Annuloplasty system and locking tool therefor - Patent application

Abstract

To provide valve repair, e.g., repair of an atrioventricular valve of a patient.SOLUTION: The invention provides an apparatus comprising an implantable annuloplasty structure (1152), which comprises a primary body portion and a contracting member (226). A contracting member fastener (1560) can surround the contracting member, and comprise a clamping structure that is biased toward assuming a closed state to clamp the contracting member passed therethrough. A stop (1570) can be removably coupled to the fastener, and maintain the fastener in an open state. A contracting-member uptake tool (1502) can comprise static and dynamic cutting elements (1510, 1520) and graspers (1505) configured to pull the stop proximally so that the stop pushes and moves the dynamic cutting element onto the static cutting element in order to facilitate severing the contracting member. Other applications are also provided.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority from the following: a) U.S. Provisional Patent Application No. 62 / 697,186, filed July 12, 2018, entitled “Annuloplasty system and locking tool therefor” to Brauon et al.; and b) U.S. Provisional Patent Application No. 62 / 811,693, filed February 28, 2019, to Brauon et al., entitled “Annuloplasty system and locking tool therefor.”

[0002] Both of these applications are incorporated herein by reference.

[0003] The present invention relates generally to valve repair, for example, repair of an atrioventricular valve in a patient. [Background technology]

[0004] Ischemic heart disease can cause valvular regurgitation. For example, the combination of ischemic insufficiency of the papillary muscles and the left ventricular dilation seen in ischemic heart disease, with subsequent displacement of the papillary muscles and dilation of the mitral annulus, can cause mitral regurgitation.

[0005] Dilatation of the mitral annulus can prevent the leaflets from fully coapting when the valve is closed. Mitral regurgitation of blood from the left ventricle into the left atrium results in increased total stroke volume and decreased cardiac output, and eventual collapse of the left ventricle secondary to volume and pressure overload of the left atrium. Summary of the Invention [Means for solving the problem]

[0006] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples in this summary and elsewhere in this disclosure may be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatus, combinations, etc. that may be utilized for valve repair. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0007] In some applications, a multi-component tubular system is provided for accessing a patient's heart. The system can include one or more steerable guide catheters (e.g., one, two, three, or more) configured to direct passage of a device into the heart through the interior. The multi-component tubular system can be configured to deliver an implant in a desired orientation relative to a patient's heart annulus and promote anchoring of the implant to the annulus. In some applications, the guide system can be advanced or advanceable transluminally or transthoracically to access an atrium of the heart. In some applications, the guide system can be advanced surgically. The system can include two or more steerable catheters. A first catheter has a distal portion that is steerable to a first desired spatial orientation. A second catheter is disposed within the first catheter and has a distal portion that is steerable to a second desired spatial orientation. The system provides techniques and relative spatial orientation control devices for controlling an orientation of a distal portion of the second catheter relative to the first catheter without substantially distorting a first spatial orientation of the distal portion of the first catheter. In some applications, the relative spatial orientation control device comprises a rotational locking mechanism provided by a component of the catheter system.

[0008] The distal portion of the first catheter may be steered in a suitable direction following advancement of the first catheter through the patient's vasculature. Following advancement of the first catheter and steering of the distal portion of the first catheter in any one or more suitable planes, a second catheter is advanced through the first catheter. The first and second catheters may be rotationally locked to allow steering of the distal portion of the second catheter in any one or more suitable planes relative to the distal portion of the first catheter in a manner that substantially maintains the spatial orientation of the first catheter during steering of the second catheter. Additionally, the first catheter may be further steered without substantially disrupting the spatial orientation of the distal portion of the second catheter.

[0009] The distal portions and / or distal ends of the first and second catheters may be configured such that once they are positioned within the atrium of the patient's heart, an implantable adjustable annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, or other annuloplasty device) may be deployed, for example, from within the second catheter and secured to the patient's heart annulus. The annuloplasty structure may comprise a flexible main body portion and a contraction member having a first portion extending along a longitudinal length of the main body portion. A second portion of the contraction member may extend away from the main body portion of the annuloplasty structure and outside the patient's body. From a location outside the patient's body, a contraction member snare of a contraction member capture tool is used to engage a proximal end portion of the contraction member positioned outside the patient's body. Using the snare, the proximal end portion of the contraction member may then be fed through a distal portion of a primary tube of the tool and thereafter through a lumen of a secondary tube of the tool. The retraction member capture tool can then be advanced along the retraction member toward the patient's annulus. During advancement of the tool toward the annulus, the secondary tube of the tool can move distally along the retraction member as the retraction member is pulled by the snare through a lumen of the secondary tube of the tool.

