Treatment technology for the tip of a valve

Abstract

The implant (150) comprises a patch (210), a patch anchor (240), a downstream assembly (300) comprising a winch (320) coupled to a winch anchor (310), and a tether (160) for mooring the winch to the patch. The delivery tool (400) has a distal portion that is translatable transvascularly to the heart while the implant is attached to the delivery tool. The delivery tool has a shaft and a clamp (430) comprising an upstream support and a downstream support configured to grip a portion of the valve leaflet of a heart valve between the upstream and downstream supports of the clamp, and a driver configured to use the patch anchor to anchor the patch to the portion of the valve leaflet while the portion of the valve leaflet remains gripped by the clamp. Other implementations are also described.

Description

Technical Field

[0001] Cross - reference to related applications This application claims priority to the following applications: U.S. Provisional Patent Application No. 63 / 341,376 to Pesach et al., filed May 12, 2022, entitled "Valve Leaflet Treatment Techniques", and U.S. Provisional Patent Application No. 63 / 369,927 to Pesach et al., filed Jul. 29, 2022, entitled "Valve Leaflet Treatment Techniques".

[0002] This application is related to International Patent Application PCT / IB2021 / 060436 by Tennenbaum et al., published as International Publication No. 2022 / 101817, entitled "Valve leaflet treatment systems and methods", filed Nov. 11, 2021.

[0003] Each of the above - mentioned applications is hereby incorporated by reference in its entirety for all purposes.

Background Art

[0004] Ischaemic heart disease can cause mitral regurgitation due to a combination of ischaemic dysfunction of the papillary muscles, left ventricular dilation seen in ischaemic heart disease, and subsequent displacement of the papillary muscles and dilation of the mitral valve annulus.

[0005] Dilation of the mitral valve annulus prevents complete apposition of the valve leaflets when the valve is closed. Mitral regurgitation of blood from the left ventricle to the left atrium results in an increase in total cardiac output and a decrease in cardiac output, as well as subsequent left ventricular weakening secondary to volume overload and pressure overload of the left atrium.

[0006] Chronic or acute left ventricular dilation can cause displacement of the papillary muscles due to increased tension in the chordae tendineae and increased tethering of the valve leaflets due to annulus dilation.

Summary of the Invention

Means for Solving the Problems

[0007] The 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 an example of the summary of the present invention does not become a requirement according to the claims unless the claims explicitly list those features. Also, the described features can be combined in various ways. The various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0008] In some implementations, systems and devices are provided that include a valve tip patch (e.g., a valve tip reinforcement patch), a repair chordal tissue, and / or a delivery tool for its implantation. The system / device may include a sub-valve device and / or components. In some implementations, systems / devices are provided that facilitate valve tip reinforcement.

[0009] In some implementations, the systems, devices, and methods described herein can be used to provide inlet chordae tendineae and / or valve tip reinforcement to the left side of the heart. In some implementations, the systems, devices, and methods described herein can be used to provide inlet chordae tendineae and / or valve tip reinforcement to the right side of the heart.

[0010] In some implementations, the systems, devices, and methods described herein can be used to adjust the length between two portions of the heart wall.

[0011] According to some implementations, the system and / or device (e.g., for use in or usable with a valve disposed between the atrium and ventricle of an actual or simulated heart of an actual or simulated subject) includes an implant and / or a delivery tool.

[0012] In some embodiments, the implant may include a patch, a patch anchor, a downstream assembly, and / or a tether.

[0013] In some embodiments, the patch may include a flexible sheet. In some embodiments, the downstream assembly may include a ventricular anchor.

[0014] In some embodiments, the tether may couple or moor the downstream assembly to the patch.

[0015] In some embodiments, the delivery tool may have a distal portion that is telescopically advanceable into the heart while the implant is mounted to the delivery tool.

[0016] In some embodiments, the delivery tool may include a shaft, a clip, and / or a driver.

[0017] In some embodiments, the shaft may define the longitudinal axis of the delivery tool.

[0018] In some embodiments, the clip may include an upstream support and a downstream support.

[0019] In some embodiments, the clip may be configured to be translatable between an open state and a gripping state.

[0020] In some embodiments, in the open state, the upstream support and the downstream support are positioned apart from each other. In some embodiments, in the open state, the clip is configured to receive a portion of the valve leaflet between the upstream support and the downstream support.

[0021] In some embodiments, in the gripping state, the clip is configured to grip a portion of the valve leaflet received between the upstream support and the downstream support by transitioning from the open state to the gripping state while a portion of the valve leaflet remains disposed between the upstream support and the downstream support.

[0022] In some embodiments, the driver may be configured to use a patch anchor to anchor the patch to a portion of the valve tip while a portion of the valve tip is gripped by a clip.

[0023] In some embodiments, the clip is movable toward an open state after anchoring the patch to the valve tip, releasing a portion of the valve tip from the clip with the patch anchored thereto.

[0024] In some embodiments, in the gripped state, the upstream support and the downstream support are closer to each other than in the open state.

[0025] In some embodiments, the ventricular anchor is a first ventricular anchor and the downstream assembly further includes a second ventricular anchor.

[0026] In some embodiments, the tether couples and / or moors the patch to both the first ventricular anchor and the second ventricular anchor.

[0027] In some embodiments, the patch includes a first portion of the sheet, and a second portion of the sheet is shaped to extend away from the patch in a manner that defines the tether.

[0028] In some embodiments, when the clip grips a portion of the valve tip between the upstream support and the downstream support, the portion of the valve tip moves the gripping indicator relative to the upstream support in a manner detectable by fluoroscopy, and the clip includes the gripping indicator flexibly coupled to the upstream support.

[0029] In some embodiments, the patch anchor is coupled to the patch in a manner that facilitates (i) temporarily moving the patch anchor away from the patch while the patch anchor remains coupled to the patch and / or (ii) biasing the patch anchor back toward the patch to anchor the patch to a portion of the valve tip.

[0030] In some embodiments, the delivery tool is configured such that an operable portion of the shaft distal from the clip is operable via the operation of the proximal portion of the delivery tool outside the body.

[0031] In some embodiments, the implant is mounted to, or mountable to, the delivery tool such that the tether extends along the shaft from the downstream assembly, through the clip, and to the patch.

[0032] In some embodiments, the clip is disposed entirely laterally from the shaft in both the open and gripping states.

[0033] In some embodiments, the ventricular anchor includes a helical tissue engagement element.

[0034] In some embodiments, the tether extends from the downstream assembly to the patch and back to the downstream assembly.

[0035] In some embodiments, the ventricular anchor is a first ventricular anchor and the downstream assembly further includes 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.

[0036] In some embodiments, the implant includes an upstream assembly that includes a patch and a patch anchor, and / or the tether is slidably coupled to the upstream assembly.

[0037] In some embodiments, the upstream assembly defines an eyelet and the tether is slidably coupled to the upstream assembly by being screwed through the eyelet.

[0038] In some embodiments, the downstream assembly includes a winch coupled to the ventricular anchor. In some embodiments, the tether is disposed in a pulley arrangement where a first end of the tether is operably coupled to the winch. In some embodiments, the tether is disposed in a pulley arrangement where a curved portion of the tether is slidably coupled to the upstream assembly. In some embodiments, the tether is disposed in a pulley arrangement where a second end of the tether is fixed to the downstream assembly.

[0039] In some embodiments, the winch has a housing fixedly attached to the ventricular anchor, and the second end of the tether is fixed to the housing.

[0040] In some embodiments, the patch has a lip region, and the tether is attached to the patch via two lateral lines that branch away from the tether and from each other and are attached to opposing lateral sites of the lip region.

[0041] In some embodiments, the attachment of the tether to the patch via the two lateral lines is set such that, due to the tension applied to the tether, the patch is bent inward, and the patch is configured to elastically bend inward.

[0042] In some embodiments, the system further includes an inner line that connects the tether to an inner site of the lip region in a manner that limits the degree to which the patch is bent inward due to the tension applied to the tether.

[0043] In some embodiments, the downstream assembly further includes a winch, the ventricular anchor is a winch anchor coupled to the winch, and / or the tether moors the winch to the patch.

[0044] In some embodiments, the winch includes a housing and a spool disposed therein, and the spool is operably coupled to the tether such that when the winch is actuated, tension is applied to the tether. In some embodiments, the tether extends out of an opening of the housing from the spool, and the opening has a rim.

[0045] In some implementations, the downstream assembly further includes a spring coupled to the housing in a manner that biases the tether away from contact with the rim.

[0046] In some implementations, the spring is a coil spring. In some implementations, the spring is a cantilever spring. In some implementations, the spring is a wave spring.

[0047] In some implementations, the spring is coupled to the housing in a manner that biases the tether away from contact with the side of the rim that is furthest from the winch anchor.

[0048] In some implementations, the downstream assembly includes a helical structure that defines a gripping region adapted to grip (i) the spring and / or (ii) the tether.

[0049] In some implementations, the spring defines a helical structure having a series of turns.

[0050] In some implementations, the helical structure extends circumferentially around the outside of the winch housing.

[0051] In some implementations, the spring is adapted to grip the tether between the turns of the helical structure.

[0052] In some implementations, the delivery tool further includes a drive shaft sub-assembly, the drive shaft sub-assembly including one or more drive shafts that extend through the shaft and are operatively coupled to the downstream assembly in a specification that configures the drive shaft sub-assembly to (i) anchor the winch anchor to the ventricular tissue of the heart by applying an anchor fixing force to the winch anchor and / or (ii) operate the winch, independent of applying the anchor fixing force.

[0053] In some implementations, the delivery tool is configured to operate the winch by applying torque to the winch via a drive shaft subassembly.

[0054] In some implementations, the downstream assembly includes a slip clutch that operably couples the drive shaft subassembly to the winch in a manner that limits the amount of torque that the delivery tool can apply to the winch.

[0055] In some implementations, the drive shaft subassembly includes a reference force tube that extends through the shaft and engages the downstream assembly.

[0056] In some implementations, one or more drive shafts extend through the reference force tube to the downstream assembly.

[0057] In some implementations, the drive shaft subassembly is configured to operate the winch by applying torque to the winch while the reference force tube applies a reference force to the downstream assembly.

[0058] In some implementations, the downstream assembly and the delivery tool are configured to facilitate rotation of the winch anchor relative to the shaft without operating the winch.

[0059] In some implementations, the driver is configured to anchor the patch to a portion of the valve tip by driving a patch anchor through a portion of the valve tip gripped by a clip.

[0060] In some implementations, the patch anchor is a toggle that is biased to automatically expand upon deployment.

[0061] In some implementations, the toggle has a cellular structure that is biased to automatically expand by foreshortening.

[0062] In some embodiments, the delivery tool is configured to anchor a downstream assembly to ventricular tissue by anchoring a ventricular anchor to the ventricular tissue.

[0063] In some embodiments, the ventricular anchor includes a tissue engagement element, and the delivery tool is configured to anchor a downstream assembly to ventricular tissue by driving the tissue engagement element into the ventricular tissue.

[0064] In some embodiments, the implant is attachable or attachable to the delivery tool such that the ventricular anchor is disposed at the distal end of the shaft.

[0065] In some embodiments, the delivery tool further includes a drive shaft sub-assembly, and the drive shaft sub-assembly includes one or more drive shafts that extend through the shaft and are operably coupled to the downstream assembly in a manner that anchors the ventricular anchor to the ventricular tissue by applying an anchoring force to the ventricular anchor.

[0066] In some embodiments, the delivery tool includes a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is transvascularly advanceable into the heart while the downstream assembly is housed within the capsule.

[0067] In some embodiments, the capsule includes a shroud formed from an elastic polymer.

[0068] In some embodiments, the capsule is flexible and further includes a housing having a plurality of fingers circumferentially distributed and embedded within the shroud to approximate a tubular shape.

[0069] In some embodiments, the downstream assembly further includes a winch, and the ventricular anchor is a winch anchor coupled to the winch.

[0070] In some embodiments, the delivery tool further includes a drive shaft sub-assembly, the drive shaft sub-assembly including one or more drive shafts that extend through the shaft and are operably coupled to a downstream assembly in a manner that configures the drive shaft sub-assembly to apply torque to the winch anchor to screw the tissue engagement element into the ventricular tissue without rotating the winch relative to the ventricular tissue.

[0071] In some embodiments, the distal portion of the delivery tool is coupled to the implant in a manner that configures the drive shaft sub-assembly to apply torque to the winch anchor to screw the tissue engagement element into the ventricular tissue without rotating the winch relative to the shaft.

[0072] In some embodiments, the delivery tool includes a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is transvascularly advanceable into the heart while the downstream assembly is housed within the capsule.

[0073] In some embodiments, the capsule and the winch are shaped to inhibit rotation of the winch relative to the shaft while the drive shaft sub-assembly screws the tissue engagement element into the ventricular tissue.

[0074] In some embodiments, the capsule defines a track in which the winch is engaged while being housed by the capsule.

[0075] In some embodiments, the capsule and the downstream assembly are configured such that the downstream assembly advances distally out of the capsule in a manner that configures the drive shaft sub-assembly to screw the tissue engagement element into the ventricular tissue while the winch slides linearly along the track.

[0076] In some embodiments, the track is a lateral opening within the capsule.

[0077] In some embodiments, the winch defines an opening through which the tether extends from the patch out to the winch.

[0078] In some embodiments, by the opening protruding into the side opening, the downstream assembly is configured such that the tissue engagement element is screwed into the ventricular tissue in a manner that the downstream assembly advances distally out of the capsule with the opening of the winch sliding linearly along the side opening.

[0079] In some embodiments, the capsule includes (i) a housing that houses the winch and defines the side opening, and / or (ii) an elastic shroud that covers the housing.

[0080] In some embodiments, the shroud covers the distal region of the side opening and defines a window of the capsule with the proximal region of the side opening remaining exposed.

[0081] In some embodiments, the distal portion of the delivery tool is transvascularly advanceable into the heart while the downstream assembly is housed within the capsule with the opening exposed by the window.

[0082] In some embodiments, the shroud defines a slit that extends distally from the window and is aligned with the side opening.

[0083] In some embodiments, by the opening protruding into the side opening, the drive shaft sub-assembly is configured such that the tissue engagement element is screwed into the ventricular tissue in a manner that the downstream assembly advances distally out of the capsule with the opening of the winch temporarily separating the shroud by the slit when the opening of the winch slides linearly along the side opening.

[0084] In some embodiments, the implant includes an upstream assembly that includes a patch anchor coupled to the patch.

[0085] In some embodiments, the upstream assembly further includes a cord through which the patch anchor is coupled to the patch.

[0086] In some embodiments, the patch anchor is a toggle anchor.

[0087] In some embodiments, the toggle anchor is a helical coil that defines a lumen therethrough.

[0088] In some embodiments, the driver is configured to drive the anchor through the valve tip while the driver extends through the lumen.

[0089] In some embodiments, the system further includes a retrieval line that extends away from the toggle anchor, and when tension is applied to the retrieval line, it is threaded through the turns of the coil in a manner that the turns of the coil are compressed against each other to reinforce the anchor.

[0090] In some embodiments, the helical coil extends helically along the toggle axis around the toggle axis, and the system further includes a retrieval line that extends away from the toggle anchor along the toggle axis, and when tension is applied to the retrieval line, the turns of the coil are compressed against each other to reinforce the anchor.

[0091] In some embodiments, the retrieval line is fixed to a first end of the toggle anchor and extends from the second end of the toggle anchor away from the toggle anchor along the toggle axis to the second end of the toggle anchor.

[0092] In some embodiments, the cord is connected to the central portion of the coil.

[0093] In some embodiments, the cord is connected to the intermediate portion by looping around the turns of the coil.

[0094] In some embodiments, the toggle anchor has a tip, a heel portion, and an eyelet midway between the tip and the heel portion.

[0095] In some implementations, the heel portion is flared in a manner that (i) facilitates passage in a first direction through the tip of the heel portion and / or (ii) inhibits passage in a second direction opposite the first direction through the tip of the heel portion.

[0096] In some implementations, the heel portion defines wings adapted to temporarily bend inwardly towards each other during passage of the heel portion through the tip in the first direction.

[0097] In some implementations, the heel portion defines wings adapted to bend laterally away from each other when the heel portion is pushed in the second direction relative to the tip.

[0098] In some implementations, the toggle anchor has a tip, a heel portion, and a lateral eyelet midway between the tip and the heel portion.

[0099] In some implementations, the cord is connected to the toggle anchor via the lateral eyelet in a manner that when tension is applied to the cord, the heel portion extends away from the lateral eyelet.

[0100] In some implementations, the toggle anchor has a sharp tip.

[0101] In some implementations, the cord is connected to the toggle anchor via the lateral eyelet in a manner that when tension is applied to the cord, simultaneously (i) the heel portion extends away from the lateral eyelet and (ii) the tip is retracted towards the lateral eyelet.

[0102] In some implementations, the system further includes a retrieval line that is screwed through the toggle anchor such that when tension is applied to the retrieval line, the heel portion is retracted towards the lateral eyelet.

[0103] In some implementations, the toggle anchor further includes a spring configured to bias the heel portion to extend away from the lateral eyelet.

[0104] In some embodiments, the toggle anchor has a sharp tip, and the spring is configured to bias the tip to be received toward the side eyelet.

[0105] In some embodiments, the toggle anchor has a tip, a heel portion, and a side eyelet midway between the tip and the heel portion. In some embodiments, the first segment of the toggle anchor defines the tip.

[0106] In some embodiments, the second segment of the toggle anchor is slidably coupled to the first segment.

[0107] In some embodiments, the system further includes a longitudinal member that extends through the side eyelet and is connected to the toggle anchor in a manner such that when the longitudinal member is pulled, the second segment slides axially relative to the first segment.

[0108] In some embodiments, the second segment of the toggle anchor defines the heel portion.

[0109] In some embodiments, the driver is configured to push the toggle anchor, first the tip, through a portion of the valve tip. The driver has a drive head and a rod extending proximally from the drive head. The drive head is connected to the heel portion via complementary geometries such that (i) it preferentially allows deflection rather than lateral translation of the toggle anchor relative to the driver, and (ii) the heel portion is separable from the driver when the toggle anchor reaches a predetermined angle relative to the driver.

[0110] In some embodiments, the drive head has a first distally facing surface and defines a shoulder portion that defines a second distally facing surface proximal to the first surface.

[0111] In some implementations, at the heel portion, the toggle anchor defines a lateral opening through which the shoulder portion projects, such that the driver is configured to push the toggle anchor, tip first, through a portion of the valve tip by (i) a second distally facing surface that pushes the toggle anchor distally at the lateral opening, and (ii) a first distally facing surface that pushes the toggle anchor distally substantially opposite the lateral opening.

[0112] In some implementations, at the heel portion, the toggle anchor defines a lateral opening through which the shoulder portion projects, such that the toggle anchor is separable from the driver by deflecting around a point on the proximal driver from a second distally facing surface, such that the lateral opening moves laterally away from the shoulder portion.

[0113] In some implementations, the drive head defines a knob and a neck portion that connects the knob to the rod.

[0114] In some implementations, at the heel portion, the toggle anchor defines appendages that extend proximally beyond the knob, proximally from the knob, inwardly towards each other, and towards the neck portion, such that (i) the appendages inhibit proximal housing and lateral translation of the toggle anchor from the driver, and / or (ii) the knob is biased between the appendages such that deflection of the toggle anchor relative to the driver causes the appendages to deflect laterally away from each other and away from the neck portion.

[0115] In some implementations, (i) the drive head defines a socket having a rim, (ii) at the heel portion, the toggle anchor defines a knob, (iii) the knob is disposed within the socket in a manner that inhibits lateral translation of the toggle anchor from the driver, and / or (iv) deflection of the toggle anchor relative to the driver causes the rim to be pressed against the toggle anchor in a manner that distally leverages the knob out of the socket.

[0116] In some implementations, coupling the tether to the upstream assembly is configured such that pulling on the tether causes the patch anchor to be drawn toward the patch in a manner that the cord is drawn, as if the cord is being pulled.

[0117] In some implementations, the upstream assembly includes a one-way mechanism through which the cord extends, and the one-way mechanism is configured to (i) be attached to the patch, (ii) facilitate passage of the patch anchor toward the patch in a first direction through the one-way mechanism of the cord, and / or (iii) inhibit passage of the patch anchor in a second direction opposite the first direction through the one-way mechanism of the cord.

[0118] In some implementations, the upstream assembly is configured such that pulling on the tether causes the cord to be pulled in a first direction through the one-way mechanism.

[0119] In some implementations, the delivery tool is configured to pull on the tether such that the tether pulls the cord in a first direction through the one-way mechanism.

[0120] In some implementations, the delivery tool is configured to pull on the tether by moving the downstream assembly away from the upstream assembly after anchor-fixing the patch to a portion of the valve tip.

[0121] In some implementations, the patch anchor has a sharp tip and is configured to be driven through the valve tip by a driver with the sharp tip penetrating the valve tip.

[0122] In some implementations, the delivery tool further includes a hollow needle, and the patch anchor is configured to be driven through the valve tip by a driver while being disposed within the hollow needle.

[0123] In some implementations, the delivery tool further includes a hollow needle configured to pierce the valve tip, and the driver is configured to drive the patch anchor out of the hollow needle while the hollow needle extends through the valve tip.

[0124] In some implementations, the patch anchor includes a toggle that partially defines an eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0125] In some implementations, the eyelet extends across the toggle.

[0126] In some implementations, the toggle is substantially tubular and has side walls that define a lumen.

[0127] In some implementations, the upstream assembly further includes a spring configured to apply tension to the cord.

[0128] In some implementations, the spring is a compression spring.

[0129] In some implementations, the spring is disposed substantially flat with respect to the patch.

[0130] In some implementations, the spring is configured to facilitate driving the patch anchor through the valve tip by temporarily pulling in response to the tension applied to the cord when the driver pushes the patch anchor away from the patch through the valve tip.

[0131] In some implementations, the spring is coupled to the sheet in a manner such that the patch temporarily contracts linearly when the spring is temporarily pulled.

[0132] In some implementations, the spring is coupled to the sheet in a manner such that the spring slides across the sheet when the spring is temporarily pulled.

[0133] In some implementations, the patch has a lip and a root, and the driver is configured to anchor the root of the patch to the valve tip such that the lip of the patch extends toward the opposing valve tip of the valve.

[0134] In some implementations, the patch includes at least one frame that defines (i) a lip brace at the lip of the patch and / or (ii) a root brace at the root of the patch.

[0135] In some implementations, the spring is configured such that a temporary pull is substantially from a temporary compression of the spring between the lip brace and the root brace.

[0136] In some implementations, at least one frame defines a patch anchor support coupled to the root brace, and the cord extends from the spring, through the patch anchor support, to the patch anchor.

[0137] In some implementations, the tether is connected to the lip brace.

[0138] In some implementations, the spring is attached to the root brace.

[0139] In some implementations, the spring extends from the root brace to the lip brace.

[0140] In some implementations, the spring extends from the root brace to the lip brace along the centerline of the patch.

[0141] In some implementations, the spring does not extend to the lip brace.

[0142] In some implementations, the fastener defines a slot, and the driver is configured to anchor the patch to the valve tip by driving the patch anchor through the valve tip and the slot.

[0143] In some implementations, the fastener defines resilient teeth configured to facilitate driving the patch anchor through the slot by the driver and to inhibit withdrawal of the patch anchor through the slot in the reverse direction.

[0144] In some embodiments, the teeth are configured to be temporarily pushed out by a patch anchor that is driven through the slot by a driver.

[0145] In some embodiments, the delivery tool is configured to orient the driver relative to the slot such that as the driver drives the patch anchor through the slot, the patch anchor rubs along the rim of the slot.

[0146] In some embodiments, the slot is defined by a downstream support of the fastener.

[0147] In some embodiments, the fastener defines a slot guard configured to prevent heart tissue from entering the slot.

[0148] In some embodiments, the patch is coupled to the patch anchor via a cord, and the slot guard has a resting position that is (i) elastic, (ii) covers the entrance to the slot, thereby preventing heart tissue from entering the slot, and / or (iii) is temporarily deflectable away from the slot by the cord, thereby facilitating the discharge of the cord from the slot.

[0149] In some embodiments, the free end of the slot guard is pushed under the downstream support.

[0150] In some embodiments, the delivery tool further includes a capsule at the distal end of the shaft, and the capsule is configured to house the downstream assembly.

[0151] In some embodiments, the capsule includes a shroud formed from an elastic polymer.

[0152] In some embodiments, the capsule is flexible and further includes a housing having a plurality of fingers circumferentially distributed and embedded within the shroud so as to approximate a tubular shape.

[0153] In some embodiments, the capsule is shaped to define a side window therein.

[0154] In some embodiments, the capsule is shaped to define a narrow slit extending between the side window and the open distal end of the capsule.

[0155] In some embodiments, the delivery tool has a proximal extracorporeal portion that includes a clasp control device operably coupled to the clasp, such that operating the clasp control device causes the clasp to transition between an open state and a gripping state.

[0156] In some embodiments, the clasp control device is operably coupled to an upstream support of the clasp, such that operating the clasp control device causes the clasp to transition between an open state and a gripping state via movement of the upstream support relative to the shaft.

[0157] In some embodiments, the delivery tool further includes a pair of clasp control wires through which the clasp control device is operably coupled to the clasp.

[0158] In some embodiments, the extracorporeal portion includes a lever (i) through which the clasp control device is operably coupled to both wires of the pair and / or (ii) adapted to pivot in a manner that balances the wires relative to each other.

[0159] In some embodiments, the lever has a fulcrum about which the clasp control device is pivotally attached to the lever, and each wire of the pair is coupled to the lever on opposite sides of the fulcrum.

[0160] In some embodiments, the proximal extracorporeal portion further includes a driver control device operably coupled to the driver, such that operating the driver control device induces the driver to anchor the patch anchor to the valve tip.

[0161] In some embodiments, the patch anchor is a first patch anchor and the implant further includes a second patch anchor.

[0162] In some embodiments, the driver is a first driver configured to anchor the patch to a portion of the valve tip by pushing the first patch anchor through a portion of the valve tip. In some embodiments, the delivery tool further includes a second driver configured to anchor the patch to a portion of the valve tip by pushing the second patch anchor through a portion of the valve tip.

[0163] In some embodiments, the extracorporeal portion includes a lever that is (i) operably coupled to the first and second drivers via which the driver control device and / or (ii) adapted to pivot in a manner that balances the first driver and the second driver.

[0164] In some embodiments, the lever has a fulcrum to which the driver control device is pivotally attached, and the first and second drivers are coupled to the lever on opposite sides of the fulcrum.

[0165] In some embodiments, within the distal portion of the delivery tool, the shaft has a proximal portion and a distal portion.

[0166] In some embodiments, the extracorporeal proximal portion of the delivery tool further includes a shaft extension device operably coupled to the shaft such that upon operation of the shaft extension device, the distal portion of the shaft is reversibly extended distally from the proximal portion of the shaft.

[0167] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, the downstream support deflects relative to the shaft.

[0168] In some embodiments, the delivery tool includes a frame that defines a downstream support.

[0169] In some embodiments, the first portion of the frame is attached to the proximal portion of the shaft, and the second portion of the frame is attached to the distal portion of the shaft, such that when the degree of extension of the distal portion of the shaft from the proximal portion of the shaft is adjusted, the downstream support deflects with respect to the shaft.

[0170] In some embodiments, the distal portion of the shaft includes an operable portion, and the attachment of the first portion of the frame and the second portion of the frame to the proximal portion of the shaft and the second portion of the shaft, respectively, is such that when the distal portion of the shaft extends distally from the proximal portion of the shaft by an amount exceeding a threshold, the frame pulls and deflects the distal portion of the shaft.

[0171] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect with respect to the shaft.

[0172] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect with respect to the shaft without changing the arrangement between the downstream support and the upstream support.

[0173] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect with respect to the shaft while the fastener remains in a gripping state.

[0174] In some embodiments, the extracorporeal proximal portion further includes an anchor control device.

[0175] In some embodiments, the delivery tool further includes a drive shaft sub-assembly including one or more drive shafts extending through a shaft, and in at least one state of the delivery tool, the drive shaft sub-assembly is configured such that the anchor control device is operably coupled to the ventricular anchor, and as a result, when the anchor control device is operated, an anchor fixing force is applied to the ventricular anchor.

