Self-locking capstan

Abstract

The winch (40) of the implant (300) includes a driver interface (64), a base (46), and a spool (42). The base is coupled to the driver interface such that driving of the driver interface causes the base to rotate about an axis of rotation (d48). A tether (44) is coupled to the spool and extends away from the winch toward an end (62) of the tether. The spool is fixedly coupled to the base in a position and orientation that (i) facilitates the spool to draw the end of the tether toward the winch by wrapping the tether around the spool in response to forward rotation of the base about the axis of rotation; but (ii) inhibits pulling the end away from the spool to cause reverse rotation of the base and unwinding of the tether from the spool. Other embodiments are also described.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Patent Application 62 / 993,669 entitled “Self-locking winch”, filed March 23, 2020, which is incorporated herein by reference for all purposes. Background Technology

[0003] Dilation of the valve annulus (e.g., caused by ischemic heart disease) prevents the valve leaflets from fully engaging when the valve closes. The return of blood from the ventricles to the atria results in an increase in total stroke volume and a decrease in cardiac output, ultimately weakening the ventricles due to volume overload and atrial pressure overload. Summary of the Invention

[0004] This invention is intended to provide examples and is not intended to limit the scope of the invention in any way. For example, the claims do not require any features included in the examples of this invention unless those features are expressly enumerated in the claims. Furthermore, the described features can be combined in various ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized herein.

[0005] Some applications of this invention relate to systems, apparatus, and methods for adjusting medical implants using an adjustment mechanism.

[0006] The adjustment mechanism may include a winch. In some applications, adjustment is achieved by applying tension to a tether using the winch, with the tether extending away from the winch toward its end. The winch may include a reel coupled to the tether. The winch may be fixedly coupled to a base having a drive interface, such that actuation of the drive interface causes the base to rotate about a rotation axis, pulling the end of the tether toward the reel by winding the tether around the reel's axis.

[0007] The reel can be coupled to the base in a position and orientation relative to the axis of rotation, which facilitates the reel pulling the end of the tether toward the winch by winding a tether around the reel in response to rotation of the base about the axis of rotation in the forward direction. Furthermore, the reel can be coupled to the base in a position and orientation relative to the axis of rotation, which prevents the tether from detaching from the reel in response to pulling its end away from the reel by inhibiting pull that causes the base to rotate about the axis of rotation in the reverse direction.

[0008] In other words, while the position and orientation of the reel facilitates the reel's response to the forward rotation of the base about the axis of rotation by winding the tether around the reel to pull the end of the tether toward the winch, this position and orientation generally inhibits the end from being pulled away from the reel, causing the base to rotate in the opposite direction and the tether to come loose from the reel.

[0009] Typically, the reel (e.g., the axis of the reel defined by the reel) is not on the same axis as the axis of rotation.

[0010] For some applications, the reel can be positioned transversely to (e.g., parallel to) the axis of rotation. For some such applications, the reel is positioned completely transversely to the axis of rotation, for example, such that when the base rotates about the axis of rotation, the reel rotates about the axis of rotation.

[0011] Alternatively, the reel may be orthogonal to the axis of rotation, for example, such that the axis of rotation passes through the reel, such that when the base rotates about the axis of rotation, the reel rotates about the axis of rotation in a manner similar to a propeller rotating on its axis.

[0012] For some applications, the adjustment mechanism includes at least one tilting guide coupled to the base and positioned transversely to the axis of rotation. The tilting guide can be positioned such that when the base rotates in the forward rotation direction, the guide guides the tether around the reel. For some such applications, actuation of the actuator interface causes the guide to move together with the base about the axis of rotation.

[0013] For some applications, the adjustment mechanism includes a housing that accommodates the winch and is configured to allow the base to rotate relative to the housing about an axis of rotation, with the reel moving together with the base. The housing may define an aperture configured to allow the tether to pass from outside the winch to the reel when the reel pulls the end of the tether toward the winch.

[0014] For some applications, the adjustment mechanism includes at least one flange configured to provide mechanical separation between the tether and the drive interface.

[0015] For some applications, the winch includes an eyelet defining a hole through which it passes. This eyelet can be configured to allow the tether to pass from outside the winch to the reel when the reel pulls the end of the tether toward the winch. For some applications, the eyelet mechanically engages with a guide such that, as the base rotates in the forward rotation direction, the tilting guide guides the tether around the reel by moving the eyelet longitudinally parallel to the axis of rotation (e.g., along a track, such as a track defined by the housing).

[0016] In some applications, at least one anchor is used to anchor the end of the tether to the tissue of the object. Some such applications include annulus angioplasty structures configured such that the traction of the tether end from the anchor toward the winch reduces the length of the structure. For example, the annulus angioplasty structure may include a longitudinally flexible sleeve defining an elongated lumen coupled to the winch and having a constricted portion along which the tether extends. Pulling the end of the tether toward the winch longitudinally constricts the constricted portion.

[0017] Therefore, for some applications, a system and / or device is provided for use with a catheter-propellable actuator, the system / device including an implant. The implant may include a tether having an end and a winch.

[0018] For some applications, the winch includes a drive interface and a base. The drive interface can be engaged and driven by a drive, and the base is coupled to the drive interface, such that the drive's action on the drive interface causes the base to rotate about a rotation axis.

[0019] For some applications, the winch includes a spool coupled to a tether and fixedly coupled to a base in position and orientation relative to the axis of rotation, the tether extending toward its end away from the winch. In some applications, this position and orientation facilitates that the spool, in response to rotation of the base about the axis of rotation in the forward direction, pulls the end of the tether toward the winch by winding the tether around the spool; and prevents the tether from detaching from the spool in response to pulling its end away from the spool by inhibiting pulls that cause the base to rotate about the axis of rotation in the reverse direction.

[0020] In one application, the reel is fixedly coupled to the base, such that the reel is positioned completely transverse to the axis of rotation.

[0021] In one application, the reel is shaped to define an eyelet through which a rope passes.

[0022] In one application, the reel is fixedly coupled to the base at a position and orientation that provides at least one stable rotational orientation of the base, in which pulling is prevented from causing the base to rotate about the rotation axis in the opposite rotational direction. In another application, the reel is fixedly coupled to the base at exactly one stable rotational orientation that provides the base, in which pulling is prevented from causing the base to rotate about the rotation axis in the opposite rotational direction.

[0023] In one application, the reel is fixedly coupled to the base at at least two stable rotational orientations, where pulling is prevented from causing the base to rotate about the axis of rotation in opposite rotational directions. In another application, the reel is fixedly coupled to the base at exactly two stable rotational orientations, where pulling is prevented from causing the base to rotate about the axis of rotation in opposite rotational directions.

[0024] In one application, the winch includes at least one flange configured to provide mechanical separation between the tether and the drive interface. In another application, the base is shaped to define at least one flange.

[0025] In one application, the position and orientation prevent the tether from releasing from the reel in response to a pull by limiting the base's rotation in the opposite direction of rotation to less than 180 degrees. In another application, the position and orientation prevent the tether from releasing from the reel in response to a pull by limiting the base's rotation in the opposite direction of rotation to less than 90 degrees. In yet another application, the position and orientation prevent the tether from releasing from the reel in response to a pull by limiting the base's rotation in the opposite direction of rotation to less than 45 degrees.

[0026] In one application, the system / device includes a housing that houses a winch, the housing being configured to facilitate movement of the base and the reel relative to the housing about an axis of rotation.

[0027] In one application, the housing defines a hole configured to facilitate the passage of the tether from outside the winch to the reel when the reel pulls the end of the tether toward the winch.

[0028] In one application, the driver can be connected to the driver interface when the winch is housed within a housing.

[0029] In one application, the housing is shaped to define a hole, and a tether extends from the spool, through the hole, out of the winch, and toward the end away from the winch.

[0030] In one application, the hole defined by the housing is a circular hole.

[0031] In one application, the hole defined by the housing is an elongated hole. In another application, the elongated hole has a long axis disposed on a hole plane transverse to the axis of rotation.

[0032] In one application, the implant also includes at least one anchor configured to anchor the end of the tether to the tissue of the object.

[0033] In one application, the at least one anchor includes a plurality of anchors, the tether is slidable relative to at least one of the anchors, and the winch is configured such that in response to rotation of the base in the positive rotational direction, pulling the end of the tether toward the winch causes at least one of the anchors to slide distally relative to the tether.

[0034] In one application, the implant includes a valve annuloplasty structure and is configured such that the end of the tether is directed toward the winch to reduce the length of the structure.

[0035] In one application, the annulusoplasty structure includes a longitudinally flexible sleeve that defines an elongated lumen, is coupled to a winch, and can be anchored to tissue via anchors such that a tether is anchored to the tissue by anchoring the sleeve to the tissue. The longitudinally flexible sleeve has a contraction portion along which the tether extends. In one application, the system / device is configured such that the end of the tether longitudinally contracts towards the contraction portion of the winch's traction.

[0036] In one application, the sleeve is coupled to the winch via a suture.

