Systems and techniques for percutaneous control of slack in tethers

Abstract

Techniques are described for controlling slack in a tether of an implant during implantation of the implant. An implant (140) includes a spool (147) and a tether (148) coupled to the spool. A delivery tool (110) is configured to transluminally deliver the implant to the heart. The delivery tool may include a shaft (116), a handle (112), and a depth stop (120) extending axially from the handle. The shaft is coupled with the spool. The handle includes a controller (114) and is coupled with a proximal portion of the shaft such that distal movement of the handle may move the shaft distally into the heart. The controller is operatively coupled with the spool and the depth stop such that operation of the controller adjusts an amount of winding of the tether about the spool and also adjusts an axial extension of the depth stop from the handle. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 336,489 filed by Pesach et al. on April 29, 2022, which is incorporated herein by reference for all purposes. Background Art

[0003] Dilation of the native valve annulus can prevent the valve leaflets from fully coapting when the valve closes. Backflow of blood through the valve in the wrong direction (e.g., from the left ventricle into the left atrium, etc.) leads to increased total stroke volume and decreased cardiac output, and eventual weakening of the heart (e.g., weakening of the ventricles and volume and pressure overload of the left atrium).

[0004] Chronic or acute ventricular dilatation may result in displacement of the papillary muscles and increased leaflet tethering due to tension on the chordae tendineae, as well as annular dilatation.

[0005] Several techniques and implants used to treat these and other conditions utilize the implantation of tethers or similar elongated and / or tensile members. Summary of the invention

[0006] The present invention is intended to provide some examples, and is not intended to limit the scope of the present disclosure in any way. For example, any feature included in the examples of the present invention is not required by the claims, unless the claims clearly state these features. In addition, the described features can be combined in a variety of ways. Various features and steps as described elsewhere in the present disclosure can be included in the examples summarized here.

[0007] Methods and systems for controlling slack in a tether of an implant during implantation of the implant are disclosed.For example, the methods and systems described herein may relate to methods and systems for controlling slack in a tether during advancement of a component of an implant from a first location within the heart toward a second location within the heart.

[0008] In some embodiments, the implant can be a tissue modification implant, such as a leaflet augmentation implant, a prosthetic cable implant, or an annulus forming implant, and the tether can be used to together pump, constrict, and / or restrict movement of tissue of the heart.

[0009] In some embodiments, a tether can be used to tether a first component of an implant (which can be secured to tissue at a first location in the heart) to a second component of an implant (which can be secured to tissue at a second location in the heart), e.g., to draw the first component and / or the second component together and / or to limit movement of the first component and / or the second component. Alternatively or additionally, a tether can be configured to contract a component of the implant.

[0010] In some embodiments, a tether (e.g., a first end of a tether that can be connected to a first component of an implant) is secured to the heart at a first location, and then a second component of the implant coupled to the tether (e.g., coupled to a second end of the tether) is advanced away from the first location of the heart toward a second location, e.g., to secure the tether at the second location (e.g., by securing the second component at the second location).

[0011] In some embodiments, devices and techniques are described for reducing excess slack in a tether during implantation of an implant (e.g., during advancement of a second component toward a second site), e.g., to reduce the likelihood of tether entanglement and / or invagination. Similarly, in some embodiments, devices and techniques are described for providing sufficient slack in a tether during implantation of an implant (e.g., during advancement of a second component toward a second site), e.g., to reduce the likelihood of a tether becoming entangled in a first site or disconnected from the first site. For example, devices and techniques are described to ensure that a tether is gradually released during movement of a second component toward a second site.

[0012] In some embodiments, the second component comprises a capstan including a spool around which the distal portion of the tether is wound.

[0013] In some embodiments, a delivery tool (e.g., a delivery tool that can be used for delivery, positioning, and implantation of an implant) may include an external handle coupled to a flexible shaft (e.g., a catheter or sheath) that extends from the handle to the implant. Due to this coupling, an implant (e.g., a capstan of an implant) can be moved in the vascular system (e.g., in the heart) by advancing and extracting the handle, and thereby advancing and extracting the delivery tool. For example, the capstan is pushed distally through the vascular system by pushing the handle distally, and the capstan is pulled proximally in the vascular system by pulling the handle proximally.

[0014] In some embodiments, the handle may be adapted to control the winch so as to control the amount of tether contained by / released from the winch.For example, the handle may include a winch controller operatively coupled to the winch.

[0015] In some embodiments, the handle is arranged so that axial movement of the handle is limited in a manner related to operation of the capstan (e.g., by a limiter) to ensure that the tether has sufficient but not excessive slack as the capstan is moved through the vasculature by axial movement of the handle.

[0016] In some embodiments, after the tether has been fixed to the first location, the axial movement of the handle in the direction that the capstan moves toward the second location may be limited. Some tethers are released from the capstan to modify the limit in a manner that allows further advancement in this direction. In some embodiments, this is achieved by a delivery tool that includes a limiter that limits the axial movement of the handle and associates these limits with the amount of the tether released from the capstan.

[0017] In some embodiments, this limitation is provided by a handle that includes a depth stop that extends axially from the handle and acts as a limiter (or a component thereof).

[0018] In some embodiments, the handle may be limited from axial movement by a depth stop that abuts a mount or other component in the path of the depth stop.

[0019] In some embodiments, the capstan controller, in addition to being operatively coupled to the spool, is also operatively coupled to the depth stop such that operation of the capstan controller in a manner that operates the capstan also adjusts the axial extension of the depth stop relative to the handle, and thereby adjusts the extent to which the handle can be axially moved (e.g., relative to the mounting member).

[0020] Alternatively or additionally, a distal portion of the shaft (eg, a portion of the shaft adapted to position an implant within the heart) can include a telescoping assembly (eg, a distal portion and a proximal portion that are axially slidable relative to each other).

[0021] In some embodiments, the handle includes a shaft controller (e.g., a shaft extender) operatively coupled to the shaft such that operation of the shaft controller reversibly extends the distal portion of the shaft distally from the proximal portion of the shaft. Thus, in some embodiments, advancement of the capstan from a first location to a second location can be accomplished by telescopically extending the shaft within the heart.

[0022] In some embodiments, the shaft controller may be operatively coupled to the winch controller in a manner that limits telescopic extension based on the amount of tether paid out from the winch, thereby defining a limiter having similar functionality to that described above, albeit without a depth stop.

[0023] In some embodiments, an operative connection between the axis controller and the capstan controller can be such that operating the axis controller to extend the axis within the heart (e.g., causing the capstan to move toward the second location) causes the capstan controller to automatically operate (e.g., causing more of the tether to be exposed within the heart). Such a connection between the axis controller and the capstan controller can automatically ensure that the tether is paid out at a rate required for movement of the capstan, thereby preventing excessive slack in the tether and / or tether wrapping around the first location.

[0024] Additional techniques for controlling excess slack in a tether of an implant during implantation of the implant are also described. For example, and similar to the methods and systems described above, the current techniques can be used to prevent excess slack in a tether during advancement of a portion (e.g., an end portion) of a tether from a first location within the heart to which the tether is attached toward a second location within the heart, e.g., to reduce the likelihood of tether entanglement and / or intussusception. Similarly, the described devices and techniques can be used to reduce the likelihood of a tether becoming entangled on or disconnected from a first location.

[0025] In some embodiments, during the implant is advanced from the first site toward the second site, a part of the tether is limited in the passage (e.g., in the lumen of the catheter), and is gradually released as the end portion of the tether is advanced to the second site. For example, the middle portion of the tether can extend into the passage and return to leave the passage as a bend, and extend toward the end portion of the tether. In some embodiments, limiting this middle portion of the tether can prevent the tether from tangling and / or folding in the heart during the advancement and / or implantation of the implant.

[0026] In some embodiments, this restriction is achieved by a retaining member at least partially disposed within the channel. A portion of the retaining member (e.g., an end portion) can be constrained within the channel to define a hook through the inner wall of the channel, the hook hooking the bend, thereby retaining the middle portion within the channel.

[0027] In some embodiments, the retaining member includes a deformable portion that is deformable such that pulling the tether (e.g., due to moving the end portion of the tether toward the second location) can pull the hook toward the distal opening of the passage, thereby increasing the amount of the tether exposed within the heart. That is, the tether can be gradually released from the passage as it is pulled. Once a predetermined amount of pulling has occurred, the hook is exposed from the opening of the passage and responsively opens and unhooks from the bend (e.g., pulled away by the tether).

[0028] In some embodiments, the predetermined pull amount of hook exposure can depend on the deformability (eg, flexibility and / or stretchability) of the retaining member and / or the length of the channel.

[0029] In some embodiments, the deformable portion of the retaining member is elastically deformable so that if the tether is pulled, but not to a predetermined amount (and thus the bend of the tether is retained within the channel by being caught by the hook), the relaxation of the pulling causes the retaining member to pull the tether back into the channel. For example, the deformable portion can be a spring (e.g., an extension spring).

[0030] In some embodiments, the predetermined pull amount of hook exposure can depend on the spring constant of the spring and / or the length of the channel. Such an elastically deformable portion can allow the end of the tether to be repeatedly repositioned within the heart while maintaining tension on the tether (e.g., a small amount of tension sufficient to reduce slack without interfering with repositioning).

[0031] In some embodiments, the retaining member is plastically deformable.Thus, in some embodiments, the predetermined pull amount of hook exposure may depend on the plasticity of the retaining member and / or the length of the channel.

[0032] In some embodiments, the retaining member comprises an elongated element (e.g., a needle, suture, thread, or wire), a portion of which is constrained by a channel to define a hook. In some embodiments, the same elongated element is also shaped to define a deformable portion (e.g., a spring) of the retaining member, for example, a unitary elongated member (e.g., a single wire) defines both the deformable portion and the hook.

[0033] In some embodiments, rather than an elongated element constrained by a channel to define a hook, a retaining member is provided that includes an elongated member (e.g., a needle, suture, thread, or wire) that extends distally through the channel, loops around the bend of the tether, and returns proximally through the channel.

[0034] In some embodiments, one or both ends of the elongated member are disposed outside of the proximal opening of the channel and can be disposed at a proximal portion of the system that is configured to remain external to the subject.

[0035] In some embodiments, pulling the tether (eg, an end portion of the tether) within the heart pulls the loop toward the distal opening of the passage, thereby increasing the amount of the tether exposed from the passage within the heart.

[0036] Once advancement of the end portion is determined to be complete (eg, once the end portion reaches the second location), the bend can be released from the elongate member by releasing the loop from around the bend (eg, by releasing one end of the elongate member and pulling the other end of the elongate member).

[0037] In some embodiments, the end of the elongated member is coupled to a deformable member, for example, to maintain tension on the tether (eg, a small amount of tension sufficient to reduce slack).

[0038] The above methods / procedures and steps herein may be performed on a live animal or on a mimetic, such as a cadaver, a cadaver heart, a mimetic (eg, having a simulated body part, heart, tissue, etc.).

[0039] According to some embodiments, a system (e.g., for use with a subject's heart or a system that can be used with a subject's heart) includes an implant and a delivery tool. In some embodiments, the implant includes (i) a capstan, the capstan including a bobbin, and (ii) a tether, the tether being coupled to the bobbin. In some embodiments, the delivery tool is configured to deliver the implant to the heart transcavitary.

[0040] In some embodiments, the delivery tool comprises a shaft coupled to the capstan. The shaft can be configured to position the capstan transluminally within the heart.

[0041] In some embodiments, the delivery tool comprises a handle including a capstan control that can be coupled to a proximal portion of the shaft such that distal movement of the handle moves the capstan distally into the heart.

[0042] In some embodiments, the proximal portion of the shaft defines an axis of the delivery tool.

[0043] In some embodiments, the delivery tool includes a depth stop that can extend outwardly (eg, axially) from the handle.

[0044] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that operation of the winch controller in a manner that adjusts the amount of spooling of the tether around the spool also adjusts the axial extension of the depth stop from the handle.

[0045] In some embodiments, the depth stop comprises a rod.

[0046] In some embodiments, the depth stop extends parallel to the axis.

[0047] In some embodiments, the shaft is configured to transluminally position the capstan within the heart while the shaft extends from the handle through the vasculature of the subject to the capstan within the heart.

[0048] In some embodiments, the winch controller includes a control knob and is operatively coupled to the winch and the depth stop such that rotation of the control knob in a manner that adjusts the amount of spooling of the tether around the spool also adjusts the axial extension of the depth stop from the handle.

