Anchor storage device with helical channel

Abstract

A system (100) includes a series of anchors (140), an anchor storage device (110), and an anchor drive (130) slidably coupled to the anchor storage device. The anchor storage device includes a spring (124) and a housing (120) shaped to define: (i) a loading site (129) and (ii) a helical channel (122) helical inwardly to the loading site, the series of anchors being arranged along the helical channel, and the spring is configured to urge the series of anchors along the helical channel towards the loading site. The anchor driver includes a rod (134) that can extend through the loading site in a manner that blocks the series of anchors from the spiral channel into the loading site. Other embodiments are also described.

Description

[0001] Cross-reference to related applications This application claims priority to: Provisional U.S. Patent Application No. 63 / 433,906, filed December 20, 2022, to Sussman, entitled “Anchor-storage devices”; and Provisional U.S. patent application No. 63 / 497,435, filed April 20, 2023, entitled “ANCHOR STORAGE DEVICE,” to Sussman.

[0002] Each of the above references is incorporated herein by reference. Background Art

[0003] Tissue anchors can be placed in the body to anchor an implant to a subject's tissue. Such tissue anchors can be small enough to be advanced via catheter. Due to their small size, they can benefit from systems or devices that reduce the manual dexterity required to handle the anchors. Furthermore, maintaining the sterility of the anchors can be advantageous. Therefore, it would be advantageous to provide devices and techniques to facilitate the storage and handling of such tissue anchors. Summary of the Invention

[0004] In some embodiments, methods and systems are disclosed for containing and utilizing tissue anchors during transluminal surgery, wherein the anchor is implanted within a body cavity of a subject (e.g., within the heart). The body cavity and / or subject can be a living subject or a mimic.

[0005] In some embodiments, a series of tissue anchors can be anchored to tissue (e.g., tissue of the heart, heart valves, muscle, etc.), for example, to anchor an implant to the tissue. In some embodiments, for each anchor in the series, an anchor driver of a delivery assembly (e.g., a driver head at the distal end of the anchor driver) can sequentially engage the anchor, advance the anchor through the delivery assembly (e.g., through its catheter), and anchor the anchor to the tissue.

[0006] In some embodiments, for each anchor in the series, once the anchor is anchored to the tissue, the driver head is disengaged from the anchor and the anchor driver is withdrawn (leaving the anchor implanted in the tissue) to allow the anchor driver to engage the next anchor in the series.

[0007] In some embodiments, the systems, devices, apparatus, etc. herein include an anchor storage device that facilitates such an iterative anchoring process, but advantageously, without requiring removal of the drive head from the delivery assembly.

[0008] According to some embodiments, a system and / or apparatus includes a series of anchors and an anchor storage device.

[0009] In some embodiments, an anchor storage device includes a spring and a housing.

[0010] In some embodiments, the housing is shaped to define: (i) a loading site and (ii) a helical channel that spirals inwardly to the loading site, the series of anchors being arranged along the helical channel, and the spring being configured to urge the series of anchors along the helical channel toward the loading site.

[0011] In some embodiments, the system / device further comprises an anchor driver slidably coupled to the anchor storage device and comprising a rod extendable through the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

[0012] In some embodiments, a system / device comprises an implant comprising a series of anchors and a tether extending between anchors in the series.

[0013] In some embodiments, a spring is positioned along a portion of the channel.

[0014] In some embodiments, the anchor driver defines a driver head at the distal end of the rod.

[0015] In some embodiments, for each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is positioned in the loading site.

[0016] In some embodiments, the anchor driver is configured to advance the anchor transluminally into the heart of the subject by advancing the rod distally through the loading site while the driver head remains engaged with the anchor.

[0017] In some embodiments, the anchor driver is configured to anchor the anchor to tissue of the heart while the rod remains extended through the loading site.

[0018] In some embodiments, the system / device further comprises an anchor release mechanism at the proximal end of the system / device, the anchor release mechanism being adapted to release the anchor from the driver head once the anchor is anchored to tissue.

[0019] In some embodiments, after the rod is withdrawn from the loading site, the urging of the spring on the series of anchors automatically moves the anchors in the series into the loading site.

[0020] In some embodiments, the spring is disposed within the helical channel and is configured to automatically deploy within the channel upon withdrawal of the rod from the loading station.

[0021] In some embodiments, the anchor driver defines a drive head at a distal end of the rod. In some embodiments, the housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

[0022] In some embodiments, the rod is slidable past the proximal stop.

[0023] In some embodiments, the system / device further includes a driver spring disposed within the housing.

[0024] In some embodiments, the anchor storage device is configured such that withdrawing the anchor driver proximally from the loading station compresses the driver spring toward the proximal stop.

[0025] In some embodiments, the driver spring is a coil compression spring.

[0026] In some embodiments, the anchor driver further defines a lateral protrusion at the distal portion of the rod. In some embodiments, the protrusion is sized such that withdrawing the anchor driver proximally from the loading site causes the protrusion to compress the driver spring toward the proximal stop.

[0027] In some embodiments, the anchor driver includes a ring mounted on the distal portion of the shaft and defining a protrusion.

[0028] In some embodiments, the anchor storage device further includes a ferrule that threads onto the rod and is reversibly positionable within the stowage site.

[0029] In some embodiments, the protrusion and cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the protrusion to draw the cuff proximally to compress the driver spring toward the proximal stop.

[0030] In some embodiments, the anchor driver can extend through the loading site in a manner that positions the cuff within the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

[0031] In some embodiments, the driver spring is configured to urge the driver head to the anchor at the loading site.

[0032] In some embodiments, the driver head is configured to automatically lock to the anchor member upon being pushed to the anchor member by the driver spring.

[0033] In some embodiments, the housing defines an opening in communication with the loading site, the opening configured to allow the anchor driver to push each anchor distally out of the loading site.

[0034] In some embodiments, the helical channel surrounds the axis, and the opening is configured to allow an anchor driver to push each anchor distally along the axis and out of the loading site.

[0035] In some embodiments, the spring is arcuate about the axis.

[0036] In some embodiments, the anchor driver has a drive head at a distal end of the shaft. In some embodiments, for each anchor: (i) the drive head is configured to engage the anchor, and (ii) the anchor driver is configured to transluminally anchor the anchor to tissue of the heart of the subject by advancing the drive head and anchor distally through the opening, out of the anchor storage device, and transluminally to the heart while the shaft remains extended through the loading site.

[0037] In some embodiments, the system / device further comprises a series of cartridges, each cartridge in the series housing a corresponding anchor in the series and arranged along the helical channel.

[0038] In some embodiments, for each cartridge in the series, the housing is configured to retain the cartridge as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0039] In some embodiments, the housing defines a receptacle that communicates with the loading site via the opening and is sized to retain each cartridge in the series within the receptacle.

[0040] In some embodiments, the receptacle is positioned distally of the helical channel.

[0041] In some embodiments, the receptacle defines a back plate defining an aperture sized, for each anchor in the series, to allow the anchor to exit the housing distally without allowing the corresponding cartridge to do so.

[0042] In some embodiments, each cartridge in the series is configured to remain threaded onto the rod within the receptacle as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0043] In some embodiments, each cartridge in the series is shaped such that proximally withdrawing the anchor driver from the receptacle rotates the cartridge out of the shaft, retaining the cartridge within the receptacle.

[0044] In some embodiments, the system / device further comprises a catheter coupled to the housing and extending distally away from the housing.

[0045] In some embodiments, the anchor driver is configured to transluminally anchor the anchor to tissue of the subject's heart by advancing the driver head and anchor distally through the opening, out of the anchor storage device, and through the catheter to the heart while the rod remains extended through the loading site.

[0046] In some embodiments, the system / device further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

[0047] In some embodiments, the catheter control handle is positioned axially between the anchor storage device and the catheter.

[0048] According to some embodiments, a method (which can be used with, for example, tissue of a living subject or tissue of a simulant) includes advancing a first anchor distally out of a loading site defined by a housing of an anchor storage device and through a cavity to the tissue of the subject.

[0049] In some embodiments, pushing the first anchor distally out of the loading site is accomplished by sliding an anchor driver engaged with the anchor distally through the loading site.

[0050] In some embodiments, the housing defines a spiral channel that spirals inwardly to the loading site.

[0051] In some embodiments, the method further comprises subsequently disengaging the anchor actuator from the anchor within the subject.

[0052] In some embodiments, the method further comprises subsequently withdrawing the anchor driver proximally from the loading site, such that the anchor storage device automatically advances the second anchor from the helical channel into the loading site.

[0053] In some embodiments, the anchor driver comprises a driver head. In some embodiments, sliding the anchor driver into engagement with the anchor comprises sliding the anchor driver while the driver head is engaged with the anchor.

[0054] In some embodiments, drawing and withdrawing the anchor driver proximally from the loading site includes withdrawing the anchor driver proximally from the loading site without withdrawing the driver head from the anchor storage device.

[0055] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue through a catheter.

[0056] In some embodiments, the method further comprises actively directing the catheter toward the tissue through a vasculature of the subject.

[0057] In some embodiments, drawing and withdrawing the anchor driver proximally from the loading site includes withdrawing the anchor driver proximally from the loading site such that the driver spring is compressed within the anchor storage device.

[0058] In some embodiments, the method further comprises releasing the anchor driver after withdrawal such that the driver spring pushes the anchor driver toward the second anchor in the loading site.

[0059] In some embodiments, releasing the anchor driver such that the driver spring pushes the anchor driver toward the second anchor in the loading site includes releasing the anchor driver such that the anchor driver locks to the second anchor.

[0060] In some embodiments, the first anchor is housed in the cartridge, and advancing the first anchor transluminally to the tissue includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device.

[0061] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue by sliding an anchor driver through a barrel.

[0062] In some embodiments, pushing the first anchor out of the cartridge and the anchor storage device includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device, threaded onto the anchor driver.

[0063] In some embodiments, the method further comprises, after disengaging the anchor driver from the anchor, unscrewing the anchor driver from the barrel by withdrawing the anchor driver proximally from the barrel.

[0064] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0065] According to some embodiments, a system and / or apparatus includes a series of anchors, an anchor storage device, and an anchor driver. In some embodiments, the anchor storage device includes a spring and / or a housing.