[0037] In one application, the winch is attached to the outer side surface of the sleeve.

[0038] In one application, the first part of the tether extends along the contraction section; and the second part of the tether: exits from the sleeve at the exit point and is coupled to the winch.

[0039] In one application, the system / device includes a delivery tool for delivering an implant into a subject's body, the delivery tool including a catheter, the distal portion of which can be advanced into the subject's body.

[0040] In one application, the catheter is a maneuverable transluminal catheter.

[0041] In one application, the system / device includes an actuator and a guide member, and in the delivery state of the system / device: the implant is positioned at the distal portion of the catheter, and the guide member is coupled to a winch and extends proximally through the catheter to the proximal portion of the catheter, and the actuator is slidable on and along the guide member.

[0042] In one application, the spool is fixedly coupled to the base transversely to the axis of rotation, such that in the cross-section of the winch orthogonal to the axis of rotation, the radius of the winch extends radially outward from the axis of rotation toward the spool, reaches the spool at a first surface point, passes through the spool, and exits the spool at a second surface point.

[0043] In one application, the reel has a trapezoidal cross-sectional shape in cross-section. In another application, the reel has a D-shaped cross-sectional shape in cross-section. In yet another application, the reel is shaped to define a reel axis parallel to the axis of rotation.

[0044] In one application, in a cross-section, the first surface point of the reel is the point on the reel closest to the axis of rotation. In one application, in a cross-section, the first surface point of the reel is at least 0.2 mm from the axis of rotation. In one application, in a cross-section, the first surface point of the reel is 0.2 to 4 mm from the axis of rotation. In one application, in a cross-section, the first surface point of the reel is 0.3 to 2 mm from the axis of rotation.

[0045] In one application, the reel is fixedly coupled to the base orthogonal to the axis of rotation.

[0046] In one application, the winch includes at least one tilting guide coupled to a base, disposed transversely to the axis of rotation, and positioned such that when the base rotates in the forward rotation direction, the at least one tilting guide guides the tether around the reel.

[0047] In one application, the at least one tilt guide is fixedly coupled to the base such that when the driver interface is driven by the driver, the at least one tilt guide moves together with the base about a rotation axis.

[0048] In one application, the at least one tilting guide defines a guide surface that extends helically around and along the axis of rotation.

[0049] In one application, the at least one tilting guide includes a first tilting guide and a second tilting guide, the first tilting guide being positioned such that when the base rotates in the positive rotational direction, the first tilting guide guides the tether to a second side of the reel, and the second tilting guide being positioned such that when the base rotates in the positive rotational direction, the second tilting guide guides the tether to a first side of the reel opposite to the second side of the reel.

[0050] In one application, the winch defines a first shoulder and a second shoulder, a first tilting guide is coupled at the first shoulder to a first end of the reel, and a second tilting guide is coupled at the second shoulder to a second end of the reel. The first tilting guide is positioned such that when the base rotates in the forward rotation direction, the first tilting guide guides a tether across the first shoulder to a second side of the reel, and the second tilting guide is positioned such that when the base rotates in the forward rotation direction, the second tilting guide guides a tether across the second shoulder to a first side of the reel.

[0051] In one application, the winch also includes an eyelet defining a hole through which the tether passes. The hole is configured to facilitate the passage of the tether from outside the winch to the reel when the reel pulls the end of the tether toward the winch. The eyelet mechanically engages with a guide such that when the base rotates in the positive rotation direction, at least one tilting guide guides the tether around the reel by longitudinally moving the eyelet parallel to the axis of rotation.

[0052] In one application, the system / device includes a housing that houses a winch, the housing being configured to facilitate movement of the base and the reel relative to the housing about an axis of rotation.

[0053] In one application, the housing defines a longitudinal track along a track axis parallel to the axis of rotation, the track being configured to facilitate longitudinal movement of the eyelet along the track axis when the base rotates in the positive rotational direction.

[0054] In one application, the driver can be connected to the driver interface when the winch is housed within a housing.

[0055] According to some applications, a system and / or device for use with a catheter-propellable actuator is further provided, the system / device including an implant comprising: a tether having an end; and a winch.

[0056] For some applications, the winch includes a drive interface and a base. The drive interface can be engaged and driven by a drive, and the base is coupled to the drive interface, such that the drive's action on the drive interface causes the base to rotate about a rotation axis.

[0057] For some applications, the winch includes a spool that defines a spool axis and is coupled to a tether that extends away from the winch toward its end. The spool can be fixedly coupled to a base such that rotation of the base about an axis of rotation pulls the end of the tether toward the spool by winding the tether around the spool axis, and the spool axis is not coaxial with the axis of rotation.

[0058] In one application, the reel is fixedly coupled to the base, such that the reel is positioned completely transverse to the axis of rotation.

[0059] In one application, the axis of the reel is parallel to the axis of rotation.

[0060] In one application, the reel is shaped to define an eyelet through which a rope is threaded.

[0061] In one application, the winch includes at least one flange configured to provide mechanical separation between the tether and the drive interface.

[0062] In one application, the base is shaped to define at least one flange.

[0063] In one application, the system / device includes a housing that houses a winch, the housing being configured to facilitate movement of the base and the reel relative to the housing about an axis of rotation.

[0064] In one application, the driver can be connected to the driver interface when the winch is housed within a housing.

[0065] In one application, the housing is shaped to define a hole through which a tether extends from a spool, through the hole, out of the winch and toward the end away from the winch, and the hole is configured to facilitate the tether's insertion into the winch when the spool pulls the end of the tether toward the winch.

[0066] In one application, the housing defines the hole as a circular shape. In another application, the housing defines the hole as an elongated shape.

[0067] In one application, the housing defines the hole as having a long axis, which is positioned on the hole plane transverse to the axis of rotation.

[0068] In one application, the implant also includes at least one anchor configured to anchor the end of the tether to the tissue of the object.

[0069] In one application, the at least one anchor includes a plurality of anchors, the tether is slidable relative to at least one of the anchors, and the winch is configured such that in response to rotation of the base in the positive rotational direction, pulling the end of the tether toward the winch causes at least one of the anchors to slide distally relative to the tether.

[0070] In one application, the implant includes a valve annuloplasty structure and is configured such that the end of the tether is directed toward the winch to reduce the length of the structure.

[0071] In one application, the annulusoplasty structure includes a longitudinally flexible sleeve defining an elongated lumen coupled to a winch and having a contraction portion along which a tether extends, and the system / device is configured such that the end of the tether longitudinally contracts toward the winch's traction contraction portion.

[0072] In one application, the sleeve is coupled to the winch via a suture.

[0073] In one application, the winch is coupled to the outer side surface of the sleeve.

[0074] In one application, the first part of the tether extends along the contraction section; and the second part of the tether: exits from the sleeve at the exit point and is coupled to the winch.

[0075] In one application, the system / device includes a delivery tool for delivering an implant into a subject's body, the delivery tool including a catheter, the distal portion of which can be advanced into the subject's body.

[0076] In one application, the catheter is a maneuverable transluminal catheter.

[0077] In one application, the system / device includes an actuator and a guide member, and in the delivery state of the system / device: the implant is positioned at the distal portion of the catheter, and the guide member is coupled to a winch and extends proximally through the catheter to the proximal portion of the catheter, and the actuator is slidable on and along the guide member.

[0078] In one application, the spool is fixedly coupled to the base transversely to the axis of rotation, such that in the cross-section of the winch orthogonal to the axis of rotation, the radius of the winch extends radially outward from the axis of rotation toward the spool, reaches the spool at a first surface point, passes through the spool, and exits the spool at a second surface point.

[0079] In one application, the reel has a trapezoidal cross-sectional shape in cross-section. In another application, the reel has a D-shaped cross-sectional shape in cross-section.

[0080] In one application, in a cross-section, the first surface point of the reel is the point on the reel closest to the axis of rotation. In one application, in a cross-section, the first surface point of the reel is at least 0.2 mm from the axis of rotation. In one application, in a cross-section, the first surface point of the reel is 0.2 to 4 mm from the axis of rotation. In one application, in a cross-section, the first surface point of the reel is 0.3 to 2 mm from the axis of rotation.

[0081] In one application, the reel is fixedly coupled to the base orthogonal to the axis of rotation.

[0082] In one application, the winch includes at least one tilting guide coupled to a base, disposed transversely to the axis of rotation, and positioned such that when the base rotates in the forward rotation direction, the at least one tilting guide guides the tether around the reel.

[0083] In one application, at least one tilt guide is fixedly coupled to the base such that when the driver interface is driven by the driver, at least one tilt guide moves together with the base about a rotation axis.

[0084] In one application, at least one tilting guide defines a guide surface that extends helically around and along the axis of rotation.

[0085] In one application, at least one tilting guide includes a first tilting guide and a second tilting guide, the first tilting guide being positioned such that when the base rotates in the positive rotational direction, the first tilting guide guides the tether to a second side of the reel, and the second tilting guide being positioned such that when the base rotates in the positive rotational direction, the second tilting guide guides the tether to a first side of the reel opposite to the second side of the reel.

