Valve leaflet treatment techniques

Abstract

The present invention provides an implant (150), the implant comprising: a patch (210); a patch anchor (240); a downstream assembly (300) comprising a capstan (320) coupled to a capstan anchor (310); and a tether (160), the tether tethering the winch to the patch. A delivery tool (400) has a distal portion that is lumen advanceable to the heart when the implant is mounted on the delivery tool. The delivery tool has a shaft; a clasp (430) comprising an upstream support and a downstream support, the clasp configured to grip a portion of a leaflet of a valve of the heart between the upstream support and the downstream support of the clasp; and a driver configured to anchor the patch to the portion of the leaflet using the patch anchor when the portion of the leaflet remains grasped by the clasp. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to:

[0003] U.S. Provisional Patent Application 63 / 341,376, entitled “Valve Leaflet Treatment Techniques,” to Pesach et al., filed May 12, 2022; and

[0004] U.S. Provisional Patent Application 63 / 369,927, entitled “Valve Leaflet Treatment Techniques,” filed on July 29, 2022, to Pesach et al.

[0005] This application is related to international patent application PCT / IB2021 / 060436, filed on November 11, 2021, to Tennenbaum et al. and entitled “Valve leaflet treatment systems and methods,” which is published as WO 2022 / 101817.

[0006] Each of the above applications is incorporated herein by reference in its entirety for all purposes. Background Art

[0007] Ischemic heart disease can cause mitral regurgitation through a combination of ischemic dysfunction of the papillary muscles and left ventricular dilatation present in ischemic heart disease with subsequent displacement of the papillary muscles and dilation of the mitral annulus.

[0008] Dilation of the mitral valve annulus prevents the valve leaflets from fully coapting when the valve closes. Mitral regurgitation of blood from the left ventricle to the left atrium results in an increased total stroke volume, decreased cardiac output, and eventual weakening of the left ventricle secondary to left atrial volume and pressure overload.

[0009] Chronic or acute left ventricular dilatation can lead to papillary muscle displacement, with increased leaflet tethering due to tension on the chordae tendineae, and annular dilatation. Summary of the Invention

[0010] Summary of the present invention is intended to provide some examples, and is not intended to limit the scope of the present invention in any way. For example, any feature included in the examples of Summary of the present invention is not necessary for the claims unless the claims clearly state these features. In addition, the described features can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples outlined here.

[0011] In some embodiments, systems and / or devices are provided that include a leaflet patch (e.g., a leaflet augmentation patch), a repair tendon, and / or a delivery tool for implanting the same. The systems / devices may include subvalvular devices and / or components. In some embodiments, the systems / devices are provided for facilitating leaflet augmentation.

[0012] In some embodiments, the systems, devices, and methods described herein can be used to provide artificial chordae and / or leaflet augmentation to the left side of the heart. In some embodiments, the systems, devices, and methods described herein can be used to provide artificial chordae and / or leaflet augmentation to the right side of the heart.

[0013] In some embodiments, the systems, devices, and methods described herein can be used to adjust the length between two portions of a heart wall.

[0014] According to some embodiments, a system and / or device (e.g., for use or usable with a valve positioned between an atrium and a ventricle of a real or simulated heart of a real or simulated subject) comprises an implant and / or a delivery tool.

[0015] In some embodiments, an implant can comprise a patch, a patch anchor, a downstream component, and / or a tether.

[0016] In some embodiments, the patch can comprise a flexible sheet. In some embodiments, the downstream component can comprise a ventricular anchor.

[0017] In some embodiments, a tether may couple or tether the downstream component to the patch.

[0018] In some embodiments, the delivery tool can have a distal portion that can be advanced transluminally into the heart when the implant is mounted on the delivery tool.

[0019] In some embodiments, a delivery tool may comprise a shaft, a clasp, and / or a driver.

[0020] In some embodiments, the shaft can define a longitudinal axis of the delivery tool.

[0021] In some embodiments, the clasp may include an upstream support and a downstream support.

[0022] In some embodiments, the clasp can be configured to transition between an open state and a gripping state.

[0023] In some embodiments, in the open state, the upstream support and the downstream support are positioned away from each other. In some embodiments, in the open state, the clasp is configured to receive a portion of a leaflet of the valve between the upstream support and the downstream support.

[0024] In some embodiments, in the grasping state, the clasp is configured to grasp a portion of the leaflet by transitioning from an open state to a grasping state while the portion of the leaflet received between the upstream support and the downstream support remains disposed between the upstream support and the downstream support.

[0025] In some embodiments, the actuator can be configured to anchor the patch to the portion of the leaflet using the patch anchor while the portion of the leaflet remains grasped by the clasp.

[0026] In some embodiments, after anchoring the patch to the leaflet, the clasp can be transitioned toward an open state to release the portion of the leaflet having the patch anchored thereto from the clasp.

[0027] In some embodiments, in the gripped state, the upstream support and the downstream support are closer to each other than in the open state.

[0028] In some embodiments, the ventricular anchor is a first ventricular anchor, and the downstream assembly further comprises a second ventricular anchor.

[0029] In some embodiments, a tether couples and / or tethers the patch to both the first ventricular anchor and the second ventricular anchor.

[0030] In some embodiments, the patch comprises a first component of a sheet material, and a second component of the sheet material is shaped to extend away from the patch in a manner to define a tether.

[0031] In some embodiments, the clasp includes a grasping indicator that is flexibly connected to the upstream support in such a manner that the portion of the leaflet moves the grasping indicator relative to the upstream support in a manner detectable by fluoroscopy when the portion of the leaflet is grasped between the upstream support and the downstream support.

[0032] In some embodiments, the patch anchor is coupled to the patch in a manner that facilitates anchoring the patch to a portion of the leaflet by: (i) allowing the driver to temporarily move the patch anchor away from the patch while the patch anchor remains coupled to the patch, and / or (ii) biasing the patch anchor to return toward the patch.

[0033] In some embodiments, the delivery tool is configured such that a steerable portion of the shaft distal to the clasp can be steered via manipulation of an extracorporeal proximal portion of the delivery tool.

[0034] In some embodiments, the implant is mounted or mountable on a delivery tool such that the tether extends from the downstream component along the shaft, through the clasp, and to the patch.

[0035] In some embodiments, the clasp is disposed completely laterally from the shaft in both the open state and the grasping state.

[0036] In some embodiments, the ventricular anchor comprises a helical tissue engaging element.

[0037] In some embodiments, the tether extends from the downstream component to the patch and back to the downstream component.

[0038] In some embodiments, the ventricular anchor is a first ventricular anchor, and the downstream assembly further comprises a second ventricular anchor. In some embodiments, the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0039] In some embodiments, the implant comprises an upstream component comprising a patch and a patch anchor, and / or a tether slidably coupled to the upstream component.

[0040] In some embodiments, the upstream component defines an eyelet, and the tether is slidably coupled to the upstream component by passing through the eyelet.

[0041] In some embodiments, the downstream assembly comprises a capstan coupled to the ventricular anchor. In some embodiments, the tether is arranged in a pulley arrangement, wherein a first end of the tether is operably coupled to the capstan. In some embodiments, the tether is arranged in a pulley arrangement, wherein a loop of the tether is slidably coupled to the upstream assembly. In some embodiments, the tether is arranged in a pulley arrangement, wherein a second end of the tether is secured to the downstream assembly.

[0042] In some embodiments, the capstan has a housing fixedly attached to the ventricular anchor, and the second end of the tether is secured to the housing.

[0043] In some embodiments, the patch has a lip region, and wherein the tether is attached to the patch via two lateral lines that diverge away from the tether and each other and attach to opposite lateral locations in the lip region.

[0044] In some embodiments, the tether is attached to the patch via two lateral wires such that tension applied to the tether deflects the patch medially, the patch being configured to resiliently deflect medially.

[0045] In some embodiments, the system further comprises a medial wire connecting the tether to a medial location in the lip region in a manner that limits the extent to which tension applied to the tether causes the patch to flex medially.

[0046] In some embodiments, the downstream assembly further comprises a capstan, the ventricular anchor is a capstan anchor coupled to the capstan, and / or the tether tethers the capstan to the patch.

[0047] In some embodiments, the winch includes a housing and a spool disposed therein, the spool being operably coupled to the tether such that actuation of the winch tensions the tether. In some embodiments, the tether extends from the spool and out of an aperture in the housing, the aperture having a rim.

[0048] In some embodiments, the downstream assembly further includes a spring coupled to the housing in a manner that pushes the tether away from contact with the rim.

[0049] In some embodiments, the spring is a scroll spring. In some embodiments, the spring is a cantilever spring. In some embodiments, the spring is a wave spring.

[0050] In some embodiments, the spring is coupled to the housing in a manner that pushes the tether out of contact with the side of the rim furthest from the winch anchor.

[0051] In some embodiments, the downstream component comprises a helix defining: (i) a spring, and / or (ii) a gripping region adapted to grip a tether.

[0052] In some embodiments, the spring defines a helix having a series of turns.

[0053] In some embodiments, the helix extends circumferentially around the exterior of the capstan housing.

[0054] In some embodiments, the spring is adapted to capture the tether between the turns of the helix.

[0055] In some embodiments, the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to a downstream assembly in a manner that configures the drive shaft subassembly to: (i) anchor the capstan anchor to ventricular tissue of the heart by applying an anchoring force to the capstan anchor, and / or (ii) actuate the capstan independently of applying the anchoring force.

[0056] In some embodiments, the delivery tool is configured to actuate the capstan by applying torque to the capstan via the drive shaft subassembly.

[0057] In some embodiments, the downstream assembly includes a sliding clutch that operably couples the drive shaft subassembly to the capstan in a manner that limits the amount of torque that the delivery tool can apply to the capstan.

[0058] In some embodiments, the drive shaft subassembly includes a reference force tube extending through the shaft and engaging a downstream component.

[0059] In some embodiments, one or more drive shafts extend through the reference force tube to downstream components.

[0060] In some embodiments, the drive shaft subassembly is configured to actuate the capstan by applying torque to the capstan when the reference force tube provides a reference force to a downstream assembly.

[0061] In some embodiments, the downstream assembly and the delivery tool are configured to facilitate the delivery tool rotating the capstan anchor relative to the shaft without actuating the capstan.

[0062] In some embodiments, the actuator is configured to anchor the patch to a portion of the leaflet by driving the patch anchor through the portion of the leaflet grasped by the clasp.

[0063] In some embodiments, the patch anchor is a toggle that is biased to automatically widen upon deployment.

[0064] In some embodiments, the toggle has a honeycomb structure that is biased to automatically widen by shortening.

[0065] In some embodiments, the delivery tool is configured to anchor the downstream component to the ventricular tissue by anchoring the ventricular anchor to the ventricular tissue of the ventricle.

[0066] In some embodiments, the ventricular anchor comprises a tissue engaging element, and the delivery tool is configured to anchor the downstream component to the ventricular tissue by driving the tissue engaging element into the ventricular tissue.

[0067] In some embodiments, the implant is mounted or mountable on the delivery tool such that the ventricular anchor is disposed at the distal end of the shaft.

[0068] In some embodiments, the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to a downstream assembly in a manner that configures the drive shaft subassembly to anchor the ventricular anchor to ventricular tissue by applying an anchoring force to the ventricular anchor.

[0069] In some embodiments, the delivery tool comprises a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool can be advanced transluminally to the heart while the downstream components are housed within the capsule.

[0070] In some embodiments, the capsule comprises a shield formed from an elastic polymer.

[0071] In some embodiments, the capsule further comprises a housing having a plurality of fingers that are flexible, circumferentially distributed to approximate a tubular shape, and embedded within the shield.

[0072] In some embodiments, the downstream assembly further comprises a capstan, and the ventricular anchor is a capstan anchor coupled to the capstan.

[0073] In some embodiments, the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to a downstream assembly in a manner that configures the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue by applying torque to the capstan anchor without rotating the capstan relative to the ventricular tissue.

[0074] In some embodiments, the distal portion of the delivery tool is coupled to the implant in a manner that configures the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue by applying torque to the capstan anchor without rotating the capstan relative to the shaft.

[0075] In some embodiments, the delivery tool comprises a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool can be advanced transluminally to the heart while the downstream components are housed within the capsule.

[0076] In some embodiments, the capsule and capstan are shaped to inhibit rotation of the capstan relative to the shaft when the drive shaft subassembly threads the tissue engaging element into ventricular tissue.

[0077] In some embodiments, the capsule defines a track and the capstan engages the track when received by the capsule.

[0078] In some embodiments, the capsule and downstream assembly configure the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue as the downstream assembly is advanced distally out of the capsule while the capstan slides linearly along the track.

[0079] In some embodiments, the track is a side opening in the capsule.

[0080] In some embodiments, the capstan defines an aperture through which the tether extends out of the capstan and to the patch.

[0081] In some embodiments, the orifice protruding into the lateral opening configures the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue by advancing the downstream assembly distally out of the capsule while the orifice of the capstan slides linearly along the lateral opening.

[0082] In some embodiments, the capsule comprises: (i) a housing housing the capstan and defining a lateral opening, and / or (ii) an elastomeric shield covering the housing.

[0083] In some embodiments, the shield covers a distal region of the lateral opening, leaving a proximal region of the lateral opening exposed to define a window of the capsule.

[0084] In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the downstream components contained within the capsule and the orifice exposed at the window.

[0085] In some embodiments, the shield defines a slit extending distally from the window that is aligned with the lateral opening.

[0086] In some embodiments, the protrusion of the orifice into the lateral opening configures the drive shaft subassembly to advance the downstream assembly distally out of the capsule while the orifice of the capstan screws the tissue engaging element into the ventricular tissue in a manner that momentarily separates the shield at the slit as the orifice slides linearly along the lateral opening.

[0087] In some embodiments, the implant comprises an upstream component comprising a patch anchor coupled to the patch.

[0088] In some embodiments, the upstream assembly further comprises a cord via which the patch anchor is coupled to the patch.

[0089] In some embodiments, the patch anchor is a toggle anchor.

[0090] In some embodiments, the toggle anchor is a helical coil defining a lumen therethrough.

[0091] In some embodiments, the actuator is configured to drive the anchor through the leaflet as the actuator extends through the lumen.

[0092] In some embodiments, the system further comprises a retrieval wire extending away from the toggle anchor, the retrieval wire being threaded through the turns in such a manner that tensioning the retrieval wire strengthens the anchor by compressing the turns of the coil against each other.

[0093] In some embodiments, the helical coil extends helically around and along the toggle axis, and the system further comprises a retrieval wire extending along the toggle axis and away from the toggle anchor in such a manner that tensioning the retrieval wire strengthens the anchor by compressing the turns toward each other.

[0094] In some embodiments, the retrieval line is secured to the first end of the toggle anchor and extends along the toggle axis to the second end of the toggle anchor and from the second end of the toggle anchor away from the toggle anchor.

[0095] In some embodiments, the cord is connected to the middle portion of the coil.

[0096] In some embodiments, the cord is connected to the intermediate portion by being looped over the turns of the coil.

[0097] In some embodiments, the toggle anchor has a tip, a heel, and an eyelet midway between the tip and the heel.

[0098] In some embodiments, the heel flares in a manner that: (i) facilitates passage of the heel through the leaflets in a first direction, and / or (ii) inhibits passage of the heel through the leaflets in a second direction opposite the first direction.

[0099] In some embodiments, the heel defines flaps adapted to momentarily flex inwardly toward each other during passage of the heel through the leaflet in the first direction.

[0100] In some embodiments, the heel defines tabs adapted to flex laterally toward each other when the heel is urged against the leaflet in the second direction.

[0101] In some embodiments, the toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel.

[0102] In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord extends the heel away from the lateral eyelet.

[0103] In some embodiments, the toggle anchor has a sharp point.

[0104] In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord simultaneously (i) extends the heel away from the lateral eyelet and (ii) retracts the point toward the lateral eyelet.

[0105] In some embodiments, the system further includes a retrieval line that passes through the toggle anchor in such a manner that tensioning the retrieval line retracts the heel toward the lateral eyelet.

[0106] In some embodiments, the toggle anchor further includes a spring configured to bias the heel to extend away from the lateral eyelet.

[0107] In some embodiments, the toggle anchor has a sharp point, and the spring is configured to bias the point to retract toward the lateral eyelet.

[0108] In some embodiments, the toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel. In some embodiments, the first section of the toggle anchor defines a tip.

[0109] In some embodiments, the second section of the toggle anchor is slidably coupled to the first section.

[0110] In some embodiments, the system further comprises a longitudinal member extending through the lateral eyelet and connected to the toggle anchor in such a manner that pulling the longitudinal member axially slides the second segment relative to the first segment.

[0111] In some embodiments, the second section of the toggle anchor defines a heel.

[0112] In some embodiments, the driver is configured to push the forward-most tip of the toggle anchor through a portion of the leaflet, the driver having a driver head and a rod extending proximally from the driver head, the driver head being connected to the heel via complementary geometry in a manner that: (i) preferentially allows the toggle anchor to deflect relative to the driver rather than lateral translation, and (ii) allows the heel to disconnect from the driver when the toggle anchor reaches a predetermined angle relative to the driver.

[0113] In some embodiments, the driver head has a first distal-facing face and defines a shoulder defining a second distal-facing face proximal to the first face.

[0114] In some embodiments, at the heel, the toggle anchor defines a lateral opening, and the shoulder protrudes through the lateral opening, such that the driver is configured to push the anterior-most tip of the toggle anchor through a portion of the leaflet by: (i) the second distal-facing surface pushing the toggle anchor distally at the lateral opening, and (ii) the first distal-facing surface pushing the toggle anchor distally substantially opposite the lateral opening.

[0115] In some embodiments, the toggle anchor defines a lateral opening at the heel, and the shoulder projects through the lateral opening to allow the toggle anchor to be disconnected from the driver by deflecting about a point on the driver proximal to the second distal-facing surface, causing the lateral opening to move laterally away from the shoulder.

[0116] In some embodiments, the drive head defines a knob, and the knob is connected to the neck of the shaft.

[0117] In some embodiments, at the heel, the toggle anchor defines appendages that extend proximally beyond the knob and extend proximally from the knob, toward each other, and medially toward the neck such that: (i) the appendages inhibit proximal retraction and lateral translation of the driver from the toggle anchor, and / or (ii) deflection of the toggle anchor relative to the driver pushes the knob between the appendages, causing the appendages to deflect laterally away from each other and away from the neck.

[0118] In some embodiments: (i) the drive head defines a socket having a rim, (ii) at the heel, the toggle anchor defines a knob, (iii) the knob is disposed in the socket in a manner to inhibit lateral translation of the toggle anchor from the driver, and / or (iv) deflection of the toggle anchor relative to the driver presses the rim against the toggle anchor in a manner that pries the knob distally out of the socket.

[0119] In some embodiments, the tether is coupled to the upstream component such that pulling the tether pulls the cord in a manner that draws the patch anchor toward the patch.

[0120] In some embodiments, the upstream component includes a one-way mechanism through which the cord extends, the one-way mechanism being: (i) mounted on the patch, (ii) configured to facilitate passage of the cord through the one-way mechanism in a first direction that pulls the patch anchor toward the patch, and / or (iii) configured to inhibit passage of the cord through the one-way mechanism in a second direction opposite to the first direction.

[0121] In some embodiments, the upstream assembly is configured such that pulling the tether pulls the cord in a first direction through the one-way mechanism.

[0122] In some embodiments, the delivery tool is configured to pull the tether such that the tether pulls the cord through the one-way mechanism in a first direction.

[0123] In some embodiments, the delivery tool is configured to pull the tether by moving the downstream component away from the upstream component and subsequently anchoring the patch to a portion of the leaflet.

[0124] In some embodiments, the patch anchor has a sharpened tip and is configured to be driven through the leaflet by an actuator, wherein the sharpened tip penetrates the leaflet.

[0125] In some embodiments, the delivery tool further comprises a hollow needle, and the patch anchor is configured to be driven through the leaflet by the actuator while disposed within the hollow needle.

[0126] In some embodiments, the delivery tool further comprises a hollow needle configured to pierce the valve leaflets, and the actuator is configured to drive the patch anchor out of the hollow needle as the hollow needle extends through the valve leaflets.

[0127] In some embodiments, the patch anchor includes a toggle defining an eyelet midway along the toggle, the cord being attached to the patch anchor at the eyelet.

[0128] In some embodiments, the eyelet extends completely laterally through the toggle.

[0129] In some embodiments, the toggle is substantially tubular with sidewalls defining a lumen.

[0130] In some embodiments, the upstream assembly further includes a spring configured to tension the cord.

[0131] In some embodiments, the spring is a compression spring.

[0132] In some embodiments, the spring lies substantially flat relative to the patch.

[0133] In some embodiments, the spring is configured to be instantaneously strained by tension applied to the cord in response to the actuator pushing the patch anchor away from the patch and through the leaflets, thereby facilitating the actuator driving the patch anchor through the leaflets.

[0134] In some embodiments, the spring is coupled to the sheet in such a way that the patch contracts linearly instantaneously with instantaneous strain of the spring.

[0135] In some embodiments, the spring is coupled to the sheet in such a way that the spring slides across the sheet as the spring momentarily strains.

[0136] In some embodiments, the patch has a lip and a root, and the actuator is configured to anchor the root of the patch to the leaflet such that the lip of the patch extends toward the opposing leaflet of the valve.

[0137] In some embodiments, the patch comprises at least one frame defining: (i) a lip support at a lip of the patch, and / or (ii) a root support at a root of the patch.

[0138] In some embodiments, the spring is configured such that the transient strain substantially comprises a transient compression of the spring between the lip support and the root support.

[0139] In some embodiments, at least one frame defines a patch anchor support coupled to the root stent, the cord extending from the spring through the patch anchor support to the patch anchor.

[0140] In some embodiments, the tether is connected to the lip support.

[0141] In some embodiments, a spring is attached to the root support.

[0142] In some embodiments, the spring extends from the root support to the lip support.

[0143] In some embodiments, the spring extends along the midline of the patch from the root support to the lip support.

[0144] In some embodiments, the spring does not extend to the lip support.

[0145] In some embodiments, the clasp defines a slot, and the actuator is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet and the slot.

[0146] In some embodiments, the clasp defines a resilient tooth configured to facilitate driving the patch anchor through the slot by the actuator and to inhibit withdrawal of the patch anchor through the slot in an opposite direction.

[0147] In some embodiments, the teeth are configured to be momentarily pushed aside by the patch anchor being driven through the slot by the driver.

[0148] In some embodiments, the delivery tool is configured to orient the driver relative to the slot such that the patch anchor rubs along the rim of the slot as the driver drives the patch anchor through the slot.

[0149] In some embodiments, the slot is defined by a downstream support of the clasp.

[0150] In some embodiments, the clasp defines a slot guard configured to block cardiac tissue from entering the slot.

[0151] In some embodiments, the patch is coupled to the patch anchor via a tether, and the slot guard: (i) is elastic, (ii) has a rest position in which the slot guard covers the entrance to the slot, thereby blocking cardiac tissue from entering the slot, and / or (iii) is momentarily deflectable from the slot by the tether, thereby facilitating exit of the tether from the slot.

[0152] In some embodiments, the free end of the slot guard is tucked under the downstream support.

[0153] In some embodiments, the delivery tool further comprises a capsule located at the distal end of the shaft, the capsule being configured to house the downstream components.

[0154] In some embodiments, the capsule comprises a shield formed from an elastic polymer.

[0155] In some embodiments, the capsule further comprises a housing having a plurality of fingers that are flexible, circumferentially distributed to approximate a tubular shape, and embedded within the shield.

[0156] In some embodiments, the capsule is shaped to define a lateral window therein.

[0157] In some embodiments, the capsule is shaped to define a narrow slit extending between the lateral window and the open distal end of the capsule.

[0158] In some embodiments, the delivery tool has an extracorporeal proximal portion that includes a clasp controller operably coupled to the clasp such that operation of the clasp controller transitions the clasp between an open state and a grasping state.

[0159] In some embodiments, the clasp controller is operably coupled to an upstream support of the clasp such that operation of the clasp controller transitions the clasp between the open state and the grasped state via movement of the upstream support relative to the shaft.

[0160] In some embodiments, the delivery tool further comprises a pair of clasp control wires via which the clasp controller is operably coupled to the clasp.

[0161] In some embodiments, the extracorporeal portion comprises a lever: (i) the clasp controller is operably coupled to both of the paired wires via the lever, and / or (ii) the lever is adapted to pivot in a manner that balances the paired wires relative to each other.

[0162] In some embodiments, the lever has a fulcrum, the clasp controller is pivotally attached to the lever at the fulcrum, and each wire of the pair is coupled to the lever at respective opposite sides of the fulcrum.

[0163] In some embodiments, the extracorporeal proximal portion further comprises a driver controller operably coupled to the driver such that operation of the driver controller causes the driver to anchor the patch anchor to the leaflet.

[0164] In some embodiments, (i) the patch anchor is a first patch anchor, and the implant further comprises a second patch anchor.

[0165] In some embodiments, the actuator is a first actuator configured to anchor the patch to the portion of the leaflet by pushing a first patch anchor through the portion of the leaflet. In some embodiments, the delivery tool further comprises a second actuator configured to anchor the patch to the portion of the leaflet by pushing a second patch anchor through the portion of the leaflet.

[0166] In some embodiments, the extracorporeal portion includes a lever: (i) the actuator controller is operably coupled to the first actuator and the second actuator via the lever, and / or (ii) the lever is adapted to pivot in a manner that balances the first actuator with the second actuator.

[0167] In some embodiments, the lever has a fulcrum at which the actuator controller is pivotally attached to the lever, and the first actuator and the second actuator are coupled to the lever at respective opposing sides of the fulcrum.

[0168] In some embodiments, within the distal portion of the delivery tool, the shaft has a proximal component and a distal component.

[0169] In some embodiments, the extracorporeal proximal portion of the delivery tool further comprises a shaft extender operably coupled to the shaft such that operation of the shaft extender reversibly extends the distal component of the shaft distally from the proximal component of the shaft.

[0170] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects the downstream support relative to the shaft.

[0171] In some embodiments, the delivery tool comprises a frame defining a downstream support.

[0172] In some embodiments, a first portion of the frame is attached to a proximal portion of the shaft and a second portion of the frame is attached to a distal portion of the shaft such that adjusting the extent to which the distal portion of the shaft extends from the proximal portion of the shaft deflects the downstream support relative to the shaft.

[0173] In some embodiments, the distal component of the shaft includes a steerable component, and the first component of the frame and the second component of the frame are attached to the proximal component of the shaft and the second component of the shaft, respectively, such that extending the distal component of the shaft distally from the proximal component of the shaft beyond a threshold range causes the frame to pull the distal component of the shaft to deflect.

[0174] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects both the downstream support and the upstream support relative to the shaft.

[0175] In some embodiments, the clasp is coupled to the shaft such that extending the distal portion of the shaft distally from the proximal portion of the shaft deflects both the downstream support and the upstream support relative to the shaft without changing the arrangement between the downstream support and the upstream support.

[0176] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects both the downstream support and the upstream support relative to the shaft while the clasp remains in a grasping state.

[0177] In some embodiments, the extracorporeal proximal portion further comprises an anchor controller.

[0178] In some embodiments, the delivery tool further includes a drive shaft subassembly including one or more drive shafts extending through the shaft, the drive shaft subassembly being configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the anchor controller to the ventricular anchor such that operation of the anchor controller applies an anchoring force to the ventricular anchor.

[0179] In some embodiments, the downstream assembly further comprises a capstan, and the ventricular anchor is a capstan anchor coupled to the capstan.

[0180] In some embodiments, a tether tethers the capstan to the patch.

[0181] In some embodiments, the extracorporeal proximal portion further comprises a capstan controller, the drive shaft subassembly being configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the capstan controller to the capstan such that operation of the capstan controller actuates the capstan.

[0182] In some embodiments, operation of the winch controller actuates the winch by applying torque to the winch via the drive shaft subassembly.

[0183] In some embodiments, the downstream assembly includes a sliding clutch that operably couples the drive shaft subassembly to the capstan in a manner that limits the amount of torque that the drive shaft assembly can apply to the capstan.

[0184] In some embodiments, the drive shaft subassembly includes: (i) a winch control drive shaft, through which the winch controller is operably connected to the winch, and / or (ii) an anchor control drive shaft, through which the anchor control drive shaft is set, and the anchor controller is operably connected to the anchor via the anchor control drive shaft.

[0185] In some embodiments, the anchor control drive shaft operably couples the anchor controller to the anchor via engagement of the anchor by a distal end portion of the anchor control drive shaft.

[0186] In some embodiments, the delivery tool further comprises a release spring biased to pull the anchor control drive shaft proximally away from the anchor, engagement of the anchor by the distal end portion of the anchor control drive shaft resisting the pulling of the release spring on the anchor control drive shaft.

[0187] In some embodiments, the drive shaft subassembly further includes a locking rod at the distal end portion of the anchor-controlled drive shaft, wherein the locking rod maintains engagement of the anchor by the distal end portion of the anchor-controlled drive shaft, such that retraction of the locking rod from the distal end portion of the anchor-controlled drive shaft triggers a release spring to pull the anchor-controlled drive shaft proximally away from the anchor.

[0188] In some embodiments, the release spring is a first release spring. In some embodiments, the delivery tool further comprises a second release spring biased to pull the capstan control drive shaft proximally away from the capstan, engagement of the anchor by the distal end portion of the anchor control drive shaft resists the pulling of the capstan control drive shaft by the second release spring, such that retraction of the locking rod from the distal end portion of the anchor control drive shaft also triggers the second release spring to pull the capstan control drive shaft proximally away from the capstan.

[0189] In some embodiments, the bias of the first release spring further maintains the capstan control drive shaft in engagement with the capstan by exerting a distally directed force on the capstan control drive shaft.

[0190] In some embodiments, the system is configured such that triggering the first and second release springs by retracting the locking rod from the anchor-controlled distal end portion of the drive shaft decouples the downstream assembly from the delivery tool.

[0191] In some embodiments, the downstream assembly further comprises a capstan, and the ventricular anchor is a capstan anchor coupled to the capstan.

[0192] In some embodiments, the drive shaft subassembly includes downstream components to control the drive shaft.

[0193] In some embodiments, the system has an anchor state in which the anchor controller controls the drive shaft operatively coupled to the winch anchor via a downstream component such that operation of the anchor controller applies an anchoring force to the winch anchor.

[0194] In some embodiments, the system has an engaged state in which the downstream component controls the drive shaft: (i) operably decoupled from the capstan anchor such that operation of the anchor controller does not apply an anchoring force to the capstan anchor, and / or (ii) operably coupled to the capstan such that the downstream component controls rotation of the drive shaft to actuate the capstan.

[0195] In some embodiments, the downstream component includes a shaft that is axially movable within the downstream component such that: (i) positioning the shaft in a first axial position within the downstream component places the system in an anchored state, and / or (ii) positioning the shaft in a second axial position within the downstream component places the system in a twisted state.

