connection of the anchor is formed into a loop that defines the eyelet of the anchor.

[0369] Example 16. The system according to example 15, wherein, for each anchor, the cord / connection is secured in the loop by an end portion of the cord / connection burrowing through a stretch of the cord / connection, such that the stretch squeezes on the end portion therewithin.

[0370] Example 17. The system according to example 15, wherein the cord / connection is secured in the loop via a knot.

[0371] Example 18. The system according to example 15, wherein the cord / connection is secured in the loop via a lock.

[0372] Example 19. The system according to example 15, wherein the cord / connection is coupled to the head by looping around the head to define a collar, and the loop loops through the collar to extend away from the collar to define the eyelet.

[0373] Example 20. The system according to any one of examples 1-19, wherein the system further comprises a delivery tool adapted to, for each anchor, anchor the anchoradjacent the valve by driving the tissue-engaging element into tissue while the delivery tool is engaged with the head.

[0374] Example 21. The system according to example 20, wherein the delivery tool is adapted to anchor the anchors in an arc around a first portion of the valve.

[0375] Example 22. The system according to example 20, wherein: (i) the delivery tool comprises a driver that comprises: (a) a flexible shaft, and / or (b) a drive head at a distal end of the shaft that is adapted to, for each anchor, reversibly engage the head, and / or (ii) the driver is adapted to anchor each of the anchors adjacent the valve by, for each anchor, applying an anchoring force to the anchor to drive the tissue-engaging element into the tissue.

[0376] Example 23. The system according to example 22, wherein the delivery tool comprises a tube, each anchor being transluminally advanceable towards the heart by being advanced, while engaged with the driver, through the tube and towards the heart.

[0377] Example 24. The system according to example 20, wherein the delivery tool is further configured to, while the anchors remain anchored adjacent the valve, tension the tether such that the eyelets converge to form a node.

[0378] Example 25. The system according to example 24, wherein the system further comprises a covering, and wherein the delivery tool is further adapted to transluminally advance the covering over and along the tensioned tether to the node such that the covering encases the node.

[0379] Example 26. The system according to example 24, wherein the delivery tool is configured to tension the tether such that, for each anchor, the tether pulls the cord / connection away from its respective anchor in a manner that causes the corresponding eyelet to become spaced away from the anchor.

[0380] Example 27. The system according to example 24, wherein the delivery tool is configured to tension the tether such that: (i) for each anchor of a first subset of the anchors, the cord / connection becomes taut, and / or (ii)for each anchor of a second subset of the anchors, the cord / connection does not become taut.

[0381] Example 28. The system according to example 27, wherein the first subset of anchors comprises two anchors, and wherein the second subset of anchors comprises a single anchor.

[0382] Example 29. The system according to example 20, wherein: (i) the anchors are a set of 2-8 anchors, and / or (ii) the delivery tool is adapted to anchor each of the anchors of the set adjacent the valve.

[0383] Example 30. The system according to example 29, wherein the set of anchors are a set of 2 anchors.

[0384] Example 31. The system according to example 29, wherein the set of anchors are a set of 3 anchors.

[0385] Example 32. The system according to example 20, wherein: (i) the anchors are a set of anchors, (ii) the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on a first portion of the valve such that the tether becomes secured to the first portion, and / or (iii) the delivery tool is further adapted to secure the tether to a second portion of the heart, such that: (a) the tether spans between the first portion and the second portion, and / or (b) tensioning the tether towards a tensioned state draws the first portion and the second portion of the valve toward each other.

[0386] Example 33. The system according to example 32, wherein: (i) the implant further comprises a second- side anchor, and / or (ii) the delivery tool is configured to secure the tether to the second portion by anchoring the second-side anchor into a wall of an annulus of the valve at the second portion.

[0387] Example 34. The system according to example 32, wherein the implant further comprises a leaflet anchor, and wherein the delivery tool is configured to secure the tether to the second portion by anchoring the leaflet anchor into a leaflet of the valve.

[0388] Example 35. The system according to example 32, wherein: (i) the implant further comprises a flexible helical member that defines a plurality of turns, the tether extending through the turns, and / or (ii) the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion of the valve, such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0389] Example 36. The system according to example 32, wherein: (i) the implant further comprises a flexible helical member that defines a plurality of turns, the tether extending through the turns, and / or (ii) the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion of the valve, such that the helical member becomes fully submerged within the tissue.

[0390] Example 37. The system according to example 32, wherein: (i) the implant further comprises a stent through which the tether is threaded, and / or (ii) the delivery tool is configured to secure the tether to the second portion by implanting the stent in a coronary blood vessel of the heart adjacent the second portion.

[0391] Example 38. The system according to example 32, wherein: (i) the tether is a first tether, (ii) the implant further comprises a second tether, and / or (iii) the delivery tool is adapted to secure the second tether to both the first portion of the valve and the second portion of the valve such that: (a) the second tether spans across the valve, independently of the first tether, and / or (b) tensioning the second tether draws the first portion and the second portion of the valve toward each other.