[0049] In some embodiments, the capstan controller is operatively coupled to the capstan and the depth stop via a rotary-to-linear mechanism.

[0050] In some embodiments, the rotary-to-linear mechanism includes a worm drive.

[0051] In some embodiments, the implant includes an anchor coupled to the capstan and configured to anchor the capstan to tissue at a site in the heart.

[0052] In some embodiments, the anchor is a second anchor, the site is a second site, and the implant further includes a first anchor coupled to the first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart. In some embodiments, the shaft is configured to advance the capstan and the second anchor transluminally toward the second site while the first anchor remains anchored at the first site.

[0053] In some embodiments, the first site is a leaflet site at a leaflet of a valve of the heart, and the first anchor is a leaflet anchor adapted to be anchored to the leaflet. In some embodiments, the second site is a ventricular site in a ventricle downstream of the valve, the second anchor is a ventricular anchor, and the shaft is configured to advance the capstan and the ventricular anchor transcavitarily toward the ventricular site while the first anchor remains anchored at the leaflet site.

[0054] In some embodiments, the delivery tool has a configuration wherein the depth stop extends distally from the handle.

[0055] In some embodiments, the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop proximally relative to the handle.

[0056] In some embodiments, the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop distally relative to the handle.

[0057] In some embodiments, the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop distally relative to the handle.

[0058] In some embodiments, the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop proximally relative to the handle.

[0059] In some embodiments, the state is a first state, and wherein the delivery tool has a second state wherein the depth stop extends proximally from the handle.

[0060] In some embodiments, in the state, the depth stop extends both distally and proximally from the handle.

[0061] In some embodiments, the system further includes a mounting member, the handle is mountable in the mounting member, and when the handle is mounted in the mounting member, the mounting member is configured to block axial movement of the depth stop along the axial path by being disposed in the axial path.

[0062] In some embodiments, the mount extends perpendicular to the axis.

[0063] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that (i) operation of the winch controller in a manner that reduces the amount of tether wrap around the spool also moves the depth stop proximally relative to the mount, and (ii) operation of the winch controller in a manner that increases the amount of tether wrap around the spool also moves the depth stop distally relative to the mount.

[0064] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that: (i) operation of the winch controller in a manner that increases the amount of tether wrap around the spool also moves the depth stop proximally relative to the mount, and (ii) operation of the winch controller in a manner that decreases the amount of tether wrap around the spool also moves the depth stop distally relative to the mount.

[0065] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that operation of the winch controller in a manner that adjusts the amount of spooling of the tether around the spool also adjusts the axial position of the depth stop relative to the mount.

[0066] In some embodiments, the mounting member includes: (i) a distal stop, which is positioned to block the depth stop from moving distally by being disposed in the axial path when the handle is mounted in the mounting member; and (ii) a proximal stop, which is positioned to block the depth stop from moving proximally by being disposed in the axial path when the handle is mounted in the mounting member.

[0067] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that: (i) operation of the winch controller in a manner that reduces the amount of tether wrap around the spool also moves the depth stop axially away from the distal stop, and (ii) operation of the winch controller in a manner that increases the amount of tether wrap around the spool also moves the depth stop axially toward the distal stop.

[0068] In some embodiments, the winch controller is operatively coupled to the winch and the depth stop such that: (i) operation of the winch controller in a manner that reduces the amount of tether wrap around the spool also moves the depth stop axially toward the distal stop, and (ii) operation of the winch controller in a manner that increases the amount of tether wrap around the spool also moves the depth stop axially away from the distal stop.

[0069] According to some embodiments, a method (eg, for use or usable with a subject's heart) comprises using a delivery tool having a handle to transluminally advance a capstan operatively coupled to a tether to the subject's heart.

[0070] In some embodiments, the method includes attaching a tether to tissue at a first site within the heart.

[0071] In some embodiments, the method includes (i) operating a capstan controller of a handle to actuate the capstan and move a depth stop extending axially from the handle in a first axial direction relative to the handle; and / or (ii) advancing the capstan away from the first location by advancing the handle of the delivery tool in a second axial direction opposite to the first direction while the tether remains connected to the tissue at the first location.

[0072] In some embodiments, advancing the capstan away from the first position includes advancing the capstan away from the first position after operating a capstan controller of the handle to actuate the capstan.

[0073] In some embodiments, the method further comprises mounting the handle in a mount.

[0074] In some embodiments, installing the handle in the mount includes installing the handle in the mount after the step of advancing the capstan transluminally into the heart and before the step of operating the capstan controller.

[0075] In some embodiments, operating the capstan control includes operating the capstan control to move the depth stop in a first axial direction relative to the handle such that the depth stop approaches a stop defined by the mount.

[0076] In some embodiments, operating the winch controller includes operating the winch controller until the depth stop abuts the stop.

[0077] In some embodiments, advancing the handle of the delivery tool in the second axial direction includes advancing the handle of the delivery tool in the second axial direction such that the depth stop approaches a stop defined by the mount.

[0078] In some embodiments, advancing the handle of the delivery tool in the second axial direction includes advancing the handle of the delivery tool in the second axial direction until the depth stop abuts the stop.

[0079] In some embodiments, the steps of operating the capstan controller and advancing the capstan are performed at least iteratively until the capstan reaches a second location within the heart.

[0080] In some embodiments, the method further comprises anchoring the capstan to tissue at the second site.

[0081] In some embodiments, the method further includes actuating the capstan to adjust an amount of tether paid out from the capstan after anchoring the capstan to tissue at the second site by operating a capstan controller.

[0082] In some embodiments, the method further includes actuating the capstan to adjust tension on the tether by operating a capstan controller after anchoring the capstan to the tissue at the second site.

[0083] The above methods can be performed on a living animal or on a simulated object, such as a cadaver, a cadaver heart, a simulated body (eg, having a simulated body part, tissue, etc.).

[0084] According to some embodiments, a system (e.g., for use with or usable with the heart of a subject) comprises: (i) an implant comprising a spool and a tether coupled to the spool; and (ii) a delivery tool configured to deliver the implant transluminally to the heart.

[0085] In some embodiments, the delivery tool includes a shaft coupled to the spool and configured to transluminally position the spool within the heart.

[0086] In some embodiments, the delivery tool includes (i) a mounting member and / or (ii) a handle that is mountable on the mounting member and coupled to the proximal end of the shaft such that axial movement of the handle relative to the mounting member causes axial movement of the shaft relative to the mounting member.

[0087] In some embodiments, the delivery tool includes a limiter configured to define a limit to which the handle can move axially relative to the mount.

[0088] In some embodiments, the handle includes a controller that operatively couples the spool with the limiter such that operation of the controller in a manner that adjusts the amount of wrapping of the tether around the spool also modifies the limit.

[0089] In some embodiments, the limiter comprises a depth stop.

[0090] In some embodiments, the delivery tool comprises a shaft controller adapted to extend the shaft within the heart.

[0091] In some embodiments, operating the shaft controller to lengthen the shaft within the heart causes the controller to automatically operate to increase the amount of tether exposed within the heart.

[0092] In some embodiments, the shaft is configured to transluminally position the spool within the heart while the shaft extends from the handle through the vasculature of the subject to the spool within the heart.

[0093] In some embodiments, the controller includes a control knob and is operatively coupled to the spool and the limiter such that rotation of the control knob adjusts the amount of wrapping of the tether around the spool and also modifies the limit.

[0094] In some embodiments, the controller is operatively coupled to the spool and the limiter via a rotary-to-linear mechanism.

[0095] In some embodiments, the rotary-to-linear mechanism comprises a worm drive.

[0096] In some embodiments, the implant comprises an anchor coupled to the spool and / or configured to anchor the spool to tissue at a site in the heart.

[0097] In some embodiments, the anchor is a second anchor and the site is a second site. In some embodiments, the implant further comprises a first anchor coupled to the first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart. In some embodiments, the shaft is configured to cause the spool and the second anchor to be advanced transluminally toward the second site while the first anchor is anchored at the first site.

[0098] In some embodiments, the first site is a leaflet site at a leaflet of a valve of the heart, the first anchor is adapted to be anchored to the leaflet site, the second site is a ventricular site in a ventricle downstream of the valve, and / or the second anchor is adapted to be anchored to the ventricular site.

[0099] In some embodiments, the shaft is configured to transluminally advance the spool and the second anchor toward the ventricular site while the first anchor is anchored at the leaflet site.

[0100] In some embodiments, when the handle is mounted on the mount, the mount is positioned in the axial path such that when the handle reaches the limit, the mount blocks the axial movement of the handle.

[0101] In some embodiments, the mount includes a distal stop positioned to block distal movement of the limiter by being disposed in the axial path when the handle is mounted on the mount.

[0102] In some embodiments, a proximal stop is positioned to block proximal movement of the limiter by being disposed in the axial path when the handle is mounted on the mount.

[0103] In some embodiments, the handle can be mounted on the mount after the shaft transluminally positions the spool within the heart.

[0104] In accordance with some embodiments, a system for controlling slack in a tether during implantation of the tether into the heart of a subject (e.g., a living subject or a simulator), the system comprising: (i) a tether having a first end portion, a second end portion, and defining a bend therebetween (e.g., shaped to form an open loop therebetween); and (ii) a delivery tool configured to secure the first end portion of the tether and the second end portion of the tether within the heart.

[0105] In some embodiments, the delivery tool comprises a channel having an inner wall and a distal opening.

[0106] In some embodiments, the delivery tool includes a retaining member constrained by the inner wall to define a hook within the channel.

[0107] In some embodiments, the bend of the tether is trapped within the channel by hooking onto the hook.

[0108] In some embodiments, the retaining member can be deformed in response to pulling the tether out of the distal opening in a manner that moves the hook toward the distal opening.

[0109] In some embodiments, the retaining member is configured such that when the hook exits the channel through the distal opening, the hook responsively opens and unwinds from the bend.

[0110] In some embodiments, the retaining member includes a deformable portion that can plastically deform in response to pulling on the tether.

[0111] In some embodiments: (i) the delivery tool includes a shaft and an extracorporeal handle coupled to a proximal portion of the shaft, and / or (ii) the distal portion of the shaft is coupled to a tether, such that when the shaft is positioned through the vasculature of a subject to the tether within the heart, the shaft is configured to transluminally position the tether within the heart by pulling the tether out of the distal opening in a manner that moves the hook toward the distal opening.

[0112] In some embodiments, the delivery tool includes a tube defining a passageway, and the shaft extends through the tube and is configured to transluminally position the tether within the heart by sliding the shaft distally out of the tube in a manner that pulls the tether distally out of a distal opening.

[0113] In some embodiments, the handle is coupled to the proximal portion of the tube, and the handle is configured to slide the shaft distally outwardly away from the tube.

[0114] In some embodiments, the retaining member includes a deformable portion that is elastically deformable in response to pulling on the tether and is adapted to draw the tether back into the channel in response to release of the pulling on the tether.

[0115] In some embodiments, the deformable portion includes a spring.

[0116] In some embodiments, the retaining member comprises a unitary elongated member shaped to define a deformable portion and a hook.

[0117] In some embodiments, the system includes an implant comprising a tether, a first component, and a second component, the tether tethering the first component to the second component.

[0118] In some embodiments, the delivery tool is configured to: (A) anchor the first component at a first site within the heart, and (B) subsequently advance the second component from the first site toward a second site within the heart, while (i) the first component remains anchored at the first site and (ii) the bend of the tether is held confined within the channel by the hook of the retaining member.

[0119] In some embodiments, the second component includes a winch operatively coupled to a tether.

[0120] In some embodiments, the first site is a leaflet site at a leaflet of a valve of the heart, and the first component is a leaflet anchor adapted to be anchored to the leaflet. In some embodiments, the second site is a ventricular site in a ventricle downstream of the valve, and the second component is a ventricular anchor adapted to be anchored to ventricular tissue. In some embodiments, the delivery tool is configured to advance the ventricular anchor transluminally toward the ventricular site while the first component remains anchored at the leaflet site.

[0121] According to some embodiments, a method (e.g., for use with or usable with the heart of a subject) comprises: (i) advancing a tether to the heart using a delivery tool having a channel defined at a distal portion thereof while a bend of the tether is maintained within the channel by a hook disposed in the channel; and (ii) while the distal portion of the delivery tool is disposed within the heart, gradually pulling the tether out of an opening of the channel such that the hook moves toward the opening of the channel.