[0086] In one application, the winch defines a first shoulder and a second shoulder, a first tilting guide is coupled at the first shoulder to a first end of the reel, and a second tilting guide is coupled at the second shoulder to a second end of the reel. The first tilting guide is positioned such that when the base rotates in the forward rotation direction, the first tilting guide guides a tether across the first shoulder to a second side of the reel, and the second tilting guide is positioned such that when the base rotates in the forward rotation direction, the second tilting guide guides a tether across the second shoulder to a first side of the reel.

[0087] In one application, the system / apparatus includes an eyelet defining a hole through which the tether passes. The hole is configured to facilitate the passage of the tether from outside the winch to the reel when the reel pulls the end of the tether toward the winch. The eyelet is mechanically engaged with a guide such that when the base rotates in the positive rotation direction, at least one tilting guide guides the tether around the reel by longitudinally moving the eyelet parallel to the axis of rotation.

[0088] In one application, the system / device includes a housing that houses a winch, the housing being configured to facilitate movement of the base and the reel relative to the housing about an axis of rotation.

[0089] In one application, the housing defines a longitudinal track along a track axis parallel to the axis of rotation, the track being configured to facilitate longitudinal movement of the eyelet along the track axis when the base rotates in the positive rotational direction.

[0090] In one application, the driver can be connected to the driver interface when the winch is housed within a housing.

[0091] According to some applications, a method is further provided, comprising: delivering an implant via a catheter to the tissue of a subject, the implant including a tether having an end and a winch.

[0092] For some applications, the winch includes a driver interface and a base, with the base coupled to the driver interface so that the driver interface drives the base to rotate about a rotation axis.

[0093] For some applications, the winch includes a spool that defines a spool axis opposite to the axis of rotation, is coupled to a tether that extends toward the end of the winch away from the winch, and the spool is fixedly coupled to a base. For some applications, the end of the tether is pulled toward the spool by rotating the base about the axis of rotation and by winding the tether around the spool axis opposite to the axis of rotation.

[0094] In one application, the spool axis is parallel to the axis of rotation, and winding the tether around the spool axis includes winding the tether around the spool axis parallel to the axis of rotation.

[0095] In one application, the spool axis is orthogonal to the axis of rotation, and winding the tether around the spool axis includes winding the tether around the spool axis orthogonal to the axis of rotation.

[0096] In one application, the method includes engaging a driver interface with a driver, and rotating a base about a rotation axis by driving the driver interface with the driver to rotate the base about a rotation axis.

[0097] In one application, the method includes advancing the actuator through the catheter into the actuator interface after the implant has been delivered to the tissue of the object via a catheter and before engaging the actuator interface with the actuator.

[0098] This method can be performed on living animals or simulations, such as on corpses, corpse hearts, simulators (e.g., simulating body parts, tissues, etc.).

[0099] According to some applications, a method is further provided, comprising delivering an implant via a catheter to tissue of a subject, the implant comprising: a tether having an end; and a winch including a drive interface and a base. The winch may also include a spool defining a spool axis.

[0100] For some applications, the method involves engaging the drive interface with the drive. For some applications, the method involves using the drive to tension the tether by rotating the base about the axis of rotation in the positive rotational direction to wind the tether toward the winch.

[0101] For some applications, without locking the discrete locking mechanism, the method includes disengaging the driver from the driver interface, causing the suppression base to rotate in the opposite direction about the rotation axis in response to a pull from the tensioned tether.

[0102] In one application, the spool axis is parallel to the axis of rotation, and the winding of the tether toward the winch includes winding the tether around the spool axis parallel to the axis of rotation.

[0103] In one application, the spool axis is orthogonal to the axis of rotation, and the winding of the tether toward the winch includes winding the tether around the spool axis orthogonal to the axis of rotation.

[0104] In one application, the method includes advancing the actuator through the catheter into the actuator interface after the implant has been delivered to the tissue of the object via a catheter and before engaging the actuator interface with the actuator.

[0105] This method can be performed on living animals or simulations, such as on corpses, corpse hearts, simulators (e.g., simulating body parts, tissues, etc.).

[0106] The invention will be more fully understood from the following detailed description of its application in conjunction with the accompanying drawings, wherein: Attached Figure Description

[0107] Figures 1A-1C and 2A-2C are schematic diagrams illustrating prior art winches;

[0108] Figure 3A- Figure 3E and Figures 4A-4C This is a schematic diagram illustrating an adjustment mechanism including a winch according to some applications;

[0109] Figures 5A-5B , Figures 6A-6C , Figures 7A-7L And Figure 8A- Figure 8E , Figures 9A-9C This is a schematic diagram showing the adjustment mechanism, including a winch, for various applications;

[0110] Figure 10 This is a schematic diagram of a multi-component system, including an implant and a delivery tool for delivering the implant to the recipient's heart, based on some applications; and

[0111] Figures 11A-11F are schematic diagrams illustrating the use of adjustment mechanisms in systems including implants and delivery tools, according to some applications. Detailed Implementation

[0112] Referring to Figures 1A-1C and 2A-2C, these are schematic diagrams illustrating prior art winches 10 and 10b. For some applications, and as shown in Figure 1A, winch 10 includes a spool 12 to which a tether 14 is secured. The tether 14 includes elongated components (e.g., cord, tie, rope, cable, wire, filament, etc.).

[0113] The winch 10 may also include a base 16 to which the reel 12 is fixedly attached, such that the base and the reel rotate together about a common axis of rotation d18. Thus, as shown in FIG1B, the rotation of the base and the reel (indicated by the solid arrow) about the axis d18 winds the tether 14 into the winch (indicated by the dashed arrow), and the tether winds around the reel 12.

[0114] Throughout this patent application, the direction of rotation of the winch (or its base) around its axis of rotation, which causes the tether to be wound around the spool, is defined as "forward rotation".

[0115] It should be noted that the base 16 and the scroll 12 are coaxial.

[0116] As shown in Figure 1C, without any restraining force or element, the tension applied to the distal end of the tether 14 pulls the tether out of the winch. This is because the tension causes the spool 12 to rotate in the opposite direction of rotation (indicated by the dashed arrow) (in the direction opposite to the direction in which the accompanying tether is wound around the spool), causing the tether to detach from the spool. Throughout this disclosure, the direction of rotation causing the tether to detach from the winch around the spool is defined as "opposite rotation".

[0117] For some applications, it may be desirable to prevent the tether 14 from loosening in response to a tension applied to the distal end of the tether. For example, after tension is applied to the tether 14 during winding in the forward direction, it may be desirable to maintain that tension in the tether. Figure 2A illustrates a prior art solution for this, in which a locking mechanism 20 is incorporated into the winch 10, thereby forming the winch 10b. For example, and as shown, the locking mechanism 20 may include a ratchet 22 and a pawl 24 fixed to the base 16. Typically, as shown, the ratchet 22 is fixed to the base 16 in such a way that both the base and the reel 12 are rotatably movable about axis d18. Furthermore, the ratchet 22 may be shaped to define teeth 26, and the pawl 24 is shaped to complementarily engage the teeth 26 of the ratchet. The pawl 24 may be (e.g., by means of a spring) biased to engage the ratchet 22 such that the pawl abuts the continuous teeth 26 of the ratchet as the ratchet rotates. Due to the shape of the teeth 26 and the pawl 24, the rotation of the spool 12 in the forward direction (counterclockwise in Figure 2A) causes the pawl to slide from the braking area 28a of the first tooth 26 along the ramp area 30 of the second tooth to the braking area 28b of the second tooth.

[0118] Typically, as shown, the locking mechanism 20 causes the rotation of the spool about axis d18 (solid arrow in Figure 2B) to accompany the winding of the tether 14 (dashed arrow in Figure 2B). However, when a pulling force is applied to the distal end of the tether 14 (solid arrow in Figure 2C), the spool 12 is largely prevented from rotating in the opposite direction (dashed arrow in Figure 2C). That is, the pulling force pulls the spool in the opposite direction, causing the pawl 24 to pass approximately across a portion of the ramp area 30 until the pawl abuts against the braking area 28, stopping the backward rotation of the winch 10. In this way, the tether 14 can be released by a rotational length less than that of the tooth 26 until the pawl 24 statically abuts against the braking area 28, preventing further release of the tether. In other words, the locking mechanism 20 inhibits the tether 14 from being released from the spool 12 in response to pulling the end of the tether away from the spool by providing unidirectionality to the winch 10.

[0119] Other prior art solutions for preventing the tether from loosening from the reel include an actuable locking mechanism that unlocks during the winding of the tether and is subsequently locked to prevent further rotation of the reel (e.g., in either direction). An example of such a locking mechanism is described in U.S. Patent Application Publication 2010 / 0280604 by Zipory et al. (e.g., see reference 1). Figure 6A -Figure 8).

[0120] Now refer to Figure 3A- Figure 3E , Figures 4A-4C These are schematic diagrams showing an adjustment mechanism 36 including a winch 40 according to some applications.