[0196] In some embodiments, the winch includes a spool disposed therein, the spool being operably coupled to the tether such that rotation of the spool tensions the tether.

[0197] In some embodiments, (i) the shaft defines a protruding rim therearound, (ii) the downstream component includes a spring-loaded pawl biased to protrude into a recess defined by a surface of the spool, thereby maintaining the spool in a locked state in which the spool cannot rotate, and / or (iii) transitioning the shaft to the second shaft position automatically unlocks the capstan by the rim pushing the pawl out of the recess, thereby allowing the spool to rotate.

[0198] In some embodiments, the downstream assembly control drive shaft defines an angled slot and the shaft defines a transverse pin.

[0199] In some embodiments, in an engaged state of the downstream component control drive shaft in which the downstream component control drive shaft is locked to the shaft: (i) a transverse pin is disposed laterally within a slot of the downstream component control drive shaft, and / or (ii) a reference force tube of the drive shaft subassembly is disposed above the inclined slot and the shaft in a manner such that the reference force tube cooperates with the transverse pin within the slot to prevent proximal movement of the downstream component control drive shaft away from the shaft by blocking lateral movement of the downstream component control drive shaft relative to the shaft.

[0200] In some embodiments, retracting the reference force tube from over the angled slot and shaft allows downstream components to control movement of the drive shaft proximally away from the shaft by allowing the slot to slide obliquely from the pin.

[0201] In some embodiments, the first axial position is distal to the second axial position.

[0202] In some embodiments, the system further has a mid-range state in which the downstream assembly controls the drive shaft to be coupled to the downstream assembly but operably decoupled from both the winch anchor and the winch.

[0203] In some embodiments, in the anchored state, the downstream assembly controls the drive shaft to be disposed in a first axial position relative to the downstream assembly.

[0204] In some embodiments, in the twisted state, the downstream component controls the drive shaft to be positioned at a second, different axial position relative to the downstream component.

[0205] In some embodiments, the delivery tool can be transitioned between the anchored state and the twisted state by controlling axial movement of the drive shaft relative to the downstream component via the downstream component.

[0206] In some embodiments, the first axial position is distal to the second axial position.

[0207] In some embodiments, the delivery tool can control proximal movement of the drive shaft relative to the downstream component via the downstream component to transition from the anchored state to the twisted state.

[0208] In some embodiments, the delivery tool further comprises a mounting member configured to support the patch mounted thereon and configured to carry the patch toward the clasp when the clasp is in the grasping state.

[0209] In some embodiments, the mounting member is configured to carry the patch toward the upstream support of the clasp by moving distally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

[0210] In some embodiments, the mounting member is configured to carry the patch toward the upstream support of the clasp by moving distally and laterally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

[0211] In some embodiments, the delivery tool comprises a beam that provides a mechanical linkage between the shaft and the mount that couples distal movement of the mount with lateral movement of the mount.

[0212] In some embodiments, the mount has a retracted position, and the distal portion of the delivery tool can be advanced transluminally to the heart when the mount is in the retracted position and the patch is mounted on the mount.

[0213] In some embodiments, the mounting member has an initial position in which the mounting member is disposed closer to the clasp than in the retracted position.

[0214] In some embodiments, the actuator is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet when the mount is in an initial position and the patch is mounted on the mount.

[0215] In some embodiments, (i) the mounting member defines a channel therein, (ii) a distal portion of the delivery tool can be advanced through the cavity to the heart when the mounting member is in a retracted position and the patch is mounted on the mounting member and the patch anchor is positioned within the channel, and / or (ii) the driver is configured to anchor the patch to a portion of the leaflet by driving the patch anchor out of the channel and through the portion of the leaflet.

[0216] In some embodiments, the delivery tool comprises a needle disposed within the channel.

[0217] In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the mount in the retracted position and the patch mounted on the mount and the patch anchor disposed within the needle within the channel.

[0218] In some embodiments, the delivery tool is configured to facilitate the driver driving the patch anchor through a portion of the leaflet by pushing the needle out of the channel.

[0219] In some embodiments, the delivery tool further comprises a spring that biases the needle to retract into the channel.

[0220] In some embodiments, the delivery tool further includes a mount lever operably coupled to the mount in a manner that configures the mount lever to transition between a retracted position and an initial position.

[0221] In some embodiments, the mount lever is operably coupled to the mount by coupling to the needle.

[0222] In some embodiments, the mount control rod is operably connected to the mount such that: (i) pushing the needle from the retracted position by the mount control rod pushes the mount toward the initial position via the spring, and / or (ii) when the mount is in the initial position, pushing the needle by the mount control rod strains the spring and pushes the needle out of the channel.

[0223] In some embodiments, the delivery tool comprises a spring configured to bias the mounting member toward the initial position.

[0224] In some embodiments, the spring is a spring-loaded beam that provides a mechanical linkage between the shaft and the mount and biases the mount toward the initial position by biasing the mount to move distally and laterally.

[0225] In some embodiments, the driver comprises a rod and a driver head, the driver head being coupled to the mount such that tension on the rod constrains the mount in the retracted position.

[0226] In some embodiments, the patch anchor and the driver head are disposed within a channel defined in the mounting member. In some embodiments, removing the tension on the rod allows the spring to move the mounting member to the initial position.

[0227] In some embodiments, when the mounting member is in the initial position, pushing the rod moves the driver head through the channel and deploys the patch anchor out of the channel.

[0228] In some embodiments, the clasp is transitionable between an open state and a gripping state while the mounting member is maintained in the retracted position.

[0229] In some embodiments, the delivery tool has an extracorporeal proximal portion comprising a mount controller operably coupled to the mount such that operation of the mount controller moves the mount between the retracted position and the initial position.

[0230] In some embodiments, the delivery tool further comprises a mount control lever via which the mount controller is operably coupled to the mount.

[0231] In some embodiments, the mount control lever is a first mount control lever, and the delivery tool further includes a second mount control lever via which the mount controller is operably coupled to the mount.

[0232] In some embodiments, the extracorporeal portion includes a lever: (i) the mount controller is operably coupled to the first mount control lever and the second mount control lever via the lever, and / or (ii) the lever is adapted to pivot in a manner that balances the first mount control lever with the second mount control lever.

[0233] In some embodiments, the lever has a fulcrum at which the mount controller is pivotally attached to the lever, and the first and second mount control levers are coupled to the lever at respective opposing sides of the fulcrum.

[0234] In some embodiments, the extracorporeal proximal portion further comprises a driver controller operably coupled to the driver such that operation of the driver controller causes the driver to drive the patch anchor through the leaflet.

[0235] In some embodiments, the mount control rod is tubular and the actuator extends from the actuator controller through the mount control rod.

[0236] In some embodiments, the extracorporeal proximal portion of the delivery tool further comprises a clasp controller operably coupled to the clasp such that operation of the clasp controller transitions the clasp between the open state and the grasping state.

[0237] In some embodiments, the delivery tool further comprises a clasp control wire via which the clasp controller is operably coupled to the mount.

[0238] In some embodiments, the clasp control wire is a first clasp control wire, and the delivery tool further includes a second clasp control wire via which the clasp controller is operably coupled to the mount.

[0239] In some embodiments, the extracorporeal portion includes a lever: (i) the clasp controller is operably connected to the first clasp control wire and the second clasp control wire via the lever, and / or (ii) the lever is adapted to pivot in a manner that balances the first clasp control wire with the second clasp control wire.

[0240] In some embodiments, the lever has a fulcrum at which the clasp controller is pivotally attached to the lever, and the first clasp control wire and the second clasp control wire are coupled to the lever at respective opposing sides of the fulcrum.

[0241] In some embodiments, the mount controller is configured to move the mount between the retracted position and the initial position by sliding the mount over and along the clasp control wire toward the clasp when the clasp is in the grasping state.

[0242] In some embodiments, the clasp controller is configured to transition the clasp from the grasping state to the open state by retracting the clasp control wire through the mounting member when the mounting member is in the retracted position.

[0243] In some embodiments, the delivery tool further comprises one or more wraps, and a distal portion of the delivery tool can be advanced transluminally into the heart while the mount is in a retracted position and the patch is held against the mount by the one or more wraps wrapped around the patch and the mount.

[0244] In some embodiments, the one or more entanglements are one or more kirigami entanglements.

[0245] In some embodiments, the delivery tool further comprises a release mechanism adapted to release the patch from the mount by applying tension to the one or more kirigami wraps.

[0246] In some embodiments, the delivery tool further comprises a release mechanism adapted to release the patch from the mount by releasing tension in the one or more kirigami wraps.

[0247] In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the mount in the retracted position and the patch held against the mount by one or more wraps wrapped around the patch, mount, and shaft.

[0248] In some embodiments, the delivery tool further comprises one or more spring-loaded brackets configured to keep the wrap taut.

[0249] In some embodiments, the delivery tool further comprises a rod that cooperates with the spring-loaded bracket to keep the wraps taut and that is retractable to release one or more wraps.

[0250] In some embodiments, in the retracted position, the mount is bent into an arc midway around the axis.

[0251] In some embodiments, the mounting member has a convex outer surface, and the patch is mounted on the mounting member in a manner such that the patch lies in a curvilinear position against the convex outer surface of the mounting member.

[0252] In some embodiments, the mounting member is shaped to receive the patch anchor when the patch is mounted on the mounting member.

[0253] In some embodiments, a patch anchor is coupled to the patch, and the system is configured such that receipt of the patch anchor by the mount secures the patch to the mount.

[0254] In some embodiments, the patch is connected to the patch anchor via a tether and is secured to the surface of the mounting member by the patch anchor being disposed in a channel defined in the surface of the mounting member, the channel being shaped to: (i) facilitate sliding of the patch anchor along the channel, and / or (ii) prevent the patch anchor from moving laterally out of the channel.

[0255] In some embodiments, the actuator is configured to anchor the patch to the leaflet by driving the patch anchor along the channel out of the end of the channel and through the leaflet when the mount is in an initial position and the patch is mounted on the mount.

[0256] In some embodiments, the cord extends laterally from the patch anchor out of the channel to the patch.

[0257] In some embodiments, the shaft is telescopic within the distal portion of the delivery tool.

[0258] In some embodiments, the delivery tool has a delivery state in which: (i) the shaft is telescopically extended, (ii) the clasp faces distally, and / or (iii) the distal portion of the delivery tool is advanceable transluminally to the heart.

[0259] In some embodiments, in the delivery state, the downstream support is deflected distally compared to the open state.

[0260] In some embodiments, in the delivery state, the downstream support is disposed adjacent to and substantially parallel to the shaft.

[0261] In some embodiments, in the delivery state, the clasp is closed.

[0262] In some embodiments, the delivery tool has a collapsed state in which: (i) the shaft is telescopically collapsed, and / or (ii) the clasp faces proximally.

[0263] In some embodiments, the distal portion of the delivery tool is configured to be advanced downstream through the valve when in the contracted state.

[0264] In some embodiments, in the retracted state, the clasp is closed.

[0265] In some embodiments, in the collapsed state, the downstream support is deflected proximally compared to the expanded state.

[0266] In some embodiments, in the retracted state, the clasp extends laterally further from the shaft than in the open state.

[0267] In some embodiments, the delivery tool has an extracorporeal proximal portion comprising a shaft extender operably coupled to the shaft such that operation of the shaft extender reversibly extends the distal component of the shaft distally from the proximal component of the shaft.

[0268] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects the downstream support relative to the shaft.

[0269] In some embodiments, the patch is substantially trapezoidal.

[0270] In some embodiments, (i) the patch has a lip and a root, (ii) the actuator is configured to anchor the root of the patch to the leaflet such that the lip of the patch extends toward the opposite leaflet of the valve, and / or (iii) the lip is longer than the root.

[0271] In some embodiments, the delivery tool further comprises a retrieval wire releasably coupled to the anchor such that tensioning the retrieval wire de-anchors the patch anchor from the leaflet.

[0272] In some embodiments, the delivery tool has an extracorporeal portion, and the retrieval wire: (i) extends transluminally through the delivery tool from a first end portion of the retrieval wire at the extracorporeal portion to the anchor, (ii) at the anchor, the retrieval wire loops around the anchor, and / or (iii) extends transluminally from the anchor back through the delivery tool to the extracorporeal portion, wherein the retrieval wire defines a second end portion.

[0273] In some embodiments, both the first end portion and the second end portion are coupled to a barrel mounted on the external portion.

[0274] In some embodiments, each of the first and second end portions extends proximally from the barrel along the extracorporeal portion toward the bearing and, at the bearing, turns back on itself to extend distally through the delivery tool to the anchor such that sliding the barrel distally along the extracorporeal portion tensions the retrieval wire.

[0275] In some embodiments, the first end portion is wrapped circumferentially around the barrel, the barrel defines a slot that provides accessibility to the first end portion, and / or the retrieval line can be released from the anchor by cutting the first end portion through the slot and then removing the barrel from the extracorporeal portion and moving the barrel away from the extracorporeal portion.

[0276] In some embodiments, the barrel defines a lateral slit, and the barrel is removable from the extracorporeal portion by moving the barrel laterally away from the extracorporeal portion through the lateral slit.

[0277] In some embodiments, the groove is a groove in a series of grooves distributed circumferentially around the barrel.

[0278] In some embodiments, the patch anchor comprises a tubular toggle and includes a retrieval feature comprising a notch at the heel of the toggle and a retrieval eyelet.

[0279] In some embodiments, the retrieval wire: (i) extends into the lumen of the toggle at the heel of the toggle in line with the toggle, (ii) exits the sidewall of the toggle via a retrieval eyelet, and / or (iii) loops back upon itself via a notch to connect to itself.

[0280] In some embodiments, the retrieval wire is releasably coupled to the anchor such that tensioning the retrieval wire facilitates unanchoring the patch anchor from the leaflet by reorienting the patch anchor.

[0281] In accordance with some embodiments, a system and / or device (e.g., for use with a valve positioned between an atrium and a ventricle of a real or simulated heart of a real or simulated subject, the valve having at least a first leaflet and a second leaflet) may include an implant comprising a leaflet reinforcement patch and / or a patch anchor.

[0282] In some embodiments, a leaflet reinforcement patch can include: (i) a flexible sheet, and / or (ii) a frame supporting the flexible sheet.

[0283] In some embodiments, the patch anchor can be coupled to the patch in a manner that facilitates anchoring the patch to the first leaflet by: (i) allowing the patch anchor to temporarily move away from the patch while the patch anchor remains coupled to the patch, and / or (ii) biasing the patch anchor to return toward the patch.

[0284] In some embodiments, the patch anchor has a sharpened tip and is configured to be driven through the first leaflet, wherein the sharpened tip penetrates the first leaflet.

[0285] In some embodiments, the patch anchor is configured to be driven through the first leaflet while positioned within the hollow needle.

[0286] In some embodiments, the patch anchor comprises a tubular toggle and includes a retrieval feature comprising a notch at the heel of the toggle and a retrieval eyelet, the system / device further comprising a retrieval line that: (i) extends colinearly with the toggle at the heel of the toggle into the lumen of the toggle, (ii) exits the side wall of the toggle via the retrieval eyelet, and / or (iii) loops back onto itself via the notch to connect to itself.

[0287] In some embodiments, the implant comprises: (i) an upstream component comprising a patch and a patch anchor; (ii) a downstream component comprising a ventricular anchor; and / or (iii) a tether tethering the patch to the ventricular anchor.

[0288] In some embodiments: (i) the ventricular anchor is a first ventricular anchor, (ii) the downstream assembly further comprises a second ventricular anchor, and / or (iii) the tether tethers the patch to both the first ventricular anchor and the second ventricular anchor.

[0289] In some embodiments, the tether extends from the downstream component to the patch and back to the downstream component.

[0290] In some embodiments: (i) the ventricular anchor is a first ventricular anchor, (ii) the downstream assembly further comprises a second ventricular anchor, and / or (iii) the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0291] In some embodiments, the tether is slidably coupled to the upstream component.

[0292] In some embodiments, the upstream component defines an eyelet, and the tether is slidably coupled to the upstream component by passing through the eyelet.

[0293] In some embodiments, the downstream component includes a winch coupled to the ventricular anchor, and / or the tether is arranged in a pulley arrangement wherein: (i) a first end of the tether is operably coupled to the winch, (ii) a loop of the tether is slidably coupled to the upstream component, and / or (iii) a second end of the tether is secured to the downstream component.

[0294] In some embodiments, the capstan has a housing fixedly attached to the ventricular anchor, and the second end of the tether is secured to the housing.

[0295] In some embodiments, the patch anchor is a toggle that is biased to automatically widen upon deployment.

[0296] In some embodiments, the toggle has a honeycomb structure that is biased to automatically widen by shortening.

[0297] In some embodiments, the system / device further includes a delivery tool configured to deliver the implant to the heart and anchor the patch anchor to the first leaflet by: (i) anchoring the patch anchor to the first leaflet by temporarily moving the patch anchor away from the patch while the patch anchor remains connected to the patch, and / or (ii) subsequently releasing the patch anchor such that the implant responsively returns the patch anchor toward the patch.

[0298] In some embodiments, the delivery tool is configured to move the patch anchor away from the patch by driving the patch anchor through the first leaflet.

[0299] In some embodiments, the delivery tool is configured to deliver the implant to the heart, wherein the patch is mounted laterally on the delivery tool.

[0300] In some embodiments, an implant comprises an upstream component comprising a patch and a patch anchor.

[0301] In some embodiments, the implant further comprises: (i) a downstream component comprising a capstan coupled to a capstan anchor configured to anchor the downstream component to tissue of the ventricle; and / or (ii) a tether tethering the capstan to the patch.

[0302] In some embodiments, the patch comprises a first component of a sheet material, and a second component of the sheet material is shaped to extend away from the patch in a manner to define a tether.

[0303] In some embodiments, the implant further comprises a cord via which the patch anchor is coupled to the patch.

[0304] In some embodiments, the patch includes a spring, and the patch anchor is coupled to the spring in a manner that biases the patch anchor back toward the patch.

[0305] In some embodiments, the frame defines a spring.

[0306] In some embodiments, the spring is a compression spring.

[0307] In some embodiments, the spring lies substantially flat relative to the patch.

[0308] In some embodiments, the implant further comprises a cord via which the patch anchor is coupled to the spring.

[0309] In some embodiments, the spring is configured to be instantaneously strained by tension applied to the cord in response to pushing the patch anchor away from the patch and through the first leaflet, thereby facilitating driving the patch anchor through the first leaflet.

[0310] In some embodiments, the spring is coupled to the sheet in such a way that the patch contracts linearly instantaneously with instantaneous strain of the spring.

[0311] In some embodiments, the spring is coupled to the sheet in such a way that the spring slides across the sheet as the spring momentarily strains.

[0312] In some embodiments, the patch has a lip and a root. In some embodiments, the cord couples the patch anchor to the patch in such a way that anchoring the patch anchor to the first leaflet positions the patch so that the lip of the patch extends toward the second leaflet.

[0313] In some embodiments, the framework defines: (i) a lip support at the lip of the patch, and / or (ii) a root support at the root of the patch.

[0314] In some embodiments, the spring is configured such that the transient strain substantially comprises a transient compression of the spring between the lip support and the root support.

[0315] In some embodiments, the patch defines a root-to-lip axis between the lip and the root along a midline of the patch, and the spring is configured such that the transient strain substantially comprises a deflection of the spring relative to the root-to-lip axis.

[0316] In some embodiments, the spring is configured such that the transient strain substantially comprises a deflection of the spring toward the root to lip axis.

[0317] In some embodiments, the spring is a first spring, and wherein the frame further comprises a second spring, the first and second springs being configured such that the transient strain substantially comprises a deflection of the first and second springs toward each other.

[0318] In some embodiments, the cord extends back and forth between the first spring and the second spring.

[0319] In some embodiments, the framework defines a patch anchor support coupled to the root stent, the cord extending from the spring through the patch anchor support to the patch anchor.

[0320] In some embodiments, a spring is attached to the root support.

[0321] In some embodiments, the spring is configured such that the transient strain substantially comprises a transient deflection of the spring relative to the root support.

[0322] In some embodiments, the spring does not extend to the lip support.

[0323] In some embodiments, the spring extends from the root support to the lip support.

[0324] In some embodiments, the spring extends along the midline of the patch from the root support to the lip support.

[0325] In some embodiments, (i) the spring is a first spring extending from the root support to the lip support along a first lateral edge of the patch, and / or (ii) the frame defines a second spring extending from the root support to the lip support along a second lateral edge of the patch.

[0326] In some embodiments, the patch anchor includes a toggle defining an eyelet substantially midway along the toggle, the cord being attached to the patch anchor at the eyelet.

[0327] In some embodiments, the system / device further comprises a retrieval wire extending from an end of the toggle member and configured to de-anchor the patch anchor from the first leaflet when the retrieval wire is tensioned.

[0328] In some embodiments, the eyelet extends completely laterally through the toggle.

[0329] In some embodiments, the toggle is substantially tubular with sidewalls defining a lumen.

[0330] In some embodiments, the sidewall defines two lateral apertures adjacent to each other, and the eyelet is defined by a portion of the sidewall disposed between the two lateral apertures.

[0331] According to some embodiments, a system (e.g., for use or usable with a valve disposed between an atrium and a ventricle of a real or simulated heart of a real or simulated subject) comprises an implant and / or a delivery tool. In some embodiments, the implant comprises a tether and / or assembly.

[0332] In some embodiments, the assembly may include a winch and / or a winch anchor.

[0333] In some embodiments, the winch may include a housing and a spool disposed therein, with the tether extending from the winch and the spool operably coupled to the tether such that actuation of the winch tensions the tether.

[0334] In some embodiments, a winch anchor may be coupled to a winch.

[0335] In some embodiments, the delivery tool, when coupled to the implant, can have a distal portion that is advanceable transluminally into the heart.

[0336] In some embodiments, a delivery tool can include a drive shaft subassembly including a reference force tube and / or a drive shaft.The reference force tube can be coupled to the housing.

[0337] In some embodiments, the drive shaft may extend through the reference force tube.

[0338] In some embodiments, the system has an anchored state in which the drive shaft is: (i) operably coupled to the capstan anchor such that rotation of the drive shaft applies an anchoring force to the capstan anchor, and / or (ii) operably decoupled from the capstan such that rotation of the drive shaft does not actuate the capstan, and / or

[0339] In some embodiments, there is a twisted state in which the drive shaft is: (i) operably decoupled from the winch anchor such that rotation of the drive shaft does not apply an anchoring force to the winch anchor, and / or (ii) operably coupled to the winch such that rotation of the drive shaft actuates the winch.

[0340] In some embodiments, the system further has a mid-range state in which the drive shaft is coupled to the implant but operably decoupled from both the capstan anchor and the capstan.

[0341] In some embodiments, the assembly includes a shaft that is axially movable within the assembly such that: (i) positioning the shaft in a first axial position within the assembly places the system in an anchored state, and / or (ii) positioning the shaft in a second axial position within the assembly places the system in a twisted state.

[0342] In some embodiments, the winch includes a spool disposed therein, the spool being operably coupled to the tether such that rotation of the spool tensions the tether. In some embodiments, the shaft defines a protruding rim therearound.

[0343] In some embodiments, the assembly includes a spring-loaded pawl that is biased to project into a recess defined by a surface of the spool, thereby maintaining the spool in a locked state in which the spool cannot rotate.

[0344] In some embodiments, shifting the shaft to the second shaft position automatically unlocks the capstan by the edge pushing the pawl out of the recess, thereby allowing the spool to rotate.

[0345] In some embodiments, the drive shaft defines an angled slot, and / or the shaft defines a transverse pin.

[0346] In some embodiments, in an engaged state of the drive shaft in which the drive shaft is locked to the shaft: (i) a transverse pin is disposed laterally within a slot of a downstream component controlling the drive shaft, and / or (ii) a reference force tube is disposed above the inclined slot and the shaft in a manner such that the reference force tube cooperates with the transverse pin within the slot to prevent proximal movement of the drive shaft away from the shaft by blocking lateral movement of the drive shaft relative to the shaft.

[0347] In some embodiments, retracting the reference force tube from over the angled slot and shaft allows the drive shaft to move proximally away from the shaft by allowing the slot to slide obliquely from the pin.

[0348] In some embodiments, the first axial position is distal to the second axial position.

[0349] In some embodiments, in the anchored state, the drive shaft is disposed in a first axial position relative to the capstan.

[0350] In some embodiments, in the capstan state, the drive shaft is disposed at a second, different axial position relative to the capstan.

[0351] In some embodiments, the delivery tool is transitionable between an anchored state and a twisted state via axial movement of the drive shaft relative to the capstan.

[0352] In some embodiments, the first axial position is distal to the second axial position, and / or the delivery tool is transitionable from the anchored state to the capstan state via proximal movement of the drive shaft relative to the capstan.

[0353] According to some embodiments, a system (eg, for use or usable with real or simulated tissue of a real or simulated subject) comprises a toggle anchor and / or a delivery tool.

[0354] In some embodiments, a toggle anchor can have a tip and a heel and define an anchor axis therebetween.

[0355] In some embodiments, the delivery tool can: define a channel in which the toggle anchor is disposed; and / or include a driver configured to advance the forward-most tip of the toggle anchor distally away from the channel, the driver having a driver head and a rod extending proximally from the driver head.

[0356] In some embodiments, the driver head is connected to the heel via complementary geometry in a manner that: (i) preferentially allows the toggle anchor to deflect relative to the driver rather than lateral translation, and (ii) allows the heel to disconnect from the driver when the anchor reaches a predetermined angle relative to the driver.

[0357] In some embodiments, the drive head defines a knob, and the knob is connected to the neck of the shaft.

[0358] In some embodiments, at the heel, the toggle anchor defines appendages that extend proximally beyond the knob and extend proximally from the knob, toward each other, and medially toward the neck such that: (i) the appendages inhibit proximal retraction and lateral translation of the driver from the toggle anchor, and / or (ii) deflection of the toggle anchor relative to the driver pushes the knob between the appendages, causing the appendages to deflect laterally away from each other and away from the neck.

[0359] In some embodiments: (i) the drive head defines a socket having a rim, (ii) at the heel, the toggle anchor defines a knob, (iii) the knob is disposed in the socket in a manner to inhibit lateral translation of the toggle anchor from the driver, and / or (iv) deflection of the toggle anchor relative to the driver presses the rim against the toggle anchor in a manner that pries the knob distally out of the socket.

[0360] In some embodiments, the delivery tool can be advanced transluminally to the tissue.

[0361] In some embodiments, the tip of the anchor has a sharp point.

[0362] In some embodiments, the driver head has a first distal-facing face and defines a shoulder defining a second distal-facing face proximal to the first face.

[0363] In some embodiments, at the heel, the toggle anchor defines a lateral opening, and the shoulder protrudes through the lateral opening, such that the driver is configured to urge the forward-most tip of the toggle anchor through tissue by: (i) the second distal-facing surface urging the toggle anchor distally at the lateral opening, and (ii) the first distal-facing surface urging the toggle anchor distally substantially opposite the lateral opening.

[0364] In some embodiments, the toggle anchor defines a lateral opening at the heel, and the shoulder protrudes through the lateral opening to allow the toggle anchor to be disconnected from the driver head by deflecting about a point on the driver proximal to the second distal-facing surface, so that the lateral opening moves laterally away from the shoulder.

[0365] In some embodiments, the driver further includes a stabilizer configured such that pushing the tip of the toggle anchor against tissue by the driver causes the stabilizer to move relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor to a stable position, wherein the stabilizer inhibits deflection of the toggle anchor relative to the driver when in the stable position.

[0366] In some embodiments, the system further comprises a cord attached to the toggle anchor.

[0367] In some embodiments, the system includes an implant comprising a toggle anchor, a cord, and another component, the cord connecting the other component to the toggle anchor such that the toggle anchor is configured to anchor the other component to tissue.

[0368] According to some embodiments, a system comprises an implant and / or a delivery vehicle.

[0369] In some embodiments, an implant can include a toggle anchor having a body, a tip, and a heel, the toggle anchor defining an anchor axis between the tip and the heel.

[0370] In some embodiments, a delivery tool can be configured to advance an implant transluminally to real or simulated tissue of a real or simulated subject when the implant is coupled to a distal portion of the tool.

[0371] In some embodiments, the delivery tool can include a driver comprising a driver head and a rod extending proximally from the driver head, the driver configured to push the forward-most tip of the toggle anchor through tissue.

[0372] In some embodiments, the system can include an extendable member and can be configured such that the extendable member responsively slides axially relative to the body when the driver pushes the tip of the toggle anchor against tissue.

[0373] In some embodiments, at least the tip of the toggle anchor is hollow.

[0374] In some embodiments, the extendable member is part of a delivery tool.

[0375] In some embodiments, the extendable member is a component that toggles the anchor.

[0376] In some embodiments, the extendable member is a column.

[0377] In some embodiments, the system defines a sharp point configured to penetrate tissue in a manner that facilitates the driver to push the forward-most tip of the toggle anchor through the tissue, and / or the system has a rest state in which the sharp point is functionally obscured.

[0378] In some embodiments, the system is configured such that when the driver pushes the tip of the anchor against tissue, the extendable member automatically functionally exposes the sharp point by sliding axially relative to the body.

[0379] In some embodiments, (i) the sharp point is defined by the tip of the toggle anchor, (ii) in a static state, the extendable member functionally obscures the sharp point, and / or (iii) the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member automatically functionally exposes the sharp point by sliding proximally away from the sharp point.

[0380] In some embodiments, the extendable member is a component that toggles the anchor.

[0381] In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp point by sliding into the interior of the toggle anchor.

[0382] In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp point by sliding over an exterior of the toggle anchor.

[0383] In some embodiments, (i) the sharp point is defined by an extendable member, (ii) in a static state, the toggle anchor functionally obscures the sharp point, and / or (iii) the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member automatically slides distally beyond the tip, thereby functionally exposing the sharp point.

[0384] In some embodiments, the extendable member is part of a delivery tool and comprises a needle defining a sharp point.

[0385] In some embodiments, in the rest state, the sharp point is functionally obscured by the toggle anchor.

[0386] In some embodiments, in the rest state, the sharp point is functionally obscured by being disposed within the body of the toggle anchor.

[0387] According to some embodiments, a system comprises an implant and / or a delivery vehicle.

[0388] In some embodiments, an implant can include a toggle anchor having a body, a tip, and a heel, the toggle anchor defining an anchor axis between the tip and the heel.

[0389] In some embodiments, a delivery tool can be configured to advance an implant transluminally to real or simulated tissue of a real or simulated subject when the implant is coupled to a distal portion of the tool.

[0390] In some embodiments, the delivery tool can include a driver and / or a stabilizer. The driver can include a driver head and a rod extending proximally from the driver head, the driver being configured to push the forward tip of the toggle anchor through tissue.