[0176] In some embodiments, the downstream assembly further includes a winch, and the ventricular anchor is a winch anchor coupled to the winch.

[0177] In some embodiments, the tether moors the winch to the patch.

[0178] In some embodiments, the extracorporeal proximal portion further includes a winch control device, and in at least one state of the delivery tool, the drive shaft sub-assembly is configured such that the drive shaft sub-assembly is operably coupled to the winch control device, and as a result, when the winch control device is operated, the winch is actuated.

[0179] In some embodiments, when the winch control device is operated, the winch is actuated by applying torque to the winch via the drive shaft sub-assembly.

[0180] In some embodiments, the downstream assembly includes a slip clutch that operably couples the drive shaft sub-assembly to the winch in a manner that limits the magnitude of torque that the drive shaft assembly can apply to the winch.

[0181] In some embodiments, the drive shaft sub-assembly includes (i) a winch control drive shaft through which the winch control device is operably coupled to the winch, and / or (ii) an anchor control drive shaft disposed through the winch control drive shaft and through which the anchor control device is operably coupled to the anchor.

[0182] In some embodiments, the anchor control drive shaft operably couples the anchor control device to the anchor via engagement of the anchor by a distal end portion of the anchor control drive shaft.

[0183] In some embodiments, the delivery tool further includes a release spring biased to proximally pull the anchor control drive shaft away from the anchor, and engagement of the anchor by the distal end portion of the anchor control drive shaft resists pulling of the anchor control drive shaft by the release spring.

[0184] In some embodiments, the drive shaft subassembly further includes a locking rod at the distal end portion of the anchor control drive shaft to maintain engagement of the anchor by the distal end portion of the anchor control drive shaft, such that housing of the locking rod from the distal end portion of the anchor control drive shaft triggers the release spring to pull the anchor control drive shaft proximally away from the anchor.

[0185] In some embodiments, the release spring is a first release spring. In some embodiments, the delivery tool further includes a second release spring biased to proximally pull the winch control drive shaft away from the winch, and engagement of the anchor by the distal end portion of the anchor control drive shaft resists pulling of the winch control drive shaft by the second release spring, such that housing of the locking rod from the distal end portion of the anchor control drive shaft also triggers the second release spring to pull the winch control drive shaft proximally away from the winch.

[0186] In some embodiments, biasing of the first release spring also engages and maintains the winch control drive shaft with the winch by applying a force directed distally to the winch control drive shaft.

[0187] In some implementations, the system is configured such that, upon triggering of a first release spring and a second release spring by retraction of a locking rod from a distal end portion of an anchor control drive shaft, a downstream assembly separates from a delivery tool.

[0188] In some implementations, the downstream assembly further includes a winch, and the ventricular anchor is a winch anchor coupled to the winch.

[0189] In some implementations, the drive shaft sub-assembly includes a downstream assembly control drive shaft.

[0190] In some implementations, the system has an anchor fixation state in which, upon operation of an anchor control device, the anchor control device is operably coupled to a winch anchor via a downstream assembly control drive shaft such that an anchor fixation force is applied to the winch anchor.

[0191] In some implementations, the system has a winching state in which (i) the downstream assembly control drive shaft is operably decoupled from the winch anchor such that, upon operation of the anchor control device, an anchor fixation force is not applied to the winch anchor, and / or (ii) the downstream assembly control drive shaft is operably coupled to the winch such that the winch operates when the downstream assembly control drive shaft rotates.

[0192] In some implementations, the downstream assembly includes an axially movable shaft within the downstream assembly such that (i) positioning the shaft at a first axial position within the downstream assembly causes the system to enter an anchor fixation state, and / or (ii) positioning the shaft at a second axial position within the downstream assembly causes the system to enter a winching state.

[0193] In some implementations, the winch includes a spool disposed therein, and the spool is operably coupled to a tether such that tension is applied to the tether when the spool rotates.

[0194] In some embodiments, (i) the shaft defines a protruding rim around it, (ii) the downstream assembly includes a spring-loaded detent biased to protrude into a recess defined by the surface of the spool, thereby maintaining the spool in a locked state where it cannot rotate, and / or (iii) when the shaft is shifted to a second shaft position, the rim pushes the detent out of the recess, thereby automatically unlocking the winch and allowing the spool to rotate.

[0195] In some embodiments, the downstream assembly control drive shaft defines an inclined slot and the shaft defines a transverse pin.

[0196] In some embodiments, in the engaged state of the downstream assembly control drive shaft where the downstream assembly control drive shaft is axially locked, (i) the transverse pin is disposed transversely within the slot of the downstream assembly control drive shaft, and / or (ii) the reference force tube of the drive shaft sub-assembly is disposed over the inclined slot and the shaft and cooperates with the transverse pin within the slot to prevent proximal movement of the downstream assembly control drive shaft away from the shaft by obstructing lateral movement of the downstream assembly control drive shaft relative to the shaft.

[0197] In some embodiments, by housing the reference force tube over the inclined slot and the shaft, the slot can slide obliquely outward from the pin, allowing the downstream assembly control drive shaft to move proximally away from the shaft.

[0198] In some embodiments, the first axial position is distal to the second axial position.

[0199] In some embodiments, the system further has a neutral state where the downstream assembly control drive shaft is coupled to the downstream assembly but operably decoupled from both the winch anchor and the winch.

[0200] In some embodiments, in the anchor-fixed state, the downstream assembly control drive shaft is disposed at a first axial position relative to the downstream assembly.

[0201] In some embodiments, in the wound-up state, the downstream assembly control drive shaft is disposed at a second different axial position relative to the downstream assembly.

[0202] In some embodiments, the delivery tool is movable between the anchor-fixed state and the wound-up state via an axial movement of the downstream assembly control drive shaft relative to the downstream assembly.

[0203] In some embodiments, the first axial position is distal to the second axial position.

[0204] In some embodiments, the delivery tool is movable from the anchor-fixed state to the wound-up state via a proximal movement of the downstream assembly control drive shaft relative to the downstream assembly.

[0205] In some embodiments, the delivery tool further includes a mount configured to support a patch mounted thereon and configured to carry the patch toward the fastener while the fastener is in a gripping state.

[0206] In some embodiments, the mount is configured to carry the patch toward the upstream support of the fastener by moving distally toward the fastener with the patch mounted thereon while the fastener is in a gripping state.

[0207] In some embodiments, the mount is configured to carry the patch toward the upstream support of the fastener by moving distally and laterally toward the fastener with the patch mounted thereon while the fastener is in a gripping state.

[0208] In some embodiments, the delivery tool includes a beam that provides a mechanical linkage between the shaft and the mount, and the mechanical linkage links the distal movement of the mount and the lateral movement of the mount.

[0209] In some embodiments, the mount has a storage position, and the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in the storage position with the patch attached to the mount.

[0210] In some embodiments, the mount has a ready position where the mount is positioned closer to the fastener than the storage position.

[0211] In some embodiments, the driver is configured to secure the patch to the valve tip by driving the patch anchor through the valve tip while the mount is in the ready position with the patch attached to the mount.

[0212] In some embodiments, (i) the mount defines a channel therein, (ii) the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in the storage position with the patch attached to the mount and the patch anchor disposed within the channel, and / or (ii) the driver is configured to secure the patch to a portion of the valve tip by driving the patch anchor out of the channel and through a portion of the valve tip.

[0213] In some embodiments, the delivery tool includes a needle disposed within the channel.

[0214] In some embodiments, the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in the storage position with the patch attached to the mount and the patch anchor disposed within the needle within the channel.

[0215] In some embodiments, the delivery tool is configured to facilitate driving of the patch anchor through a portion of the valve tip by advancing the needle out of the channel.

[0216] In some implementations, the delivery tool further includes a spring that biases the needle into the channel for storage.

[0217] In some implementations, the delivery tool further includes a mount control rod operatively coupled to the mount in a manner that configures the mount control rod to move the mount between a storage position and a ready position.

[0218]

[0219] In some implementations, the mount control rod is operatively coupled to the mount by being coupled to the needle. In some implementations, the operative coupling of the mount control rod to the mount is such that (i) from the storage position, the mount is pushed towards the ready position via the spring by pressing the needle with the mount control rod, and / or (ii) while the mount is in the ready position, the spring is pulled by pressing the needle with the mount control rod such that the needle advances out of the channel.

[0220] In some implementations, the delivery tool includes a spring configured to bias the mount to the ready position.

[0221] In some implementations, the spring is a spring beam that provides a mechanical linkage between the shaft and the mount and biases the mount to the ready position by biasing the mount to move distally and laterally.

[0222] In some implementations, the driver includes a rod and a drive head, and the drive head is coupled to the mount such that the tension on the rod restrains the mount in the storage position.

[0223] In some embodiments, the patch anchor and the drive head are disposed within a channel defined within the mount. In some embodiments, by reducing the tension on the rod, the spring can move the mount to the ready position.

[0224] In some embodiments, while the mount is in the ready position, pushing the rod causes the drive head to move through the channel and the patch anchor to deploy out of the channel.

[0225] In some embodiments, the fastener is movable between an open state and a gripping state while the mount remains in the storage position.

[0226] In some embodiments, the delivery tool includes an extracorporeal proximal portion having a mount control device operably coupled to the mount such that when the mount control device is actuated, the mount moves between the storage position and the ready position.

[0227] In some embodiments, the delivery tool further includes a mount control rod through which the mount control device is operably coupled to the mount.

[0228] In some embodiments, the mount control rod is a first mount control rod, and the delivery tool further includes a second mount control rod through which the mount control device is operably coupled to the mount.

[0229] In some embodiments, the extracorporeal portion includes a lever adapted to pivot in a manner that (i) the mount control device is operably coupled to the first and second mount control rods through it and / or (ii) balances the first mount control rod and the second mount control rod.

[0230] In some embodiments, the lever has a fulcrum about which the mount control device is pivotally attached to the lever, and the first and second mount control rods are coupled to the lever on opposite sides of the fulcrum.

[0231] In some embodiments, the extracorporeal proximal portion further includes a driver control device operably coupled to the driver such that operating the driver control device induces the driver to drive the patch anchor through the valve tip.

[0232] In some embodiments, the mount control rod is tubular and the driver extends from the driver control device through the mount control rod.

[0233] In some embodiments, the extracorporeal proximal portion of the delivery tool further includes a fastener control device operably coupled to the fastener such that operating the fastener control device causes the fastener to transition between an open state and a gripping state.

[0234] In some embodiments, the delivery tool further includes a fastener control wire through which the fastener control device is operably coupled to the mount.

[0235] In some embodiments, the fastener control wire is a first fastener control wire and the delivery tool further includes a second fastener control wire through which the fastener control device is operably coupled to the mount.

[0236] In some embodiments, the extracorporeal portion includes a lever adapted to pivot (i) through which the fastener control device is operably coupled to the first and second fastener control wires and / or (ii) in a manner that balances the first fastener control wire and the second fastener control wire.

[0237] In some embodiments, the lever has a fulcrum about which the fastener control device is pivotally attached to the lever, and the first and second fastener control wires are coupled to the lever on opposite sides of the fulcrum.

[0238] In some embodiments, while the fastener is in the gripped state, the mount control device is configured to move the mount between the storage position and the ready position by sliding the mount over and along the fastener control wire toward the fastener.

[0239] In some embodiments, while the mount is in the storage position, the fastener control device is configured to move the fastener from the gripped state to the open state by retracting the fastener control wire through the mount.

[0240] In some embodiments, the delivery tool further includes one or more wraps, and the distal portion of the delivery tool is transvascularly advancable to the heart while the mount is in the storage position where the patch is held against the mount by one or more wraps that wrap around the patch and the mount.

[0241] In some embodiments, the one or more wraps are one or more origami wraps.

[0242] In some embodiments, the delivery tool further includes a release mechanism adapted to release the patch from the mount by applying tension to the one or more origami wraps.

[0243] In some embodiments, the delivery tool further includes a release mechanism adapted to release the patch from the mount by releasing the tension of the one or more origami wraps.

[0244] In some embodiments, the distal portion of the delivery tool is transvascularly advancable to the heart while the mount is in the storage position where the patch is held against the mount by one or more wraps that wrap around the patch, the mount, and the shaft.

[0245] In some embodiments, the delivery tool further includes one or more spring brackets configured to stretch and hold the wrap with a pin.

[0246] In some implementations, the delivery tool further includes a rod that is stowable and that cooperates with a spring bracket to pin and tension the wrap and release one or more wraps.

[0247] In some implementations, at the stowed position, the mount is partially arcuately curved about the shaft.

[0248] In some implementations, the mount has a convex outer surface and the patch is attached to the mount in a manner such that the patch is curved against the convex outer surface of the mount.

[0249] In some implementations, the mount is shaped to receive a patch anchor while the patch is attached to the mount.

[0250] In some implementations, the patch anchor is coupled to the patch and the system is configured such that accommodation of the patch anchor by the mount fixes the patch to the mount.

[0251] In some implementations, the patch is coupled to the patch anchor via a cord and is fixed to the surface of the mount by placing the patch anchor within a channel defined in the surface of the mount, the channel being shaped to (i) facilitate sliding of the patch anchor along the channel and / or (ii) prevent the patch anchor from exiting the channel laterally.

[0252] In some implementations, the driver is configured to anchor the patch to the valve tip by driving the patch anchor along the channel, out of the end of the channel, and through the valve tip while the mount is in the ready position with the patch attached to the mount.

[0253] In some implementations, the cord extends laterally from the patch anchor out of the channel to the patch.

[0254] In some embodiments, within the distal portion of the delivery tool, the shaft is telescopically extendable.

[0255] In some embodiments, the delivery tool has a delivery configuration in which (i) the shaft extends telescopically, (ii) the clip faces distally, and / or (iii) the distal portion of the delivery tool is transvascularly advanceable into the heart.

[0256] In some embodiments, in the delivery configuration, the downstream support is deflected distally relative to the open configuration.

[0257] In some embodiments, in the delivery configuration, the downstream support is adjacent to the shaft and disposed substantially parallel to the shaft.

[0258] In some embodiments, in the delivery configuration, the clip is closed.

[0259] In some embodiments, the delivery tool has a retracted configuration in which (i) the shaft is telescopically retracted and / or (ii) the clip faces proximally.

[0260] In some embodiments, the distal portion of the delivery tool is configured to advance distally through a valve while in the retracted configuration.

[0261] In some embodiments, in the retracted configuration, the clip is closed.

[0262] In some embodiments, in the retracted configuration, the downstream support is deflected proximally relative to the open configuration.

[0263] In some embodiments, in the retracted configuration, the clip extends further laterally from the shaft than in the open configuration.

[0264] In some embodiments, the delivery tool has a proximal extracorporeal portion including a shaft extension device operably coupled to the shaft such that operation of the shaft extension device causes the distal portion of the shaft to extend reversibly distally from the proximal portion of the shaft.

[0265] In some embodiments, the clip is coupled to the shaft such that as the distal portion of the shaft extends distally from the proximal portion of the shaft, the downstream support deflects relative to the shaft.

[0266] In some embodiments, the patch is substantially trapezoidal.

[0267] In some embodiments, (i) the patch has a lip and a root, (ii) the driver is configured to anchor the root of the patch to the valve tip, such that the lip of the patch extends toward the opposing valve tip of the valve, and / or (iii) the lip is longer than the root.

[0268] In some embodiments, the delivery tool includes a retrieval line removably coupled to the anchor, such that applying tension to the retrieval line releases the patch anchor from the valve tip.

[0269] In some embodiments, the delivery tool has an extracorporeal portion, and the retrieval line (i) extends tubally from a first end portion of the extracorporeal portion of the retrieval line, through the delivery tool to the anchor, (ii) extends through the anchor and loops around the anchor, and / or (iii) extends tubally back from the anchor, through the delivery tool to a second end portion of the extracorporeal portion that defines the retrieval line.

[0270] In some embodiments, both the first end portion and the second end portion are coupled to a bobbin mounted on the extracorporeal portion.

[0271] In some embodiments, each of the first end portion and the second end portion extends proximally along the extracorporeal portion, toward a bearing, from the bobbin, and at the bearing, turns back on itself and extends distally through the delivery tool to the anchor, such that tension is applied to the retrieval line by sliding the bobbin distally along the extracorporeal portion.

[0272] In some embodiments, the first end portion is circumferentially wrapped around the bobbin, the bobbin defines a trough providing access to the first end portion, and / or the retrieval line is removable from the anchor by cutting the first end portion through the trough and then removing the bobbin from the extracorporeal portion and moving the bobbin away from the extracorporeal portion.

[0273] In some embodiments, the bobbin defines a lateral slit and is removable from the extracorporeal portion by moving the bobbin laterally from the extracorporeal portion through the lateral slit.

[0274] In some embodiments, the trough is one of a series of troughs circumferentially distributed around the bobbin.

[0275] In some embodiments, the patch anchor includes a tubular toggle and a retrieval mechanism including a notch at the heel of the toggle and a retrieval eyelet.

[0276] In some embodiments, the retrieval line (i) extends coaxially with the toggle into the lumen of the toggle at the heel of the toggle, (ii) exits the sidewall of the toggle through the retrieval eyelet, and / or (iii) loops back to itself through the notch for connection to itself.

[0277] In some embodiments, the retrieval line is removably coupled to the anchor such that applying tension to the retrieval line facilitates release of the patch anchor from the valve tip by reorienting the patch anchor.

[0278] According to some embodiments, a system and / or device (e.g., for use in or usable with a valve disposed between the atrium and ventricle of a real or simulated heart, the valve having at least a first valve tip and a second valve tip) may include an implant including a valve tip reinforcement patch and / or a patch anchor.

[0279] In some embodiments, the leaflet reinforcement patch may include (i) a flexible sheet and / or (ii) a frame that supports the flexible sheet.

[0280] In some embodiments, the patch anchor may be coupled to the patch in a manner that facilitates anchoring the patch to the first leaflet by (i) allowing the patch anchor to be temporarily moved away from the patch while remaining coupled to the patch, and / or (ii) biasing the patch anchor to return toward the patch.

[0281] In some embodiments, the patch anchor has a sharp tip and is configured to be driven through the first leaflet with the sharp tip penetrating the first leaflet.

[0282] In some embodiments, the patch anchor is configured to be driven through the first leaflet while disposed within a hollow needle.

[0283] In some embodiments, the patch anchor includes a tubular toggle and a recovery mechanism that includes a notch at the heel of the toggle and a retrieval eyelet, and the system / device further includes a retrieval line that (i) extends coaxially with the toggle into the lumen of the toggle at the heel of the toggle, (ii) exits the sidewall of the toggle via the retrieval eyelet, and / or (iii) loops back to itself via the notch for connection to itself.

[0284] In some embodiments, the implant includes (i) an upstream assembly that includes a patch and a patch anchor, (ii) a downstream assembly that includes a ventricular anchor, and / or (iii) a tether that moors the patch to the ventricular anchor.

[0285] In some embodiments, (i) the ventricular anchor is a first ventricular anchor, (ii) the downstream assembly further includes a second ventricular anchor, and / or (iii) the tether moors the patch to both the first ventricular anchor and the second ventricular anchor.

[0286] In some implementations, the tether extends from the downstream assembly to the patch and back to the downstream assembly.

[0287] In some implementations, (i) the ventricular anchor is a first ventricular anchor, (ii) the downstream assembly further includes 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.

[0288] In some embodiments, the tether is slidably coupled to the upstream assembly.

[0289] In some implementations, the upstream assembly defines an eyelet, and the tether is slidably coupled to the upstream assembly by being screwed through the eyelet.

[0290] In some implementations, the downstream assembly includes a winch coupled to the ventricular anchor, and / or the tether is arranged in a pulley arrangement where (i) a first end of the tether is operably coupled to the winch, (ii) a curved portion of the tether is slidably coupled to the upstream assembly, and / or (iii) a second end of the tether is fixed to the downstream assembly.

[0291] In some implementations, the winch has a housing fixedly attached to the ventricular anchor, and the second end of the tether is fixed to the housing.

[0292] In some implementations, the patch anchor is a toggle biased to automatically expand upon deployment.

[0293] In some implementations, the toggle has a cellular structure biased to automatically expand by foreshortening.

[0294] In some embodiments, the system / apparatus further includes a delivery tool configured to deliver the implant to the heart and (i) anchor the patch anchor to the first valve cusp by temporarily moving the patch anchor away from the patch while the patch anchor remains coupled to the patch, and / or (ii) thereafter anchor the patch to the first valve cusp by releasing the patch anchor such that the implant responsively returns the patch anchor towards the patch.

[0295] 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 valve cusp.

[0296] In some embodiments, the delivery tool is configured to deliver the implant to the heart with the patch laterally mounted on the delivery tool.

[0297] In some embodiments, the implant includes an upstream assembly including the patch and the patch anchor.

[0298] In some embodiments, the implant further includes (i) a downstream assembly including a winch coupled to a winch anchor configured to anchor the downstream assembly to the ventricular tissue, and / or (ii) a tether that moors the winch to the patch.

[0299] In some embodiments, the patch includes a first portion of the sheet, and a second portion of the sheet is shaped to extend away from the patch in a manner that defines the tether.

[0300] In some embodiments, the implant further includes a cord through which the patch anchor is coupled to the patch.

[0301] 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 to return towards the patch.

[0302] In some embodiments, the frame defines a spring.

[0303] In some embodiments, the spring is a compression spring.

[0304] In some embodiments, the spring is disposed substantially flat with respect to the patch.

[0305] In some embodiments, the implant further includes a cord through which the patch anchor is coupled to the spring.

[0306] In some embodiments, the spring is configured to facilitate driving the patch anchor through the first valve tip by temporarily pulling the patch anchor away from the patch and through the first valve tip in response to the tension applied to the cord.

[0307] In some embodiments, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the patch temporarily contracts linearly.

[0308] In some embodiments, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the spring slides across the sheet.

[0309] In some embodiments, the patch has a lip and a root. In some embodiments, the cord couples the patch anchor to the patch in a manner such that when the patch anchor is anchored to the first valve tip, the lip of the patch extends toward the second valve tip.

[0310] In some embodiments, the frame defines (i) a lip brace at the lip of the patch and / or (ii) a root brace at the root of the patch.

[0311] In some embodiments, the spring is configured such that the temporary pull is substantially from a temporary compression of the spring between the lip brace and the root brace.

[0312] In some embodiments, the patch defines an axis from the root to the lip along the centerline of the patch, between the lip and the root, and the spring is configured such that the temporary tension consists substantially of a deflection with respect to the axis from the root to the lip of the spring.

[0313] In some embodiments, the spring is configured such that the temporary tension consists substantially of a deflection towards the axis from the root to the lip of the spring.

[0314] In some embodiments, the spring is a first spring, the frame further includes a second spring, and the first spring and the second spring are configured such that the temporary tension consists substantially of a deflection towards each other of the first spring and the second spring.

[0315] In some embodiments, the cord extends back and forth between the first spring and the second spring.

[0316] In some embodiments, the frame defines a patch anchor support coupled to the root brace, and the cord extends from the spring, through the patch anchor support, to the patch anchor.

[0317] In some embodiments, the spring is attached to the root brace.

[0318] In some embodiments, the spring is configured such that the temporary tension consists substantially of a temporary deflection with respect to the root brace of the spring.

[0319] In some embodiments, the spring does not extend to the lip brace.

[0320] In some embodiments, the spring extends from the root brace to the lip brace.

[0321] In some embodiments, the spring extends along the centerline of the patch from the root brace to the lip brace.

[0322] In some implementations, (i) the spring is a first spring extending from the root brace to the lip brace along the first lateral edge of the patch, and / or (ii) the frame defines a second spring extending from the root brace to the lip brace along the second lateral edge of the patch.

[0323] In some implementations, the patch anchor includes a toggle defining a substantially intermediate eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0324] In some implementations, the system / device further includes a recovery line extending from the end of the toggle and configured to unanchor the patch anchor from the first valve tip when tension is applied to the recovery line.

[0325] In some implementations, the eyelet extends across the toggle.

[0326] In some implementations, the toggle is substantially tubular and has side walls defining a lumen.

[0327] In some implementations, the side walls define two lateral holes adjacent to each other, and the eyelet is defined by a portion of the side wall disposed between the two lateral holes.

[0328] According to some implementations, a system (e.g., for use in or usable with a valve disposed between the atria and ventricles of an actual or simulated heart, whether actual or simulated) includes an implant and / or a delivery tool. In some implementations, the implant includes a tether and / or an assembly.

[0329] In some implementations, the assembly may include a winch and / or a winch anchor.

[0330] In some embodiments, the winch comprises a housing and a spool disposed therein, a tether extends from the winch, and the spool is operatively coupled to the tether such that when the winch is actuated, tension is applied to the tether.

[0331] In some embodiments, a winch anchor may be coupled to the winch.

[0332] In some embodiments, the delivery tool may have a distal portion that is transvascularly advanceable into the heart while being coupled to the implant.

[0333] In some embodiments, the delivery tool may include a drive shaft subassembly that includes a reference force tube and / or a drive shaft. The reference force tube may be coupled to the housing.

[0334] In some embodiments, the drive shaft may extend through the reference force tube.

[0335] In some embodiments, the system has an anchor fixation state in which the drive shaft is operatively coupled to the winch anchor such that when the drive shaft rotates, an anchor fixation force is applied to the winch anchor and / or is operatively decoupled from the winch such that when the drive shaft rotates, the winch is inoperable.

[0336] In some embodiments, the system has a winching state in which the drive shaft is operatively decoupled from the winch anchor such that when the drive shaft rotates, no anchor fixation force is applied to the winch anchor and / or is operatively coupled to the winch such that when the drive shaft rotates, the winch is actuated.

[0337] In some embodiments, the system further has a neutral state in which the drive shaft is coupled to the implant but is operatively decoupled from both the winch anchor and the winch.

[0338] In some embodiments, the assembly includes a shaft that is axially movable within the assembly, such that (i) when the shaft is positioned at a first axial position within the assembly, the system is in an anchored state and / or (ii) when the shaft is positioned at a second axial position within the assembly, the system is in a winched-up state.

[0339] In some embodiments, the winch includes a spool disposed therein, and the spool is operatively coupled to the tether such that tension is applied to the tether when the spool rotates. In some embodiments, the shaft defines a protruding rim therearound.

[0340] In some embodiments, the assembly includes a spring detent biased to protrude into a recess defined by the surface of the spool, thereby maintaining the spool in a locked state where it cannot rotate.

[0341] In some embodiments, moving the shaft to the second axial position automatically unlocks the winch by the rim pushing the detent out of the recess, thereby enabling the spool to rotate.

[0342] In some embodiments, the drive shaft defines an inclined slot and / or the shaft defines a transverse pin.

[0343] In some embodiments, in the engaged state of the drive shaft, where the drive shaft is locked to the shaft, (i) the transverse pin is disposed transversely within a slot of the downstream assembly control drive shaft and / or (ii) the reference force tube is disposed over the inclined slot and the shaft in a manner that cooperates with the transverse pin within the slot to prevent lateral movement of the drive shaft relative to the shaft of the drive shaft, thereby preventing proximal movement away from the shaft of the drive shaft.

[0344] In some embodiments, by housing the reference force tube from above the diagonal slot and the shaft, the slot is diagonally disengaged from the pin and becomes slidable, enabling the drive shaft to move proximally away from the shaft.

[0345] In some embodiments, the first axial position is distal to the second axial position.

[0346] In some embodiments, in the anchor fixed state, the drive shaft is disposed at a first axial position relative to the winch.

[0347] In some embodiments, in the retracted state, the drive shaft is disposed at a second different axial position relative to the winch.

[0348] In some embodiments, the delivery tool is movable between the anchor fixed state and the retracted state via the axial movement of the drive shaft relative to the winch.

[0349] In some embodiments, the first axial position is distal to the second axial position, and the delivery tool is movable from the anchor fixed state to the retracted state via the proximal movement of the drive shaft relative to the winch.

[0350] According to some embodiments, a system (e.g., for use in or with an actual or simulated tissue of an actual or simulated subject) includes a toggle anchor and / or a delivery tool.