[0122] In some embodiments, the method includes subsequently releasing the bend from the hook by pulling the tether sufficiently to pull the hook out of the opening such that the hook responsively unhooks from the bend.

[0123] In some embodiments, a portion of the retaining member is fixed relative to the channel at the attachment site, and gradually pulling the tether out of the opening of the channel includes gradually pulling the tether away from the attachment site and out of the opening of the channel.

[0124] In some embodiments: (i) the hook is a component of the retaining member, the retaining member further includes a deformable portion connected to the hook, and (ii) gradually pulling the tether out of the opening of the channel includes gradually pulling the tether out of the opening of the channel so that the deformable portion deforms as the hook moves toward the distal opening.

[0125] In some embodiments, pulling the tether sufficiently to pull the hook out of the opening includes withdrawing the delivery tool proximally away from the tether while the tether remains within the heart.

[0126] In some embodiments: the tether is a component of the implant, the implant further comprises an anchor coupled to the tether, and / or the method further comprises anchoring the anchor to tissue of the heart.

[0127] In some embodiments, anchoring the anchor to the tissue of the heart includes anchoring the anchor to the tissue of the heart after releasing the hook from the bend.

[0128] In some embodiments, anchoring the anchor to the tissue of the heart includes anchoring the anchor to the tissue of the heart before releasing the hook from the bend.

[0129] In some embodiments, the implant further comprises a capstan, and anchoring the anchor comprises anchoring the capstan to the tissue by anchoring the anchor.

[0130] In some embodiments, the method further comprises adjusting an amount of tether paid out from the capstan by actuating the capstan after anchoring the capstan to the tissue.

[0131] In some embodiments, the method further comprises adjusting the tension on the tether by actuating the capstan after anchoring the capstan to the tissue.

[0132] In some embodiments: (i) the anchor is a second anchor, the implant further includes a first anchor coupled to the tether, and (ii) anchoring the anchor includes anchoring the second anchor at a second location within the heart such that the tether extends from the second anchor anchored at the second location to the first anchor.

[0133] In some embodiments, the method further includes anchoring the first anchor at the first site within the heart before anchoring the second anchor at the second site.

[0134] In some embodiments, gradually pulling the tether out of the opening of the passage comprises gradually pulling the tether out of the opening of the passage by advancing the second anchor away from the first location toward the second location after anchoring the first anchor.

[0135] The above methods can be performed on a living animal or on a simulated object, such as a cadaver, a cadaver heart, a simulated body (eg, having a simulated body part, tissue, etc.).

[0136] In accordance with some embodiments, a system for controlling slack in a tether of an implant during implantation of the tether into the heart of a subject (e.g., a living subject or a simulator), the system comprising: (i) an implant comprising a tether having a first end portion, a second end portion, and a bend therebetween; and (ii) a delivery tool configured to secure the first end portion of the tether and the second end portion of the tether within the heart.

[0137] In some embodiments, the delivery vehicle comprises an in vitro control moiety.

[0138] In some embodiments, the delivery tool includes a shaft extending from the external control portion to the implant, and the shaft is adapted to position the implant within the heart.

[0139] In some embodiments, the delivery tool includes a channel with a distal opening at a distal portion of the shaft and an elongated member coupled to the extracorporeal control portion and extending away from the extracorporeal control portion to form a loop within the channel.

[0140] In some embodiments, the system has a delivery state wherein: (i) the bend of the tether is positioned within the channel, (ii) the first end portion and the second end portion of the tether are positioned outside of the distal opening of the channel, and (iii) the elongated member defines the bend of the tether within the channel by being wrapped around the bend.

[0141] In some embodiments, at least a portion of the elongate member can be separated from the extracorporeal control portion to facilitate release of the bend from the elongate member by unbending the elongate member from the bend.

[0142] In some embodiments, in the delivery state, both the first end and the second end of the elongate member are coupled to an extracorporeal control portion.

[0143] In some embodiments, the implant further comprises a first component and a second component, the tether tethering the first component to the second component.

[0144] In some embodiments, the delivery tool is configured to: (A) anchor the first component at a first site within the heart, and (B) subsequently advance the second component away from the first site toward a second site within the heart, while (i) the first component remains anchored at the first site and (ii) the bend of the tether is maintained within the channel by the slender member wrapped around the bend.

[0145] In some embodiments, the second component includes a winch operatively coupled to a tether.

[0146] In some embodiments, (i) the first site is located at a leaflet of a valve of the heart, and the first component is a leaflet anchor adapted to be anchored to the leaflet. In some embodiments, the second site is located in a ventricle downstream of the valve, the second component is a ventricular anchor adapted to be anchored to tissue of the ventricle, and the delivery tool is configured to advance the ventricular anchor transluminally toward the second site in the ventricle while the first component remains anchored to the leaflet.

[0147] In some embodiments, the delivery tool includes a tube, the channel is fixed relative to the tube, and the shaft extends through the tube and is configured to position the tether transluminally within the heart by sliding the shaft distally through the tube in a manner that pulls the tether distally out of the distal opening of the channel.

[0148] In some embodiments, the tube is shaped to define a channel.

[0149] In some embodiments, the extracorporeal control portion is coupled to the proximal portion of the tube and is configured to slide axially distally through the tube.

[0150] In some embodiments, the elongated member is reversibly coupled to a deformable member that deforms in response to pulling the tether toward the distal opening.

[0151] In some embodiments, the deformable member is located at the control portion outside the body.

[0152] In some embodiments, the deformable member can be configured to elastically deform in a manner that pulls the bend back into the channel in response to relaxation of the pull tether.

[0153] In some embodiments, the deformable member can plastically deform in response to pulling on the tether.

[0154] In some embodiments, the deformable member comprises a spring that deforms in response to pulling the tether toward the distal opening.

[0155] In some embodiments, the deformable member comprises a torsion spring.

[0156] In some embodiments, the extracorporeal control portion includes a barrel operatively coupled to the elongated member in a manner that configures the barrel to unwind the elongated member from the bend by winding the elongated member around the barrel.

[0157] In some embodiments, the deformable member comprises a torsion spring.

[0158] In some embodiments, the torsion spring is disposed within the barrel.

[0159] In some embodiments, the torsion spring is disposed around the bobbin.

[0160] In some embodiments, a portion of the elongated member is coupled to the in vitro control portion in a manner that exposes the portion of the elongated member, such that the portion of the elongated member can be separated from the in vitro control portion by cutting the portion of the elongated member.

[0161] In some embodiments, the portion of the elongated member can be separated from the external control portion by cutting the portion of the elongated member, thereby producing a cut end of the elongated member. In some embodiments, the portion of the elongated member can be separated from the external control portion to facilitate releasing the bend from the elongated member by pulling the cut end distally through the passage, so that the elongated member is untied from the bend.

[0162] According to some embodiments, a method (e.g., for use with or usable with the heart of a subject) comprises: advancing a tether to the heart using a delivery tool having a channel defined at a distal portion thereof, and when the distal portion of the delivery tool is positioned within the heart, gradually pulling the tether out of the opening of the channel so that the slender member moves toward the opening of the channel.

[0163] In some embodiments, the tether is advanced into the heart using a delivery tool while: (i) the curved portion of the tether is maintained within the channel by an elongated member looped over the curved portion within the channel, and (ii) at least a portion of the elongated member is coupled to an extracorporeal control portion of the delivery tool.

[0164] In some embodiments, the method includes subsequently releasing the tether from the channel by: (i) separating at least a portion of the slender member from the extracorporeal control portion, and (ii) pulling the portion of the slender member distally through the channel so that the slender member is untied from the bend.

[0165] In some embodiments, separating the portion of the elongated member from the in vitro control portion comprises cutting the portion of the elongated member.

[0166] In some embodiments, advancing the tether to the heart includes advancing the tether to the heart while both the first end and the second end of the elongate member are coupled to the extracorporeal control portion.

[0167] In some embodiments, the extracorporeal control portion includes a barrel operatively coupled to a first end of the elongated member, and pulling the portion of the elongated member distally through a channel includes pulling a second end of the elongated member distally through a channel by wrapping the elongated member around the barrel.

[0168] In some embodiments, the portion of the elongated member is a second end of the elongated member, and separating the portion of the elongated member from the in vitro control portion includes cutting the second end of the elongated member.

[0169] In some embodiments, the slender member is a component of a retaining member, the retaining member further includes a deformable member connected to the slender member, and gradually pulling the tether out of the opening of the channel includes gradually pulling the tether out of the opening of the channel so that the deformable member deforms as the slender member moves toward the opening.

[0170] In some embodiments, the deformable member can be configured to elastically deform in a manner that pulls the bend back into the channel in response to relaxation of the pull tether.

[0171] In some embodiments, the deformable member includes a spring that deforms in response to pulling the tether toward the distal opening, and gradually pulling the tether out of the opening of the channel includes gradually pulling the tether out of the opening of the channel so that the spring deforms as the slender member moves toward the opening.

[0172] In some embodiments, the extracorporeal control portion includes a barrel that is operably connected to the slender member, and pulling the portion of the slender member distally through the channel includes wrapping the slender member around the barrel so that the portion of the slender member is pulled distally into the channel.

[0173] In some embodiments, the tether is a component of an implant, the implant further comprises an anchor coupled to the tether, and the method further comprises using a delivery tool to anchor the anchor to tissue of the heart.

[0174] In some embodiments, anchoring the anchor to the tissue of the heart includes anchoring the anchor to the tissue of the heart after releasing the tether from the channel.

[0175] In some embodiments, anchoring the anchor to the tissue of the heart includes anchoring the anchor to the tissue of the heart before releasing the tether from the channel.

[0176] In some embodiments, the implant further comprises a capstan, and anchoring the anchor comprises anchoring the capstan to the tissue by anchoring the anchor to the tissue.

[0177] In some embodiments, the method further comprises adjusting an amount of tether paid out from the capstan by actuating the capstan after anchoring the capstan to the tissue.

[0178] In some embodiments, the method further comprises adjusting the tension on the tether by actuating the capstan after anchoring the capstan to the tissue.

[0179] In some embodiments, the anchor is a second anchor, the implant further includes a first anchor connected to a tether, and anchoring the anchor includes anchoring the second anchor to a second site within the heart such that the tether extends from the second anchor anchored at the second site to the first anchor.

[0180] In some embodiments, the method further includes anchoring the first anchor at the first site within the heart before anchoring the second anchor at the second site.

[0181] In some embodiments, gradually pulling the tether out of the opening of the passage comprises gradually pulling the tether out of the opening of the passage by advancing the second anchor away from the first location toward the second location after anchoring the first anchor.

[0182] 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.

[0183] Any of the above-described systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for patient use, and the above-described methods may include (or the additional method includes or consists of) sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. herein.

[0184] Features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure may be combined in various ways. Various features and steps as described elsewhere in this disclosure may be included in the examples outlined here. BRIEF DESCRIPTION OF THE DRAWINGS

[0185] Figure 1 , 2A -B and 3A-B are schematic diagrams of systems and techniques for controlling excess slack in a tether of an implant during implantation of the implant; and

[0186] Figure 4A -E and 5A-C are schematic diagrams of systems and techniques for controlling excess slack in the tether of an implant during implantation of the implant. DETAILED DESCRIPTION

[0187] Methods and systems for controlling slack in a tether of an implant during implantation of the implant are described. For example, the methods and systems described herein may relate to methods and systems for controlling slack in a tether during advancement of a component of an implant from a first location within the heart toward a second location within the heart.

[0188] refer to Figure 1 , 2A -B, 3A-B, 4A-E and 5A-C. In some embodiments, a tether (e.g., a first end of the tether that can be connected to a first component of an implant) is fixed to the heart at a first site, and then a second component of the implant coupled to the tether (e.g., coupled to a second end of the tether) is advanced away from the first site toward a second site of the heart, for example, so as to fix the tether at the second site (e.g., by fixing the second component at the second site). Devices and techniques for reducing excessive slack in the tether during implantation of the implant (e.g., during advancement of the second component toward the second site) are described, for example, to reduce the possibility of tether entanglement and / or intussusception. Similarly, devices and techniques for providing sufficient slack in the tether during implantation of the implant (e.g., during advancement of the second component toward the second site) are described, for example, to reduce the possibility of the tether being wrapped around the first site or disconnected from the first site. For example, devices and techniques for ensuring that the tether is gradually released during movement of the second component toward the second site are described.