[0392] Example 39. The system according to example 32, wherein the delivery tool is configured to secure the tether to the second portion using a single anchor.

[0393] Example 40. The system according to example 32, wherein the delivery tool is configured to secure the tether to the second portion using an anchor of the set.

[0394] Example 41. The system according to example 32, wherein: (i) the implant further comprises a second-side anchor that comprises a head, a tissue-engaging element, and an eyelet, directly attached to the head, the tether being threaded through the eyelet, and / or (ii) the delivery tool is configured to secure the tether to the second portion by anchoring the second-side anchor, via engagement with the head of the second-side anchor, to tissue of the second portion of the heart.

[0395] Example 42. The system according to example 32, wherein the implant further comprises a pledget anchor, and wherein the delivery tool is configured to secure the tether to the second portion using the pledget anchor.

[0396] Example 43. The system according to example 32, wherein the implant further comprises a self-expanding anchor, and wherein the delivery tool is configured to secure the tether to the second portion using the self-expanding anchor.

[0397] Example 44. The system according to example 32, wherein the implant further comprises a lock, transluminally advanceable over and along the tether to maintain the tether in the tensioned state.

[0398] Example 45. The system according to example 44, wherein: (i) the lock further comprises a shock-absorber, and / or (ii) the tether is insertable into the lock via the shock- absorber.

[0399] Example 46. The system according to example 44, wherein the delivery tool further comprises a tool adapted to cut excess tether proximal to the lock.

[0400] Example 47. The system according to example 32, wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets converge to form a node that is disposed between the first portion and the second portion.

[0401] Example 48. The system according to example 47, wherein the valve defines an orifice therethrough, and wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the valve orifice.

[0402] Example 49. The system according to example 47, wherein the valve defines a plurality of leaflets, and wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over a leaflet of the plurality.

[0403] Example 50. The system according to example 47, wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the first portion.

[0404] Example 51. The system according to example 47, wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the second portion.

[0405] Example 52. The system according to example 32, wherein the implant further comprises a toggle anchor, and wherein the delivery tool is configured to secure the tether to the second portion using the toggle anchor.

[0406] Example 53. The system according to example 52, wherein the toggle anchor comprises a self-expanding frame.

[0407] Example 54. The system according to example 32, wherein the implant further comprises an expandable hydrogel bead, and wherein the delivery tool is configured to secure the tether to the second portion via the expandable hydrogel bead.

[0408] Example 55. The system according to example 54, wherein the delivery tool is configured to implant the hydrogel bead into annular tissue on the second portion of the heart such that the hydrogel bead expands by drawing liquid into itself from the annular tissue.

[0409] Example 56. The system according to example 32, wherein: (i) the implant further comprises a second-side anchor, (ii) the valve has an annulus circumscribing the valve, (iii) the heart has a ventricle downstream of the valve, and / or (iv) the delivery tool is configured to secure the tether to the second portion by, at the second portion, driving the second-side anchor through the annulus and into the ventricle while the second-side anchor is attached to the tether.

[0410] Example 57. The system according to example 56, wherein the second-side anchor has a bulky shape.

[0411] Example 58. The system according to example 32, wherein: (i) the set of anchors is a first set of anchors, (ii) the implant further comprises a second set of anchors, each comprising: (a) a head, (b) a tissue-engaging element, (c) a cord, coupled to the head, and / or (d) an eyelet, coupled to the head by the cord / connection extending from the head to the eyelet, (iii) the tether is threaded through the eyelet of each anchor of the second set such that the anchors of the second set are arranged in series along the tether, and / or (iv) the delivery tool is adapted to secure the tether to the second portion of the valve by, for each anchor of the second set, via engagement with the head, anchoring each of the anchors of the second set adjacent to the second portion of the valve by, for each anchor, driving the tissue-engaging element into tissue.

[0412] Example 59. The system according to example 58, wherein each of the first set of anchors and the second set of anchors comprise two anchors.

[0413] Example 60. The system according to example 58, wherein the valve is a tricuspid valve of the heart.

[0414] Example 61. The system according to example 58, wherein the valve is a mitral valve of the heart.

[0415] Example 62. The system according to example 58, wherein the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion, such that the eyelets of the anchors of the first set converge to form a first node, and the eyelets of the anchors of the second set converge to form a second node.

[0416] Example 63. The system according to example 58, wherein: (i) the implant further comprises a third set of anchors, each comprising: (a) a head, (b) a tissue-engaging element, (c) a cord, coupled to the head, and / or (d) an eyelet, coupled to the head by the cord / connection extending from the head to the eyelet, (ii) the tether is threaded through the eyelet of each anchor of the third set such that the anchors of the third set are arranged in series along the tether, (iii) the delivery tool is adapted to secure the tether to the first portion of the valve by: (a) anchoring the anchors of the first set to a first anchoring site at the first portion of the valve, and / or (b) subsequently to anchoring the first set of anchors to the first anchoring site, and the second set of anchors to the second portion of the valve, anchoring the anchors of the third set to the first portion at a second anchoring site at the first portion by, for each anchor of the third set, via engagement with the head, anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue, and / or (iv) the tether is tensionable, while the anchors of each of the first, second and third sets remain anchored, such that the eyelets of the anchors of the first set converge to form a first node, the eyelets of the anchors of the second set converge to form a second node, and the eyelets of the anchors of the third set converge to form a third node.