[0351] In some embodiments, the toggle anchor may have a tip and a heel portion and may define an anchor shaft therebetween.

[0352] In some embodiments, the delivery tool may define a channel in which the toggle anchor is disposed and / or may include a driver configured to push the toggle anchor distally out of and away from the channel, starting with the tip. The driver has a drive head and a rod extending proximally from the drive head.

[0353] In some embodiments, the drive head is connected to the heel portion via complementary geometric shapes in a manner that (i) prioritizes deflection over lateral translation of the toggle anchor relative to the driver, and (ii) enables the heel portion to be separable from the driver when the anchor reaches a predetermined angle relative to the driver.

[0354] In some embodiments, the drive head defines a knob and a neck portion that connects the knob to the rod.

[0355] In some embodiments, at the heel portion, the toggle anchor defines appendages that extend proximally beyond the knob, proximally from the knob, inwardly towards each other, and towards the neck portion, such that (i) the appendages inhibit proximal accommodation and lateral translation of the toggle anchor from the driver, and / or (ii) the knob is biased between the appendages such that deflection of the toggle anchor relative to the driver causes the appendages to deflect laterally away from each other and away from the neck portion.

[0356] In some embodiments, (i) the drive head defines a socket having a rim, (ii) at the heel portion, the toggle anchor defines a knob, (iii) the knob is disposed within the socket in a manner that inhibits lateral translation of the toggle anchor from the driver, and / or (iv) deflection of the toggle anchor relative to the driver causes the rim to be pressed against the toggle anchor in a manner that distally moves the knob out of the socket like a lever.

[0357] In some embodiments, the delivery tool is capable of advancing transductally into the tissue.

[0358] In some embodiments, the tip of the anchor has a sharp tip.

[0359] In some embodiments, the drive head has a first distally facing surface and defines a shoulder portion that defines a second distally facing surface proximal to the first surface.

[0360] In some embodiments, at the heel portion, the toggle anchor defines a lateral opening through which the shoulder portion projects, such that the driver is configured to push the toggle anchor through tissue, tip first, by (i) a second distally facing surface that pushes the toggle anchor distally at the lateral opening, and (ii) a first distally facing surface that pushes the toggle anchor distally substantially opposite the lateral opening.

[0361] In some embodiments, at the heel portion, the toggle anchor defines a lateral opening through which the shoulder portion projects, such that the toggle anchor is separable from the drive head by deflecting around the proximal driver such that the lateral opening moves laterally away from the shoulder portion.

[0362] In some embodiments, the driver is an anchor, and the system further includes an anchor configured to move to a stabilized position relative to the toggle anchor via axial sliding of the anchor relative to the toggle anchor by pushing the tip of the toggle anchor against tissue by the driver, wherein the anchor suppresses deflection of the toggle anchor relative to the driver at the stabilized position.

[0363] In some embodiments, the system further includes a cord attached to the toggle anchor.

[0364] In some embodiments, the system includes an implant including a toggle anchor, a cord, and another component, wherein the cord connects the other component to the toggle anchor such that the toggle anchor is configured to anchor the other component to tissue.

[0365] According to some embodiments, the system includes an implant and / or a delivery tool.

[0366] In some embodiments, the implant may include a toggle anchor having a body, a tip, and a heel portion, the toggle anchor defining an anchor axis between the tip and the heel portion.

[0367] In some embodiments, the delivery tool may be configured to advance the implant transversely through the actual or simulated tissue of an actual or simulated subject while the implant is coupled to the distal portion of the tool.

[0368] In some embodiments, the delivery tool may include a driver including a drive head and a rod extending proximally from the drive head, the driver being configured to first push the toggle anchor through the tissue with the tip.

[0369] In some embodiments, the system may include an extensible member, configured such that when the driver pushes the tip of the toggle anchor against the tissue, the extensible member slides axially in response relative to the body.

[0370] In some embodiments, at least the tip of the toggle anchor is hollow.

[0371] In some embodiments, the extensible member is a component of the delivery tool.

[0372] In some embodiments, the extensible member is a component of the toggle anchor.

[0373] In some embodiments, the extensible member is a post.

[0374] In some embodiments, the system defines a sharp tip configured to pierce tissue in a manner that facilitates the driver pushing the toggle anchor through the tissue with the tip first, and / or the system has a rest state in which the sharp tip is functionally obscure.

[0375] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extensible member axially slides relative to the body to automatically and functionally expose a sharp tip.

[0376] In some embodiments, (i) the sharp tip is defined by the tip of the toggle anchor, (ii) in the rest state, the extensible member functionally obscures the sharp tip, and / or (iii) the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extensible member slides proximally away from the sharp tip by sliding axially relative to the body to automatically and functionally expose the sharp tip.

[0377] In some embodiments, the extensible member is a component of the toggle anchor.

[0378] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extensible member slides proximally away from the sharp tip by sliding inside the toggle anchor.

[0379] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extensible member slides proximally away from the sharp tip by sliding over the outside of the toggle anchor.

[0380] In some embodiments, (i) the sharp tip is defined by the extensible member, (ii) in the rest state, the toggle anchor functionally obscures the sharp tip, and / or (iii) the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extensible member automatically slides distally beyond the tip, thereby functionally exposing the sharp tip.

[0381] In some embodiments, the extensible member is a component of the delivery tool and includes a needle that defines the sharp tip.

[0382] In some implementations, in the stationary state, the sharp tip is functionally obscured by the toggle anchor.

[0383] In some implementations, in the stationary state, the sharp tip is functionally obscured by being disposed within the body of the toggle anchor.

[0384] According to some implementations, the system includes an implant and / or a delivery tool.

[0385] In some implementations, the implant may include a toggle anchor having a body, a tip, and a heel portion, the toggle anchor defining an anchor axis between the tip and the heel portion.

[0386] In some implementations, the delivery tool may be configured to advance the implant transductally through actual or simulated tissue of an actual or simulated subject while the implant is coupled to the distal portion of the tool.

[0387] In some implementations, the delivery tool may include a driver and / or a stabilizer. The driver may include a drive head and a rod extending proximally from the drive head, the driver being configured to push the toggle anchor through the tissue with the tip first.

[0388] In some implementations, the stabilizer is configured such that by pushing the tip of the toggle anchor against the tissue by the driver, the stabilizer moves to a stabilized position relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor, and the stabilizer suppresses deflection of the toggle anchor relative to the driver in the stabilized position.

[0389] In some implementations, the delivery tool includes a spring that biases the stabilizer away from the stabilized position.

[0390] In some embodiments, the delivery tool is configured such that axial sliding of the stabilizer relative to the toggle anchor involves proximal movement of the drive head toward the rod.

[0391] In some embodiments, the drive head is coupled to the rod via a compression spring that compresses when the driver presses the tip of the toggle anchor against tissue, and compression of the spring facilitates axial sliding of the stabilizer relative to the toggle anchor.

[0392] In some embodiments, the compression spring is configured to facilitate disengagement of the toggle anchor from the driver when the driver stops pushing.

[0393] In some embodiments, the stabilizer includes a post configured such that when the driver presses the tip of the toggle anchor against tissue, the stabilizer moves to a stabilized position via distal sliding of the post into the toggle anchor.

[0394] In some embodiments, at least the heel portion of the toggle anchor is tubular, and the post is configured such that when the driver presses the tip of the toggle anchor against tissue, the stabilizer moves to a stabilized position via axial sliding of the post into the tubular lumen defined by the toggle anchor.

[0395] In some embodiments, the stabilizer is disposed inside the driver.

[0396] In some embodiments, the drive head is coupled to the rod via a compression spring that extends over at least a portion of the post.

[0397] In some embodiments, the delivery tool is configured such that distal sliding of the post into the toggle anchor involves proximal movement of the drive head toward the rod.

[0398] In some embodiments, the stabilizer is a receptacle configured such that when the tip of the toggle anchor is pushed against tissue by a driver, the stabilizer moves to a stabilized position via proximal sliding of the heel portion into the receptacle. The stabilizer includes a receptacle.

[0399] In some embodiments, the heel portion is sized to fit snugly within the receptacle.

[0400] In some embodiments, the receptacle is tubular.

[0401] In some embodiments, the receptacle is a cup.

[0402] In some embodiments, the drive head is coupled to the rod via a compression spring that extends through at least a portion of the receptacle.

[0403] In some embodiments, the delivery tool is configured such that axial sliding of the heel portion into the receptacle is accompanied by proximal sliding of the drive head into the receptacle.

[0404] In some embodiments, the delivery tool is configured such that axial sliding of the heel portion into the receptacle is accompanied by proximal movement of the drive head toward the rod.

[0405] According to some embodiments, a system and / or device (e.g., for use in or usable with an actual tissue or a simulated tissue) includes an implant that includes a toggle anchor and / or a longitudinal member.

[0406] In some embodiments, the toggle anchor can have a tip, a heel portion, and an anchor axis between the tip and the heel portion, and can define a lateral eyelet midway between the tip and the heel portion.

[0407] In some embodiments, the toggle anchor may include (i) a first segment defining a tip, and / or (ii) a second segment slidably coupled to the first segment and defining a heel portion.

[0408] In some embodiments, the longitudinal member may extend through a lateral eyelet and may be connected to the toggle anchor such that pulling on the longitudinal member causes the second segment to slide axially relative to the first segment.

[0409] In some embodiments, the longitudinal member is connected to the toggle anchor such that pulling on the longitudinal member causes the heel portion to slide toward the lateral eyelet.

[0410] In some embodiments, the longitudinal member is connected to the toggle anchor such that pulling on the longitudinal member causes the heel portion to slide away from the lateral eyelet.

[0411] In some embodiments, the longitudinal member is connected to the toggle anchor such that pulling on the longitudinal member causes the heel portion to extend away from the first segment such that the lateral eyelet is disposed substantially intermediate the tip and the heel portion of the toggle anchor.

[0412] In some embodiments, (i) the longitudinal member is attached to the attachment point of the toggle anchor, and / or (ii) prior to being pulled, the longitudinal member defines a path that includes at least one loop between the lateral eyelet and the attachment point.

[0413] In some embodiments, the longitudinal member is connected to the toggle anchor such 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.

[0414] In some embodiments, at least a portion of the second segment is coaxial with at least a portion of the first segment.

[0415] In some embodiments, the second segment is telescopically coupled to the first segment, and the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the second segment telescopically slides relative to the first segment.

[0416] In some embodiments, the second segment is coupled to the first segment such that the second segment is axially slidable within the first segment.

[0417] In some embodiments, the toggle anchor includes a spring that biases the second segment towards a predetermined axial position relative to the first segment.

[0418] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the second segment slides axially away from a predetermined axial position relative to the first segment.

[0419] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the spring is pulled.

[0420] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the axial length of the toggle anchor is changed by sliding the second segment relative to the first segment.

[0421] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the axial length of the toggle anchor is increased by sliding the second segment relative to the first segment.

[0422] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the axial length of the toggle anchor is reduced by sliding the second segment relative to the first segment.

[0423] In some embodiments, the second segment defines a sharp tip from the heel portion to the opposite end of the second segment, and the system / device is configured such that when the longitudinal member is pulled, the second segment slides relative to the first segment in a manner that draws the sharp tip into the first segment.

[0424] In some embodiments, the system / device is configured such that when the longitudinal member is pulled, the second segment slides relative to the first segment in a manner that draws the sharp tip into the first segment and extends the heel portion away from the first segment.

[0425] In some embodiments, the implant further includes a frame, and the longitudinal member is a cord that connects a toggle anchor to the frame.

[0426] In some embodiments, the frame includes a spring that pulls the cord.

[0427] In some embodiments, the longitudinal member is a retrieval line configured to pull a toggle anchor out of tissue.

[0428] In some embodiments, the lateral eyelet is disposed at the end of the first segment closest to the heel portion.

[0429] According to some embodiments, a system and / or device (e.g., for use in or with actual or simulated tissue) includes an implant that includes a toggle anchor, a cord, and / or a retrieval line.

[0430] In some embodiments, the toggle anchor may have a tip, a heel portion, and / or a lateral eyelet. The lateral eyelet may be midway between the tip and the heel portion.

[0431] In some embodiments, the cord may be connected to the toggle anchor via the lateral eyelet.

[0432] In some embodiments, the retrieval line can be screwed through the toggle anchor in such a manner that when tension is applied to the retrieval line, the heel portion is retracted toward the side eyelet.

[0433] In some embodiments, the toggle anchor is a helical coil that defines a lumen therethrough.

[0434] In some embodiments, the retrieval line is a winding of the helical coil such that when tension is applied to the retrieval line, the anchor is reinforced by compressing the windings against each other, and the retrieval line is screwed through the winding of the helical coil.

[0435] In some embodiments, the toggle anchor further includes a spring configured to bias the heel portion to extend away from the side eyelet.

[0436] In some embodiments, the toggle anchor has a sharp tip and / or the spring is configured to bias the tip toward the side eyelet.

[0437] In some embodiments, the toggle anchor includes (i) a body that defines a lumen and a retrieval eyelet, the retrieval eyelet opening into the lumen, and / or (ii) a stock at least a portion of which is disposed within the lumen.

[0438] In some embodiments, the cord extends through the retrieval eyelet to the stock such that when tension is applied to the retrieval line, the heel portion is retracted by sliding the stock relative to the body.

[0439] In some embodiments, the cord extends through the retrieval eyelet and a transverse channel in the stock and is attached to a side surface of the body opposite the retrieval eyelet.

[0440] In some embodiments, the stock is shaped to define the heel portion.

[0441] In some embodiments, the body defines a lateral eyelet.

[0442] According to some embodiments, a system and / or apparatus (e.g., for use in or usable in an actual or simulated tissue) includes an implant that includes a toggle anchor and / or a cord.

[0443] In some embodiments, the toggle anchor has a tip, a heel portion, and / or a lateral eyelet midway between the tip and the heel portion.

[0444] In some embodiments, the cord can be connected to the toggle anchor via the lateral eyelet in a manner such that when tension is applied to the cord, the heel portion extends away from the lateral eyelet.

[0445] In some embodiments, the toggle anchor has a sharp tip.

[0446] In some embodiments, the cord is connected to the toggle anchor via the lateral eyelet such that when tension is applied to the cord, (i) the heel portion extends away from the lateral eyelet and (ii) the tip is retracted toward the lateral eyelet simultaneously.

[0447] In some embodiments, the toggle anchor includes (i) a body that defines a lumen and a lateral eyelet that opens into the lumen, and / or (ii) a stock at least a portion of which is disposed within the lumen.

[0448] In some embodiments, the cord extends through the lateral eyelet to the stock such that when tension is applied to the cord, the heel portion extends and the stock is slid relative to the body to retract the tip.

[0449] In some embodiments, the stock is shaped to define a heel portion and a tip.

[0450] In some embodiments, the cord extends through the lateral eyelets and transverse channels in the stock and is attached to the side surface of the body opposite the lateral eyelets.

[0451] According to some embodiments, a system (e.g., for use in or with an actual or simulated heart of an actual or simulated subject) includes an implant that includes a tether and / or an assembly.

[0452] 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.

[0453] In some embodiments, the winch may include a housing and a spool disposed therein.

[0454] In some embodiments, the spool may be operably coupled to the tether such that when the winch is actuated, tension is applied to the tether.

[0455] In some embodiments, the tether may extend out of the opening of the housing from the spool. In some embodiments, the opening may have a rim.

[0456] In some embodiments, the spring may be coupled to the housing in a manner that biases the tether away from contact with the rim.

[0457] In some embodiments, the spring is a torsion spring. In some embodiments, the spring is a cantilever spring. In some embodiments, the spring is a wave spring.

[0458] In some embodiments, the spring is coupled to the housing in a manner that biases the tether away from contact with the side surface of the rim farthest from the winch anchor.

[0459] In some embodiments, the assembly is the first assembly of the implant, the implant further includes a second assembly including an anchor, and the first assembly and the second assembly are connected via a tether.

[0460] In some embodiments, the heart has an atrium, a ventricle, and a valve therebetween.

[0461] In some embodiments, the system has a distal portion that is telescopically advanceable into the heart while coupled to the implant and is adapted to (i) anchor an anchor to the valve leaflet of the valve and / or (ii) anchor a winch anchor to the ventricular tissue of the ventricle such that the tether extends from the anchor at the valve leaflet to the winch anchor within the ventricle, and further includes a delivery tool.

[0462] In some embodiments, the first assembly is a helical structure and includes a helical structure that is shaped to define (i) a spring and / or (ii) a gripping region adapted to grip a tether between the turns of the helix.

[0463] In some embodiments, the spring defines a helical structure having a series of turns extending circumferentially around a housing, and during ventricular contraction of the heart, the pitch between the turns of the first portion of the helical structure is reduced.

[0464] In some embodiments, the spring is adapted to grip the tether between the turns of the second portion of the helical structure.

[0465] In some embodiments, the spring defines a helical structure having a series of turns.

[0466] In some embodiments, the helical structure extends circumferentially around the outside of the winch housing.

[0467] In some embodiments, the spring is adapted to grip the tether between the turns of the helical structure.

[0468] According to some implementations, a method of connecting a tether to a component of an implant includes (i) forming a bend in the tether by looping an end portion of the tether around a portion of the component and / or (ii) closing the loop by coaxially embedding the end portion through an extension of the tether such that the extension compresses and closes the end portion therein.

[0469] In some implementations, (i) the bend is a first bend, (ii) the loop is a first loop, and / or (ii) coaxially embedding the end portion through the extension includes coaxially embedding a first portion of the end portion through the extension.

[0470] In some implementations, the method further includes (i) forming a second bend in the end portion and / or (ii) closing the second bend into a second loop by coaxially embedding a second portion of the end through the extension such that the first portion and the second portion extend along each other within the extension.

[0471] In some implementations, the bend is a first bend, the loop is a first loop, and / or the extension is a first extension. In some implementations, the method further includes (i) forming a second bend in the end portion and / or (ii) closing the second bend into a second loop by coaxially embedding the end portion through a second extension of the tether such that the second extension compresses and closes the end portion therein.

[0472] In some implementations, (i) the end portion is a first end portion of the tether, (ii) a second end portion of the tether extends away from the first end portion from the extension and an end of the second end portion is coupled to a downstream assembly, and / or (iii) looping the end portion of the tether around a portion of the component includes looping the first end portion of the tether around a portion of a valve tip patch of an upstream assembly.

[0473] In some embodiments, the extension portion is a braid, and coaxially burying the end portion through the extension portion includes coaxially burying the end portion through the extension portion such that the strands of the braid are pushed apart.

[0474] In some embodiments, the extension portion includes woven strands, and coaxially burying the end portion through the extension portion includes coaxially burying the end portion through the extension portion such that the woven strands are pushed apart.

[0475] In some embodiments, the method further includes trimming an end of the end portion that extends from the extension portion to the end of the tether after coaxially burying the end portion through the extension portion.

[0476] According to some embodiments, a system and / or device (e.g., for use in or usable with an actual or simulated tissue) includes an implant that includes a toggle anchor, a retrieval adapter, and / or a retrieval line.

[0477] In some embodiments, the toggle anchor can have a heel portion that defines a retrieval eyelet.

[0478] In some embodiments, the retrieval adapter can have a first loop at a first end and a second loop at a second end, with the first loop extending through the retrieval eyelet.

[0479] In some embodiments, the retrieval line can be looped through the second loop in a manner such that pulling on the retrieval line reorients the toggle anchor for retrieval.

[0480] 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.

[0481] 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 on the retrieval line reorients both the first toggle anchor and the second toggle anchor for retrieval.

[0482] According to some embodiments, a system (e.g., for use with or usable with an actual or simulated subject) includes a toggle anchor, a cord, and / or a retrieval line.

[0483] 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.

[0484] In some embodiments, the cord can be connected to the coil at a location between the first end portion and the second end portion and can extend orthogonally away from the longitudinal axis at the location.

[0485] In some embodiments, the retrieval line can extend from a first end portion to a second end portion and away from the toggle anchor, and the retrieval line is fixed to the toggle anchor in a manner that the anchor is reinforced by compressing the turns of the coil against each other when the retrieval line is pulled.

[0486] In some embodiments, the retrieval line is fixed to an end portion of the toggle anchor.

[0487] In some embodiments, the system further includes a driver adapted to drive the toggle anchor from a first side of the cardiovascular tissue of the subject through the tissue to the 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 where the turns of the coil are movable relative to each other.

[0488] In some implementations, the driver is adapted to deliver a toggle anchor through tissue while extending through a lumen defined by the coil.

[0489] According to some implementations, a system and / or device (e.g., for use with or usable with an actual or simulated subject) includes a medical tool that includes an external component, a shaft, and / or a pair of wires.

[0490] The external component can be at the proximal end of the tool.

[0491] In some implementations, the shaft can extend distally from the external component and can be configured to be advanced transversely into a subject.

[0492] In some implementations, a pair of wires can extend from the external component along the shaft to the distal portion of the tool.

[0493] In some implementations, the external component can include a control device and / or a lever.

[0494] In some implementations, the lever can operably couple the control device to the distal portion via the pair of wires such that (i) the control device is pivotally attached to the lever at a fulcrum of the lever and / or (ii) each wire of the pair is coupled to the lever on opposite sides of the fulcrum such that when the control device is actuated and the lever pivots dynamically, the distal portion of the tool is manipulated while the wires balance against each other.

[0495] In some implementations, the control device is axially slidable along the external component such that when the control device is slid in a first axial direction while the lever continues to balance the wires against each other, the distal portion of the tool moves in the first axial direction.

[0496] According to some embodiments, a system and / or device (e.g., for use in or with an actual or simulated subject) includes an implant and / or a delivery tool.

[0497] In some embodiments, the delivery tool may include a kirigami wrap and / or a release mechanism.

[0498] In some embodiments, the kirigami wrap may be adapted to hold the implant. The delivery tool may be configured to advance the implant transvascularly to the subject while the implant is held by the kirigami wrap.

[0499] In some embodiments, the release mechanism may be operably coupled to the kirigami wrap such that actuation of the release mechanism releases the hold of the kirigami wrap on the implant.

[0500] According to some embodiments, a system (e.g., for use in or with an actual or simulated heart of an actual or simulated subject) includes an implant that includes a tether and / or an assembly.

[0501] In some embodiments, the assembly may include a winch, a winch anchor, and / or a shock absorber. The winch anchor may be coupled to the winch.

[0502] In some embodiments, the winch may include a housing and a spool disposed therein.

[0503] In some embodiments, the spool may be operably coupled to the tether such that tension is applied to the tether when the winch is actuated.

[0504] In some embodiments, the tether may extend out of an opening in the housing from the spool.

[0505] In some implementations, the shock absorber can be coupled to the housing in a manner that reduces the force acting on the winch anchor.

[0506] According to some implementations, a system (e.g., for use in or usable with a valve disposed between the atria and ventricles of a target heart) includes an implant that includes a patch, a patch anchor, a downstream assembly, and / or a tether.

[0507] In some implementations, the patch can include a flexible sheet. In some implementations, the downstream assembly can include a ventricular anchor. In some implementations, the tether can tether the downstream assembly to the patch.

[0508] In some implementations, the system further includes a delivery tool having a distal portion that is transvascularly advanceable into the heart while the implant is attached to the delivery tool. In some implementations, the delivery tool can include a shaft, a clamp, and / or a driver. The shaft can define the longitudinal axis of the delivery tool.

[0509] In some implementations, the clamp can include an upstream support and / or a downstream support.

[0510] In some implementations, the clamp can be movable between an open state and a gripping state. In some implementations, in the open state, the upstream support and the downstream support are positioned apart from each other, and the clamp can be configured to receive a portion of the valve leaflet between the upstream support and the downstream support.

[0511] In some implementations, in the gripping state, the clamp can be configured to grip a portion of the valve leaflet received between the upstream support and the downstream support by transitioning from the open state to the gripping state while a portion of the valve leaflet remains disposed between the upstream support and the downstream support.

[0512] In some implementations, the driver may be configured to use a patch anchor to anchor the patch to a portion of the valve tip while a portion of the valve tip is gripped by a clip.

[0513] In some implementations, the clip is movable toward an open state after anchoring the patch to the valve tip, and releases a portion of the valve tip from the clip with the patch anchored thereto.

[0514] In some implementations, in a gripping state, the upstream support and the downstream support are closer to each other than in an open state.

[0515] In some implementations, the ventricular anchor is a first ventricular anchor, the downstream assembly further includes a second ventricular anchor, and / or the tether tethers the patch to both the first ventricular anchor and the second ventricular anchor.

[0516] In some implementations, the patch includes a first portion of the sheet, and a second portion of the sheet is shaped to extend away from the patch in a manner that defines the tether.

[0517] In some implementations, when the clip grips a portion of the valve tip between the upstream support and the downstream support, the portion of the valve tip moves a gripping indicator relative to the upstream support in a manner detectable by fluoroscopy, and the clip includes the gripping indicator flexibly coupled to the upstream support.

[0518] In some implementations, the patch anchor is coupled to the patch in a manner that facilitates (i) temporarily moving 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 to anchor the patch to a portion of the valve tip.

[0519] In some embodiments, the delivery tool is configured such that an operable portion of the shaft distal to the clip is operable via the operation of the portion of the delivery tool proximal to the body.

[0520] In some embodiments, the implant is attached to or attachable to the delivery tool such that the tether extends along the shaft from the downstream assembly, through the clip, and to the patch.

[0521] In some embodiments, the clip is disposed laterally from the shaft in its entirety in both the open and gripping states.

[0522] In some embodiments, the ventricular anchor includes a helical tissue engagement element.

[0523] In some embodiments, the tether extends from the downstream assembly to the patch and back to the downstream assembly.

[0524] In some embodiments, the ventricular anchor is a first ventricular anchor, the downstream assembly further includes a second ventricular anchor, and / or the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0525] In some embodiments, the implant includes an upstream assembly including a patch and a patch anchor, and / or the tether is slidably coupled to the upstream assembly.

[0526] In some embodiments, the upstream assembly defines an eyelet and the tether is slidably coupled to the upstream assembly by being screwed through the eyelet.

[0527] In some embodiments, the downstream assembly includes a winch coupled to the ventricular anchor and the tether is arranged in a pulley arrangement such that (i) a first end of the tether is operably coupled to the winch, (ii) a bend in the tether is slidably coupled to the upstream assembly, and / or (iii) a second end of the tether is fixed to the downstream assembly.

[0528] In some embodiments, the winch has a housing fixedly attached to the ventricular anchor, and the second end of the tether is fixed to the housing.

[0529] In some embodiments, the patch has a lip region, and the tether is attached to the patch via two lateral lines that branch away from the tether and from each other and are attached to opposing lateral sites of the lip region.

[0530] In some embodiments, the attachment of the tether to the patch via the two lateral lines is set such that, due to the tension applied to the tether, the patch is bent inwardly, and the patch is configured to elastically bend inwardly.

[0531] In some embodiments, the system further includes an inner line that connects the tether to an inner site of the lip region in a manner that limits the degree to which the patch is bent inwardly due to the tension applied to the tether.

[0532] In some embodiments, the downstream assembly further includes a winch, the ventricular anchor is a winch anchor coupled to the winch, and / or the tether moors the winch to the patch.

[0533] In some embodiments, the delivery tool further includes a drive shaft sub-assembly, the drive shaft sub-assembly extends through the shaft, and is configured to (i) anchor the winch anchor to the ventricular tissue of the heart by applying an anchor force to the winch anchor, and / or (ii) operate the winch regardless of applying the anchor force, and includes one or more drive shafts operably coupled to the downstream assembly.

[0534] In some embodiments, the drive shaft subassembly includes a reference force tube that extends through the shaft and engages a downstream assembly, and / or one or more drive shafts extend through the reference force tube to the downstream assembly, and the drive shaft subassembly is configured to operate the winch by applying torque to the winch while the reference force tube provides a reference force to the downstream assembly.

[0535] In some embodiments, the downstream assembly and the delivery tool are configured to facilitate rotation of the winch anchor relative to the shaft without operating the winch.

[0536] In some embodiments, the driver is configured to anchor the patch to a portion of the valve tip by driving a patch anchor through a portion of the valve tip gripped by a clip.