[0121] As shown in Figure 3A, the winch 40 includes a base 46, a reel 42, and a drive interface 64. As shown in Figure 3B, the drive 66, which can be advanced via a conduit, engages with and drives the drive interface, causing the base 46 to rotate about the rotation axis d48 of the winch.

[0122] The spool 42 is typically shaped to define a longitudinal spool axis d50.

[0123] Although the base and spool of winch 10 are coaxial, in winch 40, spool 42 is not coaxial with the axis of rotation d48. Instead, as described in more detail below, spool 42 is positioned transversely to axis d48.

[0124] Similar to winch 10, for winch 40, in response to rotation in the forward direction, the tether 44 is drawn into the winch and wound around the reel 42. However, compared to winch 10, the position and orientation of the reel 42 coupled to the base 46 inhibits the subsequent release of the tether 44 from the reel in response to pulling its end away from the reel. That is, the position and orientation of the reel 42 coupled to the base 46 at least partially avoids the need for the adjustment mechanism 36 to include a discrete locking mechanism (e.g., a discrete actuable locking mechanism). It should be noted that, despite this, winch 40 can be rotated bidirectionally by the drive 66.

[0125] For some applications, and as shown in Figures 3A-3B, the adjustment mechanism 36 further includes a housing 68 in which the winch is housed, such that the base 46 rotates relative to the housing about axis d48. Typically, as shown, the housing 68 is shaped to define a hole 90, and a tether 44 extends from the reel 42, through the hole, out of the winch 40, and toward the end 62 away from the winch. For some applications, and as shown, the hole 90 is shaped to define an elongated shape, with its long axis positioned on a hole plane d38 transverse to the reel axis d50.

[0126] As shown in Figure 3B, for applications in which the winch 40 is housed within the housing 68, the driver 66 can be accessed from outside the housing via the driver interface 64.

[0127] The tether 44 (e.g., its proximal end) is securely attached (e.g., fastened, crimped, brazed, soldered, or welded) to the reel 42. For some applications, and as shown, the reel 42 is shaped to define an eyelet 80, which is configured to facilitate this attachment.

[0128] For some applications, and such as Figure 3C As shown, the winch 40 also includes at least one flange 32, for example, two flanges 32, one flange at each end of the reel 42 (e.g., adjacent to the reel). For some applications, the flanges 32 are defined by and / or integral with the base 46. Typically, the flanges 32 are shaped to provide mechanical separation between the reel 42 and the drive interface 64. Thus, it is assumed that the flanges 32 prevent the tether 44 from slipping off the reel 42 and / or getting stuck between the elements of the adjustment mechanism.

[0129] As described above, in response to the rotation of the base 46 in its positive rotational direction ( Figure 4A (Solid arrow in the middle), rope 44 is pulled into the winch ( Figure 4A (The dashed arrow in the image), and wrap it around the reel 42, for example, as shown. Figure 4A and Figure 4B The transition between these is shown. Also as described above, the position and orientation of the reel 42 coupled to the base 46 inhibits the subsequent pulling of the tether 44 away from the reel ( Figure 4C (The solid arrow in the middle) and released from the scroll (by Figure 4C (There is no rotating arrow indicating this). That is, pulling the tether 44 will not cause the base 46 to rotate about the axis of rotation in the opposite direction. In fact, in some rotational positions of the base 46, pulling the tether 44 will cause the base to rotate a little further in the forward rotational orientation (e.g., as shown in the image). Figure 4B and Figure 4C (as shown in the transitions), for example, until the winch reaches a stable rotational orientation.

[0130] Figure 4B and Figure 4C The diagram illustrates the winch 40 from its dynamic rotation position ( Figure 4B ) to stable rotation orientation ( Figure 4C The change in rotation. In both the dynamic rotational position and the stable rotational orientation, the tension (solid arrow) is applied to the tether 44 in the same direction. (As...) Figure 4B As shown by the dashed arrow in the diagram, the tension causes the spool 42 to rotate in the positive rotation direction until it reaches... Figure 4C The stable rotational orientation is shown. When the winch 40 exhibits its stable rotational orientation, further pulling of the tether will not: (i) cause the tether 44 to detach from the reel 42 in response to pulling the tether 44 away from the reel, nor (ii) cause the base 46 to rotate about the axis of rotation.

[0131] As described above, the stable rotational orientation that provides resistance to loosening in response to the pulling of the tether is generated by the position and orientation of the reel 42 coupled to the base 46. As shown, the reel 42 is arranged transversely to the axis d48; for example, the reel axis d50 is not coaxial with the rotation axis d48. For example, and as shown, the reel axis d50 may be parallel to the rotation axis d48.

[0132] For some applications, the spool 42 is positioned completely transverse to the axis of rotation. That is, the radius d52 of the winch extends radially outward from the axis d48 toward the spool 42, reaches the spool 42 at a first surface point 54, passes through the spool, and exits the spool at a second surface point 56. For some applications, the spool 42 defines two opposite sides: (i) a first side 58 including the surface point 54 and facing the axis d48, and (ii) a second side 60 including the surface point 56 and facing away from the axis d48. Both sides 58 and 60 are positioned on the same transverse side of the axis of rotation d48 such that the axis d48 does not pass through the spool 42.

[0133] Due to the position of the spool 42 relative to the base 46, as the base rotates about the rotation axis d48, the spool rotates about the rotation axis d48, but generally does not intersect the rotation axis. That is, during the rotation of the winch 40, the spool axis d50 remains radially outward from the rotation axis d48.

[0134] Typically, the position and orientation of the spool 42 coupled to the base 46 are such that a portion of the tether 44 wound around the spool is positioned transversely to the axis of rotation d48 (e.g., on one side of the line d94).

[0135] Typically, the spool 42 is fixedly coupled to the base 46 such that the spool is positioned completely transverse to the axis of rotation d48. That is, typically, the center line d94 (e.g., a diameter or its secant) can be drawn transverse to the axis of rotation d48, and this line does not pass through the spool. For example, in a cross-section (such as... Figures 4A-4C As shown), the first surface point 54 is the point on the reel 42 closest to the axis of rotation d48, and is typically far enough from the axis of rotation d48 to provide space for winding the rope to be positioned between the reel and the axis of rotation d48. The first surface point 54 may be at least 0.2 mm (e.g., 0.2 to 4 mm, or 0.3 to 2 mm) from the axis of rotation d48 and / or from the line d94. Similarly, the first side 58 may be completely set at least 0.2 mm (e.g., 0.2 to 4 mm, or 0.3 to 2 mm) from the line d94. It is assumed that both the reel and the rope are positioned transversely to the axis of rotation to facilitate a stable rotational orientation of the winch, despite the tension at the end of the rope.

[0136] For some applications, the spool 42 has a circular cross-sectional shape. For some applications, and as shown, the cross-sectional shape of the spool 42 is non-circular, for example, such that the first side 58 defines the long side of the spool. For example, the cross-sectional shape in the cross-section (such as...) Figures 4A-4C The reel 42 may have a trapezoidal cross-sectional shape (e.g., where the longer of the parallel sides of the trapezoid is the first side 58). Alternatively, in the cross-section (e.g. Figures 4A-4CAs shown), the reel 42 may have a D-shaped cross-sectional shape (e.g., where the curved side of the D-shape is the second side). The cross-sectional shape shown is configured to provide a relatively large perimeter so that the tether 44 is wound with a relatively long length per turn while remaining completely transverse to the axis d48. These exemplary cross-sectional shapes of the reel 42 are not intended to be exhaustive, and other shapes may be envisioned.

[0137] See now Figures 5A-5B , Figures 6A-6C , Figures 7A-7L And Figure 8A- Figure 8E , Figures 9A-9C These are schematic diagrams illustrating adjustment mechanisms 136 and 236, respectively, including winches 140 and 240, for various applications. First, the common features of adjustment mechanisms 136 and 236 will be presented, followed by a description of aspects unique to each winch.

[0138] Although the base and reel of winch 10 are coaxial, in winches 140 and 240, reels 142 and 242 are not coaxial with the rotation axes d148 and d248. Instead, as described in more detail below, reels 142 and 242 are orthogonal to axes d148 and d248. It should be noted that, despite this, winches 140 and 240 are also rotated bidirectionally by drive 66.

[0139] The tether 44 (e.g., its proximal end) is securely attached (e.g., fastened, crimped, brazed, soldered, or welded) to the reels 142, 242. For some applications, and as shown, the reels 142, 242 are shaped to define eyelets 180, 280 that facilitate this attachment.

[0140] Similar to winch 40, for winches 140 and 240, in response to rotation in the forward direction, tether 44 is drawn into the winch and wound around the respective spools 142 and 242. Further similar to winch 40, the spools 142 and 242 are coupled to the bases 146 and 246, respectively, and their position and orientation are inhibited. Subsequently, the tether 44 is released from the spools in response to pulling its end away from the spool. In this way, the tension applied to the spools 142 and 242 does not result in substantial rotational movement, thus producing a stable rotational orientation for winches 140 and 240. That is, the position and orientation of the spools 142 and 242 coupled to the bases 146 and 246, respectively, at least partially eliminates the need for adjustment mechanisms 136 and 236 to include discrete locking mechanisms (e.g., discrete actuable locking mechanisms).