[0417] Example 64. The system according to example 63, wherein: (i) the implant further comprises a fourth set of anchors, each comprising: (a) a head, (b) a tissue-engaging element, (c) a cord, coupled to the head, and / or (d) an eyelet, coupled to the head by the cord / connection extending from the head to the eyelet, (ii) the tether is threaded through the eyelet of each anchor of the fourth set such that the anchors of the fourth set are arranged in series along the tether, (iii) the delivery tool is adapted to secure the tether to the second portion of the valve by: (A) subsequently to anchoring the anchors of the first set to the first anchoring site at the first portion of the valve, anchoring the anchors of the second set to the second portion at a third anchoring site at the second portion, (B) subsequently anchoring the anchors of the fourth set to a fourth anchoring site at the second portion of the valve, by, for each anchor of the fourth set, via engagement with the head, anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue, suchthat the tether spans between the third anchoring site and the fourth anchoring site on the second portion of the valve, and / or (C) the tether is tensionable, while the anchors of each of the first, second third, and fourth sets remain anchored, such that the eyelets of the anchors of the first set converge to form the first node, the eyelets of the anchors of the second set converge to form the second node, the eyelets of the anchors of the third set converge to form the third node, and the anchors of the fourth set converge to form a fourth node.

[0418] Example 65. The system according to example 64, wherein the implant further comprises a spacer, threaded along the tether between the second node and the fourth node.

[0419] Example 66. The system according to example 58, wherein the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion, such that the eyelets of the anchors of the first set and the eyelets of the anchors of the second set all converge to form a single node.

[0420] Example 67. The system according to any one of examples 1-66, wherein: (i) the valve is a tricuspid valve of the heart, having: (a) a first leaflet adjacent a first portion of the valve, a second leaflet adjacent a second portion of the valve, and a third leaflet adjacent a third portion of the valve, and / or (b) an annulus that circumscribes the valve; and / or (ii) the system further comprises a delivery tool adapted to: (A) anchor a first anchor of the anchors into tissue of the annulus at the first portion, (B) anchor a second anchor of the anchors into tissue of the annulus at the second portion, and / or (C) anchor a third anchor of the anchors into tissue of the annulus at the third portion, such that tensioning the tether draws the first portion, the second portion, and the third portion toward each other.

[0421] Example 68. The system according to example 67, wherein tensioning the tether causes the eyelets to converge to form a node that is disposed medially between the first portion, the second portion, and the third portion.

[0422] Example 69. The system according to any one of examples 1-68, wherein the implant is sterile.

[0423] Example 70. A method for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.), the method comprising: (a) for each anchor of a set of anchors, sequentially: (i) transluminally advancing the anchor towards the heart, an eyelet of the anchor being coupled to a head of the anchor via a cord or other connection, and / or (ii) anchoring the anchor to tissue adjacent the valve; and / or (b) subsequently, drawing togetherthe eyelets of the anchors of the set to form a node by tensioning a tether that extends through the eyelets.

[0424] Example 71. The method according to example 70, wherein, one or more anchors of the set define at least one of a helical tissue -engaging element or longitudinal tissueengaging element, and wherein anchoring each anchor of the set to the tissue comprises driving the helical tissue-engaging element or the longitudinal tissue-engaging element into the tissue.

[0425] Example 72. The method according to any one of examples 70-71, wherein the eyelet of each anchor is flexibly coupled to the head of the anchor via the cord or other connection and can extend away from the head to the eyelet.

[0426] Example 73. The method according to any one of examples 70-72, drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set to form the node such that: (i) for each anchor of a first subset of the anchors, the cord or other connection becomes taut, and / or (ii) for each anchor of a second subset of the anchors, the cord or other connection does not become taut.

[0427] Example 74. The method according to any one of examples 70-73, wherein anchoring the anchors of the set to the tissue comprises anchoring the anchors such that the anchors collectively form an arc around a first portion of the valve.

[0428] Example 75. The method according to any one of examples 70-74, wherein the method further comprises, subsequently to forming the node, advancing a covering over and along the tether to the node such that the covering encases the node.

[0429] Example 76. The method according to any one of examples 70-75, wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set to form the node such that, for each anchor, the tether pulls the cord or other connection away from its respective anchor in a manner that causes the corresponding eyelet to become spaced away from the anchor.

[0430] Example 77. The method according to any one of examples 70-76, wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set such that the node is formed between a first portion of the valve and a second portion of the valve.