[0066] In some embodiments, the housing is shaped to define: (i) a loading site and / or (ii) a helical channel that spirals inwardly to the loading site, the series of anchors being arranged along the helical channel, and the spring being configured to urge the series of anchors along the helical channel toward the loading site.

[0067] In some embodiments, the anchor driver is slidably coupled or coupleable to the anchor storage device and / or includes a rod that can extend through the loading site in a manner that blocks the series of anchors from entering the loading site from the helical channel.

[0068] In some embodiments, a system / device comprises an implant comprising a series of anchors and a tether extending between anchors in the series.

[0069] In some embodiments, a spring is positioned along a portion of the channel.

[0070] In some embodiments, the anchor driver defines a driver head at the distal end of the shaft, and for each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is positioned in the loading site.

[0071] In some embodiments, the anchor driver is configured to advance the anchor transluminally into the heart of the subject by advancing the rod distally through the loading site while the driver head remains engaged with the anchor.

[0072] In some embodiments, the anchor driver is configured to anchor the anchor to tissue of the heart while the rod remains extended through the loading site.

[0073] In some embodiments, the system / device further comprises an anchor release mechanism at the proximal end of the system / device, the anchor release mechanism being adapted to release the anchor from the driver head once the anchor is anchored to tissue.

[0074] In some embodiments, after the rod is withdrawn from the loading site, the urging of the spring on the series of anchors automatically moves the anchors in the series into the loading site.

[0075] In some embodiments, the spring is disposed within the helical channel and is configured to automatically deploy within the channel upon withdrawal of the rod from the loading station.

[0076] In some embodiments, the anchor driver defines a driver head at the distal end of the rod.

[0077] In some embodiments, the housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

[0078] In some embodiments, the rod is slidable past the proximal stop.

[0079] In some embodiments, the system / device further includes a driver spring disposed within the housing.

[0080] In some embodiments, the anchor storage device is configured such that withdrawing the anchor driver proximally from the loading station compresses the driver spring toward the proximal stop.

[0081] In some embodiments, the driver spring is a coil compression spring.

[0082] In some embodiments, the anchor driver further defines a lateral protrusion at the distal portion of the shaft, and the lateral protrusion is sized such that withdrawing the anchor driver proximally from the loading site causes the lateral protrusion to compress the driver spring toward the proximal stop.

[0083] In some embodiments, the anchor driver includes a ring mounted on the distal portion of the shaft and defining a lateral protrusion.

[0084] In some embodiments, the anchor storage device further includes a ferrule that threads onto the rod and is reversibly positionable within the stowage site.

[0085] In some embodiments, the lateral projections and cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the lateral projections to draw the cuff proximally to compress the driver spring toward the proximal stop.

[0086] In some embodiments, the anchor driver can extend through the loading site in a manner that positions the cuff within the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

[0087] In some embodiments, the driver spring is configured to urge the driver head to the anchor at the loading site.

[0088] In some embodiments, the driver head is configured to automatically lock to the anchor member upon being pushed to the anchor member by the driver spring.

[0089] In some embodiments, the housing defines an opening in communication with the loading site, the opening configured to allow the anchor driver to push each anchor distally out of the loading site.

[0090] In some embodiments, the helical channel surrounds the axis, and the opening is configured to allow an anchor driver to push each anchor distally along the axis and out of the loading site.

[0091] In some embodiments, the spring is arcuate about the axis.

[0092] In some embodiments, the anchor driver has a drive head at the distal end of the rod.

[0093] In some embodiments, for each anchor: (i) the drive head is configured to engage the anchor, and / or (ii) the anchor driver is configured to anchor the anchor transluminally to tissue of the subject's heart by advancing the drive head and anchor distally through the opening, out of the anchor storage device, and transluminally to the heart while the rod remains extended through the loading site.

[0094] In some embodiments, the system / device further comprises a series of cartridges, each cartridge in the series housing a corresponding anchor in the series and arranged along the helical channel.

[0095] In some embodiments, for each cartridge in the series, the housing is configured to retain the cartridge as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0096] In some embodiments, the housing defines a receptacle that communicates with the loading site via the opening and is sized to retain each cartridge in the series within the receptacle.

[0097] In some embodiments, the receptacle is positioned distally of the helical channel.

[0098] In some embodiments, the receptacle defines a back plate defining an aperture sized, for each anchor in the series, to allow the anchor to exit the housing distally without allowing the corresponding cartridge to do so.

[0099] In some embodiments, each cartridge in the series is configured to remain threaded onto the rod within the receptacle as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0100] In some embodiments, each cartridge in the series is shaped such that proximally withdrawing the anchor driver from the receptacle rotates the cartridge out of the shaft, retaining the cartridge within the receptacle.

[0101] In some embodiments, the system / device further comprises a catheter coupled to the housing and extending distally away from the housing.

[0102] In some embodiments, the anchor driver is configured to transluminally anchor the anchor to tissue of the heart by advancing the driver head and anchor distally through the opening, out of the anchor storage device, and through the catheter to the heart while the rod remains extended through the loading site.

[0103] In some embodiments, the system / device further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

[0104] In some embodiments, the catheter control handle is positioned axially between the anchor storage device and the catheter.

[0105] According to some embodiments, a method (for use with a real or simulated subject) includes distally advancing a first anchor from a loading site defined by a housing of an anchor storage device by sliding the first anchor distally through the loading site and advancing it transluminally into tissue of the subject. In some embodiments, an anchor driver engages the anchor. In some embodiments, the housing defines a helical channel that spirals inwardly to the loading site.

[0106] In some embodiments, the method includes subsequently disengaging the anchor actuator from the anchor within the subject.

[0107] In some embodiments, the method includes subsequently withdrawing the anchor driver proximally from the loading site, causing the anchor storage device to automatically advance the second anchor from the helical channel into the loading site.

[0108] In some embodiments, the anchor driver includes a driver head.

[0109] In some embodiments, sliding the anchor driver engaged with the anchor includes sliding the anchor driver while the driver head is engaged with the anchor.

[0110] In some embodiments, drawing and withdrawing the anchor driver proximally from the loading site includes withdrawing the anchor driver proximally from the loading site without withdrawing the driver head from the anchor storage device.

[0111] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue through a catheter.

[0112] In some embodiments, the method further comprises actively directing the catheter toward the tissue through a vasculature of the subject.

[0113] In some embodiments, drawing and withdrawing the anchor driver proximally from the loading site includes withdrawing the anchor driver proximally from the loading site such that the driver spring is compressed within the anchor storage device.

[0114] In some embodiments, the method further comprises releasing the anchor driver after withdrawal such that the driver spring pushes the anchor driver toward the second anchor in the loading site.

[0115] In some embodiments, releasing the anchor driver such that the driver spring pushes the anchor driver toward the second anchor in the loading site includes releasing the anchor driver such that the anchor driver locks to the second anchor.

[0116] In some embodiments, the first anchor is housed in the cartridge, and advancing the first anchor transluminally to the tissue includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device.

[0117] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue by sliding an anchor driver through a barrel.

[0118] In some embodiments, pushing the first anchor out of the cartridge and the anchor storage device includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device, threaded onto the anchor driver.

[0119] In some embodiments, the method further comprises, after disengaging the anchor driver from the anchor, unscrewing the anchor driver from the barrel by withdrawing the anchor driver proximally from the barrel.

[0120] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0121] According to some embodiments, a system and / or apparatus includes a tether, a series of anchors threaded onto the tether, and / or an anchor storage device. In some embodiments, the anchor storage device includes a housing rotatable about an axis and including a plurality of anchor storage compartments arranged about the axis, each of the anchor storage compartments housing a respective anchor from the series of anchors.

[0122] In some embodiments, the anchor storage device includes a backing plate defining an aperture through which each anchor in the series can be pushed distally out of the housing.

[0123] In some embodiments, the anchor storage device includes a spool having a portion of the tether wound thereon.

[0124] In some embodiments, the housing can be rotated relative to the backplate in a manner that enables each of the anchor storage compartments to be aligned in sequence to align with the aperture.

[0125] In some embodiments, a system / device comprises an implant comprising a tether and a series of anchors.

[0126] In some embodiments, the system / device further comprises an anchor driver slidably coupled to the anchor storage device and comprising a rod extendable through the orifice to drive an anchor in a series of anchors distally out of the anchor storage device, the anchor being disposed in one of the plurality of anchor storage compartments aligned with the orifice.

[0127] In some embodiments, the housing can be rotated relative to the backing plate when the anchor driver is disengaged from the aperture.

[0128] In some embodiments, the housing is not rotatable relative to the backing plate when the anchor driver is extended through the aperture.

[0129] In some embodiments, the housing can be manually rotated relative to the back plate.

[0130] In some embodiments, the anchor storage device further comprises an engagement arm, and the outer surface of the housing comprises a ratchet mechanism adapted to be engaged by the engagement arm to effectuate the measured rotation of the housing relative to the backing plate.

[0131] In some embodiments, the housing can automatically rotate relative to the back plate.

[0132] In some embodiments, the anchor driver defines a driver head at the distal end of the rod.

[0133] In some embodiments, the housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

[0134] In some embodiments, the rod is slidable past the proximal stop.

[0135] In some embodiments, the system / device further includes a driver spring disposed within the housing.

[0136] In some embodiments, the anchor storage device is configured such that withdrawing the anchor driver proximally from the aperture in the backplate compresses the driver spring toward the proximal stop.

[0137] In some embodiments, the driver spring is a coil compression spring.

[0138] In some embodiments, the anchor driver further defines a lateral protrusion at the distal portion of the shaft.

[0139] In some embodiments, the lateral projections are sized such that withdrawing the anchor driver proximally from the aperture in the backing plate causes the lateral projections to compress the driver spring toward the proximal stop.

[0140] In some embodiments, the anchor driver includes a ring mounted on the distal portion of the shaft and defining a lateral protrusion.

[0141] In some embodiments, the anchor storage device further includes a ferrule that threads onto the rod and is reversibly positionable within the stowage site.

[0142] In some embodiments, the lateral projections and cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the lateral projections to draw the cuff proximally to compress the driver spring toward the proximal stop.

[0143] In some embodiments, the driver spring is configured to urge the driver head toward the anchor aligned with the aperture.

[0144] In some embodiments, the driver head is configured to automatically lock to the anchor member upon being pushed to the anchor member by the driver spring.

[0145] In some embodiments, the spool is rotatable relative to the backplate.