[0141] For some applications, spool 42 is fixedly coupled to base 46 in at least one stable rotational orientation (e.g., exactly one stable rotational orientation) of the base, in which pulling is inhibited to cause the base to rotate in the opposite direction about the rotation axis d48. That is, depending on the initial rotational orientation of winch 40, applying tension to end 62 of tether 44 can cause the winch to rotate almost a full revolution until the winch reaches a stable position. Conversely, spools 142, 242 are fixedly coupled to bases 146, 246 in at least two stable rotational orientations of the base, in which pulling is inhibited to cause the base to rotate in the opposite direction about the rotation axes d148, d248. That is, depending on the initial rotational orientation of the winch, applying tension to end 62 of tether 44 can cause the winch to rotate almost half a revolution until the winch reaches a stable position.

[0142] Reels 142, 242 are fixedly coupled to corresponding bases 146, 246. For some applications, and as shown, reels 142, 242 are shaped to define reel axes d150, d250 (e.g., through the axes of rotation) orthogonal to the axes of rotation d148, d248.

[0143] For some applications, winches 140, 240 are housed within housings 168, 268, such that bases 146, 246 and spools 142, 242 rotate relative to the housings about axes d148, d248. Furthermore, when winches 140, 240 are housed within housings 168, 268, the actuator 66 is accessible to actuator interfaces 164, 264. This accessibility of actuator interfaces 164, 264 when winches 140, 240 are housed within housings 168, 268 facilitates engagement and actuation of the winches by the actuator 66 while the winches are housed within the housings.

[0144] like Figures 5A-5B As shown, the housing 168 is shaped to define a hole 190 therethrough, which is configured to facilitate the passage of the tether 44 from outside the winch 140 to the reel 142 when the reel pulls the end 62 of the tether toward the winch.

[0145] For some applications, and as shown, winches 140, 240 include at least one tilting guide 170, 270. Typically, the tilting guide 170, 270 is coupled to a base 146, 246. For some applications, the base 146, 246 is formed to define the guide 170, 270. For example, the guide 170, 270 may be integral with the base 146, 246 (i.e., molded from the same material). Typically, as shown, the tilting guide 170, 270 is coupled to the base 146, 246 and positioned transversely to the axis of rotation d148, 248. Thus, the tilting guide 170, 270 is positioned such that when the base 146, 246 rotates in the forward rotation direction, the tilting guide guides the tether 44 around the spool 142, 242.

[0146] As described below, the way the rope 44 is guided around the reel 142 is different from the way the rope is guided around the reel 242.

[0147] like Figures 7A-7L As shown, rotation of the base 146 about the axis of rotation d148 causes the tether 44 to wind around the reel—that is, around the reel axis d150. Typically, as shown, the tilt guide 170 is shaped such that when the driver interface 164 is driven by the driver 66, the tilt guide rotates together with the base about the axis of rotation d148. For some applications, and as shown, the tilt guide 170 defines a guide surface 172 that extends helically around and along the axis of rotation d148. The contact between the tether 44 and the guide surface 172 along the helical ramp of the tilt guide 170 facilitates the conversion of the circular movement of the base 146 into the winding of the tether 44 around the reel 142.

[0148] For example, and as Figures 7A-7L As shown, the winch 140 includes a first tilting guide 170a and a second tilting guide 170b. The first tilting guide 170a is positioned such that when the base 146 rotates in the forward rotation direction, the first tilting guide guides the tether 44 to a second side 182b of the reel 142. The second tilting guide 170b is positioned such that when the base 146 rotates in the forward direction, the second tilting guide guides the tether 44 to a first side 182a of the reel 142. Typically, the first tilting guide 170a is generally disposed on the first side 182a of the reel, and the second tilting guide 170b is generally disposed on the second side 182b of the reel.

[0149] In some applications, such as Figures 7A-7LAs shown, the tether 44 is guided to the corresponding sides 174, 176 of the reel 142 by the corresponding tilting guides 170a and 170b via a winch, which is shaped to define two shoulders: a first shoulder 178a and a second shoulder 178b. The first tilting guide 170a is coupled to the second side 182b of the reel 142 at the first shoulder 178a, and the second tilting guide 170b is coupled to the first side 182a of the reel 142 at the second shoulder 178b.

[0150] For some applications, and as shown, the tilt guides 170a and 170b are positioned such that when the base 146 rotates in the forward direction, the first tilt guide guide cord 44 passes over the first shoulder 178a to the second side 182b of the reel, and the second tilt guide guide cord passes over the second shoulder 178b to the first side 182a of the reel.

[0151] For example, such as Figures 7A-7D As shown, the forward rotation of the winch 140 initially causes the tether 44 to contact the inclined guide 170a at the guide surface 172a. Continued forward rotation of the winch 140 causes the tether 44 to be guided along the guide surface 172a toward the first shoulder 178a. Figure 7E As shown, the continuous forward rotation of the winch 140 causes the tether 44 to be further guided over the first shoulder 178a, so that the tether becomes suspended over the second side 182b of the reel 142. Figure 7F As shown, the winch 140 rotates half a turn in the forward direction to facilitate winding the rope 44 around at least half of the circumference of the reel 142.

[0152] like Figures 7G-7K As shown, the continuous forward rotation of the winch 140 causes the tether 44 to climb up the guide surface 172b toward the second shoulder 178b, so that the tether becomes suspended above the first side 182a of the reel 142. In this way, a full rotation of the winch 140 in the forward direction facilitates the winding of the tether 44 around at least one full circumference of the reel 142.

[0153] like Figure 7L As shown, when no rotational force is applied to the winch 140 (e.g., when the drive 66 disengages from the winch), if the tension ( Figure 7L If the solid arrow (in the diagram) is applied to the tether 44, the tension will not significantly translate into reverse rotation of the winch 140, nor into loosening of the tether. It is assumed that, at least in part, because the spool 142 is fixedly coupled to the base 146 orthogonal to the axis of rotation d148, the tension will not significantly translate into reverse rotation of the winch. That is, the tension on the tether 44 “attempts” to rotate the spool 142 about the spool axis d150 (by…). Figure 7L(Indicated by the dashed arrow in the diagram), but this axis is orthogonal to the base 146 and is configured to rotate about axis d148. The winch 140 cannot rotate about axis d150 within the housing 168 (as indicated by...). Figure 7L (Highlighted by the dashed arrow in the diagram). Therefore, the tension applied to the tether 44 during the winding of the winch will not automatically release the winch when the drive 66 subsequently disengages.

[0154] It is further assumed that this at least partially eliminates the need for the adjustment mechanism 136 to include a separate locking mechanism (e.g., a separate actuable locking mechanism). It is further assumed that this contributes to the simplicity and ease of use of the winch 140.

[0155] Refer again to Figure 8A- Figure 8E , Figures 9A-9C These are schematic diagrams showing a winch 240 including a base 246 and a reel 242 according to some applications.

[0156] Although the shapes of the tilting guides 270a and 270b of winch 240 are similar to those of the tilting guide 170 of winch 140, the guides 270a and 270b of winch 240 are not configured to directly contact the tether 44. Instead, they are configured to indirectly guide the tether through guide eyelets 288, which define holes 290 through which the tether passes. For some applications, holes 290 are configured to facilitate the passage of the tether 44 from outside winch 240 to spool 242 when the spool pulls the end 62 of the tether toward the winch.

[0157] Furthermore, for some applications, and as described in more detail below, the eyelet 288 is mechanically engaged with the guide surfaces 272a, 272b of the guides 270a, 270b, such that when the base 246 rotates in the positive rotation direction, the guide eyelet is linearly parallel to the axis of rotation d248.

[0158] As shown in Figure 8A, Figures 8C-8D As shown, the winch 240 includes tilting guides 270a and 270b, each tilting guide extending helically around and along the axis of rotation d248, and generally parallel to each other. For some applications, the tilting guides 270a and 270b are coupled to a base 246. For some applications, the base 246 is shaped to define the guides 270a and 270b. For example, the guides 270a and 270b may be integral with the base 246 (i.e., molded from the same material).

[0159] For some applications, and as shown in Figures 8A-8B, the adjustment mechanism 236 also includes a housing 268 that accommodates the winch 240. For some applications, the housing 268 is configured to allow the base 246 and the reel 242 to rotate relative to the housing about a rotation axis d248.

[0160] For some applications, the adjustment mechanism 236 (e.g., its housing 268) defines a track 284 along a track axis d286, which is generally parallel to the rotation axis d248. An eyelet 288 mechanically engages with the track 284, allowing the eyelet to slide linearly along the track. The mechanical engagement of the eyelet 288 with (i) guide surfaces 272a and 272b and (ii) the track 284 converts the rotation of the winch 240 (including guides 270a and 270b) into the reciprocating movement of the eyelet along the track.