[0537] In some embodiments, the patch anchor is a toggle that is biased to automatically expand upon deployment.

[0538] In some embodiments, the toggle has a cellular structure that is biased to automatically expand by foreshortening.

[0539] In some embodiments, the delivery tool is configured to anchor the downstream assembly to the ventricular tissue of the ventricle by anchoring a ventricular anchor to the ventricular tissue.

[0540] In some embodiments, the ventricular anchor includes one or more tissue engagement elements (e.g., one or more of a screw, helix, barb, pin, hook, staple, loop, arm, sharp portion, etc.), and the delivery tool is configured to anchor the downstream assembly to the ventricular tissue by driving the tissue engagement element into the ventricular tissue.

[0541] In some embodiments, the implant is attachable or attachable to the delivery tool such that the ventricular anchor is disposed at the distal end of the shaft.

[0542] In some embodiments, the delivery tool further includes a drive shaft sub-assembly, the drive shaft sub-assembly including one or more drive shafts that extend through the shaft and are operably coupled to a downstream assembly in a manner that the drive shaft sub-assembly is configured to anchor the ventricular anchor to the ventricular tissue by applying an anchor fixation force to the ventricular anchor through the shaft.

[0543] In some embodiments, the delivery tool includes a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is tubally advanceable to the heart while the downstream assembly is housed within the capsule.

[0544] In some embodiments, the capsule includes a shroud formed from an elastic polymer.

[0545] In some embodiments, the capsule is flexible and further includes a housing having a plurality of fingers circumferentially distributed and embedded within the shroud so as to approximate a tubular shape.

[0546] In some embodiments, the downstream assembly further includes a winch, the ventricular anchor being a winch anchor coupled to the winch, the delivery tool further including a drive shaft sub-assembly, the drive shaft sub-assembly including one or more drive shafts that extend through the shaft and are operably coupled to the downstream assembly in a manner that the drive shaft sub-assembly is configured to drive a tissue engagement element into the ventricular tissue (e.g., screw in, rotate, push, etc.), such as by applying torque to the winch anchor without rotating the winch relative to the ventricular tissue.

[0547] In some embodiments, the distal portion of the delivery tool is coupled to the implant in a manner that the drive shaft sub-assembly is configured to drive a tissue engagement element into the ventricular tissue by applying torque to the winch anchor without rotating the winch relative to the shaft.

[0548] In some embodiments, the delivery tool includes a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is transvascularly advanceable into the heart while the downstream assembly is housed within the capsule and / or the capsule and winch are shaped to inhibit rotation of the winch shaft relative to the drive shaft subassembly while the drive shaft subassembly screws the tissue engagement element into the ventricular tissue.

[0549] In some embodiments, the capsule defines an engaging track while the winch is housed by the capsule and / or the capsule and downstream assembly are configured such that the downstream assembly screws the tissue engagement element into the ventricular tissue in a manner that the winch slides linearly along the track and advances distally out of the capsule.

[0550] In some embodiments, the track is a lateral opening within the capsule, and the winch defines an opening through which a tether extends from the winch to a patch outside the winch, and the drive shaft subassembly is configured such that the opening of the winch slides linearly along the lateral opening and the downstream assembly screws the tissue engagement element into the ventricular tissue in a manner that the downstream assembly advances distally out of the capsule.

[0551] In some embodiments, the capsule includes a housing that houses the winch and defines a lateral opening and / or an elastic shroud that covers the housing.

[0552] In some embodiments, the shroud covers the distal region of the lateral opening, leaves the proximal region of the lateral opening exposed, defines a window of the capsule, and / or the distal portion of the delivery tool is transvascularly advanceable into the heart while the opening is exposed through the window and the downstream assembly is housed within the capsule.

[0553] In some embodiments, the shroud extends distally from the window and defines a slit that is aligned with the lateral opening.

[0554] In some embodiments, when the opening linearly slides along the side opening by protruding into the side opening, the opening of the winch temporarily separates the shroud at the slit, and the downstream assembly advances distally out of the capsule so that the tissue engagement element screws into the ventricular tissue, and the drive shaft sub-assembly is configured.

[0555] In some embodiments, the implant includes an upstream assembly including a patch anchor coupled to the patch.

[0556] In some embodiments, the upstream assembly further includes a cord through which the patch anchor is coupled to the patch.

[0557] In some embodiments, the patch anchor is a toggle anchor.

[0558] 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 such that when tension is applied to the cord, the heel extends away from the lateral eyelet.

[0559] In some embodiments, the toggle anchor has a sharp tip, and / or the cord is connected to the toggle anchor via the lateral eyelet such that when tension is applied to the cord, simultaneously, (i) the heel extends away from the lateral eyelet and (ii) the tip is received towards the lateral eyelet.

[0560] In some implementations, the toggle anchor has a tip, a heel portion, and a lateral eyelet midway between the tip and the heel portion. In some implementations, the cord is connected to the toggle anchor via the lateral eyelet. In some implementations, the system further includes a retrieval line that is threaded through the toggle anchor and is configured such that when tension is applied to the retrieval line, the heel portion is retracted toward the lateral eyelet.

[0561] In some implementations, the toggle anchor further includes a spring configured to bias the heel portion to extend away from the lateral eyelet.

[0562] In some implementations, the toggle anchor has a sharp tip, and the spring is configured to bias the retracted tip toward the lateral eyelet.

[0563] In some implementations, the toggle anchor has a tip, a heel portion, and a lateral eyelet midway between the tip and the heel portion. In some implementations, a first segment of the toggle anchor defines the tip and / or a second segment of the toggle is slidably coupled to the first segment.

[0564] In some implementations, the system further includes a longitudinal member that extends through the lateral eyelet and is connected to the toggle anchor such that when the longitudinal member is pulled, the second segment slides axially relative to the first segment.

[0565] In some implementations, the second segment of the toggle anchor defines the heel portion.

[0566] In some implementations, the driver is configured to push the toggle anchor, tip first, through a portion of the valve tip, and the driver has a drive head and a rod extending proximally from the drive head, and the drive head is connected to the heel portion via complementary geometries in a manner that (i) preferentially allows deflection rather than lateral translation of the toggle anchor relative to the driver, and (ii) allows the heel portion to be separable from the driver when the toggle anchor reaches a predetermined angle relative to the driver.

[0567] In some implementations, the drive head defines a first distally facing surface and a shoulder portion that defines a second distally facing surface proximal to the first surface. In some implementations, at the heel portion, the toggle anchor defines a laterally opening through which the shoulder portion projects, such that the driver is configured to push the toggle anchor, tip first, through a portion of the valve tip by (i) a second distally facing surface that pushes the toggle anchor distally at the laterally opening, and (ii) a first distally facing surface that pushes the toggle anchor distally substantially opposite the laterally opening.

[0568] In some implementations, at the heel portion, the toggle anchor defines a laterally opening through which the shoulder portion projects, such that the toggle anchor is separable from the driver by deflecting around a point on the driver proximal to the second distally facing surface, such that the laterally opening moves laterally away from the shoulder portion.

[0569] In some implementations, the drive head defines a knob and a neck portion that connects the knob to the rod. In some implementations, at the heel portion, the toggle anchor defines appendages that extend proximally beyond the knob, proximally from the knob, and inwardly towards each other and towards the neck portion, such that the appendages inhibit proximal accommodation and lateral translation of the driver from the toggle anchor.

[0570] In some embodiments, the toggle anchor defines an appendage portion that extends proximally beyond the knob, proximally from the knob, inwardly towards each other, and towards the neck portion, such that deflection of the toggle anchor relative to the driver causes the appendage portions to deflect laterally away from each other and away from the neck portion. As a result, the knob is biased between the appendage portions such that the appendage portions deflect laterally away from each other and away from the neck portion due to the deflection of the toggle anchor relative to the driver.

[0571] In some embodiments, the drive head defines a socket having a rim. In some embodiments, at the heel portion, the toggle anchor defines a knob. In some embodiments, the knob is disposed within the socket in a manner that inhibits lateral translation of the toggle anchor from the driver.

[0572] In some embodiments, due to the deflection of the toggle anchor relative to the driver, the rim is pressed against the toggle anchor in a manner that moves the knob distally out of the socket like a lever.

[0573] In some embodiments, the attachment of the tether to the upstream assembly is such that pulling on the tether causes the patch anchor to be pulled towards the patch in a manner that the cord is pulled.

[0574] In some embodiments, the upstream assembly includes a one-way mechanism through which the cord extends, and the one-way mechanism is configured to (i) be attached to the patch, (ii) facilitate passage of the patch anchor towards the patch in a first direction through the one-way mechanism of the cord, and / or (iii) inhibit passage of the patch anchor in a second direction opposite the first direction through the one-way mechanism of the cord.

[0575] In some embodiments, the upstream assembly is configured such that pulling on the tether causes the cord to be pulled in a first direction through the one-way mechanism.

[0576] In some embodiments, the delivery tool is configured to pull on the tether such that the tether pulls the cord in a first direction through the one-way mechanism.

[0577] In some embodiments, the delivery tool is configured to pull the tether by moving the downstream assembly away from the upstream assembly after anchoring the patch to a portion of the valve tip.

[0578] In some embodiments, the patch anchor has a tip with a sharpened distal end (e.g., sharpened towards the end), and is configured to be driven through the valve tip by a driver with the sharpened distal end penetrating the valve tip.

[0579] In some embodiments, the delivery tool further includes a hollow needle, and the patch anchor is configured to be driven through the valve tip by a driver while being disposed within the hollow needle.

[0580] In some embodiments, the delivery tool further includes a hollow needle configured to pierce the valve tip, and the driver is configured to drive the patch anchor out of the hollow needle while the hollow needle extends through the valve tip.

[0581] In some embodiments, the patch anchor includes a toggle that partially defines an eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0582] In some embodiments, the eyelet extends across the toggle through the entire toggle.

[0583] In some embodiments, the toggle is substantially tubular and has side walls defining a lumen.

[0584] In some embodiments, the upstream assembly further includes a spring configured to apply tension to the cord.

[0585] In some embodiments, the spring is a compression spring.

[0586] In some embodiments, the spring is disposed substantially flat with respect to the patch.

[0587] In some implementations, the spring is configured to facilitate driving the driver through the valve tip to the patch anchor by temporarily pulling in response to the tension applied to the cord as the driver pushes the patch anchor away from the patch through the valve tip.

[0588] In some implementations, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the patch is temporarily linearly contracted.

[0589] In some implementations, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the spring slides across the sheet.

[0590] In some implementations, the patch has a lip and a root, and the driver is configured to anchor the root of the patch to the valve tip such that the lip of the patch extends toward the opposing valve tip of the valve, and / or the patch includes at least one frame that defines (i) a lip brace at the lip of the patch and / or (ii) a root brace at the root of the patch.

[0591] In some implementations, the spring is configured such that the temporary pull is substantially from a temporary compression of the spring between the lip brace and the root brace.

[0592] In some implementations, at least one frame defines a patch anchor support coupled to the root brace, and the cord extends from the spring, through the patch anchor support, to the patch anchor.

[0593] In some implementations, the tether is connected to the lip brace.

[0594] In some implementations, the spring is attached to the root brace.

[0595] In some implementations, the spring extends from the root brace to the lip brace.

[0596] In some embodiments, the spring extends from the root brace to the lip brace along the centerline of the patch.

[0597] In some embodiments, the spring does not extend to the lip brace.

[0598] In some embodiments, the fastener defines a slot, and the driver is configured to anchor the patch to the valve tip by driving the patch anchor through the valve tip and the slot.

[0599] In some embodiments, the slot is defined by a downstream support of the fastener.

[0600] In some embodiments, the fastener defines a slot guard configured to prevent heart tissue from entering the slot.

[0601] In some embodiments, the patch is coupled to the patch anchor via a cord, and the slot guard has a rest position that is (i) elastic, (ii) covers the entrance to the slot, thereby preventing heart tissue from entering the slot, and / or (iii) is temporarily deflectable away from the slot by the cord, thereby facilitating the discharge of the cord from the slot.

[0602] In some embodiments, the free end of the slot guard is pushed under the downstream support.

[0603] In some embodiments, the delivery tool further includes a capsule at the distal end of the shaft, and the capsule is configured to house the downstream assembly.

[0604] In some embodiments, the capsule includes a shroud formed from an elastic polymer.

[0605] In some embodiments, the capsule further includes a housing that is flexible, circumferentially distributed to approximate a tubular shape, and has a plurality of fingers embedded within the shroud.

[0606] In some embodiments, the capsule is shaped to define a lateral window therein.

[0607] In some embodiments, the capsule is shaped to define a narrow slit that extends between the lateral window and the open distal end of the capsule.

[0608] In some embodiments, the delivery tool has a proximal extracorporeal portion that includes a clasp control device operably coupled to a clasp, such that when the clasp control device is operated, the clasp transitions between an open state and a gripping state.

[0609] In some embodiments, the clasp control device is operably coupled to an upstream support of the clasp, such that when the clasp control device is operated, the clasp transitions between an open state and a gripping state via movement of the upstream support relative to the shaft.

[0610] In some embodiments, the proximal extracorporeal portion further includes a driver control device operably coupled to a driver, such that when the driver control device is operated, the driver is induced to anchor a patch anchor to a valve tip.

[0611] In some embodiments, (i) within the distal portion of the delivery tool, the shaft has a proximal portion and a distal portion, and / or (ii) the proximal extracorporeal portion of the delivery tool further includes a shaft extension device operably coupled to the shaft, such that when the shaft extension device is operated, the distal portion of the shaft extends distally and reversibly from the proximal portion of the shaft.

[0612] In some embodiments, the clasp is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, the downstream support deflects relative to the shaft.

[0613] In some embodiments, the delivery tool includes a frame that defines a downstream support, and / or a first portion of the frame is attached to the proximal portion of the shaft and a second portion of the frame is attached to the distal portion of the shaft, such that when the degree of extension of the distal portion of the shaft from the proximal portion of the shaft is adjusted, the downstream support deflects relative to the shaft.

[0614] In some embodiments, the distal portion of the shaft includes an operable portion, and the attachment of the first portion of the frame and the second portion of the frame to the proximal portion of the shaft and the second portion of the shaft, respectively, is such that when the distal portion of the shaft extends distally from the proximal portion of the shaft by an amount that exceeds a threshold, the frame pulls on and deflects the distal portion of the shaft.

[0615] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect relative to the shaft.

[0616] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect relative to the shaft without changing the arrangement between the downstream support and the upstream support.

[0617] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, both the downstream support and the upstream support deflect relative to the shaft while the fastener remains in a gripping state.

[0618] In some embodiments, the extracorporeal proximal portion further includes an anchor control device and / or 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 control device to the ventricular anchor such that when the anchor control device is operated, an anchor fixation force is applied to the ventricular anchor.

[0619] In some embodiments, the downstream assembly further includes a winch, the ventricular anchor is a winch anchor coupled to the winch, the tether moors the winch to the patch, and / or the extracorporeal proximal portion further includes a winch control device, the drive shaft subassembly being configured such that in at least one state of the delivery tool, the drive shaft subassembly operably couples the winch control device to the winch such that when the winch control device is operated, the winch is actuated.

[0620] In some embodiments, the drive shaft subassembly includes (i) a winch control drive shaft through which the winch control device is operably coupled to the winch and / or (ii) an anchor control drive shaft disposed through the winch control drive shaft through which the anchor control device is operably coupled to the anchor.

[0621] In some embodiments, (A) the downstream assembly further includes a winch, the ventricular anchor is a winch anchor coupled to the winch, (B) the drive shaft sub-assembly includes a downstream assembly control drive shaft, (C) the system has an anchor fixation state in which, when the anchor control device operates, an anchor fixation force is applied to the winch anchor, and the anchor control device is operably coupled to the winch anchor via the downstream assembly control drive shaft, and / or (D) the system has a winching state in which (i) when the anchor control device is operated, the winch anchor is operably decoupled from the winch anchor so that no anchor fixation force is applied to the winch anchor, and (ii) when the downstream assembly control drive shaft rotates, the winch is operably coupled to the winch so that the winch operates.

[0622] In some embodiments, the downstream assembly includes a shaft that is axially movable within the downstream assembly, such that (i) when the shaft is positioned at a first axial position within the downstream assembly, the system is in an anchor fixation state, and (ii) when the shaft is positioned at a second axial position within the downstream assembly, the system is in a winching state.

[0623] In some embodiments, the first axial position is distal to the second axial position.

[0624] In some embodiments, the system further has a neutral state in which the downstream assembly control drive shaft is coupled to the downstream assembly but is operably decoupled from both the winch anchor and the winch.

[0625] In some embodiments, (i) in the anchor fixation state, the downstream assembly control drive shaft is disposed at a first axial position relative to the downstream assembly, (ii) in the winching state, the downstream assembly control drive shaft is disposed at a second different axial position relative to the downstream assembly, and / or (iii) the delivery tool is movable between the anchor fixation state and the winching state via axial movement of the downstream assembly control drive shaft relative to the downstream assembly.

[0626] In some embodiments, the first axial position is distal to the second axial position and / or the delivery tool is movable from an anchored state to a retracted state via proximal movement of the downstream assembly control drive shaft relative to the downstream assembly.

[0627] In some embodiments, the delivery tool further includes a mount configured to support a patch mounted thereon and configured to carry the patch toward the clip while the clip is in a gripping state.

[0628] In some embodiments, the mount is configured to carry the patch toward the upstream support of the clip by moving distally toward the clip while the patch is mounted thereon and the clip is in a gripping state.

[0629] In some embodiments, the mount is configured to carry the patch toward the upstream support of the clip by moving distally and laterally toward the clip while the patch is mounted thereon and the clip is in a gripping state.

[0630] In some embodiments, the delivery tool includes a beam providing a mechanical linkage between the shaft and the mount, the mechanical linkage linking distal movement of the mount and lateral movement of the mount.

[0631] In some embodiments, the mount has a storage position, the distal portion of the delivery tool is transvascularly advanceable to the heart while the patch is mounted on the mount and the mount is in the storage position, the mount has a ready position disposed closer to the clip than the storage position, and / or the driver is configured to anchor the patch to the valve tip by driving the patch anchor through the valve tip while the patch is mounted on the mount and the mount is in the ready position.

[0632] In some embodiments, the mount defines a channel therein. In some embodiments, the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in a storage position where the patch is attached to the mount and the patch anchor is disposed within the channel.

[0633] In some embodiments, the driver is configured to anchor the patch to a portion of the valve tip by driving the patch anchor out of the channel and through a portion of the valve tip.

[0634] In some embodiments, the delivery tool includes a needle disposed within the channel. In some embodiments, the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in a storage position where the patch is attached to the mount and the patch anchor is disposed within the needle within the channel.

[0635] In some embodiments, the delivery tool is configured to facilitate driving of the patch anchor through a portion of the valve tip by advancing the needle out of the channel.

[0636] In some embodiments, the delivery tool further includes a spring that biases the needle to be retracted within the channel.

[0637] In some embodiments, the delivery tool further includes a mount control rod operably coupled to the mount in a manner that configures the mount to transition between a storage position and a ready position.

[0638] In some embodiments, the mount control rod is operably coupled to the mount by being coupled to the needle.

[0639] In some embodiments, the operable coupling of the mount control rod to the mount is such that when the needle is pressed by the mount control rod from the storage position, the mount is pushed toward the ready position via the spring.

[0640] In some implementations, the operable coupling of the mounting control rod to the mount is such that when the needle is pressed by the mounting control rod while the mount is in the ready position, the spring is pulled and the needle is advanced out of the channel.

[0641] In some implementations, the delivery tool includes a spring configured to bias the mount to the ready position.

[0642] In some implementations, the spring is a spring beam that provides a mechanical linkage mechanism between the shaft and the mount and biases the mount to the ready position by biasing the mount to move distally and laterally.

[0643] In some implementations, the driver includes a rod and a drive head, and the drive head is coupled to the mount such that the tension on the rod restrains the mount in the storage position.

[0644] In some implementations, the patch anchor and the drive head are disposed within a channel defined within the mount, and when the tension on the rod is reduced such that the spring moves the mount to the ready position and / or when the rod is pushed while the mount is in the ready position, the drive head moves through the channel and the patch anchor is deployed out of the channel.

[0645] In some implementations, the fastener is movable between an open state and a gripping state while the mount remains in the storage position.

[0646] In some implementations, the delivery tool includes an extracorporeal proximal portion having a mount control device operably coupled to the mount such that when the mount control device is operated, the mount moves between the storage position and the ready position.

[0647] In some implementations, the delivery tool further includes a mount control rod operably coupled to the mount through which the mount control device is operably coupled to the mount.

[0648] In some embodiments, the extracorporeal proximal portion further includes a driver control device operably coupled to the driver, such that operating the driver control device induces the driver to drive the patch anchor through the valve tip.

[0649] In some embodiments, the mount control rod is tubular and the driver extends from the driver control device through the mount control rod.

[0650] In some embodiments, the extracorporeal proximal portion of the delivery tool further includes a fastener control device operably coupled to the fastener, such that operating the fastener control device causes the fastener to transition between an open state and a gripping state.

[0651] In some embodiments, the delivery tool further includes a fastener control wire through which the fastener control device is operably coupled to the mount.

[0652] In some embodiments, the mount control device is configured to move the mount between a storage position and a ready position by sliding the mount over and along the fastener control wire toward the fastener while the fastener is in the gripping state.

[0653] In some embodiments, the fastener control device is configured to transition the fastener from the gripping state to the open state by retracting the fastener control wire through the mount while the mount is in the storage position.

[0654] In some embodiments, the delivery tool further includes one or more wraps, and the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the mount is in a storage position in which the patch is held against the mount by one or more wraps that package the patch and the mount therearound.

[0655] In some embodiments, the distal portion of the delivery tool is transvascularly advanceable to the heart while the mount is in a storage position in which the patch is held against the mount by one or more wraps that wrap around the patch, mount, and shaft.

[0656] In some embodiments, the delivery tool further includes one or more spring brackets configured to hold the wrap taut.

[0657] In some embodiments, the delivery tool further includes a rod that is retractable to cooperate with the spring bracket to hold the wrap taut and release one or more wraps.

[0658] In some embodiments, at the storage position, the mount is partially arcuately curved around the shaft.

[0659] In some embodiments, the mount has a convex outer surface and the patch is attached to the mount in a manner such that the patch is curved against the convex outer surface of the mount.

[0660] In some embodiments, the mount is shaped to receive a patch anchor while the patch is attached to the mount.

[0661] In some embodiments, the patch anchor is coupled to the patch and the system is configured such that the patch is secured to the mount by the receipt of the patch anchor by the mount.

[0662] In some embodiments, the patch is coupled to the patch anchor via a cord and is secured to the surface of the mount by placing the patch anchor within a channel defined in the surface of the mount, the channel being shaped to (i) facilitate sliding of the patch anchor along the channel and / or (ii) prevent the patch anchor from exiting the channel laterally.

[0663] In some embodiments, the driver is configured to anchor the patch to the valve tip by driving the patch anchor along the channel, out from the end of the channel, and through the valve tip while the mount is in the ready position with the patch mounted to the mount.

[0664] In some embodiments, the cord extends laterally from the patch anchor to the patch outside the channel.

[0665] In some embodiments, within the distal portion of the delivery tool, the shaft is telescopic, and the delivery tool has a delivery state in which (i) the shaft is telescopically extended, (ii) the fastener faces distally, and / or (iii) the distal portion of the delivery tool is transvascularly advanceable to the heart.

[0666] In some embodiments, in the delivery state, the downstream support is deflected distally compared to the open state.

[0667] In some embodiments, in the delivery state, the downstream support is adjacent to the shaft and disposed substantially parallel to the shaft.

[0668] In some embodiments, in the delivery state, the fastener is closed.

[0669] In some embodiments, the delivery tool has a retracted state in which the shaft is telescopically retracted and / or the fastener faces proximally.

[0670] In some embodiments, the distal portion of the delivery tool is configured to be advanced downstream through the valve while in the retracted state.

[0671] In some embodiments, in the retracted state, the fastener is closed.

[0672] In some embodiments, in the retracted state, the downstream support is deflected proximally compared to the open state.

[0673] In some embodiments, in the retracted state, the fastener extends further laterally from the shaft than in the open state.

[0674] In some embodiments, the extracorporeal proximal portion of the delivery tool further includes a shaft extension device operably coupled to the shaft such that operation of the shaft extension device reversibly extends the distal portion of the shaft distally from the proximal portion of the shaft.

[0675] In some embodiments, the fastener is coupled to the shaft such that when the distal portion of the shaft extends distally from the proximal portion of the shaft, the downstream support deflects with respect to the shaft.

[0676] In some embodiments, the patch is substantially trapezoidal.

[0677] In some embodiments, (i) the patch has a lip and a root, (ii) the driver is configured to anchor the root of the patch to the valve tip such that the lip of the patch extends toward the opposing valve tip of the valve, and / or (iii) the lip is longer than the root.

[0678] In some embodiments, the delivery tool further includes a retrieval line removably coupled to the anchor such that applying tension to the retrieval line facilitates release of the anchoring of the patch anchor from the valve tip.

[0679] In some embodiments, (A) the patch anchor includes a tubular toggle and a retrieval mechanism including a notch and a retrieval eyelet in the heel portion of the toggle, and (B) the retrieval line (i) extends coaxially with the toggle into the lumen of the toggle in the heel portion of the toggle, (ii) exits the sidewall of the toggle through the retrieval eyelet, and / or (iii) loops back on itself through the notch for connection to itself.

[0680] In some embodiments, the retrieval line is removably coupled to the anchor such that tension applied to the retrieval line facilitates release of the patch anchor from the valve tip by reorienting the patch anchor.

[0681] According to some embodiments, a system and / or device for use in a valve disposed between an atrium and a ventricle of a target heart, the valve having a first valve tip and a second valve tip, the system / device including an implant including a valve tip reinforcement patch and / or a patch anchor.

[0682] The valve tip reinforcement patch may include a flexible sheet and / or a frame supporting the flexible sheet.

[0683] In some embodiments, the patch anchor may be coupled to the patch in a manner that facilitates anchoring the patch to the first valve tip by allowing the patch anchor to be temporarily moved away from the patch while remaining coupled to the patch and / or by biasing the patch anchor back towards the patch.

[0684] In some embodiments, the patch anchor has a sharp tip and is configured to be driven through the first valve tip with the sharp tip penetrating the first valve tip.

[0685] In some embodiments, the patch anchor is configured to be driven through the first valve tip while disposed within a hollow needle.

[0686] In some embodiments, the patch anchor includes a tubular toggle and a retrieval mechanism including a notch at the heel of the toggle and a retrieval eyelet, the system / device further including a retrieval line that (i) extends collinearly with the toggle into the lumen of the toggle at the heel of the toggle, (ii) exits the sidewall of the toggle via the retrieval eyelet, and / or (iii) loops back onto itself via the notch for connection to itself.

[0687] In some embodiments, the implant includes: (i) an upstream assembly including a patch and a patch anchor, (ii) a downstream assembly including a ventricular anchor, and / or (iii) a tether that moors the patch to the ventricular anchor.

[0688] In some embodiments, the ventricular anchor is a first ventricular anchor, the downstream assembly further includes a second ventricular anchor, and / or the tether moors the patch to both the first ventricular anchor and the second ventricular anchor.

[0689] In some embodiments, the tether extends from the downstream assembly to the patch and back to the downstream assembly.

[0690] In some embodiments, the ventricular anchor is a first ventricular anchor, the downstream assembly further includes a second ventricular anchor, and / or the tether extends from the first ventricular anchor to the patch and back to the second ventricular anchor.

[0691] In some embodiments, the tether is slidably coupled to the upstream assembly.

[0692] In some embodiments, the upstream assembly defines an eyelet, and the tether is slidably coupled to the upstream assembly by being screwed through the eyelet.

[0693] In some embodiments, the downstream assembly includes a winch coupled to the ventricular anchor, and the tether is arranged in a pulley arrangement such that: (i) a first end of the tether is operably coupled to the winch, (ii) a curved portion of the tether is slidably coupled to the upstream assembly, and / or (iii) a second end of the tether is fixed to the downstream assembly.