[0391] In some embodiments, the stabilizer can be configured such that pushing the tip of the toggle anchor against tissue by the driver causes the stabilizer to move relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor to a stable position, wherein the stabilizer inhibits deflection of the toggle anchor relative to the driver when in the stable position.

[0392] In some embodiments, the delivery tool comprises a spring that biases the stabilizer away from the stable position.

[0393] In some embodiments, the delivery tool is configured such that axial sliding of the stabilizer relative to the toggle anchor is accompanied by proximal movement of the driver head toward the rod.

[0394] In some embodiments, the driver head is coupled to the rod via a compression spring that compresses when the driver pushes the tip of the toggle anchor against tissue, the compression of the spring facilitating axial sliding of the stabilizer relative to the toggle anchor.

[0395] In some embodiments, the compression spring is configured to facilitate disengagement of the toggle anchor from the driver when the driver stops pushing.

[0396] In some embodiments, the stabilizer comprises a post configured such that pushing the tip of the toggle anchor against tissue by the driver causes the stabilizer to slide distally through the post and into the toggle anchor to move to a stable position.

[0397] In some embodiments, at least the heel of the toggle anchor is tubular, and the post is configured such that pushing the tip of the toggle anchor against tissue by the driver moves the stabilizer to a stable position by sliding axially through the post into the tubular lumen defined by the toggle anchor.

[0398] In some embodiments, the stabilizer is disposed within the driver.

[0399] In some embodiments, the drive head is coupled to the rod via a compression spring extending over at least a portion of the post.

[0400] In some embodiments, the delivery tool is configured such that distal sliding of the post into the toggle anchor is accompanied by proximal movement of the driver head toward the rod.

[0401] In some embodiments, the stabilizer includes a socket configured such that pushing the tip of the anchor against tissue by the driver causes the stabilizer to slide proximally via the heel into the socket to move to a stable position.

[0402] In some embodiments, the heel is sized to fit tightly within the socket.

[0403] In some embodiments, the socket is tubular.

[0404] In some embodiments, the socket is a cup.

[0405] In some embodiments, the drive head is coupled to the rod via a compression spring extending through at least a portion of the socket.

[0406] In some embodiments, the delivery tool is configured such that axial sliding of the heel into the socket is accompanied by proximal sliding of the driver head into the socket.

[0407] In some embodiments, the delivery tool is configured such that axial sliding of the heel into the socket is accompanied by proximal movement of the driver head toward the rod.

[0408] According to some embodiments, a system and / or device (eg, for use or usable with real or simulated tissue) includes an implant comprising a toggle anchor and / or a longitudinal member.

[0409] In some embodiments, the toggle anchor can have a tip, a heel, and an anchor axis between the tip and the heel, and define a lateral eyelet midway between the tip and the heel.

[0410] In some embodiments, a toggle anchor can include: (i) a first segment defining a tip, and / or (ii) a second segment slidably coupled to the first segment and defining a heel.

[0411] In some embodiments, the longitudinal member can extend through the lateral eyelet and be connected to the toggle anchor in such a manner that pulling the longitudinal member causes the second section to slide axially relative to the first section.

[0412] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member slides the heel toward the lateral eyelet.

[0413] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member slides the heel away from the lateral eyelet.

[0414] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that pulling the longitudinal member extends the heel away from the first segment such that the lateral eyelet becomes disposed substantially midway between the toggle anchor's tip and heel.

[0415] In some embodiments: (i) the longitudinal member is attached to the attachment point of the toggle anchor, and / or (ii) before the longitudinal member is pulled, the longitudinal member defines a path including at least one turn between the lateral eyelet and the attachment point.

[0416] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that axial sliding of the second segment relative to the first segment is accompanied by sliding of the longitudinal member out of the lateral eyelet.

[0417] In some embodiments, at least a portion of the second segment is coaxial with at least a portion of the first segment.

[0418] In some embodiments, the second section is telescopically coupled to the first section, and wherein the longitudinal member is connected to the toggle anchor in such a manner that pulling the longitudinal member causes the second section to telescopically slide relative to the first section.

[0419] In some embodiments, the second segment is coupled to the first segment such that the second segment is axially slidable within the first segment.

[0420] In some embodiments, the toggle anchor includes a spring that biases the second segment toward a predetermined axial position relative to the first segment.

[0421] In some embodiments, the longitudinal member is coupled to the toggle anchor in such a manner that pulling the longitudinal member causes the second section to slide axially relative to the first section away from the predetermined axial position.

[0422] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling on the longitudinal member strains the spring.

[0423] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member changes the axial length of the toggle anchor by sliding the second section relative to the first section.

[0424] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member increases the axial length of the toggle anchor by sliding the second section relative to the first section.

[0425] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member reduces the axial length of the toggle anchor by sliding the second section relative to the first section.

[0426] In some embodiments, the second segment defines a sharp point at an end of the second segment opposite the heel, and the system / device is configured such that pulling the longitudinal member causes the second segment to slide relative to the first segment in a manner that draws the sharp point into the first segment.

[0427] In some embodiments, the system / device is configured such that pulling the longitudinal member causes the second segment to slide relative to the first segment in a manner that draws the sharp point into the first segment and extends the heel away from the first segment.

[0428] In some embodiments, the implant further comprises a frame, and the longitudinal member is a cord connecting the toggle anchor to the frame.

[0429] In some embodiments, the frame includes a spring that pulls the cord.

[0430] In some embodiments, the longitudinal member is a retrieval wire configured to pull the toggle anchor out of tissue.

[0431] In some embodiments, the lateral eyelet is provided at the end of the first segment closest to the heel.

[0432] According to some embodiments, a system and / or device (eg, for use or usable with real or simulated tissue) includes an implant comprising a toggle anchor, a cord, and / or a retrieval line.

[0433] In some embodiments, the toggle anchor can have a tip, a heel, and / or a lateral eyelet. The lateral eyelet can be midway between the tip and the heel.

[0434] In some embodiments, the cord may be connected to the toggle anchor via a lateral eyelet.

[0435] In some embodiments, the retrieval line may be threaded through the toggle anchor in such a manner that tensioning the retrieval line retracts the heel toward the lateral eyelet.

[0436] In some embodiments, the toggle anchor is a helical coil defining a lumen therethrough.

[0437] In some embodiments, the retrieval wire is passed through the turns of the helical coil in such a way that tensioning the retrieval wire strengthens the anchor by compressing the turns toward each other.

[0438] In some embodiments, the toggle anchor further includes a spring configured to bias the heel to extend away from the lateral eyelet.

[0439] In some embodiments, the toggle anchor has a sharp point, and / or the spring is configured to bias the point toward the lateral eyelet.

[0440] In some embodiments, a toggle anchor comprises: (i) a body defining a lumen and a retrieval aperture, the retrieval aperture opening into the lumen, and / or (ii) a shank, at least a portion of which is disposed within the lumen.

[0441] In some embodiments, the cord extends through the retrieval eyelet to the anchor such that tensioning the retrieval line retracts the heel by sliding the anchor relative to the body.

[0442] In some embodiments, the cord extends through the retrieval eyelet and a transverse passage in the anchor and is attached to a side of the body opposite the retrieval eyelet.

[0443] In some embodiments, the anchor is shaped to define a heel.

[0444] In some embodiments, the body defines a lateral eyelet.

[0445] According to some embodiments, a system and / or device (eg, for use or usable with real or simulated tissue) includes an implant including a toggle anchor and / or a cord.

[0446] In some embodiments, the toggle anchor has a tip, a heel, and / or a lateral eyelet midway between the tip and the heel.

[0447] In some embodiments, the cord can be connected to the toggle anchor via the lateral eyelet in such a way that tensioning the cord extends the heel away from the lateral eyelet.

[0448] In some embodiments, the toggle anchor has a sharp point.

[0449] In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord simultaneously (i) extends the heel away from the lateral eyelet and (ii) retracts the point toward the lateral eyelet.

[0450] In some embodiments, the toggle anchor comprises: (i) a body defining a lumen and a lateral eyelet, the lateral eyelet opening into the lumen; and / or (ii) a shank, at least a portion of which is disposed within the lumen.

[0451] In some embodiments, the cord extends through the lateral eyelet to the anchor such that tensioning the cord simultaneously extends the heel and retracts the point by sliding the anchor relative to the body.

[0452] In some embodiments, the anchor is shaped to define a heel and a point.

[0453] In some embodiments, the cord extends through the lateral eyelet and the transverse passage in the anchor and is attached to a side of the body opposite the lateral eyelet.

[0454] According to some embodiments, a system (eg, for use or usable with a real or simulated heart of a real or simulated subject) includes an implant including a tether and / or assembly.

[0455] In some embodiments, the assembly may include a winch, a winch anchor, and / or a spring. In some embodiments, the winch anchor may be coupled to the winch.

[0456] In some embodiments, a winch may include a housing and a spool disposed therein.

[0457] In some embodiments, the spool may be operably coupled to the tether such that actuation of the winch tensions the tether.

[0458] In some embodiments, the tether may extend from the spool and out of the aperture of the housing. In some embodiments, the aperture may have a rim.

[0459] In some embodiments, the spring may be coupled to the housing in a manner that pushes the tether away from contact with the rim.

[0460] In some embodiments, the spring is a scroll spring. In some embodiments, the spring is a cantilever spring. In some embodiments, the spring is a wave spring.

[0461] In some embodiments, the spring is coupled to the housing in a manner that pushes the tether out of contact with the side of the rim furthest from the winch anchor.

[0462] In some embodiments, the component is a first component of an implant, and the implant further comprises a second component comprising an anchor, the first component and the second component being connected via a tether.

[0463] In some embodiments, the heart has atria, ventricles, and valves therebetween.

[0464] In some embodiments, the system further comprises a delivery tool having a distal portion that is advanceable through the cavity into the heart when coupled to the implant and is adapted to: (i) anchor the anchor into the leaflets of the valve, and / or (ii) anchor the capstan anchor into tissue of the ventricle such that the tether extends from the anchor at the leaflet to the capstan anchor within the ventricle.

[0465] In some embodiments, the first component comprises a helix shaped to define: (i) a spring, and / or (ii) a gripping region adapted to grip the tether between turns of the helix.

[0466] In some embodiments, the spring defines a helix having a series of turns extending circumferentially around the housing, and a pitch between turns of a first portion of the helix decreases during ventricular contraction of the heart.

[0467] In some embodiments, the spring is adapted to capture the tether between the turns of the second portion of the helix.

[0468] In some embodiments, the spring defines a helix having a series of turns.

[0469] In some embodiments, the helix extends circumferentially around the exterior of the capstan housing.

[0470] In some embodiments, the spring is adapted to capture the tether between the turns of the helix.

[0471] According to some embodiments, a method of connecting a tether to a component of an implant comprises: (i) forming a loop in the tether by wrapping an end portion of the tether around a component of the component, and / or (ii) closing the loop into a ring by coaxially drilling the end portion through a tensile portion of the tether such that the tensile portion squeezes the end portion therein.

[0472] In some embodiments: (i) the bight is a first bight, (ii) the ring is a first ring, and / or (iii) coaxially drilling the end portion through the tensile portion includes coaxially drilling a first component of the end portion through the tensile portion.

[0473] In some embodiments, the method further comprises: (i) forming a second loop in the end portion, and / or (ii) closing the second loop into a second ring by coaxially drilling a second component of the end portion through the stretch portion such that the first component and the second component extend side by side with each other within the stretch portion.

[0474] In some embodiments, the loop is a first loop, the loop is a first loop, and / or the stretch is a first stretch. In some embodiments, the method further comprises: (i) forming a second loop in the end portion, and / or (ii) closing the second loop into a second ring by coaxially drilling the end portion through the second stretch of the tether such that the second stretch compresses the end portion therein.

[0475] In some embodiments: (i) the end portion is a first end portion of a tether, (ii) a second end portion of the tether extends from the stretch portion away from the first end portion, an end of the second end portion being coupled to a downstream component, and / or (iii) wrapping the end portion of the tether around a component of the component includes wrapping the first end portion of the tether around a component of a leaflet patch of an upstream component.

[0476] In some embodiments, the tensile portion is a braid, and coaxially drilling the end portion through the tensile portion includes coaxially drilling the end portion through the tensile portion such that anchors of the braid are pushed apart.

[0477] In some embodiments, the stretch portion comprises an anchor for the fabric, and coaxially drilling the end portion through the stretch portion comprises coaxially drilling the end portion through the stretch portion such that the anchor for the fabric is pushed apart.

[0478] In some embodiments, the method further comprises, after coaxially drilling the end portion through the stretch portion, trimming an end component of the end portion extending from the stretch portion to the end of the tether.

[0479] According to some embodiments, a system and / or device (eg, for use or usable with real or simulated tissue) includes an implant comprising a toggle anchor, a retrieval adapter, and / or a retrieval wire.

[0480] In some embodiments, the toggle anchor can have a heel defining a retrieval eyelet.

[0481] In some embodiments, the retrieval adapter may have a first loop at a first end and a second loop at a second end, the first loop extending through the retrieval eyelet.

[0482] In some embodiments, the retrieval line may be looped through the second loop in such a manner that pulling the retrieval line redirects the toggle anchor for retrieval.

[0483] In some embodiments, the toggle anchor is a first toggle anchor, the retrieval adapter is a first retrieval adapter, and / or the system / device further includes a second toggle anchor and a second retrieval adapter.

[0484] In some embodiments, the retrieval line is looped through both the second loop of the first retrieval adapter and the second loop of the second retrieval adapter such that pulling the retrieval line redirects both the first and second toggle anchors for retrieval.

[0485] According to some embodiments, a system (eg, for use or usable with a real or simulated subject) includes a toggle anchor, a cord, and / or a retrieval line.

[0486] In some embodiments, the toggle anchor can be in the form of a helical coil.The coil can have a longitudinal axis extending from a first end portion of the coil to a second end portion of the coil.

[0487] In some embodiments, the cord may be connected to the coil at a location between the first end portion and the second end portion and may extend orthogonally from the location away from the longitudinal axis.

[0488] In some embodiments, the retrieval wire may extend from the first end portion to the second end portion and away from the toggle anchor, the retrieval wire being secured to the toggle anchor in such a manner that tensioning the retrieval wire strengthens the anchor by compressing the turns of the coil toward each other.

[0489] In some embodiments, the retrieval line is secured to an end portion of the toggle anchor.

[0490] In some embodiments, the system further comprises a driver adapted to drive the toggle anchor from a first side of cardiovascular tissue of the subject through the tissue to an opposite side of the tissue such that, on the opposite side: (i) the longitudinal axis of the helical coil is parallel to the tissue, and / or (ii) the coil is in an uncompressed state in which the turns of the coil are able to move relative to each other.

[0491] In some embodiments, the driver is adapted to deliver the toggle anchor through tissue as the driver extends through a lumen defined by the coil.

[0492] According to some embodiments, a system and / or device (eg, for use or usable with a real or simulated subject) comprises a medical tool comprising an extracorporeal component, a shaft, and / or a pair of wires.

[0493] The extracorporeal component may be at the proximal end of the tool.

[0494] In some embodiments, the shaft can extend distally from the extracorporeal component and can be configured to be advanced transluminally into the subject.

[0495] In some embodiments, the pair of wires can extend along a shaft from the extracorporeal component to a distal component of the tool.

[0496] In some embodiments, the extracorporeal component may include a controller and / or a lever.

[0497] In some embodiments, the lever can operably couple the controller to the distal component via the pair of wires by: (a) the controller being pivotally attached to the lever at a fulcrum of the lever, and / or (b) each wire in the pair being coupled to the lever at respective opposite sides of the fulcrum, such that actuation of the controller manipulates the distal component of the tool while the lever dynamically pivots to balance the wires relative to each other.

[0498] In some embodiments, the controller is axially slidable along the extracorporeal component such that sliding the controller in a first axial direction moves the distal component of the tool in the first axial direction as the lever continues to balance the wires relative to each other.

[0499] According to some embodiments, a system and / or device (eg, for use or usable with a real or simulated subject) comprises an implant and / or a delivery vehicle.

[0500] In some embodiments, the delivery tool may comprise a kirigami wrap and / or release mechanism.

[0501] In some embodiments, the kirigami wrap can be adapted to retain the implant.The delivery tool can be configured to advance the implant transluminally into the subject while the implant is retained by the kirigami wrap.

[0502] In some embodiments, the release mechanism can be operably coupled to the kirigami wrap in such a manner that actuation of the release mechanism releases the hold of the kirigami wrap on the implant.

[0503] According to some embodiments, a system (eg, for use or usable with a real or simulated heart of a real or simulated subject) includes an implant including a tether and / or assembly.

[0504] In some embodiments, an assembly may include a winch, a winch anchor, and / or a shock absorber.The winch anchor may be coupled to the winch.

[0505] In some embodiments, a winch may include a housing and a spool disposed therein.

[0506] In some embodiments, the spool may be operably coupled to the tether such that actuation of the winch tensions the tether.

[0507] In some embodiments, the tether may extend from the spool and out of the aperture of the housing.

[0508] In some embodiments, a shock absorber may be coupled to the housing in a manner that reduces forces acting on the winch anchor.

[0509] According to some embodiments, a system (e.g., for use or usable with a valve positioned between an atrium and a ventricle of a subject's heart) includes an implant comprising a patch, a patch anchor, a downstream component, and / or a tether.

[0510] In some embodiments, the patch can comprise a flexible sheet. In some embodiments, the downstream component can comprise a ventricular anchor. In some embodiments, a tether can tether the downstream component to the patch.

[0511] In some embodiments, the system further comprises a delivery tool having a distal portion that can be advanced transluminally into the heart when the implant is mounted on the delivery tool. In some embodiments, the delivery tool can comprise a shaft, a clasp, and / or a driver. The shaft can define a longitudinal axis of the delivery tool.

[0512] In some embodiments, the clasp may include an upstream support and / or a downstream support.

[0513] In some embodiments, the clasp can be transitioned between an open state and a gripping state. In some embodiments, in the open state, the upstream support and the downstream support can be positioned away from each other, and the clasp can be configured to receive a portion of the leaflet of the valve between the upstream support and the downstream support.

[0514] In some embodiments, in the grasping state, the clasp can be configured to grasp a portion of the leaflet by transitioning from an open state to a grasping state while the portion of the leaflet received between the upstream support and the downstream support remains disposed between the upstream support and the downstream support.

[0515] In some embodiments, the actuator can be configured to anchor the patch to the portion of the leaflet using the patch anchor while the portion of the leaflet remains grasped by the clasp.

[0516] In some embodiments, after anchoring the patch to the leaflet, the clasp can be transitioned toward an open state to release the portion of the leaflet having the patch anchored thereto from the clasp.

[0517] In some embodiments, in the gripped state, the upstream support and the downstream support are closer to each other than in the open state.

[0518] In some embodiments: the ventricular anchor is a first ventricular anchor, the downstream assembly further comprises a second ventricular anchor, and / or the tether tethers the patch to both the first ventricular anchor and the second ventricular anchor.

[0519] In some embodiments, the patch comprises a first component of a sheet material, and a second component of the sheet material is shaped to extend away from the patch in a manner to define a tether.

[0520] In some embodiments, the clasp includes a grasping indicator that is flexibly connected to the upstream support in such a manner that the portion of the leaflet moves the grasping indicator relative to the upstream support in a manner detectable by fluoroscopy when the portion of the leaflet is grasped between the upstream support and the downstream support.

[0521] In some embodiments, the patch anchor is coupled to the patch in a manner that facilitates anchoring the patch to a portion of the leaflet by: (i) allowing the driver to temporarily move the patch anchor away from the patch while the patch anchor remains coupled to the patch, and / or (ii) biasing the patch anchor to return toward the patch.

[0522] In some embodiments, the delivery tool is configured such that a steerable portion of the shaft distal to the clasp can be steered via manipulation of an extracorporeal proximal portion of the delivery tool.

[0523] In some embodiments, the implant is mounted or mountable on a delivery tool such that the tether extends from the downstream component along the shaft, through the clasp, and to the patch.

[0524] In some embodiments, the clasp is disposed completely laterally from the shaft in both the open state and the grasping state.

[0525] In some embodiments, the ventricular anchor comprises a helical tissue engaging element.

[0526] In some embodiments, the tether extends from the downstream component to the patch and back to the downstream component.

[0527] In some embodiments, the ventricular anchor is a first ventricular anchor, the downstream assembly further comprises a second ventricular anchor, and / or the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0528] In some embodiments, the implant comprises an upstream component comprising a patch and a patch anchor, and / or a tether slidably coupled to the upstream component.

[0529] In some embodiments, the upstream component defines an eyelet, and the tether is slidably coupled to the upstream component by passing through the eyelet.

[0530] In some embodiments, the downstream component includes a capstan coupled to the ventricular anchor, and the tether is arranged in a pulley arrangement wherein: (i) a first end of the tether is operably coupled to the capstan, (ii) a loop of the tether is slidably coupled to the upstream component, and / or (iii) a second end of the tether is secured to the downstream component.

[0531] In some embodiments, the capstan has a housing fixedly attached to the ventricular anchor, and the second end of the tether is secured to the housing.

[0532] In some embodiments, the patch has a lip region, and wherein the tether is attached to the patch via two lateral lines that diverge away from the tether and each other and attach to opposite lateral locations in the lip region.

[0533] In some embodiments, the tether is attached to the patch via two lateral wires such that tension applied to the tether deflects the patch medially, the patch being configured to resiliently deflect medially.

[0534] In some embodiments, the system further comprises a medial wire connecting the tether to a medial location in the lip region in a manner that limits the extent to which tension applied to the tether causes the patch to flex medially.

[0535] In some embodiments, the downstream assembly further comprises a capstan, the ventricular anchor is a capstan anchor coupled to the capstan, and / or the tether tethers the capstan to the patch.

[0536] In some embodiments, the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to a downstream assembly in a manner that configures the drive shaft subassembly to: (i) anchor the capstan anchor to ventricular tissue of the heart by applying an anchoring force to the capstan anchor, and / or (ii) actuate the capstan independently of applying the anchoring force.

[0537] In some embodiments, the drive shaft subassembly includes a reference force tube extending through the shaft and engaging with a downstream component, and / or one or more drive shafts extend through the reference force tube to the downstream component, and the drive shaft subassembly is configured to actuate the capstan by applying torque to the capstan when the reference force tube provides a reference force to the downstream component.

[0538] In some embodiments, the downstream assembly and the delivery tool are configured to facilitate the delivery tool rotating the capstan anchor relative to the shaft without actuating the capstan.

[0539] In some embodiments, the actuator is configured to anchor the patch to a portion of the leaflet by driving the patch anchor through the portion of the leaflet grasped by the clasp.

[0540] In some embodiments, the patch anchor is a toggle that is biased to automatically widen upon deployment.

[0541] In some embodiments, the toggle has a honeycomb structure that is biased to automatically widen by shortening.

[0542] In some embodiments, the delivery tool is configured to anchor the downstream component to the ventricular tissue by anchoring the ventricular anchor to the ventricular tissue of the ventricle.

[0543] In some embodiments, the ventricular anchor comprises a tissue engaging element (e.g., one or more of a screw, spiral, dart, pin, hook, staple, barb, arm, sharpened portion, etc.), and the delivery tool is configured to anchor the downstream component to the ventricular tissue by driving the tissue engaging element into the ventricular tissue.

[0544] In some embodiments, the implant is mounted or mountable on the delivery tool such that the ventricular anchor is disposed at the distal end of the shaft.

[0545] In some embodiments, the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to a downstream assembly in a manner that configures the drive shaft subassembly to anchor the ventricular anchor to ventricular tissue by applying an anchoring force to the ventricular anchor.

[0546] In some embodiments, the delivery tool comprises a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool can be advanced transluminally to the heart while the downstream components are housed within the capsule.

[0547] In some embodiments, the capsule comprises a shield formed from an elastic polymer.

[0548] In some embodiments, the capsule further comprises a housing having a plurality of fingers that are flexible, circumferentially distributed to approximate a tubular shape, and embedded within the shield.

[0549] In some embodiments, the downstream component further includes a capstan, the ventricular anchor is a capstan anchor coupled to the capstan, and the delivery tool further includes a drive shaft subassembly comprising one or more drive shafts extending through the shaft and / or being operably coupled to the downstream component in a manner such that the drive shaft subassembly is configured to drive (e.g., screw, rotate, push, etc.) the tissue engaging element into the ventricular tissue (e.g., screw the tissue engaging element into the ventricular tissue) by applying torque to the capstan anchor without rotating the capstan relative to the ventricular tissue.

[0550] In some embodiments, the distal portion of the delivery tool is coupled to the implant in a manner that configures the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue by applying torque to the capstan anchor without rotating the capstan relative to the shaft.

[0551] In some embodiments, the delivery tool comprises a capsule coupled to a distal end of the shaft, the distal portion of the delivery tool being advanceable through the cavity into the heart while the downstream components are housed within the capsule, and / or (ii) the capsule and capstan are configured to inhibit rotation of the capstan relative to the shaft as the drive shaft subassembly threads the tissue engaging element into the ventricular tissue.

[0552] In some embodiments, the capsule defines a track with which the capstan engages when received by the capsule, and / or the capsule and downstream assembly configure the drive shaft subassembly to thread the tissue engaging element into the ventricular tissue as the downstream assembly is advanced distally out of the capsule while the capstan slides linearly along the track.

[0553] In some embodiments, the track is a lateral opening in the capsule, the capstan defines an aperture, the tether extends out of the capstan through the aperture and extends to the patch, and / or the aperture protrudes into the lateral opening to configure the drive shaft subassembly to advance the downstream assembly distally out of the capsule while the aperture of the capstan slides linearly along the lateral opening to screw the tissue engaging element into the ventricular tissue.

[0554] In some embodiments, the capsule comprises a housing housing the capstan and defining a lateral opening, and / or an elastomeric shield covering the housing.

[0555] In some embodiments, the shield covers a distal region of the lateral opening, leaving a proximal region of the lateral opening exposed to define a window of the capsule, and / or a distal portion of the delivery tool can be advanced transluminally to the heart with the downstream components contained within the capsule and the orifice exposed at the window.

[0556] In some embodiments, the shield defines a slit extending distally from the window that is aligned with the lateral opening.

[0557] In some embodiments, the protrusion of the orifice into the lateral opening configures the drive shaft subassembly to advance the downstream assembly distally out of the capsule while the orifice of the capstan screws the tissue engaging element into the ventricular tissue in a manner that momentarily separates the shield at the slit as the orifice slides linearly along the lateral opening.

[0558] In some embodiments, the implant comprises an upstream component comprising a patch anchor coupled to the patch.

[0559] In some embodiments, the upstream assembly further comprises a cord via which the patch anchor is coupled to the patch.

[0560] In some embodiments, the patch anchor is a toggle anchor.

[0561] In some embodiments, the toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel, and / or the cord is connected to the toggle anchor via the lateral eyelet in such a way that tensioning the cord extends the heel away from the lateral eyelet.

[0562] In some embodiments, the toggle anchor has a sharp point, and / or the cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord simultaneously (i) extends the heel away from the lateral eyelet and (ii) retracts the point toward the lateral eyelet.

[0563] In some embodiments, the toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel. In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet. In some embodiments, the system further comprises a retrieval line that passes through the toggle anchor in such a manner that tensioning the retrieval line retracts the heel toward the lateral eyelet.

[0564] In some embodiments, the toggle anchor further includes a spring configured to bias the heel to extend away from the lateral eyelet.

[0565] In some embodiments, the toggle anchor has a sharp point, and the spring is configured to bias the point to retract toward the lateral eyelet.

[0566] In some embodiments, the toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel. In some embodiments, a first segment of the toggle anchor defines a tip, and / or a second segment of the toggle is slidably coupled to the first segment.

[0567] In some embodiments, the system further comprises a longitudinal member extending through the lateral eyelet and connected to the toggle anchor in such a manner that pulling the longitudinal member axially slides the second segment relative to the first segment.

[0568] In some embodiments, the second section of the toggle anchor defines a heel.

[0569] In some embodiments, the driver is configured to push the forward-most tip of the toggle anchor through a portion of the leaflet, the driver having a driver head and a rod extending proximally from the driver head, the driver head being connected to the heel via complementary geometry in a manner that: (i) preferentially allows the toggle anchor to deflect relative to the driver rather than lateral translation, and (ii) allows the heel to disconnect from the driver when the toggle anchor reaches a predetermined angle relative to the driver.

[0570] In some embodiments, the driver head has a first distal-facing surface and defines a shoulder defining a second distal-facing surface proximal to the first surface. In some embodiments, at the heel portion, the toggle anchor defines a lateral opening, and the shoulder protrudes through the lateral opening, such that the driver is configured to urge the anterior-most tip of the toggle anchor through a portion of the leaflet by: (i) the second distal-facing surface urging the toggle anchor distally at the lateral opening, and (ii) the first distal-facing surface urging the toggle anchor distally substantially opposite the lateral opening.

[0571] In some embodiments, the toggle anchor defines a lateral opening at the heel, and the shoulder projects through the lateral opening to allow the toggle anchor to be disconnected from the driver by deflecting about a point on the driver proximal to the second distal-facing surface, causing the lateral opening to move laterally away from the shoulder.

[0572] In some embodiments, the driver head defines a knob, and the knob is connected to the neck of the shaft. In some embodiments, at the heel, the toggle anchor defines an appendage that extends proximally beyond the knob and extends proximally from the knob, toward each other, and medially toward the neck, such that the appendage inhibits proximal retraction and lateral translation of the driver from the toggle anchor.

[0573] In some embodiments, the toggle anchor defines appendages that extend proximally beyond the knob and extend proximally from the knob, toward each other, and medially toward the neck, such that deflection of the toggle anchor relative to the driver pushes the knob between the appendages, causing the appendages to deflect laterally away from each other and away from the neck.

[0574] In some embodiments, the driver head defines a socket having an edge. In some embodiments, the toggle anchor defines a knob at the heel. In some embodiments, the knob is disposed in the socket in a manner that inhibits lateral translation of the toggle anchor from the driver.

[0575] In some embodiments, deflection of the toggle anchor relative to the driver presses the rim against the toggle anchor in a manner that pries the knob distally out of the socket.

[0576] In some embodiments, the tether is coupled to the upstream component such that pulling the tether pulls the cord in a manner that draws the patch anchor toward the patch.

[0577] In some embodiments, the upstream component includes a one-way mechanism through which the cord extends, the one-way mechanism being: (i) mounted on the patch, (ii) configured to facilitate passage of the cord through the one-way mechanism in a first direction that pulls the patch anchor toward the patch, and / or (iii) configured to inhibit passage of the cord through the one-way mechanism in a second direction opposite to the first direction.

[0578] In some embodiments, the upstream assembly is configured such that pulling the tether pulls the cord in a first direction through the one-way mechanism.

[0579] In some embodiments, the delivery tool is configured to pull the tether such that the tether pulls the cord through the one-way mechanism in a first direction.