[0161] This movement of the eyelet 288 guides the tether 44 around one side of the spool 242 and then around the other side of the spool 242. Thus, (1) the longitudinal movement of the eyelet 288 and the end 62 of the tether 44 relative to the housing 268 and (2) the forward rotation of the base 246 cause the tether to wind around the spool 242.

[0162] Similar to the description of winch 140 above, when no rotational force is applied to winch 240 (e.g., when the actuator 66 disengages from the winch), if a pull force is applied to the tether 44, this pull force will not significantly translate into reverse rotation of winch 240, nor into loosening of the tether. As in winch 140, the spool axis d250 is orthogonal to axis d248, and the base 246 is configured to rotate about axis d248. Therefore, the pull on the tether 44 applies a pull force to spools 142 and 242, but the pull force is applied orthogonally to axes d148 and d248 and does not cause rotational movement, thereby producing stable rotational orientations for winches 140 and 240, respectively. Therefore, winch 240 cannot rotate about axis d250 within housing 268, similarly eliminating both locking mechanisms and locking actuation mechanisms from winch 240, and contributing to the simplicity and ease of use of the winch.

[0163] refer to Figure 10 The diagram is based on a multi-part system 310 for some applications, which includes an implant 300 and a delivery tool 312 for delivering the implant 300 to the heart 390 of a subject.

[0164] The implant 300 includes an adjustment mechanism 336, which includes a winch. The adjustment mechanism 336 may include any other adjustment mechanism described herein, but for illustrative purposes... Figure 10 - As shown in Figure 11F, it includes the adjustment mechanism 236.

[0165] Figure 10The distal portion of system 310 is shown, including annulusoplasty structure 320 (e.g., annulusoplasty band) partially disposed within catheter 322 of tool 312. For some applications, and as shown, structure 320 includes a cannula 330 defining an elongated lumen surrounded by sidewalls (e.g., the interior of structure 320 is shaped into an elongated lumen). For some applications, cannula 330 defines an end wall 334 of annulusoplasty structure 320.

[0166] The cannula 330 is typically a flexible cannula, including a braided fabric mesh, for example, including polyethylene terephthalate (e.g., Dacron™). The cannula 330 is typically configured to be partially or completely anchored around the valve annulus 388 of the heart valve and subsequently contract to adjust the periphery of the annulus (i.e., to tighten the annulus circumferentially).

[0167] The annular valvuloplasty structure 320 includes a flexible, elongated tether 344 that extends along at least a portion of the cannula 330, for example, to the end 362 of the tether. The portion of the cannula along which the tether extends is therefore a constricted portion of the cannula. For some applications, the tether 344 generally corresponds to the tether 44 described above (with necessary modifications).

[0168] For some applications, and as shown in Figure 11A, the sleeve 330 (i.e., its outer side surface) is coupled to the winch via a connector 370 (e.g., via a stitch) such that the end 362 of the tether 344 is oriented toward and enters the winch's traction longitudinally to retract the contracted portion.

[0169] Tether 344 may include cords, straps, ropes, or belts, and may include flexible and / or hyperelastic materials such as nitinol, polyester, stainless steel, or cobalt-chromium alloys. For some applications, the cords include radiopaque materials. For some applications, tether 344 includes braided polyester thread (e.g., Ticron). For some applications, tether 344 is coated with polytetrafluoroethylene (PTFE). For some applications, tether 344 includes multiple cords intertwined to form a rope structure.

[0170] Adjustment mechanism 336 facilitates the axial contraction (and re-expansion) of the annulusoplasty structure 320. As described with respect to other adjustment mechanisms herein, adjustment mechanism 336 includes a winch with a spool arranged such that rotation of the winch winds a tether 344 around the spool, drawing the tether into the winch. This thereby contracts the implant structure 320. For some applications, adjustment mechanism 336 includes a housing in which the winch is disposed, as described above. Adjustment mechanism 336 (e.g., its spool) is coupled to tether 344. As the winch of adjustment mechanism (e.g., relative to its housing) rotates, the winch adjusts the length of structure 320 by applying tension to (or releasing tension from) tether 344. In particular, drawing the end 362 of tether 344 toward adjustment mechanism 336 reduces the length of structure 320.

[0171] System 310 typically includes a flexible longitudinal guide member 346 (e.g., a rope) coupled to a portion of the winch. For example, in Figure 10 In the delivery configuration shown, structure 320 is positioned at the distal portion of the conduit, and guide member 346 is coupled to the winch of adjustment mechanism 336. For some applications, and as shown, guide member 346 extends proximally from adjustment mechanism 336 (e.g., its actuator interface) through conduit 322 (e.g., through the parallel side lumen of the conduit). For some applications, the proximal portion of guide member 346 may be accessed from outside the object body.

[0172] Referring now to Figures 11A-11F, they are schematic diagrams illustrating the use of an adjustment mechanism 336 in a system 310 comprising an implant 300 and a delivery tool 312, according to some applications.

[0173] For some applications, and as shown in Figure 11A, the delivery tool 312 includes a catheter 322, the distal portion of which can be advanced (e.g., transcavitably manipulated) into the body of the subject. For some applications, the catheter 322 is used to advance the structure 320 into the left atrium 380. For some applications, and as shown, this is performed by advancing the catheter 322 and the structure 320 disposed therein. Alternatively, the catheter 322 can be advanced first, and the structure 320 (or another implant) can then be advanced via the catheter. While Figure 11A shows access to the mitral valve via the femoral artery and septum, the scope of this document includes alternative methods for accessing the mitral valve, the tricuspid valve, other locations within the heart (e.g., its valves), and other locations within the body.

[0174] For some applications, and as shown in the figure, the annulusoplasty structure 320 can be advanced within the annulusoplasty structure using an anchor deployment manipulator 360 disposed in the anchor channel 350. Alternatively, the anchor deployment manipulator 360 can be introduced into the interior after the annulusoplasty structure 320 (or another implant) has been advanced.

[0175] After at least the adjusting mechanism 336 (and typically at least the end wall 334 of the sleeve 330) is exposed from the conduit 322, the winch moves away from the end wall 334 (Figure 11B). For some applications, this is achieved by moving the guide member 346 proximally, causing the adjusting mechanism 336 (and its winch) to move away from the longitudinal axis of the sleeve (e.g., translate, deflect, and / or rotate), typically becoming transverse to the sleeve 330.

[0176] For some applications, connector 370 facilitates this technology by flexibly and / or hingedly coupling adjustment mechanism 336 to sleeve 330. For some such applications, guide member 346 is also tensioned or relaxed to reposition adjustment mechanism.

[0177] The movement of the adjusting mechanism 336 (and its winch) away from the end wall 334 of the sleeve 330 advantageously facilitates (1) advancing the structure to the mitral valve when the adjusting mechanism 336 is positioned on the longitudinal axis of the sleeve 330 (e.g., collinear with the sleeve) to maintain a small cross-sectional diameter of the structure for transcavitary delivery; and (2) subsequently moving the adjusting mechanism away from the longitudinal axis, for example, to allow the end wall 334 of the sleeve to be placed against the valve annulus, and / or to allow the anchor 338 to be driven through the end wall of the sleeve (FIG. 11B).

[0178] For some applications, implant 300 includes at least one anchor 338 configured to anchor a tether 344 (e.g., its end 362) to the tissue of the recipient. For some applications, anchor 338 is deployed from the distal end of manipulator 360 into the tissue of the recipient. For example, and as shown in FIG11B, anchor deployment manipulator 360 is advanced into the lumen of cannula 330 (typically within anchor channel 350), and from within the lumen, anchor is deployed through the wall of cannula and into the cardiac tissue. This process is repeated along cannula 330 for several anchors 338 to anchor the cannula around a portion of the valve annulus. For some applications, annulusoplasty structure 320 is implanted using the techniques described (with necessary modifications) in one or more of the following publications, each of which is incorporated herein by reference:

[0179] Zipory et al.'s U.S. patent application publication 2010 / 0286767,

[0180] Zipory et al.'s U.S. patent application publication 2010 / 0280604,

[0181] U.S. patent application publication 2012 / 0078355 by Zipory et al.

[0182] Sheps et al.'s U.S. patent application publication 2014 / 0309661,

[0183] Sheps et al.'s U.S. patent application publication 2015 / 0272734,

[0184] Iflah et al.'s U.S. patent application publication 2018 / 0049875.

[0185] As shown in Figure 11B, the anchor 338 is implanted using a manipulator 360 contained within a cannula 330 of the annulusoplasty structure 320, and at least a portion (e.g., the proximal portion) of the annulusoplasty structure 320 is contained within a peripheral catheter 322.

[0186] As shown in Figure 11C, after the anchor 338 is implanted, the continuous portion of the sleeve 330 is released, and the deployment manipulator 360 is repositioned along the valve ring 388 to the second location selected for deployment of the second of the anchors 338.