[0694] In some embodiments, the winch has a housing fixedly attached to the ventricular anchor, and the second end of the tether is fixed to the housing.

[0695] In some implementations, the patch anchor is a toggle that is biased to automatically expand upon deployment.

[0696] In some implementations, the toggle has a cellular structure that is biased to automatically expand by foreshortening.

[0697] In some implementations, the system / device further includes a delivery tool configured to deliver the implant to the heart and (i) anchor the patch anchor to the first valve cusp by temporarily moving the patch anchor away from the patch while the patch anchor remains coupled to the patch, and / or (ii) thereafter anchor the patch to the first valve cusp by releasing the patch anchor such that the implant responsively returns the patch anchor toward the patch.

[0698] In some implementations, the delivery tool is configured to move the patch anchor away from the patch by driving the patch anchor through the first valve cusp.

[0699] In some implementations, the implant includes an upstream assembly including the patch and the patch anchor, and the implant further includes a downstream assembly including a winch coupled to a winch anchor configured to anchor the downstream assembly to the ventricular tissue, and / or (ii) a tether that moors the winch to the patch.

[0700] In some implementations, the patch includes a first portion of the sheet, and a second portion of the sheet is shaped to extend away from the patch in a manner that defines the tether.

[0701] In some implementations, the implant further includes a cord through which the patch anchor is coupled to the patch.

[0702] In some implementations, the patch includes a spring, and the patch anchor is coupled to the spring in a manner that biases the patch anchor to return toward the patch.

[0703] In some implementations, the frame defines a spring. In some implementations, the spring is a compression spring.

[0704] In some implementations, the spring is configured to facilitate driving the patch anchor through the first valve tip by temporarily pulling the patch anchor away from the patch through the first valve tip in response to the tension applied to the cord.

[0705] In some implementations, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the patch is temporarily linearly contracted.

[0706] In some implementations, the spring is coupled to the sheet in a manner such that when the spring is temporarily pulled, the spring slides across the sheet.

[0707] In some implementations, (A) the patch has a lip and a root, (B) the cord couples the patch anchor to the patch in a manner such that when the patch anchor is anchored to the first valve tip, the patch is positioned, and as a result, the lip of the patch extends toward the second valve tip, and / or (C) the frame defines (i) a lip brace for the lip of the patch and / or (ii) a root brace for the root of the patch.

[0708] In some implementations, the spring is configured such that the temporary pull is substantially from a temporary compression of the spring between the lip brace and the root brace.

[0709] In some implementations, the patch defines an axis from the root to the lip along the centerline of the patch between the lip and the root, and the spring is configured such that the temporary pull is substantially from a deflection of the spring about an axis from the root to the lip of the spring.

[0710] In some embodiments, the spring is configured such that a temporary pull substantially consists of a deflection from the root of the spring towards the axis up to the lip.

[0711] In some embodiments, the spring is a first spring and the frame further includes a second spring, and the first spring and the second spring are configured such that a temporary pull substantially consists of a deflection of the first spring and the second spring towards each other.

[0712] In some embodiments, at least one frame defines a patch anchor support coupled to a root brace, and the cord extends from the spring, through the patch anchor support, to the patch anchor.

[0713] In some embodiments, the spring is a first spring extending from a root brace to a lip brace along a first lateral edge of the patch, and / or at least one frame defines a second spring extending from a root brace to a lip brace along a second lateral edge of the patch.

[0714] In some embodiments, the patch anchor includes a toggle defining a substantially intermediate eyelet along the toggle, and the cord is attached to the patch anchor at the eyelet.

[0715] In some embodiments, the system / device further includes a retrieval line configured to extend from an end of the toggle and, when tension is applied to the retrieval line, release the patch anchor from a first valve tip.

[0716] In some embodiments, the sidewall defines two lateral holes adjacent to each other, and the eyelet is defined by a portion of the sidewall disposed between the two lateral holes.

[0717] According to some embodiments, a system (for use in or usable with a valve disposed between the atrium and ventricle of a target heart) includes an implant and / or a delivery tool.

[0718] In some embodiments, the implant may include a tether and an assembly. In some embodiments, the assembly may include a winch and / or a winch anchor coupled to the winch.

[0719] In some embodiments, the winch may include a housing and a spool disposed therein. The tether may extend from the winch with the spool operably coupled to the tether such that when the winch is actuated, tension is applied to the tether.

[0720] In some embodiments, the delivery tool may have a distal portion that is transvascularly advanceable into the heart while being coupled to the implant.

[0721] In some embodiments, the delivery tool includes a drive shaft subassembly that includes a reference force tube coupled to a housing and / or a drive shaft. The drive shaft may extend through the reference force tube.

[0722] In some embodiments, the system may have an anchor fixation state in which the drive shaft is operably coupled to the winch anchor such that when the drive shaft rotates, an anchor fixation force is applied to the winch anchor and / or is operably decoupled from the winch such that when the drive shaft rotates, the winch does not operate.

[0723] In some embodiments, the system may have a winding-up state in which the drive shaft is operably decoupled from the winch anchor such that when the drive shaft rotates, an anchor fixation force is not applied to the winch anchor and / or is operably coupled to the winch such that when the drive shaft rotates, the winch operates.

[0724] In some implementations, the system further has a neutral state in which the drive shaft is coupled to the implant but operably decoupled from both the winch anchor and the winch.

[0725] In some implementations, the assembly includes a shaft that is axially movable within the assembly such that (i) when the shaft is positioned in a first axial position within the assembly, the system is in an anchor-fixed state and / or (ii) when the shaft is positioned in a second axial position within the assembly, the system is in a winching state.

[0726] In some implementations, (i) in the anchor-fixed state, the drive shaft is disposed in a first axial position relative to the winch, (ii) in the winching state, the drive shaft is disposed in a second different axial position relative to the winch, and / or (iii) the delivery tool is movable between the anchor-fixed state and the winching state via axial movement of the drive shaft relative to the winch.

[0727] In some implementations, the first axial position is distal to the second axial position, and the delivery tool is movable from the anchor-fixed state to the winching state via proximal movement of the drive shaft relative to the winch.

[0728] According to some implementations, the system (e.g., for use in or usable in a target tissue) includes a toggle anchor and / or a delivery tool. In some implementations, the toggle anchor can have a tip and a heel portion and can define an anchor shaft therebetween. The toggle anchor and / or the delivery tool can be the same or similar to any toggle anchor and / or delivery tool herein.

[0729] In some implementations, 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 toggle anchor distally out of and then away from the channel, first with the tip.

[0730] In some embodiments, the driver may have a drive head and / or a rod extending proximally from the drive head.

[0731] In some embodiments, the drive head may be connected to the heel portion via complementary geometric shapes such that (i) the drive head preferentially allows deflection rather than lateral translation of the toggle anchor relative to the driver and / or (ii) the heel portion is separable from the driver when the anchor reaches a predetermined angle relative to the driver.

[0732] In some embodiments, the drive head defines a knob and a neck portion connecting the knob to the rod. In some embodiments, at the heel portion, the toggle anchor defines appendages that extend proximally beyond the knob, proximally from the knob, inwardly towards each other, and towards the neck portion, such that the appendages inhibit proximal storage and lateral translation of the toggle anchor from the driver.

[0733] In some embodiments, the toggle anchor defines appendages that extend proximally beyond the knob, proximally from the knob, inwardly towards each other, and towards the neck portion, such that the knob is biased between the appendages such that deflection of the toggle anchor relative to the driver causes the appendages to deflect laterally away from each other and away from the neck portion.

[0734] In some embodiments, the drive head defines a socket having a rim. In some embodiments, at the heel portion, the toggle anchor defines a knob. In some embodiments, the knob is disposed within the socket in a manner that inhibits lateral translation of the toggle anchor from the driver.

[0735] In some embodiments, deflection of the toggle anchor relative to the driver causes the rim to be pressed against the toggle anchor in a manner that leverages the knob to move distally out of the socket.

[0736] In some implementations, the driver is a stabilizer that further includes a stabilizer configured to move the stabilizer to a stabilized position relative to the toggle anchor through axial sliding of the toggle anchor relative to the stabilizer by pushing the tip of the toggle anchor against the tissue by the driver, and the stabilizer suppresses deflection of the toggle anchor relative to the driver in the stabilized position.

[0737] In some implementations, the system further includes a cord attached to the toggle anchor.

[0738] In some implementations, the system includes an implant that includes a toggle anchor, a cord, and another component, and the cord connects the other component to the toggle anchor such that the toggle anchor is configured to anchor the other component to the tissue.

[0739] According to some implementations, the system includes an implant and / or a delivery tool. In some implementations, the implant may include a toggle anchor having a body, a tip, and a heel portion, and the toggle anchor defines an anchor axis between the tip and the heel portion.

[0740] In some implementations, the system may include an extensible member. In some implementations, the system may be configured such that when the driver presses the tip of the toggle anchor against the tissue, the extensible member slides axially in response relative to the body.

[0741] In some implementations, the extensible member is a component of the delivery tool. In some implementations, the extensible member is a component of the toggle anchor.

[0742] In some implementations, the system defines a sharp tip configured to pierce tissue in a manner that facilitates the driver pushing the toggle anchor through the tissue with the tip first. In some implementations, the system has a rest state in which the sharp tip is functionally obscure.

[0743] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extendable member axially slides relative to the body, thereby automatically and functionally exposing a sharp tip.

[0744] In some embodiments, the sharp tip is defined by the tip of the toggle anchor. In some embodiments, in the rest state, the extendable member functionally obscures the sharp tip. In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp tip by sliding axially relative to the body, thereby automatically and functionally exposing the sharp tip.

[0745] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp tip by sliding into the interior of the toggle anchor.

[0746] In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extendable member slides proximally away from the sharp tip by sliding over the exterior of the toggle anchor.

[0747] In some embodiments, the sharp tip is defined by the extendable member. In some embodiments, in the rest state, the toggle anchor functionally obscures the sharp tip. In some embodiments, the system is configured such that when the driver presses the tip of the toggle anchor against tissue, the extendable member automatically slides distally past the tip, thereby functionally exposing the sharp tip.

[0748] According to some embodiments, the system and / or device includes an implant that includes a toggle anchor and / or a longitudinal member. In some embodiments, the toggle anchor may have a tip, a heel, and an anchor axis between the tip and the heel, and defines a lateral eyelet midway between the tip and the heel.

[0749] In some embodiments, the toggle anchor may include a first segment that defines a tip and a second segment slidably coupled to the first segment. In some embodiments, the second segment may define a heel.

[0750] In some embodiments, the longitudinal member may extend through the lateral eyelet and / or may be connected to the toggle anchor such that pulling on the longitudinal member causes the second segment to slide axially relative to the first segment.

[0751] In some embodiments, the longitudinal member is connected to the toggle anchor such that pulling on the longitudinal member causes the heel to slide toward the lateral eyelet.

[0752] In some embodiments, the longitudinal member is connected to the toggle anchor such that pulling on the longitudinal member causes the heel to extend away from the first segment such that the lateral eyelet is disposed substantially midway between the tip and the heel of the toggle anchor.

[0753] In some embodiments, the longitudinal member is attached to the attachment point of the toggle anchor and / or defines a path that includes at least one loop between the lateral eyelet and the attachment point before the longitudinal member is pulled.

[0754] In some embodiments, the longitudinal member is connected to the toggle anchor such 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.

[0755] In some embodiments, the second segment is telescopically coupled to the first segment, and the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the second segment telescopically slides relative to the first segment.

[0756] In some embodiments, the second segment is coupled to the first segment such that the second segment is axially slidable within the first segment.

[0757] In some embodiments, the toggle anchor includes a spring that biases the second segment toward a predetermined axial position relative to the first segment.

[0758] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the axial length of the toggle anchor increases by sliding the second segment relative to the first segment.

[0759] In some embodiments, the longitudinal member is connected to the toggle anchor in such a manner that when the longitudinal member is pulled, the axial length of the toggle anchor decreases by sliding the second segment relative to the first segment.

[0760] According to some embodiments, the system and / or device includes an implant that includes a toggle anchor and / or a cord. In some embodiments, the toggle anchor may have a tip, a heel, and a lateral eyelet midway between the tip and the heel.

[0761] In some embodiments, the cord may be connected to the toggle anchor via the lateral eyelet in such a manner that when tension is applied to the cord, the heel extends away from the lateral eyelet.

[0762] In some embodiments, the cord is connected to the toggle anchor via a lateral eyelet such that when tension is applied to the cord, simultaneously, (i) the heel portion extends away from the lateral eyelet, and (ii) the tip is retracted toward the lateral eyelet.

[0763] In some embodiments, the toggle anchor includes (i) a body defining a lumen and a lateral eyelet, the lateral eyelet opening into the lumen, and / or (ii) a stock at least a portion of which is disposed within the lumen.

[0764] In some embodiments, the cord extends through the lateral eyelet to the stock such that when tension is applied to the cord, simultaneously, the heel portion extends and the tip is retracted by sliding the stock relative to the body.

[0765] In some embodiments, the stock is shaped to define a heel portion and a tip.

[0766] In some embodiments, the cord extends through the lateral eyelet and a transverse channel in the stock and is attached to a side surface of the body opposite the lateral eyelet.

[0767] The above methods and any methods of using the systems, assemblies, instruments, devices, etc. described herein can be performed on a living subject (e.g., a human or other animal) or a simulation (e.g., a cadaver, cadaver heart, virtual person, simulator, etc.). In a simulation, body parts can optionally be referred to as “simulations” (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, computerized representations and / or physical representations.

[0768] Any of the above systems, assemblies, devices, instruments, components, etc. can be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safe use on patients, and the methods herein can include (or additional methods can include or consist of) the sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, instruments, components, etc. described herein.

[0769] The present invention will be more fully understood from the following detailed description taken in conjunction with the drawings.

Brief Description of the Drawings

[0770]

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DETAILED DESCRIPTION OF THE INVENTION

[0792] Refer to FIGS. 1A - B, FIGS. 2A - R, FIGS. 3A - B, FIGS. 4A - C, FIGS. 5A - B, and FIGS. 6A - C, which are schematic diagrams of an exemplary system 100 and exemplary techniques for using the system to treat a target heart 4 according to some implementations. In particular, system 100 is used to reduce (e.g., eliminate) backflow through the atrioventricular valve 7 of the heart due to sub - optimal junction of the valve leaflets. System 100 includes an implant 150 and a delivery tool 400 for delivering and implanting the implant.

[0793] FIG. 1A shows system 100 by an exploded view of delivery tool 400 and an implant 150 separate from the delivery tool. FIG. 1B shows system 100 assembled with implant 150 loaded onto delivery tool 400. Implant 150 includes a patch 210 (e.g., a leaflet reinforcement patch) and may further include at least one patch anchor 240. In the illustrated embodiment, implant 150 includes two patch anchors 240. Patch 210 and patch anchor 240 can be considered components of the upstream assembly 200 of implant 150. Implant 150 further includes a downstream assembly 300 and a tether 160 that tethers the downstream assembly to the upstream assembly 200.

[0794] In some implementations, tether 160 includes a suture. In some implementations, tether 160 includes a flexible and / or super - elastic material, such as ePTFE, nitinol, PTFE, polyester, stainless steel, or cobalt chrome. In some implementations, tether 160 is coated with polytetrafluoroethylene (PTFE).

[0795] While inset A of FIG. 1B uses a perspective view to show frame 230 within patch 210, inset B does not use a perspective view for clarity. Inset B is a view of the opposite side of the device shown in inset A. Inset C of FIG. 1B shows a cross-section of tool 400. For simplicity, in this cross-section, shaft 410 (described below) is shown as solid, although it can be tubular and other components, such as drive shaft sub-assembly 490 (e.g., the drive shaft of the drive shaft sub-assembly), can extend through it.

[0796] Patch 210 may comprise a flexible sheet 220 and may further comprise at least one frame 230 to which the sheet is attached. Sheet 220 can include a polymer such as polyethylene, expanded polytetrafluoroethylene, or polyethylene terephthalate. Sheet 220 can have a fabric or film structure. Frame 230 can provide mechanical properties to patch 210 that would not be obtained with sheet 220 alone. Such properties are described in more detail below. Although this disclosure generally refers to a singular sheet 220, patch 210 can comprise multiple sheets arranged in layers, for example, with frame 230 disposed between the sheets. (This can alternatively be described as sheet 220 comprising multiple layers, i.e., a multi-layer sheet.) In some implementations, the composition and / or structure of sheet 220, the techniques for manufacturing the sheet, and / or the techniques for incorporating frame 230 into patch 210 can be described, with the necessary changes, in U.S. Provisional Patent Application No. 63 / 341,354 to Vaid et al., filed May 12, 2022, and / or International Patent Application No. PCT / US2023 / 021399 to Vaid et al., filed May 8, 2023, each of which is hereby incorporated by reference in its entirety.

[0797] The implant 150 (e.g., its upstream assembly 200) may comprise, for example, as shown, at least one patch anchor 240 coupled to the patch 210. However, in some implementations (e.g., some variations of the implant 150 and / or the system 100), anchoring of the patch may include coupling the patch anchor to the patch (e.g., driving the patch anchor through the patch) in situ.

[0798] The downstream assembly 300 comprises an anchor 310 for anchoring to ventricular tissue (e.g., a ventricular anchor). The downstream assembly 300 may also comprise, for example, a winch 320 coupled to the anchor 310 such that the winch is disposed within or forms part of the head of the anchor. Thus, for implementations where the downstream assembly 300 comprises a winch 320, the anchor 310 can be considered a winch anchor. The winch anchor 310 has tissue engagement elements 312 (e.g., one or more of a screw, helix, dart, pin, hook, staple, barb, arm, sharp portion, etc.) that can be configured to be driven into the tissue. In some implementations, the tissue engagement elements 312 are configured to be driven into the tissue along the anchor axis ax2 of the winch anchor. In the illustrated example, the tissue engagement elements 312 are helical tissue engagement elements configured to be screwed into the tissue along the axis ax2. However, note that the winch anchor 310 can include different types of tissue engagement elements such as, but not limited to, darts, pins, hooks, staples, barbs, arms, etc.

[0799] The winch 320 may comprise, as shown, a spool 322 (see, e.g., FIGS. 3A - 4C) that can be mounted such that the spool and / or its axis of rotation is collinear with the anchor axis ax2. However, other spool orientations are possible.

[0800] The tether 160 is coupled to the patch 210 and extends therefrom to the winch 320, thereby mooring the winch to the patch. As shown, the tether 160 can enter the winch 320 through a side opening 326 in the housing 321 of the winch and / or 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 winch 320, in some implementations, the housing can be considered the housing of the downstream assembly 300.

[0801] The tether 160 is operably coupled to the winch 320 such that when the winch is actuated, the effective length of the tether, i.e., the length of the tether between the winch and the patch 210, can be adjusted.

[0802] The delivery tool 400 has a distally advancing transvascular (e.g., transfemoral) portion 404 that can reach the heart and a proximally external portion 402 that can include a handle and / or a control unit through which an operator (e.g., a physician) can control (e.g., steer, operate, etc.) components of the distally portion of the tool to deliver and implant, for example, the implant 150. The delivery tool 400 includes a shaft 410, a clip 430, and at least one driver 450.

[0803] The delivery tool 400 can include an overtube 406 that defines a primary lumen 407 through which the shaft 410 extends. The overtube 406 can also define one or more auxiliary lumens 408 that communicate with the distally portion 404, for example, for one or more other components of the delivery tool 400 to extend therethrough.

[0804] Shaft 410 defines the longitudinal axis ax1 of delivery tool 400. In some implementations, as shown, shaft 410 (and the lumen 407 through which the shaft extends) is eccentric with respect to overtube 406, and thus, even if the longitudinal axis ax1 is centered with respect to shaft 410, the longitudinal axis may not be centered with respect to the entire delivery tool 400. In the illustrated embodiment, auxiliary lumen 408 is generally disposed on one side of primary lumen 407, and for example, the auxiliary lumen is circumferentially dispersed around less than 220 degrees (e.g., less than 200 degrees such as less than 180 degrees) around the primary lumen. This arrangement can advantageously facilitate efficiently incorporating clip 430 within the overall diameter of delivery tool 400. For example, as shown, clip 430 can be disposed on the same side of shaft 410 when it is disposed distally from the distal end of the auxiliary lumen where the auxiliary lumen is located.

[0805] Shaft 410 (e.g., its distal end) is advanceable into ventricle 8 downstream of valve 7 (as will be described in more detail below). As shown in FIG. 1B, shaft 410 (e.g., its distal end) is coupled to downstream assembly 300 of implant 150. As will be described in more detail below, this coupling serves to (i) anchor winch anchor 310 to the ventricular tissue of the heart by applying an anchor force to the winch anchor, and (ii) configure delivery tool 400 for implementations in which downstream assembly 300 includes winch 320 to operate the winch. That is, delivery tool 400 (e.g., one or more of its components) can remain coupled to downstream assembly 300 throughout the anchoring of winch anchor 310 and the operation of winch 320. Further, as will be described in more detail below, delivery tool 400 can be actuated to operate winch 320 independent of applying an anchor force to winch anchor 310.

[0806] The fastener 430 includes a downstream support 434 and, in some implementations, may also include an upstream support 432. The fastener 430 is movable between (i) an open state and (ii) a gripping state (e.g., a closed state). In the open state, the fastener 430 is configured to receive a portion of the valve tip (e.g., valve tip 10) of the valve 7. For example, in the open state, the upstream support 432 and the downstream support 434 may be positioned apart from each other to receive a portion of the valve tip therebetween. The fastener 430 is configured to grip a portion of the valve tip (e.g., between the upstream support 432 and the downstream support 434) by transitioning from the open state to the gripping state while a portion of the valve tip is disposed within the fastener (e.g., between the upstream support and the downstream support). In the gripping state, the upstream support 432 and the downstream support 434 may be closer to each other than in the open state. In some implementations, in the gripping state, when there is no obstacle (e.g., a portion of the valve tip), the upstream support 432 and the downstream support 434 may contact each other, e.g., by pressing against each other.

[0807] The driver 450 is configured to use the patch anchor 240 to anchor the patch 210 to the valve tip (e.g., a portion of the valve tip gripped between the upstream support 432 and the downstream support 434) by driving the patch anchor, for example, through the valve tip. FIGS. 1A - 5B show (similar to other figures) a configuration where (i) the patch anchor 240 is a toggle anchor having a tip 250 with a sharp tip or edge (e.g., that tapers to a sharp end / edge), and (ii) the driver 450 is configured to drive the patch anchor through the valve tip by pushing the heel portion 252 of the patch anchor distally while the patch anchor is substantially in line with the driver and / or the pressing vector, for example, without the patch anchor being disposed within a needle. However, the scope of the present disclosure includes embodiments where a needle is used (e.g., a variation of the system 100), and for example, the patch anchor 240 may be disposed within a needle that pierces the valve tip and advanced therefrom, and for example, the tip 250 may not have a sharp tip / edge.

[0808] 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 assembly 300 of the implant 150 during delivery and implantation of the implant. In some embodiments, the capsule 470 is sized to be invisible to the tissue engagement element 312 to reduce the likelihood of inadvertently engaging and / or damaging the tissue while the distal portion 404 of the tool 400 advances transvascularly.

[0809] The capsule 470 has an open distal end 471 through which the downstream assembly 300 is deployable. In some embodiments where the winch 320 (e.g., its housing 321) has a side opening 326 through which the tether 160 passes, the capsule 470 may define a side window 474, for example, in an orientation where the side window 474 is aligned with the opening 326, such that the tether can reach the winch as the capsule houses the downstream assembly 300.

[0810] The capsule 470 may be a single element or may comprise a housing 472 and a shroud 476 as shown. The shroud 476 may cover the distal portion of the housing 472 and may even extend distally beyond the housing to form a rim 477. The shroud 476 may be formed from a material that is softer and / or more flexible than the housing 472 to reduce the likelihood of damaging the tissue (e.g., the shroud may comprise a polymer or silicone). In some embodiments where the shroud 476 extends distally beyond the housing to form the rim 477, the rim may function as a non-traumatic tip, which can be particularly advantageous when positioning the capsule 470 relative to the ventricular tissue while driving the tissue engagement element 312 of the anchor 310 into the ventricular tissue.

[0811] In some embodiments, the housing 472 itself may also be configured to contribute to the non-invasiveness of the capsule 470. For example, as shown, the distal portion of the housing 472 may be defined by a plurality of circumferentially distributed (e.g., parallel to each other) fingers 473 that approximate a tubular shape but have a gap therebetween. For such an embodiment, the fingers 473 may be embedded within a shroud 476. By being formed in this way, the distal portion of the housing 472 may be more flexible than if it were substantially tubular (e.g., if there were no gaps between the fingers). Thus, when the distal capsule 470 is pressed against ventricular tissue, the housing 472, and thus the capsule, may flex responsively, for example, rather than damaging the tissue.

[0812] In some embodiments, the capsule 470 defines an elongated lateral opening that extends proximally from the distal opening of the housing, e.g., that is open to the distal opening of the housing. For example, in some embodiments where the capsule 470 comprises a housing 472 and a shroud 476, the housing may define an elongated lateral opening 475 that extends proximally from the distal opening of the housing, e.g., that is open to the distal opening of the housing. In such an embodiment, as shown, the shroud 476 may substantially cover the distal region of the elongated lateral opening 475, such that the window 474 is defined proximally of the elongated lateral opening, i.e., proximally of the shroud. In some such embodiments, the shroud 476 defines a narrow slit 478 that extends between the distal opening of the shroud (which may function as the open distal end 471 of the capsule 470) and the window 474. The slit 478 may be aligned with the elongated lateral opening 475.

[0813] The elongated lateral opening 475, the fingers 473, and / or the slit 478 may be substantially parallel to the axis ax1.

[0814] The narrow slit 478 is configured to facilitate passage of the tether 160 therethrough while deploying the downstream assembly 300 from the capsule 470, but otherwise can reduce the potential for harmful interaction with tissue during advancement of the capsule into the ventricle, such as inadvertent entrapment of the chordae within the elongated lateral opening 475, as compared to a similar capsule having only the elongated lateral opening 475.

[0815] The narrow slit 478 is narrower than the elongated lateral opening 475 and may have a width of less than 1 mm. In some implementations, the narrow slit 478 is configured to be closed at rest, for example, with its sides in contact with each other, and to temporarily separate as the tether 160 passes therebetween while the downstream assembly 300 is deployed from the capsule 470.

[0816] The implant 150 is loaded into the delivery tool 400 by an upstream assembly 200 disposed proximally from the downstream assembly 300. As shown, the upstream assembly 200 can be fixedly attached laterally from the shaft 410. In some implementations, as shown, the upstream assembly 200 is attached to a mount 440 that can be disposed laterally from the shaft 410. In such an implementation, the attachment of this upstream assembly 200 can be such that the patch 210 is disposed toward the surface of the mount 440. In some such implementations, the mount 440 can have a convex outer surface (e.g., the mount can be partially curved substantially in an arc shape around the shaft 410), and the patch 210 can be curved and disposed, for example, as shown, relative to the convex outer surface of the mount. In some implementations, the patch 210 is held against the mount 440 by one or more wraps 442 wrapped around the patch and the mount in this manner. In some such implementations, as shown, the wrap 442 is also wrapped around the shaft 410, thereby holding the patch 210 to the shaft. As will be described in more detail below, the mount 440 is configured to carry the patch 210 toward the clip 430.

[0817] In some embodiments, as shown (e.g., in inset B of FIG. 1B), each wrap 442 comprises (i) a pair of longitudinally extending portions 442L that extend around the patch, and (ii) two curved portions 442B that form a flexible loop (e.g., a closed loop) that loops around the patch 210 itself to connect one end of one of the pair of longitudinally extending portions to the end of the other pair of longitudinally extending portions. For each wrap 442, one of the curved portions is fixed to the bracket 444 and the rod 446 extends through the other of the curved portions, thereby holding the looped wrap around the patch. The bracket 444 can be spring-loaded, thereby holding the wrap 442 taut. In some embodiments, as shown, the orientation in which the wraps 442 and brackets 444 are arranged is alternating, so that the rod 446 is held in place. To release the wrap 442 (e.g., to release the patch 210 from being held by the wrap to the mount 440), the rod 446 is retracted. This is described with reference to FIG. 2I in connection with the implantation of the implant 150. However, it should be noted that other types of wraps may be used.