[0189] In some embodiments, the implant can be a tissue adjustment implant, such as a leaflet augmentation implant, a prosthetic cable implant (as shown), and / or a ring forming implant, and the tether can be used to draw together, contract, and / or limit the movement of the tissue of the heart. In some embodiments, the tether can be used to tether a first component of the implant (which can be fixed to tissue at a first point in the heart) to a second component of the implant (which can be fixed to tissue at a second point in the heart), for example, to draw together the first component and / or the second component and / or limit the movement of the first component and / or the second component. Alternatively or additionally, the tether can be configured to contract components of the implant.

[0190] The tether may be or include a wire, a conductor, a ribbon, a rope, a braid, a contracting member, and / or a suture. The tether may include (eg, may be formed of) metal, a polymer, and / or natural fibers.

[0191] Figure 1 , 2A 3A-3B and 3A-3B are schematic diagrams of a system 100 comprising an implant 140 and a delivery tool 110 for use with the implant according to some embodiments. Implant 140 comprises a capstan 146 and a tether 148 coupled to the capstan. For example, capstan 146 may comprise a spool 147 around which a tether 148 (e.g., one end of a tether) is wound. Capstan 146 is configured to adjust the amount of the tether 148 (e.g., wound around the spool) in the capstan, and therefore adjusts the amount of the tether placed outside the capstan.

[0192] When the system 100 is used, a portion of the tether 148 (e.g., the other end of the tether) is secured (e.g., anchored) to a first location of tissue (e.g., a leaflet of a valve 7 of a subject's heart) and extends from the location to the capstan 146. The system 100 is configured to move the capstan 146 within the heart relative to the first location (e.g., away from the first location) and / or toward a second location (e.g., within a ventricle 8 of the heart) while providing sufficient, but not excessive, slack on the tether 148.

[0193] In the particular example shown, the implant 140 is shown as an implant for reducing (e.g., eliminating) regurgitation through the atrioventricular valve 7 of the heart caused by suboptimal coaptation of the leaflets of the valve. The implant 140 can include a leaflet anchor 142 adapted to be attached to (e.g., anchored to) the leaflets 12 of the valve 7 located at a first site 60 of the heart. The leaflet anchor 142 can be considered an upstream assembly 143 of the implant 140 (or a component of the upstream assembly). The implant 140 further includes a downstream assembly 145, which includes a capstan 146. In some embodiments, and as shown, the downstream assembly further includes a ventricular anchor (e.g., anchor) 144 adapted to be attached to the ventricle 8 downstream of the valve 7 at a second site 80 of the heart after the leaflet anchor 142 is attached to the leaflets 12 at the first site 60. The tether 148 tethers the downstream assembly to the upstream assembly.

[0194] Although implant 140 is described as including leaflet anchor 142 and ventricular anchor 144, it should be understood that the techniques described below can be used with other implants in which a capstan attached to a tether (e.g., one end of the tether) moves relative to a site in which the tether is secured (e.g., the other end of the tether). Non-limiting examples of such implants include cable repair implants, cable replacement implants, and ring forming implants.

[0195] A delivery tool 110 is provided and configured for delivery, positioning and implantation of an implant 140. The tool 110 includes an in vitro handle 112 (e.g., an in vitro control portion of a delivery tool) coupled to a flexible shaft 116 (e.g., a catheter or sheath) extending from the handle to the implant 140. For example, a proximal portion of the shaft 116 can be coupled to the handle. During delivery and / or implantation of the implant 140, the implant (e.g., a downstream assembly 145, such as a capstan 146) can be advanced through the shaft 116, pushed out from the shaft and / or coupled to the shaft.

[0196] Figure 1 A leaflet anchor 142 (and thereby a first end of a tether 148 ) is shown anchored to a first site 60 on the leaflet 12 and a capstan 146 within the ventricle 8 coupled to the distal end of the shaft 116 with a given amount of slack in the tether 148 .

[0197] The coupling of the handle 112 to the shaft 116 allows the implant 140 (eg, the capstan 146 of the implant) to be moved within the vasculature (eg, within the heart) by axially moving the handle 112, thereby moving the shaft and capstan 146 therewith.

[0198] Figure 1A system 100 (e.g., a delivery tool 110 thereof) is shown including a mount 122 defining a track 117 within which a slider 118 is slidably mounted (e.g., axially slidable), and a handle 112 that can be mounted on the slider 118, e.g., such that axial movement of the handle causes the slider to slide along the track. For example, once the leaflet anchor 142 has been attached to the leaflet, and before attaching the ventricular anchor 144 to the ventricle, an operator can mount the handle 112 on the slider 118 such that pushing the handle (and therefore the slider) distally along the track pushes the capstan 146 distally through the vasculature (e.g., downstream of / deeper into the ventricle 8); Figure 2B ), and pulling the handle and slider proximally along the track pulls the capstan proximally within the vasculature (e.g., upstream of / toward the atrium 6; Figure 2A ).

[0199] In the example shown, the handle 112 (and thus the capstan 146) is moved along the track 117 from Figure 1 Pulling proximally from the position shown in FIG. 14 moves the capstan toward the first position 60, thereby increasing the slack on the tether 148 ( Figure 2A ). Similarly, the handle 112 (and thus the winch 146) is moved along the track 117 from Figure 1 Pushing distally from the position shown in FIG. 1 moves the capstan away from the first location 60 (and toward the second location 80), thereby reducing the slack on the tether 148 ( Figure 2B ).

[0200] The delivery tool 110 (e.g., handle 112) can be adapted to control the capstan 146 so as to control the amount of tether 148 received by / released from the capstan. For example, the handle can include a capstan controller 114 that is operatively coupled to the capstan, such as by a drive shaft extending through shaft 116, such that operating the capstan controller adjusts the amount of tether positioned within the heart (e.g., by rotating the drive shaft so that more tether is wound / unwound around spool 147).

[0201] In some embodiments, the delivery tool 110 (e.g., the handle 112) is configured such that during advancement of the capstan 146 (and typically the ventricular anchor 144) away from the first site 60 and toward the second site 80, axial movement of the handle is limited in a manner related to the operation of the capstan 146 so as to ensure that the tether 148 has sufficient, but not excessive, slack.

[0202] For example, after the tether 148 has been secured to the first site 60 (e.g., by attaching the leaflet anchor 142 to the leaflet), axial movement of the handle 112 in the direction of moving the ventricular anchor 144 toward the second site 80 may be limited. Paying out some of the tether 148 from the capstan 146 modifies the limit in a manner that allows further advancement in this direction. This is accomplished by the system 100 (e.g., the delivery tool 110) including a limiter 124 that defines the limits of axial movement of the handle 112 and relates these limits to the amount of tether that has been paid out from the capstan.

[0203] In some embodiments, this limitation is provided at least in part by a handle 112 that includes a depth stop 120 extending axially from the handle. The depth stop 120 can serve at least as a component of a limiter 124. The handle 112 can be limited from axial movement by the depth stop 120 being adjacent to (e.g., blocked by) a portion of the mount 122. For example, the mount 122 can include or define one or more stops 123, such as a distal stop 123a and a proximal stop 123b, that are positioned to block the depth stop 120. Figure 2A The handle 112 is shown restricted from further proximal sliding along the track 117 due to the depth stop 120 abutting the proximal stop 123b of the mount. Figure 2B The handle 112 is shown restricted from sliding further distally along the track 117 due to the depth stop abutting the distal stop 123a of the mount.

[0204] In addition to being operatively coupled to the spool 147, the winch controller 114 is also operatively coupled to the depth stop 120 such that operation of the winch controller in the same manner as the spool also adjusts the axial extension of the depth stop and thereby adjusts the extent to which the handle can be axially moved (e.g., relative to the mounting member 122).

[0205] For example, and as shown, the capstan controller 114 can be configured as a control knob such that rotation of the control knob causes axial movement of the depth stop 120 (e.g., via rotation to linear translation between the control knob and the depth stop, such as via a worm drive). For example, the handle 112 can be arranged such that rotating the knob in a manner that causes the tether 148 to pay out from about the spool 147 also causes the depth stop 120 to move proximally relative to the mount 122, thereby increasing the extent to which the handle (and therefore the capstan 146) can be advanced distally.

[0206] Figure 3A-B shows that in this way, the spool can be progressively advanced toward the second site 80 while the operator avoids winding / pulling the tether at the first site, or avoiding releasing too much tether within the heart. Figure 3A The capstan 146 is shown as being moved from a position where the capstan 146 is closer to the first point 60 (e.g., from Figure 2B The winch is advanced to a position closer to the second position ( Figure 3A ).

[0207] Figure 3A Illustration A shows the Figure 2B The handle 112 is in the same position as in the embodiment of the present invention. Figure 3A Illustration B of FIG. 1 shows the spool control (e.g., control knob) 114 being operated, thereby (i) paying out (e.g., untying) the tether 148 from around the spool 147, and (ii) moving the depth stop 120 proximally relative to the handle 112, e.g., as described above. Such movement of the depth stop 120 relative to the handle 112 allows the handle to be moved further than previously possible ( Figure 3A C) is positioned further away (relative to the mount 122). For embodiments in which the mount 122 includes a proximal stop 123b, such proximal movement of the depth stop 120, and therefore such payout of the tether 148, is limited by the depth stop adjacent the proximal stop. This can advantageously prevent the operator from creating excessive slack in the tether 148.

[0208] like Figure 3A As shown in the main image of FIG. 1 , movement of the handle 112 relative to the mount 122 to this further position allows the capstan 146 to move toward the second location 80 within the heart. Thus, movement of the depth stop 120 relative to the handle 112 allows the capstan 146 to move toward the second location 80 within the heart, for example, until it is again limited by the depth stop adjacent the distal stop 123a, as shown in FIG. Figure 3A As shown in illustration C.

[0209] It should be noted that operation of the winch controller 114 may be viewed as reconfiguring the limiter 124, modifying the limits defined by the limiter through which the handle 112 may move axially relative to the mount.

[0210] Figure 3B Further advancement of the capstan 146 toward the second location (eg, Figure 3BThe main image of 116 shows that the capstan has reached the second location). At this point, the anchor 144 can be driven into the tissue at the second location (e.g., tissue of the ventricle 8). In some embodiments, the shaft 116 can include and / or a sheath anchor control drive shaft (not shown) that operatively couples the anchor controller 111 of the handle 112 (which can be a control knob, as shown) with the anchor 144, such that operation of the anchor controller can drive (e.g., spiral) the anchor into the tissue, for example, and the anchor control drive shaft transmits torque from the anchor controller 111 to the anchor.

[0211] In some embodiments, shaft 116 may be used as described for shaft 810 and / or drive shaft subassembly 890 of International Patent Application No. PCT / IB2021 / 060436, mutatis mutandis, which is incorporated herein by reference.

[0212] After optional additional actuation of the capstan 146 to adjust the tension and / or length of the tether 148 (not shown), the shaft 116 can then be withdrawn from the heart, leaving the implant 140 implanted within the heart (i.e., the upstream assembly 143 connected to the downstream assembly 145 by the tether 148). In some embodiments, this additional actuation is performed after operatively disabling the limiter 124 (e.g., by operatively decoupling the capstan controller 114 from the depth stop 120, such as by operating the decoupling switch 115, or by moving / decoupling the handle 112 and / or the depth stop 120 from the mount 122).

[0213] In some embodiments, the distal portion of the shaft 116 (e.g., the portion of the shaft suitable for positioning the implant 140 within the heart) can be telescopic, for example, having a distal portion and a proximal portion that are axially slidable relative to each other. Examples of such telescopic shafts are described in International Patent Application No. PCT / IB2021 / 060436, which is incorporated herein by reference, mutatis mutandis.

[0214] In some embodiments where the shaft 116 is telescopic, the handle 112 includes a shaft controller (e.g., a shaft extender) operatively coupled to the shaft such that operation of the shaft controller reversibly extends the distal portion of the shaft distally from the proximal portion of the shaft. Thus, in some embodiments, advancement of the capstan 146 from the first location 60 to the second location 80 can be accomplished by telescopically extending the shaft 116 within the heart.

[0215] In some embodiments, the shaft controller may be operatively coupled to the winch controller 114 in a manner that limits telescopic extension based on the amount of tether 148 paid out from the winch, thereby defining a limiter having similar functionality to that described above, albeit without a depth stop.