[0010] The constriction member introduction tool can include an ejector movable at a distal end portion of the tool. The ejector can be bent to an open state through which the constriction member can pass, and can be removably coupled to a suture fastener that includes a clamping structure that is biased to a closed position or state that clamps the constriction member passed therethrough. The tool can have at least one stop that maintains the suture fastener (e.g., its clamping structure) in its open state.

[0011] The snare portion can be configured or adapted to capture and pull the constriction member proximally, through the suture fastener and out of an aligned port in the tool. The tool can then be advanced along the annulus toward the implanted annuloplasty structure. The tool can then capture successive portions of the constriction member to constrict the annuloplasty structure. An ejector of the tool can then be moved to transform the suture fastener (e.g., its clamping structure) from its open state to its closed state to clamp the constriction member passed therethrough.

[0012] The tool can include a handle portion that can include a contraction member capture device that captures a continuous portion of the contraction member. The handle portion can include a tension meter configured to measure a degree of tension in the contraction member.

[0013] In some applications, an annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device) comprises a main body portion comprising a contractible sleeve, a contraction member passing along the contractible sleeve, and a housing comprising a fastener through which the contraction member passes. Once the annuloplasty structure or annuloplasty ring structure has contracted, the fastener is deployed within the housing to maintain the contraction of the annuloplasty structure or annuloplasty ring structure.

[0014] A contraction member severing tool is provided that is capable of severing the contraction member passing through the tool only once the contraction member has been locked in place by a fastener coupled thereto. The contraction member severing tool can be configured in various ways to apply a cutting surface to the contraction member, such as, for example, having a sharp edge that moves toward the contraction member, and / or multiple edges and / or surfaces that move relative to each other in a scissor-like motion or like a wire cutter tool.

[0015] Thus, according to some applications, there is provided a system and / or device including an implantable annuloplasty structure, the annuloplasty structure including a main body portion and a constriction member. In some implementations, the constriction member can have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main portion of the annuloplasty structure.

[0016] The system and / or device can include a retraction member capture tool. The retraction member capture tool can include a primary tube terminating at a distal end portion of the retraction member capture tool, the distal end portion of the retraction member capture tool having a distal tip, and a secondary tube disposed alongside the primary tube, the secondary tube having a secondary lumen configured for passage of the retraction member therethrough. In some implementations, the retraction member capture tool also includes a retraction member snare including a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion configured to engage a portion of the retraction member. The retraction member snare can be sized to pass through the secondary lumen of the secondary tube to pull a second portion of the retraction member through a length of the secondary tube.

[0017] In some applications, the distal snare portion is configured to pull a second portion of the retraction member through the distal tip of the retraction member capture tool and then through the length of the secondary tube.

[0018] In some applications, the retractable member snare comprises a wire comprising stainless steel. In some applications, the retractable member snare comprises a wire having a diameter of 0.2 to 0.25 mm.

[0019] In some applications, the primary and / or secondary tubes are flexible.

[0020] In some applications, the annuloplasty structure defines a complete annuloplasty ring structure. In some applications, the annuloplasty structure defines a partial annuloplasty ring structure.

[0021] In some applications, the secondary tube is shaped to define a longitudinal slit.

[0022] For some applications, the constriction member incorporating tool includes a handle portion, and the first and second tubes are connected to the handle portion.

[0023] For some applications, the handle portion includes a contraction member capture device configured to capture a continuous portion of the contraction member and a tension meter configured to measure a degree of tension in the contraction member.

[0024] In some applications, the contraction member entrapment device is operable to increase the tension in the contraction member.

[0025] In some applications, the contraction member capture device includes a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally, hi some applications, the knob is fixedly coupled to the proximal portion of the contraction member.