[0818] As shown, the tether 160 can be attached (e.g., fixedly attached) to the lip region of the patch 210, such as to the lip 211 of the patch, or proximate to the lip 211 of the patch. As will be described in more detail below, the lip 211 is the edge of the patch that, after implantation, is located furthest from the root of the valve tip to which the patch is secured. Further, the lip 211 can also be the edge of the patch that is furthest from the patch anchor 240. The patch 210 can also be considered to have a root region, such as at or proximate to the root edge 212 of the patch. The root edge 212 is on the opposite side of the lip 211 and is the edge of the patch that, after implantation, is located proximate to the root of the valve tip to which the patch is secured, as will be described in more detail below in this specification. The patch anchor 240 can be located in the root region of the patch 210, such as at or proximate to the root edge 212. The patch 210 can also have lateral edges, such as two lateral edges 213' and 213'', on opposite sides of the patch. The lateral edges of the patch 210 can extend between the lip 211 and the root edge 212.

[0819] In some implementations, as shown, the patch 210 is wider (e.g., the distance between the lateral edges 213' and 213'' is greater) toward the lip 211 (e.g., at the lip 211) than toward the root edge 212 (e.g., at the root edge 212). For example, the patch 210 can approximate a trapezoidal shape (e.g., an isosceles trapezoid), with the lip 211 being the longer side of the trapezoid and the root 212 being the shorter side of the trapezoid.

[0820] The implant 150 can be loaded onto the delivery tool 400, for example, with the patch 210 oriented with a lip 211 proximal to the root 212 as shown. In this orientation, in an implementation where the tether 160 is attached to the lip region of the patch 210, the tether can extend beyond the root edge 212 along the patch on its path to the lip region. For example, as shown, a portion 161 of the tether 160 can extend along the patch on a side surface of the patch (e.g., the concave surface of the patch) facing the shaft 410. In an implementation where the delivery tool 400 includes a mount 440, the portion 161 of the tether 160 can be disposed (e.g., sandwiched) between the patch and the mount, as shown, for example, in FIG. 1B.

[0821] In some implementations, alternatively or additionally to examples where the patch 210 is held against the surface of the mount 440 (e.g., by a wrap 442), the patch may be secured to the tool 400 (e.g., the mount) by a patch anchor 240. For example, the mount 440 may be shaped to receive the patch anchor 240 (or may include one or more components configured to engage it). In the example shown, the mount 440 is shaped to define a channel (e.g., a groove) 448 shaped to receive the patch anchor 240 (e.g., one channel per patch anchor). As shown, the channel 448 can be defined on a side surface / convex surface of the mount 440, i.e., the surface on which the patch 210 is typically disposed.

[0822] In some embodiments, channel 448 can be shaped such that patch anchor 240 can slide along the channel, but is obstructed from exiting the channel laterally. For example, each channel 448 can be narrower at the surface of the mount than deeper within the mount. For example, as shown, each channel 448 can have a cross-sectional shape of a generally circular segment, e.g., as shown, with its cord open at the surface of the mount. (It should be understood that non-circular equivalents can also be used with necessary modifications.) Thus, in some embodiments where implant 150 is provided with patch anchor 240 coupled to patch 210, placing patch anchor 240 within channel 448 fixes the patch to mount 440. This relationship will be described below with reference to FIGS. 2I-K.

[0823] In some embodiments where implant 150 is provided with patch anchor 240 coupled to patch 210, this coupling is provided by cord 242, e.g., each patch anchor is coupled to the patch by its respective cord. For example, each patch anchor 240 can define an eyelet 244 through at least one sidewall (e.g., through only one sidewall or through the entire anchor), through which cord 242 is attached to the patch anchor. Eyelet 244 can be generally intermediate along anchor 240 and / or can be a pair of eyelets.

[0824] In some embodiments where patch anchor 240 is disposed within channel 448 and the channel is shaped to inhibit the patch anchor from exiting the channel laterally, each cord 242 extends away from the patch anchor to patch 210 (e.g., substantially orthogonally to the anchor axis of the patch anchor) by exiting the channel laterally, thereby fixing patch 210 to mount 440. This is visible, for example, in FIG. 2I.

[0825] In some embodiments, as shown, the patch anchor 240 may be provided with a recovery mechanism 241 (e.g., a recovery outlet) to which a recovery line can be removably attached. The recovery mechanism 241 may be disposed at the heel portion 252 of the patch anchor or at another location. Examples of such recovery lines and recovery mechanisms are described in more detail below.

[0826] In some embodiments, the delivery tool 400 is configured such that the mount 440 is movable between a storage position and a ready position. FIG. 1B shows the mount 440 in its storage position, which is typically also the position of the mount as the distal portion 404 of the tool 400 advances transvascularly, as shown, for example, in FIG. 2A. In the ready position (FIG. 2J), the mount 440 is closer to the clip 430 than in the storage position and can contact the clip (e.g., its upstream support 432). As described in more detail below, the driver 450 may be configured to drive the patch anchor 240 through the valve tip while the mount is in the ready position, as shown, for example, in FIG. 2K.

[0827] In some embodiments in which a wrap 442 is used, the wrap may hold the patch 210 against the mount 440 while the mount is in its storage position. In some embodiments, the wrap 442 is released, for example, as shown in FIG. 2I, before the mount 440 moves to its ready position.

[0828] In some embodiments, as shown in FIG. 2B, at the storage position of the mount 440, the channel 448 is substantially parallel to the axis ax1. In some embodiments, as shown in FIG. 2J, at the ready position of the mount 440, the channel 448 is oblique to the axis ax1, for example, due to deflection of the mount during its transition to the ready position.

[0829] In some implementations where the patch anchor 240 is disposed within the channel 448, the driver 450 is configured to anchor the patch to the valve tip (described below) by driving the patch anchor out from the distal end of the channel. In some such implementations, the driver 450 enters the channel via the proximal end of the channel. In some implementations, the delivery tool 400 is provided with the distal end of the driver 450 (e.g., the driver head) already disposed within the channel 448. In some implementations, the driver 450 simply abuts the patch anchor 240, while in other implementations, the driver head is configured to engage and / or grip the anchor (e.g., the driver head and / or the anchor comprises a mechanism that facilitates engagement and / or gripping of the anchor by the driver head).

[0830] As described above herein, the delivery tool 400 comprises at least one driver 450. In the illustrated embodiment, the tool 400 comprises one driver 450 per patch anchor 240, e.g., two drivers.

[0831] The extracorporeal proximal portion 402 may comprise one or more control devices. The depiction of these control devices in FIG. 1A is merely schematic, and each of these control devices may be or may comprise a knob, wheel, lever, slider, or other control element or interface via which an operator (e.g., a physician) may operate the tool 400, e.g., to deliver and implant the implant 150 using the techniques described herein.

[0832] In some implementations, the proximal portion 402 comprises a clip control device 110 that is operably coupled to the clip 430 (e.g., to its upstream support 432) such that operation of the clip control device causes the clip to transition between its open state and its gripping state (e.g., closed state). This operable coupling may be provided by a wire 130 coupled to the upstream support 432.

[0833] In the illustrated embodiment, two wires (e.g., parallel to each other) are used, but as shown, the wire can be formed from a single length of wire that loops through the upstream support 432 and returns upon itself. Operating the fastener control device 110 to pull on the wire 130 causes the upstream support 432 to move (e.g., deflect) relative to the downstream support 434, typically relative to the shaft 410, causing the fastener 430 to transition between its open and gripping states. For example, the fastener 430 can be biased (e.g., spring-biased) toward its gripping state, the fastener can be opened by pulling on the wire 130 (e.g., applying tension), and the fastener can be closed by simply releasing the tension on the wire. For example, the biasing (e.g., spring-biasing) of the fastener enables the fastener to respondently transition toward its gripping state.

[0834] In some implementations, the proximal portion 402 includes a driver control device 112 operably coupled to the driver 450 such that operating the driver control device induces the driver to drive the patch anchor 240 through the valve tip to which the upstream assembly 200 is anchored. In the illustrated embodiment, operating the driver control device 112 pushes the driver 450 distally such that each driver pushes the heel portion of its respective patch anchor 240 distally.

[0835] The proximal portion 402 may include a mount control device 116 operably coupled to the mount 440 such that operating the mount control device causes the mount to move between its storage position and its ready position. This operable coupling may be provided by one or more mount control rods 136, the distal ends of which may be fixed to the mount 440. In some implementations, the mount control rods 136 extend through a dedicated auxiliary lumen 408. In some implementations, each mount control rod 136 may be tubular and the auxiliary lumen may be shared with another control component of the tool 400, such as another control component that extends through a tubular mount control rod. For example, as shown, the driver 450 may extend through the mount control rod 136. Alternatively, the mount control rod 136 may be non-hollow and may extend, for example, substantially parallel to the driver 450.

[0836] In some implementations, within the distal portion 404, the shaft 410 has a proximal portion 411 and a distal portion 412 that are axially slidable relative to each other, for example, in a telescoping arrangement as shown. In some such implementations, the proximal portion 402 includes a shaft control device 114 (e.g., a shaft extender) operably coupled to the shaft 410 such that operating the shaft control device causes the distal portion of the shaft to reversibly extend distally from the proximal portion of the shaft. Note that the distal portion 412 may extend proximally at least to the proximal portion 411, but is still referred to as the "distal" portion because it extends further distally than the proximal portion.

[0837] Note that the functions of the various control devices of the proximal portion 402 may be separated into single-function control devices or combined into a multi-function control device.

[0838] The proximal portion 411 may be tubular and may, for example, house the distal portion 412. The distal portion 412 may be tubular and may, for example, house one or more drive shafts that control the downstream assembly 300 as described below.

[0839] In some embodiments, the fastener 430 (e.g., its downstream support 434) is coupled to the shaft 410 such that as the distal portion 412 extends distally from the proximal portion 411, the downstream support 434 moves (e.g., deflects) relative to the shaft. For example, the delivery tool 400 may include one or more frame elements 436 (e.g., arms, extensions, tabs, ribbons, wedges, sheets, etc.) coupled to the shaft 410 and cooperating with the shaft to define a mechanical linkage that moves (e.g., deflects) the downstream support 434 relative to the shaft. In the illustrated embodiment, a single frame element 436 preconfigured to bend or articulate in a particular manner (e.g., by use of a hinge joint) provides this functionality. One end of the frame element is coupled to the proximal portion 411 of the shaft, and the other end of the frame element is coupled to the distal portion 412 of the shaft. Note that a similar effect can be achieved by using multiple frame elements coupled to each other in an articulable (e.g., hinged) manner.

[0840] In some embodiments, as shown, a single piece of stock material defines an upstream support 432, a downstream support 434, and a hinge joint 433 that operably couples the upstream support to the downstream support. For such an embodiment, as further shown, the downstream support 434 is secured to the region 435 of the frame element 436. However, for other embodiments, it should be understood that the downstream support 434 may simply be defined by the region 435, e.g., a single piece of stock material may define the frame element 436 and the downstream support 434. In such other embodiments, the upstream support 432 may be formed from a separate piece of material and operably coupled to the downstream support 434.

[0841] In some embodiments, when the distal portion 412 is axially moved relative to the proximal portion 411 with no tension applied to the wire 130, both the downstream support 434 and the upstream support 432 move (e.g., deflect) relative to the shaft 410. For example, the fastener 430 can be biased into its gripping state and can remain in that state (e.g., the arrangement between the upstream support 432 and the downstream support 434 may not change) as the downstream support moves (e.g., deflects) relative to the shaft 410. FIGS. 1B and 2A show a state in which the distal portion 412 is sufficiently extended such that the upstream support 432 faces distally, e.g., with the fastener 430 in its gripping state, due to the downstream support 434 and the lack of tension on the wire 130.

[0842] In some implementations, as shown, the clip 430 defines one or more slots 437 through which the driver 450 is configured to drive the patch anchor 240 (e.g., one slot per patch anchor). In some implementations, the slot 437 is defined by the downstream support 434 (whether it is part of a single stock material that also defines the upstream support 432 or is defined by part of the frame element 436). That is, the downstream support 434 provides a counterforce while driving the patch anchor 240 through the valve tip, and the patch anchor is positioned to pass through the downstream support at the slot 437, as described in more detail with reference to FIGS. 2K - L, for example. As will be described in more detail herein, as a result, the cord 242 is screwed through the slot 437. Although the cord 242 is allowed to exit the slot 437 laterally, to prevent tissue (e.g., chordae tendineae) from entering and being trapped in the slot, the clip 430 (e.g., its downstream support 434) may define or include at least one slot guard 438, e.g., a respective slot guard for each slot. In some implementations, as shown, the slot guard 438 is elastic and has a rest position where the slot guard blocks (completely covers) the entrance to the slot and is temporarily deflectable away from the slot as the cord exits the slot, thereby facilitating the discharge of the cord from the slot, as described with reference to FIGS. 2L and 6A - C, for example.

[0843] Note that the scope of the present disclosure includes variations of the system 100 where (i) the delivery tool 400 comprises one or more needles, (ii) the tip of the patch anchor 240 may not have a sharp protruding tip, and (iii) the patch anchor is not driven directly through the valve tip, but rather the needle penetrates the valve tip and then the patch anchor is advanced out of the needle.

[0844] Refer to FIGS. 2A - R, which are schematic diagrams showing at least some of the steps in a technique for treating a target heart valve 7 according to some implementations. Although this technique is shown as being used with system 100, in some implementations, a variant of system 100 (e.g., having a variant of implant 150 and / or tool 400), and / or another system may be used instead. In each of FIGS. 2A - D and FIGS. 2F - N, the left - hand frame shows the position and / or interaction of system 100 with the heart, and the right - hand figure emphasizes the state of the system itself.

[0845] With implant 150 loaded onto the distal portion 404 of delivery tool 400, the distal portion is advanced transvaginally into the target heart 4, e.g., the atrium 6 upstream of valve 7. For example, as shown, the distal portion 404 can be advanced transseptally into the left atrium of the heart transvaginally (e.g., via the inferior or superior vena cava) (FIG. 2A).

[0846] The transvaginal advancement of tool 400 can be facilitated by one or more catheters 102, 104, one or more of which can be steerable (i.e., actively steerable, e.g., using a pull - wire or other components known in the art). In some implementations, catheter 102 and / or catheter 104 can be advanced into the atrium, and then tool 400 can be advanced through the catheter. In some implementations, at least catheter 104 is advanced by tool 400 disposed within the catheter (with implant 150 mounted thereon). For some such implementations, capsule 470 (with downstream assembly 300 disposed therein) can be disposed outside the distal end of catheter 104 during such advancement of the catheter and tool.

[0847] In the illustrated embodiment, the tool 400 is advanced transcutaneously while in the delivery state (FIG. 2A). In the delivery state, the patch 210 can be held against the mount 440 and / or the shaft 410 by the wrap 442, for example, to facilitate smooth advancement and / or to protect the patch. In some implementations, as shown, in the delivery state, the clip 430 is in a thin state. In some such implementations, as shown, the clip 430 in the thin state is closed (i.e., in its gripping state), but is deflected distally (i.e., the clip faces distally and both the upstream support 432 and the downstream support 434 are deflected distally), such that, for example, the downstream support 434 is disposed substantially parallel and adjacent to the shaft 410 (e.g., its distal portion 412). As described above herein, this is achieved by extending the distal portion 412 of the shaft 410 from the proximal portion 411 (i.e., by telescopically extending the shaft), thereby straightening the frame element 436. In some implementations, in the thin state, the clip 430 can be overly opened such that the upstream support 432 is aligned substantially collinear with the downstream support 434 (e.g., by extending the distal portion 412 while applying tension to the wire 130).

[0848] The thin state is advantageous for transvascular advancement, but in some cases, due to the relatively large overall length of the distal portion 404 resulting from the extending distal site 412, it may be disadvantageous for operations within the heart. Thus, in some implementations, once the distal portion 404 passes through (e.g., entirely through) the atrial septum 5 and is disposed within the atrium 6 (e.g., disposed throughout the interior), the distal portion 404 is transitioned to a contracted state (FIG. 2B) by, for example, operating the shaft control device 114 to draw the distal site 412 of the shaft 410 into the proximal site 411 (i.e., telescopically contract the shaft). The clip 430 is also typically closed in the contracted state of the distal portion 404 but is biased proximally (i.e., the clip faces proximally). Thus, the widest portion of the distal portion 404 in the contracted state (at the level of the clip 430) is wider than the widest portion in the thin configuration, but if the overall length of the distal portion is shorter, advantageously, the "circle of rotation" is more likely to be smaller when the distal portion is maneuvered within the heart.

[0849] Thereafter, the distal portion 404 (e.g., in its contracted state) is rotated toward the valve 7 (FIG. 2C), and the clip 430 is transitioned to an open state (FIG. 2D) where the upstream support 432 and the downstream support 434 are positioned away from each other and the clip is configured to receive a portion of the valve leaflet between the upstream and downstream supports. Although FIGS. 2C-D show the distal portion 404 being rotated toward the valve 7 before the clip 430 is opened, it should be understood that these steps may be performed in the reverse order or simultaneously.

[0850] In some embodiments, as shown, the transition of the fastener 430 to its open state is performed in a single step by partially extending the distal portion 412 while maintaining tension on the wire 130 (thereby holding the upstream support 432 substantially stationary), which in turn deflects the downstream support 434. However, it is understood that the scope of the present disclosure includes (i) deflecting the entire fastener (e.g., in the downstream direction) so that, with the fastener closed, the fastener (or at least its downstream support 434) is substantially orthogonal to the shaft 410 and thus projects maximally laterally, such as by operating the shaft control device 114, and (ii) then deflecting the upstream support 432 while the downstream support 434 remains stationary (e.g., by applying tension to the wire 130) by operating the fastener control device 110, etc., to transition the fastener to the open state in separate steps.

[0851] The deflection of the fastener 430 during the transition between FIGS. 2C and 2D is shown to be effected by the partial extension of the distal portion 412 such that the capsule 470 is maintained substantially stationary with respect to the anatomical structure and the proximal portion 411 is retracted proximally in a manner that nests the patch 210 proximally / upstream with respect to the anatomical structure. However, it should be understood that this extension can also be achieved in a manner that maintains the patch 210 substantially stationary with respect to the anatomical structure and advances the capsule 470 distally / towards the ventricle.

[0852] While the fastener 430 remains in its open state, the distal portion 404 is advanced distally through the valve 7 into the ventricle 8 (Figs. 2E - F). Passage of the widest portion of the distal portion 404 through the valve 7 (e.g., the frame element 436 and / or the downstream support 434) can be distinguishable, for example, using imaging techniques (e.g., fluoroscopy and / or ultrasound) because it prevents the valve leaflets 10 from moving toward the shaft 410 and / or the opposing valve leaflets during ventricular contraction (Fig. 2E). Further, the subsequent recovery of the movement of the valve leaflets 10 toward the shaft 410 and / or the opposing valve leaflets during ventricular contraction can also be distinguishable using such imaging techniques and can indicate that the downstream support 434 has passed well beyond the valve leaflets to facilitate subsequent capture of the valve leaflets (Fig. 2F).

[0853] Thereafter, the distal portion 404 is manipulated to move the fastener 430 in order to receive a portion of the valve leaflet 10 (Fig. 2G). For example, as shown, the distal portion 404 can be moved proximally until the valve leaflet 10 is stationary on the downstream support 434 and / or resists pulling of the distal portion toward the atrium. While a portion of the valve leaflet 10 remains between the upstream support 432 and the downstream support 434, the fastener 430 is closed (e.g., transitioned toward its gripping state), thereby gripping a portion of the valve leaflet (Fig. 2H). As described above, this can be accomplished by pushing the wire 130 distally and / or by the fact that they can be pulled distally by the upstream support 432.

[0854] In an implementation where the tool 400 includes a wrap 442, the wrap can be released at least at this stage. The insertion view of FIG. 2H shows a wrap 442 that securely holds the patch 210 against a mount 440 (not shown). As described above herein and as shown in FIG. 2H, in some implementations, the wrap 442 can extend around the shaft 410. In such an implementation, the wrap 442 should thus be released to facilitate subsequent steps in which the patch 210 carried by the mount 440 is moved away from the shaft 410. FIG. 2I shows the wrap 442 released by the retraction of the rod 446 and the patch 210 from which the wrap has been removed in response around the shaft 410. The bracket 444 is shown as having changed shape in response to the release of the tension of the wrap 442.

[0855] In some implementations, such removal of the wrap from the patch 210 can be passive, for example, in response to the movement of blood, for example, after its release. In some implementations, for example, in some implementations where the patch 210 includes a frame 230, the frame can include a spring or otherwise be biased to open the patch.

[0856] While a portion of the valve tip 10 remains gripped by the clip 430, the mount 440 is advanced (FIG. 2J) towards the clip 430, for example, its upstream support 432. This new position of the mount 440 can be considered the "ready" position, while the previous position of the mount can be considered the "stowed" position. As shown, advancing the mount 440 to its ready position can be accomplished by operating the mount control device 116 to advance the mount control rod 136 so as to push the mount onto and along the wire 130 (FIG. 2J).

[0857] As described above in this specification, note that in an implementation where the patch 210 is coupled to the mount via the anchor 240, even though the wrap is removed from around the shaft 410 and / or the mount 440, the patch can remain coupled to the mount at this stage, as shown, for example, in the insertion view of FIG. 2I. Thus, when the mount 440 is advanced toward the clip 430, the mount carries the patch 210 toward the clip (FIG. 2J).

[0858] Note that the movement of the mount 440, and thus the patch 210, toward the clip 430 can include movement distally and / or downstream. Also note that this movement can also include lateral movement, i.e., movement away from the shaft 410 and toward the opening end of the clip 430. In some implementations where the wire 130 is used to operate the clip 430, as shown in FIG. 2H, the wire can be pulled laterally by the articulation of the upstream support 432 during closure of the clip. Thus, additionally, for such some implementations where the mount 440 slides along the wire 130, the wire functions as a rail that guides the mount not only distally but also obliquely (e.g., distally outwardly) toward the clip.

[0859] The steps shown in FIGS. 2K-L are also shown in FIGS. 6A-C from a different perspective. However, for clarity, the valve tip 10 is not shown in FIGS. 6A-C.

[0860] (i) While a portion of the valve tip 10 remains gripped by the clip 430 and (ii) while the mount 440 is positioned in the clip (i.e., its ready position), the driver 450 drives the patch anchor 240 into the valve tip (e.g., through the gripped portion of the valve tip) by operating the driver control device 112 or the like, thereby using it to anchor the patch 210 to the valve tip (FIGS. 2K and 6A). For example, as shown, the patch anchor 240 can be driven out from the end of the channel 448, through the valve tip 10 and the slot 437. The lateral portion of the movement of the mount 440 and the patch 210 before anchoring advantageously positions the patch anchor 240 (and typically the patch) away from the lip of the valve tip 10, i.e., towards the root of the valve tip, which can advantageously enhance the reliability of the positioning and / or the anchoring of the patch.

[0861] Thereafter, the clip 430 is opened again and the distal portion 404 is moved away from the patch 210 and the valve tip 10 to which it is anchored (FIGS. 2L and 6B - C). Note that this can be facilitated by (i) the patch 210 being automatically released from the mount 440 when the patch anchor 240 exits the mount (FIG. 6A) and (ii) when the cord 242 disposed through the slot 437 exits the slot laterally and optionally slips through the slot when the clip 430 is moved away, being facilitated by a temporary deflection (away from each other) of the slot guard 438 (FIG. 6B). Once removed from the cord 242, the slot guard 438 can then return to its original rest state, e.g., deflecting towards each other (FIG. 6C).

[0862] In some embodiments, as shown, for each slot guard 438, the free end of the slot guard can be pushed under another portion of the downstream support 434 such that the slot 437 is actually fully closed. This can, for example, by pushing the slot guard in that direction, significantly prevent inadvertent introduction of tissue (e.g., chordae tendineae) into the slot 437 since the slot does not open. This pushed-in configuration is particularly visible in FIGS. 6A-C and the inset of FIG. 1A.

[0863] The patch 210 can be anchored to the valve leaflet 10 in such a manner that the patch (e.g., its lip 211) projects from the lip of the valve leaflet and extends, for example, further into the ventricle 8 than the valve leaflet. Thus, the patch 210 can function as an extension of the valve leaflet 10 and advantageously facilitates joining with the opposing valve leaflet after implantation.

[0864] In some embodiments, after the patch 210 is anchor-fixed to the valve tip 10, the downstream assembly 300 is anchor-fixed to the tissue of the ventricle 8. In some embodiments, the shaft 410 is extended (FIG. 2M) to reach the ventricular tissue, for example, by operating the shaft control device 114. As shown, this allows the clip 430 to return to its thin state. In some embodiments, the tether 160 is released (e.g., untethered) from the winch 320 substantially simultaneously to accommodate the expanded distance between the upstream assembly 200 (e.g., its patch 210) and the downstream assembly 300 (e.g., its winch). For example, it may be advantageous to avoid releasing a large amount of the tether 160 with respect to the distance of the downstream assembly 300 from the upstream assembly 200 in order to maintain control of the behavior of the tether in the blood flow, such as to reduce the likelihood of the tether becoming entangled or captured by the tool 400. In some embodiments, the adjustment between the advancement of the downstream assembly 300 and the spool release 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 to Pesach et al., filed Apr. 29, 2022, and / or International Patent PCT / IB2023 / 054169 to Pesach et al., filed Apr. 24, 2023, each of which is hereby incorporated by reference in its entirety.

[0865] FIG. 3A is a schematic view showing (i) some components of the drive shaft sub-assembly 490 at the distal end of the distal portion 404 of the delivery tool 400, and (ii) an exploded view of the downstream assembly 300. FIG. 3B is an inverted version of FIG. 3A showing an inverted view of each component. FIGS. 4A-C show the components shown in FIGS. 3A-B, but assembled (e.g., in the manner shown in FIG. 1B) and in cross-section.

[0866] Once a location within the ventricle is selected, the downstream assembly 300 is anchored to the location, for example, by driving tissue engagement element 312 into the tissue and by anchoring winch anchor 310 to the tissue (FIG. 2N). This can be accomplished by operating anchor control device 118 at proximal portion 402. Anchor control device 118 is operably coupled to winch anchor 310 such that when the anchor control device is operated, an anchoring force is applied to the winch anchor (FIG. 4A). For example, delivery tool 400 may include an anchor control drive shaft 480 that operably couples anchor control device 118 to winch anchor 310. In some implementations, as shown, the anchoring force is torque (or includes torque) applied through engagement between anchor control drive shaft 480 and winch anchor 310. Winch anchor 310 may include a driver interface 316 defined by or fixedly coupled to winch anchor head 314, which is a component of the winch anchor. Drive shaft 480 engages driver interface 316 and applies torque to the driver interface through this engagement. For example, as shown, drive shaft 480 may include a drive head 483 having one or more (e.g., two) protrusions 484 that engage and are retained with driver interface 316 by locking rod 486 at the distal end of the drive shaft, or may define the same. That is, locking rod 486 locks the engagement between drive head 483 and driver interface 316.

[0867] In some embodiments, as shown by the transition from FIG. 2M to FIG. 2N, the capsule 470 (e.g., the rim 477 of the capsule shroud 476) is positioned (e.g., pressed) against the ventricular tissue before the winch anchor 310 is advanced out of the capsule, such that, at any time, the tissue engagement element 312 is not exposed from the capsule, thereby advantageously reducing the likelihood of snagging and / or damaging the tissue. Although the winch anchor 310 is shown to be anchored near the apex, it should be noted that it can be anchored at different locations, such as another part of the ventricular septum or ventricular wall.