[0146] In some embodiments, the spool is rotatable independent of rotation of the housing.

[0147] In some embodiments, rotation of the spool tightens the tether during distal delivery of one or more of the series of tissue anchors out of the housing.

[0148] In some embodiments, the spool is functionally associated with a spring configured to rotate the spool, thereby tightening the tether.

[0149] In some embodiments, the anchor driver defines a driver head at the distal end of the rod.

[0150] In some embodiments, for each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is aligned with the aperture in the backing plate.

[0151] In some embodiments, the anchor driver is configured to: (i) advance the anchor transluminally into the heart of the subject by advancing the rod distally through the orifice in the backplate while the driver head remains engaged with the anchor, and / or (ii) anchor the anchor to tissue of the heart while the rod remains extended through the orifice.

[0152] In some embodiments, the system / device further comprises an anchor release mechanism at the proximal end of the system / device, the anchor release mechanism being adapted to release the anchor from the driver head once the anchor is anchored to tissue.

[0153] In some embodiments, the system further comprises a series of cartridges, each cartridge in the series housing a corresponding anchor in the series, the cartridges being arranged about the axis of the housing.

[0154] In some embodiments, the system / device further comprises a catheter coupled to the housing and extending distally away from the housing.

[0155] In some embodiments, the anchor driver is configured to transluminally anchor the anchor to tissue of the heart by advancing the driver head and anchor distally out of the anchor storage device and through the catheter to the heart while the rod remains extended through the aperture in the backplate.

[0156] In some embodiments, the system / device further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

[0157] According to some embodiments, a method (e.g., usable by or for use with a subject) includes obtaining an anchor storage device comprising a housing rotatable about an axis, the housing comprising a plurality of anchor storage compartments arranged about the axis, each of the anchor storage compartments housing a respective anchor from a series of anchors for threading onto a tether.

[0158] In some embodiments, the anchor storage device further includes a backing plate defining an aperture.

[0159] In some embodiments, the method includes pushing a first anchor in a series of anchors distally out of one of the anchor storage compartments in the housing through an aperture in the backplate by sliding an anchor driver engaged with the anchor distally through the aperture and into the tissue of the subject through the cavity.

[0160] In some embodiments, the method includes subsequently disengaging the anchor driver from the anchor within the subject and withdrawing the anchor driver proximally from the orifice.

[0161] In some embodiments, the method includes rotating the housing relative to the backplate about the axis to align a second anchor in the series with the aperture in the backplate.

[0162] In some embodiments, rotating includes manually rotating the housing about the axis.

[0163] In some embodiments, the anchor driver includes a driver head, and sliding the anchor driver into engagement with the anchor includes sliding the anchor driver while the driver head is engaged with the anchor.

[0164] In some embodiments, drawing and withdrawing the anchor driver proximally from the orifice includes withdrawing the anchor driver proximally from the orifice while withdrawing the driver head from the anchor storage device.

[0165] In some embodiments, rotating includes automatically rotating the housing about the axis.

[0166] In some embodiments, the anchor driver includes a driver head, and sliding the anchor driver into engagement with the anchor includes sliding the anchor driver while the driver head is engaged with the anchor.

[0167] In some embodiments, drawing and withdrawing the anchor driver proximally from the orifice includes withdrawing the anchor driver proximally from the orifice without withdrawing the driver head from the anchor storage device.

[0168] In some embodiments, drawing and withdrawing the anchor driver proximally from the loading site includes withdrawing the anchor driver proximally from the loading site such that the driver spring is compressed within the anchor storage device.

[0169] In some embodiments, the automatic rotation includes releasing the anchor driver after extraction, causing the driver spring to rotate the housing to align the second anchor with the orifice.

[0170] In some embodiments, releasing the anchor driver includes releasing the anchor driver such that the anchor driver locks to a second anchor aligned with the orifice.

[0171] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue through a catheter.

[0172] In some embodiments, the method further comprises actively directing the catheter toward the tissue through a vasculature of the subject.

[0173] In some embodiments, the first anchor is housed in the cartridge, and advancing the first anchor transluminally to the tissue includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device.

[0174] In some embodiments, advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue by sliding an anchor driver through a barrel.

[0175] In some embodiments, pushing the first anchor out of the cartridge and the anchor storage device includes pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device, threaded onto the anchor driver.

[0176] In some embodiments, the method further comprises, after disengaging the anchor driver from the anchor, unscrewing the anchor driver from the barrel by withdrawing the anchor driver proximally from the barrel.

[0177] In some embodiments, the method further comprises repeating the steps of advancing, disengaging, and rotating for each anchor in a series of anchors.

[0178] Any of the above methods can be performed on a living subject (e.g., a human or other animal) or on a simulator (e.g., a cadaver, a cadaver heart, a virtual human, a simulated body, etc.). In the case of a simulator, the body part can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, etc.) and can include, for example, a computerized and / or physical representation.

[0179] Any of the above-described systems, assemblies, devices, apparatuses, components, etc. may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the above-described methods may include (or the additional method includes or consists of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, assemblies, apparatuses, components, etc. herein.

[0180] This disclosure is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any feature included in the examples of this disclosure is not required by the claims unless the claims clearly state these features. In addition, the features, components, steps, concepts, etc. described in the examples of this disclosure and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized here. BRIEF DESCRIPTION OF THE DRAWINGS

[0181] Figure 1 and 2 is a schematic diagram of an example system including a delivery assembly including an anchor storage device adapted to store therein an array of anchors including aesthetic features thereof, according to some embodiments; Figure 3A -C, 4A-C, 5A-C, 6A-B, 7A-C, and 8 represent methods that can be used according to some embodiments. Figure 1-2 at least some of a series of steps performed by a system for anchoring a series of anchors to tissue of a subject, and illustrating some aesthetic features of the system; Figure 9A -B is an implant and a device for use with the implant according to some embodiments Figure 1-2 A schematic diagram of a delivery assembly of FIG. 1 and also illustrating some aesthetic features; Figure 10 is a schematic perspective view of an anchor delivery system according to some embodiments; Figure 11 According to some embodiments, Figure 10 an exploded view of an anchor delivery assembly that is part of a system; Figure 12A 、 12B and 12C is a cross-sectional view of an anchor delivery assembly according to some embodiments; and Figure 13A 、 13B , 13C, 13D and 13E are used according to some embodiments Figure 11-12C Schematic diagram of at least some steps of a process for delivering and implanting a tissue anchor in a series of tissue anchors using an anchor delivery assembly. DETAILED DESCRIPTION

[0182] The present disclosure especially Methods and systems are directed to containing and utilizing tissue anchors during transluminal surgery, wherein the anchors are implanted within a body cavity (eg, within the heart) of a subject.

[0183] In some embodiments, the implant can include and / or be anchored using a series of tissue anchors. For example, during annuloplasty, a series of tissue anchors can be implanted around the heart's annulus to facilitate subsequent contraction of the annulus.

[0184] In some embodiments, during such a procedure, for each anchor in the series, an anchor driver of the delivery assembly (e.g., a drive head at the distal end of the anchor driver) can sequentially engage the anchor, advance the anchor through the delivery assembly (e.g., through its catheter), and anchor the anchor to the tissue.

[0185] In some embodiments, for each anchor in the series, once the anchor is anchored to the tissue, the driver head is disengaged from the anchor and the anchor driver is withdrawn (leaving the anchor implanted in the tissue) to allow the anchor driver to engage the next anchor in the series.

[0186] The present disclosure facilitates an iterative anchoring process, but advantageously, this process does not require complete removal of the anchor driver from the delivery assembly after anchoring each anchor. For example, in some embodiments, the next anchor in the series can be positioned to be engaged by the anchor driver, and / or the driver head of the anchor driver can engage the next anchor in the series without requiring the driver head to be removed from the delivery assembly.

[0187] Examples of such annuloplasty implants, systems (e.g., delivery tools), and technologies that may be utilized by and / or with which the devices and aspects of the present disclosure may be combined include those described in the following publications, each of which is incorporated herein by reference: US Patent Application Publication 2012 / 0022557 to Cabiri et al.

[0188] U.S. Patent Application Publication 2014 / 0309661 to Sheps et al.

[0189] U.S. Patent Application Publication 2015 / 0272734 to Sheps et al.

[0190] U.S. Patent Application Publication 2018 / 0049875 to Iflah et al.

[0191] U.S. Patent Application Publication 2021 / 0145584 to Kasher et al.

[0192] Now refer to Figure 1 、 2 , 3A-C, 4A-C, 5A-C, 6A-B, 7A-C, and 8, which are schematic diagrams of an example system 100 including a delivery assembly 102 comprising an anchor storage device 110 suitable for storing a series of anchors 140 therein, according to some embodiments.

[0193] In some embodiments, the delivery assembly 102 includes an anchor driver 130 having a rod 134 adapted to extend through the anchor storage device 110, and a drive head 136 at a distal end of the rod adapted to anchor a series of anchors 140 to tissue of a subject as the rod extends through the anchor storage device.

[0194] Figure 1 An overall view of the system 100 is shown. Figure 2 An exploded view of system 100 is shown. Figures 3A-7C At least some of a series of steps that may be used with system 100 are shown. Figure 8 A rear view of the anchor storage device 110 is shown after use. Figure 6B Outside China, Figure 2-8 The catheter handle 162 is omitted.

[0195] In some embodiments, the delivery assembly 102 includes a catheter 160 through which the anchor driver 130 can advance the anchor 140 transluminally (eg, through the femoral artery), for example, to the heart.

[0196] In some embodiments, a catheter handle 162 is positioned at a proximal portion of the catheter (e.g., at the handle portion 104 of the delivery assembly), the catheter handle being adapted to facilitate transluminal advancement of the catheter toward the heart, for example, by manipulating the distal steering portion of the catheter via an operative coupling between the catheter handle and the distal steering portion (e.g., via a pull wire). Non-limiting examples of how this manipulation may be implemented include those described in the following publications, each of which is incorporated by reference: U.S. Patent Application Publication 2014 / 0309661 to Sheps et al.

[0197] U.S. Patent Application Publication 2015 / 0272734 to Sheps et al.

[0198] In some embodiments, the anchor driver 130 includes an anchor release mechanism comprising an anchor release trigger 138 at a proximal portion of the anchor driver, such as at a driver handle 137 of the anchor driver.