[0580] In some embodiments, the delivery tool is configured to pull the tether by moving the downstream component away from the upstream component and subsequently anchoring the patch to a portion of the leaflet.

[0581] In some embodiments, the patch anchor has a tip having a sharp point (ie, is sharpened to a point) and is configured to be driven through the leaflet by an actuator, wherein the sharp point penetrates the leaflet.

[0582] In some embodiments, the delivery tool further comprises a hollow needle, and the patch anchor is configured to be driven through the leaflet by the actuator while disposed within the hollow needle.

[0583] In some embodiments, the delivery tool further comprises a hollow needle configured to pierce the valve leaflets, and the actuator is configured to drive the patch anchor out of the hollow needle as the hollow needle extends through the valve leaflets.

[0584] In some embodiments, the patch anchor includes a toggle defining an eyelet midway along the toggle, the cord being attached to the patch anchor at the eyelet.

[0585] In some embodiments, the eyelet extends completely laterally through the toggle.

[0586] In some embodiments, the toggle is substantially tubular with sidewalls defining a lumen.

[0587] In some embodiments, the upstream assembly further includes a spring configured to tension the cord.

[0588] In some embodiments, the spring is a compression spring.

[0589] In some embodiments, the spring lies substantially flat relative to the patch.

[0590] In some embodiments, the spring is configured to be instantaneously strained by tension applied to the cord in response to the actuator pushing the patch anchor away from the patch and through the leaflets, thereby facilitating the actuator driving the patch anchor through the leaflets.

[0591] In some embodiments, the spring is coupled to the sheet in such a way that the patch contracts linearly instantaneously with instantaneous strain of the spring.

[0592] In some embodiments, the spring is coupled to the sheet in such a way that the spring slides across the sheet as the spring momentarily strains.

[0593] In some embodiments, the patch has a lip and a root, the actuator is configured to anchor the root of the patch to the leaflet such that the lip of the patch extends toward the opposite leaflet of the valve, and / or the patch includes at least one frame defining: (i) a lip support at the lip of the patch, and / or (ii) a root support at the root of the patch.

[0594] In some embodiments, the spring is configured such that the transient strain substantially comprises a transient compression of the spring between the lip support and the root support.

[0595] In some embodiments, at least one frame defines a patch anchor support coupled to the root stent, the cord extending from the spring through the patch anchor support to the patch anchor.

[0596] In some embodiments, the tether is connected to the lip support.

[0597] In some embodiments, a spring is attached to the root support.

[0598] In some embodiments, the spring extends from the root support to the lip support.

[0599] In some embodiments, the spring extends along the midline of the patch from the root support to the lip support.

[0600] In some embodiments, the spring does not extend to the lip support.

[0601] In some embodiments, the clasp defines a slot, and the actuator is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet and the slot.

[0602] In some embodiments, the slot is defined by a downstream support of the clasp.

[0603] In some embodiments, the clasp defines a slot guard configured to block cardiac tissue from entering the slot.

[0604] In some embodiments, the patch is coupled to the patch anchor via a tether, and the slot guard: (i) is elastic, (ii) has a rest position in which the slot guard covers the entrance to the slot, thereby blocking cardiac tissue from entering the slot, and / or (iii) is momentarily deflectable from the slot by the tether, thereby facilitating exit of the tether from the slot.

[0605] In some embodiments, the free end of the slot guard is tucked under the downstream support.

[0606] In some embodiments, the delivery tool further comprises a capsule located at the distal end of the shaft, the capsule being configured to house the downstream components.

[0607] In some embodiments, the capsule comprises a shield formed from an elastic polymer.

[0608] In some embodiments, the capsule further comprises a housing having a plurality of fingers that are flexible, circumferentially distributed to approximate a tubular shape, and embedded within the shield.

[0609] In some embodiments, the capsule is shaped to define a lateral window therein.

[0610] In some embodiments, the capsule is shaped to define a narrow slit extending between the lateral window and the open distal end of the capsule.

[0611] In some embodiments, the delivery tool has an extracorporeal proximal portion that includes a clasp controller operably coupled to the clasp such that operation of the clasp controller transitions the clasp between an open state and a grasping state.

[0612] In some embodiments, the clasp controller is operably coupled to an upstream support of the clasp such that operation of the clasp controller transitions the clasp between the open state and the grasped state via movement of the upstream support relative to the shaft.

[0613] In some embodiments, the extracorporeal proximal portion further comprises a driver controller operably coupled to the driver such that operation of the driver controller causes the driver to anchor the patch anchor to the leaflet.

[0614] In some embodiments, (i) within the distal portion of the delivery tool, the shaft has a proximal component and a distal component, and / or (ii) the proximal portion of the delivery tool outside the body further includes a shaft extender, which is operably connected to the shaft such that operation of the shaft extender reversibly extends the distal component of the shaft from the proximal component of the shaft.

[0615] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects the downstream support relative to the shaft.

[0616] In some embodiments, the delivery tool includes a frame that defines a downstream support member, and / or a first component of the frame is attached to a proximal component of the shaft and a second component of the frame is attached to a distal component of the shaft, such that adjusting the extent to which the distal component of the shaft extends from the proximal component of the shaft causes the downstream support member to deflect relative to the shaft.

[0617] In some embodiments, the distal component of the shaft includes a steerable component, and the first component of the frame and the second component of the frame are attached to the proximal component of the shaft and the second component of the shaft, respectively, such that extending the distal component of the shaft distally from the proximal component of the shaft beyond a threshold range causes the frame to pull the distal component of the shaft to deflect.

[0618] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects both the downstream support and the upstream support relative to the shaft.

[0619] In some embodiments, the clasp is coupled to the shaft such that extending the distal portion of the shaft distally from the proximal portion of the shaft deflects both the downstream support and the upstream support relative to the shaft without changing the arrangement between the downstream support and the upstream support.

[0620] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects both the downstream support and the upstream support relative to the shaft while the clasp remains in a grasping state.

[0621] In some embodiments, the extracorporeal proximal portion further includes an anchor controller, and / or the delivery tool further includes a drive shaft subassembly, wherein the drive shaft subassembly includes one or more drive shafts extending through the shaft, and the drive shaft subassembly is configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the anchor controller to the ventricular anchor such that operation of the anchor controller applies an anchoring force to the ventricular anchor.

[0622] In some embodiments, the downstream component further includes a capstan, the ventricular anchor is a capstan anchor coupled to the capstan, the tether tethers the capstan to the patch, and / or the extracorporeal proximal portion further includes a capstan controller, the drive shaft subassembly being configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the capstan controller to the capstan such that operation of the capstan controller actuates the capstan.

[0623] In some embodiments, the drive shaft subassembly includes: (i) a winch control drive shaft, through which the winch controller is operably connected to the winch, and / or (ii) an anchor control drive shaft, through which the anchor control drive shaft is set, and the anchor controller is operably connected to the anchor via the anchor control drive shaft.

[0624] In some embodiments: (A) the downstream component further includes a capstan, and the ventricular anchor is a capstan anchor coupled to the capstan, (B) the drive shaft subassembly includes a downstream component controlling the drive shaft, (C) the system has an anchored state, in which the anchor controller controls the drive shaft via the downstream component to be operably coupled to the capstan anchor such that operation of the anchor controller applies an anchoring force to the capstan anchor, and / or (D) the system has a twisted state, in which the downstream component controls the drive shaft: (i) to be operably decoupled from the capstan anchor such that operation of the anchor controller does not apply an anchoring force to the capstan anchor, and / or (ii) to be operably coupled to the capstan such that the downstream component controls rotation of the drive shaft to actuate the capstan.

[0625] In some embodiments, the downstream component includes a shaft that is axially movable within the downstream component such that: (i) positioning the shaft in a first axial position within the downstream component places the system in an anchored state, and (ii) positioning the shaft in a second axial position within the downstream component places the system in a twisted state.

[0626] In some embodiments, the first axial position is distal to the second axial position.

[0627] In some embodiments, the system further has a mid-range state in which the downstream assembly controls the drive shaft to be coupled to the downstream assembly but operably decoupled from both the winch anchor and the winch.

[0628] In some embodiments, (i) in the anchored state, the downstream component controls the drive shaft to be set at a first axial position relative to the downstream component, (ii) in the twisted state, the downstream component controls the drive shaft to be set at a different second axial position relative to the downstream component, and / or (iii) the delivery tool can be converted between the anchored state and the twisted state via the downstream component controlling the axial movement of the drive shaft relative to the downstream component.

[0629] In some embodiments, the first axial position is distal to the second axial position, and / or the delivery tool can control proximal movement of the drive shaft relative to the downstream component via the downstream component to transition from the anchored state to the twisted state.

[0630] In some embodiments, the delivery tool further comprises a mounting member configured to support the patch mounted thereon and configured to carry the patch toward the clasp when the clasp is in the grasping state.

[0631] In some embodiments, the mounting member is configured to carry the patch toward the upstream support of the clasp by moving distally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

[0632] In some embodiments, the mounting member is configured to carry the patch toward the upstream support of the clasp by moving distally and laterally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

[0633] In some embodiments, the delivery tool comprises a beam that provides a mechanical linkage between the shaft and the mount that couples distal movement of the mount with lateral movement of the mount.

[0634] In some embodiments, the mount has a retracted position in which the distal portion of the delivery tool can be advanced through the cavity to the heart when the mount is in the retracted position and the patch is mounted on the mount, the mount has an initial position in which the mount is positioned closer to the hook than in the retracted position, and / or the drive is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet when the mount is in the initial position and the patch is mounted on the mount.

[0635] In some embodiments, the mounting member defines a passageway therein. In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the mounting member in the retracted position and the patch mounted on the mounting member and the patch anchor disposed within the passageway.

[0636] In some embodiments, the actuator is configured to anchor the patch to the portion of the leaflet by driving the patch anchor out of the channel and through the portion of the leaflet.

[0637] In some embodiments, the delivery tool comprises a needle disposed within the passageway. In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the mount in the retracted position and the patch mounted on the mount and the patch anchor disposed within the needle within the passageway.

[0638] In some embodiments, the delivery tool is configured to facilitate the driver driving the patch anchor through a portion of the leaflet by pushing the needle out of the channel.

[0639] In some embodiments, the delivery tool further comprises a spring that biases the needle to retract into the channel.

[0640] In some embodiments, the delivery tool further includes a mount lever operably coupled to the mount in a manner that configures the mount lever to transition between a retracted position and an initial position.

[0641] In some embodiments, the mount lever is operably coupled to the mount by coupling to the needle.

[0642] In some embodiments, the mount lever is operably coupled to the mount such that pushing the needle from the retracted position by the mount lever urges the mount toward the initial position via a spring.

[0643] In some embodiments, the mount lever is operatively coupled to the mount such that when the mount is in the initial position, pushing the needle by the mount lever strains the spring and pushes the needle out of the channel.

[0644] In some embodiments, the delivery tool comprises a spring configured to bias the mounting member toward the initial position.

[0645] In some embodiments, the spring is a spring-loaded beam that provides a mechanical linkage between the shaft and the mount and biases the mount toward the initial position by biasing the mount to move distally and laterally.

[0646] In some embodiments, the driver comprises a rod and a driver head, the driver head being coupled to the mount such that tension on the rod constrains the mount in the retracted position.

[0647] In some embodiments, the patch anchor and the drive head are positioned within a channel defined in the mounting member, removing tension on the rod allows the spring to move the mounting member to an initial position, and / or when the mounting member is in the initial position, pushing the rod causes the drive head to move through the channel and deploy the patch anchor out of the channel.

[0648] In some embodiments, the clasp is transitionable between an open state and a gripping state while the mounting member is maintained in the retracted position.

[0649] In some embodiments, the delivery tool has an extracorporeal proximal portion comprising a mount controller operably coupled to the mount such that operation of the mount controller moves the mount between the retracted position and the initial position.

[0650] In some embodiments, the delivery tool further comprises a mount control lever via which the mount controller is operably coupled to the mount.

[0651] In some embodiments, the extracorporeal proximal portion further comprises a driver controller operably coupled to the driver such that operation of the driver controller causes the driver to drive the patch anchor through the leaflet.

[0652] In some embodiments, the mount control rod is tubular and the actuator extends from the actuator controller through the mount control rod.

[0653] In some embodiments, the extracorporeal proximal portion of the delivery tool further comprises a clasp controller operably coupled to the clasp such that operation of the clasp controller transitions the clasp between the open state and the grasping state.

[0654] In some embodiments, the delivery tool further comprises a clasp control wire via which the clasp controller is operably coupled to the mount.

[0655] In some embodiments, the mount controller is configured to move the mount between the retracted position and the initial position by sliding the mount over and along the clasp control wire toward the clasp when the clasp is in the grasping state.

[0656] In some embodiments, the clasp controller is configured to transition the clasp from the grasping state to the open state by retracting the clasp control wire through the mounting member when the mounting member is in the retracted position.

[0657] In some embodiments, the delivery tool further comprises one or more wraps, and a distal portion of the delivery tool can be advanced transluminally into the heart while the mount is in a retracted position and the patch is held against the mount by the one or more wraps wrapped around the patch and the mount.

[0658] In some embodiments, the distal portion of the delivery tool can be advanced transluminally to the heart with the mount in the retracted position and the patch held against the mount by one or more wraps wrapped around the patch, mount, and shaft.

[0659] In some embodiments, the delivery tool further comprises one or more spring-loaded brackets configured to keep the wrap taut.

[0660] In some embodiments, the delivery tool further comprises a rod that cooperates with the spring-loaded bracket to keep the wraps taut and that is retractable to release one or more wraps.

[0661] In some embodiments, in the retracted position, the mount is bent into an arc midway around the axis.

[0662] In some embodiments, the mounting member has a convex outer surface, and the patch is mounted on the mounting member in a manner such that the patch lies in a curvilinear position against the convex outer surface of the mounting member.

[0663] In some embodiments, the mounting member is shaped to receive the patch anchor when the patch is mounted on the mounting member.

[0664] In some embodiments, a patch anchor is coupled to the patch, and the system is configured such that receipt of the patch anchor by the mount secures the patch to the mount.

[0665] In some embodiments, the patch is connected to the patch anchor via a tether and is secured to the surface of the mounting member by the patch anchor being disposed in a channel defined in the surface of the mounting member, the channel being shaped to: (i) facilitate sliding of the patch anchor along the channel, and / or (ii) prevent the patch anchor from moving laterally out of the channel.

[0666] In some embodiments, the actuator is configured to anchor the patch to the leaflet by driving the patch anchor along the channel out of the end of the channel and through the leaflet when the mount is in an initial position and the patch is mounted on the mount.

[0667] In some embodiments, the cord extends laterally from the patch anchor out of the channel to the patch.

[0668] In some embodiments, the shaft is telescopic within a distal portion of the delivery tool, and the delivery tool has a delivery state in which: (i) the shaft is telescopically extended, (ii) the hook faces distally, and / or (iii) the distal portion of the delivery tool is advanceable transluminally into the heart.

[0669] In some embodiments, in the delivery state, the downstream support is deflected distally compared to the open state.

[0670] In some embodiments, in the delivery state, the downstream support is disposed adjacent to and substantially parallel to the shaft.

[0671] In some embodiments, in the delivery state, the clasp is closed.

[0672] In some embodiments, the delivery tool has a collapsed state in which: the shaft is telescopically collapsed, and / or the clasp faces proximally.

[0673] In some embodiments, the distal portion of the delivery tool is configured to be advanced downstream through the valve when in the contracted state.

[0674] In some embodiments, in the retracted state, the clasp is closed.

[0675] In some embodiments, in the collapsed state, the downstream support is deflected proximally compared to the expanded state.

[0676] In some embodiments, in the retracted state, the clasp extends laterally further from the shaft than in the open state.

[0677] In some embodiments, the extracorporeal proximal portion of the delivery tool further comprises a shaft extender operably coupled to the shaft such that operation of the shaft extender reversibly extends the distal component of the shaft distally from the proximal component of the shaft.

[0678] In some embodiments, the clasp is coupled to the shaft such that extending the distal component of the shaft distally from the proximal component of the shaft deflects the downstream support relative to the shaft.

[0679] In some embodiments, the patch is substantially trapezoidal.

[0680] In some embodiments, (i) the patch has a lip and a root, (ii) the actuator is configured to anchor the root of the patch to the leaflet such that the lip of the patch extends toward the opposite leaflet of the valve, and / or (iii) the lip is longer than the root.

[0681] In some embodiments, the delivery tool further comprises a retrieval wire releasably coupled to the anchor such that tensioning the retrieval wire facilitates de-anchoring the patch anchor from the leaflet.

[0682] In some embodiments: (A) the patch anchor comprises a tubular toggle and comprises a retrieval feature comprising a notch at the heel of the toggle and a retrieval eyelet, and / or (B) the retrieval wire: (i) extends colinearly with the toggle at the heel of the toggle into the lumen of the toggle, (ii) exits the side wall of the toggle via the retrieval eyelet, and / or (iii) loops back upon itself via the notch to connect to itself.

[0683] In some embodiments, the retrieval wire is releasably coupled to the anchor such that tensioning the retrieval wire facilitates unanchoring the patch anchor from the leaflet by reorienting the patch anchor.

[0684] According to some embodiments, a system and / or device for use with a valve positioned between an atrium and a ventricle of a subject's heart, the valve having a first leaflet and a second leaflet, and the system / device includes an implant comprising a leaflet reinforcement patch and / or a patch anchor.

[0685] The leaflet reinforcement patch may comprise a flexible sheet and / or a frame supporting the flexible sheet.

[0686] In some embodiments, the patch anchor can be coupled to the patch in a manner that facilitates anchoring the patch to the first leaflet by allowing the patch anchor to temporarily move away from the patch while the patch anchor remains coupled to the patch, and / or biasing the patch anchor to return toward the patch.

[0687] In some embodiments, the patch anchor has a sharpened tip and is configured to be driven through the first leaflet, wherein the sharpened tip penetrates the first leaflet.

[0688] In some embodiments, the patch anchor is configured to be driven through the first leaflet while positioned within the hollow needle.

[0689] In some embodiments, the patch anchor comprises a tubular toggle and includes a retrieval feature comprising a notch at the heel of the toggle and a retrieval eyelet, the system / device further comprising a retrieval line that: (i) extends colinearly with the toggle at the heel of the toggle into the lumen of the toggle, (ii) exits the side wall of the toggle via the retrieval eyelet, and / or (iii) loops back onto itself via the notch to connect to itself.

[0690] In some embodiments, the implant comprises: (i) an upstream component comprising a patch and a patch anchor; (ii) a downstream component comprising a ventricular anchor; and / or (iii) a tether tethering the patch to the ventricular anchor.

[0691] In some embodiments: the ventricular anchor is a first ventricular anchor, the downstream assembly further comprises a second ventricular anchor, and / or the tether tethers the patch to both the first ventricular anchor and the second ventricular anchor.

[0692] In some embodiments, the tether extends from the downstream component to the patch and back to the downstream component.

[0693] In some embodiments, the ventricular anchor is a first ventricular anchor, the downstream assembly further comprises a second ventricular anchor, and / or the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0694] In some embodiments, the tether is slidably coupled to the upstream component.

[0695] In some embodiments, the upstream component defines an eyelet, and the tether is slidably coupled to the upstream component by passing through the eyelet.

[0696] In some embodiments, the downstream component includes a capstan coupled to the ventricular anchor, and the tether is arranged in a pulley arrangement wherein: (i) a first end of the tether is operably coupled to the capstan, (ii) a loop of the tether is slidably coupled to the upstream component, and / or (iii) a second end of the tether is secured to the downstream component.

[0697] In some embodiments, the capstan has a housing fixedly attached to the ventricular anchor, and the second end of the tether is secured to the housing.

[0698] In some embodiments, the patch anchor is a toggle that is biased to automatically widen upon deployment.

[0699] In some embodiments, the toggle has a honeycomb structure that is biased to automatically widen by shortening.

[0700] In some embodiments, the system / device further includes a delivery tool configured to deliver the implant to the heart and anchor the patch anchor to the first leaflet by: (i) anchoring the patch anchor to the first leaflet by temporarily moving the patch anchor away from the patch while the patch anchor remains connected to the patch, and / or (ii) subsequently releasing the patch anchor such that the implant responsively returns the patch anchor toward the patch.

[0701] In some embodiments, the delivery tool is configured to move the patch anchor away from the patch by driving the patch anchor through the first leaflet.

[0702] In some embodiments, the implant comprises an upstream component comprising a patch and a patch anchor, the implant further comprising: (i) a downstream component comprising a capstan coupled to a capstan anchor, the capstan anchor being configured to anchor the downstream component to tissue of the ventricle; and / or (ii) a tether tethering the capstan to the patch.

[0703] In some embodiments, the patch comprises a first component of a sheet material, and a second component of the sheet material is shaped to extend away from the patch in a manner to define a tether.

[0704] In some embodiments, the implant further comprises a cord via which the patch anchor is coupled to the patch.

[0705] In some embodiments, the patch includes a spring, and the patch anchor is coupled to the spring in a manner that biases the patch anchor back toward the patch.

[0706] In some embodiments, the frame defines a spring. In some embodiments, the spring is a compression spring.

[0707] In some embodiments, the spring is configured to be instantaneously strained by tension applied to the cord in response to pushing the patch anchor away from the patch and through the first leaflet, thereby facilitating driving the patch anchor through the first leaflet.

[0708] In some embodiments, the spring is coupled to the sheet in such a way that the patch contracts linearly instantaneously with instantaneous strain of the spring.

[0709] In some embodiments, the spring is coupled to the sheet in such a way that the spring slides across the sheet as the spring momentarily strains.

[0710] In some embodiments: (A) the patch has a lip and a root, (B) the tether connects the patch anchor to the patch in a manner that anchoring the patch anchor to the first leaflet positions the patch so that the lip of the patch extends toward the second leaflet, and / or (C) the frame defines: (i) a lip support at the lip of the patch, and / or (ii) a root support at the root of the patch.

[0711] In some embodiments, the spring is configured such that the transient strain substantially comprises a transient compression of the spring between the lip support and the root support.

[0712] In some embodiments, the patch defines a root-to-lip axis between the lip and the root along a midline of the patch, and the spring is configured such that the transient strain substantially comprises a deflection of the spring relative to the root-to-lip axis.

[0713] In some embodiments, the spring is configured such that the transient strain substantially comprises a deflection of the spring toward the root to lip axis.

[0714] In some embodiments, the spring is a first spring, and wherein the frame further comprises a second spring, the first and second springs being configured such that the transient strain substantially comprises a deflection of the first and second springs toward each other.

[0715] In some embodiments, at least one frame defines a patch anchor support coupled to the root stent, the cord extending from the spring through the patch anchor support to the patch anchor.

[0716] In some embodiments, the spring is a first spring extending from the root support to the lip support along a first lateral edge of the patch, and / or at least one frame defines a second spring extending from the root support to the lip support along a second lateral edge of the patch.

[0717] In some embodiments, the patch anchor includes a toggle defining an eyelet substantially midway along the toggle, the cord being attached to the patch anchor at the eyelet.

[0718] In some embodiments, the system / device further comprises a retrieval wire extending from an end of the toggle member and configured to de-anchor the patch anchor from the first leaflet when the retrieval wire is tensioned.

[0719] In some embodiments, the sidewall defines two lateral apertures adjacent to each other, and the eyelet is defined by a portion of the sidewall disposed between the two lateral apertures.

[0720] According to some embodiments, a system (eg, for use or usable with a valve positioned between an atrium and a ventricle of a subject's heart) comprises an implant and / or a delivery tool.

[0721] In some embodiments, the implant can include a tether and an assembly. In some embodiments, the assembly can include a capstan and / or a capstan anchor coupled to the capstan.

[0722] In some embodiments, the winch can include a housing and a spool disposed therein. A tether can extend from the winch, wherein the spool is operably coupled to the tether such that actuation of the winch tensions the tether.

[0723] In some embodiments, the delivery tool, when coupled to the implant, can have a distal portion that is advanceable transluminally into the heart.

[0724] In some embodiments, a delivery tool can include a drive shaft subassembly including a reference force tube coupled to a housing, and / or a drive shaft. The drive shaft can extend through the reference force tube.

[0725] In some embodiments, the system can have an anchored state in which the drive shaft is: (i) operably coupled to the winch anchor such that rotation of the drive shaft applies an anchoring force to the winch anchor, and / or (ii) operably decoupled from the winch such that rotation of the drive shaft does not actuate the winch.

[0726] In some embodiments, the system can have a twisted state in which the drive shaft is: (i) operably decoupled from the capstan anchor such that rotation of the drive shaft does not apply an anchoring force to the capstan anchor, and / or (ii) operably coupled to the capstan such that rotation of the drive shaft actuates the capstan.

[0727] In some embodiments, the system further has a mid-range state in which the drive shaft is coupled to the implant but operably decoupled from both the capstan anchor and the capstan.

[0728] In some embodiments, the assembly includes a shaft that is axially movable within the assembly such that: (i) positioning the shaft in a first axial position within the assembly places the system in an anchored state, and / or (ii) positioning the shaft in a second axial position within the assembly places the system in a twisted state.

[0729] In some embodiments: (i) in the anchored state, the drive shaft is disposed in a first axial position relative to the capstan, (ii) in the twisted state, the drive shaft is disposed in a second, different axial position relative to the capstan, and / or (iii) the delivery tool is transitionable between the anchored state and the twisted state via axial movement of the drive shaft relative to the capstan.

[0730] In some embodiments, the first axial position is distal to the second axial position, and / or the delivery tool is transitionable from the anchored state to the capstan state via proximal movement of the drive shaft relative to the capstan.

[0731] According to some embodiments, a system (e.g., for use with or usable with tissue of a subject) includes a toggle anchor and / or a delivery tool. In some embodiments, the toggle anchor can have a tip and a heel and can define an anchor axis therebetween. The toggle anchor and / or delivery tool can be the same or similar to any toggle anchor and / or delivery tool described herein.

[0732] In some embodiments, the delivery tool can define a channel in which the toggle anchor is disposed.The delivery tool can include a driver configured to push the forward-most tip of the toggle anchor distally out and away from the channel.

[0733] In some embodiments, the driver can have a drive head and / or a shaft extending proximally from the drive head.

[0734] In some embodiments, the driver head can be connected to the heel via complementary geometry in a manner that: (i) preferentially allows the toggle anchor to deflect relative to the driver rather than lateral translation, and / or (ii) allows the heel to disconnect from the driver when the anchor reaches a predetermined angle relative to the driver.

[0735] In some embodiments, the driver head defines a knob, and the knob is connected to the neck of the shaft. In some embodiments, at the heel, the toggle anchor defines an appendage that extends proximally beyond the knob and extends proximally from the knob, toward each other, and medially toward the neck, such that the appendage inhibits proximal retraction and lateral translation of the driver from the toggle anchor.

[0736] In some embodiments, the toggle anchor defines appendages that extend proximally beyond the knob and extend proximally from the knob, toward each other, and medially toward the neck, such that deflection of the toggle anchor relative to the driver pushes the knob between the appendages, causing the appendages to deflect laterally away from each other and away from the neck.

[0737] In some embodiments, the driver head defines a socket having an edge. In some embodiments, the toggle anchor defines a knob at the heel. In some embodiments, the knob is disposed in the socket in a manner that inhibits lateral translation of the toggle anchor from the driver.

[0738] In some embodiments, deflection of the toggle anchor relative to the driver presses the rim against the toggle anchor in a manner that pries the knob distally out of the socket.

[0739] In some embodiments, the driver further includes a stabilizer configured such that pushing the tip of the toggle anchor against tissue by the driver causes the stabilizer to move relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor to a stable position, wherein the stabilizer inhibits deflection of the toggle anchor relative to the driver when in the stable position.

[0740] In some embodiments, the system further comprises a cord attached to the toggle anchor.

[0741] In some embodiments, the system includes an implant comprising a toggle anchor, a cord, and another component, the cord connecting the other component to the toggle anchor such that the toggle anchor is configured to anchor the other component to tissue.

[0742] According to some embodiments, a system includes an implant and / or a delivery tool.In some embodiments, the implant can include a toggle anchor having a body, a tip, and a heel, the toggle anchor defining an anchor axis between the tip and the heel.

[0743] In some embodiments, the system can include an extendable member. In some embodiments, the system can be configured such that the extendable member responsively slides axially relative to the body when the driver pushes the tip of the toggle anchor against tissue.

[0744] In some embodiments, the extendable member is a component of a delivery tool. In some embodiments, the extendable member is a component of a toggle anchor.

[0745] In some embodiments, the system defines a sharp point configured to penetrate tissue in a manner that facilitates the driver to push the forward tip of the toggle anchor through the tissue. In some embodiments, the system has a rest state in which the sharp point is functionally obscured.

[0746] In some embodiments, the system is configured such that when the driver pushes the tip of the anchor against tissue, the extendable member automatically functionally exposes the sharp point by sliding axially relative to the body.

[0747] In some embodiments, the sharp point is defined by the tip of the toggle anchor. In some embodiments, in a rest state, the extendable member functionally obscures the sharp point. In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member automatically functionally exposes the sharp point by sliding proximally away from the sharp point.

[0748] In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp point by sliding into the interior of the toggle anchor.

[0749] In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp point by sliding over an exterior of the toggle anchor.

[0750] In some embodiments, the sharp point is defined by an extendable member. In some embodiments, in a resting state, the toggle anchor functionally obscures the sharp point. In some embodiments, the system is configured such that when the driver pushes the tip of the toggle anchor against tissue, the extendable member automatically slides distally beyond the tip, thereby functionally exposing the sharp point.

[0751] According to some embodiments, a system and / or device includes an implant comprising a toggle anchor and / or a longitudinal member. In some embodiments, the toggle anchor can have a tip, a heel, and an anchor axis between the tip and the heel, and can define a lateral eyelet midway between the tip and the heel.

[0752] In some embodiments, the toggle anchor can include a first segment defining a tip and / or a second segment slidably coupled to the first segment. In some embodiments, the second segment can define a heel.

[0753] In some embodiments, the longitudinal member can extend through the lateral eyelet and / or can be connected to the toggle anchor in such a manner that pulling the longitudinal member causes the second section to slide axially relative to the first section.

[0754] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member slides the heel toward the lateral eyelet.

[0755] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that pulling the longitudinal member extends the heel away from the first segment such that the lateral eyelet becomes disposed substantially midway between the toggle anchor's tip and heel.

[0756] In some embodiments, the longitudinal member is attached to the attachment point of the toggle anchor and / or before the longitudinal member is pulled, the longitudinal member defines a path including at least one turn between the lateral eyelet and the attachment point.

[0757] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that axial sliding of the second segment relative to the first segment is accompanied by sliding of the longitudinal member out of the lateral eyelet.

[0758] In some embodiments, the second section is telescopically coupled to the first section, and wherein the longitudinal member is connected to the toggle anchor in such a manner that pulling the longitudinal member causes the second section to telescopically slide relative to the first section.