[0216] In some embodiments, the operative coupling between the axis controller and the capstan controller 114 can be such that operating the axis controller to extend the axis within the heart (e.g., causing the capstan to move toward the second location) causes the capstan controller to automatically operate (e.g., causing more of the tether 148 to be exposed within the heart). Such coupling between the axis controller and the capstan controller 114 can automatically ensure that the tether 148 is paid out at a rate required for movement of the capstan 146, thereby preventing excessive slack in the tether and / or tether wrapping around the first location 60.

[0217] Reference now Figure 4A -E and Figure 5A -C, the accompanying drawings are schematic diagrams of systems and techniques for controlling excessive slack in a tether of an implant during implantation of the implant. For example, and similar to the methods and systems described above, the current technology can be used to prevent excessive slack in the tether 248 during advancement of a portion of the tether (e.g., its end portion 248c) from a first site in the heart (e.g., the first site 60) toward a second site in the heart (e.g., the second site 80), for example, to reduce the likelihood of tether entanglement and / or intussusception. Similarly, the described devices and techniques can be used to reduce the likelihood of a tether being entangled in or disconnected from the first site. The methods and techniques can be performed on a living animal or on a simulated object, such as on a corpse, a cadaver heart, a simulated body (e.g., having a simulated body part, heart, tissue, etc.).

[0218] Figure 4A -E shows a system 200 including an implant 240 and a delivery tool 210 for use with the implant according to some embodiments. In some embodiments, and as Figure 4A -E, implant 240 may be considered a variation of implant 140 described above (or substantially the same as implant 140). For example, implant 240 may include an upstream assembly including leaflet anchor 242 (which may be considered a variation of leaflet anchor 142), a downstream assembly including ventricular anchor 244 (which may be considered a variation of ventricular anchor 144), and a tether (e.g., tether 248) extending therebetween. In some embodiments, implant 240 may differ from implant 140 by not including a capstan.

[0219] In some embodiments, implant 240 does not include anchor 242 (e.g., a leaflet anchor at one end of tether 248). In some embodiments, implant 240 does not include anchor 244 (e.g., a ventricular anchor at the other end of tether 248). For example, one or both ends of the tether of implant 240 can be attached to their respective sites by suturing. For example, implant 240 can consist essentially of a tether (e.g., tether 248 or suture) for securing at a first site and a second site of the heart by suturing.

[0220] In some embodiments, implant 240 can be a ring forming implant, such as a ring forming ring structure.

[0221] In some embodiments, delivery tool 210 is provided and configured for delivery, positioning and implantation of implant 240. Tool 210 includes an external handle 212 connected to a flexible shaft 216 (e.g., a catheter or sheath), and the flexible shaft extends from the handle to the distal portion of the tool, and implant 240 is placed in the distal portion (e.g., implant 240 is connected to the distal portion). Tube 216 is shaped to define a cavity 217 passing therethrough. During the delivery and / or implantation of implant 240, at least a portion of implant 240 can be connected to the distal portion of tube 216 and / or be placed in the distal portion. Delivery tool 210 further includes channel 218. In some embodiments, and as shown in the figure, channel 218 can be the cavity (e.g., secondary cavity) of tube 216. In some embodiments, channel 218 can be another component (e.g., another tube / channel) of the delivery tool or can be defined by the other component. In some embodiments, the delivery tool 210 includes a shaft 214 for delivery and implantation of the anchor 244 within the heart. The shaft 214 may be considered a variation of the shaft 116 or may be substantially the same as the shaft, mutatis mutandis, e.g., the shaft 214 may include and / or a sheath drive shaft for driving the anchor 244 into the tissue.

[0222] The shaft 214 may extend through the tube 216 (eg, through the lumen 217 as shown), or may extend along the tube.

[0223] A portion of the tether 248 (e.g., the middle portion 248b) may be confined within the channel 218. In some embodiments, and as Figure 4AAs shown in Figure 2-C, after the tether 248 (e.g., its first end portion 248a) is fixed to the first site 60 (e.g., at the leaflet of the valve), the tether is gradually released from the channel 218 as the second end portion 248c of the tether moves away from the first site and toward the second site. For example, the middle portion 248b of the tether can extend from the portion 248a into the channel 218 as a bend 258 and return out of the channel toward the end portion 248c. It is assumed that defining the middle portion 248b and controlling / limiting its release can prevent entanglement and / or folding of the tether within the heart during advancement and / or implantation of the implant 240 (e.g., during advancement and / or implantation of its ventricular anchor 244).

[0224] In some embodiments, this limitation is achieved by retaining member 230. Figure 4A -D, a portion of the retaining member (e.g., an end portion) may be constrained to define a hook 234 through the inner wall of the channel 218 that hooks onto the bend 258 of the tether 248, thereby retaining the intermediate portion 248b within the channel.

[0225] A portion of retaining member 230 may be fixed relative to channel 218. For example, a portion of the retaining member may be fixed relative to the channel at the attachment site so that gradually pulling the tether out of the channel's opening pulls the tether away from the attachment site and out of the channel's opening.

[0226] In some embodiments, this attachment can be provided by a proximal portion of a retaining member that is fixed and / or attached to the inner wall of the channel and / or the proximal portion of the channel. For embodiments in which channel 218 is defined by tube 216 and / or fixed to the tube, portions of the retaining member can be fixed to the tube.

[0227] In some embodiments, retaining member 230 may include a deformable portion 232 that is deformable such that pulling tether 248 (e.g., by moving end portion 248c of the tether toward second location 80) may pull hook 234 toward distal opening 218a of passage 218, thereby increasing the amount of tether 248 exposed within the heart (i.e., exposed outside opening 218a). That is, and as described by FIG. 4A to FIG. 4C As shown in the transition of , the gradual deformation of the retaining member 230 allows the tether 248 to be gradually released from the channel 218 when it is pulled.

[0228] In some embodiments, once a predetermined amount of pulling has occurred, the hook 234 is exposed from the opening 218a and once no longer constrained by the inner wall of the channel 218, the hook responsively opens, thereby being released from the bend (e.g., the hook is pulled apart by the tether).

[0229] The predetermined pull amount for hook exposure can depend on the mechanical properties of the deformable portion 232 (e.g., its deformability, e.g., stretchability and / or elasticity, such as a spring constant) and / or on the dimensions (e.g., length) of the retaining member 230 and the channel 218.

[0230] Figure 4A -E represents a series of exemplary steps that may be performed by an operator during implantation of implant 240 within the heart. After end portion 248a is attached to first site 60 (e.g., after leaflet anchor 242 is anchored to the leaflet), end portion 248c of tether 248 (and anchor 244, if present) is moved from a position where the anchor is closer to the first site ( Figure 4A ) away from the first location (eg, away from the leaflet anchor 242) toward the second location 80 ( Figure 4B ) is advanced while the portion 248b of the tether remains confined within the channel 218. This pulls the portion 248b and thus the retaining member 230 (e.g., its hook 234) toward the distal opening 218a of the channel 218, which is facilitated by the deformation of the deformable portion 232 (e.g., Figure 4A -B).

[0231] In some embodiments, system 200 is configured to facilitate and / or ensure that anchor 244 is implanted within tissue of the heart (e.g., implanted within tissue of ventricle 8) while hook 234 remains hooked onto bend 258 and / or remains seated within channel 218 ( Figure 4C ).

[0232] Alternatively, in some embodiments, the system 200 can be configured to facilitate and / or ensure release of the bend 258 from the retaining member 230 before the anchor 244 is implanted into tissue (e.g., releasing the bend once it has been determined that the anchor 244 is positioned at the second site prior to anchoring the anchor).

[0233] Once it has been determined that tether 248 can be released from channel 218 (e.g., once it has been determined that implant 240 has been successfully implanted), the operator can simply withdraw tube 216 (and optionally shaft 214) from the subject. Figure 4D As shown in , when tube 216 is withdrawn, hook 234 is pulled out of distal opening 218a (via tether 248) so that it is no longer constrained by the inner wall of channel 218 and thus responsively opens and unhooks from bend 258 (e.g., the hook is pulled open by the tether).

[0234] At this point, for embodiments in which implant 240 includes a capstan at anchor 244, shaft 214 and / or a drive shaft disposed therein may remain temporarily coupled with a downstream assembly in order to operate the capstan.

[0235] In some embodiments, the deformable portion 232 of the retaining member 230 is elastically deformable so that if the tether 248 is pulled, but not to a predetermined amount (i.e., such that the bend 258 of the tether is retained within the channel 218 by being hooked by the hook 234, as in Figure 4A -C), the slack in pulling causes the retaining member to pull the tether back into the channel 218. For example, and as shown, the retaining member 230 (e.g., the deformable portion 232 thereof) can be a spring (e.g., an extension spring). Thus, releasing the tension on the tether 248 allows the deformable portion 232 to be pulled from the pulled state (e.g., as Figure 4B ) back to a more relaxed state (e.g., Figure 4A ). Such an elastically deformable portion can allow for repeated repositioning of the end of tether 248 (and anchor 244, if present) within the heart while maintaining tension on the tether (e.g., a small amount of tension sufficient to reduce slack without interfering with repositioning).

[0236] In some embodiments, the deformable portion 232 of the retaining member 230 is plastically deformable.

[0237] In some embodiments, a single elongated element (eg, a wire) is shaped to define both the deformable portion 232 (eg, a spring) and the hook 234 .

[0238] Figure 5A -C shows a system 300 comprising implant 240 and a delivery tool 310 for use with the implant, according to some embodiments. System 300 may be considered a variation of system 200, mutatis mutandis, for example comprising tool 310 instead of tool 210.

[0239] The tool 310 includes an external handle 312 connected to a flexible shaft 316 (e.g., a catheter or sheath), the flexible shaft extending from the handle to the distal portion of the tool, and the implant 240 is placed in the distal portion (e.g., the implant 240 is connected to the distal portion). The tube 316 is shaped to define a cavity 317 passing therethrough. During the delivery and / or implantation of the implant 240, at least a portion of the implant 240 can be connected to the distal portion of the tube 316 and / or be placed in the distal portion. The delivery tool 310 further includes a channel 318, which can be a cavity (e.g., a secondary cavity) of the tube 316, or can be another component of the delivery tool (e.g., another catheter / channel). In some embodiments, the delivery tool 310 includes an axis 314 for delivery and implantation of the anchor 244 in the heart. Shaft 314 may be considered a variation of shaft 116 and / or shaft 214, mutatis mutandis, or may be substantially identical thereto, for example, shaft 314 may include and / or sheath drive shaft for driving anchor 244 into tissue.

[0240] The shaft 314 may extend through the tube 316 (eg, as shown), or may extend along the tube.

[0241] Similar to system 200, after the tether (e.g., its first end portion 248a) is secured to a first location 60 (e.g., at a leaflet), a portion of the tether remains confined within the channel 318 (the channel can be a lumen of the tube 316 and / or secured to the tube), and the tether can be gradually released from the channel as the second end portion 248c is advanced to the second location. For example, the middle portion 248b of the tether 248 can extend into the channel 318 as a bend 258 and back out of the channel and toward the end portion 248c of the tether. This middle portion 248b of the tether can advantageously prevent entanglement and / or folding of the tether within the heart during advancement and / or implantation of the implant 240 (e.g., during advancement and / or implantation of its ventricular anchor 244).

[0242] Compared to using hook 234 to confine tether 248 in a channel as described above with respect to system 200, Figure 5A -C shows the confinement of the tether 248 within the channel 318, the channel being provided by a retaining member 320, the retaining member being defined by an elongated member 330 (e.g., a needle, suture, thread, or wire) extending distally through the channel, looping around the bend 258 of the tether (e.g., the elongated member 330 forms a loop 330b around the bend), and returning proximally through the channel ( Figure 5A ).

[0243] In some embodiments, one or both ends (330a, 330c) of the elongated member 330 are disposed at a proximal portion of the system 300 that is configured to remain external to the subject (e.g., by coupling with the handle 312). Pulling the tether 248 (e.g., the end portion 248c of the tether) within the heart pulls the loop 330b toward the distal opening 318a of the passage, thereby increasing the amount of the tether exposed from the passage within the heart.

[0244] In some embodiments, end 330a of elongated member 330 is coupled to deformable member 380 (e.g., which may be a variation of or substantially identical to deformable portion 232, mutatis mutandis), e.g., to maintain tension (e.g., a small amount of tension sufficient to reduce slack) on tether 248 during implantation of implant 240. In the example shown, deformable member 380 is a torsion spring.