[0026] In some applications, the contraction member capture device includes a wheel having a groove, the groove configured to couple the contraction member to the wheel, hi some applications, the groove is shaped to receive an intermediate portion of the contraction member.

[0027] In some applications, the secondary lumen of the secondary tube is sized to maintain a connection between the distal snare portion and the retraction member.

[0028] In some applications, the snare portion includes a flexible loop, and the secondary lumen is configured to collapse the loop around the constriction member when the elongated flexible body portion is pulled through the secondary lumen. In some applications, the secondary lumen of the secondary tube has a diameter of 0.5 to 1.5 mm.

[0029] In some applications, the retractable member snare comprises a metal wire.

[0030] For some applications, at least the distal snare portion of the retractable member snare is corrugated to increase friction between the snare portion and the retractable member.

[0031] In some applications, the distal snare portion is configured to pull the second portion of the retractable member through the entire length of the secondary tube.

[0032] In some applications, the shrink member capture tool may include: At least one contraction member fastener disposed within a distal end portion of the contraction member intake tool, the contraction member fastener including a clamping structure that (a) can be biased to a closed state, in which the clamping structure is configured to clamp a contraction member passed therethrough, and (b) can be bent to an open state in which the contraction member can move, and a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state.

[0033] For some applications, the at least one contraction member fastener includes at least first and second contraction member fasteners disposed within a distal end portion of the contraction member introduction tool.

[0034] In some applications, the distal snare portion and elongated flexible body portion of the retraction member snare are sized to pass distally through the open retraction member fastener, and the snare portion is adapted to capture and pull the retraction member proximally through the retraction member fastener and through aligned ports in the distal end portion of the retraction member capture tool.

[0035] In some applications, the contraction member capture tool includes a fastener ejector movable within a distal end portion of the contraction member capture tool, where movement of the fastener ejector contacts the contraction member fastener and transforms it from an open state to a closed state, tightening the contraction member passed therethrough.

[0036] In some applications, the fastener ejector is coupled to a fastener and moves the fastener which is removably coupled to the fastener.

[0037] In some applications, a distal end portion of the constriction member capture tool is shaped to define a sharp edge and the constriction member is positioned proximate to the sharp edge such that movement of the fastener ejector relative to the sharp edge severs the constriction member extending through the fastener.

[0038] In some applications, the system and / or apparatus further comprises: At least one contraction member fastener configured to encircle a contraction member, the contraction member fastener including a clamping structure, the clamping structure (a) being biased to a closed state, in which the clamping structure is configured to clamp a contraction member passed therethrough, and (b) being capable of being bent to an open state in which the contraction member can move, and a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state.

[0039] In some applications, the contraction member capture tool includes a fastener ejector movable within a distal end portion of the contraction member capture tool, the movement of the fastener ejector configured to contact the contraction member fastener and transform it from an open state to a closed state to tighten the contraction member passed therethrough.

[0040] In some applications, the fastener ejector is removably coupled to the fastener and moves the fastener which is removably coupled to the fastener.

[0041] In some applications, the tool includes a movable cutting element having a sharp edge, and movement of the stop strikes the stop against the movable cutting element, whereby movement of the movable cutting element severs the contraction member extending through the fastener and through the movable cutting element.

[0042] In some applications, the system and / or device further includes a lock slidable along the contraction member, the lock fixedly connectable to the contraction member to prevent movement of the contraction member. The lock may be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock may define a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock. The lock lumen may be configured to surround the contraction member. In some applications, the slit allows the lock to close around the contraction member when the lock is compressed, thereby locking the lock to the contraction member.

[0043] For some applications, the annuloplasty structure is shaped to define a recess dimensioned to compress the lock when the lock is at least partially disposed within the recess.

[0044] For some applications, the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess.

[0045] For some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen.

[0046] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0047] In some applications, the lock is disposed within a distal end portion of the retraction member capture tool.

[0048] For some applications, the lock is at least partially disposed within the recess when the constriction member introduction tool is coupled to the annuloplasty structure.

[0049] In some applications, when the constriction member incorporation tool is coupled to the annuloplasty structure, the lock is positioned completely proximal to the recess.