[0759] In some embodiments, the second segment is coupled to the first segment such that the second segment is axially slidable within the first segment.

[0760] In some embodiments, the toggle anchor includes a spring that biases the second segment toward a predetermined axial position relative to the first segment.

[0761] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member increases the axial length of the toggle anchor by sliding the second section relative to the first section.

[0762] In some embodiments, the longitudinal member is connected to the toggle anchor in such a way that pulling the longitudinal member reduces the axial length of the toggle anchor by sliding the second section relative to the first section.

[0763] According to some embodiments, a system and / or device comprises an implant comprising a toggle anchor and / or a cord.In some embodiments, the toggle anchor can have a tip, a heel, and a lateral eyelet midway between the tip and the heel.

[0764] In some embodiments, the cord can be connected to the toggle anchor via the lateral eyelet in such a way that tensioning the cord extends the heel away from the lateral eyelet.

[0765] In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord simultaneously (i) extends the heel away from the lateral eyelet and (ii) retracts the point toward the lateral eyelet.

[0766] In some embodiments, the toggle anchor comprises: (i) a body defining a lumen and a lateral eyelet, the lateral eyelet opening into the lumen; and / or (ii) a shank, at least a portion of which is disposed within the lumen.

[0767] In some embodiments, the cord extends through the lateral eyelet to the anchor such that tensioning the cord simultaneously extends the heel and retracts the point by sliding the anchor relative to the body.

[0768] In some embodiments, the anchor is shaped to define a heel and a point.

[0769] In some embodiments, the cord extends through the lateral eyelet and the transverse passage in the anchor and is attached to a side of the body opposite the lateral eyelet.

[0770] Any of the above methods, as well as any methods using the systems, components, devices, apparatus, etc. herein, can be performed on a living subject (e.g., a human or other animal) or on a simulated object (e.g., a cadaver, a cadaver heart, a virtual human, a simulator, etc.). In the case of a simulated object, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, computerized and / or physical representations.

[0771] Any of the above-described systems, components, devices, equipment, parts, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and the methods herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) one or more systems, devices, equipment, parts, etc. herein (or the additional method includes or consists of such sterilization).

[0772] The present invention will be more fully understood by reading the following detailed description of the embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0773] Figure 1A -B, 2A-R, 3A-B, 4A-C, 5A-B, and 6A-C are schematic diagrams of exemplary systems and exemplary techniques for using the same to treat a subject's heart, according to some embodiments;

[0774] Figure 7A - C is a schematic diagram of an exemplary grip indicator according to some embodiments;

[0775] Figure 8A 9A-B and 9A-B are schematic diagrams of exemplary steerable versions of a delivery vehicle according to some embodiments;

[0776] Figure 10A - B is a schematic diagram of an exemplary patch anchor according to some embodiments;

[0777] Figure 11A - B is a schematic diagram of an exemplary patch anchor according to some embodiments;

[0778] Figure 12 is a schematic diagram of at least a portion of an exemplary implant according to some embodiments;

[0779] Figure 13 is a schematic diagram of at least a portion of an exemplary implant according to some embodiments;

[0780] Figure 14 and 15A - B is a schematic diagram of an exemplary implant and techniques for use therewith, according to some embodiments;

[0781] Figure 16 、 17 , 18A-B, and 19A-D are schematic diagrams of exemplary implants according to some embodiments, wherein one or more ventricular anchors are connected to an upstream component via multiple stretches of a tether;

[0782] Figure 20A-E is a schematic diagram of a distal region of an exemplary delivery tool for an implant, according to some embodiments;

[0783] Figure 21A -E is a schematic diagram of some components of an exemplary drive shaft subassembly and downstream components of an implant according to some embodiments;

[0784] Figure 22A -C, 23A-D, 24A-C, 25A-E, 26A-E, 27A-D, 28A-B, 29A-D, 30A-B, 31A-D, 32A-B, 33A-D, 34A-B, and 35A-C are schematic diagrams of various patch anchors and / or anchor drivers according to some embodiments;

[0785] Figure 36A - C is a schematic diagram of a patch anchor in the form of a helical coil according to some embodiments;

[0786] Figure 37A - C is a schematic diagram of a technique for coupling a tether to components of an implant, according to some embodiments;

[0787] Figure 38A - E and 39 are schematic diagrams of techniques for coupling two components of a system thereto via a tether, according to some embodiments;

[0788] Figure 40A -C, 41A-C, and 42 are schematic diagrams of various systems and techniques for preventing inadvertent withdrawal of a patch anchor through cardiac tissue, according to some embodiments;

[0789] Figure 43A - B is a schematic illustration of a kirigami wrapping of components for holding an implant against a delivery tool, according to some embodiments;

[0790] Figure 44A - B is a schematic diagram of a shock absorbing spring for a ventricular anchor according to some embodiments;

[0791] Figure 45 and 46 is a schematic diagram of a torque limiter for preventing over-tensioning of a tether according to some embodiments;

[0792] Figure 47A -B is a schematic diagram of exemplary downstream components according to some embodiments;

[0793] Figure 48A - D is a schematic diagram of an exemplary coupling of a drive shaft subassembly to a downstream component according to some embodiments; and

[0794] Figure 49 、50A -B, 51A-B, 52A-B, and 53A-B are schematic illustrations of a proximal portion of a delivery tool according to some embodiments. DETAILED DESCRIPTION

[0795] refer to Figure 1A -B, 2A-R, 3A-B, 4A-C, 5A-B, and 6A-C are schematic diagrams of an exemplary system 100 and exemplary techniques for using the system to treat a subject's heart 4, according to some embodiments. In particular, the system 100 is used to reduce (e.g., eliminate) regurgitation through the atrioventricular valve 7 of the heart caused by suboptimal coaptation of the leaflets of the valve. The system 100 includes an implant 150 and a delivery tool 400 for delivering and implanting the implant.

[0796] Figure 1A The system 100 is shown with an exploded view of the delivery tool 400 shown with the implant 150 separated therefrom. Figure 1B The assembled system 100 is shown with the implant 150 loaded onto a delivery tool 400. The implant 150 includes a patch 210 (e.g., a leaflet reinforcement patch) and may also include at least one patch anchor 240. In the example shown, the implant 150 includes two patch anchors 240. The patch 210 and the patch anchors 240 can be considered to be components of the upstream component 200 of the implant 150. The implant 150 also includes a downstream component 300 and a tether 160 that tethers the downstream component to the upstream component 200.

[0797] In some embodiments, the tether 160 comprises suture. In some embodiments, the tether 160 comprises a flexible and / or superelastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt-chromium alloy. In some embodiments, the tether 160 is coated with polytetrafluoroethylene (PTFE).

[0798] Figure 1B Illustration A of FIG uses transparency to illustrate the frame 230 within the patch 210, while illustration B does not use this transparency for clarity. Illustration B is a view of the device from the opposite side to that shown in illustration A. Figure 1B FIGURE C inset shows a cross section of tool 400. It should be noted that for simplicity, in this cross section, shaft 410 (described below) is shown as solid, even though it is tubular and other components such as drive shaft subassembly 490 (e.g., a drive shaft of the drive shaft subassembly) may extend through the shaft.

[0799] The patch 210 comprises a flexible sheet 220 and may further comprise at least one frame 230 to which the sheet is attached. The sheet 220 may comprise a polymer, such as polyethylene, expanded polytetrafluoroethylene, or polyethylene terephthalate. The sheet 220 may have a fabric or film structure. The frame 230 may provide the patch 210 with mechanical properties that the sheet 220 alone cannot provide. Such properties will be described in more detail below. Although the present disclosure generally refers to the sheet 220 in the singular, the patch 210 may comprise more than one sheet arranged in layers, such as a frame 230 disposed between the sheets. (This may alternatively be described as a sheet 220 comprising multiple layers, i.e., a multilayer sheet.) In some embodiments, the composition and / or structure of the sheet 220, the techniques for manufacturing the sheet, and / or the techniques for incorporating the frame 230 into the patch 210 may be as described (mutatis mutandis) in U.S. Provisional Patent Application No. 63 / 341,354 to Vaid et al., filed on May 12, 2022, and / or International Patent Application No. PCT / US2023 / 021399 to Vaid et al., filed on May 8, 2023, each of which is incorporated herein by reference in its entirety.

[0800] The implant 150 (e.g., its upstream component 200) can be provided with at least one patch anchor 240 coupled to the patch 210, for example, as shown. However, in some embodiments (e.g., for some variations of the implant 150 and / or system 100), anchoring of the patch can include coupling the patch anchor to the patch in situ (e.g., driving the patch anchor through the patch).

[0801] The downstream component 300 includes an anchor 310 (e.g., a ventricular anchor) for anchoring to ventricular tissue. The downstream component 300 may also include a capstan 320 coupled to the anchor 310, e.g., the capstan is disposed within the head of the anchor or forms a portion of the head of the anchor. Thus, for embodiments in which the downstream component 300 includes a capstan 320, the anchor 310 may be considered a capstan anchor. The capstan anchor 310 has a tissue engaging element 312 (e.g., one or more of a screw, spiral, dart, pin, hook, nail, barb, arm, sharpened portion, etc.) that may be configured to be driven into the tissue. In some embodiments, the tissue engaging element 312 is configured to be driven into the tissue along the anchor axis ax2 of the capstan anchor. In the example shown, the tissue engaging element 312 is a spiral tissue engaging element configured to be screwed into the tissue along the axis ax2. However, it should be noted that the capstan anchor 310 may include different types of tissue engaging elements, such as, but not limited to, darts, pins, hooks, spikes, barbs, arms, and the like.

[0802] The winch 320 includes a spool 322 (see, for example, Figures 3A-4C ), as shown, the spool may be mounted so that the spool and / or the axis of rotation of the spool is co-linear with the anchor axis ax2. However, other spool orientations are possible.

[0803] The tether 160 can be coupled to the patch 210 and extend from the patch to the capstan 320, thereby tethering the capstan to the patch. As shown, the tether 160 can enter the capstan 320 via a lateral aperture 326 in the capstan's housing 321 and / or can reach the spool 322 in an orientation substantially orthogonal to the anchor axis ax2. Although the housing 321 is referred to as the housing of the capstan 320, in some embodiments, it can be considered the housing of the downstream component 300.

[0804] The tether 160 is operably coupled to the winch 320 such that actuation of the winch can adjust the effective length of the tether, ie, the length of the tether between the winch and the patch 210 .

[0805] The delivery tool 400 has a distal portion 404 that can be advanced transluminally (e.g., transfemorally) to the heart and can have an extracorporeal proximal portion 402 that can include a handle and / or controls via which an operator (e.g., a physician) can control (e.g., steer, actuate, etc.) components at the distal portion of the tool, e.g., to deliver and implant the implant 150. The delivery tool 400 includes a shaft 410, a clasp 430, and at least one driver 450.

[0806] The delivery tool 400 can include an outer tube 406 defining a primary lumen 407 through which a shaft 410 extends. The outer tube 406 can also define one or more auxiliary lumens 408 that provide communication with the distal portion 404, e.g., for extending one or more other components of the delivery tool 400 therethrough.

[0807] The shaft 410 defines the longitudinal axis ax1 of the delivery tool 400. In some embodiments, as shown, the shaft 410 (and the lumen 407 through which the shaft extends) is eccentric relative to the outer tube 406, and therefore even if the longitudinal axis ax1 is centered relative to the shaft 410, it may not be centered relative to the delivery tool 400 as a whole. In the example shown, the auxiliary lumen 408 is generally provided on one side of the main lumen 407, for example, the auxiliary lumen is circumferentially distributed around the main lumen at an angle of less than 220 degrees (e.g., less than 200 degrees, such as 180 degrees). This arrangement can advantageously facilitate the effective inclusion of the clasp 430 within the overall diameter of the delivery tool 400. For example, and as shown, the clasp 430 can be provided on the same side of the shaft 410 as the auxiliary lumen 408, but distal to the distal end of the auxiliary lumen.

[0808] The shaft 410 (eg, its distal end) can be advanced into the ventricle 8 downstream of the valve 7 (eg, as described in more detail below). Figure 1B As shown, the shaft 410 (e.g., its distal end) is coupled to the downstream assembly 300 of the implant 150. As described in more detail below, this coupling configures the delivery tool 400 to: (i) anchor the capstan anchor 310 to the ventricular tissue of the heart by applying an anchoring force to the capstan anchor; and (ii) for embodiments in which the downstream assembly 300 includes a capstan 320, actuate the capstan. That is, the delivery tool 400 (e.g., one or more components thereof) can remain coupled to the downstream assembly 300 throughout the anchoring of the capstan anchor 310 and the actuation of the capstan 320. In addition, and as described in more detail below, the delivery tool 400 is capable of actuating the capstan 320 independently of applying an anchoring force to the capstan anchor 310.

[0809] The clasp 430 includes a downstream support 434 and, in some embodiments, may also include an upstream support 432. The clasp 430 is convertible between (i) an open state and (ii) a grasping state (e.g., a closed state). In the open state, the clasp 430 is configured to receive a portion of a leaflet (e.g., leaflet 10) of the valve 7. For example, in the open state, the upstream support 432 and the downstream support 434 may be positioned away from each other to receive a portion of the leaflet between the upstream support and the downstream support. The clasp 430 is configured to grasp the portion of the leaflet (grasped between the upstream support and the downstream support) by transitioning from the open state to the grasping state when the portion of the leaflet is disposed within the clasp (between the upstream support 432 and the downstream support 434). In the grasping state, the upstream support 432 and the downstream support 434 may be closer to each other than in the open state. In some embodiments, in the grasping state, in the absence of obstacles (e.g., the portion of the leaflet), the upstream support 432 and the downstream support 434 are in contact with each other, e.g., pressed against each other.

[0810] The driver 450 is configured to anchor the patch 210 to the leaflet (e.g., to the portion of the leaflet that is captured between the upstream support 432 and the downstream support 434) using the patch anchor 240, for example, by driving the patch anchor through the leaflet. Figures 1A-5B(and other figures) illustrate a configuration in which (i) the patch anchor 240 is a toggle anchor having a tip 250 with a sharp point or edge (i.e., sharpened to a point / edge); and (ii) the driver 450 is configured to drive the patch anchor through the leaflet by pushing the heel 252 of the patch anchor distally while the patch anchor is substantially co-linear with the driver and / or with the push vector, e.g., the patch anchor is not disposed within a needle. However, the scope of the present disclosure includes instances in which a needle is used (e.g., a modification of system 100), e.g., the patch anchor 240 can be disposed within and advanced from a needle that punctures the leaflet, e.g., the tip 250 can lack a sharp point / edge.

[0811] In some embodiments, the tool 400 includes a capsule 470 at the distal end of the shaft 410. The capsule 470 is configured to house the downstream component 300 of the implant 150 during delivery and implantation of the implant. In some embodiments, the capsule 470 is sized to conceal the tissue engaging element 312 to reduce the likelihood of inadvertent engagement of tissue with the tissue engaging element and / or damage to tissue during transluminal advancement of the distal portion 404 of the tool 400.

[0812] The capsule 470 has an open distal end 471 through which the downstream assembly 300 can be deployed. In some embodiments in which the capstan 320 (e.g., its housing 321) has a lateral aperture 326 through which the tether 160 passes, the capsule 470 can define a lateral window 474 to allow the tether to reach the capstan, for example, by accommodating the downstream assembly 300 in an orientation in which the lateral window 474 is aligned with the aperture 326.

[0813] Capsule 470 can be an integral component, or as shown, can include a shell 472 and a shield 476. Shield 476 can cover the distal component of shell 472, and can even extend distally beyond shell to form a rim 477. Shield 476 can be formed by a material softer and / or more flexible than the material of shell 472 (e.g., shield can include polymers or silicone) to reduce the possibility of injuring tissue. In some embodiments in which shield 476 extends distally beyond shell to form rim 477, the rim can therefore be used as an atraumatic tip, which may be particularly advantageous for placing capsule 470 against ventricular tissue during driving the tissue engaging elements 312 of anchor 310 to ventricular tissue.

[0814] In some embodiments, the housing 472 itself can also be configured to contribute to the atraumatic nature of the capsule 470. For example, and as shown, the distal component of the housing 472 can be defined by a plurality of fingers 473 that are circumferentially distributed (e.g., parallel to each other) to approximate a tubular shape but with gaps therebetween. For such embodiments, the fingers 473 can be embedded within the shield 476. By forming in this manner, the distal component of the housing 472 can be more flexible than being substantially tubular (e.g., without gaps between the fingers). Thus, when the distal capsule 470 is pressed against ventricular tissue, the housing 472, and therefore the capsule, can flex responsively, e.g., without injuring the tissue.

[0815] In some embodiments, capsule 470 defines an elongated lateral opening extending proximally from the distal opening of the housing (e.g., opening toward the distal opening of the housing). For example, in some embodiments in which capsule 470 includes a housing 472 and a shield 476, the housing can define an elongated lateral opening 475 extending proximally from the distal opening of the housing (e.g., opening toward the distal opening of the housing). For such embodiments, and as shown, shield 476 can substantially cover the distal region of elongated lateral opening 475, such that window 474 is defined by the proximal region of the elongated lateral opening, i.e., proximally from the shield. For some such embodiments, shield 476 defines a narrow slit 478 extending between the distal opening of the shield (which can serve as the open distal end 471 of capsule 470) and window 474. Slit 478 can be aligned with elongated lateral opening 475.

[0816] The elongated lateral openings 475 , the fingers 473 , and / or the slits 478 may be substantially parallel to the axis ax1 .

[0817] The narrow slit 478 is configured to facilitate passage of the tether 160 therethrough during deployment of the downstream component 300 from the capsule 470, but also to reduce the likelihood of adverse interaction with tissue during advancement of the capsule into the ventricle (e.g., chordae tendineae being inadvertently captured within the elongated lateral openings 475) compared to other similar capsules having only the elongated lateral openings 475.

[0818] The narrow slit 478 is narrower than the elongated lateral opening 475 and can be less than 1 mm wide. In some embodiments, the narrow slit 478 is closed at rest, e.g., its sides are in contact with each other, and is configured to separate momentarily when the tether 160 passes between the sides during deployment of the downstream component 300 from the capsule 470.

[0819] Implant 150 is loaded onto delivery tool 400, with upstream assembly 200 positioned proximally of downstream assembly 300. As shown, upstream assembly 200 can be secured laterally from shaft 410. In some embodiments, and as shown, upstream assembly 200 is mounted on mounting member 440, which can be positioned laterally from shaft 410. For such embodiments, such mounting of upstream assembly 200 can position patch 210 against the surface of mounting member 440. For some such embodiments, mounting member 440 can have a convex outer surface (e.g., the mounting member can be substantially arcuate, curving midway along shaft 410), and patch 210 can be positioned in a curved line against the convex outer surface of the mounting member, for example, as shown. In some embodiments, patch 210 is held against mounting member 440 in this manner by one or more wraps 442 wrapped around the patch and mounting member. For some such embodiments, and as shown, wraps 442 also wrap around shaft 410, thereby securing patch 210 to the shaft. As described in more detail below, the mount 440 is configured to carry the patch 210 toward the clasp 430 .

[0820] In some embodiments, and as shown (e.g., in Figure 1B B), each wrap 442 comprises a flexible loop (e.g., a closed loop) that itself surrounds the patch 210 so as to form: (i) a pair of longitudinal sections 442L that extend around the patch, and (ii) two loops 442B, each of which connects the end of one of the longitudinal sections in the pair to the end of the other longitudinal section in the pair. For each wrap 442, one of the loops is secured to a bracket 444, and a rod 446 extends through the other of the loops, thereby holding the wrap around the patch. The bracket 444 can be spring-loaded, thereby keeping the wrap 442 taut. In some embodiments, and as shown, the orientation of the wrap 442 and bracket 444 arrangements alternates so that the rod 446 is held in place. To release the wrap 442 (e.g., to release the patch 210 from being held against the mount 440 by the wrap), the rod 446 is retracted. This is referred to in the context of implantation of implant 150. Figure 2I However, it should be noted that other types of windings may be used.

[0821] As shown, the tether 160 can be attached (e.g., fixedly attached) to a lip region of the patch 210, for example, at or near a lip 211 of the patch. As described in more detail below, the lip 211 is the edge of the patch that, after implantation, is positioned farthest from the root of the leaflet to which the patch is secured. Additionally, the lip 211 can also be the edge of the patch farthest from the patch anchor 240. The patch 210 can also be considered to have a root region, for example, at or near a root edge 212 of the patch. The root edge 212 is the edge of the patch opposite the lip 211, and, as described in more detail below, after implantation, the root edge is positioned closest to the root of the leaflet to which the patch is secured. The patch anchor 240 can be positioned in the root region of the patch 210, for example, at or near the root edge 212. The patch 210 may also have lateral edges on opposite sides of the patch, such as two lateral edges 213 ′ and 213 ″. The lateral edges of the patch 210 may extend between the lip edge 211 and the root edge 212 .

[0822] In some embodiments, and as shown, the patch 210 is wider (e.g., the distance between the lateral edges 213' and 213" is greater) toward the lip edge 211 (e.g., at the lip edge) than toward the root edge 212 (e.g., at the root edge). For example, the patch 210 can be approximately trapezoidal in shape (e.g., an isosceles trapezoid), with the lip edge 211 being the longer base of the trapezoid and the root 212 being the shorter base of the trapezoid.

[0823] The implant 150 can be loaded onto the delivery tool 400, wherein the patch 210 can be oriented so that the lip 211 is proximate to the root 212, for example, as shown. In this orientation, in embodiments where the tether 160 is attached to the lip region of the patch 210, the tether can therefore extend past the root edge 212 and alongside the patch on its way from the patch to the lip region. For example, and as shown, a portion 161 of the tether 160 can extend alongside the patch on the side of the patch facing the axis 410 (e.g., on the concave side of the patch). In some embodiments where the delivery tool 400 includes a mounting member 440, a portion 161 of the tether 160 can be disposed (e.g., sandwiched) between the patch and the mounting member, for example, as shown. Figure 1B shown.

[0824] In some embodiments, instead of or in addition to the patch 210 being held against a surface of the mounting member 440 (e.g., by wrap 442), the patch can be secured to the tool 400 (e.g., to the mounting member) via a patch anchor 240. For example, the mounting member 440 can be shaped to accommodate the patch anchor 240 (or can include one or more components configured to engage the patch anchor). In the illustrated example, the mounting member 440 is shaped to define channels (e.g., grooves) 448 that are shaped to receive the patch anchors 240 (e.g., one channel per patch anchor). As shown, the channels 448 can be defined in a lateral / convex surface of the mounting member 440, i.e., the surface against which the patch 210 is typically positioned.

[0825] In some embodiments, the channels 448 can be shaped to allow the patch anchor 240 to slide along the channels, but to prevent the patch anchor from moving laterally out of the channels. For example, each channel 448 can be implemented to be narrower at the surface of the mounting member than at a deeper level in the mounting member. For example, as shown, each channel 448 can have a cross-sectional shape of a major circular arc segment, the chord of which is open at the surface of the mounting member, for example, as shown. (It will be understood that non-circular equivalents can also be used, mutatis mutandis.) Therefore, in some embodiments in which the implant 150 is provided with a patch anchor 240 coupled to the patch 210, positioning the patch anchor 240 within the channels 448 will secure the patch to the mounting member 440. Figure 2I -K discusses this dependency.

[0826] In some embodiments in which the implant 150 is provided with a patch anchor 240 coupled to the patch 210, such coupling is provided by a cord 242, e.g., each patch anchor is coupled to the patch by a respective cord. For example, each patch anchor 240 can define an eyelet 244 passing through at least one sidewall (e.g., through only one sidewall, or through the entire anchor) through which the cord 242 is attached to the patch anchor. The eyelet 244 can be located approximately midway along the anchor 240 and / or can be a pair of eyelets.

[0827] In some embodiments where the patch anchor 240 is disposed in the channel 448 and where the channel is shaped to inhibit the patch anchor from exiting the channel laterally, each cord 242 extends away from its patch anchor (e.g., substantially orthogonal to the anchor axis of the patch anchor) by exiting the channel laterally to the patch 210, thereby securing the patch 210 to the mount 440. This is for example Figure 2I Visible in.

[0828] In some embodiments, and as shown, the patch anchor 240 can be provided with a retrieval feature 241 (e.g., a retrieval eyelet) to which a retrieval line can be releasably attached. The retrieval feature 241 can be provided at the heel 252 of the patch anchor or at another location. Examples of such retrieval lines and retrieval features are described in more detail below.

[0829] In some embodiments, the delivery tool 400 is configured such that the mount 440 is movable between a retracted position and an initial position. Figure 1B The mounting member 440 is shown in its retracted position, which is also typically the position of the mounting member during transluminal advancement of the distal portion 404 of the tool 400, e.g., as shown in FIG. Figure 2A As shown. In the initial position ( Figure 2J ), the mounting member 440 is closer to the clasp 430 than in the retracted position and can be in contact with the clasp (e.g., with its upstream support 432). As described in more detail below, the actuator 450 can be configured to drive the patch anchor 240 through the leaflet when the mounting member is in the initial position, for example, as Figure 2K shown.

[0830] In some embodiments where a wrap 442 is used, the wrap can hold the patch 210 against the mount 440 when the mount is in its retracted position. In some embodiments, the wrap 442 is released before the mount 440 is moved to its initial position, e.g., Figure 2I As shown in .

[0831] In some embodiments, and as Figure 2B As shown in , in the retracted position of the mount 440, the channel 448 is substantially parallel to the axis ax1. In some embodiments, and as Figure 2J As shown, in the initial position of the mount 440, the passage 448 is inclined relative to the axis ax1, for example, due to deflection of the mount during transition toward its initial position.

[0832] In some embodiments in which the patch anchor 240 is arranged in the channel 448, the driver 450 is configured to anchor the patch to the leaflet (as described below) by driving the patch anchor out of the distal end of the channel. For some such embodiments, the driver 450 enters the channel via the proximal end of the channel. In some embodiments, the delivery tool 400 is provided with a distal end (e.g., a drive head) of the driver 450 already arranged in the channel 448. In some embodiments, the driver 450 only abuts the patch anchor 240, while for other embodiments, the drive head is configured to engage and / or grasp the anchor (e.g., the drive head and / or the anchor include features that facilitate engagement and / or grasping of the anchor by the drive head).

[0833] As described above, the delivery tool 400 includes at least one actuator 450. In the example shown, the tool 400 includes one actuator 450 per patch anchor 240, such as two actuators.

[0834] The extracorporeal proximal portion 402 may include one or more controllers. Figure 1A The representation of these controllers is purely schematic, and each of these controllers can be or can include a knob, wheel, lever, slider, or other control element or interface through which an operator (e.g., a physician) can operate tool 400 to deliver and implant implant 150, for example using the techniques described herein.

[0835] In some embodiments, the proximal portion 402 includes a clasp controller 110 that is operably coupled to the clasp 430 (e.g., coupled to its upstream support 432) such that operation of the clasp controller transitions the clasp between its open state and its gripping (e.g., closed) state. This operative coupling can be provided by a wire 130 coupled to the upstream support 432.

[0836] In the example shown, two wires are used (e.g., parallel to each other), although as shown, these wires can be formed from a single length of wire that is looped through the upstream support 432 and folded back on itself. The clasp controller 110 is operated to pull the wire 130 by moving (e.g., deflecting) the upstream support 432 relative to the downstream support 434 and typically also relative to the shaft 410 to transition the clasp 430 between its open state and its gripping state. For example, the clasp 430 can be biased (e.g., spring-loaded) toward being in its gripping state, the clasp can be opened by pulling (e.g., tensioning) the wire 130, and the clasp can be closed simply by releasing the tension on the wire, for example, thereby allowing the clasp to be biased (e.g., spring-loaded) to responsively transition the clasp toward its gripping state.

[0837] In some embodiments, the proximal portion 402 includes a driver controller 112 that is operably coupled to the drivers 450 such that operation of the driver controller causes the drivers to drive the patch anchors 240 through the leaflets to which the upstream assembly 200 is to be anchored. In the example shown, operation of the driver controller 112 pushes the drivers 450 distally, causing each driver to push the heel of the corresponding patch anchor 240 distally.

[0838] The proximal portion 402 can include a mount control 116 operably coupled to the mount 440 such that operation of the mount control moves the mount between its retracted position and its initial position. This operative coupling can be provided by one or more mount control rods 136, the distal ends of which can be secured to the mount 440. In some embodiments, the mount control rods 136 extend through a dedicated auxiliary lumen 408. In some embodiments, each mount control rod 136 can be tubular and can share an auxiliary lumen with another control component of the tool 400, e.g., with another control component that extends through a tubular mount control rod. For example, and as shown, the driver 450 can extend through the mount control rod 136. Alternatively, the mount control rod 136 can be non-cannulated, e.g., can operate substantially parallel to the driver 450.

[0839] In some embodiments, within the distal portion 404, the shaft 410 has a proximal component 411 and a distal component 412 that are axially slidable relative to each other, for example, in a telescoping arrangement, as shown. For some such embodiments, the proximal portion 402 includes a shaft controller 114 (e.g., a shaft extender) that is operably coupled to the shaft 410 such that operation of the shaft controller reversibly extends the distal component of the shaft from the proximal component to the distal component of the shaft. It should be noted that the distal component 412 can extend proximally at least as far as the proximal component 411, but is still referred to as a "distal" component because it extends further distally than the proximal component.

[0840] It should be noted that the functionality of the various controls of the proximal portion 402 may be separated into single function controls or combined into multi-function controls.

[0841] The proximal portion 411 can be tubular, for example, to accommodate the distal portion 412. The distal portion 412 can be tubular, for example, to accommodate one or more drive shafts that control the downstream assembly 300, for example, as described below.

[0842] In some embodiments, the hook 430 (e.g., its downstream support 434) is coupled to the shaft 410 such that distal extension of the distal component 412 from the proximal component 411 causes the downstream support 434 to move (e.g., deflect) relative to the shaft. For example, the delivery tool 400 can include one or more frame elements 436 (e.g., arms, extensions, straps, ribbons, wedges, sheets, etc.) coupled to the shaft 410 and cooperating therewith to define a mechanical linkage that moves (e.g., deflects) the downstream support 434 relative to the shaft. In the illustrated example, a single frame element 436 preconfigured to bend or articulate in a particular manner (e.g., using a flexure joint) provides this functionality. One end of the frame element is coupled to the proximal component 411 of the shaft, and the other end of the frame element is coupled to the distal component 412 of the shaft. It should be noted that a similar effect can be achieved by using multiple frame elements that are articulated (e.g., hingedly) coupled to each other.

[0843] In some embodiments, and as shown, a unitary piece of anchor material defines an upstream support member 432, a downstream support member 434, and a flexure joint 433 that articulates the upstream support member to the downstream support member. For such embodiments, and as further shown, the downstream support member 434 is secured to a region 435 of a frame member 436. However, it should be understood that for other embodiments, the downstream support member 434 may be simply defined by the region 435, e.g., the unitary piece of anchor material may define the frame member 436 and the downstream support member 434. For such other embodiments, the upstream support member 432 may be formed from a single piece of material and articulately coupled to the downstream support member 434.