[0431] Example 78. The method according to any one of examples 70-77, wherein the valve defines an orifice therethrough, and wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set such that the node is formed over the valve orifice.

[0432] Example 79. The method according to any one of examples 70-78, wherein the valve defines a plurality of leaflets, and wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set such that the node is formed over a leaflet of the plurality.

[0433] Example 80. The method according to any one of examples 70-79, wherein anchoring the anchor to tissue adjacent the valve comprises anchoring the anchor to tissue adjacent a first portion of the valve, and wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set such that the node is formed over the first portion.

[0434] Example 81. The method according to any one of examples 70-80, wherein anchoring the anchor to tissue adjacent the valve comprises anchoring the anchor to tissue adjacent a first portion of the valve, and wherein drawing together the eyelets of the anchors of the set to form the node comprises drawing together the eyelets of the anchors of the set such that the node is formed over a second, opposite portion of the valve.

[0435] Example 82. The method according to any one of examples 70-81, wherein: (i) the node is a first node; (ii) anchoring the anchors of the set to the tissue comprises anchoring a first subset of the anchors of the set to the tissue in a first cluster of anchors, and anchoring a second subset of anchors of the anchors of the set to the tissue in a second cluster of anchors, such that the tether spans from the first cluster to the second cluster; and / or (iii) tensioning the tether comprises tensioning the tether in a manner that: (a) draws together the eyelets of the anchors of the first cluster to form the first node; (b) draws together the eyelets of the anchors of the second cluster to form a second node; and / or (c) draws the first cluster and the second cluster toward each other.

[0436] Example 83. The method according to example 82, wherein anchoring the first subset of anchors to the tissue comprises anchoring the first subset of anchors to the tissue at a first portion of the valve, and wherein anchoring the second subset of anchors to the tissue comprises anchoring the second subset of anchors to a second portion of the valve,such that tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0437] Example 84. The method according to example 82, wherein anchoring the first subset of anchors to the tissue comprises anchoring the first subset of anchors to tissue of a fibrous trigone of the heart.

[0438] Example 85. The method according to example 84, wherein the valve is a mitral valve of the heart, and wherein anchoring the second subset of anchors to the tissue comprises anchoring the second subset of anchors to tissue of an annulus of the mitral valve that is disposed behind a root of a posterior leaflet of the valve.

[0439] Example 86. The method according to example 82, wherein: (i) the valve is a tricuspid valve of the heart, (ii) the tissue is tissue of an annulus of the tricuspid valve, (iii) anchoring the first subset of anchors to the tissue comprises anchoring the first subset of anchors to the annulus behind a root of a septal leaflet of the tricuspid valve, and / or (iv) anchoring the second subset of anchors to the tissue comprises anchoring the second subset of anchors to the annulus behind a root of an inferior leaflet of the tricuspid valve.

[0440] Example 87. The method according to example 82, wherein: (i) the valve is a tricuspid valve of the heart, (ii) the tissue is tissue of an annulus of the tricuspid valve, (iii) anchoring the first subset of anchors to the tissue comprises anchoring the first subset of anchors to the annulus behind a root of an inferior leaflet of the tricuspid valve, and / or (iv) anchoring the second subset of anchors to the tissue comprises anchoring the second subset of anchors to the annulus behind a root of a superior leaflet of the tricuspid valve.

[0441] Example 88. The method according to example 82, wherein: (i) anchoring the anchors of the set to the tissue further comprises anchoring a third subset of the anchors of the set to the tissue in a third cluster of anchors, such that the tether spans from the second cluster to the third cluster, and / or (ii) tensioning the tether comprises tensioning the tether in a manner that draws together the eyelets of the anchors of the third cluster to form a third node.

[0442] Example 89. The method according to example 88, wherein anchoring the first subset and the third subset of anchors to the tissue comprises anchoring the first subset and the third subset of anchors to the tissue at a first portion of the valve, and wherein anchoring the second subset of anchors to the tissue comprises anchoring the second subset of anchors to a second portion of the valve, such that: (a) the tether spans, from the first cluster at thefirst portion, across the valve to the second cluster at the second portion, and, from the second cluster at the second portion, back across the valve to the third cluster at the first portion, and / or (b) tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0443] Example 90. The method according to example 88, wherein: (i) anchoring the anchors of the set to the tissue further comprises anchoring a fourth subset of the anchors of the set to the tissue in a fourth cluster of anchors, such that the tether spans from the third cluster to the fourth cluster, and / or (ii) anchoring the first subset and the fourth subset of anchors to the tissue comprises anchoring the first subset and the fourth subset of anchors to the tissue at a first portion of the valve, and anchoring the second subset and the third subset of anchors to the tissue comprises anchoring the second subset and the third subset of anchors to a second portion of the valve, such that: (a) the tether spans, from the first cluster at the first portion, across the valve to the second cluster at the second portion, along the second portion of the valve to the third cluster, and, from the third cluster at the second portion, back across the valve to the fourth cluster at the first portion, and / or (b) tensioning the tether draws the first portion of the valve towards the second portion of the valve.