[0050] In some applications, the lock is disposed within a distal end portion of the retraction member capture tool.

[0051] In some applications, the distal snare portion and elongated flexible body portion of the retraction member snare are sized to pass distally through the lock, and the snare portion is adapted to capture and pull the retraction member proximally through the lock and through aligned ports in the distal end portion of the retraction member capture tool.

[0052] Additionally, in accordance with some applications, there is provided a system and / or device including an implantable annuloplasty structure, the implantable annuloplasty structure including a main body portion and a contraction member. The contraction member can have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty ring structure, and (2) a second portion extending away from the main body portion of the annuloplasty ring structure.

[0053] The system and / or device may also include a housing configured to be positionable relative to the main body portion of the annuloplasty ring structure.

[0054] The system and / or device may also include a contraction member fastener disposed at least partially within the housing, the contraction member fastener including a clamping structure that (a) is biased to assume a closed state in which the clamping structure is configured to clamp a contraction member passed therethrough, and (b) is capable of being bent to an open state in which the contraction member is movable.

[0055] The system and / or apparatus may also include a stop removably coupled to the fastener and configured to maintain the contraction member fastener in an open state, and a fastener ejector engageable with the stop such that movement of the fastener ejector moves the stop removably coupled to the stop and transforms the clamping structure from an open state to a closed state to clamp the contraction member passed therethrough.

[0056] In some applications, the fastener ejector is configured such that its movement facilitates severing of a contraction member extending through the fastener.

[0057] In some applications, the fastener includes a deformable element having an angled state and a straight state, and the stop is configured to maintain the fastener in the angled state, and when the stop is removed, the fastener is configured to transition to the straight state and require a shrink member between the fastener and the surface of the housing.

[0058] For some applications, the fastener is shaped to define a plurality of teeth configured to increase friction between the contraction member and the fastener.

[0059] Further, according to some applications, a method is provided that includes advancing, toward a patient's heart, an implantable annuloplasty structure including a main body portion and a contraction member. The contraction member may be the same or similar to other contraction members herein and may have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure and (2) a second portion extending away from the main portion of the annuloplasty ring structure.

[0060] The method further includes passing the second portion of the contraction member through a contraction member capture tool. The contraction member capture tool can include a primary tube terminating at a distal end portion of the contraction member capture tool, the distal end portion of the contraction member having a distal tip, and a secondary tube disposed alongside the primary tube, the secondary tube having a secondary lumen configured for passage of the contraction member therethrough. The contraction member capture tool can also include a contraction member snare including a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion configured to engage a portion of the contraction member and sized to pass through the secondary lumen of the secondary tube and pull the second portion of the contraction member through a length of the secondary tube.

[0061] In some applications, the threading includes engaging the portion of the constriction member using the distal snare portion, pulling the portion of the constriction member through the secondary tube using the constriction member snare, and advancing a constriction member capture tool along the constriction member toward the annuloplasty structure following the threading.

[0062] In some applications, passing the second portion of the retractable member includes passing the second portion of the retractable member subsequent to the advancing.

[0063] In some applications, pulling the portion of the constriction member through the secondary tube includes pulling a second portion of the constriction member through a distal tip of the constriction member intake tool and then through the length of the secondary tube.

[0064] In some applications, pulling the portion of the retraction member through the secondary tube includes strengthening a connection between the retraction member and the snare portion.

[0065] In some applications, following advancement of the constriction member incorporating tool, the method further includes constricting the annuloplasty structure using the constriction member incorporating tool.

[0066] In some applications, constricting the annuloplasty structure using the constriction member loading tool includes advancing successive portions of the constriction member relative to the constriction member loading device.

[0067] For some applications, the method further includes maintaining the annuloplasty structure in a contracted state by tightening a contraction member fastener around a portion of the contraction member following contraction.

[0068] In some applications, tightening includes deploying a fastener from within a distal end portion of the constriction member capture tool.

[0069] In some applications, the method further includes severing the contraction member using a sharp edge of the contraction member capture tool subsequent to maintaining the annuloplasty structure in a contracted state.