[0844] In some embodiments, in the absence of tension on the wire 130, axial movement of the distal component 412 relative to the proximal component 411 can move (e.g., deflect) both the downstream support 434 and the upstream support 432 relative to the shaft 410. For example, the clasp 430 can be biased (e.g., spring-loaded) toward its gripping state and can remain in that state (e.g., can remain constant between the upstream support 432 and the downstream support 434) as the downstream support moves (e.g., deflects) relative to the shaft 410. Figure 1B and 2A A condition is shown in which the distal component 412 is fully extended such that the downstream support 434 and, due to the lack of tension on the wire 130, the upstream support 432 are directed distally, eg, with the clasp 430 in its grasping condition.

[0845] In some embodiments, and as shown, the clasp 430 defines one or more slots 437 through which the actuator 450 is configured to actuate the patch anchors 240 (e.g., one slot per patch anchor). In some embodiments, the slots 437 are defined by the downstream support 434 (whether as part of an integral piece of anchor material that also defines the upstream support 432, or as part of the frame element 436). That is, the downstream support 434 provides an opposing force during actuation of the patch anchor 240 through the leaflet, and the patch anchor is positioned to pass through the downstream support at the slots 437, e.g., as described with reference to FIG. Figure 2K -L is described in more detail. As will also be described in more detail below, this causes the cord 242 to pass through the slot 437. In order to allow the cord 242 to exit the slot 437 laterally, but prevent tissue (e.g., chordae tendineae) from entering and being captured in the slot, the hook 430 (e.g., its downstream support 434) can define or include at least one slot guard 438, for example, a respective slot guard for each slot. In some embodiments, and as shown, the slot guard 438 is resilient, has a rest position in which the slot guard blocks (e.g., completely covers) the entrance to the slot, and can be momentarily deflected away from the slot by the cord exiting the slot, thereby facilitating the exit of the cord from the slot, for example, as described in reference Figure 2L and 6A -C as described.

[0846] It should be noted that the scope of the present disclosure includes variations of system 100 in which (i) the delivery tool 400 comprises one or more needles, (ii) the tip of the patch anchor 240 may not have a sharp point, and (iii) rather than driving the patch anchor directly through the leaflet, the needle penetrates the leaflet and the patch anchor is subsequently advanced out of the needle.

[0847] Now refer to Figure 2A -R, which is a schematic diagram illustrating at least some steps in a technique for treating a valve 7 of a subject's heart, according to some embodiments. Although the technique is shown for use with system 100, in some embodiments, variations of system 100 (e.g., including variations of implant 150 and / or tool 400) and / or other systems may be used instead. Figure 2A In each of 2D and 2F-N, the left image shows the position and / or interaction of the system 100 with the heart, while the right image emphasizes the status of the system itself.

[0848] With the implant 150 loaded on the distal portion 404 of the delivery tool 400, the distal portion is advanced transluminally into the subject's heart 4, e.g., to the atrium 6 upstream of the valve 7. For example, and as shown, the distal portion 404 can be advanced transluminally (e.g., via the inferior vena cava or the superior vena cava) and transseptally into the left atrium of the heart ( Figure 2A ).

[0849] In the example shown, transluminal advancement of the tool 400 is facilitated by one or more catheters 102, 104, one or more of which can be steerable (i.e., actively steerable, e.g., using pull wires or other components known in the art). In some embodiments, the catheter 102 and / or the catheter 104 can be advanced to the atrium, and the tool 400 can then be advanced through the catheter. In some embodiments, the catheter 104 is advanced with at least the tool 400 disposed within the catheter (with the implant 150 mounted thereon). For some such embodiments, the capsule 470 (with the downstream assembly 300 disposed therein) can be disposed externally at the distal end of the catheter 104 during such advancement of the catheter and tool.

[0850] In the example shown, the tool 400 is advanced transluminally in a delivery state ( Figure 2A ). In the delivery state, the patch 210 can be held against the mounting member 440 and / or the shaft 410 by the wrap 442, for example, to facilitate smooth advancement and / or to protect the patch. In some embodiments, and as shown, in the delivery state, the clasp 430 is in a low-profile state. For some such embodiments, and as shown, in the low-profile state, the clasp 430 is normally closed (i.e., in its gripping state), but is deflected distally (i.e., the clasp faces distally and both the upstream support 432 and the downstream support 434 are deflected distally), for example, such that the downstream support 434 is disposed adjacent to and substantially parallel to the shaft 410 (e.g., its distal component 412). As described above, this is achieved by extending the distal component 412 of the shaft 410 from the proximal component 411 (i.e., telescopically extending the shaft), thereby straightening the frame element 436. For other such embodiments, in the low-profile state, the clasp 430 is over-opened such that the upstream support 432 is substantially co-linear with the downstream support 434 (e.g., by extending the distal component 412 while also tensioning the wire 130).

[0851] The low-profile state is advantageous for transluminal advancement, but in some cases, the relatively long configuration of the distal portion 404 resulting from the extended distal component 412 may be detrimental to maneuverability within the heart. Thus, in some embodiments, once the distal portion 404 has passed (e.g., completely passed) through the atrial septum 5 and / or is positioned (e.g., completely positioned) within the atrium 6, the distal portion 404 is transitioned to the retracted state, e.g., by withdrawing the distal component 412 of the shaft 410 into the proximal component 411 (i.e., telescopically retracting the shaft), e.g., by operating the shaft controller 114 ( Figure 2B The clasp 430 is also normally closed in the collapsed state of the distal portion 404, but is proximally deflected (i.e., the clasp faces proximally). Thus, the widest component of the distal portion 404 in the collapsed state (at the level of the clasp 430) is wider than the widest component in the low-profile configuration, but the shorter overall length of the distal portion advantageously promotes a smaller "turning circle" when the distal portion is turned within the heart.

[0852] Subsequently, the distal portion 404 (eg, in its contracted state) is rotated toward the valve 7 ( Figure 2C ), the clasp 430 transitions to its open state in which the upstream support 432 and the downstream support 434 are positioned away from each other and wherein the clasp is configured to receive a portion of the leaflet of the valve between the upstream support and the downstream support ( Figure 2D ).although Figure 2C -D shows the distal portion 404 rotated towards the valve 7 before opening the clasp 430, but it will be appreciated that these steps may be performed in the reverse order, or simultaneously.

[0853] In some embodiments, and as shown, transitioning the clasp 430 to its open state is performed in a single step by partially extending the distal component 412 (thereby deflecting the downstream support 434) while maintaining tension on the wire 130 (thereby keeping the upstream support 432 substantially stationary). However, it should be understood that the scope of the present disclosure encompasses performing the transition in the following discrete steps: (i) while the clasp remains closed, deflecting the entire clasp (e.g., in the downstream direction) so that the clasp (or at least its downstream support 434) is substantially orthogonal to the axis 410 and thus projects maximally laterally, such as by operating the axis controller 114; and (ii) subsequently, transitioning the clasp to its open state by deflecting the upstream support 432 (e.g., by tensioning the wire 130) while the downstream support 434 remains stationary, such as by operating the clasp controller 110.

[0854] exist Figure 2C and Figure 2DThe deflection of the clasp 430 in the transition between the illustrated embodiment and the embodiment of the present invention shows that the distal component 412 is partially extended by proximally retracting the proximal component 411, for example, by maintaining the capsule 470 substantially stationary relative to the anatomy and retracting the patch 210 proximally / upstream relative to the anatomy. However, it should be understood that the extension can also be achieved by maintaining the patch 210 substantially stationary relative to the anatomy and advancing the capsule 470 distally / deeper into the ventricle.

[0855] While the clasp 430 remains in its open state, the distal portion 404 is advanced distally through the valve 7 into the ventricle 8 ( Figure 2E -F). The widest component of the distal portion 404 (e.g., the frame element 436 and / or the downstream support 434) passing through the valve 7 can be identified using imaging techniques (e.g., fluoroscopy and / or ultrasound), for example, because it blocks the movement of the leaflets 10 toward the axis 410 and / or relative to the leaflets during ventricular systole ( Figure 2E ). In addition, subsequent resumption of movement of the leaflets 10 toward the axis 410 and / or relative to the leaflets during ventricular systole can also be identified using such imaging techniques and can indicate that the downstream support members 434 have passed the leaflets 10 sufficiently to facilitate subsequent capture of the leaflets ( Figure 2F ).

[0856] The distal portion 404 is then manipulated to move the clasp 430 to receive a portion of the leaflet 10 ( Figure 2G ). For example, and as shown, distal portion 404 can be moved proximally until leaflet 10 rests on downstream support 434 and / or resists pulling the distal portion into the atrium. With the portion of leaflet 10 retained between upstream support 432 and downstream support 434, clasp 430 closes (transitions toward its gripping state), thereby gripping the portion of leaflet 10 ( Figure 2H As described above, this can be accomplished by pushing the wires 130 distally and / or allowing them to be pulled distally by the upstream support 432.

[0857] In some embodiments where the tool 400 includes a wrap 442, the wrap may be released at this stage (if not released at an earlier stage). Figure 2H The illustration of FIG. 4 shows that the wrap 442 holds the patch 210 securely against the mounting member 440 (not visible). As described above, and as Figure 2H As shown, in some embodiments, the wrap 442 can extend around the shaft 410. For such embodiments, the wrap 442 should therefore be released to facilitate a subsequent step in which the patch 210 carried by the mount 440 is removed from the shaft 410. Figure 2IThe wrap 442 is shown having been released by retraction of the rod 446, and the patch 210 responsively unwound from around the shaft 410. The bracket 444 is shown changing shape in response to the release of tension on the wrap 442.

[0858] In some embodiments, such unwinding of the patch 210 can be passive, e.g., simply in response to movement of blood after its release. In some embodiments, e.g., in some embodiments where the patch 210 includes a frame 230, the frame can include a spring or be otherwise biased to open the patch.

[0859] While the portion of the leaflet 10 remains grasped by the clasp 430, the mounting member 440 is advanced toward the clasp 430, for example, toward its upstream support 432 ( Figure 2J ). This new position of the mount 440 can be considered the "home" position, while the previous position of the mount can be considered the "retracted" position. As shown, the mount control lever 136 can be advanced by operating the mount controller 116 to push the mount onto and along the wire 130 ( Figure 2J ) to advance the mounting member 440 to its initial position.

[0860] It should be noted, and as described above, that although the patch 210 is unwound from around the shaft 410 and / or mount 440, in some embodiments where the patch is coupled to the mount via the anchor 240, the patch may remain coupled to the mount at this stage, e.g., Figure 2I Thus, when the mounting member 440 is advanced toward the clasp 430, the mounting member carries the patch 210 toward the clasp ( Figure 2J ).

[0861] It should be noted that movement of the mounting member 440, and thus the patch 210, toward the clasp 430 may include movement distally and / or downstream. It should also be noted that such movement may also include movement laterally, i.e., away from the shaft 410 toward the open end of the clasp 430. Figure 2H As shown, in some embodiments in which the wire 130 is used to operate the clasp 430, articulation of the upstream support 432 during closure of the clasp can pull the wire laterally. Thus, for some such embodiments in which the mounting member 440 additionally slides along the wire 130, the wire serves as a guide that not only guides the mounting member distally, but also guides the mounting member obliquely (e.g., end-to-end) to the clasp.

[0862] Figure 6A -C also shows from different angles Figure 2K -L. However, for clarity, Figure 6A -C does not show the leaflets 10.

[0863] While (i) the portion of the leaflet 10 remains grasped by the clasp 430, and (ii) the mounting member 440 is disposed at the clasp (i.e., in its initial position), the actuator 450 is used to drive the patch anchor 240 through the leaflet (e.g., through the grasping portion of the leaflet), such as by operating the actuator controller 112, thereby anchoring the patch 210 to the leaflet ( Figure 2K and Figure 6A ). For example, and as shown, the patch anchor 240 can be driven out of the end of the channel 448 and through the leaflet 10 and the slot 437. Assuming that prior to anchoring, the lateral portion of the movement of the mounting member 440 and the patch 210 can advantageously position the patch anchor 240 (and the patch generally) away from the lip of the leaflet 10, i.e., toward the root of the leaflet, and this advantageously enhances the positioning of the patch and / or the reliability of its anchoring.

[0864] The clasp 430 is then reopened and the distal portion 404 is moved away from the patch 210 and the leaflet 10 to which it is anchored ( Figure 2L and Figure 6B -C). It should be noted that this is facilitated by: (i) the automatic release of the patch 210 from the mount 440 as the patch anchor 240 leaves the mount ( Figure 6A and (ii) optionally facilitating lateral exit of the slot by the cord 242 disposed through the slot 437 during anchoring due to the momentary deflection (e.g., away from each other) of the slot guards 438 as the cord slides past when the hook 430 is removed. Figure 6B Once the cord 242 is removed, the slot guards 438 may return to their original resting state, e.g., deflected toward each other ( Figure 6C ).

[0865] In some embodiments, and as shown, for each slot guard 438, the free end of the slot guard can be tucked under another portion of the downstream support 434, such that the slot 437 is effectively completely closed. This can significantly hinder the inadvertent introduction of tissue (e.g., chordae tendineae) into the slot 437, for example, because pushing the slot guard in the direction described will not cause the slot to open. This tuck configuration is Figure 6A -C and Figure 1A This is especially evident in the illustrations.

[0866] Patch 210 can be anchored to leaflet 10 in a manner such that the patch (e.g., its lip 211) overhangs the lip of the leaflet, e.g., extending further into ventricle 8 than the leaflet. Thus, patch 210 can serve as an extension of leaflet 10, advantageously facilitating coaptation with the opposing leaflet after implantation.

[0867] In some embodiments, after the patch 210 is anchored to the leaflet 10, the downstream assembly 300 is anchored to the tissue of the ventricle 8. In some embodiments, for example by operating the axis controller 114, the shaft 410 is extended to reach the ventricular tissue ( Figure 2M ). This can return the clasp 430 to its low-profile state, as shown. In some embodiments, the tethers 160 are released (e.g., unwound) from the capstan 320 at approximately the same time to accommodate the increased distance between the upstream component 200 (e.g., its patch 210) and the downstream component 300 (e.g., its capstan). It can also be advantageous to avoid releasing too many tethers 160 relative to the distance between the downstream component 300 and the upstream component 200 in order to maintain control over the behavior of the tethers in the bloodstream, e.g., to reduce the likelihood of the tethers becoming tangled or stuck on the tool 400. In some embodiments, coordination between advancement of the downstream component 300 and unwinding of the tether 160 can be achieved using the systems, devices and / or techniques described in U.S. Provisional Patent Application No. 63 / 336,489, filed on April 29, 2022, to Pesach et al. and / or International Patent No. PCT / IB2023 / 054169, filed on April 24, 2023, to Pesach et al., each of which is incorporated herein by reference in its entirety.

[0868] Figure 3A is a schematic diagram showing an exploded view of: (i) certain components of the drive shaft subassembly 490 located at the distal portion 404 of the delivery tool 400 and (ii) the downstream assembly 300 . Figure 3B yes Figure 3A An inverted version of the diagram shows an inverted view of each component. Figure 4A -C shows the Figure 3A -Components shown in B, but assembled (e.g., with Figure 1B ) and shown in cross section.

[0869] Once a site in the ventricle has been selected, the downstream assembly 300 is anchored to the site by anchoring the capstan anchor 310 to the tissue, such as by driving the tissue engaging element 312 into the tissue. Figure 2N This can be accomplished by operating the anchor controller 118 at the proximal portion 402. The anchor controller 118 is operably coupled to the capstan anchor 310 such that operation of the anchor controller applies an anchoring force to the capstan anchor ( Figure 4A). For example, the delivery tool 400 can include an anchor control drive shaft 480, which controls the drive shaft to operably couple the anchor controller 118 to the capstan anchor 310. In some embodiments, and as shown, the anchoring force is (or includes) torque, which is applied via the engagement between the anchor control drive shaft 480 and the capstan anchor 310. The capstan anchor 310 can include a driver interface 316, which is a component of the head 314 of the capstan anchor, is defined by the head, or is fixedly coupled to the head. The drive shaft 480 engages the driver interface 316 and applies torque to the driver interface via this engagement. For example, and as shown, the drive shaft 480 can include or define a drive head 483 at the distal end of the drive shaft, the drive head including one or more (e.g., two) convex bodies 484, which are held in engagement with the driver interface 316 by a locking rod 486. In other words, the locking rod 486 locks the engagement between the drive head 483 and the driver interface 316.

[0870] In some embodiments, and as from Figure 2M to Figure 2N As shown in the transition of FIG. 4 , before capstan anchor 310 is advanced out of the capsule, capsule 470 (e.g., rim 477 of capsule shield 476) is placed (e.g., pressed) against ventricular tissue such that tissue engaging elements 312 are not exposed from the capsule at any time, thereby advantageously reducing the likelihood of catching and / or damaging tissue. It should be noted that while capstan anchor 310 is shown anchored near the apex of the heart, it can be anchored at a different location, such as to the interventricular septum or another portion of the ventricular wall.

[0871] Driving the capstan anchor 310 into the tissue advances the entire downstream assembly 300 distally through the capsule 470 toward the tissue surface. Figure 1AIn some embodiments (described in conjunction with FIG. 4B ), as the downstream component moves distally through the capsule, the aperture 326, which generally protrudes from the housing 472, protrudes into the lateral opening 475 and moves axially along the lateral opening, rotationally constrained by the lateral opening. That is, the lateral opening 475 can serve as a linear track along which the capstan 320 (e.g., its housing 321) can slide as the capstan anchor 310 is driven into tissue. Such a configuration allows the capsule 470 to continuously provide a reference force to the capstan housing 321 throughout the anchoring process of the anchor 310, so that the capstan housing does not rotate with the anchor. (Such rotation of the housing could otherwise adversely wrap the tether 160 around the tool 400, such as its shaft 410.) In some embodiments in which the capsule 470 includes a shield 476, as the downstream component moves distally through the capsule, the tether 160 enters the slit 478 from the window 474 and extends from the aperture 326 out of the progressively more downstream portion of the slit 478. Depending on the extent to which the orifice 326 protrudes from the housing 472 , the orifice may momentarily separate the shield 476 at the slit 478 as the orifice moves along the lateral opening 475 and the slit. Figure 2N The fully anchored anchor 310 is shown with the aperture 326 separating the shield 476 at the portion of the slit 478 proximate the open distal end of the capsule and the tether 160 extending from the aperture.

[0872] Once the capstan anchor 310 has been anchored, the effective length of the tether 160 (i.e., the length of the tether between the capstan 320 and the patch 210) can be adjusted to achieve optimal hemodynamics, such as minimal regurgitation between the leaflets of the valve 7. Although the patch 210 itself is a leaflet reinforcement patch that can improve coaptation between the leaflets by providing an extension and / or alternative coaptation surface, the tether 160, especially when having an optimal length, can further improve coaptation, such as by guiding and / or limiting movement of the patch and the leaflets to which it is anchored during the cardiac cycle. This length adjustment can be achieved by operating the capstan controller 119 at the proximal portion 402.

[0873] In some embodiments, prior to length adjustment, the tool 400 is substantially withdrawn from the ventricle 8, e.g., from the heart, and / or completely withdrawn from the subject's body ( Figure 2O). Such retraction primarily includes retracting the shaft 410 to which the mounting member 440, clasp 430, and capsule 470 remain attached. This leaves the drive shaft subassembly 490 of the tool 400 extending through the valve 7 to the downstream component 300 to which the drive shaft subassembly remains coupled. This can advantageously facilitate accurate hemodynamic monitoring during adjustment of the effective length of the tether 160 (described below) because the drive shaft subassembly 490 is typically thinner and / or more flexible than the shaft 410 or the tool 400 as a whole and is thus less likely to produce significant hemodynamic artifacts due to: (i) compression of the downstream component 300 and the ventricular tissue to which it is anchored, (ii) obstruction of leaflet movement and coaptation, and / or (iii) direct obstruction or induction of turbulence in the blood flow. In this state, the leaflets of the valve 7 can coapt around the drive shaft subassembly 490, for example, as Figure 2O shown.

[0874] However, to further facilitate accurate hemodynamic monitoring during adjustment of the effective length of the tether 160, the drive shaft subassembly 490 can be moved laterally toward the commissure (e.g., pivoted on the downstream assembly 300) to further minimize any interference it may have with the behavior of the leaflets ( Figure 2P ).

[0875] While withdrawing the shaft 410 prior to adjusting the effective length of the tether 160 has the advantages described above, in some embodiments, the length adjustment is performed while the shaft 410 and capsule 470 remain in place.

[0876] The drive shaft subassembly 490 includes at least one drive shaft and may also include a reference force tube 492, for example, as described below.

[0877] The winch controller 119 is operably coupled to the winch 320 such that operation of the winch controller actuates the winch ( Figure 4A). For example, the delivery tool 400 (e.g., its drive shaft subassembly 490) can include a capstan control drive shaft 482, which operably couples the capstan controller 119 to the capstan 320. In some embodiments, and as shown, the actuation of the capstan 320 is achieved by, for example, applying torque to the capstan via the engagement between the capstan control drive shaft 482 and the capstan 320. The capstan 320 can include a drive shaft interface 324, which is defined by the spool 322 of the capstan, is a component of the spool, or is fixedly coupled to the spool. The drive shaft 482 engages the drive shaft interface 324 and applies torque to the drive shaft interface via this engagement. For example, and as shown, the drive shaft 482 can include or define a drive head 485 at the distal end of the drive shaft, the drive head including one or more (e.g., two) protrusions 488, which extend into a recess defined by the interface 324, for example, so that torque can be applied to the spool 322 via these protrusions. This engagement can be maintained indirectly by locking the locking rod 486 between the driver head 483 and the driver interface 316, for example, due to a preload between the drive shafts 480 and 482. For example, regardless of advancement of the tool 400 through the vasculature, and throughout the steps of the implantation procedure, the drive shaft 480 can be maintained under a limited amount of tension, while the drive shaft 482 can be maintained under a limited amount of axial compression.

[0878] The reference force tube 492 is also engaged with the downstream component 300. As shown, this engagement can be with the housing 321. For example, the reference force tube 492 (e.g., its distal end) and the housing 321 can include or define complementary couplings (e.g., mating surfaces) 494 and 331, respectively. Thus, the downstream component 300 (e.g., its housing 321) can be considered to include or define a reference force tube interface 332, which includes one or more couplings (e.g., mating surfaces) 331, with which the reference force tube 492 engages. The engagement between the reference force tube 492 and the reference force tube interface 332 can rotationally lock the reference force tube to the reference force tube interface, thereby allowing the reference force tube to provide a reference force during rotation of the capstan 320. In particular, this rotational locking and reference force facilitates rotation of spool 322 without rotating housing 321 (or rotation of aperture 326 about axis ax2), which may be advantageous due to the presence of tether 160 extending between downstream assembly 300 and upstream assembly 200. For example, if housing 321 rotates during rotation of spool 322, tether 160 may become entangled around drive shaft subassembly 490.

[0879] In some embodiments, the engagement between the reference force tube 492 and the housing 321 can be maintained indirectly by locking the locking rod 486 between the driver head 483 and the driver interface 316, for example due to a preload between the drive shaft 480 and the reference force tube 492. For example, regardless of advancement of the tool 400 through the vasculature, and throughout the steps of the implantation protocol, the drive shaft 480 can be maintained under a limited amount of tension, while the reference force tube 492 can be maintained under a limited amount of axial compression.

[0880] Figure 2Q The tether 160 is shown after its length has been adjusted. Figure 2P In the middle, it is relaxed and Figure 2Q 1. The tether 160 is shown as being tightened, but it should be understood that this is illustrative and is not intended to limit the adjustment of the length of the tether.

[0881] Once the optimal effective length of the tether 160 is reached, the drive shaft subassembly 490 is disengaged from the downstream assembly 300 and thereby from the implant 150 as a whole ( Figure 2R and Figure 4B -C). For example, and as shown, the locking bar 486 can be withdrawn at least sufficiently to allow the drive shaft 480 to disengage from the interface 316 via intermediate deflection of the projection 484 ( Figure 4B Once disengaged, the drive shaft 480 and drive shaft subassembly 490 as a whole can be withdrawn from the downstream assembly 300 ( Figure 4C ). When the drive shaft subassembly 490 is withdrawn from the downstream assembly 300, and more specifically, when the capstan control drive shaft 482 (e.g., its protrusion 488) is withdrawn from the capstan 320 of the downstream assembly, one or more spring-loaded pawls 328 can responsively move to engage the housing 321 in a manner that locks the spool 322 from rotating relative to the housing (i.e., locks the capstan 320), so that tension on the tether 160 cannot unwind the tether, thereby fixing the effective length of the tether. In some embodiments, the capstan 320 includes a plurality of pawls 328 equal to the number of protrusions 488, each of which holds a corresponding one of the pawls out of engagement with the housing 321 until the protrusion is withdrawn.

[0882] In some embodiments, and as shown, this movement of the pawl 328 is an intermediate movement. In some embodiments, the housing 321 defines a set of ridges 330 (and / or recesses in which the pawl can be disposed) between which the pawl 328 can be disposed when the drive shaft 482 is withdrawn.

[0883] In some embodiments, housing 321 includes at least two subcomponents that are secured to one another during manufacturing, such as a first subcomponent (e.g., an annular or circumferential subcomponent) 321a and a second subcomponent (e.g., a cover subcomponent) 321b. For some such embodiments, and as shown, spine 330 is defined by second subcomponent 321b. For some such embodiments, reference force pipe interface 332 is defined by second subcomponent 321b.

[0884] In some embodiments, within the downstream assembly 300 , the tissue engaging element 312 , the head 314 , and the driver interface 316 are rotationally fixed relative to one another and are collectively rotatably coupled to the housing 321 and the spool 322 .

[0885] In some embodiments, within the downstream component 300, the pawl 328 (e.g., the frame defining the pawl) is rotationally fixed relative to the spool 322 even when unlocked due to the presence of the drive shaft 482, for example, (i) via one or more tongue-shaped members 329 defined by the frame, which defines the pawl disposed in one or more recesses 323 defined in the spool 322 (or vice versa), and / or (ii) because the pawl 328 is disposed in a narrow slot 325 defined by the spool.

[0886] In some embodiments, within the downstream assembly 300 , the spool 322 is rotatably coupled to the housing 321 except when a pawl 328 , which is rotationally fixed relative to the spool, is locked to the housing.

[0887] The slot 325 may also provide space for the pawl 328 to deflect between its unlocked and locked conditions.

[0888] In some embodiments, and as shown, the downstream component 300 can include a hub 317 or shaft on which the spool 322 and the pawl 328 (e.g., a frame defining the pawl) are mounted, thereby providing at least some of the above-mentioned rotatable couplings.

[0889] In some embodiments, housing 321 is mounted to be rotatable (eg, freely rotatable) relative to anchor 310. This can advantageously allow the housing to naturally find a rotational orientation in which lateral aperture 326 is optimally positioned, eg, in response to movement and tension of tether 160.

[0890] Figure 5A -B is a schematic diagram of an upstream assembly 200 according to some embodiments. As described above, the patch 210 may include a flexible sheet 220 and may further include at least one frame 230 supporting the sheet. As further described above, the upstream assembly 200 may be provided with at least one patch anchor 240 coupled to the patch 210.

[0891] The frame 230 supports the sheet 220, thereby providing shape to the patch 210. However, the frame 230 can be flexible so that the patch 210 can respond to conditions in the heart, such as the shape of one or both leaflets, to promote optimal apposition. In some embodiments, the frame 230 (and thus the patch 210) is configured to be more flexible along one axis than another. For example, the frame 230 can provide greater flexibility along the root-to-lip axis ax3 of the patch 210 (e.g., the lip 211 moves relative to the root 212) than along the mediolateral axis ax4 of the patch that is transverse to the root-to-lip axis (e.g., one lateral edge 213 moves relative to the other lateral edge). This higher mediolateral stiffness can promote the opening of the patch 210 when released from the wrap 442 and / or can advantageously inhibit the patch from folding over on itself after implantation.

[0892] The frame 230 may include a root support 232, which may include a beam extending along the root 212, for example, from one lateral edge 213 to the other lateral edge. The frame 230 may also define a lip support 231, which may include a beam extending substantially along the lip 211, for example, from one lateral edge 213 to the other lateral edge. The lip support 231 and the root support 232 may provide a degree of medial-lateral rigidity to the patch 210, for example, as described in the previous paragraph.

[0893] The frame 230 may include a spring 234 that may extend between the lip support 231 and the root support 232. In the example shown, the spring 234 extends substantially along the root-to-lip midline of the patch 210 (e.g., along axis ax3 if axis ax3 is the central root-to-lip axis).

[0894] The spring 234 can provide the root-to-lip flexibility described above. However, the spring 234 can also provide a patch anchor securing function, for example, as described below.

[0895] Figure 5A 1 and 2 are front and isometric views of the patch 210 in its resting state, e.g., before being loaded onto the delivery tool 400. In some embodiments, in addition to the curvature of the patch 210 about the mount 440 and the shaft 410 when loaded onto the delivery tool 400, Figure 5A It may also represent the state of the patch during the initial stages of delivery.

[0896] In some embodiments, the upstream component 200 can have a patch anchor fastening function. That is, the upstream component itself (e.g., patch 210, such as frame 230) can be configured to tighten the patch anchor 240, for example, by pulling the patch anchor 240 toward the patch (e.g., automatically). For example, the upstream component 200 can bias the patch anchor 240 toward the patch 210, but can allow the patch anchor to temporarily move away from the patch during anchoring. In some embodiments, and as shown, this biasing applies tension to the cord 242 via the upstream component 200. For some such embodiments, this is achieved as follows:

[0897] As described above, the cords 242 couple the patch anchor 240 to the patch 210. For example, and as shown, each patch anchor can be coupled to the patch by a corresponding cord. However, rather than each cord 242 being secured to the patch 210 (e.g., its frame 230) at a point 214 proximate to where the cord reaches the patch, the cord passes through the patch at point 214 and extends along the patch (e.g., in a root-to-lip direction, e.g., substantially parallel to axis ax3) to a lip bracket 231 where the cord is secured. Thus, the cords 242 are slidably coupled to the patch 210 at point 214, which can be at or near the root 212, and are fixedly attached to the patch at the lip bracket 231, which can be at or near the lip 211.

[0898] In some embodiments, and as shown, the cord 242 extends along the patch within the sheet 220, such as between its layers, thereby advantageously allowing the surface of the patch presented to the opposing leaflet to be smooth and cord-free. For such embodiments, the cord 242 can slide within the sheet 220.