[0868] By driving the winch anchor 310 into the tissue, the entire downstream assembly 300 advances distally through the capsule 470 toward the tissue surface. In an implementation where the capsule 470 (e.g., its housing 472) defines an elongated lateral opening 475 (described with reference to FIGS. 1A - B), as the downstream assembly moves distally through the capsule, the opening 326 typically protrudes from the housing 472 into the lateral opening 475 and moves axially along the lateral opening while being restricted in the rotational direction by the lateral opening. That is, the lateral opening 475 functions as a linear track along which the winch 320 (e.g., its housing 321) can slide as the winch anchor 310 is driven into the tissue. With such a configuration, the capsule 470 can continuously apply a reference force to the winch housing 321 throughout the entire anchor fixation of the anchor 310, and as a result, the winch housing does not rotate with the anchor. (Such rotation of the housing could otherwise damage the tether 160 by wrapping it around the tool 400, e.g., its shaft 410.) In an implementation where the capsule 470 includes a shroud 476, as the downstream assembly moves distally through the capsule, the tether 160 enters from the window 474 into the slit 478 and extends out from the more downstream portion of the slit 478 into the opening 326. Depending on the extent to which the opening 326 protrudes from the housing 472, the opening can temporarily separate the shroud 476 at the slit 478 as it moves along the lateral opening 475 and the slit. FIG. 2N shows the fully anchor - fixed anchor 310, with the opening 326 separating the shroud 476 at a portion of the slit 478 near the open distal end of the capsule and the tether 160 extending therefrom.

[0869] Once the winch anchor 310 is anchored, the effective length of the tether 160 (i.e., the length of the tether between the winch 320 and the patch 210) can be adjusted to achieve an optimal hemodynamics, e.g., a minimum backflow between the leaflets of the valve 7. The patch 210 itself is a leaflet reinforcement patch that can improve the junction between the leaflets by providing an extended and / or surrogate junction surface, but the tether 160, particularly when it is of an optimal length, can further improve the junction during the cardiac cycle, e.g., by directing and / or restricting the movement of the patch and the leaflets to which it is anchored. This length adjustment can be achieved by operating the winch control device 119 at the proximal portion 402.

[0870] In some implementations, prior to length adjustment, most of the tool 400 is withdrawn out of the ventricle 8, e.g., out of the heart and / or completely out of the subject's body (FIG. 2O). Such withdrawal mainly consists of withdrawing the shaft 410 to which the mount 440, the fastener 430, and the capsule 470 remain attached. Thereby, the drive shaft sub-assembly 490 of the tool 400 that extends through the valve 7 to the downstream assembly 300 remains, and the drive shaft sub-assembly remains coupled to the downstream assembly. Advantageously, since the drive shaft sub-assembly 490 is typically slimmer and / or more flexible than the shaft 410 or the entire tool 400, accurate hemodynamic monitoring can be facilitated during adjustment of the effective length of the tether 160 (described below), thereby reducing the likelihood of creating significant hemodynamic artifacts due to (i) pushing on the downstream assembly 300 and ventricular tissue to which it is anchored, (ii) interfering with the movement and junction of the leaflets, and / or (iii) directly interfering with or causing turbulence in the blood flow. In this state, the leaflets of the valve 7 can join around the drive shaft sub-assembly 490, e.g., as shown in FIG. 2O.

[0871] Notwithstanding, to further facilitate accurate hemodynamic monitoring during adjustment of the effective length of tether 160, drive shaft subassembly 490 can be moved laterally toward the anastomosis (e.g., swivel on downstream assembly 300) to further reduce any interference it may have on the behavior of the valve tip (FIG. 2P).

[0872] Despite the advantages described above of pulling out shaft 410 prior to adjustment of the effective length of tether 160, in some implementations, the length adjustment is performed while shaft 410 and capsule 470 remain in place.

[0873] Drive shaft subassembly 490 includes at least one drive shaft and can further include, for example, a reference force tube 492 as described below.

[0874] When the winch control device 119 is operated, it is operably coupled to the winch 320 such that the winch is activated (FIG. 4A). For example, the delivery tool 400 (e.g., its drive shaft sub-assembly 490) may include a winch control drive shaft 482 that operably couples the winch control device 119 to the winch 320. In some implementations, as shown, activation of the winch 320 is achieved, for example, by applying torque to the winch via an engagement between the winch control drive shaft 482 and the winch 320. The winch 320 may include a drive shaft interface 324 that is a component of the winch defined by the winch spool 322 or fixedly coupled to the winch spool 322. The drive shaft 482 engages the drive shaft interface 324 and applies torque to the drive shaft interface via this engagement. For example, as shown, the drive shaft 482 may include or define a drive head 485 having one or more (e.g., two) protrusions 488 that extend into a recess defined by the interface 324 at the distal end of the drive shaft, and for example, torque may be applied to the spool 322 via these protrusions. This engagement may be indirectly maintained, for example, by locking with a locking rod 486 between the drive head 483 and the driver interface 316 due to a preload between the drive shafts 480 and 482. For example, throughout the steps of the implantation procedure, the drive shaft 480 may be held under limited tension while the drive shaft 482 may be held under limited axial compression, regardless of the advancement of the tool 400 through the vasculature.

[0875] The reference force tube 492 is also engaged with the downstream assembly 300. As shown, this engagement can be directed at the housing 321. For example, the reference force tube 492 (e.g., its distal end) and the housing 321 can each include or define complementary couplings (e.g., mating surfaces) 494 and 331. Thus, the downstream assembly 300 (e.g., its housing 321) can be considered to include or define one or more couplings (e.g., mating surfaces) 331 and a reference force tube interface 332 that engages the reference force tube at the interface of the reference force tube. The engagement between the reference force tube 492 and the reference force tube interface 332 rotationally locks the reference force tube to the reference force tube interface and enables the reference force tube to provide a reference force during rotation of the winch 320. In particular, this rotational locking and reference force facilitates rotation of the spool 322 without rotating the housing 321 (or rotation about the axis ax2 of the opening 326), which can be advantageous due to the presence of the tether 160 extending between the downstream assembly 300 and the upstream assembly 200. For example, if the housing 321 rotates during rotation of the spool 322, the tether 160 may be wrapped around the drive shaft sub-assembly 490.

[0876] In some implementations, the engagement between the reference force tube 492 and the housing 321 can be indirectly maintained, for example, by the engagement of a locking rod 486 between the drive head 483 and the driver interface 316, due to a preload between the drive shaft 480 and the reference force tube 492. For example, the drive shaft 480 can be held under a limited tension while the reference force tube 492 can be held under a limited axial compression, throughout the advancement of the tool 400 through the vasculature and the steps of the implantation procedure.

[0877] FIG. 2Q shows the tether 160 after its length has been adjusted. This is represented by the sag in the tether 160 in FIG. 2P and the tautness in FIG. 2Q, but this is schematic and is not intended to be limiting with respect to the adjustment of the length of the tether.

[0878] Once the optimal effective length of the tether 160 is achieved, the drive shaft sub-assembly 490 is disengaged from the downstream assembly 300, thereby disengaging the entire assembly from the implant 150 (FIG. 2R, as well as FIGS. 4B - C). For example, as shown, the locking rod 486 can be pulled out at least sufficiently so that the drive shaft 480 can disengage from the interface 316 due to deflection of the drive shaft 480 inwardly of the protrusion 484 (FIG. 4B). The entire drive shaft 480 and drive shaft sub-assembly 490 can be pulled out from the downstream assembly 300 once disengaged (FIG. 4C). When the drive shaft sub-assembly 490 is pulled out from the downstream assembly 300, more specifically, when the winch control drive shaft 482 (e.g., its protrusion 488) is pulled out from the winch 320 of the downstream assembly, one or more spring-loaded detents 328 can move in response to engage the housing 321 in a manner such that the spool 322 does not rotate relative to the housing (i.e., locks the winch 320), as a result of which the tension on the tether 160 cannot be unwound, thereby fixing the effective length of the tether. In some implementations, the winch 320 includes a number of detents 328 equal to the number of protrusions 488, with each of the protrusions holding each of the detents in engagement with the housing 321 until the protrusion is pulled out.

[0879] In some implementations, as shown, this movement of the detent 328 is an inward movement. In some implementations, the housing 321 defines a series of protrusions 330 (and / or recesses in which the detents can be disposed) between which the detents 328 can be disposed when the drive shaft 482 is pulled out.

[0880] In some implementations, the housing 321 includes at least two dependent components that are fixed to each other during manufacture, such as a first dependent component (e.g., an annular or circumferential dependent component) 321a and a second dependent component (e.g., a lid dependent component) 321b. For some such implementations, as shown, the protrusion 330 is defined by the second dependent component 321b. For some such implementations, the reference force tube interface 332 is defined by the second dependent component 321b.

[0881] In some implementations, within the downstream assembly 300, the tissue engagement element 312, the head 314, and the driver interface 316 are fixed relative to each other in the rotational direction and are collectively rotatably coupled to the housing 321 and the spool 322.

[0882] In some implementations, within the downstream assembly 300, the detent 328 (e.g., a frame that defines the detent) is rotationally fixed relative to the spool 322, for example, (i) via one or more flanges 329 defined by a frame that defines a detent disposed within one or more recesses 323 defined by the spool 322 and / or (ii) by the detent 328 disposed within a slot 325 defined by the spool, even while being unlocked by the presence of the drive shaft 482.

[0883] In some implementations, within the downstream assembly 300, the spool 322 is rotatably coupled to the housing 321, except when a detent 328 that is rotationally fixed relative to the spool is locked to the housing.

[0884] The slot 325 can also provide space for the detent 328 to deflect between an unlocked state and a locked state.

[0885] In some embodiments, as shown, the downstream assembly 300 may include a hub 317 or shaft to which a spool 322 and a detent 328 (e.g., a frame defining the detent) are attached, providing at least a portion of the rotatable coupling described hereinabove.

[0886] In some embodiments, the housing 321 is rotatably (e.g., freely rotatably) attached to the anchor 310. Advantageously, this allows the housing to naturally find a rotational orientation in which the side opening 326 is optimally positioned, e.g., in response to movement and tension of the tether 160.

[0887] Figures 5A - B are schematic views of an upstream assembly 200 according to some embodiments. As described hereinabove, the patch 210 may include a flexible sheet 220 and at least one frame 230 supporting the sheet. As further described hereinabove, the upstream assembly 200 may include at least one patch anchor 240 coupled to the patch 210.

[0888] The frame 230 supports the sheet 220, thereby giving shape to the patch 210. However, the frame 230 may be flexible such that the patch 210 can respond to in - heart conditions, e.g., the shape of one or both valve leaflets, to facilitate optimal attachment. In some embodiments, the frame 230 (and thus the patch 210) is configured to be more flexible on one axis than on another. For example, the frame 230 may provide greater flexibility along the outer - medial axis ax4 of the patch, which traverses the axis from the root to the lip of the patch, than along the axis ax3 from the root to the lip of the patch 210 (e.g., in a state where the lip 211 moves relative to the root 212). This higher outer - medial rigidity may facilitate the opening of the patch 210 when released from the wrap 442 and / or advantageously may prevent the patch from collapsing after implantation.

[0889] Frame 230 may include a root brace 232 that, for example, may include a beam extending along root 212 from one lateral edge 213 to the other. Frame 230 may also define a lip brace 231 that, for example, may include a beam extending substantially along lip 211 from one lateral edge 213 to the other. Lip brace 231 and root brace 232 may provide some medial-lateral stiffness to patch 210, such as described in the previous paragraph.

[0890] Frame 230 may include a spring 234 that can extend between lip brace 231 and root brace 232. In the illustrated embodiment, spring 234 extends substantially along the centerline from the root to the lip of patch 210 (e.g., along axis ax3 if axis ax3 is the axis from the central root to the lip).

[0891] Spring 234 can provide the flexibility from the root to the lip as described hereinabove. However, spring 234 can also provide a patch anchor clamping function, such as described below.

[0892] FIG. 5A shows, for example, a front view and an isometric view of patch 210 in its stationary state before being loaded onto delivery tool 400. In some mounting configurations other than the curvature of patch 210 around mount 440 and shaft 410 during loading onto delivery tool 400, FIG. 5A can also represent the state of the patch during the initial stages of delivery.

[0893] In some implementations, the upstream assembly 200 may have a patch anchor tightening function. That is, the upstream assembly itself (e.g., the patch 210 such as the frame 230) may be configured to tighten the patch anchor 240, such as by pulling the patch anchor 240 (e.g., automatically) toward the patch. For example, the upstream assembly 200 may bias the patch anchor 240 toward the patch 210, although the patch anchor may be temporarily displaced away from the patch during anchor fixation. In some implementations, as shown, this biasing is via the upstream assembly 200 that applies tension to the cord 242. In some such implementations, this is achieved as follows.

[0894] As described above herein, the cord 242 couples the patch anchor 240 to the patch 210. For example, as shown, each patch anchor may be coupled to the patch by its respective cord. However, rather than each cord 242 being fixed to the patch 210 (e.g., its frame 230) at the point 214 where the coat reaches the patch, the cord passes through the patch at point 214 and extends along the patch (e.g., in a direction from the root to the lip, such as substantially parallel to the axis ax3) to the lip brace 231 where the cord is fixed. Thus, the cord 242 is slidably coupled to the patch 210 at point 214, which may be at or near the position of the root 212, and is fixedly attached to the patch at the lip brace 231, which may be at or near the position of the lip 211.

[0895] In some implementations, 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 valve tips to be smooth and cord-free. For such implementations, the cord 242 may be slidable within the sheet 220.

[0896] In FIG. 5A, cord 242 is shown relatively slack. When patch anchor 240 is driven by driver 450 (as described herein with reference to FIGS. 2J - K, for example) to the far (e.g., downstream) side of valve tip 10, the patch anchor is temporarily moved (e.g., pushed) away from patch 210, which remains on the near (e.g., upstream) side of the valve tip. This applies tension to cord 242, and thus lip brace 231 is pulled toward root brace 232, placing spring 234 under stress (FIG. 5B). This is represented in FIGS. 5A - B as a linear compression of spring 234 and patch 210, temporarily reducing the length L1 (FIG. 5A) from the root to the lip of the patch to a contracted length L2 (FIG. 5B), i.e., linearly contracting the patch. In some implementations, placing spring 234 under stress causes the spring to slide across the sheet. When patch anchor 240 is released from driver 450, spring 234 returns to its original (e.g., rest) state, pulling the patch anchor back toward patch 210, thereby fixing the patch to the valve tip by sandwiching the valve tip between the patch anchor and the patch, as shown by the transition from FIGS. 2K and 5B to FIGS. 2L and 5A, for example. By providing such a self - fastening patch anchor (e.g., by including a patch with a spring biased to tightly pull the patch anchor) in the upstream assembly, advantageously, the need to perform individual fastening or locking steps and / or include individual locking components can be eliminated.

[0897] Note 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, winches, screws, etc.) that can linearly contract the patch, or cannot contract the patch, or can contract the patch anyway, or cannot contract the patch at all. Some non-limiting examples of other patch anchor fastening mechanisms are described in the international patent application PCT / IB2021 / 060436 of Tennenbaum et al. filed on November 11, 2021, titled "Valve leaflet treatment systems and methods", and published as WO2022 / 101817 (see, for example, FIGS. 36A-K), which is incorporated herein by reference.

[0898] In some implementations, 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 implementations, as shown, the spring 234 can be coupled to the root brace 232 via the patch anchor support 236. The patch anchor support 236 advantageously (1) functions to reinforce the patch at the point 214, for example, to protect the cord 242 as it passes through the sheet 220, (2) functions as a bearing surface for the cord 242 to slide thereon as it passes through the point 214, and / or (3) provides, for example, an opposing (e.g., counteracting force) against which the patch anchor 240 can push the valve tip compared to a similar patch where the patch anchor presses against a portion of the patch where the sheet 220 is not supported by the frame 230, thereby improving the clamping of the valve tip between the patch anchor and the patch 210.

[0899] As described above in this specification, a tether that moors an upstream assembly to a downstream assembly can be attached to the lip region of a patch. In some implementations where the patch comprises a frame that defines a lip brace, the tether can be attached to the lip brace. As shown in FIGS. 5A - B, for patch 210, tether 160 is attached at an intermediate point of lip 211 to lip brace 231 (e.g., an eyelet defined by the lip brace). Although both tether 160 and cord 242 are attached to lip brace 231, note that they act at least partially independently. For example, spring 234 applies tension to cord 242 regardless of whether tether 160 pulls on the lip brace. Further, lip brace 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. Nevertheless, the finite length of cord 242 can limit the extent to which such force is received by patch 210 itself (e.g., sheet 220), e.g., preventing the patch from being stretched detrimentally. That is, once cord 242 tightly pulls its patch anchor against the valve tip and firmly clamps the valve tip against contact surface 221 of patch 210, the cord inhibits further separation of lip brace 231 from root brace 232.

[0900] Referring now to FIGS. 7A - C, which are schematic views of a gripping indicator 431 according to some implementations. The indicator 431 can be a component of the clip 430 or can be coupled to the clip. The indicator 431 can be radiopaque and / or acoustic and is configured to change its position and / or orientation (e.g., with respect to the upstream support 432 and / or the downstream support 434) in response to successful gripping of the valve tip 10 by the clip 430. This configuration can be due to the shape and / or size of the indicator 431 and / or the nature of its coupling to the upstream support 432 and / or the downstream support 434. The change in the position and / or orientation of the indicator 431 is detectable (e.g., visually) using imaging (e.g., fluoroscopy or ultrasound) and enables verification of the successful gripping of the valve tip 10 before an operator (e.g., a physician) drives the patch anchor 240.

[0901] In the illustrated embodiment, the indicator 431 includes a radiopaque material and is flexibly coupled to the upstream support 432. In a stationary state, the indicator 431 projects minimally or not at all from the clip 430 (FIG. 7A). When the clip 430 is opened, the indicator 431 can remain stationary relative to the upstream support 432, e.g., remain in its stationary state (FIG. 7B). However, when the clip 430 is closed again to grip the valve tip 10, the presence of the valve tip between the upstream support 432 and the downstream support 434 causes the indicator 431 to be pushed (e.g., deflected), e.g., to project through the opening of the upstream support and project from the clip 430, such as by protruding. This protrusion is detectable (e.g., visually) using imaging (e.g., fluoroscopy) and indicates that the gripping of the valve tip 10 has been successful prior to driving the patch anchor 240. To achieve this effect, in the stationary state, a portion of the indicator 431 can project from the upstream support 432 toward the downstream support 434 (e.g., project into the gap between these supports), such that when the valve tip 10 is clamped, the valve tip displaces a portion of the indicator, thereby displacing the entire indicator. The portion of the indicator 431 that projects into the gap between the supports can be disposed deeper (e.g., closer to the articulation point between the supports) than the slot 437 (e.g., the point through which the patch anchor passes) by the clip 430, thereby ensuring that the display is provided only when the valve tip 10 is clamped sufficiently deeply within the clip 430 such that the patch anchor is driven through the valve tip tissue far enough from the lip of the valve tip.

[0902] Refer to FIGS. 8A - B and FIGS. 9A - B, which are schematic diagrams of operable variants of the delivery tool 400 according to some implementations. Referring to these figures, throughout this application, when a subscript of a letter (e.g., a, b, etc.) is added to a reference number, the element with the subscripted reference number is a variant of another element described in this specification that has the same name and has the same reference number without a subscript or with a different subscript. In any case, the variant can be as described for other elements (e.g., can have a similar structure and / or function) except as described. For example, the delivery tools 400a and 400b, described with reference to FIGS. 8A - B and FIGS. 9A - B respectively, are variants of the delivery tool 400 and can be as described for the delivery tool 400 except as described. Further, in any case, the variant can be replaced with other elements or other variants of the elements described in this specification with the necessary changes made.

[0903] As described above in this specification, the transvascular advancement of the tool 400 with the implant 150 mounted thereon through the vasculature can be facilitated by one or more catheters 102, 104, one or more of which can be operable (i.e., actively steerable, e.g., using a pull - wire or other components known in the art). To facilitate this, the tool 400 is primarily flexible along its length such that it can, for example, passively follow the path of the catheter and / or be passively bent by the catheter. An exception to this is a portion of the shaft 410 of the distal portion 404, which can be a telescopically arranged proximal site 411 and distal site 412. However, in some implementations, these can also be flexible. Further, as shown in FIGS. 8A - B and FIGS. 9A - B, in some implementations, at the distal portion of the delivery tool, the shaft itself can have an actively steerable steerable portion independent of the catheters 102 and 104, e.g., via the operation of the extracorporeal proximal portion 402 (e.g., the operation of its control device).

[0904] Figures 8A - B show a delivery tool 400a, which is operable, for example, using one or more pull wires 413 disposed within the wall of the shaft of the delivery tool. In the illustrated embodiment, four pull wires 413 are disposed within the wall of shaft 410a and extend, for example, through the distal portion 412a of the shaft. However, fewer (e.g., one, two, or three) or more pull wires can be used. The pull wires 413 operably couple the extracorporeal proximal portion 402 (e.g., its control device) to the operable portion of the shaft 410a such that the extracorporeal proximal portion can be used to bend the shaft (e.g., its portion 412a) in a manner similar to bending a catheter that is operable using pull wires. FIG. 8A shows the distal portion of tool 400a advanced into the ventricle 8 but not actively manipulated. In this state (e.g., a resting state), the operable portion of the shaft can be substantially straight. However, in some implementations, the operable portion of the shaft (e.g., the distal portion 412a of shaft 410a) can be biased to assume a curved shape, for example, in its resting state.

[0905] FIG. 8B shows the distal portion of tool 400a being actively bent by applying tension to at least one of the pull wires 413. In the illustrated embodiment, it is the distal portion 412a of shaft 410a that bends in response to applying tension to the pull wires and is configured to be flexible enough to bend, for example. The resulting deflection of the distal portion of tool 400a advantageously can allow the operator greater control over the positioning of the downstream assembly 300 and / or greater choice regarding the site at which the downstream assembly 300 is anchored.

[0906] Figures 9A - B show the steerable delivery tool 400b via the extension and contraction of its shaft 410b. As described hereinabove for the delivery tool 400, the frame element 436 may extend from the proximal portion 411b of the shaft 410b to the distal portion 412b of the shaft, thereby enabling deflection of at least a portion of the clip 430 via extension and contraction (e.g., telescoping). In the delivery tool 400b, sufficient extension of the distal portion 412b of the shaft 410b from the proximal portion 411b of the shaft causes the shaft (e.g., its distal portion 412b) to bend, thereby causing the capsule 470 and the downstream assembly 300 to deflect within it. As shown, this can be facilitated by configuring the frame element 436 (e.g., its length between its attachment points and the proximal portion 411b and the distal portion 412b), such that beyond a threshold extension length of the distal portion 412b from the proximal portion 411b, further extension of the distal portion from the proximal portion causes the frame element to pull on the distal portion of the shaft, e.g., by applying tension to the frame element, and deflect to the side on which the frame element is disposed.

[0907] Figure 9A shows the distal portion of the tool 400b advanced into the ventricle 8 but not actively steered. In this state (e.g., the rest state), the distal portion of the tool may be substantially straight. However, in some implementations, the distal portion of the tool (e.g., the distal portion 412b of the shaft 410b) may be biased to assume a curved shape, e.g., in its rest state.

[0908] Figure 9B shows the distal portion of the tool 400b actively bent via extension of the distal portion 412b from the proximal portion 411b. In the illustrated embodiment, this is accomplished by retracting the proximal portion 411b proximally, e.g., towards the atrium 6. However, it should be understood that this can be similarly accomplished by advancing the distal portion 412b distally (e.g., deeper into the ventricle 8), or a combination of moving the proximal portion 411b proximally and the distal portion 412b distally.

[0909] In the illustrated embodiment, it is the distal portion 412b of the shaft 410b that is configured to bend responsively, e.g., to be sufficiently flexible to bend. Due to the resulting deflection of the distal portion of the tool 400b, advantageously, the operator may have greater control over the positioning of the downstream assembly 300 and / or greater choice regarding the site where the downstream assembly 300 is anchored.

[0910] In some implementations, the delivery tool 400b differs from the tool 400 only in that, at its distal portion, the shaft 410b (e.g., its distal portion 412b) is sufficiently flexible to bend as described and / or the shaft 400b and the frame element 436 are appropriately dimensioned for this behavior.

[0911] Note that for both the tool 400a and the tool 400b, a portion of the shaft that is actively bendable can be disposed distally from the mount 440 (e.g., distally from the axial position where the patch 210 is attached) and proximally from the capsule 470. In some implementations, as shown, the portion of the shaft that is actively bendable is disposed distally from the clip 430.

[0912] Refer to FIGS. 10A - B, which are schematic views of a patch anchor 240a according to some implementations. The patch anchor 240a can be considered a variant of the patch anchor 240 and can be used in place of the patch anchor 240 with the necessary modifications in any of the implants or systems described herein.

[0913] Similar to the patch anchor 240, the patch anchor 240a is provided with a toggle, i.e., it is a toggle anchor. However, the patch anchor 240a is also biased to automatically expand when deployed. FIG. 10A shows the patch anchor 240a constrained within the channel 448a, and FIG. 10B shows the patch anchor that has been deployed out of the channel (e.g., by the driver 450a) and automatically expanded in response to not being constrained by the channel. Thus, the patch anchor 240a can be formed (e.g., cut out) from an elastic, superelastic, and / or shape memory material such as nitinol or cobalt chrome.

[0914] In some implementations, as shown, the patch anchor 240a has a cellular structure (e.g., similar to the structure of a stent) and expands by short circuiting. In some such implementations, the cellular structure defines, for example, just two expansion cells, as shown. The patch anchor 240a can define an eyelet 244a through the toggle, through which the cord 242 is attached to the patch anchor. The eyelet 244a can be disposed, for example, between the two cells, as shown.

[0915] In some implementations, the channel 448a can be a channel defined by a mount such as the mount 440. For some such implementations, the tip 250a of the patch anchor 240a has, for example, a sharp tip (e.g., is sharpened to the end), as shown.

[0916] In some implementations, the channel 448 can be defined by a needle configured to pierce the valve tip 10 itself. For some such implementations, the patch anchor 240a has a blunt tip.

[0917] By expanding the patch anchor 240a, force can be distributed over a larger surface area of the valve tip and thus over more collagen fibers of the valve tip. This can increase the anchor fixation force / reliability compared to a narrower and / or non-expanded patch anchor. Further, since the resulting length of the patch anchor 240a is shorter, in some implementations where the expansion occurs via foreshortening, its end is less likely to harmfully impinge on the valve tip to which the valve tip is anchor-fixed. Even in some implementations where the expansion does not occur via foreshortening, the increased width allows the patch anchor 240a to be manufactured shorter than a similar non-expanded toggle anchor, thereby similarly reducing impingement on the valve tip.

[0918] In some implementations, the patch anchor 240a includes a retrieval mechanism 241a through which a retrieval line 502 is connected to the patch anchor. In some implementations, as shown, the retrieval mechanism 241a is located (e.g., at that location) toward the proximal end of the patch anchor (e.g., of a toggle), referred to herein as the "heel portion" of the patch anchor, at the opposing end of the tip of the patch anchor. In the illustrated embodiment, the retrieval mechanism 241a is or includes a post around which the retrieval line 502 is looped.

[0919] During anchor fixation of the patch anchor 240a (e.g., during implantation of the patch to which it belongs), the retrieval line 502 extends proximally from the retrieval mechanism 241a. During the implantation process, if it is determined that the patch anchor is to be retrieved, pulling on the retrieval line 502 facilitates retrieval of the patch anchor (e.g., release of the anchor fixation). Since the retrieval mechanism 241a is disposed at the heel portion of the patch anchor, pulling on the retrieval line 502 causes the patch anchor to be (i) reoriented axially (e.g., such that the valve tip aligns with the vector along which the patch anchor is advanced, such as through the hole in the valve tip through which the valve tip has passed) and (ii) pulled proximally. The system 100 (e.g., its delivery tool 400) can be modified to accommodate the retrieval line 502 and facilitate its use.

[0920] Refer to FIGS. 11A - B, which are schematic views of a patch anchor 240b according to some embodiments. The patch anchor 240b is a toggle anchor and may have the mechanisms of other patch anchors described herein. For example, the patch anchor 240b may define at least one eyelet 244b through which a cord 242 is attached to the patch anchor. Similarly, the patch anchor 240b may have a sharp tip. The patch anchor 240b has a recovery mechanism 241b through which a recovery line 502 is connected to the patch anchor. The recovery mechanism 241b includes a recovery eyelet 246 and a notch 247, both of which are cut by the circumferential wall of the toggle and which may be substantially tubular. The notch 247 is disposed in the heel portion of the patch anchor 240b and is defined by removing one or more portions of the circumferential wall of the toggle. The recovery eyelet 246 is disposed near the notch 247 and may be disposed on the same side as the notch. In the illustrated embodiment, the recovery eyelet 246 is disposed in the same circumferential position as the notch, immediately distal from the notch 247.