[0245] In some embodiments, once it has been determined that the tether 248 can be released from the channel 318 (e.g., once it has been determined that the implant 240 has been successfully implanted), the loop 330b can be released from around the bend 258. For example, and as Figure 5B As shown in FIG. 3C , such release may be achieved by, for example, cutting one end of the elongated member ( FIG. 370 ) using a scalpel 370 . Figure 5B ) and then pulling the other end of the elongated member so that the loop 300b can be withdrawn from around the bend 258 and out of the subject ( Figure 5C ). In the example shown, the end that is cut is end 330c, i.e., the end that is not coupled to deformable member 380. However, in some embodiments, end 330a may be cut. Regardless of which end is cut, tool 310 may be configured such that the end to be cut is exposed at an extracorporeal proximal portion of the tool (e.g., from handle 312), e.g., so that it is presented to and / or accessible by an operator for cutting.

[0246] In some embodiments, the bend 258 is released from the elongated member 330 before the tether is secured to the second site 80 (e.g., before the anchor 244 is anchored to the tissue at the second site). In some embodiments, the bend 258 is released from the elongated member 330 after the tether is secured to the second site 80 (e.g., before the anchor 244 is anchored to the tissue at the second site).

[0247] In some embodiments, the tool 310 includes a barrel 390 (e.g., mounted on the handle 312) such that the elongated member 330 can be withdrawn from the channel 318 by wrapping the elongated member around the barrel. The barrel 390 can be coupled to a key or knob by which an operator can rotate the barrel to pull and untie the elongated member from the bend 258 of the tether 248.

[0248] In some embodiments, such as those in which the deformable member 380 comprises a torsion spring, the deformable member can be disposed circumferentially around the barrel 390, such as shown. In some embodiments, the deformable member 380 can rotate with the barrel 390.

[0249] In some embodiments, such as those in which the deformable member 380 comprises a torsion spring, the deformable member can be disposed inside the barrel 390. In some embodiments, the deformable member 380 can rotate with the barrel 390.

[0250] Examples (Some non-limiting examples of the concepts herein are listed below):

[0251] Example 1. A system comprising: (A) an implant comprising a capstan comprising a spool; and a tether coupled to the spool; and (B) a delivery tool configured to deliver the implant transluminally to a heart and comprising: (i) a shaft coupled to the capstan and configured to position the capstan transluminally within the heart, (ii) a handle comprising a capstan controller and coupled to a proximal portion of the shaft such that distal movement of the handle moves the capstan distally into the heart, the proximal portion of the shaft defining an axis of the delivery tool, and / or (iii) a depth stop extending axially from the handle; wherein the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that adjusts the amount of winding of the tether around the spool also adjusts the axial extension of the depth stop from the handle.

[0252] Example 2. A system according to Example 1, wherein the depth stop comprises a rod.

[0253] Example 3. The system of any one of examples 1 to 2, wherein the depth stop extends parallel to the axis.

[0254] Example 4. A system according to any of Examples 1 to 3, wherein the shaft is configured to transluminally position the capstan within the heart while the shaft extends from the handle through the subject's vasculature to the capstan within the heart.

[0255] Example 5. A system according to any one of Examples 1 to 4, wherein the winch controller includes a control knob and is operably connected to the winch and the depth stop, such that rotation of the control knob in a manner that adjusts the amount of winding of the tether around the spool also adjusts the axial extension of the depth stop from the handle.

[0256] Example 6. The system of Example 5, wherein the capstan controller is operatively coupled to the capstan and the depth stop via a rotary-to-linear mechanism.

[0257] Example 7. The system of Example 6, wherein the rotational-to-linear mechanism comprises a worm drive.

[0258] Example 8. A system according to any one of Examples 1 to 7, wherein the implant includes an anchor coupled to the capstan and configured to anchor the capstan to tissue at a site in the heart.

[0259] Example 9. A system according to Example 8, wherein (i) the anchor is a second anchor, (ii) the site is a second site, and (iii) the implant further includes a first anchor coupled to a first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart, and (iv) the shaft is configured to advance the capstan and the second anchor transluminally toward the second site while the first anchor remains anchored at the first site.

[0260] Example 10. A system according to Example 9, wherein: (i) the first site is a leaflet site at a leaflet of a valve of the heart, (ii) the first anchor is a leaflet anchor adapted to be anchored to the leaflet, (iii) the second site is a ventricular site in a ventricle downstream of the valve, (iv) the second anchor is a ventricular anchor, and (v) the shaft is configured to advance the capstan and the ventricular anchor transcavitarily toward the ventricular site while the first anchor remains anchored at the leaflet site.

[0261] Example 11. The system of any of Examples 1 to 10 wherein the delivery tool has a condition wherein the depth stop extends distally from the handle.

[0262] Example 12. A system according to Example 11, wherein the winch controller is operably connected to the winch and the depth stop, such that operation of the winch controller in a manner that reduces the amount of wrapping of the tether around the spool also causes the depth stop to move proximally relative to the handle.

[0263] Example 13. A system according to Example 12, wherein the winch controller is operably connected to the winch and the depth stop, such that operation of the winch controller in a manner that increases the amount of tether wrap around the spool also causes the depth stop to move distally relative to the handle.

[0264] Example 14. A system according to Example 11, wherein the winch controller is operably connected to the winch and the depth stop, such that operation of the winch controller in a manner that reduces the amount of wrapping of the tether around the spool also causes the depth stop to move distally relative to the handle.

[0265] Example 15. A system according to Example 14, wherein the winch controller is operably connected to the winch and the depth stop, such that operation of the winch controller in a manner that increases the amount of tether wrap around the spool also causes the depth stop to move proximally relative to the handle.

[0266] Example 16. The system of example 11 wherein the state is a first state, and wherein the delivery tool has a second state wherein the depth stop extends proximally from the handle.

[0267] Example 17. The system of Example 11, wherein in the state, the depth stop extends both distally and proximally from the handle.

[0268] Example 18. A system according to any one of Examples 1 to 17, further comprising a mounting member, in which the handle can be mounted, and when the handle is mounted in the mounting member, the mounting member is configured to block axial movement of the depth stop along the axial path by being disposed in the axial path.

[0269] Example 19. The system of Example 18, wherein the mount extends perpendicular to the axis.

[0270] Example 20. A system according to Example 18, wherein the winch controller is operably connected to the winch and the depth stop such that: (i) operation of the winch controller in a manner that reduces the amount of tether wrapped around the spool also causes the depth stop to move proximally relative to the mounting member, and / or (ii) operation of the winch controller in a manner that increases the amount of tether wrapped around the spool also causes the depth stop to move distally relative to the mounting member.

[0271] Example 21. A system according to Example 18, wherein the winch controller is operably connected to the winch and the depth stop such that: (i) operation of the winch controller in a manner that increases the amount of tether wrapped around the spool also causes the depth stop to move proximally relative to the mounting member, and / or (ii) operation of the winch controller in a manner that decreases the amount of tether wrapped around the spool also causes the depth stop to move distally relative to the mounting member.

[0272] Example 22. A system according to Example 18, wherein the winch controller is operatively connected to the winch and the depth stop, such that operation of the winch controller in a manner that adjusts the amount of winding of the tether around the spool also adjusts the axial position of the depth stop relative to the mount.

[0273] Example 23. A system according to Example 22, wherein the mounting member includes: (i) a distal stop, which is positioned to block the depth stop from moving distally by being disposed in the axial path when the handle is mounted in the mounting member; and / or (ii) a proximal stop, which is positioned to block the depth stop from moving proximally by being disposed in the axial path when the handle is mounted in the mounting member.

[0274] Example 24. A system according to Example 23, wherein the winch controller is operably connected to the winch and the depth stop such that: (i) operation of the winch controller in a manner that reduces the amount of tether wrapped around the spool also causes the depth stop to move axially away from the distal stop, and / or (ii) operation of the winch controller in a manner that increases the amount of tether wrapped around the spool also causes the depth stop to move axially toward the distal stop.

[0275] Example 25. A system according to Example 23, wherein the winch controller is operably connected to the winch and the depth stop such that: (i) operation of the winch controller in a manner that reduces the amount of tether wrapped around the spool also causes the depth stop to move axially toward the distal stop, and / or (ii) operation of the winch controller in a manner that increases the amount of tether wrapped around the spool also causes the depth stop to move axially away from the distal stop.

[0276] Example 26. A system comprising: (A) an implant comprising a spool and a tether coupled to the spool; and (B) a delivery tool configured to deliver the implant transluminally to the heart and comprising: (i) a shaft coupled to the spool and configured to position the spool transluminally within the heart, (ii) a mounting member, and (iii) a handle mountable on the mounting member and coupled to a proximal end of the shaft such that axial movement of the handle relative to the mounting member causes axial movement of the shaft relative to the mounting member, wherein the delivery tool comprises a limiter configured to define a limit to which the handle can move axially relative to the mounting member, and / or wherein the handle comprises a controller operatively coupling the spool to the limiter such that operation of the controller in a manner that adjusts the amount by which the tether is wrapped around the spool also modifies the limit.

[0277] Example 27. The system of Example 26 wherein the handle is mountable on the mount after the shaft transluminally positions the spool within the heart.

[0278] Example 28. A system according to any of Examples 26 to 27, wherein the limiter includes a depth stop.

[0279] Example 29. A system according to any one of Examples 26 to 28, wherein: (i) the delivery tool includes an axis controller suitable for extending the axis within the heart, and / or (ii) operating the axis controller to extend the axis within the heart causes the controller to automatically operate to increase the amount of tether exposed within the heart.

[0280] Example 30. A system according to any of Examples 26 to 29, wherein the shaft is configured to transluminally position the spool within the heart while the shaft extends from the handle through the subject's vasculature to the spool within the heart.

[0281] Example 31. A system according to any of Examples 26 to 30, wherein the controller includes a control knob and is operatively connected to the spool and the limiter, such that rotation of the control knob adjusts the amount of wrapping of the tether around the spool and also modifies the limit.

[0282] Example 32. The system of any one of Examples 26 to 31, wherein the controller is operatively coupled to the spool and the limiter via a rotary-to-linear mechanism.

[0283] Example 33. A system according to Example 32, wherein the rotational-to-linear mechanism comprises a worm drive.

[0284] Example 34. A system according to any of Examples 26 to 33, wherein the implant includes an anchor coupled to the spool and configured to anchor the spool to tissue at a site in the heart.

[0285] Example 35. A system according to Example 34, wherein the anchor is a second anchor, the site is a second site, and the implant further includes a first anchor coupled to a first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart, and the shaft is configured to advance the spool and the second anchor transluminally toward the second site while the first anchor is anchored at the first site.

[0286] Example 36. A system according to Example 35, wherein the first location is a leaflet site at a leaflet of a valve of the heart, the first anchor is suitable for anchoring to the leaflet site, the second location is a ventricular site in a ventricle downstream of the valve, the second anchor is suitable for anchoring to the ventricular site, and / or the shaft is configured to advance the spool and the second anchor transcavitarily toward the ventricular site while the first anchor is anchored at the leaflet site.

[0287] Example 37. A system according to any one of Examples 26 to 36, wherein when the handle is mounted on the mounting member, the mounting member is positioned in the axial path so that when the handle reaches the limit, the mounting member blocks the axial movement of the handle.

[0288] Example 38. A system according to Example 37, wherein the mounting member includes: (i) a distal stop member, which is positioned to block the limiter from moving distally by being disposed in the axial path when the handle is mounted on the mounting member; and / or (ii) a proximal stop member, which is positioned to block the limiter from moving proximally by being disposed in the axial path when the handle is mounted on the mounting member.

[0289] Example 39. A method comprising (i) advancing a capstan operably connected to a tether transluminally into a heart using a delivery tool having a handle, (ii) attaching the tether to tissue at a first location within the heart, (iii) operating a capstan controller on the handle to actuate the capstan and move a depth stop extending axially from the handle in a first axial direction relative to the handle; and (iv) advancing the capstan away from the first location by advancing the handle of the delivery tool in a second axial direction opposite to the first direction while the tether remains connected to the tissue at the first location.

[0290] Example 40. The method of Example 39, wherein advancing the winch away from the first location includes advancing the winch away from the first location after operating a winch controller to actuate the winch.

[0291] Example 41. The method of any one of Examples 39 to 40, further comprising mounting the handle in a mounting member.