[0899] exist Figure 5A , the cord 242 is shown as being relatively slack. When the patch anchor 240 is driven by the driver 450 through the distal (eg, downstream) side of the leaflet 10 (eg, as described above with reference to Figure 2J -K), the patch anchor is temporarily pushed away from the patch 210, which remains on the proximal (e.g., upstream) side of the leaflet. This tensions the cord 242, which thereby pulls the lip support 231 toward the root support 232, thereby placing the spring 234 under stress ( Figure 5B ). This is Figure 5A -B is represented by the linear compression of the spring 234 and the patch 210, which temporarily extends the root of the patch to the lip length L1 ( Figure 5A ) is reduced to a reduced length L2 ( Figure 5B), i.e., linearly contracting the patch. In some embodiments, placing the spring 234 under stress causes the spring to slide through the sheet. When the patch anchor 240 is released from the actuator 450, the spring 234 returns to its initial (e.g., resting) state, pulling (e.g., traction) the patch anchor back onto the patch 210, and thereby securing the patch to the leaflet by sandwiching the leaflet between the patch anchor and the patch, e.g., as from Figure 2K and 5B arrive Figure 2L and 5A Providing upstream components with self-tensioning patch anchors such as these (e.g., by including a patch with a spring biased to tension the patch anchor) can advantageously avoid the need to perform a separate tightening or locking step, and / or the need to include a separate locking component.

[0900] It should be noted that the scope of the present disclosure includes the use of other patch anchor fastening mechanisms (e.g., one or more springs, elastic regions, tensioners, capstans, screws, etc.) that may or may not linearly contract the patch, or may or may not fully contract the patch. Some non-limiting examples of other patch anchor fastening mechanisms are described in International Patent Application No. PCT / IB2021 / 060436, entitled “Valve leaflet treatment systems and methods,” filed on November 11, 2021, to Tennenbaum et al., published as WO 2022 / 101817 (e.g., reference thereto). Figure 36A -K), which is incorporated herein by reference.

[0901] In some embodiments, and as shown, the frame 230 defines at least one patch anchor support 236 that can be positioned and shaped to partially or completely surround the point 214. In some embodiments, and as shown, the spring 234 can be coupled to the root support 232 via the patch anchor support 236. The patch anchor support 236 can advantageously provide one or more of the following benefits: (1) serving to reinforce the patch at the point 214, e.g., to prevent the cord 242 from cutting through the sheet 220; (2) serving as a bearing surface on which the cord 242 slides as it moves through the point 214; and / or (3) providing resistance (e.g., an opposing force) to the pressure of the patch anchor 240 against the leaflets, thereby improving the clamping of the leaflets between the patch anchor and the patch 210, e.g., compared to a similar patch in which the patch anchor presses the leaflets against a portion of the patch where the sheet 220 is not supported by the frame 230.

[0902] As described above, the tether that tethers the upstream component to the downstream component can be attached to the lip region of the patch. In some embodiments where the patch includes a frame defining a lip support, the tether can be attached to the lip support. Figure 5A As shown in FIG-B , for patch 210, tether 160 is attached to lip support 231 (e.g., to an eyelet defined by the lip support) at a mid-portion of lip 211. It should be noted that while both tether 160 and cord 242 are attached to lip support 231, they function at least partially independently, e.g., spring 234 tensions cord 242 regardless of whether tether 160 pulls on the lip support. Furthermore, lip support 231 can be configured to distribute at least a portion of the force exerted on patch 210 by tether 160 (e.g., during ventricular systole) across the width of the patch, e.g., across the width of lip 211. However, the limited length of cord 242 can limit the extent to which such forces are experienced by patch 210 itself (e.g., by sheet 220), e.g., preventing the patch from being undesirably stretched. That is, once the cord 242 has tightened its patch anchor against the leaflet, thereby firmly clamping the leaflet to the contact surface 221 of the patch 210 , the cord can inhibit further movement of the lip support 231 away from the root support 232 .

[0903] Now refer to Figure 7A -C, which is a schematic diagram of a grasping indicator 431 according to some embodiments. The indicator 431 can be a component of the clasp 430, or can be coupled to the clasp. The indicator 431 can be radiopaque and / or echogenic and configured to change its position and / or orientation (e.g., relative to the upstream support 432 and / or the downstream support 434) in response to successful grasping of the leaflet 10 by the clasp 430. This configuration can be attributable to the shape and / or size of the indicator 431, and / or to the nature of its coupling to the upstream support 432 and / or the downstream support 434. Changes in the position and / or orientation of the indicator 431 can be detected (e.g., visually) using imaging (e.g., fluoroscopy or ultrasound), thereby allowing an operator (e.g., a physician) to verify successful grasping of the leaflet 10 before actuating the patch anchor 240.

[0904] In the example shown, the indicator 431 comprises a radiopaque material and is flexibly coupled to the upstream support 432. In its resting state, the indicator 431 protrudes minimally or not at all from the clasp 430 ( Figure 7A When the clasp 430 is open, the indicator 431 may remain stationary relative to the upstream support 432, for example, it may remain in its stationary state ( Figure 7B). However, when the clasp 430 recloses to grasp the leaflet 10, the presence of the leaflet between the upstream support 432 and the downstream support 434 pushes (e.g., deflects) the indicator 431 to protrude from the clasp 430, for example, to protrude through an opening in the upstream support. This protrusion is detectable (e.g., visually) using imaging (e.g., fluoroscopy), indicating successful grasping of the leaflet 10 before actuating the patch anchor 240. To achieve this effect, in a static state, a portion of the indicator 431 can protrude from the upstream support 432 toward the downstream support 434 (e.g., can protrude into a gap between these supports) so that when the leaflet 10 is clasped, the leaflet displaces the portion of the indicator, and thereby the entire indicator. It should be noted that the portion of the indicator 431 that protrudes into the gap between the supports can be set deeper into the hook 430 (e.g., closer to the hinge point between the supports) than the narrow slot 437 (e.g., the point through which the patch anchor will pass), thereby ensuring that the indication is provided only when the leaflet 10 is sufficiently clamped within the hook 430 so that the patch anchor will be driven through the leaflet tissue far enough away from the lip edge of the leaflet.

[0905] Now refer to Figure 8A 9A-B and 9A-B, which are schematic diagrams of steerable variations of delivery tool 400 according to some embodiments. With reference to these figures, and throughout this application, a suffix of a letter (e.g., a, b, etc.) indicates that the element with the suffixed reference numeral is a variation of another element described herein having the same name and the same reference numeral, no suffix, or a different suffix. In each case, the variation may be as described with respect to the other element except as indicated (e.g., may have similar structure and / or function as the other element). For example, reference to Figure 8A 9A-B and 9A-B are variations of delivery tool 400 and, except as otherwise noted, may be the same as described for delivery tool 400. Furthermore, in each case, the variations may be replaced mutatis mutandis with another element or with other variations of the elements described herein.

[0906] As described above, one or more catheters 102, 104 can facilitate advancement of the tool 400 having the implant 150 mounted thereon through the vasculature, wherein one or more of the catheters can be steerable (i.e., actively steerable, such as using a pull wire or other components known in the art). To facilitate this, the tool 400 is flexible to a large extent along its length, e.g., so that it can passively follow the path of the catheter and / or can be passively bent by the catheter. An exception to this may be the components of the shaft 410 at the distal portion 404, e.g., the telescopic arrangement of the proximal component 411 and the distal component 412. However, in some embodiments, these may also be flexible. In addition, and as Figure 8A -B and 9A-B, in some embodiments, at the distal portion of the delivery tool, the shaft itself may have a steerable component that can be actively steerable independently of the catheters 102 and 104, for example via operation of the proximal portion 402 outside the body (e.g., operation of its controller).

[0907] Figure 8A -B shows a delivery tool 400a that can be steered using, for example, one or more pull wires 413 disposed within the wall of the delivery tool's shaft. In the example shown, four pull wires 413 are disposed within the wall of the shaft 410a, for example, extending through the distal component 412a of the shaft. However, fewer (e.g., one, two, or three) or more pull wires may be used. The pull wires 413 operably couple the proximal portion 402 (e.g., a controller thereof) outside the body to the steerable component of the shaft 410a, such that the proximal portion outside the body can be used to bend the shaft (e.g., component 412a thereof) in a manner similar to that of a pull wire for bending a steerable catheter. Figure 8A The distal portion of tool 400a is shown having been advanced into ventricle 8 but not actively steered. In this state (e.g., a resting state), the steerable portion of the shaft can be substantially straight. However, in some embodiments, the steerable portion of the shaft (e.g., distal portion 412a of shaft 410a) can be biased to assume a curved shape, for example, in its resting state.

[0908] Figure 8B The distal portion of the tool 400a is shown to be actively bent by tensioning at least one of the pull wires 413. In the example shown, the distal component 412a of the shaft 410a bends in response to the tensioning of the pull wire, for example, being configured to be sufficiently flexible to bend. The resulting deflection of the distal portion of the tool 400a can advantageously allow the operator to better control the positioning of the downstream assembly 300 and / or have greater choice regarding the location at which the downstream assembly 300 will be anchored.

[0909] Figure 9A-B shows a delivery tool 400b that can be steered by extending and retracting its shaft 410b. As described above with respect to delivery tool 400, frame element 436 can extend from a proximal component 411b of shaft 410b to a distal component 412b of the shaft, thereby enabling at least a portion of clasp 430 to be deflected (e.g., telescopically) via extension and retraction. In delivery tool 400b, sufficient extension of distal component 412b of shaft 410b from proximal component 411b of the shaft causes the shaft (e.g., distal component 412b thereof) to bend, thereby deflecting capsule 470 and downstream component 300 therein. As shown, this can be facilitated by constructing the frame element 436 (e.g., its length between its attachment points to the proximal component 411b and the distal component 412b) such that when the distal component 412b extends from the proximal component 411b beyond a threshold extent, further extension of the distal component from the proximal component causes the frame element to pull the distal component of the shaft to deflect to the side on which the frame element is disposed, for example, by tensioning the frame element.

[0910] Figure 9A The distal portion of tool 400b is shown having been advanced into ventricle 8 but not actively turned. In this state (e.g., a resting state), the distal portion of the tool can be substantially straight. However, in some embodiments, the distal portion of the tool (e.g., distal component 412b of shaft 410b) can be biased to assume a curved shape, for example, in its resting state.

[0911] Figure 9B The distal portion of tool 400b is shown actively bending via extension of distal component 412b from proximal component 411b. In the example shown, this is achieved by retracting proximal component 411b proximally, for example, toward atrium 6. However, it should be understood that this can similarly be achieved by advancing distal component 412b distally (e.g., deeper into ventricle 8), or a combination of moving proximal component 411b and distal component 412b.

[0912] In the example shown, the distal component 412b of the shaft 410b bends responsively, e.g., is configured to be sufficiently flexible to bend. The resulting deflection of the distal portion of the tool 400b can advantageously allow the operator to better control the positioning of the downstream assembly 300 and / or have greater choice regarding the location where the downstream assembly 300 will be anchored.

[0913] In some embodiments, delivery tool 400b differs from tool 400 only in that, at its distal portion, shaft 410b (e.g., distal component 412b thereof) is sufficiently flexible to bend as described, and / or shaft 400b and frame element 436 are appropriately sized for such behavior.

[0914] It should be noted that for both tools 400a and 400b, the actively bendable portion of the shaft can be disposed distally from the mount 440 (e.g., distally from the axial location where the patch 210 is mounted) and proximally from the capsule 470. In some embodiments, and as shown, the actively bendable portion of the shaft is disposed distally from the clasp 430.

[0915] refer to Figure 10A -B, which is a schematic diagram of a patch anchor 240a according to some embodiments. Patch anchor 240a can be considered a variation of patch anchor 240 and can be used mutatis mutandis in place of patch anchor 240 in any implant or system described herein.

[0916] Similar to patch anchor 240, patch anchor 240a includes a toggle, ie, is a toggle anchor. However, patch anchor 240a is also biased to automatically widen upon deployment. Figure 10A Patch anchor 240a is shown constrained within channel 448a, and Figure 10B The patch anchor is shown having been deployed out of the channel (e.g., by actuator 450a) and automatically widening in response to being freed from the channel. Thus, the patch anchor 240a can be formed (e.g., cut) from an elastic, superelastic, and / or shape memory material (e.g., nitinol or cobalt chromium alloy).

[0917] In some embodiments, and as shown, the patch anchor 240a has a honeycomb structure (e.g., similar to the honeycomb structure of a stent) and is widened by shortening. For some such embodiments, the honeycomb structure precisely defines two expansion units, for example, as shown. The patch anchor 240a can define an eyelet 244a by a toggle, through which the cord 242 is attached to the patch anchor. The eyelet 244a can be disposed between the two units, for example, as shown.

[0918] In some embodiments, channel 448a can be a channel defined by a mounting member, such as mounting member 440. For some such embodiments, tip 250a of patch anchor 240a has a sharpened point (eg, sharpened to a point), for example, as shown.

[0919] In some embodiments, channel 448 can be defined by a needle, which itself can be configured to pierce leaflet 10. For some such embodiments, patch anchor 240a has a blunt tip.

[0920] The widening of the patch anchor 240a can distribute the force over a larger surface area of ​​the leaflet and, therefore, over more collagen fibers of the leaflet. Thus, this can increase anchoring force / reliability compared to a narrower and / or non-widened patch anchor. Furthermore, in some embodiments where widening occurs by shortening, due to the resulting smaller length of the patch anchor 240a, its end may be less likely to inadvertently puncture the leaflet to which it is anchored. Even in some embodiments where widening does not occur by shortening, the increased width can allow the patch anchor 240a to be made shorter than a similar non-widened toggle anchor, thereby similarly reducing leaflet blowout.

[0921] In some embodiments, the patch anchor 240a includes a retrieval feature 241a via which the retrieval line 502 is connected to the patch anchor. In some embodiments, and as shown, the retrieval feature 241a is positioned toward (e.g., at) the proximal end of the patch anchor (e.g., of the toggle), referred to herein as the "heel" of the patch anchor, which is at the opposite end of the patch anchor's tip. In the example shown, the retrieval feature 241a is or includes a post around which the retrieval line 502 is looped.

[0922] During the anchoring of the anchoring patch anchor 240a (e.g., during the implantation of the patch to which it belongs), the retrieval line 502 extends proximally from the retrieval feature 241a. If it is determined during the implantation process that the patch anchor should be retrieved, pulling the retrieval line 502 facilitates the retrieval (e.g., unanchoring) of the patch anchor. Because the retrieval feature 241a is provided at the heel of the patch anchor, pulling the retrieval line 502 can: (i) axially reorient the patch anchor (e.g., align with the vector along which the patch anchor is advanced, such as with the hole in the leaflet through which the patch anchor passes); and (ii) withdraw the patch anchor proximally. The system 100 (e.g., its delivery tool 400) can be modified to accommodate the retrieval line 502 and facilitate its use.

[0923] refer to Figure 11A-B is a schematic diagram of a patch anchor 240b according to some embodiments. Patch anchor 240b is a toggle anchor and may have the features of other patch anchors described herein. For example, patch anchor 240b may define at least one eyelet 244b through which cord 242 is attached to the patch anchor. Similarly, patch anchor 240b may have a sharpened tip. Patch anchor 240b has a retrieval feature 241b through which retrieval line 502 is connected to the patch anchor. Retrieval feature 241b includes a retrieval eyelet 246 and a notch 247, both of which are cut into the circumferential wall of the toggle, which may be substantially tubular. Notch 247 is located at the heel of patch anchor 240b and is defined by one or more portions of the circumferential wall of the toggle that has been removed. Retrieval eyelet 246 is located adjacent to notch 247 and may be located on the same side as notch. In the example shown, the retrieval eyelet 246 is disposed just distally from the notch 247 at the same circumferential position as the notch.

[0924] The retrieval line 502 is connected to the patch anchor 240b by extending axially at the heel of the patch anchor, extending colinearly into the lumen of the toggle (which can be substantially tubular), exiting the side wall of the toggle through the retrieval eyelet 246, and looping back through the notch 247 to connect to itself at reference numeral 504, which can represent a knot.

[0925] In some embodiments where 504 represents a knot, it should be noted that Figure 11A The arrangement shown in -B results in the knot 504 being located within the width of the patch anchor 240b, for example, being tucked into the interior of the patch anchor. This can advantageously reduce the likelihood that the knot will obstruct retrieval of the toggle anchor through the leaflet 10.

[0926] It should be noted that Figure 11A The arrangement shown in -B causes the retrieval wire 502 to exit the patch anchor colinearly with the patch anchor 240b. That is, at the heel of the patch anchor, the retrieval wire 502 is aligned with the long axis of the patch anchor. Furthermore, the retrieval wire 502 extends from the very heel of the patch anchor 240b, i.e., the exit point of the retrieval wire from the patch anchor is the portion of the patch anchor farthest from the tip of the anchor. Thus, if the retrieval wire 502 is pulled, it will naturally align the patch anchor 240b with the vector of the pull, thereby facilitating retrieval of the patch anchor through the hole in the leaflet through which the patch anchor was previously introduced (and through which the retrieval wire extends), e.g., the heel of the patch anchor will not get caught on the edge of the hole in the leaflet.

[0927] refer to Figure 12, which is a schematic diagram of at least a portion of an implant 150a according to some embodiments. Similarly, for 150, implant 150a includes an upstream component 200a, which includes a patch 210a that can include a frame 230a. Also similar to implant 150, implant 150a includes a tether 160a, which tethers the upstream component 200a to a downstream component (not shown). The downstream component of implant 150a can be modified as described for other downstream components herein. For implant 150a, a single sheet 220a is shaped (e.g., cut and / or folded) to serve as both a patch sheet 210a (similar to sheet 220) and a tether 160a. That is, sheet 220a is shaped into a patch portion (e.g., a portion shaped as a patch) and a tether portion (e.g., a portion shaped as a tether). In the example shown, the patch portion is trapezoidal, and the tether portion is ribbon-shaped. In the example shown, the patch portion has a tab that is folded over to cover a portion of the frame. In the example shown, the tether portion is cut to approximately three times the width of the tether 160a, and the lateral components of the tether portion are folded over the inner components of the tether portion to form the tether (e.g., on opposite sides of the inner components, thereby forming an S-shaped cross-section), such that the thickness of the tether is approximately three times that of the sheet 220a. However, other formations of the tether portion are possible, including tether portions that are simply cut into the tether shape.

[0928] refer to Figure 13 , it is a schematic diagram of at least a portion of an implant 150b according to some embodiments. Similar to 150, implant 150b includes an upstream component 200b, which includes a patch 210b, which includes a flexible sheet 220b and can include a frame (not shown). Equally similar to implant 150, implant 150b includes a tether 160b, which tethers the upstream component 200b to a downstream component (not shown). The downstream component of implant 150b can be as described for other downstream components herein, with necessary modifications. Implant 150 is shown as having a tether 160 attached at a single inside position on a lip 211. In implant 150b, tether 160b is, for example, attached to two lateral positions on the lip 211b of patch 210b via two lateral lines 162 that diverge laterally from each other and away from the upstream end of tether 160b. In some embodiments, and as shown, these lateral attachments are in addition to the medial attachments, which may be via medial wire 164. This arrangement may alternatively be viewed as tether 160b branching into two or three branches attached to lip 211b. In some embodiments, wires 162 and 164 are fixedly attached to tether 160b and to each other, for example, at node 166.

[0929] Figure 13 The implant 150b is shown without the presence of anatomy, but behaving as if the anchor 240 were attached to the leaflet 10, with the tension on the tether 160b oscillating between low (left image) and high (right image), for example, as might occur during the cardiac cycle, with the left image representing the implant during diastole and the right image representing the implant during systole. As the tension on the tether 160b increases (from left to right image), the lateral attachments push the lip 211b, and in some embodiments, most or all of the patch 210b, to bend (e.g., flex) medially (e.g., about the root-to-tip axis ax3) to become convex on the upstream surface of the patch. Thus, the surface of the patch 210b presented to the opposing leaflet is convex, and the lateral edges of the patch are held away from the opposing leaflet. This can advantageously enhance coaptation and / or reduce friction of the lateral edges of the patch with the opposing leaflet. In some embodiments in which the patch 210b is elastic (e.g., includes an elastic frame, such as the elastic frame described herein), bending (e.g., flexure) of the patch can also serve as a force damper or shock absorber, advantageously softening the impact experienced by the patch (and its point of anchoring to the leaflet 10) as it reaches the end of the tether 160b during each ventricular contraction.

[0930] In some embodiments in which an inner attachment (e.g., inner wire 164) is also included, the inner attachment can be used to limit the extent to which the patch 210b bends in response to tension on the tether 160b. In the example shown, the length of the inner wire 164 is such that even when there is no slack in the lateral wire 162 (center image), some slack remains. This allows tension in the lateral wire 162 to cause the patch to bend when slack in the inner wire 164 is taken up. However, once no slack remains in the inner wire 164, additional tension on the tether 160b does not cause additional bending of the patch. This limitation on the extent to which the patch 210b bends can advantageously prevent the patch from bending to the extent that its lateral edges are held away from coaptation with the opposing leaflet.

[0931] Now refer to Figure 14 and 15A -B, which is a schematic diagram of an implant 150c and techniques for use therewith, according to some embodiments. Figure 15A -B shows implant 150c being implanted using tool 400, but it should be understood that implant 150c can optionally be implanted using another delivery tool such as, but not limited to, a variation of delivery tool 400 described herein.

[0932] The above description (e.g., reference Figure 5A-B) is the patch anchor fastening function of the upstream component 200 of the implant 150. In contrast, the implant 150c includes an upstream component 200c, whose patch anchor is tightened, but not by the upstream component (or implant) itself. In the example shown, the patch anchor of the upstream component 200c is the patch anchor 240 described above. However, other patch anchors, including but not limited to other toggle anchors, may be used instead, and with necessary modifications. For example, although the patch anchor fastening function of the upstream component 200 can be provided by the upstream component (e.g., its spring) biasing the patch anchor toward the patch (e.g., by pulling the patch anchor via its cord connected to the patch), the upstream component 200c does not bias the anchor toward its patch 210c (e.g., does not include such a spring). Instead, anchor fastening is achieved by pulling via a delivery tool.

[0933] FIG15a shows the anchor 240 driven through the leaflet 10 and the clasp 430 opened to release the leaflet. Thus, FIG15a can be viewed as similar to FIG15a. Figure 2L However, with Figure 2L 15, anchors 240 remain untensioned, i.e., they have not yet been pulled toward patch 210c and / or clamped against the patch on leaflet 10. As shown, patch 210c is typically relaxed at this point, e.g., because it does not include a spring to hold the patch open.

[0934] FIG15b shows at least the capsule 470 of the tool 400, and optionally the entire distal portion 404 of the tool, moved away from the patch 210c (e.g., from the upstream component 200c), such as by being advanced downstream and / or further into the ventricle 8. Thus, FIG15b may be viewed as similar to FIG15b. Figure 2M However, with Figure 2MIn contrast, when capsule 470 (with downstream component 300 therein) moves away from patch 210c, tether 160 is allowed to tighten (e.g., without loosening the tether), causing the tether to pull on patch 210c. Patch 210c and its connection to tether 160 cause this pulling to pull cord 242c, for example, by tightening patch anchor 240 by pulling the patch anchor toward the patch. In the example shown, this is achieved by tether 160 being connected to lip support 231c of patch 210c (e.g., similar to that described for implant 150) and cord 242c also being connected to the lip support (e.g., also similar to that described for implant 150). Pulling on tether 160 pulls cord 242c, pulling the cord through cord entry and / or through patch site 214c. The patch 210c includes (e.g., at each location 214c) a one-way mechanism 216 (e.g., a ratchet, a tie-like mechanism, etc.) that allows the cord 242c to be passed therethrough only in a direction that tightens the patch anchor 240, e.g., in a direction that pulls the patch anchor toward the patch. Thus, once the patch anchor 240 is tightened, it remains secured even when the tether 160 is not under tension and even when the portion of the cord 242c on the side of the mechanism 216 opposite the patch anchor 240 (e.g., the portion of the cord within and / or beside the patch 210c) is not under tension. The patch 210c can include a patch anchor support 236 (described above), and for such embodiments, each mechanism 216 can be mounted on the patch anchor support.

[0935] Because tightening of the patch anchor 240 of the upstream component 200c does not require the patch 210c to maintain force on the cord 242c, for example, by remaining in a deployed state (e.g., the patch does not include a spring), the characteristics of the patch can be more tailored to the leaflet-enhancing function of the patch, for example, without having to compromise to maintain force on the cord.

[0936] In some embodiments, and as shown, patch 210c may not include a frame component between root support 232c and lip support 231c. Furthermore, in some embodiments, patch 210c may include a frame component between root support 232c and the lip of the patch, for example, the patch may not include a root support. This lack of a frame component may advantageously enhance the flexibility of the patch.

[0937] refer to Figure 16 、 17 , 18A-B, and 19A-D, which are schematic illustrations of implants that are variations of implant 150 in which, according to some embodiments, one or more ventricular anchors are connected to an upstream component via multiple (e.g., two) stretch portions of a tether.

[0938] Figure 16An implant 150d is shown whose tether 160d extends not only from the downstream component 300d of the implant (e.g., its capstan 320) to the upstream component 200d of the implant (e.g., its patch 210d), but also back to the downstream component to which the tether (e.g., the end of the tether) is secured (e.g., back to the housing 321d or its anchor 310). This arrangement advantageously provides additional strength to the tether because the connection between the upstream and downstream components is connected via two extensions of the tether.

[0939] The tether 160d can be slidably connected to the upstream component 200d (e.g., to the patch 210d), for example, by a tether (e.g., a bight of the tether) passing through an eyelet 219 of the upstream component. In the illustrated example, the eyelet 219 is defined or provided by a ring that is flexibly connected to the patch 210d. However, it should be understood that the eyelet can be provided in a different manner, such as by being defined by a frame of the patch 210d. In some embodiments in which the tether 160d is slidably connected to the upstream component 200d, the arrangement of the tether 160d (which can be considered a pulley arrangement) provides a mechanical advantage for shortening the tether via the capstan 320. As a result, the torque required to be applied to the capstan 320 to shorten the tether 160d can be advantageously reduced (e.g., approximately halved) compared to a similar implant, such as implant 150, that does not have such a pulley arrangement. Furthermore, for each rotation of the capstan 320, the effective length of the tether 160d decreases less (e.g., by about half) than a similar implant without such a pulley arrangement. This can advantageously provide the operator with a greater degree of control (e.g., finer granularity) over shortening the tether 160d.

[0940] Figure 17 Implant 150e is shown after its implantation. Similar to the other downstream components described herein, the downstream component 300e of implant 150e includes a ventricular anchor 310. However, implant 150e also includes a supplementary ventricular anchor 310e, which may or may not be considered as a component of the downstream component 300e. Similar to the tether of implant 150d, the tether 160e of implant 150e can be slidably connected to the upstream component 200e, for example, in a pulley arrangement. However, the tether 160e (e.g., the end of the tether) is fixed to the supplementary ventricular anchor 310e. Therefore, although implant 150e has the advantages described for implant 150d, the supplementary ventricular anchor 310e can further provide additional ventricular anchoring strength. Because the operator can select an anchoring site for each of the ventricular anchors (e.g., independently of each other), implant 150e can advantageously allow additional flexibility and / or control over the behavior of patch 210e, e.g., due to the vector of the length of tether 160e between the anchor and the patch.

[0941] Figure 18A 1 and 2 are schematic perspective views and cross-sectional views of a distal portion 404e of a delivery tool 400e for use with an implant 150e, respectively, according to some embodiments. The tool 400e can be as described for tool 400, except that it adapts to the adaptation of the implant 150e and its implantation. As elsewhere herein, the suffix "e" has been added to certain reference numerals to indicate that certain components of the tool 400e are modifications of the corresponding components of the tool 400.

[0942] In some embodiments, delivery tool 400e can include a capsule 470e at the distal end of the shaft 410e of the delivery tool. Capsule 470e can be configured to accommodate anchor 310e and anchor 310 during the delivery and implantation of the implant, wherein capstan 320 is coupled thereto (e.g., downstream assembly 300e). Capsule 470e can have an open distal end, and anchor can be deployed via the open distal end. In some embodiments in which capstan 320 (e.g., its housing) has a lateral orifice 326 through which tether 160e passes, capsule 470e can limit a lateral window 474e to allow tether to reach the capstan, e.g., as described above for capsule 470, with necessary modifications.

[0943] The shaft 410e is tubular so that other components, such as a drive shaft subassembly 490e (e.g., a drive shaft of the drive shaft subassembly), can extend therethrough. The drive shaft subassembly 490e includes at least one drive shaft, such as the capstan control drive shaft 482 (described above) and an anchor control drive shaft 480e. The anchor control drive shaft 480e can be as described for the anchor control drive shaft 480, except that it can be connected to the anchor 310e ( Figure 18B ) is moved axially to engage with the anchor 310 so as to anchor the two anchors in sequence. Engagement and disengagement with each anchor can be facilitated by a locking rod 486e.

[0944] The drive shaft subassembly 490e may also include a reference force tube 492 through which one or more drive shafts extend and which is configured to provide a reference force to downstream components when the drive shaft subassembly applies torque to the capstan.

[0945] Figure 19A -D shows at least some example steps in the implantation of implant 150e according to some embodiments. For simplicity and clarity, Figure 19AVarious components of tool 400e, such as its clasp and its mounting member, are omitted from Figure 4-D. However, tool 400e can include such components, which can be similar or identical to those described with respect to tool 400. For example, tool 400e can include clasp 430 and / or mounting member 440. Furthermore, the components of tool 400e that interact with (e.g., are implanted with) upstream component 200e can be as described with respect to the components of tool 400. Furthermore, the proximal portion of tool 400e can be as described with respect to proximal portion 402 of tool 400, mutatis mutandis.

[0946] Anchor 310e is anchored to the ventricular tissue, ie, at a first location within ventricle 8 ( Figure 19A This is accomplished by the drive shaft 482e applying an anchoring force to the anchor 310e, such as applying a torque to screw the tissue engaging element of the anchor into the tissue. The drive shaft 482e is then disengaged from the anchor 310e and retracted to engage the anchor 310e. At this point, the capsule 470 can be retracted away from the ventricular tissue in preparation for its re-advancement to a second location in the ventricle ( Figure 19B In this state, the tether 160e extends from the anchor 310e (anchored in the ventricle 8) to the upstream component 200e and back to the anchor 310 (inside the capsule 470e). The capsule 470e is then advanced to a second location within the ventricle where the anchor 310 will be anchored to the ventricular tissue ( Figure 19C Once the anchor 310 has been anchored (again, force applied by the drive shaft 482e) and the length of the tether 160 has been adjusted (e.g., by actuating the capstan 320), the tool 400e can be removed, leaving the implant 150e in place ( Figure 19D ).