[0199] In some embodiments, the anchor release mechanism is adapted to release the anchor 140 from the driver head 136 once the anchor has been anchored to tissue. In some embodiments, the anchor driver 130 and / or its anchor release mechanism can be as described in one or more of the following publications ( Make necessary modifications ), each of which is incorporated herein by reference: US Patent Application Publication 2012 / 0022557 to Cabiri et al.

[0200] U.S. Patent Application Publication 2014 / 0309661 to Sheps et al.

[0201] U.S. Patent Application Publication 2015 / 0272734 to Sheps et al.

[0202] U.S. Patent Application Publication 2018 / 0049875 to Iflah et al.

[0203] U.S. Patent Application Publication 2022 / 0071620 to Brauon et al.

[0204] International patent application publication WO 2022 / 064401 to Halabi et al.

[0205] International patent application PCT / IB2022 / 051099 to Shafigh et al.

[0206] In some embodiments, and as Figure 1As shown, the anchor storage device 110 can be positioned at the handle portion 104, for example, proximal to the catheter handle 162, such as attached to the proximal end of the catheter handle.

[0207] In some embodiments, at least a proximal portion of the anchor driver 130 protrudes proximally from the anchor storage device 110. Thus, at some stage during use, the anchor driver (e.g., its shaft) extends distally through the housing 120 and the catheter handle 162 and into the catheter 160 (e.g., as explained in more detail below).

[0208] The anchor storage device 110 will now be described in greater detail. In some embodiments, the anchor storage device 110 includes a housing 120 shaped to define a spiral channel 122 that spirals inwardly toward (e.g., leading to) a loading site 129. For example, the spiral shape of the channel 122 can be centered about the loading site, e.g., thereby defining a channel plane. In some embodiments, the spiral channel 122 serves as an anchor storage compartment for storing anchors during use of the anchor storage device 110.

[0209] In some embodiments, a series of anchors 140 are arranged along a spiral path around the loading site 129, as shown. In some embodiments, the anchor storage device 110 includes a spring 124 configured to urge the series of anchors along the spiral path toward the loading site 129.

[0210] In some embodiments, during anchoring of each of the series of anchors to the heart, the rod 134 extends through the loading site 129 in a manner that blocks the series of anchors from entering the loading site from the helical channel.

[0211] In some embodiments, withdrawing the rod 134 from the loading site 129 can automatically trigger the anchor storage device 110 to move the anchor (e.g., the next anchor) in the series into the loading site. For example, the spring 124 can be arranged within the helical channel in a manner such that withdrawing the rod from the loading site allows the spring to expand within the channel, thereby pushing the series of anchors along the channel, thereby pushing the next anchor in the series into the loading site.

[0212] In some embodiments, and as explained in more detail below, based on this withdrawn state of the anchor driver 130, the anchor driver (e.g., its drive head 136) can engage with the next anchor 140 in the series by returning the anchor driver distally toward the loading site 129 so that the drive head contacts and engages the anchor, after which the anchor can be advanced via the anchor driver through the loading site 129 and the catheter 160 and toward the heart.

[0213] In some embodiments, the housing 120 defines a front plate 121 that covers the helical channel 122 (and therefore the anchor 140 within the channel) and retains the anchor within the channel.

[0214] In some embodiments, the housing 120 defines a proximal stop 127 that blocks the drive head 136 from proximally exiting the anchor storage device 110 .

[0215] In some embodiments, the anchor storage device 110 includes a driver spring 128 that is positioned and dimensioned to become tensioned (e.g., compressed) upon retraction of the anchor driver 130 (e.g., its driver head 136) proximally from the loading site 129 and thereby bias the driver to return distally toward the loading site.

[0216] In some embodiments, a driver spring 128 can be positioned within the cavity 125 defined by the housing 120. In the example shown, the driver spring 128 is a helical compression spring that can be transitioned toward a compressed state by withdrawing the anchor driver 130 from the loading station 129 such that the anchor driver presses the driver spring toward the proximal stop 127.

[0217] In some embodiments, in order to keep the driver spring in a compressed state, a proximal tension must be maintained on the anchor driver to prevent the driver spring from relaxing and pushing the anchor driver toward the loading site. In some embodiments, such tension is not necessary.

[0218] In some embodiments, to engage the anchor driver 130 with the next anchor 140 in the series (e.g., to lock the driver head 136 with the anchor disposed in the loading site 129), the operator releases the anchor driver (e.g., ceases applying proximal tension to the anchor driver), thereby allowing the driver spring 128 to relax (e.g., expand) in a manner that urges the anchor driver 130 toward the anchor 140 currently positioned within the loading site 129. (Note that, as described above, this anchor will arrive at the loading site immediately after the anchor driver has been withdrawn from the loading site.) In some embodiments, the driver spring can be configured to urge the anchor driver toward the anchor disposed within the loading site in a manner that locks the driver head to the anchor. For example, the amount of force applied by the driver spring can be greater than the amount of force required to engage the driver head 136 with the anchor 140. For example, the driver head 136 can be snap-fit into engagement with the anchor.

[0219] In some embodiments, to transition the driver spring toward the compressed state, the anchor driver defines a lateral protrusion 132 at a distal portion of the rod 134 (e.g., just proximal to the driver head 136), such as Figure 2 shown.

[0220] In some embodiments, the anchor driver 130 includes a ring 131 mounted on a distal portion of a shaft, the ring defining a lateral protrusion 132. The ring 131 is rotatable about a shaft 134.

[0221] In some embodiments, the lateral protrusions are sized to transition the driver spring toward a compressed state in response to withdrawal of the anchor driver 130 from the loading station 129. By way of example, and as shown, the ferrule 126 can be threaded onto the rod 134 and reversibly positioned within the loading station 129.

[0222] In some embodiments, when the anchor driver 130 is retracted proximally from the loading site 129 , the protrusion 132 abuts the cuff 126 , forcing the cuff proximally away from the loading site and against the driver spring 128 , thereby compressing the driver spring toward the proximal stop 127 .

[0223] In some embodiments, the cuff is sized to block the series of anchors from entering the loading site from the helical channel when the rod is extended through the loading site.

[0224] In some embodiments, the system 100 further includes a series of cartridges (eg, pods) 150 , with each anchor in the series being housed within a cartridge in the series within the helical channel 122 .

[0225] In some embodiments, the channel 122 and the barrel 150 are complementarily keyed to orient the barrel in a particular manner, for example, so that the anchor 140 arrives at the loading site 129 in a rotational orientation optimized for locking to the drive head 136. For example, the channel 122 can define a groove, and each barrel 150 can define a tongue that spans within the groove, and / or the channel can define a track, and each barrel can define a notch that spans the track. In some embodiments, each anchor 140 can fit tightly within its corresponding barrel 150, for example, so that the anchor is prevented from rotating relative to its barrel.

[0226] In some embodiments, for each cartridge in the series, the housing 120 is configured to retain the cartridge (eg, the housing prevents the cartridge from being advanced toward the heart along with the anchor) as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0227] Furthermore, the housing 120 can be configured to retain the cartridges even after their anchors have been anchored to tissue and the actuator 130 has been retracted, e.g., when each cartridge 150 is no longer needed. For example, in some embodiments, the housing 120 defines a receptacle 152 (e.g., a treatment area) that is sized to receive the cartridges. The receptacle 152 can be positioned distal to the helical channel 122. The receptacle 152 can communicate with the loading station 129, e.g., via an opening 129a.

[0228] As the anchor driver 130 drives its anchor 140 distally out of the anchor storage device, each cartridge 150 can be facilitated to remain within the housing 120 by the back plate 123 of the receptacle 152 defining an aperture 123 a shaped and / or sized to allow the anchor 140 to pass therethrough without allowing the cartridge 150 to pass therethrough. Thus, as the anchor driver 130 pushes the corresponding anchor 140 distally out of the anchor storage device 110, the rod 134 slides through the cartridge 150 (e.g., the cartridge is screwed around the rod). In some embodiments, withdrawing the anchor driver 130 proximally through the aperture 123 a and into the loading station 129 unscrews the cartridge 150 from the rod, allowing the cartridge to be stored (e.g., disposed of) within the receptacle.

[0229] Figure 3A 4A-C, 5A-C, 6A-B, 7A-C, and 8 represent at least some of a series of example steps that may be performed using the system 100 to anchor a series of anchors 140 to tissue of a subject, according to some embodiments. It should be noted that these figures are also intended to illustrate the functionality and capabilities of the system 100, and not merely to define a strict sequence of steps for a procedure. Figure 3A -C, 4A-C, 5A-C and 7A-C, each of which provides multiple views, wherein the corresponding Figure A (e.g., Figure 3A ) shows a longitudinal cross section, Figure C (e.g., Figure 3C ) shows a transverse cross section (i.e., a cross section transverse to Figure A), and Figure B (e.g., Figure 3B ) shows a perspective view with a portion of the housing 120 cut away and a portion of the system 100 (eg, the anchor driver 130 and the driver spring 128) shown in cross-section.

[0230] In some embodiments, the anchor driver 130 (e.g., its drive head 136) sequentially engages each anchor in the series that is sequentially loaded into the loading site 129 and is then used to advance the anchors into tissue as the anchor driver extends through the anchor storage device.

[0231] Figure 3AFigure 1-C shows the anchor storage device 110 before the anchor driver 130 engages any of the anchors in the series. For example, the system 100 can be provided in this state. In some embodiments, the anchor driver 130 extends through the anchor storage device 110 (e.g., the rod 134 extends through the loading station 129 and extends distally through the housing 120), such that the series of anchors is blocked from entering the loading station from the spiral channel. As noted above, this blocking can be facilitated by the cuff 126, which can be positioned within the loading station 129 in this state.

[0232] In some embodiments, to load the series of anchors (e.g., the first anchor) into the loading site 129, the anchor driver 130 is then pulled proximally (e.g., by the operator pulling the handle 137 proximally) such that the anchor driver 130 and / or the cuff 126 no longer obstruct the series of anchors from passing from the helical channel into the loading site ( Figure 4A -C). Thus, anchor 140 moves to the loading site, urged forward by spring 124, as described above. In some embodiments, and as described above, pulling the anchor driver proximally from loading site 129 compresses driver spring 128 toward proximal stop 127 (e.g., by protrusion 132 contacting ferrule 126 and pulling the ferrule toward the driver spring), as described above. Figure 4A -B.