[0292] Example 42. A method according to Example 41, wherein installing the handle in the mount includes installing the handle in the mount after the step of advancing the capstan transluminally into the heart and before the step of operating the capstan controller.

[0293] Example 43. The method of Example 41, wherein operating the capstan controller includes operating the capstan controller to move the depth stop in a first axial direction relative to the handle so that the depth stop approaches a stop defined by the mounting member.

[0294] Example 44. The method of Example 43, wherein operating the winch controller comprises operating the winch controller until the depth stop abuts the stop.

[0295] Example 45. The method of example 41, wherein advancing the handle of the delivery tool in the second axial direction includes advancing the handle of the delivery tool in the second axial direction such that the depth stop approaches a stop defined by the mount.

[0296] Example 46. The method of Example 45, wherein advancing the handle of the delivery tool in the second axial direction comprises advancing the handle of the delivery tool in the second axial direction until the depth stop abuts the stop.

[0297] Example 47. A method according to any one of Examples 39 to 46, wherein the steps of operating the capstan controller and advancing the capstan are performed at least iteratively until the capstan reaches a second location within the heart.

[0298] Example 48. The method of Example 47, further comprising anchoring the capstan to tissue at the second site.

[0299] Example 49. The method of Example 48, further comprising actuating the capstan by operating a capstan controller to adjust an amount of tether paid out from the capstan after anchoring the capstan to tissue at the second site.

[0300] Example 50. The method of Example 48, further comprising actuating the capstan to adjust tension on the tether by operating a capstan controller after anchoring the capstan to tissue at the second site.

[0301] Example 51. A system for controlling slack of a tether during implantation in a subject's heart, the system comprising: (A) a tether having a first end portion, a second end portion, and a bend therebetween; and (B) a delivery tool configured to secure the first end portion of the tether and the second end portion of the tether within the heart and comprising: (i) a channel having an inner wall and a distal opening, and (ii) a retaining member constrained by the inner wall to define a hook within the channel, wherein: (1) the bend of the tether is confined within the channel by hooking onto the hook; (2) the retaining member is deformable in response to pulling the tether out of the distal opening in a manner that moves the hook toward the distal opening; and (3) the retaining member is configured such that when the hook exits the channel through the distal opening, the hook responsively opens and detaches from the bend.

[0302] Example 52. A system according to Example 51, wherein the retaining member includes a deformable portion that can plastically deform in response to pulling on the tether.

[0303] Example 53. A system according to any of Examples 51 to 52, wherein: (i) the delivery tool comprises a shaft and an extracorporeal handle connected to a proximal portion of the shaft, and / or (ii) the distal portion of the shaft is connected to a tether, such that when the shaft is positioned through the vasculature of the subject to the tether within the heart, the shaft is configured to position the tether transluminally within the heart by pulling the tether out of the distal opening in a manner that moves the hook toward the distal opening.

[0304] Example 54. A system according to Example 53, wherein: (i) the delivery tool includes a tube defining a channel, and (ii) the shaft extends through the tube and is configured to position the tether transluminally within the heart by sliding the shaft distally away from the tube in a manner that pulls the tether distally out of the distal opening.

[0305] Example 55. A system as described in Example 54, wherein the handle is coupled to a proximal portion of the tube, and wherein the handle is configured to slide the shaft distally outwardly away from the tube.

[0306] Example 56. A system according to any of Examples 51 to 55, wherein the retaining member includes a deformable portion that is elastically deformable in response to pulling on the tether and is suitable for pulling the tether back into the channel in response to relaxation of the pull on the tether.

[0307] Example 57. A system according to Example 56, wherein the deformable portion includes a spring.

[0308] Example 58. A system as described in Example 56, wherein the retaining member comprises a unitary slender member that is shaped to define a deformable portion and a hook.

[0309] Example 59. A system according to any one of Examples 51 to 58, wherein: (A) the system comprises an implant, the implant comprising a tether, a first component and a second component, the tether tethering the first component to the second component, and (B) the delivery tool is configured to: (i) anchor the first component at a first site within the heart, and (ii) subsequently advance the second component from the first site toward a second site within the heart, while (a) the first component remains anchored at the first site, and (b) the bend of the tether is held confined within the channel by the hook of the retaining member.

[0310] Example 60. A system according to Example 59, wherein the second component includes a winch operatively connected to the tether.

[0311] Example 61. A system according to Example 59, wherein: (i) the first site is a leaflet site at a leaflet of a valve of the heart, (ii) the first component is a leaflet anchor adapted to be anchored to the leaflet, (iii) the second site is a ventricular site in a ventricle downstream of the valve, (iv) the second component is a ventricular anchor adapted to be anchored to ventricular tissue, and / or (v) the delivery tool is configured to advance the ventricular anchor transcavitarily toward the ventricular site while the first component remains anchored at the leaflet site.

[0312] Example 62. A method comprising: (i) advancing a tether into a heart using a delivery tool having a channel defined at a distal portion thereof while a bend of the tether is retained within the channel by a hook disposed in the channel; (ii) gradually pulling the tether out of an opening of the channel while the distal portion of the delivery tool is disposed within the heart such that the hook moves toward the opening of the channel; and (iii) subsequently releasing the bend from the hook by pulling the tether sufficiently to pull the hook out of the opening such that the hook responsively unwinds from the bend.

[0313] Example 63. A method according to Example 62, wherein: (i) the hook is a component of a retaining member, the retaining member further comprising a deformable portion connected to the hook, and / or (ii) gradually pulling the tether out of the opening of the channel comprises gradually pulling the tether out of the opening of the channel such that the deformable portion deforms as the hook moves toward the distal opening.

[0314] Example 64. A method according to Example 63, wherein a portion of the retaining member is fixed relative to the channel at the attachment site, and wherein gradually pulling the tether out of the opening of the channel includes gradually pulling the tether away from the attachment site and out of the opening of the channel.

[0315] Example 65. A method according to any of Examples 62 to 64, wherein pulling the tether sufficiently to pull the hook out of the opening comprises withdrawing the delivery tool proximally away from the tether while the tether remains within the heart.

[0316] Example 66. The method of Example 62, wherein the tether is a component of an implant, the implant further comprising an anchor coupled to the tether, and the method further comprises anchoring the anchor to tissue of the heart.

[0317] Example 67. The method of Example 66, wherein anchoring the anchor to the tissue of the heart comprises anchoring the anchor to the tissue of the heart after detaching the hook from the bend.

[0318] Example 68. The method of Example 66, wherein anchoring the anchor to tissue of the heart comprises anchoring the anchor to tissue of the heart before releasing the hook from the bend.

[0319] Example 69. The method of Example 66, wherein the implant further comprises a capstan, and wherein anchoring the anchor comprises anchoring the capstan to tissue by anchoring the anchor.

[0320] Example 70. The method of Example 69, further comprising adjusting an amount of tether paid out from the capstan by actuating the capstan after anchoring the capstan to the tissue.

[0321] Example 71. The method of Example 69 further comprising adjusting the tension on the tether by actuating the capstan after anchoring the capstan to the tissue.

[0322] Example 72. A method according to Example 66, wherein the anchor is a second anchor, the implant further includes a first anchor connected to the tether, and anchoring the anchor includes anchoring the second anchor to a second location within the heart such that the tether extends from the second anchor anchored at the second location to the first anchor.

[0323] Example 73. The method of Example 72, further comprising anchoring the first anchor at a first site within the heart before anchoring the second anchor at a second site.

[0324] Example 74. The method of Example 73, wherein gradually pulling the tether out of the opening of the channel comprises gradually pulling the tether out of the opening of the channel by advancing a second anchor away from the first location toward a second location after anchoring the first anchor.

[0325] Example 75. A system for controlling slack in a tether of an implant during implantation of the tether in a heart of a subject, the system comprising:

[0326] an implant comprising a tether having a first end portion, a second end portion, and a bend therebetween; and

[0327] A delivery tool configured to secure the first end portion of the tether and the second end portion of the tether within the heart and comprising: (i) an extracorporeal control portion; (ii) a shaft extending from the extracorporeal control portion to an implant and adapted to position the implant within the heart; (iii) a channel having a distal opening at a distal portion of the shaft; and / or (iv) an elongated member coupled to the extracorporeal control portion and extending away from the extracorporeal control portion to form a loop within the channel;

[0328] The system has a delivery state wherein: (i) the bend of the tether is positioned within the channel, (ii) the first end portion and the second end portion of the tether are positioned outside of the distal opening of the channel, (iii) the elongated member defines the bend of the tether within the channel by being wrapped around the bend, and / or (iv) at least a portion of the elongated member is separable from an extracorporeal control portion to facilitate release of the bend from the elongated member by uncoiling the elongated member from the bend.

[0329] Example 76. A system according to Example 75, wherein, in the delivery state, both the first end and the second end of the slender member are connected to the extracorporeal control portion.

[0330] Example 77. A system according to any of Examples 75 to 76, wherein: (A) the implant further includes a first component and a second component, the tether tethering the first component to the second component, and (B) the delivery tool is configured to: (i) anchor the first component at a first site within the heart, and (ii) subsequently advance the second component away from the first site toward a second site within the heart, while (a) the first component remains anchored at the first site, and (b) the bend of the tether is maintained within the channel by the slender member wrapped around the bend.

[0331] Example 78. A system according to Example 77, wherein the second component includes a winch operably connected to the tether.

[0332] Example 79. A system according to Example 77, wherein: (i) the first site is located at a leaflet of a valve of the heart, (ii) the first component is a leaflet anchor adapted to be anchored to the leaflet, (iii) the second site is located in a ventricle downstream of the valve, (iv) the second component is a ventricular anchor adapted to be anchored to tissue of the ventricle, and (v) the delivery tool is configured to advance the ventricular anchor transcavitarily toward the second site in the ventricle while the first component remains anchored to the leaflet.

[0333] Example 80. A system according to any of Examples 75 to 79, wherein the delivery tool comprises a tube, the channel is fixed relative to the tube, and the axis extends through the tube and is configured to position the tether transluminally within the heart by sliding the axis distally through the tube in a manner that pulls the tether distally out of a distal opening of the channel.

[0334] Example 81. A system according to Example 80, wherein the tube is shaped to define a channel.

[0335] Example 82. A system according to Example 80, wherein the extracorporeal control portion is coupled to a proximal portion of the tube and is configured to slide axially distally through the tube.

[0336] Example 83. A system according to any of Examples 75 to 82, wherein the slender member is reversibly connected to a deformable member, wherein the deformable member deforms in response to pulling the tether toward the distal opening.

[0337] Example 84. A system according to Example 83, wherein the deformable member is located at an in vitro control portion.

[0338] Example 85. A system according to Example 83, wherein the deformable member can be configured to elastically deform in a manner that pulls the bend back into the channel in response to relaxation of the pull tether.

[0339] Example 86. A system as described in Example 83, wherein the deformable member is plastically deformable in response to pulling on the tether.

[0340] Example 87. A system according to Example 83, wherein the deformable member comprises a spring that deforms in response to pulling the tether toward the distal opening.

[0341] Example 88. A system according to Example 87, wherein the deformable member comprises a torsion spring.

[0342] Example 89. A system according to Example 83, wherein the extracorporeal control portion includes a barrel that is operably connected to the slender member in a manner that configures the barrel to unwind the slender member from the bend by winding the slender member around the barrel.

[0343] Example 90. A system according to Example 89, wherein the deformable member comprises a torsion spring.

[0344] Example 91. The system of Example 90, wherein the torsion spring is disposed within the barrel.

[0345] Example 92. The system of Example 90, wherein the torsion spring is disposed around the barrel.

[0346] Example 93. A system according to any one of Examples 75 to 92, wherein a portion of the slender member is connected to the in vitro control portion in a manner that exposes the portion of the slender member, so that the portion of the slender member can be separated from the in vitro control portion by cutting the portion of the slender member.

[0347] Example 94. A system according to Example 93, wherein: (i) the portion of the slender member can be separated from the extracorporeal control portion by cutting the portion of the slender member, thereby producing a cut end of the slender member, and / or (ii) the portion of the slender member can be separated from the extracorporeal control portion to facilitate release of the bend from the slender member by pulling the cut end distally through a channel, thereby disengaging the slender member from the bend.