[0947] Adjustment of implant 150e (e.g., the length of its tether 160e) can be similar to that described for implant 150, mutatis mutandis. For example, after anchoring of anchor 310, shaft 410e can be withdrawn, exposing drive shaft assembly 490e, extending to capstan 320. In this state, capstan control drive shaft 482 can be used to apply torque to the capstan until the desired behavior of implant 150 (e.g., of its patch 210e) is achieved. At this point, drive shaft subassembly 490e can be disengaged and withdrawn.

[0948] Now refer to Figure 20A -E, which is a schematic diagram of a distal portion 404f of a delivery tool 400f for implant 150 (or variations thereof), according to some embodiments. Delivery tool 400f can be generally as described for delivery tool 400, mutatis mutandis, with the exception of the structure and function of its clasp (or at least its upstream support), its mounting, and its actuator for the patch anchor of the implant.

[0949] The tool 400f includes a shaft 410f, a clasp 430f mounted on the shaft, and a mounting member 440f disposed next to the shaft. At least the upstream support 432f of the clasp can be controlled by a clasp controller (at a proximal region of the tool 400f; not shown) that is operably coupled to the clasp 430f. This operable coupling can be provided by a wire 130f coupled to the upstream support 432f. In the example shown, a single wire 130f is used, but multiple wires 130f can be used. Pulling the wire 130f (e.g., by operating the clasp controller) causes the upstream support 432f to move (e.g., deflect) relative to the downstream support 434f of the clasp 430f, and typically also relative to the shaft 410f, thereby converting the clasp 430f between its open state and its gripping state. The wire 130f can be attached to the upstream support 432f. The vector along which the wire 130f slides can be controlled by a bearing 132 (e.g., a ring) around which the wire slides. Similarly, with respect to the clasp 430 and wire 130 of tool 400, the clasp 430f can be biased (e.g., spring-loaded) to close (e.g., move toward its gripping state) such that releasing the tension on the wire 130 allows the clasp to close responsively.

[0950] Unlike in tool 400, wire 130f may not serve as a guide for mounting member 440f (e.g., as a track along / over which the mounting member is advanced). Instead, in tool 400f, such guidance is provided by a mechanical linkage between mounting member 440f and shaft 410f. For simplicity and clarity, in addition to patch anchor 240f, Figure 20A -E does not display the implant itself. Similarly, Figure 20A -E The anatomical structures (eg, leaflets 10) are not shown. Figure 2G -K and 6A-C are useful for context and comparison.

[0951] The mechanical linkage comprises a beam 441 (which may be similar to a panel) that is pivotally attached at one end to the shaft 410f and at the other end to the mount 440f. The linkage couples distal movement of the mount 440f with lateral translation and / or deflection of the mount in a manner that directs the mount toward its initial state, i.e., into a predetermined position suitable for anchoring the implant patch. For example, the mount 440f is moved from its retracted state ( Figure 20A ) transitions to its initial state ( Figure 20B ) can be the product of the effective length of the beam 441 (e.g., the length between the point where it is attached to the shaft 410f and the mount 440f) and / or the angle that the beam deflects during the transition.

[0952] Figure 20A Tool 400f is shown with clasp 430 closed as if it had grasped leaflet 10, and mount 440f in its retracted state. Figure 20A can be considered to correspond roughly to Figure 2H , make necessary modifications. Figure 20B The mount 440f is shown moved to its initial state and can therefore be considered to correspond generally to Figure 2J , mutatis mutandis. Arrow a1 indicates deflection of beam 441, and arrow 12 indicates movement (e.g., distal advancement and lateral translation and deflection) of mounting member 440f. In some embodiments, and as shown, beam 441 may have a notch or aperture through which wire 130f extends, in order to allow the functions described herein without interference between these components.

[0953] In some embodiments, beam 441 is biased (e.g., spring-loaded) to move mount 440f to its initial position. For example, and as shown, beam 441 can be a cantilever spring. For such embodiments, beam 441 can be initially constrained ( Figure 20A ), and release the constraint to allow the beam to move the mount 440f to its initial position ( Figure 20B ). For some such embodiments, constraint is provided by a discrete dedicated component (e.g., similar to wire 130f). However, in the illustrated example, constraint is provided by one or more actuators 450f that are also configured to drive patch anchor 240f through leaflet 10. This dual functionality is facilitated by the cooperating shapes and dimensions of actuator 450f and mounting member 440f (e.g., a channel 448f of the mounting member within which patch anchor 240f is disposed).

[0954] Each driver 450f includes a driver head 452f and a rod (e.g., a pusher rod) 454f that extends proximally from the driver head, e.g., to a proximal portion of the tool 400, e.g., to a driver controller (e.g., similar to the driver controller 112 described above), thereby operably coupling the driver controller to the driver. Similar to the driver 450 of the tool 400, the driver 450f is configured to anchor the patch 210 to the leaflet 10 (e.g., to the portion of the leaflet grasped by the clasp 430f) using the patch anchor 240f, e.g., by driving the patch anchor through the leaflet. Similar to that described with respect to the implant 150 and tool 400, during delivery, the anchor 240f remains within the channel 448f of the mounting member 440f, e.g., such that the cord of the patch anchor extends laterally out of the channel to secure the patch to the mounting member. However, as described above, the actuators 450f have a dual function in that they are also configured to provide a constraint that inhibits movement of the mount 440f toward its initial position and / or pulls the mount out of its initial position.

[0955] In order to drive (for example, push) out channel 448f by patch anchor 240f, the shape and size of drive head 452f are designed to slide distally through channel. For example, and as shown in the figure, each drive head 452f can be closely matched in corresponding channel 448f. However, mounting member 440f includes or is shaped to limit an obstacle, and the obstacle blocks drive head 452 from leaving mounting member and / or detaching from mounting member to the proximal side. For example, and as shown in the figure, this obstacle is back plate 449. As shown in the figure, for each driver 450f, back plate 449 can limit an opening, and pusher rod 454f extends through the opening, but the shape and / or size of the opening road are designed to block drive head 452 from passing therethrough. For example, drive head 452f can be simply wider than push rod 454f. Therefore, pulling or constraining driver 450 can pull mounting member 440f proximally or constrain it to its retracted position ( Figure 20A ). Sufficiently releasing the actuator 450f (eg, the tension on the pusher rod 454f) allows the beam 441 to pull the mount 440f toward its initial state ( Figure 20B However, this conversion can be achieved without any relative movement between the driver 450f and the mounting member 440f. Figure 20B In the embodiment of the present invention, the drive head 452f remains in contact with the back plate 449.

[0956] From the initial position, distal movement of the driver 450f (e.g., pushing the pusher rod 454f) causes the driver head 452f to move distally away from the back plate 449 and through the channel 448f, thereby driving the patch anchor 240f out of the channel and through the leaflet held in the clasp 430f ( Figure 20C ). This anchors the patch to the leaflet as described above. Subsequent retraction of the actuator 450 (e.g., by pulling the push rod 454f) brings the actuator head 452f back into contact with the back plate 449 ( Figure 20D ), and further retraction would pull the mount 440f back to its retracted state ( Figure 20E ). The clasp can then be opened by pulling the wire 130f to deflect the upstream support 432f proximally, thereby releasing the leaflet 10 from the clasp 430f. This step of releasing the leaflet is not shown, but is similar to Figure 2L Follow the steps shown in , making necessary modifications.

[0957] In some embodiments, the delivery tool may include a spring that biases the mount to move to its initial position, rather than necessarily including a beam to provide such a mechanical linkage.

[0958] In some embodiments, this separation of the roles of clasp control and mounting member advancement can advantageously improve the predictability and / or reliability of the delivery tool. For example, because advancement of mounting member 440f does not require interaction between the mounting member and wire 130f, advancement of the mounting member may be less likely to inadvertently affect the grip of leaflet 10.

[0959] Now refer to Figure 21A -E, which is a schematic diagram of some components of a drive shaft subassembly 490g and a downstream assembly 300g according to some embodiments. Drive shaft subassembly 490g can be used as a drive shaft subassembly of any delivery system described herein, and downstream assembly 300g can be used as a downstream subassembly of an implant described herein.

[0960] Downstream assembly 300g includes a capstan anchor 310g, which includes a tissue engaging element, such as tissue engaging element 312 described above. Downstream assembly 300g also includes a capstan 320g coupled to the capstan anchor and includes a spool 322g. Downstream assembly 300g also includes a driver interface 316g. As shown, spool 322g can be installed so that it and / or its axis of rotation are colinear with the anchor axis of anchor 310g. However, other spool orientations are possible.

[0961] In drive shaft subassembly 490g, the separate anchor-controlled drive shaft and capstan-controlled drive shaft of drive shaft subassembly 490 have been replaced with an integral downstream assembly-controlled drive shaft 480g. In some embodiments, replacing two coaxial drive shafts with a single drive shaft enables drive shaft subassembly 490b to be thinner and / or more flexible than drive shaft subassembly 490, thereby advantageously being less likely to produce significant hemodynamic artifacts during adjustment of the effective length of tether 160.

[0962] The drive shaft 480g can include or define a drive head 483g at a distal end of the drive shaft, the drive head including one or more (e.g., two) protrusions that are locked to the downstream assembly 300g by a locking rod 486g (e.g., by retaining the protrusions in a laterally displaced state). That is, the locking rod 486g locks the engagement between the drive head 483g and the driver interface 316g. Through the engagement between the drive head 483g and the interface 316g, the drive shaft subassembly 490g (e.g., the drive shaft 480g thereof) facilitates (i) applying an anchoring force (e.g., torque) to the capstan anchor 310g and (ii) actuating the capstan 320 independently of each other.

[0963] Downstream assembly 300g can be converted between anchored state and twisted state. Under anchored state, the force (for example, torque) applied to interface 316 by drive shaft 480g is transferred to capstan anchor 310g in the mode that is conducive to tissue engagement element drive into tissue. Under twisted state, the force (for example, torque) applied to interface 316 by drive shaft 480g is transferred to capstan anchor 310g in the mode that actuates capstan to rotate spool 322g. The conversion between states can be controlled from the external control part (for example, its controller) of delivery instrument. Downstream assembly includes the shaft rod 317g that is usually limited and / or fixedly attached to interface 316. The conversion between downstream assembly 300g in its anchored state and its twisted state is realized by making the position (for example, axial position) of shaft rod 317g relative to other parts displacement of downstream assembly.

[0964] Figure 21A The downstream assembly 300g is shown in its anchored state, wherein the shaft 317g is engaged with the anchor head 314g of the anchor 310g, e.g., the shaft head 318 is disposed within a receptacle 315 of a complementary shape defined by the anchor head (e.g., a hexagonal drive). In this state, rotation of the drive shaft 480g rotates the shaft 317g, which rotates the tissue engaging element 312, screwing it into the tissue. Axially moving the shaft 317g (e.g., proximally) via an axial (e.g., pulling) force applied by the drive shaft 480g transitions the downstream assembly 300g to its twisted state ( Figure 21C), in the twisted state, the shaft 317g is engaged with the spool 322g of the capstan 320g, for example, the shaft head 318 is disposed within a socket 319 of a complementary shape defined by the spool 322g (e.g., a hexagonal drive).

[0965] In some embodiments, and as shown, the downstream component 300g is also provided with a mid-range state ( Figure 21B ), the downstream component transitions from its anchored state to its twisted state via the mid-range state. For example, in the mid-range state, the shaft head 318 can be disposed in neither the socket 315 nor the socket 319, e.g., the shaft head can be disposed in the space between these sockets, wherein the shaft head can freely rotate without engaging the anchor head or the spool. In some embodiments, this can facilitate the transition from the anchored state to the twisted state. For example, if, upon completion of anchoring, the socket 315 (and therefore the shaft head 318) happens not to be rotationally aligned with the socket 319, the mid-range state (e.g., the space between the sockets) can allow the shaft 317g to rotate so as to rotationally align the shaft head with the socket 319 so that the shaft head enters the socket.

[0966] Once anchoring and twisting are complete, drive shaft 480g is disengaged from interface 316g, for example, by retracting locking rod 486g, thereby allowing the projection of drive head 483g to responsively (e.g., automatically) deflect inwardly ( Figure 21D At this point, the drive shaft subassembly 490g can be completely disengaged and retracted from the downstream assembly 300g ( Figure 21E ). Note that shaft 317g, which is part of downstream assembly 300g, remains in place. Figure 21E The shaft 317g is shown still in Figure 21C -D position shown, but it will be understood that after disconnection the shaft is free to alternately return Figure 21B mid-range position shown or Figure 21A Position shown.

[0967] In some embodiments, the capstan 320g includes one or more spring-loaded pawls 328g that, in at least one state of the downstream assembly 300g, press against the spool 322g in a manner that rotationally locks the spool 322g relative to the housing 321g of the capstan. For example, the pawls 328g can protrude into recesses defined in the surface of the spool 322g and / or can press teeth in the surface of the spool into engagement with complementary teeth in the surface of the housing. For such embodiments, converting the downstream assembly 300g to its twisted state can include overcoming this lock, for example, by axially pulling the spool 322g relative to the housing 321g via the shaft 317g. However, for the sake of clarity, this is not shown.

[0968] although Figure 21A -E, but the drive shaft subassembly may include a reference force tube, such as reference force tube 492 described above, mutatis mutandis.

[0969] refer to Figure 22A -C, 23A-D, 24A-C, 25A-E, 26A-E, 27A-D, 28A-B, 29A-D, 30A-B, 31A-D, 32A-B, 33A-D, 34A-B and 35A-C, which are schematic diagrams of various patch anchors and anchor drivers according to some embodiments. Each of these patch anchors can be the same as, similar to and / or considered to be a variation of the patch anchor 240 described above. Thus, each of these patch anchors can be used to anchor a leaflet reinforcement patch (or another implantable element) to the leaflets of a valve (e.g., as described above, mutatis mutandis); can be used as a component of an implant, such as implant 150 (or variations thereof), mutatis mutandis; and / or used in combination with a delivery tool, such as delivery tool 400 (or variations thereof), mutatis mutandis. However, in some embodiments, reference is made to Figures 22A-35B The described patch anchors may be more generally considered to be toggle anchors, and / or may be used in other contexts.

[0970] Figure 22A -C, 23A-D and 24A-C schematically illustrate a patch anchor having a heel having a geometry that is complementary to the geometry of a corresponding driver such that the connection between the heel and the driver (e.g., its driver head) (i) preferentially allows deflection of the toggle anchor relative to the driver rather than lateral translation, and (ii) allows the heel to be disconnected from the driver when the toggle anchor reaches a predetermined angle relative to the driver. Figure 22A -C shows a patch anchor 240h and its corresponding actuator 450h, Figure 23A -D shows a patch anchor 240i and its corresponding driver 450i, and Figure 24A -C shows the patch anchor 240j and its corresponding actuator 450j.

[0971] Each of drivers 450h and 450i is a component of a corresponding delivery tool (e.g., delivery...

Claims

1. A system for use with a valve disposed between an atrium and a ventricle of a subject's heart, the system comprising: An implant, comprising: A patch, comprising a flexible sheet, Patch anchors, a downstream assembly comprising a ventricular anchor, and a tether tethering the downstream component to the patch; and A delivery tool having a distal portion that is capable of being advanced transluminally to the heart when the implant is mounted on the delivery tool, the delivery tool comprising: a shaft defining a longitudinal axis of the delivery tool; A clasp, the clasp comprising an upstream support and a downstream support, the clasp being capable of switching between the following positions: an open state in which the upstream support and the downstream support are positioned away from each other and in which the clasp is configured to receive a portion of a leaflet of the valve between the upstream support and the downstream support, and a grasping state, the clasp being configured to grasp the portion of the leaflet by transitioning from the open state toward the grasping state while the portion of the leaflet received between the upstream support and the downstream support remains disposed between the upstream support and the downstream support; and An actuator is configured to anchor the patch to the portion of the leaflet using the patch anchor while the portion of the leaflet remains captured by the clasp.

2. A system according to claim 1, wherein the delivery tool has an extracorporeal proximal portion, the extracorporeal proximal portion including a clasp controller, the clasp controller being operably connected to the clasp so that operation of the clasp controller causes the clasp to switch between the open state and the grasping state.

3. A system according to claim 2, wherein the clasp controller is operably connected to the upstream support of the clasp, so that operation of the clasp controller causes the clasp to switch between the open state and the grasping state via movement of the upstream support relative to the axis.

4. The system of claim 3, wherein: The delivery tool further includes a pair of clasp control wires, the clasp controller being operably coupled to the clasp via the pair of clasp control wires, and The external part includes the lever: The clasp controller is operably coupled to both of the wires in the pair via the lever, and The lever is adapted to pivot in such a way that the wires of the pair are balanced relative to each other.

5. The system of claim 2, wherein: The proximal portion further includes an anchor controller, and The delivery tool also includes a drive shaft subassembly, which includes one or more drive shafts extending through the axis, and the drive shaft subassembly is configured so that in at least one state of the delivery tool, the drive shaft subassembly operably connects the anchor controller to the ventricular anchor so that operation of the anchor controller applies an anchoring force to the ventricular anchor.

6. The system of claim 5, wherein: The downstream assembly further includes a capstan, the ventricular anchor being a capstan anchor coupled to the capstan, The tether tethers the capstan to the patch, and The extracorporeal proximal portion also includes a capstan controller, the drive shaft subassembly being configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the capstan controller to the capstan such that operation of the capstan controller actuates the capstan.

7. The system of claim 6, wherein the drive shaft subassembly comprises: a winch control drive shaft, the winch controller being operably coupled to the winch via the winch control drive shaft, and An anchor control drive shaft is disposed through the capstan control drive shaft, and the anchor controller is operably coupled to the anchor via the anchor control drive shaft.

8. The system of claim 7, wherein: the anchor control drive shaft operably coupling the anchor controller to the anchor via engagement of the anchor by a distal end portion of the anchor control drive shaft, The delivery tool further includes a release spring biased to pull the anchor control drive shaft proximally away from the anchor, the engagement of the anchor by the distal end portion of the anchor control drive shaft resisting the pulling of the anchor control drive shaft by the release spring, and The drive shaft subassembly also includes a locking rod at the distal end portion of the anchor-controlled drive shaft, which maintains the engagement of the anchor by the distal end portion of the anchor-controlled drive shaft, so that retraction of the locking rod from the distal end portion of the anchor-controlled drive shaft triggers the release spring to pull the anchor-controlled drive shaft proximally away from the anchor.

9. The system of claim 5, wherein: The downstream assembly further includes a capstan, the ventricular anchor being a capstan anchor coupled to the capstan, The drive shaft subassembly includes a downstream assembly controlling the drive shaft, The system has an anchored state in which the anchor controller controls the drive shaft operatively coupled to the capstan anchor via the downstream component such that operation of the anchor controller applies the anchoring force to the capstan anchor, and The system has a twisted state in which the downstream component controls the drive shaft: operably decoupled from the winch anchor such that operation of the anchor controller does not apply the anchoring force to the winch anchor, and The downstream component is operably coupled to the capstan such that rotation of the drive shaft is controlled by the downstream component to actuate the capstan.

10. The system of claim 9, wherein the downstream component comprises a shaft that is axially movable within the downstream component such that: Positioning the shaft in a first axial position within the downstream assembly places the system in the anchored state, and Positioning the shaft in a second axial position within the downstream assembly places the system in the twisted state.

11. The system of claim 10, wherein: The winch includes a spool disposed therein, the spool being operably coupled to the tether such that rotation of the spool tensions the tether, The shaft defines a protruding rim therearound, The downstream assembly includes a spring-loaded pawl biased to project into a recess defined by a surface of the spool, thereby maintaining the spool in a locked state in which the spool cannot rotate, and Shifting the shaft to the second shaft position automatically unlocks the capstan by the edge pushing the pawl out of the recess, thereby allowing the spool to rotate.

12. A system according to any one of claims 1 to 11, wherein: The ventricular anchor is a first ventricular anchor, The downstream assembly further includes a second ventricular anchor, and The tether tethers the patch to both the first ventricular anchor and the second ventricular anchor.

13. The system of any one of claims 1 to 12, wherein the patch comprises a first component of the sheet material, and a second component of the sheet material is shaped to extend away from the patch in a manner to define the tether.

14. A system according to any one of claims 1 to 13, wherein the clasp includes a grasping indicator, which is flexibly connected to the upstream support member in the following manner: when the portion of the leaflet is grasped between the upstream support member and the downstream support member, the portion of the leaflet moves the grasping indicator relative to the upstream support member in a manner that can be detected by fluoroscopy.

15. The system of any one of claims 1 to 14, wherein the delivery tool is configured such that a steerable portion of the shaft distal to the clasp can be steered via manipulation of an extracorporeal proximal portion of the delivery tool.

16. The system of any one of claims 1 to 15, wherein the tether extends from the downstream component to the patch and back to the downstream component.

17. A system according to any one of claims 1 to 16, wherein the patch has a lip region, and wherein the tether is attached to the patch via two lateral lines that diverge away from the tether and away from each other and are attached to opposite lateral locations in the lip region.

18. A system according to any one of claims 1 to 17, wherein: The downstream assembly further includes a capstan, the ventricular anchor being a capstan anchor coupled to the capstan, and The tether tethers the capstan to the patch.

19. The system of claim 18, wherein: The winch includes a housing and a spool disposed therein, the spool being operably coupled to the tether such that actuation of the winch tensions the tether, The tether extends from the spool and out of an aperture in the housing, the aperture having a rim, and The downstream assembly also includes a spring coupled to the housing in a manner that pushes the tether away from contact with the rim.

20. The system of claim 18, wherein the delivery tool further comprises a drive shaft subassembly comprising one or more drive shafts extending through the shaft and operably coupled to the downstream assembly in a manner that configures the drive shaft subassembly to: anchoring the capstan anchor to ventricular tissue of the heart by applying an anchoring force to the capstan anchor, and The capstan is actuated independently of applying the anchoring force.

21. The system of claim 20, wherein: The delivery tool is configured to actuate the capstan by applying torque to the capstan via the drive shaft subassembly, and The downstream assembly includes a sliding clutch that operably couples the drive shaft subassembly to the capstan in a manner that limits the amount of torque that the delivery tool can apply to the capstan.

22. A system according to any one of claims 1 to 21, wherein the actuator is configured to anchor the patch to the portion of the leaflet by driving the patch anchor through the portion of the leaflet grasped by the clasp.

23. The system of claim 22, wherein the patch anchor is a toggle member biased to automatically widen upon deployment.

24. The system of any one of claims 1 to 23, wherein the delivery tool is configured to anchor the downstream component to the ventricular tissue by anchoring the ventricular anchor to ventricular tissue of the ventricle.

25. The system of claim 24, wherein the ventricular anchor comprises a tissue engaging element, and the delivery tool is configured to anchor the downstream component to the ventricular tissue by driving the tissue engaging element into the ventricular tissue.

26. The system of claim 25, wherein the implant is mounted or mountable on the delivery tool such that the ventricular anchor is disposed at a distal end of the shaft.

27. The system of claim 26, wherein the delivery tool comprises a capsule coupled to a distal end of the shaft, the distal portion of the delivery tool being capable of being advanced transluminally to the heart while the downstream component is housed within the capsule.

28. The system of claim 27, wherein the capsule comprises a shield formed from an elastic polymer.

29. The system of claim 28, wherein the capsule further comprises a housing having a plurality of fingers, the plurality of fingers being flexible, circumferentially distributed to approximate a tubular shape, and embedded within the shield.

30. The system of any one of claims 1 to 29, wherein the implant comprises an upstream component comprising the patch anchor coupled to the patch.

31. The system of claim 30, wherein the upstream component further comprises a cord, the patch anchor being coupled to the patch via the cord.

32. The system of claim 31 , wherein the patch anchor is a toggle anchor.

33. The system of claim 32, wherein the toggle anchor is a helical coil defining a lumen therethrough.

34. The system of claim 32, wherein: The toggle anchor has a tip, a heel, and an eyelet midway between the tip and the heel, and The heel is opened in the following manner: facilitating the heel to pass through the leaflet in a first direction, and The heel is inhibited from passing through the leaflet in a second direction opposite to the first direction.

35. The system of claim 32, wherein: The toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel, and The cord is connected to the toggle anchor via the lateral eyelet in such a manner that tensioning the cord extends the heel away from the lateral eyelet.

36. The system of claim 35, wherein the system further comprises a retrieval line that passes through the toggle anchor in a manner such that tensioning the retrieval line retracts the heel toward the lateral eyelet.

37. The system of claim 32, wherein: The toggle anchor has a tip, a heel, and a lateral eyelet midway between the tip and the heel, The first section of the toggle anchor defines the tip, The second segment of the toggle anchor is slidably coupled to the first segment, and The system also includes a longitudinal member extending through the lateral eyelet and connected to the toggle anchor in such a manner that pulling the longitudinal member axially slides the second segment relative to the first segment.

38. A system according to claim 37, wherein the driver is configured to push the forward tip of the toggle anchor through the portion of the leaflet, the driver having a driver head and a rod extending proximally from the driver head, the driver head being connected to the heel via complementary geometry in a manner that: (i) preferentially allows the toggle anchor to deflect relative to the driver rather than to translate laterally, and (ii) allows the heel to disconnect from the driver when the toggle anchor reaches a predetermined angle relative to the driver.

39. The system of claim 31 , wherein the upstream component includes a one-way mechanism through which the cord extends, the one-way mechanism: mounted on the patch, is configured to facilitate passage of the cord through the one-way mechanism in a first direction pulling the patch anchor toward the patch, and The device is configured to inhibit the cord from passing through the one-way mechanism in a second direction opposite to the first direction.

40. The system of any one of claims 1 to 39, wherein the clasp defines a slot and the actuator is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet and the slot.

41. The system of claim 40, wherein the clasp defines a resilient tooth configured to facilitate driving of the patch anchor through the slot by the actuator and to inhibit withdrawal of the patch anchor through the slot in an opposite direction.

42. The system of claim 40, wherein the clasp defines a resilient slot guard configured to block tissue of the heart from entering the slot.

43. A system according to any one of claims 1 to 42, wherein the delivery tool further comprises a mounting member configured to support the patch mounted thereon and configured to carry the patch toward the clasp when the clasp is in the grasping state.

44. A system according to claim 43, wherein the mounting member is configured to carry the patch toward the upstream support member of the clasp by moving distally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

45. A system according to claim 44, wherein the mounting member is configured to carry the patch toward the upstream support member of the clasp by moving distally and laterally toward the clasp along with the patch mounted on the mounting member when the clasp is in the grasping state.

46. ​​The system of claim 45, wherein the delivery tool comprises a beam providing a mechanical linkage between the shaft and the mount, the mechanical linkage coupling distal movement of the mount with lateral movement of the mount.

47. The system of claim 43, wherein: The mounting member has a retracted position, and when the mounting member is in the retracted position and the patch is mounted on the mounting member, the distal portion of the delivery tool can be advanced transluminally to the heart, The mounting member has an initial position in which the mounting member is disposed closer to the clasp than in the retracted position, and The actuator is configured to anchor the patch to the leaflet by driving the patch anchor through the leaflet when the mount is in the initial position and the patch is mounted on the mount.

48. The system of claim 47, wherein: The mounting member defines a passage therein, The distal portion of the delivery tool is capable of being advanced transluminally to the heart when the mount is in the retracted position with the patch mounted on the mount and the patch anchor disposed within the passageway, and The actuator is configured to anchor the patch to the portion of the leaflet by driving the patch anchor out of the channel and through the portion of the leaflet.

49. A system according to claim 47, wherein the delivery tool further includes one or more wraps, and the distal portion of the delivery tool can be advanced through the cavity to the heart when the mounting member is in the retracted position and the patch is held against the mounting member by the one or more wraps wrapped around the patch and the mounting member.

50. The system of claim 49, wherein the one or more entanglements are one or more kirigami entanglements.

51. The system of any one of claims 1 to 50, wherein the delivery tool further comprises a retrieval wire releasably coupled to the anchor such that tensioning the retrieval wire releases the anchoring of the patch anchor from the leaflet.

52. The system of claim 51, wherein: The patch anchor comprises a tubular toggle and includes a retrieval feature comprising a notch at a heel of the toggle and a retrieval eyelet, and The retrieval line: extending into the lumen of the toggle member at the heel of the toggle member in line with the toggle member, exiting the side wall of the toggle member through the retrieval aperture, and It loops back onto itself via the notch to connect to itself.

53. A system for use with a tissue of a subject, the system comprising: a toggle anchor having a tip and a heel and defining an anchor axis therebetween; as well as A delivery vehicle, wherein: defining a channel in which the toggle anchor is disposed; and A driver is included, the driver being configured to push the forward tip of the toggle anchor distally away from the channel, the driver having a driver head and a rod extending proximally from the driver head, the driver head being connected to the heel via complementary geometry in the following manner: (i) The toggle anchor is preferentially allowed to deflect relative to the driver rather than to translate laterally, and (ii) the heel is allowed to disconnect from the driver when the anchor reaches a predetermined angle relative to the driver.

54. The system of claim 53, wherein: The drive head has a first distally facing surface and defines a shoulder defining a second distally facing surface proximal to the first surface, and At the heel, the toggle anchor defines a lateral opening through which the shoulder projects, such that: The driver is configured to urge the forward tip of the toggle anchor through the tissue by: (i) the second distally-facing surface urging the toggle anchor distally at the lateral opening, and (ii) the first distally-facing surface urging the toggle anchor distally substantially opposite the lateral opening, and The toggle anchor is permitted to disconnect from the driver head by deflecting about a point on the driver proximal to the second distally facing surface such that the lateral opening moves laterally away from the shoulder.

55. The system of claim 54, wherein the driver further comprises a stabilizer, the stabilizer being configured such that pushing the tip of the toggle anchor against the tissue by the driver causes the stabilizer to move to a stable position relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor, the stabilizer inhibiting deflection of the toggle anchor relative to the driver when in the stable position.

56. A system, comprising: an implant comprising a toggle anchor having a body, a tip, and a heel, the toggle anchor defining an anchor axis between the tip and the heel; as well as A delivery vehicle, wherein: configured to advance the implant transluminally into tissue of a subject when the implant is coupled to the distal portion of the tool, and comprising a driver including a driver head and a rod extending proximally from the driver head, the driver being configured to push a forward tip of the toggle anchor through the tissue, Wherein the system includes an extendable member and is configured such that when the driver pushes the tip of the toggle anchor against the tissue, the extendable member responsively slides axially relative to the body.

57. A method of connecting a tether to a component of an implant, the method comprising: forming a loop in the tether by looping an end portion of the tether around a component of the member, and The bight is closed into a loop by coaxially drilling the end portion through the tension portion of the tether such that the tension portion compresses the end portion therein.

58. The method of claim 57, wherein: The rope loop is a first rope loop, The ring is a first ring, Drilling the end portion coaxially through the stretch portion includes drilling a first component of the end portion coaxially through the stretch portion, and The method further comprises: forming a second loop in the end portion, and The second rope loop is closed into a second loop by coaxially drilling the second component of the end portion through the stretch portion so that the first component and the second component extend alongside each other in the stretch portion.

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