[0444] Example 91. The method according to example 90, wherein the method further comprises, subsequently to anchoring the second subset of anchors at the second portion, and prior to anchoring the third subset of anchors at the second portion, transluminally advancing at least one spacer over and along the tether such that, once the third subset is anchored to the tissue, the spacer maintains a spacing between the second cluster and the third cluster.

[0445] Example 92. The method according to any one of examples 70-91, wherein: (i) anchoring the anchors of the set to the tissue comprises anchoring the anchors along a first portion of the valve such that the tether becomes secured to the first portion, and / or (ii) the method further comprises: (a) securing the tether to a second, opposite portion of the heart, such that the tether spans across the valve, and / or (b) tensioning the tether towards a tensioned state to draw the first portion and the second portion of the valve toward each other.

[0446] Example 93. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart prior to securing the tether to the first portion of the heart.

[0447] Example 94. The method according to example 92, wherein the method further comprises transluminally advancing a lock over and along the tether to the node to lock the tether in the tensioned state.

[0448] Example 95. The method according to example 94, further comprising cutting excess tether proximally to the lock.

[0449] Example 96. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart using a single anchor.

[0450] Example 97. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart using an anchor that is identical to the anchors of the set.

[0451] Example 98. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart by anchoring a second-portion anchor that comprises a head, and an eyelet, directly attached to the head, to tissue of the second portion of the heart while the tether is threaded through the eyelet of the second-portion anchor.

[0452] Example 99. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart using a pledget anchor.

[0453] Example 100. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart using a self-expanding anchor.

[0454] Example 101. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart using a toggle anchor.

[0455] Example 102. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart by implanting an expandable hydrogel bead in tissue of the heart such that the bead expands by drawing liquid into itself from the tissue.

[0456] Example 103. The method according to example 92, wherein securing the tether to the second portion of the heart comprises anchoring a second- side anchor into a wall of an annulus of the valve on the second portion.

[0457] Example 104. The method according to example 92, wherein securing the tether to the second portion of the heart comprises securing the tether to the second portion of the heart by anchoring a leaflet anchor to a leaflet of the valve.

[0458] Example 105. The method according to example 92, wherein securing the tether to the second portion of the heart comprises anchoring a helical member that defines a plurality of turns helically along the second portion of the valve while the tether extends along the turns, such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

[0459] Example 106. The method according to example 92, wherein securing the tether to the second portion of the heart comprises implanting a stent in a coronary blood vessel of the heart adjacent the second portion while the tether is coupled to the stent.

[0460] Example 107. The method according to example 92, wherein: (a) the tether is a first tether, and / or (b) the method further comprises: (i) securing a second tether to both the first portion of the valve and the second portion of the valve such that the second tether spans across the valve, independently of the first tether, and / or (ii) tensioning the second tether to draw the first portion and the second portion of the valve toward each other.

[0461] Example 108. The method according to example 92, wherein: (i) the valve has an annulus circumscribing the valve, (ii) the heart has a ventricle downstream of the valve, and / or (iii) securing the tether to the second portion of the heart comprises driving a second- side anchor through the annulus and into the ventricle while the second-side anchor is attached to the tether.

[0462] Example 109. The method according to example 108, wherein the anchor is preformed to assume a bulky shape, and wherein driving the second-side anchor into the ventricle comprises advancing the anchor into the ventricle while the anchor is coupled to the tether, after the anchor has assumed the bulky shape.

[0463] Example 110. The method according to example 92, wherein: (i) the set of anchors is a first set of anchors, (ii) securing the tether to the second portion of the heart comprises, for each anchor of a second set of anchors, sequentially: (a) transluminally advancing the anchor towards the heart, an eyelet of the anchor being coupled to a head of the anchor viaa cord or other connection that that extends away from the head to the eyelet, the tether being threaded through the eyelet, and / or (b) anchoring the anchor to tissue adjacent the second portion of the valve.

[0464] Example 111. The method according to example 110, wherein: (i) the node is a first node, (ii) drawing together the eyelets of the anchors to form the node by tensioning the tether comprises drawing together the eyelets of the anchors to form the first node by tensioning the tether prior to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set converge to form the first node, and / or (iii) the method further comprises, subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, tensioning the tether to draw the eyelets of the anchors of the second set together to converge to form a second node.

[0465] Example 112. The method according to example 110, wherein: (i) the node is a first node, and / or (ii) drawing together the eyelets of the anchors to form the node by tensioning the tether comprises drawing together the eyelets of the anchors to form the first node by tensioning the tether subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set converge to form the first node, and the eyelets of the anchors of the second set converge to form a second node.

[0466] Example 113. The method according to example 110, wherein drawing together the eyelets of the anchors to form the node by tensioning the tether comprises drawing together the eyelets of the anchors to form the node by tensioning the tether subsequently to anchoring the anchors of the second set to tissue adjacent the second portion of the valve, such that the eyelets of the anchors of the first set and the eyelets of the anchors of the second set converge to form the node.