[0921] The recovery line 502 extends axially at the heel portion of the patch anchor, collinearly into the lumen of the toggle (which may be substantially tubular), exits the side wall of the toggle through the recovery eyelet 246, loops back through the notch 247, and connects to itself at a reference number 504 that may represent a knot, thereby connecting to the patch anchor 240b.

[0922] In some embodiments where 504 represents a knot, due to the arrangement shown in FIGS. 11A - B, as a result, the knot 504 is located within the width of the patch anchor 240b and is, for example, pushed into the patch anchor. This advantageously may reduce the possibility that the knot interferes with the retrieval through the valve tip 10 of the toggle anchor.

[0923] With the arrangement shown in FIGS. 11A - B, as a result, the recovery line 502 exits from the patch anchor 240b that is collinear with the patch anchor. That is, at the heel portion of the patch anchor, the recovery line 502 is aligned with the major axis of the patch anchor. Further, the recovery line 502 extends from exactly the heel portion itself of the patch anchor 240b, that is, the exit point of the recovery line from the patch anchor is part of the patch anchor that is farthest from the tip of the anchor. Thus, when the recovery line 502 is pulled, the recovery line naturally aligns the patch anchor 240b with the extraction vector, thereby facilitating the retrieval of the patch anchor through the orifice of the valve tip that the patch anchor was previously introduced into (and through which the recovery line extends), for example, without the heel portion of the patch anchor getting caught on the edge of the orifice of the valve tip.

[0924] Refer to FIG. 12, which is a schematic view of at least a portion of implant 150a according to one implementation form. Similar to 150, implant 150a includes an upstream assembly 200a that includes a patch 210a that may include a frame 230a. Also similar to implant 150, implant 150a includes a tether 160a that moors the upstream assembly 200a to a downstream assembly (not shown). The downstream assembly of implant 150a can be as described for the other downstream assemblies herein with necessary modifications. For implant 150a, a single sheet 220a is shaped (e.g., cut out and / or folded) to function as both the sheet of the patch 210a (similar to sheet 220) and the tether 160a. That is, sheet 220a is shaped into a patch portion (e.g., a patch-forming portion) and a tether portion (e.g., a tether-forming portion). In the illustrated embodiment, the patch portion is trapezoidal and the tether portion is ribbon-shaped. In the illustrated embodiment, the patch portion has tabs that are folded to cover portions of the frame. In the illustrated embodiment, the tether portion is cut out to be about three times the width of tether 160a, and the side portions of the tether portion are folded over the middle portion of the tether portion to form the tether (e.g., on both sides of the middle portion, thereby forming an S-shaped cross-section), such that the tether is about three times the thickness of sheet 220a. However, other formations of the tether portion are possible, including simply cutting the tether portion into a tether shape.

[0925] Refer to FIG. 13, which is a schematic diagram of at least a portion of the implant 150b according to some embodiments. Similar to 150, the implant 150b may include an upstream assembly 200b that includes a patch 210b that may include a flexible sheet 220b and may include a frame (not shown). Also similar to the implant 150, the implant 150b includes a tether 160b that secures the upstream assembly 200b to a downstream assembly (not shown). The downstream assembly of the implant 150b may be as described for the other downstream assemblies herein with necessary modifications. The implant 150 is shown with a tether 160 attached at a single inner location on the lip 211. In the implant 150b, the tether 160b is attached, for example, at two lateral locations on the lip 211b of the patch 210b via two lateral lines 162 that branch laterally away from each other and away from the upstream end of the tether 160b. In some embodiments, as shown, these lateral attachments may be in addition to an inner attachment via an inner line 164. This arrangement may alternatively be viewed as a tether 160b that branches into two or three branches that are attached to the lip 211b. In some embodiments, the lines 162 and 164 are fixed to the tether 160b and to each other, for example, at a node 166.

[0926] FIG. 13 shows implant 150b in the absence of an anatomical structure, where anchor 240 is attached to valve leaflet 10 and the tension in tether 160b oscillates between low (left image) and high (right image) such that it can occur during the cardiac cycle, with the left frame representing the implant during ventricular dilation and the right frame representing the implant during ventricular contraction. As the tension in tether 160b increases (from the left image to the right image), the lateral attachment curves (e.g., bends) the lip 211b, and in some implementations, most or all of patch 210b, inwardly (e.g., around axis ax3 from the root to the tip) and biases it to be convex on the upstream surface of the patch. Thus, the surface of patch 210b presented to the opposing valve leaflet is convex, and the lateral edges of the patch are held away from the opposing valve leaflet. This can advantageously strengthen the junction and / or reduce friction of the lateral edges of the patch against the opposing valve leaflet. In some implementations where patch 210b is elastic (e.g., including an elastic frame such as those described herein), the curvature (e.g., bending) of the patch can also function as a force attenuator or shock absorber, and advantageously softens the shock received by the patch (and the point anchored to valve leaflet 10) when reaching the end of tether 160b during each ventricular contraction.

[0927] In some implementations that also include an inner attachment (e.g., inner line 164), the inner attachment can function to limit the extent to which patch 210b curves in response to tension in tether 160b. In the example shown, the length of inner line 164 is such that there is some slack remaining even when there is no slack remaining in lateral line 162 (central image). This allows the tension in outer line 162 to curve the patch when the slack in inner line 164 is taken up. However, if there is no slack remaining in inner line 164, no additional curvature of the patch will occur even if additional tension is applied to tether 160b. Limiting the extent to which patch 210b curves in this way can advantageously prevent the patch from curving to such an extent that its lateral edges are held away from joining the opposing valve leaflet.

[0928] Referring now to FIGS. 14 and 15A - B, which are schematic diagrams of an implant 150c and the technology for using the same, according to some implementations. FIGS. 15A - B show an implant 150c that is implanted using a tool 400, although it should be understood that the implant 150c can optionally be implanted using another delivery tool, such as a variant of the delivery tool 400 described herein, but not limited thereto.

[0929] As described above herein (e.g., referring to FIGS. 5A - B), there is a patch anchor tightening function for the upstream assembly 200 of the implant 150. In contrast, the implant 150c includes an upstream assembly 200c in which the patch anchor is tightened, but not by the upstream assembly (or implant) itself. In the illustrated example, the patch anchor of the upstream assembly 200c is the patch anchor 240 described above herein. However, other patch anchors, including but not limited to other toggle anchors, can be used with the necessary modifications. For example, the patch anchor tightening function of the upstream assembly 200 can be provided by an upstream assembly (e.g., its spring) that biases the patch anchor towards the patch (e.g., by pulling a cord to which the patch anchor is connected via it), while the upstream assembly 200c does not bias the anchor towards the patch 210c (e.g., does not include such a spring). Instead, anchor tightening is achieved by pulling via the delivery tool.

[0930] FIG. 15a shows an anchor 240 driven through a valve tip 10 and a fastener 430 opened to release the valve tip. Thus, FIG. 15a can be considered similar to FIG. 2L. However, in contrast to FIG. 2L, in FIG. 15a, the anchor 240 remains unclamped, i.e., the anchor is not pulled towards the patch 210c and / or does not clamp the valve tip 10 against the patch. As shown, the patch 210c is typically slack in this regard because it does not include, for example, a spring to expand the patch in the open state.

[0931] FIG. 15b shows the entire distal portion 404 of the tool, at least the capsule 470 of the tool 400, and optionally moving away from the patch 210c (e.g., from the upstream assembly 200c) by being advanced, for example, downstream and / or further into the ventricle 8. Thus, FIG. 15b can be considered similar to FIG. 2M. However, in contrast to FIG. 2M, when the capsule 470 (which has the downstream assembly 300 therein) moves away from the patch 210c, the tether 160 is allowed to tighten (e.g., the tether is not released) such that the tether pulls on the patch 210c. The connection of the patch 210c and its connection to the tether 160 is such that this pulling causes the cord 242c to be pulled in a manner that tightens the patch anchor 240, for example, by pulling the patch anchor towards the patch. In the illustrated embodiment, this is achieved by the tether 160 being connected to the lip brace 231c of the patch 210c (similar to that described for the implant 150, for example), and the cord 242c also being connected to the lip brace (similar to that described for the implant 150, for example). Pulling on the tether 160 to pull on the cord 242c causes the cord to be pulled through the site 214c where the cord passes within and / or through the patch. The patch 210c includes a one-way mechanism 216 (such as a ratchet, a binding band-like mechanism, etc.) at (e.g., each site 214c), thereby allowing the cord 242c to pass only in the direction of tightening the patch anchor 240, for example, in the direction of pulling the patch anchor towards the patch. Thus, once the patch anchor 240 is tightened, it remains tightened even if the tether 160 is not under tension and even if the portion of the cord 242c on the opposite side of the mechanism 216 from the patch anchor 240 (e.g., the portion of the cord within and / or along the patch 210c) is not under tension. The patch 210c may include a patch anchor support 236 (described above herein), and for such an implementation, each mechanism 216 may be attached to the patch anchor support.

[0932] The tightening of the patch anchor 240 of the upstream assembly 200c, for example, being held in a diffused state (e.g., the patch does not include a spring), does not require the patch 210c to maintain force on the cord 242c. Thus, the characteristics of the patch can be adjustable by the valve tip enhancement function of the patch without, for example, requiring a trade-off to maintain force on the cord.

[0933] In some implementations, as shown, the patch 210c can exclude the frame component between the root brace 232c and the lip brace 231c. Further, in some implementations, the patch 210 may not include the frame component between the root brace 232c and the lip of the patch. For example, the patch may not include the root brace. This lack of the frame component may advantageously increase the flexibility of the patch.

[0934] Refer to FIGS. 16, 17, 18A - B, and FIGS. 19A - D, which are schematic views of an implant, which is a variant of the implant 150, in which one or more ventricular anchors according to some implementations are connected to the upstream assembly via a plurality of (e.g., two) extensions of the tether.

[0935] FIG. 16 shows an implant 150d in which the tether 160d extends not only from the downstream assembly 300d (e.g., its winch 320) of the implant to the upstream assembly 200d (e.g., its patch 210d) of the implant but also back to the downstream assembly (e.g., its housing 321d or its anchor 310) to which the tether (e.g., the end of the tether) is fixed. This arrangement advantageously provides additional strength to the tether due to the connection between the upstream and downstream assemblies being made via two extensions of the tether.

[0936] The tether 160d can be slidably connected to the upstream assembly 200d (e.g., the patch 210d) such that, for example, the tether (e.g., the curved portion of the tether) is screwed through the eyelet 219 of the upstream assembly. In the illustrated embodiment, 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 being defined by the frame of the patch 210d. In some implementations where the tether 160d is slidably connected to the upstream assembly 200d, the arrangement of the tether 160d (which can be considered a pulley arrangement) provides a mechanical advantage for shortening the tether by the winch 320 of the tether. Thus, the required torque applied to the winch 320 to shorten the tether 160d can be advantageously reduced (e.g., by approximately half) compared to a similar implant without such a pulley arrangement, such as the implant 150. Further, for each rotation of the winch 320, the reduction in the effective length of the tether 160d is small (e.g., about half) compared to a similar implant without such a pulley arrangement. Thereby, advantageously, a higher level of control (e.g., finer granularity) can be provided to the operator than with the shortened tether 160d.

[0937] Figure 17 shows the implant 150e after its implantation. Similar to the other downstream assemblies described herein, the downstream assembly 300e of the implant 150e includes a ventricular anchor 310. However, the implant 150e further includes an auxiliary ventricular anchor 310e, which may or may not be considered a component of the downstream assembly 300e. Similar to the tether of the implant 150d, the tether 160e of the implant 150e can be slidably connected to the upstream assembly 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. Thus, the implant 150e has the advantages described for the implant 150d, but the supplementary ventricular anchor 310e can further provide additional ventricular anchor strength. Since the operator can select the anchor fixat...

Claims

1. A system for use with a valve disposed between an atrium and a ventricle of a target heart, comprising: an implant, comprising: a patch having a flexible sheet; a patch anchor; a downstream assembly having a ventricular anchor; a tether for mooring the downstream assembly to the patch; and a delivery tool having a distal portion that is translatable transvascularly to the heart while the implant is mounted on the delivery tool, the delivery tool comprising: a shaft defining a longitudinal axis of the delivery tool; a clip having an upstream support and a downstream support, the clip being configured to: be in an open state in which the upstream support and the downstream support are positioned apart from each other and the clip is configured to receive a portion of a valve leaflet between the upstream support and the downstream support; be in a gripping state in which, while the portion of the valve leaflet remains disposed between the upstream support and the downstream support, the clip is configured to grip the portion of the valve leaflet received between the upstream support and the downstream support by transitioning from the open state to the gripping state; and a driver configured to anchor the patch to the portion of the valve leaflet using the patch anchor while the portion of the valve leaflet is gripped by the clip.

2. The system of claim 1, wherein the delivery tool has a proximal extracorporeal portion having a clip control device operably coupled to the clip, such that operation of the clip control device causes the clip to transition between the open state and the gripping state.

3. The system of claim 2, wherein the clip control device is operably coupled to the upstream support of the clip such that operation of the clip control device causes the clip to transition between the open state and the gripping state via movement of the upstream support relative to the shaft.

4. The delivery tool of claim 2 further comprises a pair of clip control wires through which the clip control device is operably coupled to the clip, and the extracorporeal portion is such that the clip control device is operably coupled to both wires of the pair. The system of claim 3, comprising a lever adapted to pivot the pair of wires in a balanced manner relative to each other. **Claim 5** The extracorporeal proximal portion further comprises an anchor control device, The delivery tool further comprises a drive shaft sub-assembly comprising one or more drive shafts extending through the shaft, the drive shaft sub-assembly being configured such that in at least one state of the delivery tool, the drive shaft sub-assembly operably couples the anchor control device to the ventricular anchor, such that upon operation of the anchor control device, an anchor fixing force is applied to the ventricular anchor, the system of claim 2. **Claim 6** The downstream assembly further comprises a winch, the ventricular anchor being a winch anchor coupled to the winch, The tether moors the winch to the patch, The extracorporeal proximal portion further comprises a winch control device, the drive shaft sub-assembly being configured such that in at least one state of the delivery tool, the drive shaft sub-assembly operably couples the winch control device to the winch, such that upon operation of the winch control device, the winch is actuated, the system of claim 5. **Claim 7** The drive shaft sub-assembly comprises A winch control drive shaft through which the winch control device is operably coupled to the winch, and An anchor control drive shaft disposed through the winch control drive shaft and through which the anchor control device is operably coupled to the anchor, the system of claim 6. **Claim 8** The anchor control drive shaft operably couples the anchor control device to the anchor via engagement of the anchor by a distal end portion of the anchor control drive shaft, The delivery tool further comprises 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, The drive shaft sub-assembly further includes a locking rod at the distal end portion of the anchor control drive shaft for maintaining the engagement of the anchor by the distal end portion of the anchor control drive shaft. As a result, the release spring is triggered by the storage of the locking rod from the distal end portion of the anchor control drive shaft, pulling the anchor control drive shaft proximally away from the anchor. The system according to claim 7.

9. The downstream assembly further includes a winch, and the ventricular anchor is a winch anchor coupled to the winch. The drive shaft sub-assembly includes a downstream assembly control drive shaft. The system has an anchor fixation state in which the anchor control device is operably coupled to the winch anchor via the downstream assembly control drive shaft such that when the anchor control device is operated, an anchor fixation force is applied to the winch anchor. The system has the downstream assembly control drive shaft. When the anchor control device is operated, the winch anchor is operably decoupled such that the anchor fixation force is not applied to the winch anchor. The system according to claim 5 has a winching state in which the winch is operably coupled to the winch such that when the downstream assembly control drive shaft rotates, the winch operates.

10. The downstream assembly includes a shaft axially movable within the downstream assembly. As a result, When the shaft is positioned at a first axial position within the downstream assembly, the system is set in the anchor fixation state. The system according to claim 9, wherein when the shaft is positioned at a second axial position within the downstream assembly, the system is set in the winching state.

11. The winch includes a spool disposed therein, and the spool is operably coupled to the tether such that when the spool rotates, tension is applied to the tether. The shaft defines a protruding rim around it. The downstream assembly includes a spring-loaded detent biased to protrude into a recess defined by the surface of the spool, thereby maintaining the spool in a locked state where it cannot rotate. When the shaft is shifted to the second shaft position, the winch is automatically unlocked as the rim pushes the detent out of the recess, whereby the spool becomes rotatable. The system according to claim 10.

12. The ventricular anchor is a first ventricular anchor, The downstream assembly further comprises a second ventricular anchor, The system according to any one of claims 1 to 11, wherein the tether moors the patch to both the first ventricular anchor and the second ventricular anchor.

13. The system according to any one of claims 1 to 12, wherein the patch comprises a first portion of the sheet, and a second portion of the sheet is shaped to extend away from the patch in a manner that defines the tether.

14. The clasp is a gripping indicator, and when the gripping indicator grips the portion of the valve tip between the upstream support and the downstream support, the portion of the valve tip moves the gripping indicator relative to the upstream support in a manner detectable by fluoroscopy and is flexibly coupled to the upstream support. The system according to any one of claims 1 to 13, comprising a gripping indicator.

15. The delivery tool is configured such that an operable portion of the shaft distal to the clasp is operable via an operation of an extracorporeal proximal portion of the delivery tool. The system according to any one of claims 1 to 14.

16. The system according to any one of claims 1 to 15, wherein the tether extends from the downstream assembly to the patch and back to the downstream assembly.

17. The system according to any one of claims 1 to 16, wherein the patch has a lip region, and the tether is attached to the patch via two lateral lines that branch away from each other away from the tether and are attached to opposing lateral sites within the lip region.

18. The downstream assembly further comprises a winch, the ventricular anchor is a winch anchor coupled to the winch, The system according to any one of claims 1 to 17, wherein the tether moors the winch to the patch.

19. The winch includes a housing and a spool disposed therein, and the spool is operably coupled to the tether such that when the winch is actuated, tension is applied to the tether. The tether extends from the spool and out of an opening of the housing, and the opening has a rim. The system of claim 18, further comprising a spring coupled to the housing in a manner that biases the tether away from contact with the rim.

20. The delivery tool further includes a drive shaft sub-assembly that extends through the shaft and operably couples the drive shaft sub-assembly to the downstream assembly in a manner that: anchors the winch anchor to the ventricular tissue of the heart by applying an anchor fixing force to the winch anchor; and operably couples one or more drive shafts to the downstream assembly in a manner that operates the winch independent of applying the anchor fixing force.

21. The delivery tool is configured to operate the winch by applying torque to the winch via the drive shaft sub-assembly. The system of claim 20, wherein the downstream assembly includes a slip clutch that operably couples the drive shaft sub-assembly to the winch in a manner that limits the magnitude of torque that the delivery tool can apply to the winch.

22. The system according to any one of claims 1 to 21, wherein the driver is configured to anchor the patch to a portion of the valve tip by driving the patch anchor through the portion of the valve tip gripped by the fastener.

23. The system of claim 22, wherein the patch anchor is a toggle that is biased to automatically expand upon deployment.

24. The system according to any one of claims 1 to 23, wherein the delivery tool is configured to anchor the downstream assembly to the ventricular tissue of the ventricle by anchoring the ventricular anchor to the ventricular tissue.

25. The ventricular anchor comprises a tissue engagement element, and the delivery tool is configured to anchor the downstream assembly to the ventricular tissue by driving the tissue engagement element into the ventricular tissue, the system of claim 24. **Claim 26** The implant is attached to or attachable to the delivery tool such that the ventricular anchor is disposed at the distal end of the shaft, the system of claim 25. **Claim 27** The delivery tool comprises a capsule coupled to the distal end of the shaft, and the distal portion of the delivery tool is tubulally advanceable into the heart while the downstream assembly is housed within the capsule, the system of claim 26. **Claim 28** The capsule comprises a shroud formed from an elastic polymer, the system of claim 27. **Claim 29** The capsule is flexible and further comprises a housing having a plurality of circumferentially distributed fingers approximating a tubular shape and embedded within the shroud, the system of claim 28. **Claim 30** The implant comprises an upstream assembly comprising the patch anchor coupled to the patch, the system of any one of claims 1 to 29. **Claim 31** The upstream assembly further comprises a cord through which the patch anchor is coupled to the patch, the system of claim 30. **Claim 32** The patch anchor is a toggle anchor, the system of claim 31. **Claim 33** The toggle anchor is a helical coil defining a lumen therethrough, the system of claim 32. **Claim 34** The toggle anchor has a tip, a heel portion, and an eyelet midway between the tip and the heel portion, wherein the heel portion, facilitates passage of the heel portion in a first direction through the valve tip, and is flared in a manner that inhibits passage of the heel portion in a second direction opposite the first direction through the valve tip, the system of claim 32. **Claim 35** The toggle anchor has a tip, a heel portion, and a lateral eyelet midway between the tip and the heel portion, The system according to claim 32, wherein when tension is applied to the cord, the heel portion is connected to the toggle anchor via the side eyelet in a manner that the heel portion extends away from the side eyelet.

36. The system according to claim 35, further comprising a recovery line, wherein when tension is applied to the recovery line, the heel portion is retracted toward the side eyelet in a manner that the recovery line passes through the toggle anchor.

37. The toggle anchor has a tip, a heel portion, and a side eyelet midway between the tip and the heel portion. A first segment of the toggle anchor defines the tip. A second segment of the toggle anchor is slidably coupled to the first segment. The system according to claim 32, further comprising a longitudinal member that extends through the side eyelet and is connected to the toggle anchor such that when the longitudinal member is pulled, the second segment slides axially relative to the first segment.

38. The driver is configured to push the toggle anchor, first the tip, through the portion of the valve tip. The driver has a drive head and a rod extending proximally from the drive head. The drive head is configured to (i) preferentially allow deflection rather than lateral translation of the toggle anchor relative to the driver, and (ii) be connected to the heel portion via complementary geometric shapes such that when the toggle anchor reaches a predetermined angle relative to the driver, the heel portion is separable from the driver.

39. The upstream assembly includes a one-way mechanism through which the cord extends. The one-way mechanism is mounted to the patch, configured to facilitate passage of the patch anchor through the one-way mechanism of the cord in a first direction toward the patch, and configured to inhibit passage of the cord through the one-way mechanism in a second direction opposite to the first direction.

40. The system according to any one of claims 1 to 39, wherein the fastener defines a slot, and the driver is configured to anchor the patch to the valve tip by driving the patch anchor through the valve tip and the slot.

41. The system according to claim 40, wherein the fastener defines elastic teeth configured to facilitate driving of the patch anchor through the slot by the driver and to inhibit withdrawal of the patch anchor through the slot in the reverse direction.

42. The system according to claim 40, wherein the fastener defines an elastic slot guard configured to prevent tissue of the heart from entering the slot.

43. The system according to any one of claims 1 to 42, further comprising a mount, wherein the delivery tool is configured to support the patch mounted thereon and to carry the patch toward the fastener while the fastener is in the gripping state.

44. The system according to claim 43, wherein the mount is configured to carry the patch toward the upstream support of the fastener by moving distally toward the fastener with the patch mounted thereon while the fastener is in the gripping state.

45. The system according to claim 44, wherein the mount is configured to carry the patch toward the upstream support of the fastener by moving distally and laterally toward the fastener with the patch mounted thereon while the fastener is in the gripping state.

46. The system according to claim 45, wherein the delivery tool includes a beam providing a mechanical linkage between the shaft and the mount, and the mechanical linkage links distal movement of the mount and lateral movement of the mount.

47. The mount has a storage position, and a distal portion of the delivery tool is transvascularly advanceable into the heart while the mount is in the storage position with the patch mounted on the mount. The mount has a ready position where the mount is disposed closer to the fastener than when in the storage position. The driver is configured to anchor the patch to the valve tip by driving the patch anchor through the valve tip while the patch is mounted on the mount and the mount is in the ready position, according to the system of claim 43.

48. The mount defines a channel therein, The distal portion of the delivery tool is capable of advancing transvascularly to the heart while the patch is mounted on the mount and the patch anchor is disposed within the channel and the mount is in the storage position, The driver is configured to anchor the patch to the portion of the valve tip by driving the patch anchor out of the channel and through the portion of the valve tip, according to the system of claim 47.

49. The delivery tool further comprises one or more wraps, and the distal portion of the delivery tool is capable of advancing transvascularly to the heart while the patch is held against the mount by the one or more wraps that are wrapped around the patch and the mount and the mount is in the storage position, according to the system of claim 47.

50. The one or more wraps are one or more kirigami wraps, according to the system of claim 49.

51. The delivery tool further comprises a retrieval line removably coupled to the anchor such that applying tension to the retrieval line releases the patch anchor from the valve tip, according to the system of any one of claims 1 to 50.

52. The patch anchor comprises a tubular toggle and includes a retrieval mechanism having a notch and a retrieval eyelet in the heel portion of the toggle, The retrieval line extends into the lumen of the toggle at the heel portion of the toggle collinearly with the toggle, exits the sidewall of the toggle through the retrieval eyelet, and loops back on itself through the notch for connection to itself, according to the system of claim 51.

53. A system for use in a target tissue, a toggle anchor having a tip and a heel portion and defining an anchor shaft therebetween, a delivery tool, defining a channel in which the toggle anchor is disposed, The toggle anchor is provided with a driver configured to first push the tip distally out of the channel and then away therefrom, the driver having a drive head and a rod extending proximally from the drive head, the drive head being configured to (i) preferentially enable deflection rather than lateral translation of the toggle anchor relative to the driver, and (ii) be connected to the heel portion via complementary geometric shapes in such a manner that when the anchor reaches a predetermined angle relative to the driver, the heel portion is separable from the driver, a delivery tool.

54. The drive head has a first distally facing surface and defines a shoulder portion that defines a second distally facing surface proximal to the first surface. At the heel portion, the toggle anchor defines a laterally opening through which the shoulder portion projects, such that the driver is configured to push the toggle anchor distally (i) with the second distally facing surface pushing the toggle anchor distally at the laterally opening and (ii) with the first distally facing surface pushing the toggle anchor distally substantially opposite the laterally opening, thereby pushing the toggle anchor through the tissue with the tip first. The toggle anchor is separable from the drive head by deflecting about a point on the driver proximal to the second distally facing surface such that the laterally opening moves laterally away from the shoulder portion, the system of claim 53.

55. The driver is a stabilizer further comprising a stabilizer configured such that by pushing the tip of the toggle anchor against the tissue by the driver, the stabilizer moves to a stabilized position relative to the toggle anchor via axial sliding of the stabilizer relative to the toggle anchor, the stabilizer suppressing deflection of the toggle anchor relative to the driver in the stabilized position, the system of claim 54.

56. A system An implant comprising a toggle anchor having a body, a tip, and a heel portion, the toggle anchor defining an anchor axis between the tip and the heel portion, an implant A delivery tool configured to advance the implant transvaginally to the target tissue while the implant is coupled to the distal portion of the tool, a delivery tool comprising a driver having a drive head and a rod extending proximally from the drive head, the driver configured to first push the toggle anchor through the tissue with its tip, the system comprising an extensible member configured to slide axially in response relative to the body when the driver pushes the tip of the toggle anchor against the tissue. **Claim 57** A method of connecting a tether to a component of an implant, forming a bend in the tether by looping an end portion of the tether around a portion of the component, and closing the bend into a loop by coaxially burying the end portion through an extension of the tether, such that the extension compresses the end portion therein. **Claim 58** wherein the bend is a first bend, wherein the loop is a first loop, wherein coaxially burying the end portion through the extension includes coaxially burying a first portion of the end portion through the extension, the method further comprising forming a second bend in the end portion, and closing the second bend into a second loop by coaxially burying a second portion of the end portion through the extension, such that the first portion and the second portion extend along each other within the extension. The method of claim 57.

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