[0187] Figure 11D illustrates a second tissue anchor 338 (shown as second tissue anchor 338b) deployed through a portion of the sidewall of cannula 330. The first of the anchors 338 deployed through end wall 334 is labeled anchor 338a. Deployment manipulator 360 deploys the second tissue anchor by driving the anchor to penetrate and pass through the wall of cannula 330 into the cardiac tissue at the second site. As shown, anchor 338b is implanted when at least a portion (e.g., the proximal portion) of the annulusoplasty structure 320 is contained within peripheral catheter 322.

[0188] As shown in Figures 11E-11F, a portion of the sidewall of the sleeve 330 is aligned with the tissue in such a way that the surface of that portion of the sidewall is set parallel to the planar surface of the tissue.

[0189] Figure 11E shows the entire length of the sleeve 330, as described above, anchored to the annulus 388 via multiple anchors 338. A deployment manipulator (i.e., deployment manipulator 360, described herein but not shown in Figure 11E) can be repositioned along the annulus to additional locations for deploying the corresponding anchors until the last anchor is deployed. The delivery tool 312 is then removed, leaving the annulusoplasty structure 320, which typically has a guide member 346 coupled thereto.

[0190] For some applications, the actuator 66 may slide over and along the guide member 346. For example, Figure 11F shows the actuator 66 being advanced over and along the guide member 346. As described above, the actuator 66 typically includes a rotary tool and is configured to engage and drive (e.g., rotate) a winch of the adjusting mechanism 336 to tension the tether 344 in response to a rotational force applied to the winch, thereby axially retracting the sleeve 330.

[0191] After adjusting the tension of the tether 344, the actuator 66 can disengage from the winch of the adjustment mechanism 336, typically without actuating or otherwise activating the locking mechanism. For some applications, and as described above with reference to winches 40, 140, and 240, the adjustment mechanism 336 typically does not include a separate locking mechanism (e.g., a separate actuable locking mechanism). As described above with reference to winches 40, 140, and 240, after the actuator 66 disengages from the adjustment mechanism 336, if tension is applied to the tether 44, this force will not significantly translate into reverse rotation of the winch of the adjustment winch, nor into loosening of the tether, thereby avoiding the need for a locking mechanism or locking actuation mechanism for the implant 300 and contributing to the simplicity and ease of use of the implant.

[0192] For some applications, implant 300 includes annulusoplasty structures of a different type than those shown above. For example, adjustment mechanism 336 can be used, with necessary modifications, as a component of the annulusoplasty structures described in one or more of the following publications, each of which is incorporated herein by reference:

[0193] Gross's U.S. patent application publication 2015 / 0081014,

[0194] Miller et al.'s U.S. patent application publication 2015 / 0230924,

[0195] U.S. patent application publication 2015 / 0105855 by Cabiri et al.

[0196] Miller et al.'s U.S. patent application publication 2016 / 0113767.

[0197] In the example shown, implant 300 is described as an annuloplasty structure 320 comprising annular tissue anchored to a natural heart valve. However, it should be noted that for some applications, the systems, devices, and techniques described herein, with necessary modifications, can be used to facilitate the adjustment of other implants. For example, the adjustment mechanism described herein can be used as a component of an artificial chordae tendineae structure, for example, to adjust the length and / or tension of the artificial chordae tendineae structure. For example, the adjustment mechanism described herein can be used instead of the adjustment mechanism for the artificial chordae tendineae structure described in one or more of the following publications, each of which is incorporated herein by reference:

[0198] Miller et al.'s U.S. patent application publication 2014 / 0222137,

[0199] Miller et al.'s U.S. patent application publication 2011 / 0288635,

[0200] Reich et al.'s U.S. patent application publication 2013 / 0096672,

[0201] U.S. Patent Application Publication No. 2014 / 0094903 by Miller et al.

[0202] The systems, apparatuses and techniques described herein may be used in conjunction with those described in U.S. Patent Application Publication 2018 / 0049875 by Iflah et al. and / or U.S. Patent 9,949,828 by Sheps et al., both of which are incorporated herein by reference.

[0203] This invention is not limited to what has been specifically shown and described above. Rather, the scope of this invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications of features that are not part of the prior art, which would be apparent to those skilled in the art upon reading the above description. Furthermore, each of the techniques, methods, operations, steps, etc., described or suggested herein can be performed on living animals or non-living simulations, such as on cadavers, cadaver hearts, simulators (e.g., simulating body parts, tissues, etc.).

Claims

1. A system comprising an implant, the implant comprising: a tether having an end, and a winch comprising: a driver interface engageable and drivable by a catheter-advancable driver, a base coupled to the driver interface such that driving of the driver interface by the driver causes the base to rotate about a rotation axis, and a spool: which defines a spool axis, which is coupled to the tether, the tether extending away from the winch toward the end, and which is fixedly coupled to the base such that: rotation of the base about the rotation axis draws the end of the tether toward the spool by winding the tether about the spool axis of the spool, and the spool axis is non-coaxial with the rotation axis.

2. The system of claim 1, wherein the spool is fixedly coupled to the base such that the spool is disposed entirely transverse to the rotation axis.

3. The system of claim 1, wherein the spool axis is parallel to the rotation axis.

4. The system of claim 1, wherein the spool is shaped to define an eyelet therethrough, the tether passing through the eyelet.

5. The system of any of claims 1-4, wherein the winch comprises at least one flange configured to provide mechanical decoupling between the tether and the driver interface.

6. The system of claim 5, wherein the base is shaped to define the at least one flange.

7. The system of any of claims 1-4, further comprising a housing that houses the winch, the housing configured to facilitate movement of the base and the spool relative to the housing about the rotation axis.

8. The system of claim 7, wherein the driver is accessible to the driver interface when the winch is housed within the housing.

9. The system of claim 8, wherein the housing is shaped to define a hole through which the tether extends from the spool, out of the winch, and away from the winch toward the end, and the hole is configured to facilitate threading of the tether into the winch as the spool draws the end of the tether toward the winch.

10. The system of claim 9, wherein the housing defines the hole as at least one of a circular shape and an elongate shape.

11. The system of claim 10, wherein the housing defines the hole as having a long axis disposed on a hole plane that is transverse to the rotation axis.

12. The system of claim 1, wherein the implant further comprises at least one anchor configured to anchor the end of the tether to tissue of a subject.

13. The system of claim 12, wherein: the at least one anchor comprises a plurality of anchors, the tether is slidable relative to at least one of the anchors, and the plurality of anchors are disposed on a plane that is transverse to the rotation axis. The capstan is configured such that traction of the end portion of the tether toward the capstan in response to rotation of the base in a forward rotational direction causes at least one of the anchors to slide distally relative to the tether.

14. The system of claim 12, wherein the implant comprises an annuloplasty structure, and is configured such that traction of the end portion of the tether toward the capstan reduces a length of the structure.

15. The system of claim 14, wherein: the annuloplasty structure comprises a longitudinally flexible sleeve that: defines an elongated lumen, is coupled to the capstan, and has a constriction portion along which the tether extends, and the system is configured such that traction of the end portion of the tether toward the capstan longitudinally constricts the constriction portion.

16. The system of claim 15, wherein the sleeve is coupled to the capstan by a suture.

17. The system of claim 15, wherein the capstan is coupled to an exterior lateral surface of the sleeve.

18. The system of claim 15, wherein: a first portion of the tether extends along the constriction portion; and a second portion of the tether: comes out of the sleeve at an exit point, and is coupled to the capstan.

19. The system of claim 1, further comprising a delivery tool for delivering the implant to a body of a subject, the delivery tool comprising a catheter, a distal portion of the catheter being advanceable into the body of the subject.

20. The system of claim 19, wherein the catheter is a steerable transluminal catheter.

21. The system of claim 19, further comprising the driver and a guide member, wherein: in a delivery state of the system: the implant is disposed at the distal portion of the catheter, and the guide member is coupled to the capstan and extends proximally therefrom through the catheter to a proximal portion of the catheter, and the driver is slidable over and along the guide member.

22. The system of any one of claims 1-4, 6, and 8-21, wherein the spool is fixedly coupled to the base transverse to the rotational axis such that, in a cross-section of the capstan orthogonal to the rotational axis, a radius of the capstan: extends radially outward from the rotational axis, reaches the spool at a first surface point of the spool, passes through the spool, and exits the spool at a second surface point of the spool.

23. The system of claim 22, wherein, In the cross-section, the spool has a cross-sectional shape of at least one of a trapezoid and a D-shape.

24. The system of claim 22, wherein, In the cross-section, the first surface point of the spool is a point of the spool closest to the rotational axis.

25. The system of claim 24, wherein, In the cross-section, the first surface point of the spool is at least 0.2 mm from the rotational axis.

26. The system of claim 13, wherein the spool is fixedly coupled to the base orthogonal to the rotational axis.

27. The system of claim 26, wherein the capstan comprises at least one inclined guide coupled to the base, disposed transverse to the axis of rotation, and positioned such that the at least one inclined guide guides the tether about the spool as the base rotates in the forward direction of rotation.