[0467] Example 114. The method according to any one of examples 70-113, wherein: (i) the valve is a tricuspid valve of the heart, having: (a) a first leaflet adjacent a first portion of the valve, a second leaflet adjacent a second portion of the valve, and a third leaflet adjacent a third portion of the valve, and / or (b) an annulus that circumscribes the valve; (ii) anchoring the anchors of the set adjacent tissue of the valve comprises: (A) anchoring a first anchor of the set into tissue of the annulus at the first portion, (B) anchoring a second anchor of the set into tissue of the annulus at the second portion, and / or (C) anchoring a third anchor of the set into tissue of the annulus at the third portion; and / or (iii) drawing together the eyeletsof the anchors to form the node by tensioning the tether comprises tensioning the tether such that the first portion, the second portion, and the third portion are drawn toward each other.

[0468] Example 115. The method according to example 114, wherein drawing together the eyelets of the anchors to form the node by tensioning the tether comprises drawing together the eyelets of the anchors such that the node is disposed medially between the first portion, the second portion, and the third portion.

[0469] Example 116. The method according to any one of examples 70-115, further comprising, for each anchor of the set, sterilizing the anchor.

[0470] Example 117. A system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.), the system comprising an implant that comprises: (i) multiple anchors, each anchor comprising: (a) a head; (b) a tissue-engaging element; and / or (c) an eyelet, coupled to the head; and / or (ii) a tether, threaded through the eyelet of each anchor such that: (A) the anchors are arranged in series along the tether, and / or (B) responsively to application of tension to the tether, the eyelets slide along the tether to form a node at which the eyelets meet.

[0471] Example 118. A system for use with a valve of a heart of a subject (e.g., a living subject, a simulation, etc.), the system comprising an implant that comprises: (i) a hypotube, (ii) a first anchor, connected to a first end of the hypotube, and anchorable into tissue at a first portion of the valve, and / or (iii) a second anchor, connected to a second end of the hypotube, and anchorable into tissue at a second portion of the valve such that the hypotube bridges the valve.

[0472] Example 119. The system according to example 118, wherein the hypotube is a laser-cut hypotube.

[0473] Example 120. The system according to any one of examples 118-119, wherein the implant is sterile.

[0474] Example 121. The system according to any one of examples 118-120, wherein at least one anchor selected from the group of the first anchor and the second anchor is a pledget anchor.

[0475] Example 122. The system according to any one of examples 118-121, wherein at least one anchor selected from the group of the first anchor and the second anchor is a helical anchor adapted to be screwed into tissue of the heart.

[0476] Example 123. The system according to any one of examples 118-122, wherein the implant further comprises a tether that connects the first anchor to the second anchor.

[0477] Example 124. The system according to any one of examples 118-123, wherein the hypotube is heat-set to define a saddle-shape.

[0478] Example 125. The system according to any one of examples 118-124, wherein the hypotube is a first hypotube, and wherein the implant further comprises: (i) a second hypotube, (ii) a third anchor, connected to a first end of the second hypotube, and anchorable into tissue at the first portion of the valve, and / or (iv) a fourth anchor, connected to a second end of the second hypotube, and anchorable into tissue at the second portion of the valve such that the second hypotube bridges the valve.

[0479] Example 126. The system according to example 125, wherein the first and second hypotubes collectively define a valve support for receiving a prosthetic valve.

[0480] Example 127. The system according to example 126, wherein the implant further comprises the prosthetic valve.

[0481] 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 subcombinations 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.

Claims

CLAIMS1. A system for use with a valve of a heart of a subject, the system comprising: an implant that comprises: multiple anchors, each anchor comprising: a head; a tissue-engaging element; and an eyelet, coupled to the head by a cord extending from the head to the eyelet, the cord of the anchor being longer than the tissue-engaging element; and a tether, threaded through the eyelet of each anchor such that the anchors are arranged in series along the tether, and a delivery tool, adapted to: for each anchor, anchor the anchor adjacent the valve by driving the tissueengaging element into tissue of the heart while the delivery tool is engaged with the head, and while the anchors remain anchored adjacent the valve, tension the tether such that the eyelets meet to form a node.

2. The system according to claim 1, wherein, for each anchor, the tissue-engaging element of the anchor is a helical tissue-engaging element adapted to be screwed into tissue of the valve of the heart.

3. The system according to any one of claims 1-2, wherein, for each anchor, the tissueengaging element of the anchor is a longitudinal tissue-engaging element adapted to be longitudinally driven into tissue of the valve of the heart.

4. The system according to any one of claims 1-3, wherein, for each anchor, the cord of the anchor has a length of at least 4 mm.

5. The system according to any one of claims 1-4, the delivery tool further comprises an adjustment tool, adapted to tension the tether such that the eyelets meet to form the node.