[0233] In some embodiments, to engage the anchor driver 130 with the anchor 140 now disposed within the loading station 129 (e.g., to lock the driver head 136 to the anchor), the anchor driver 130 is then pushed toward the anchor (e.g., from the Figure 4A -C to Figure 5A -C). This can be achieved by the operator simply releasing the anchor driver 130 (e.g., releasing the handle 137), causing the driver spring 128 to push the anchor driver toward the anchor in the loading site. In some embodiments, the force generated by the relaxation of the driver spring causes the driver head 136 to lock onto the anchor 140, e.g., the driver spring snaps the driver head into engagement with the anchor.

[0234] In some embodiments, for example, embodiments where the driver spring 128 is not present, the operator pushes the anchor driver 130 distally toward the loading site 129 such that the driver head engages and locks to an anchor disposed within the loading site.

[0235] Figure 5A -C shows the driver head 136 engaged with the anchor, which moves to Figure 4A-C, and the anchor has been pushed out of the loading site 129 and into (e.g., through) the orifice 123a, such as into the catheter 160. Although the anchor 140 typically leaves the loading site 129 while still contained within the cartridge 150, as the anchor is advanced through the orifice 123a, the cartridge 150 is stripped from the anchor 140, e.g., by preventing the cartridge from passing through the orifice 123a. Thus, in the example shown, the cartridge 150 remains within the housing 120, threaded around the rod 134 ( Figure 5A ).

[0236] In some embodiments, the force exerted by the driver spring 128 to push the driver head 136 toward the anchor 140 disposed in the loading site 129 is sufficient to cause the ferrule 126 to push the barrel 150 out of the loading site through the opening 129a. In some embodiments, the driver spring 128 also pushes the anchor 140 out of the barrel 150 and through the orifice 123a.

[0237] In some embodiments, even if the driver spring 128 generates sufficient force to lock the drive head 136 to the anchor 140 disposed in the loading site 129, the system 100 can be configured such that an operator is required to manually advance the anchor driver 130 distally in order to push the anchor 140 (e.g., along with the barrel 150) out of the loading site 129 and / or advance the anchor 140 through the orifice 123a (e.g., without passing through its barrel).

[0238] In this state, the anchor 140 can then be advanced through the catheter 160 toward the heart cavity (e.g., via the operator pushing the anchor driver 130 distally) and anchored to the tissue of the heart ( Figure 6A -B) (eg, tissue of a heart valve). Note that this advancement and anchoring can occur while the barrel 150 remains threaded onto the shaft 134 of the driver 130 .

[0239] In some embodiments, once the anchor is anchored to the tissue, the anchor release trigger 138 can be actuated to release the anchor from the driver head 136 so that the anchor driver 130 can then be withdrawn proximally from the heart and the subject to anchor the next anchor in the series to the tissue ( Figure 7A -C).

[0240] As described above, in some embodiments, withdrawing the anchor driver 130 proximally from the loading station 129 (e.g., to load the next anchor in the series into the loading station) allows the cartridge 150 housing the previous anchor to unscrew from the rod 134 and reside within the receptacle 152 (e.g., drop into the receptacle and / or away from the aperture 123a). Figure 7A is most clearly shown in .

[0241] In some embodiments, the anchor now positioned in the loading site 129 (eg, the second anchor in the series) is then engaged by the driver 130 and pushed out of the loading site and transluminally toward the heart, as described above.

[0242] In some embodiments, this iterative process can be repeated for all anchors contained within the spiral channel 122: withdrawing the anchor driver 130 from the loading site 129 allows the next anchor in the series to be advanced into the loading site, then advancing the anchor driver toward the anchor in the loading site, and then using the anchor driver to advance the anchor toward the heart. In some embodiments, the operator can simply repeat this iterative process until the desired number of anchors has been used.

[0243] Figure 8 A rear view of the anchor storage device 110 is shown with a portion of the back panel 123 cut away to reveal the cartridges having been dropped into the receptacles 152 after use of the anchors they previously contained.

[0244] In some embodiments, once the anchoring process is complete, the anchor driver 130 and the anchor storage device 110 (e.g., the delivery assembly 102) can be withdrawn, leaving the handle portion 104 and / or the catheter 160 in place, e.g., for subsequent steps in the medical procedure. In some embodiments, the entire system 100 can be withdrawn from the subject as a single entity.

[0245] Now refer to Figure 9A -B, which is a schematic diagram of an exemplary implant 240 and an exemplary delivery assembly 102 for use therewith, according to some embodiments.

[0246] In some embodiments, implant 240 includes anchors 140 and a tether 242 extending between the anchors (e.g., through an eyelet in the head of each anchor). In some embodiments, delivery assembly 102 is adapted to anchor implant 240 to cardiac tissue when the tether extends between the anchors.

[0247] In some embodiments, the implant 240 can be an annuloplasty implant, and once the anchor has been anchored to the tissue, the tether 242 can be tightened to constrict the tissue 10 of the heart. Figure 9B In some embodiments, the tether 242 extends along the anchor within the helical channel 122 before the anchor has been implanted in the heart, such as Figure 9A shown.

[0248] In some embodiments, the tether 242 can be advanced distally through the loading site 129 and toward the heart. As shown, the barrel 150 can be shaped to accommodate the tether 242 passed between the anchors 140, for example, at the proximal end of each barrel, one side of the barrel can be cut away.

[0249] Reference again Figure 1-9B It should be noted that the delivery assembly 102 can advantageously be configured such that neither the driver head 136 nor the anchors 140 are exposed from the delivery assembly during use and do not require manual handling, e.g., thereby maintaining the anchors and their drivers 130 in a sterile environment and reducing the manual dexterity required to engage the anchor driver with each anchor. For example, the front plate 121 can be sized to prevent the driver head 136 from being proximally withdrawn from the anchor storage device 110 by defining an aperture 121 a that permits proximal withdrawal of the rod 134 but not the driver head and / or protrusion 132 from the aperture.

[0250] Now refer to Figure 10 , which is a schematic perspective view of an anchor delivery system 200 according to some embodiments; Figure 11 , which is an exploded view of an anchor delivery assembly 202 forming part of an anchor delivery system 200 according to some embodiments; and reference Figure 12A 、 12B and 12C, which is a cross-sectional view of an anchor delivery assembly 202, according to some embodiments.

[0251] In some embodiments, the anchor storage device 204 differs from the anchor storage device 110 in at least one aspect: the storage device itself rotates, rather than the anchors being moved through the storage device to be aligned for use. In the system 200, the anchors are circumferentially arranged around the system's housing 206, which is rotatable to iteratively align each anchor for use.

[0252] The anchor delivery assembly 202 includes an anchor storage device 204 including a housing 206 that is rotatable about an axis 208. The housing 206 defines a plurality of anchor storage compartments 210 arranged about the axis 208. Each anchor storage compartment 210 holds a tissue anchor 212 from a series of such tissue anchors, wherein each tissue anchor 212 in the series is threaded onto a tether 214. A portion of the tether 214 is wound around a spool 216 that is also rotatable about the axis 208. Rotation of the spool 216 about the axis 208 is independent of rotation of the housing 206 about the axis.

[0253] Tissue anchor 212 and tether 214 together form an implant, such as an annuloplasty implant, suitable for implantation into the heart of a subject, as explained in further detail below.

[0254] The anchor delivery assembly 202 also includes a backing plate 220 defining an aperture 222. Each anchor 212 in the series can be pushed distally out of the housing 206 through the aperture 222. In some embodiments, the backing plate 220 is annular and includes a central hole 224 adapted to receive the spool 216 therein.

[0255] In some embodiments, the anchor delivery assembly 202 includes a base structure 230 that includes a base surface 232. A proximal support 234 extends upward from the base surface 232 and includes a notch or hole 236 engaged by the proximal end of the axis 208. A distal support 238 extends upward from the base surface 232 and includes a notch or hole 240 engaged by the distal end of the axis 208. The distal support 238 can also include a second orifice 242 that is vertically aligned with the orifice 222.

[0256] In some embodiments, the back plate 220 is disposed between the proximal support 234 and the distal support 238. In some embodiments, the anchor delivery channel 244 is disposed between the aperture 222 and the second aperture 242.

[0257] The spool 216 is functionally associated with a first spring drum 250, which is adapted to receive the axis 208 therein. A spring 252, such as a leaf spring, is coupled to the first spring drum 250 and extends to a second spring drum 256 mounted to the anchor delivery channel 244. As explained in further detail below, the spring 252 is adapted to tighten the tether 214 as needed (e.g., to maintain a certain tension in the tether) by rotating the spool 216. In some embodiments, rotation of the spring 252 redistributes the portion of the spring wound around each of the spring drums 250 and 256.

[0258] The anchor delivery assembly 202 also includes an anchor driver 260 slidably coupled to the anchor storage device 204. The anchor driver 260 includes a rod 262, the distal end of which terminates in a driver head 264. In some embodiments, the anchor driver 260 includes an anchor release mechanism disposed at the proximal end of the rod 262. For example, the anchor release mechanism can include an anchor release trigger 266 disposed in a driver handle 268 of the anchor driver 260.

[0259] As follows about Figures 13A to 13E, the anchor driver 260 can extend through the aperture 222 to drive the anchor 212 distally from one of the anchor storage compartments 210 of the housing 206, aligned with the aperture, into the anchor delivery channel 244, and further out of the anchor storage device 204 and into the subject's heart. Once the anchor 212 is anchored to the subject's heart, the anchor release mechanism is adapted to release the anchor from the driver head 264. In some embodiments, the anchor driver 260 and / or its anchor release mechanism can be as described in one or more of the following disclosures ( Add Necessary modifications ), each of which is incorporated herein by reference: US Patent Application Publication 2012 / 0022557 to Cabiri et al.

[0260] U.S. Patent Application Publication 2014 / 0309661 to Sheps et al.

[0261] U.S. Patent Application Publication 2015 / 0272734 to Sheps et al.

[0262] U.S. Patent Application Publication 2018 / 0049875 to Iflah et al.

[0263] U.S. Patent Application Publication 2022 / 0071620 to Brauon et al.

[0264] International patent application publication WO 2022 / 064401 to Halabi et al.

[0265] International patent application PCT / IB2022 / 051099 to Shafigh et al.