[0070] In some applications, advancing the retraction member introduction tool includes advancing the retraction member introduction tool through the patient's vasculature.

[0071] For some applications, the contraction member capture tool includes a handle portion including a contraction member capture device configured to capture a continuous portion of the contraction member and a tension meter configured to measure a degree of tension in the contraction member.

[0072] In some applications, the method further includes increasing tension in the contraction member using a contraction member entrapment device.

[0073] In some applications, the contraction member capture device includes a wheel and has a groove, and the method further includes coupling the contraction member to the wheel.

[0074] In some applications, coupling the contraction member to the wheel includes coupling an intermediate portion of the contraction member to the wheel.

[0075] The methods may be performed in procedures on live animals or in simulated / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0076] Further provided, according to some applications, is a method that includes advancing an implantable annuloplasty structure toward a patient's heart. The implantable annuloplasty structure may be the same or identical to other annuloplasty structures described herein or otherwise known, and may include, for example, a main body portion, a contraction member, and a housing coupled to the main body portion of the annuloplasty structure. In some applications, the contraction member has (1) a first portion that extends along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion that extends away from the main body portion of the annuloplasty structure.

[0077] In some applications, a contraction member fastener is disposed within the housing, the contraction member fastener including a clamping structure that is (a) biased to a closed state, in which the clamping structure is configured to clamp a contraction member passed therethrough, and (b) capable of being bent to an open state in which the contraction member is movable. In some applications, a stop is removably coupled to the fastener and configured to maintain the contraction member fastener in the open state.

[0078] In some applications, the method further includes transforming the contraction member fastener from an open state to a closed state to move a fastener ejector engageable with a stop, whereby movement of the fastener ejector moves a stop removably coupled to the fastener, thereby tightening the contraction member passed therethrough.

[0079] In some applications, the method further includes, following advancement, contracting the annuloplasty structure using the contraction member, and, following contraction, converting the contraction member fastener from an open state to a closed state.

[0080] In some applications, contracting the annuloplasty structure includes contracting the annuloplasty structure using a contraction member incorporating tool.

[0081] In some applications, contracting the annuloplasty structure using a constriction member loading tool includes advancing successive portions of the constriction member relative to a constriction member loading device.

[0082] In some applications, the method further includes severing the contraction member using a sharp edge of a contraction member capture tool subsequent to transforming the contraction member from the open state to the closed state.

[0083] The methods may be performed in procedures on live animals or in simulations / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0084] Further, in accordance with some applications, a system is provided that includes an implantable annuloplasty structure including a main body portion and a constriction member extending at least partially along a longitudinal length of the main body portion of the annuloplasty structure. The system also includes a constriction member introduction tool. The constriction member introduction tool can include a tube having an internal lumen configured for passage of the constriction member and the constriction member snare therethrough. The constriction member can include a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion configured to engage a portion of the constriction member and draw it into the internal lumen.

[0085] In some applications, the distal snare portion is configured to pull that portion of the retractable member through the entire length of the lumen.

[0086] In some applications, the retractable member snare comprises a wire that comprises stainless steel.In some applications, the tube is flexible.

[0087] For some applications, the constriction member capturing tool includes a handle portion and the tube is connected to the handle portion.

[0088] For some applications, the handle portion includes a contraction member capture device configured to capture a continuous portion of the contraction member and a tension meter configured to measure a degree of tension in the contraction member.

[0089] In some applications, the contraction member entrapment device is operable to increase the tension in the contraction member.

[0090] In some applications, the contraction member capture device includes a wheel having a groove, the groove configured to couple the contraction member to the wheel.

[0091] In some applications, the groove is shaped to receive an intermediate portion of the contraction member.

[0092] In some applications, the lumen of the tube is sized to maintain a connection between the distal snare portion and the retraction member.

[0093] For some applications, the distal snare portion includes a flexible loop, and the lumen is configured to collapse the loop around the retraction member when that portion of the retraction member is pulled through the lumen.

[0094] For some applications, at least the distal snare portion of the retractable member snare is corrugated to increase friction between the snare portion and the retractable member.

[0095] In some applications, a distal end portion of the contraction member capturing tool is shaped to define a sharp edge, and the contraction member capturing tool is configured to be positioned proximate to the sharp edge such that the sharp edge can sever the contraction member.