28. The system of claim 27, wherein the at least one inclined guide is fixedly coupled to the base such that the at least one inclined guide moves with the base about the axis of rotation as the drive drives the drive interface.

29. The system of claim 27, wherein the at least one inclined guide defines a guide surface that spirally extends about and along the axis of rotation.

30. The system of claim 27, wherein: the at least one inclined guide comprises a first inclined guide and a second inclined guide, the first inclined guide is positioned such that the first inclined guide guides the tether to a second side of the spool as the base rotates in the forward direction of rotation, and the second inclined guide is positioned such that the second inclined guide guides the tether to a first side of the spool opposite the second side of the spool as the base rotates in the forward direction of rotation.

31. The system of claim 30, wherein: the capstan defines a first shoulder at which the first inclined guide is coupled to a first end of the spool and a second shoulder at which the second inclined guide is coupled to a second end of the spool, the first inclined guide is positioned such that the first inclined guide guides the tether over the first shoulder to the second side of the spool as the base rotates in the forward direction of rotation, and the second inclined guide is positioned such that the second inclined guide guides the tether over the second shoulder to the first side of the spool as the base rotates in the forward direction of rotation.

32. The system of claim 27, further comprising an eyelet defining a hole therethrough configured to facilitate passage of the tether from outside the capstan to the spool as the spool pulls the end of the tether toward the spool, the eyelet being in mechanical engagement with the guide such that the at least one inclined guide guides the tether about the spool by moving the eyelet longitudinally parallel to the axis of rotation as the base rotates in the forward direction of rotation.

33. The system of claim 32, further comprising a housing that houses the capstan, the housing being configured to facilitate movement of the base and the spool relative to the housing about the axis of rotation.

34. The system of claim 33, wherein the housing defines a longitudinal track along a track axis parallel to the rotation axis, the track configured to facilitate longitudinal movement of the eyelet along the track axis as the base rotates in the forward rotation direction.

35. The system of claim 33, wherein the drive is accessible to the drive when the capstan is housed within the housing.

36. An implant, comprising: a tether having an end; and a capstan rotatable about a rotation axis and including a spool: defining a spool axis, coupled to the tether, the tether extending away from the capstan, and configured such that: rotation of the capstan about the rotation axis draws the end of the tether toward the spool by winding the tether about the spool axis of the spool, and the spool axis is non-coaxial with the rotation axis.

37. The implant of claim 36, wherein the capstan further includes a drive interface accessible to and drivable by a drive.

38. The implant of claim 37, wherein the capstan further includes a base coupled to the drive interface such that driving of the drive interface by the drive rotates the base about the rotation axis.

39. The implant of claim 38, wherein the spool is fixedly coupled to the base such that the spool is disposed entirely transverse to the rotation axis.

40. The implant of any one of claims 38-39, wherein the capstan includes at least one flange configured to provide mechanical decoupling between the tether and the drive interface.

41. The implant of claim 40, wherein the base is shaped to define the at least one flange.

42. The implant of claim 40, wherein the spool is shaped to define an eyelet therethrough, the tether passing through the eyelet.

43. The implant of claim 40, wherein the spool axis is parallel to the rotation axis.

44. The implant of claim 40, further comprising a housing housing the capstan, the housing configured to facilitate movement of the spool relative to the housing about the rotation axis.

45. The implant of claim 44, wherein the drive interface is accessible to the drive when the capstan is housed within the housing.

46. The implant of claim 44, wherein the housing is shaped to define a hole, the tether extending from the spool, out of the capstan and away from the capstan via the hole, and the hole is configured to facilitate threading of the tether into the capstan as the spool draws the end of the tether toward the capstan.

47. The implant of claim 46, wherein the housing defines the hole as at least one of: a circular shape, an elongate shape, and having a major axis disposed on a hole plane transverse to the rotation axis.

48. The implant of claim 45, further comprising at least one anchor configured to anchor the end of the tether to tissue of a subject.

49. The implant of claim 48, wherein: the at least one anchor comprises a plurality of anchors, the tether is slidable relative to at least one of the anchors, and the winch is configured such that traction of the end of the tether toward the winch in response to rotation of the base in a forward rotational direction causes at least one of the anchors to slide distally relative to the tether.

50. The implant of claim 48, further comprising an annuloplasty structure, and configured such that traction of the end of the tether toward the winch reduces a length of the annuloplasty structure.

51. The implant of claim 50, wherein: the annuloplasty structure comprises a longitudinally flexible sleeve that: defines an elongated lumen, is coupled to the winch, and has a constriction portion along which the tether extends, and the implant is configured such that traction of the end of the tether toward the winch longitudinally constricts the constriction portion.

52. The implant of claim 51, wherein the sleeve is coupled to the winch by a suture.

53. The implant of claim 51, wherein the winch is coupled to an exterior lateral surface of the sleeve.

54. The implant of claim 51, wherein: a first portion of the tether extends along the constriction portion; and a second portion of the tether: comes out of the sleeve at an exit point, and is coupled to the winch.

55. The implant of claim 51, further comprising a delivery tool for delivering the implant to a body of a subject, the delivery tool comprising a catheter, a distal portion of the catheter being advanceable into the body of the subject.

56. The implant of claim 55, wherein the catheter is a steerable transluminal catheter.

57. The implant of claim 55, further comprising the driver and a guide member, wherein: in a delivery state of the implant: the implant is disposed at the distal portion of the catheter, and the guide member is coupled to the winch and extends proximally therefrom through the catheter to a proximal portion of the catheter, and the driver is slidable over and along the guide member.

58. The implant of claim 38, wherein the spool is fixedly coupled to the base transverse to the rotational axis, such that in a cross-section of the winch orthogonal to the rotational axis, a radius of the winch: extends radially outward from the rotational axis, reaches the spool at a first surface point of the spool, passes through the spool, and exits the spool at a second surface point of the spool.

59. The implant of claim 58, wherein, in the cross-section, the spool has a cross-sectional shape of at least one of a trapezoid and a D-shape.

59. The implant of claim 38, wherein the spool is fixedly coupled to the base transverse to the rotational axis, such that in a cross-section of the winch orthogonal to the rotational axis, a radius of the winch: extends radially outward from the rotational axis, reaches the spool at a first surface point of the spool, passes through the spool, and exits the spool at a second surface point of the spool. in the cross-section, the spool has a cross-sectional shape of at least one of a trapezoid and a D-shape.

60. The implant of claim 58, wherein, In the cross-section, the first surface point of the spool is a point of the spool closest to the axis of rotation.

61. The implant of claim 60, wherein, In the cross-section, the first surface point of the spool is at least one of: at least 0.2 mm, 0.2 to 4 mm, and 0.3 to 2 mm from the axis of rotation.

62. The implant of claim 45, wherein the spool is fixedly coupled to the base orthogonally to the axis of rotation.

63. The implant of claim 62, wherein the capstan comprises at least one inclined guide disposed transverse to the axis of rotation and positioned such that, when the capstan is rotated in a forward rotational direction, the at least one inclined guide guides the tether around the spool.

64. The implant of claim 63, wherein the at least one inclined guide is fixedly coupled to the base such that, when the drive drives the drive interface, the at least one inclined guide moves with the capstan around the axis of rotation.

65. The implant of claim 63, wherein the at least one inclined guide defines a guide surface that spirally extends around and along the axis of rotation.

66. The implant of claim 63, wherein: the at least one inclined guide comprises a first inclined guide and a second inclined guide, the first inclined guide is positioned such that, when the capstan is rotated in the forward rotational direction, the first inclined guide guides the tether to a second side of the spool, and the second inclined guide is positioned such that, when the capstan is rotated in the forward rotational direction, the second inclined guide guides the tether to a first side of the spool opposite the second side of the spool.

67. The implant of claim 66, wherein: the capstan defines a first shoulder at which the first inclined guide is coupled to a first end of the spool and a second shoulder at which the second inclined guide is coupled to a second end of the spool, the first inclined guide is positioned such that, when the capstan is rotated in the forward rotational direction, the first inclined guide guides the tether over the first shoulder to the second side of the spool, and the second inclined guide is positioned such that, when the capstan is rotated in the forward rotational direction, the second inclined guide guides the tether over the second shoulder to the first side of the spool.

68. The implant of claim 63, further comprising an eyelet defining a hole therethrough, the hole configured to facilitate passage of the tether from outside the capstan to the spool when the spool is drawing the end of the tether toward the spool, the eyelet in mechanical engagement with the guide such that, when the capstan is rotated in the forward rotational direction, the at least one inclined guide guides the tether around the spool by moving the eyelet longitudinally parallel to the axis of rotation.

69. The implant of claim 68, wherein the housing defines a longitudinal track along a track axis parallel to the rotational axis, the track configured to facilitate longitudinal movement of the eyelet along the track axis as the base rotates in the forward rotational direction.

70. The implant of claim 37, wherein the driver is a catheter-propellable driver.

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