6. The system according to any one of claims 1-5, wherein, for each anchor, the cord of the anchor is flexible.

7. The system according to any one of claims 1-6, wherein, for each anchor, the cord of the anchor is at least one of a string, thread, or suture.

8. The system according to any one of claims 1-7, wherein, for each anchor, the cord of the anchor is a wire.

9. The system according to any one of claims 1-8, wherein, for each anchor, the eyelet of the anchor is a rigid ring.

10. The system according to any one of claims 1-9, wherein, for each anchor, the eyelet of the anchor is a grommet.

11. The system according to any one of claims 1-10, wherein, for each anchor, the eyelet of the anchor is made from a textile.

12. The system according to any one of claims 1-11, wherein, for each anchor, the cord of the anchor is formed into a loop that defines the eyelet of the anchor.

13. The system according to claim 12, wherein, for each anchor, the cord is secured in the loop by an end portion of the cord burrowing through a stretch of the cord, such that the stretch squeezes on the end portion therewithin.

14. The system according to claim 12, wherein the cord is secured in the loop via a knot.

15. The system according to claim 12, wherein the cord is secured in the loop via a lock.

16. The system according to claim 12, wherein the cord is coupled to the head by looping around the head to define a collar, and the loop loops through the collar to extend away from the collar to define the eyelet.

17. The system according to any one of claims 1-16, wherein the delivery tool is adapted to anchor the anchors in an arc around a first portion of the valve.

18. The system according to any one of claims 1-17, wherein: the delivery tool comprises a driver that comprises: a flexible shaft, and a drive head at a distal end of the shaft that is adapted to, for each anchor, reversibly engage the head, and the driver is adapted to anchor each of the anchors adjacent the valve by, for each anchor, applying an anchoring force to the anchor to drive the tissue-engaging element into the tissue.

19. The system according to claim 18, wherein the delivery tool comprises a tube, each anchor being transluminally advanceable towards the heart by being advanced, while engaged with the driver, through the tube and towards the heart.

20. The system according to any one of claims 1-19, wherein the system further comprises a covering, and wherein the delivery tool is further adapted to transluminally advance the covering over and along the tensioned tether to the node such that the covering encases the node.

21. The system according to any one of claims 1-20, wherein the delivery tool is configured to tension the tether such that, for each anchor, the tether pulls the cord away from its respective anchor in a manner that causes the corresponding eyelet to become spaced away from the anchor.

22. The system according to any one of claims 1-21, wherein the delivery tool is configured to tension the tether such that: for each anchor of a first subset of the anchors, the cord becomes taut, and for each anchor of a second subset of the anchors, the cord does not become taut.

23. The system according to claim 22, wherein the first subset of anchors comprises two anchors, and wherein the second subset of anchors comprises a single anchor.

24. The system according to any one of claims 1-23, wherein: the anchors are a set of 2-8 anchors, and the delivery tool is adapted to anchor each of the anchors of the set adjacent the valve.

25. The system according to claim 24, wherein the set of anchors are a set of 2 anchors.

26. The system according to claim 24, wherein the set of anchors are a set of 3 anchors.

27. The system according to any one of claims 1-26, wherein: the anchors are a set of anchors, the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve along a first portion of the valve such that the tether becomes secured to the first portion, and the delivery tool is further adapted to secure the tether to a second portion of the heart, such that: the tether spans between the first portion and the second portion, andtensioning the tether towards a tensioned state draws the first portion and the second portion of the valve toward each other.

28. The system according to claim 27, wherein: the implant further comprises a flexible helical member that defines a plurality of turns, the tether extending through the turns, and the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion of the valve, such that part of each turn of the helical member becomes embedded within the tissue, and another part of each turn lies above a surface of the tissue.

29. The system according to claim 27, wherein: the implant further comprises a flexible helical member that defines a plurality of turns, the tether extending through the turns, and the delivery tool is configured to secure the tether to the second portion by anchoring the helical member helically along the second portion of the valve, such that the helical member becomes fully submerged within the tissue.

30. The system according to claim 27, wherein: the tether is a first tether, the implant further comprises a second tether, and the delivery tool is adapted to secure the second tether to both the first portion of the valve and the second portion of the valve such that: the second tether spans across the valve, independently of the first tether, and tensioning the second tether draws the first portion and the second portion of the valve toward each other.

31. The system according to claim 27, wherein the delivery tool is configured to secure the tether to the second portion using a single anchor.

32. The system according to claim 27, wherein the delivery tool is configured to secure the tether to the second portion using an anchor of the set.

33. The system according to claim 27, wherein: the implant further comprises a second-side anchor that comprises a head, a tissueengaging element, and an eyelet, directly attached to the head, the tether being threaded through the eyelet, andthe delivery tool is configured to secure the tether to the second portion by anchoring the second-side anchor, via engagement with the head of the second-side anchor, to tissue of the second portion of the heart.

34. The system according to claim 27, wherein the implant further comprises a lock, transluminally advanceable over and along the tether to maintain the tether in the tensioned state.