[0266] In some embodiments, the anchor delivery system further includes a catheter 270 coupled to the anchor storage device 204 and extending distally therefrom. For example, the lumen of the catheter 270 can extend distally from the anchor delivery channel 244 of the anchor storage device 204. As explained in further detail below, the anchor driver 260 can deliver the anchor 212 via the catheter 270 transluminally (e.g., via the femoral artery) to the heart of the subject.

[0267] In some embodiments, a catheter handle 272 is positioned at the proximal portion of the catheter 270, the catheter handle being adapted to facilitate transluminal advancement of the catheter toward the heart, for example, by manipulating the distal steering portion of the catheter via an operative coupling between the catheter handle and the distal steering portion (e.g., via a pull wire). Non-limiting examples of how this manipulation may be implemented include those described in the following publications, each of which is incorporated by reference: U.S. Patent Application Publication 2014 / 0309661 to Sheps et al.

[0268] U.S. Patent Application Publication 2015 / 0272734 to Sheps et al.

[0269] In some embodiments, and as Figure 10 As shown, the anchor storage device 204 can be positioned proximal to the catheter handle 272, such as attached to the proximal end of the catheter handle.

[0270] As explained in further detail below, during implantation of the anchors 212 , the housing 206 must be rotated relative to the backplate 220 in order to align each anchor 212 with the orifice 222 for driving a particular anchor into the anchor delivery channel 244 and further into the catheter 270 .

[0271] In some embodiments, the housing 206 is manually rotated relative to the backplate 220. In some embodiments, the housing 206 is coupled to a ratchet mechanism 280 that defines ratchet teeth 282. The ratchet teeth 282 are functionally associated with engagement arms 284 that extend upwardly from the base 232 of the base structure 230. The ratchet mechanism 280, together with the engagement arms 284, enables measured rotation of the housing 206 relative to the backplate 220 to ensure that the anchor 212 is not lost during the implantation procedure.

[0272] In some embodiments, the housing 206 can automatically rotate relative to the back plate 220. In some embodiments, the housing 206 and the anchor driver 260 can have the same configuration as described above with respect to Figures 1 to 9B , such that pulling the anchor driver proximally compresses the driver spring, which causes the housing 206 to rotate to engage the next anchor in the series before releasing the anchor driver. In some embodiments, such an automated system may include the aforementioned Figures 1 to 9B Describe the components of the system, Make necessary modifications .

[0273] In some embodiments, each anchor storage compartment houses a cartridge or capsule (similar to Figure 2 The barrel 150) and the anchor 212 are placed in the barrel. Figures 1 to 9B In some embodiments, as the anchor driver 260 pushes the anchor 212 distally out of the housing 206, the cartridge can remain in the housing, or can be positioned around the rod of the anchor driver and then dropped into a suitable receptacle, as described herein above with respect to Figures 1 to 9B As stated, Add necessary Modifications .

[0274] Now refer to Figure 13A 、 13B , 13C, 13D, and 13E, which are schematic illustrations of at least some steps of a process of using the anchor delivery assembly 202 to deliver and implant a tissue anchor 212 from a series of tissue anchors stored within an anchor storage device 204 of the anchor delivery assembly.

[0275] like Figure 13A As shown, a specific anchor storage compartment 210a of housing 206 houses a specific anchor 212a that is threaded onto a tether 214. In the example shown, the anchor has been previously implanted such that the tether 214 extends distally through aperture 222 and anchor delivery channel 244 to the anchor 212a.

[0276] The anchor storage compartment 210a is aligned with the aperture 222 of the back plate 220 and with the anchor delivery channel 244. The anchor driver 260 is disengaged from the housing 206 with the driver head 264 aligned with the anchor storage compartment 210a.

[0277] exist Figure 13B , the drive head 264 of the anchor driver 260 has engaged the anchor 212a and has advanced the anchor distally out of the housing 206 through the aperture 222 of the back plate 220 and through the anchor delivery channel 244, into the catheter 270. As shown, during this process, the shaft 262 of the anchor driver 260 continues to extend through the housing 206, the aperture 222, and the anchor delivery channel 244.

[0278] As the driver head 264 remains engaged with the anchor 212a, the rod 262 continues to advance the anchor transluminally through the catheter 270 into the subject's heart. Subsequently, as the rod 262 remains extended through the orifice 222 and the passage 244, the anchor driver 260 drives the anchor 212a into the tissue of the subject's heart, as shown in FIG. Figure 13C For example, anchor 212a may be driven into the annulus 302 of a subject's mitral valve 304. As shown, another anchor 212' has been driven into the annulus 302 and is connected to the particular anchor 212a via a tether 214.

[0279] Steering Figure 13D , it can be seen that after the anchor 212a is installed, the drive head 264 is disengaged from the anchor 212a, for example, by operation of an anchor release mechanism. Then, as indicated by arrow 310, the anchor driver 260, and more specifically the rod 262, is pulled in a proximal direction until the drive head 264 is removed from the anchor storage compartment 210a and / or from the housing 206.

[0280] After the anchor driver 260 is withdrawn, the housing 206 is rotated relative to the back plate 220 to align another anchor 212b disposed in another anchor storage compartment 210b with the aperture 222. In this position, the anchor can be considered to be at the stowage site of the anchor storage device 204. Figure 13E The housing 206 is shown rotated in the direction of arrow 320 from a first position in which the anchor storage compartment 210a is aligned with the aperture 222 to align the anchor storage compartment 210b with the aperture. During such rotation, the engagement arm 284 is pushed downwardly by the ratchet tooth 282 in the direction of arrow 322 and reengages the next tooth in the mechanism, thereby causing a measured rotation of the housing and ensuring that no anchors are skipped.

[0281] In some embodiments, this rotation of the housing 206 is performed manually by an operator. In some embodiments, this rotation is semi-automatic or fully automatic. For example, the rotation can be achieved by a spring, for example, by withdrawing the anchor driver 260 to compress and release the spring.

[0282] It should be understood that when the anchor driver 260 is disengaged from the aperture 222 or completely disengaged from the housing, the housing 206 can rotate relative to the back plate 220. Additionally, the housing cannot rotate relative to the back plate 220 when the anchor driver 260 is extended through the aperture.

[0283] It should be understood that it is possible to repeat Figures 13A to 13E , until all anchors 212 in the series have been advanced into the subject's heart, e.g., to form Figure 9B The implant structure shown in .

[0284] It should be understood that the use of “and / or” is defined inclusively, such that the term “a and / or b” should be read to include the set: “a and b,” “a or b,” “a,” “b.”

[0285] Example Implementations (some non-limiting examples of the concepts herein are described below): Example 1. A system comprising: (A) a series of anchors; (B) an anchor storage device comprising: (i) a spring; and / or (ii) a housing shaped to define: (a) a loading location and / or (b) a spiral channel that spirals inwardly to the loading location, the series of anchors being arranged along the spiral channel, and the spring being configured to urge the series of anchors along the spiral channel toward the loading location; and / or (C) an anchor driver slidably coupled to the anchor storage device and comprising a rod that can extend through the loading location in a manner that blocks the series of anchors from entering the loading location from the spiral channel.

[0286] Example 2. The system of example 1, wherein the system comprises an implant comprising a series of anchors and a tether extending between anchors in the series.

[0287] Example 3. The system of any of examples 1-2, wherein the spring is positioned along a portion of the channel.

[0288] Example 4. A system according to any of Examples 1-3, wherein: (a) the anchor driver defines a driver head at the distal end of the rod, and / or (b) for each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is positioned in the loading site.

[0289] Example 5. A system according to Example 4, wherein the anchor driver is configured to: (a) advance the anchor transluminally into the heart of the subject by advancing the rod distally through a loading site while the drive head remains engaged with the anchor, and / or (b) anchor the anchor to tissue of the heart while the rod remains extended through the loading site.

[0290] Example 6. The system of Example 5, wherein the system further comprises an anchor release mechanism at the proximal end of the system, the anchor release mechanism adapted to release the anchor from the driver head once the anchor is anchored to tissue.

[0291] Example 7. The system of one of examples 1-6, wherein upon withdrawal of the rod from the loading site, the urging of the spring on the series of anchors automatically moves the anchors in the series into the loading site.

[0292] Example 8. The system of example 7, wherein the spring is disposed within the helical channel and is configured to automatically deploy within the channel upon withdrawal of the rod from the loading station.

[0293] Example 9. The system of Example 7, wherein: (a) the anchor driver defines a drive head at the distal end of the rod, and / or (b) the housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

[0294] Example 10. The system of Example 9, wherein the rod is slidable past the proximal stop.

[0295] Example 11. A system according to Example 9, wherein: (a) the system further comprises a driver spring disposed within the housing, and / or (b) the anchor storage device is configured such that proximally withdrawing the anchor driver from the loading site presses the driver spring toward the proximal stop.

[0296] Example 12. The system of Example 11, wherein the driver spring is a helical compression spring.

[0297] Example 13. A system according to Example 11, wherein: (a) the anchor driver further defines a lateral protrusion at the distal portion of the rod, and / or (b) the lateral protrusion is sized such that withdrawing the anchor driver proximally from the loading site causes the lateral protrusion to press the driver spring toward the proximal stop.

[0298] Example 14. The system of Example 13, wherein the anchor driver comprises a ring mounted on the distal portion of the shaft and defining a lateral protrusion.

[0299] Example 15. The system of Example 13, wherein the anchor storage device further comprises a ferrule that threads onto the rod and is reversibly positionable within the loading site.

[0300] Example 16. The system of Example 15, wherein the lateral protrusion and the cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the lateral protrusion to draw the cuff proximally to compress the driver spring toward the proximal stop.

[0301] Example 17. The system of Example 16, wherein the anchor driver is extendable through the loading site in a manner to position the cuff within the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

[0302] Example 18. The system of example 11, wherein the driver spring is configured to urge the driver head to the anchor at the loading site.

[0303] Example 19. The system of Example 18, wherein the driver head is configured to automatically lock to the anchor upon being pushed to the anchor by the driver spring.

[0304] Example 20. The system of one of examples 1-19, wherein the housing defines an opening in communication with the loading site, the opening configured to allow the anchor driver to push each anchor distally out of the loading site.