[0348] Example 95. A method comprising: (A) advancing a tether into a heart using a delivery tool having a channel defined at a distal portion thereof, while: (i) a bend of the tether is maintained within the channel by an elongated member wrapped around the bend within the channel, and (ii) at least a portion of the elongated member is coupled to an extracorporeal control portion of the delivery tool; (B) gradually pulling the tether out of an opening of the channel while the distal portion of the delivery tool is positioned within the heart such that the elongated member moves toward the opening of the channel; and (C) subsequently releasing the tether from the channel by: (i) separating at least a portion of the elongated member from the extracorporeal control portion, and (ii) pulling the portion of the elongated member distally through the channel such that the elongated member is untied from the bend.

[0349] Example 96. A method according to Example 95, wherein the extracorporeal control portion includes a tube that is operably connected to the slender member, and wherein pulling the portion of the slender member distally through a channel includes winding the slender member around the tube so that the portion of the slender member is pulled distally into the channel.

[0350] Example 97. A method according to Example 95, wherein separating the portion of the slender member from the extracorporeal control portion includes cutting the portion of the slender member.

[0351] Example 98. A method according to any one of Examples 95 to 97, wherein advancing the tether into the heart comprises advancing the tether into the heart while both the first end and the second end of the slender member are connected to the extracorporeal control portion.

[0352] Example 99. A method according to Example 98, wherein the extracorporeal control portion comprises a barrel operably connected to the first end of the slender member, and wherein pulling the portion of the slender member distally through the channel comprises pulling the second end of the slender member distally through the channel by winding the slender member around the barrel.

[0353] Example 100. A method according to Example 98, wherein the portion of the slender member is the second end of the slender member, and wherein separating the portion of the slender member from the in vitro control portion includes cutting the second end of the slender member.

[0354] Example 101. A method according to any one of Examples 95 to 100, wherein the slender member is a component of a retaining member, the retaining member further includes a deformable member connected to the slender member, and / or wherein gradually pulling the tether out of the opening of the channel includes gradually pulling the tether out of the opening of the channel such that the deformable member deforms as the slender member moves toward the opening.

[0355] Example 102. A method according to Example 101, wherein the deformable member can be configured to elastically deform in a manner that pulls the bend back into the channel in response to the relaxation of the pull tether.

[0356] Example 103. A method according to Example 101, wherein the deformable member includes a spring that deforms in response to pulling the tether toward the distal opening, and / or wherein gradually pulling the tether out of the opening of the channel includes gradually pulling the tether out of the opening of the channel such that the spring deforms as the slender member moves toward the opening.

[0357] Example 104. A method according to any one of Examples 95 to 103, wherein the tether is a component of an implant, the implant further includes an anchor coupled to the tether, and / or the method further comprises using a delivery tool to anchor the anchor to tissue of the heart.

[0358] Example 105. The method of Example 104, wherein anchoring the anchor to tissue of the heart comprises anchoring the anchor to tissue of the heart after releasing the tether from the channel.

[0359] Example 106. The method of Example 104, wherein anchoring the anchor to tissue of the heart comprises anchoring the anchor to tissue of the heart before releasing the tether from the channel.

[0360] Example 107. The method of Example 104, wherein the implant further comprises a capstan, and wherein anchoring the anchor comprises anchoring the capstan to the tissue by anchoring the anchor to the tissue.

[0361] Example 108. The method of Example 107, further comprising adjusting an amount of tether paid out from the capstan by actuating the capstan after anchoring the capstan to the tissue.

[0362] Example 109. The method of Example 107, further comprising adjusting the tension on the tether by actuating the capstan after anchoring the capstan to the tissue.

[0363] Example 110. A method according to Example 104, wherein the anchor is a second anchor, the implant further includes a first anchor connected to a tether, and / or anchoring the anchor includes anchoring the second anchor to a second location within the heart such that the tether extends from the second anchor anchored at the second location to the first anchor.

[0364] Example 111. The method of Example 110, further comprising anchoring the first anchor at a first site within the heart before anchoring the second anchor at the second site.

[0365] Example 112. The method of Example 111, wherein gradually pulling the tether out of the opening of the channel comprises gradually pulling the tether out of the opening of the channel by advancing the second anchor away from the first site toward the second site after anchoring the first anchor.

[0366] The therapeutic techniques, methods, operations, 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 simulated body, a virtual human, etc.). When performed on a simulator, a body part (e.g., a heart, a tissue, a valve, etc.) can optionally be referred to as "simulated" (e.g., a simulated heart, a simulated tissue, a simulated valve, etc.), and can include, for example, a computerized and / or physical representation of a body part, tissue, etc.

[0367] Any of the above-described systems, assemblies, devices, equipment, components, etc. may be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure safety for patient use, and the above-described methods may include (or the additional method includes or consists of) sterilization (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) of one or more of the systems, devices, equipment, components, etc. herein.

[0368] The present invention is not limited to the examples specifically shown and described above. On the contrary, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art, which will occur to those skilled in the art after reading the foregoing description.

Claims

1. A system comprising: An implant comprising: a capstan including a spool; and a tether coupled to the spool; and A delivery tool configured to deliver the implant transluminally to the heart and comprising: a shaft coupled to the capstan and configured to position the capstan transluminally within the heart, a handle containing a capstan control and coupled to a proximal portion of the shaft such that distal movement of the handle moves the capstan distally into the heart, the proximal portion of the shaft defining an axis of the delivery tool, and a depth stop extending axially from the shank, Wherein the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that adjusts an amount of spooling of the tether around the spool also adjusts an axial extension of the depth stop from the handle.

2. The system of claim 1, wherein the depth stop comprises a rod.

3. The system of any one of claims 1 to 2, wherein the depth stop extends parallel to the axis.

4. A system according to any one of claims 1 to 3, wherein the shaft is configured to transluminally position the capstan within the heart while the shaft extends from the handle through the subject's vasculature to the capstan within the heart.

5. A system according to any one of claims 1 to 4, wherein the winch controller includes a control knob and is operatively connected to the winch and the depth stop, so that rotation of the control knob in a manner that adjusts the amount of winding of the tether around the spool also adjusts the axial extension of the depth stop from the handle.

6. The system of claim 5, wherein the capstan controller is operatively coupled to the capstan and the depth stop via a rotary-to-linear mechanism.

7. The system of claim 6, wherein the rotary-to-linear mechanism comprises a worm drive.

8. The system of any one of claims 1 to 7, wherein the implant comprises an anchor coupled to the capstan and configured to anchor the capstan to tissue at a site in the heart.

9. The system of claim 8, wherein: The anchor is a second anchor, The site is a second site, and The implant further includes a first anchor coupled to the first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart, and The shaft is configured to transluminally advance the capstan and the second anchor toward the second site while the first anchor remains anchored at the first site.

10. The system of claim 9, wherein: The first site is a leaflet site at a leaflet of a valve of the heart, The first anchor is a leaflet anchor adapted to be anchored to the leaflet, the second site is a ventricular site in the ventricle downstream of the valve, The second anchor is a ventricular anchor, and The shaft is configured to transluminally advance the capstan and the ventricular anchor toward the ventricular site while the first anchor remains anchored at the leaflet site.

11. The system of any one of claims 1 to 10, wherein the delivery tool has a condition wherein the depth stop extends distally from the handle.

12. The system of claim 11 wherein the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop proximally relative to the handle.

13. The system of claim 12 wherein the winch controller is operatively coupled to the winch and the depth stop such that operation of the winch controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop distally relative to the handle.

14. The system of claim 11 wherein the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop distally relative to the handle.

15. The system of claim 14 wherein the capstan controller is operatively coupled to the capstan and the depth stop such that operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop proximally relative to the handle.

16. The system of claim 11, wherein the state is a first state, and wherein the delivery tool has a second state wherein the depth stop extends proximally from the handle.

17. The system of claim 11, wherein in the state, the depth stop extends both distally and proximally from the handle.

18. The system of any one of claims 1 to 17, further comprising a mounting member, wherein the handle is mountable in the mounting member, and when the handle is mounted in the mounting member, the mounting member is configured to block axial movement of the depth stop along the axial path by being disposed in the axial path.

19. The system of claim 18, wherein the mount extends perpendicular to the axis.

20. The system of claim 18, wherein the winch controller is operatively coupled to the winch and the depth stop such that: Operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also causes the depth stop to move proximally relative to the mount, and Operation of the winch controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop distally relative to the mount.

21. The system of claim 18, wherein the winch controller is operatively coupled to the winch and the depth stop such that: operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also causes the depth stop to move proximally relative to the mount, and Operation of the winch controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop distally relative to the mount.

22. The system of claim 18, wherein the winch controller is operatively coupled to the winch and the depth stop such that operation of the winch controller in a manner that adjusts the amount of spooling of the tether around the spool also adjusts the axial position of the depth stop relative to the mount.

23. The system of claim 22, wherein the mount comprises: a distal stop positioned to block distal movement of the depth stop by being disposed in the axial path when the handle is mounted in the mount; and A proximal stop is positioned to block proximal movement of the depth stop by being disposed in the axial path when the handle is mounted in the mount.

24. The system of claim 23, wherein the winch controller is operatively coupled to the winch and the depth stop such that: Operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also moves the depth stop axially away from the distal stop, and Operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop axially toward the distal stop.

25. The system of claim 23, wherein the winch controller is operatively coupled to the winch and the depth stop such that: Operation of the capstan controller in a manner that reduces the amount of spooling of the tether around the spool also causes the depth stop to move axially toward the distal stop, and Operation of the capstan controller in a manner that increases the amount of spooling of the tether around the spool also moves the depth stop axially away from the distal stop.

26. A system, comprising: An implant comprising: Spools; and a tether coupled to the spool; and A delivery tool configured to deliver the implant transluminally to the heart and comprising: a shaft coupled to the spool and configured to position the spool transluminally within the heart, Mounting parts, and a handle mountable on the mount and coupled to the proximal end of the shaft such that axial movement of the handle relative to the mount causes axial movement of the shaft relative to the mount, in: The delivery tool includes a limiter configured to define an extent to which the handle can move axially relative to the mount, and The handle includes a controller that operatively couples the spool with the limiter such that operation of the controller in a manner that adjusts an amount of wrapping of the tether around the spool also modifies the limit.

27. The system of claim 26, wherein the handle is mountable on the mount after the shaft transluminally positions the spool within the heart.

28. The system of any one of claims 26 to 27, wherein the limiter comprises a depth stop.

29. A system according to any one of claims 26 to 28, wherein: The delivery tool includes a shaft controller adapted to extend the shaft within the heart, and Operating the shaft controller to lengthen the shaft within the heart causes the controller to automatically operate to increase the amount of tether exposed within the heart.

30. The system of any one of claims 26 to 29, wherein the shaft is configured to transluminally position the spool within the heart while the shaft extends from the handle through the vasculature of the subject to the spool within the heart.

31. The system of any one of claims 26 to 30, wherein the controller includes a control knob and is operatively coupled to the spool and the limiter such that rotation of the control knob adjusts the amount of wrapping of the tether around the spool and also modifies the limit.

32. The system of any one of claims 26 to 31 , wherein the controller is operatively coupled to the spool and the limiter via a rotary to linear mechanism.

33. The system of claim 32, wherein the rotary to linear mechanism comprises a worm drive.

34. The system of any one of claims 26 to 33, wherein the implant comprises an anchor coupled to the spool and configured to anchor the spool to tissue at a site in the heart.

35. The system of claim 34, wherein: The anchor is a second anchor, The site is a second site, The implant further includes a first anchor coupled to the first end portion of the tether and configured to anchor the first end portion of the tether to tissue at a first site within the heart, and The shaft is configured to transluminally advance the spool and the second anchor toward the second site while the first anchor is anchored at the first site.

36. The system of claim 35, wherein: The first site is a leaflet site at a leaflet of a valve of the heart, The first anchor is adapted to be anchored to the leaflet site, the second site is a ventricular site in the ventricle downstream of the valve, The second anchor is adapted to be anchored to the ventricular site, and The shaft is configured to transluminally advance the wire shaft and the second anchor toward the ventricular site while the first anchor is anchored at the leaflet site.

37. A system according to any one of claims 26 to 36, wherein when the handle is mounted on the mounting member, the mounting member is positioned in the axial path so that when the handle reaches the limit, the mounting member blocks the axial movement of the handle.

38. The system of claim 37, wherein the mounting member comprises: a distal stop positioned to block distal movement of the limiter by being disposed in the axial path when the handle is mounted on the mount; and A proximal stop is positioned to block proximal movement of the limiter by being disposed in the axial path when the handle is mounted on the mount.

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