35. The system according to claim 34, wherein: the lock further comprises a shock-absorber, and the tether is insertable into the lock via the shock-absorber.

36. The system according to claim 27, wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve along the first portion, such that the node becomes disposed between the first portion and the second portion responsively to tensioning the tether.

37. The system according to claim 36, wherein the valve defines an orifice therethrough, and wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over the valve orifice.

38. The system according to claim 36, wherein the valve defines a plurality of leaflets, and wherein the delivery tool is adapted to anchor each of the anchors of the set adjacent to the valve on the first portion such that tensioning the tether causes the eyelets to converge to form the node over a leaflet of the plurality.

39. The system according to claim 27, wherein: the implant further comprises a second-side anchor, the valve has an annulus circumscribing the valve, the heart has a ventricle downstream of the valve, and the delivery tool is configured to secure the tether to the second portion by, at the second portion, driving the second-side anchor through the annulus and into the ventricle while the second-side anchor is attached to the tether.

40. The system according to claim 27, wherein: the set of anchors is a first set of anchors, the implant further comprises a second set of anchors, each comprising: a head,a tissue-engaging element, a cord, coupled to the head, and an eyelet, coupled to the head by the cord extending from the head to the eyelet, the tether is threaded through the eyelet of each anchor of the second set such that the anchors of the second set are arranged in series along the tether, and the delivery tool is adapted to secure the tether to the second portion of the valve by, for each anchor of the second set, via engagement with the head, anchoring each of the anchors of the second set adjacent to the second portion of the valve by, for each anchor, driving the tissue-engaging element into tissue.

41. The system according to claim 40, wherein each of the first set of anchors and the second set of anchors comprise two anchors.

42. The system according to claim 40, wherein the valve is a tricuspid valve of the heart.

43. The system according to claim 40, wherein the valve is a mitral valve of the heart.

44. The system according to claim 40, wherein: the node is a first node, and the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion, such that the eyelets of the anchors of the first set converge to form the first node, and the eyelets of the anchors of the second set converge to form a second node.

45. The system according to claim 40, wherein: the node is a first node, the implant further comprises a third set of anchors, each comprising: a head, a tissue-engaging element, a cord, coupled to the head, and an eyelet, coupled to the head by the cord extending from the head to the eyelet, the tether is threaded through the eyelet of each anchor of the third set such that the anchors of the third set are arranged in series along the tether, the delivery tool is adapted to secure the tether to the first portion of the valve by:anchoring the anchors of the first set to a first anchoring site at the first portion of the valve, and subsequently to anchoring the first set of anchors to the first anchoring site, and the second set of anchors to the second portion of the valve, anchoring the anchors of the third set to the first portion at a second anchoring site at the first portion by, for each anchor of the third set, via engagement with the head, anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue, and the tether is tensionable, while the anchors of each of the first, second and third sets remain anchored, such that the eyelets of the anchors of the first set converge to form the first node, the eyelets of the anchors of the second set converge to form a second node, and the eyelets of the anchors of the third set converge to form a third node.

46. The system according to claim 45, wherein: the implant further comprises a fourth set of anchors, each comprising: a head, a tissue-engaging element, a cord, coupled to the head, and an eyelet, coupled to the head by the cord extending from the head to the eyelet, the tether is threaded through the eyelet of each anchor of the fourth set such that the anchors of the fourth set are arranged in series along the tether, the delivery tool is adapted to secure the tether to the second portion of the valve by: subsequently to anchoring the anchors of the first set to the first anchoring site at the first portion of the valve, anchoring the anchors of the second set to the second portion at a third anchoring site at the second portion, subsequently anchoring the anchors of the fourth set to a fourth anchoring site at the second portion of the valve, by, for each anchor of the fourth set, via engagement with the head, anchoring the anchor into tissue of the second anchoring site by driving the tissue-engaging element into tissue, such that the tether spans between the third anchoring site and the fourth anchoring site on the second portion of the valve, and the tether is tensionable, while the anchors of each of the first, second third, and fourth sets remain anchored, such that the eyelets of the anchors of the first set converge toform the first node, the eyelets of the anchors of the second set converge to form the second node, the eyelets of the anchors of the third set converge to form the third node, and the anchors of the fourth set converge to form a fourth node.

47. The system according to claim 46, wherein the implant further comprises a spacer, threaded along the tether between the second node and the fourth node.

48. The system according to claim 40, wherein the tether is tensionable, while the anchors of the first set remain anchored adjacent the valve on the first portion, and the anchors of the second set remain anchored adjacent the valve on the second portion, such that the eyelets of the anchors of the first set and the eyelets of the anchors of the second set all converge to form a single node.

49. A system for use with a valve of a heart of a subject, the system comprising an implant that comprises: multiple anchors, each anchor comprising: a head; a tissue-engaging element; and an eyelet, coupled to the head by a cord or other connection extending from the head to the eyelet; and a tether, threaded through the eyelet of each anchor such that the anchors are arranged in series along the tether.

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