[0305] Example 21. The system of Example 20, wherein the helical channel surrounds the axis, and wherein the opening is configured to allow an anchor driver to push each anchor distally along the axis and out of the loading site.

[0306] Example 22. The system of Example 21, wherein the spring is arcuate about the axis.

[0307] Example 23. A system according to Example 20, wherein: (a) the anchor driver has a drive head at the distal end of the rod, and / or (b) for each anchor: (i) the drive head is configured to engage the anchor, and / or (ii) the anchor driver is configured to anchor the anchor transluminally to tissue of the subject's heart by advancing the drive head and anchor distally through the opening, out of the anchor storage device, and transluminally to the heart while the rod remains extended through the loading site.

[0308] Example 24. The system of Example 23, further comprising a series of cartridges, each cartridge in the series housing a corresponding anchor in the series and arranged along the helical channel.

[0309] Example 25. The system of Example 24, wherein, for each cartridge in the series, the housing is configured to retain the cartridge as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0310] Example 26. The system of example 25, wherein the housing defines a receptacle that communicates with the loading site via the opening, and wherein the receptacle is sized to retain each cartridge in the series within the receptacle.

[0311] Example 27. The system of Example 26, wherein the receptacle is positioned distal to the spiral channel.

[0312] Example 28. The system of example 26, wherein the receptacle defines a backplate defining an aperture sized, for each anchor in the series, to allow the anchor to exit the housing distally without allowing the corresponding cartridge to exit distally.

[0313] Example 29. The system of Example 28, wherein each cartridge in the series is configured to remain threaded onto the rod within the receptacle when the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

[0314] Example 30. The system of Example 29, wherein each cartridge in the series is shaped such that proximally withdrawing the anchor driver from the receptacle rotates the cartridge out of the shaft, retaining the cartridge within the receptacle.

[0315] Example 31. A system according to Example 23, wherein: (a) the system further comprises a catheter coupled to the housing and extending distally away from the housing, and / or (b) the anchor driver is configured to transluminally anchor the anchor to tissue of the heart by advancing the drive head and anchor distally through the opening, out of the anchor storage device, and through the catheter to the heart while the rod remains extended through the loading site.

[0316] Example 32. The system of Example 31, wherein the system further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

[0317] Example 33. The system of Example 32, wherein the catheter control handle is positioned axially between the anchor storage device and the catheter.

[0318] Example 34. A method for use with a subject, the method comprising: (a) advancing a first anchor distally out of a loading site defined by a housing of an anchor storage device and through a cavity into tissue of the subject by sliding an anchor driver engaged with the anchor distally through the loading site, the housing defining a helical channel that spirals inwardly to the loading site; (b) subsequently disengaging the anchor driver from the anchor within the subject; and / or (c) subsequently withdrawing the anchor driver proximally from the loading site such that the anchor storage device automatically advances a second anchor from the helical channel into the loading site.

[0319] Example 35. A method according to Example 34, wherein: (a) the anchor driver includes a drive head, (b) sliding the anchor driver into engagement with the anchor includes sliding the anchor driver while the drive head is engaged with the anchor, and / or (c) drawing and removing the anchor driver proximally from the loading site includes drawing the anchor driver proximally from the loading site without withdrawing the drive head from the anchor storage device.

[0320] Example 36. The method of any of Examples 34-35, wherein advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue through a catheter.

[0321] Example 37. The method of Example 36, wherein the method further comprises actively guiding the catheter toward the tissue through a vasculature of the subject.

[0322] Example 38. The method of any of Examples 34-37, wherein drawing and withdrawing the anchor driver proximally from the loading site comprises withdrawing the anchor driver proximally from the loading site such that the driver spring is compressed within the anchor storage device.

[0323] Example 39. The method of example 38, wherein the method further comprises releasing the anchor driver after withdrawal such that the driver spring pushes the anchor driver toward the second anchor in the loading site.

[0324] Example 40. The method of example 39, wherein releasing the anchor driver such that the driver spring pushes the anchor driver toward the second anchor in the loading site comprises releasing the anchor driver such that the anchor driver locks to the second anchor.

[0325] Example 41. The method of any of Examples 34-40, wherein the first anchor is contained in a cartridge, and wherein advancing the first anchor transluminally to the tissue comprises pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device.

[0326] Example 42. The method of Example 41, wherein advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue by sliding an anchor driver through a barrel.

[0327] Example 43. The method of Example 41, wherein pushing the first anchor out of the cartridge and the anchor storage device comprises pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device, threaded onto the anchor driver.

[0328] Example 44. The method of Example 43, further comprising, after disengaging the anchor driver from the anchor, unscrewing the anchor driver from the barrel by withdrawing the anchor driver proximally from the barrel.

[0329] Example 45. An apparatus comprising: (a) a tether; (b) a series of anchors threaded onto the tether; and / or (c) an anchor storage device comprising: (i) a housing rotatable about an axis and comprising a plurality of anchor storage compartments arranged about the axis, each of the anchor storage compartments housing a respective anchor of the series; (ii) a backplate defining an orifice through which each anchor in the series can be pushed distally out of the housing; and / or (iii) a spool having a portion of the tether wound thereon, wherein the housing is rotatable relative to the backplate in a manner that enables each of the anchor storage compartments to be aligned, in sequence, to align with the orifice.

[0330] Example 46. The device of Example 45, wherein the device comprises an implant comprising a tether and a series of anchors.

[0331] Example 47. An apparatus according to any of Examples 45-46, further comprising an anchor driver slidably connected to the anchor storage device and comprising a rod that extends through the orifice to drive an anchor in a series of anchors distally out of the anchor storage device, the anchor being disposed in one of the plurality of anchor storage compartments aligned with the orifice.

[0332] Example 48. The apparatus of Example 47, wherein the housing is rotatable relative to the backplate when the anchor driver is disengaged from the aperture.

[0333] Example 49. The apparatus of any of Examples 47-48, wherein the housing is non-rotatable relative to the backplate when the anchor driver is extended through the aperture.

[0334] Example 50. The apparatus of any of Examples 45 to 49, wherein the housing is manually rotatable relative to the back plate.

[0335] Example 51. The apparatus of example 50, wherein the anchor storage device further comprises an engagement arm, and the outer surface of the housing comprises a ratchet mechanism adapted to be engaged by the engagement arm to effect the measured rotation of the housing relative to the backing plate.

[0336] Example 52. The apparatus of any of Examples 47 to 49, wherein the housing is automatically rotatable relative to the backplate.

[0337] Example 53. The apparatus of Example 52, wherein: (a) the anchor driver defines a drive head at the distal end of the shaft, and / or (b) the housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

[0338] Example 54. The device of example 53, wherein the rod is slidable past the proximal stop.

[0339] Example 55. A device according to any of Examples 53-54, wherein: (a) the device further comprises a driver spring disposed within the housing, and / or (b) the anchor storage device is configured such that withdrawing the anchor driver proximally from the aperture in the backplate compresses the driver spring toward the proximal stop.

[0340] Example 56. The apparatus of Example 55, wherein the driver spring is a helical compression spring.

[0341] Example 57. A device according to any of Examples 55-56, wherein: (a) the anchor driver further defines a lateral protrusion at the distal portion of the rod, and / or (b) the lateral protrusion is sized such that withdrawing the anchor driver proximally from the aperture in the backplate causes the lateral protrusion to press the driver spring toward the proximal stop.

[0342] Example 58. The apparatus of any of Examples 55-57, wherein the anchor driver comprises a ring mounted on the distal portion of the shaft and defining a lateral protrusion.

[0343] Example 59. The apparatus of any of Examples 55-58, wherein the anchor storage device further comprises a ferrule that threads onto the rod and is reversibly positionable within the loading site.

[0344] Example 60. The apparatus of Example 59, wherein the lateral protrusion and the cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the lateral protrusion to draw the cuff proximally to compress the driver spring toward the proximal stop.

[0345] Example 61. The apparatus of any of Examples 55-60, wherein the driver spring is configured to urge the driver head toward the anchor aligned with the aperture.

[0346] Example 62. The apparatus of any of Examples 55-61, wherein the driver head is configured to automatically lock to the anchor upon being pushed to the anchor by the driver spring.

[0347] Example 63. The apparatus of any of Examples 45 to 62, wherein the spool is rotatable relative to the backplate.

[0348] Example 64. The apparatus of Example 63, wherein the spool is rotatable independently of rotation of the housing.

[0349] Example 65. The device of any of Examples 63-64, wherein rotation of the spool tightens the tether during distal delivery of one or more of the series of tissue anchors out of the housing.

[0350] Example 66. The device of example 65, wherein the spool is functionally associated with a spring, the spring configured to rotate the spool, thereby tightening the tether.

[0351] Example 67. An apparatus according to any of Examples 45-66, wherein: (a) the anchor driver defines a driver head at the distal end of the rod, and / or (b) for each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is aligned with the aperture in the backplate.

[0352] Example 68. A device according to Example 67, wherein the anchor driver is configured to: (a) advance the anchor transluminally into the heart of the subject by advancing the rod distally through an orifice in the backplate while the driver head remains engaged with the anchor, and / or (b) anchor the anchor to tissue of the heart while the rod remains extended through the orifice.

[0353] Example 69. The device of Example 68, wherein the device further comprises an anchor release mechanism at the proximal end of the device, the anchor release mechanism adapted to release the anchor from the driver head once the anchor is anchored to tissue.

[0354] Example 70. The apparatus of any of Examples 45-69, further comprising a series of cartridges, each cartridge in the series housing a corresponding anchor in the series, the cartridges being arranged about an axis of the housing.

[0355] Example 71. An apparatus according to any of Examples 45-70, wherein: (a) the apparatus further comprises a catheter coupled to the housing and extending distally away from the housing, and / or (b) the anchor driver is configured to transluminally anchor the anchor to tissue of the heart by advancing the drive head and anchor distally out of the anchor storage device and through the catheter to the heart while the rod remains extended through the orifice in the backplate.

[0356] Example 72. The device of Example 71, wherein the device further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

[0357] Example 73. A method for use with a subject, the method comprising: (a) obtaining an anchor storage device, the anchor storage device comprising a housing rotatable about an axis, the housing comprising a plurality of anchor storage compartments arranged about the axis, each of the anchor storage compartments housing a corresponding anchor from a series of anchors threaded onto a tether, the anchor storage device further comprising a back plate defining an orifice; (b) advancing a first anchor from a series of anchors distally out of one of the anchor storage compartments in the housing through the orifice and transluminally into tissue of the subject by sliding an anchor driver engaged with the anchor distally through the orifice in the back plate; (c) subsequently disengaging the anchor driver from the anchor within the subject and withdrawing the anchor driver proximally from the orifice; and / or (d) subsequently rotating the housing relative to the back plate about the axis to align a second anchor from the series with the orifice in the back plate.

[0358] Example 74. The method of Example 73, wherein rotating comprises manually rotating the housing about the axis.

[0359] Example 75. A method according to Example 74, wherein: (a) the anchor driver includes a drive head, (b) sliding the anchor driver into engagement with the anchor includes sliding the anchor driver while the drive head is engaged with the anchor, and / or (c) drawing and removing the anchor driver proximally from the orifice includes drawing the anchor driver proximally from the orifice while the drive head is withdrawn from the anchor storage device.

[0360] Example 76. The method of Example 73, wherein rotating comprises automatically rotating the housing about an axis.

[0361] Example 77. A method according to Example 76, wherein: (a) the anchor driver includes a drive head, (b) sliding the anchor driver into engagement with the anchor includes sliding the anchor driver while the drive head is engaged with the anchor, and / or (c) drawing and removing the anchor driver proximally from the orifice includes drawing the anchor driver proximally from the orifice without withdrawing the drive head from the anchor storage device.

[0362] Example 78. The method of any of Examples 76-77, wherein drawing and withdrawing the anchor driver proximally from the loading site comprises withdrawing the anchor driver proximally from the loading site such that the driver spring is compressed within the anchor storage device.

[0363] Example 79. The method of example 78, wherein the automatic rotation comprises releasing the anchor driver after extraction such that the driver spring rotates the housing to align the second anchor with the orifice.

[0364] Example 80. The method of Example 79, wherein releasing the anchor driver comprises releasing the anchor driver such that the anchor driver locks to a second anchor aligned with the orifice.

[0365] Example 81. The method of any of Examples 73-80, wherein advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue through a catheter.

[0366] Example 82. The method of Example 81, wherein the method further comprises actively guiding the catheter toward the tissue through a vasculature of the subject.

[0367] Example 83. The method of any of Examples 73-82, wherein the first anchor is contained in a cartridge, and wherein advancing the first anchor transluminally to the tissue comprises pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device.

[0368] Example 84. The method of Example 83, wherein advancing the first anchor transluminally to the tissue comprises advancing the first anchor transluminally to the tissue by sliding an anchor driver through a barrel.

[0369] Example 85. The method of any of Examples 83-84, wherein pushing the first anchor out of the cartridge and the anchor storage device comprises pushing the first anchor out of the cartridge and the anchor storage device while the cartridge remains within the anchor storage device, threaded onto the anchor driver.

[0370] Example 86. The method of Example 85, further comprising, after disengaging the anchor driver from the anchor, unscrewing the anchor driver from the barrel by withdrawing the anchor driver proximally from the barrel.

[0371] Example 87. The method of any of Examples 73-86, further comprising repeating the steps of advancing, disengaging, and rotating for each anchor in a series of anchors.

[0372] Any of the various systems, assemblies, devices, apparatuses, etc. of the present disclosure may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use by patients, and the methods herein may include (or the additional methods may include or consist of) sterilization (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of the relevant systems, assemblies, apparatuses, etc.

[0373] Furthermore, while reference has been made throughout this application to tissue anchors, it should be understood that the methods and systems for containing and handling tissue anchors described herein can be used with other implantable and / or anchorable elements besides tissue anchors, for example, neurostimulators, leadless pacemakers, darts, hooks, staples, sutures, etc. In some embodiments, a cartridge such as cartridge 150 may or may not be used to contain such elements within a storage device.

[0374] The therapeutic techniques, methods, procedures, steps, etc. described or suggested herein or in the references cited herein can be performed on a living subject (e.g., a human, other animal, etc.) or on a non-living simulator (e.g., a cadaver, a cadaver heart, a simulator, a virtual human, etc.). When performed on a simulator, the body part (e.g., a heart, tissue, a valve, etc.) can optionally be referred to as "simulated" (e.g., a simulated heart, simulated tissue, a simulated valve, etc.) and can include, for example, a computerized and / or physical representation of the body part, tissue, etc.

Claims

1. A system comprising: a series of anchors; An anchor storage device comprising: Springs; and A housing, which is shaped to define: Loading area, and a helical channel that spirals inwardly to the loading site, the series of anchors being arranged along the helical channel, the spring being configured to urge the series of anchors along the helical channel toward the loading site; and An anchor driver is slidably coupled to the anchor storage device and includes a rod extendable through the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

2. The system of claim 1, wherein the system comprises an implant comprising the series of anchors and tethers extending between the anchors in the series.

3. The system of any one of claims 1 to 2, wherein the spring is positioned along a portion of the channel.

4. The system according to any one of claims 1 to 3, wherein: The anchor driver defines a drive head at a distal end of the rod, and For each anchor in the series, the anchor is configured to be engaged by the driver head when the anchor is positioned in the loading site.

5. The system of claim 4, wherein the anchor driver is configured to: advancing the anchor transluminally into the heart of the subject by advancing the rod distally through the loading site while the driver head remains engaged with the anchor, and The anchor is anchored to tissue of the heart while the rod remains extended through the loading site.

6. The system of claim 5, wherein the system further comprises an anchor release mechanism at the proximal end of the system, the anchor release mechanism adapted to release the anchor from the driver head once the anchor is anchored to the tissue.

7. The system of any one of claims 1 to 6, wherein the urging of the series of anchors by the spring automatically moves the anchors in the series into the loading site upon withdrawal of the rod from the loading site.

8. The system of claim 7, wherein the spring is disposed within the helical channel and is configured to automatically expand within the channel upon withdrawal of the rod from the loading station.

9. The system of claim 7, wherein: The anchor driver defines a drive head at a distal end of the rod, and The housing defines a proximal stop that blocks proximal exit of the drive head from the anchor storage device.

10. The system of claim 9, wherein the rod is slidable past the proximal stop.

11. The system of claim 9, wherein: The system also includes a driver spring disposed within the housing, and The anchor storage device is configured such that proximally withdrawing the anchor driver from the loading station compresses the driver spring toward the proximal stop.

12. The system of claim 11, wherein the driver spring is a helical compression spring.

13. The system of claim 11, wherein: The anchor driver further defines a lateral protrusion at a distal portion of the shaft, and The lateral projections are sized such that proximally withdrawing the anchor driver from the loading site causes the lateral projections to compress the driver spring toward the proximal stop.

14. The system of claim 13, wherein the anchor driver comprises a ring mounted on the distal portion of the shaft and defining the lateral protrusion.

15. The system of claim 13, wherein the anchor storage device further comprises a ferrule that threads onto the rod and is reversibly positionable within the loading site.

16. The system of claim 15 wherein the lateral projections and the cuff are shaped and positioned such that withdrawing the anchor driver proximally from the loading site causes the lateral projections to pull the cuff proximally to compress the driver spring toward the proximal stop.

17. The system of claim 16, wherein the anchor driver is extendable through the loading site in a manner to position the cuff within the loading site in a manner that blocks entry of the series of anchors from the helical channel into the loading site.

18. The system of claim 11, wherein the driver spring is configured to urge the driver head to the anchor at the loading site.

19. The system of claim 18, wherein the driver head is configured to automatically lock to the anchor upon being urged to the anchor by the driver spring.

20. The system of any one of claims 1 to 19, wherein the housing defines an opening in communication with the loading site, the opening being configured to allow the anchor driver to push each anchor distally out of the loading site.

21. The system of claim 20, wherein the helical channel circumscribes an axis, and wherein the opening is configured to allow the anchor driver to push each anchor distally along the axis out of the loading site.

22. The system of claim 21, wherein the spring is arcuate about the axis.

23. The system of claim 20, wherein: The anchor driver has a drive head at the distal end of the rod, and For each anchor: The drive head is configured to engage the anchor, and The anchor driver is configured to transluminally anchor the anchor to tissue of the subject's heart by advancing the drive head and the anchor distally through the opening, out of the anchor storage device, and transluminally to the heart while the rod remains extended through the loading site.

24. The system of claim 23, further comprising a series of cartridges, each cartridge in the series housing a corresponding anchor in the series and arranged along the helical channel.

25. The system of claim 24, wherein: For each cartridge in the series, the housing is configured to retain the cartridge as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

26. The system of claim 25, wherein the housing defines a receptacle that communicates with the loading site via the opening and is sized to retain each cartridge in the series therein.

27. The system of claim 26, wherein the receptacle is positioned distally of the helical channel.

28. The system of claim 26, wherein the receptacle defines a back plate defining an aperture sized, for each anchor in the series, to allow the anchor to exit distally from the housing without allowing a corresponding cartridge.

29. The system of claim 28, wherein each cartridge in the series is configured to remain threaded onto the rod within the receptacle as the anchor driver pushes the corresponding anchor distally out of the anchor storage device.

30. The system of claim 29, wherein each cartridge in the series is shaped such that proximally withdrawing the anchor driver from the receptacle rotates the cartridge out of the shaft such that the cartridge remains within the receptacle.

31. The system of claim 23, wherein: The system also includes a catheter coupled to the housing and extending distally away from the housing, and The anchor driver is configured to transluminally anchor the anchor to the tissue of the heart by advancing the driver head and the anchor distally through the opening, out of the anchor storage device, and through the catheter to the heart while the rod remains extended through the loading site.

32. The system of claim 31 , wherein the system further comprises a catheter control handle adapted to facilitate transluminal guidance of the catheter to the heart.

33. The system of claim 32, wherein the catheter control handle is positioned axially between the anchor storage device and the catheter.

34. An apparatus comprising: tether; a series of anchors threaded onto the tether; as well as An anchor storage device comprising: a housing rotatable about an axis and comprising a plurality of anchor storage compartments arranged about the axis, each of the anchor storage compartments housing a respective anchor of the series of anchors; a back plate defining an aperture through which each anchor in the series can be pushed distally out of the housing; and a spool having a portion of the tether wound thereon; wherein the housing is rotatable relative to the back plate in a manner that enables each of the anchor storage compartments to be aligned sequentially to align with the aperture.

Images