[0096] In some applications, the shrink member capture tool may include: a contraction member fastener disposed within a distal end portion of the contraction member capture tool, the contraction member fastener including a clamping structure, the clamping structure (a) biased to a closed state, in which the clamping structure is configured to clamp a contraction member passed therethrough, and (b) capable of being bent to an open state in which the contraction member is movable; and a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in an open position.

[0097] In some applications, the distal snare portion and that portion of the retraction member are sized to pass distally through the retraction member fastener in its open state, and the distal snare portion is adapted to capture and pull that portion of the retraction member proximally through the retraction member fastener and through aligned ports in the distal end portion of the retraction member capture tool.

[0098] In some applications, the contraction member capture tool includes a fastener ejector movable within a distal end portion of the contraction member capture tool, and movement of the fastener ejector can contact and transform the contraction member fastener from its open state to its closed state, tightening the contraction member as it passes therethrough.

[0099] In some applications, the fastener ejector is coupled to a fastener and moves the fastener which is removably coupled to the fastener.

[0100] In some applications, a distal end portion of the constriction member entrapment tool is shaped to define a sharp edge, and the constriction member entrapment tool is positioned proximate to the sharp edge such that movement of the fastener ejector relative to the sharp edge is configured to sever the constriction member after it extends through the fastener.

[0101] In some applications, the implantable annuloplasty structure is a closed annuloplasty structure.

[0102] Further, according to some applications, there is provided a system and / or device including an implantable annuloplasty structure including a main body portion having a sidewall and a contraction member. In some applications, the contraction member has (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure and (2) a second portion extending away from the main body portion of the annuloplasty structure, the contraction member being configured to adjust a circumference of the annuloplasty structure.

[0103] The main body portion of the annuloplasty structure may be shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of a sidewall of the main body portion toward an opposing second surface of the sidewall of the main body portion, the sidewall of the main body portion extending away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, and the contraction member extending away from the main body portion of the annuloplasty structure through and via the recess.

[0104] The system and / or device can include a lock slidable along the contraction member and toward the recess, the lock fixedly connectable to the contraction member to prevent movement of the contraction member, and the recess shaped to facilitate fixed connection of the lock to the contraction member.

[0105] In some applications, the lock is at least partially disposable within the recess.

[0106] In some applications, the annuloplasty structure includes a complete annuloplasty ring structure, and in other applications, the annuloplasty structure includes a partial annuloplasty ring structure.

[0107] For some applications, the lock is configured to lock the contraction member when the lock moves at least partially within the recess.

[0108] In some applications, the lock is configured to fit completely within the recess.

[0109] For some applications, the main body portion includes a housing, the housing defining at least a portion of the sidewall, and the housing defining the recess.

[0110] For some applications, the lock is configured to define a locking thread portion and the annuloplasty structure is configured to define an annuloplasty structure thread portion configured to engage with the locking thread portion.

[0111] In some applications, the recess defines a recess lumen extending along a recess axis. In some applications, the recess axis is disposed at a non-zero angle.

[0112] In some applications, the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock, the lock defines a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock, the lock lumen configured to surround the contraction member, and when the lock is disposed within the recess, the slit enables the lock to close around the contraction member, thereby locking the lock to the contraction member.

[0113] For some applications, the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess.

[0114] For some applications, the slit is shaped to define a distal portion that is wider than a proximal portion of the slit.

[0115] For some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen.

[0116] For some applications, the recess is shaped to define a proximal-most portion that is narrower than any other portion of the recess distal to the proximal-most portion.

[0117] For some applications, the annuloplasty structure includes a housing, the housing shaped to define a recess, the recess having a recess axis.

[0118] For some applications, the lock is shaped to define a locking thread portion and the housing is shaped to define an annuloplasty structure thread portion configured to engage with the locking thread portion.

[0119] In some applications, the housing is shaped to define a constriction member lumen disposed at a non-zero angle relative to the recess axis.

[0120] In some applications, the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, a distal end of the lock is configured to clamp a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at least at a first clamping point.

[0121] For some applications, the recess is shaped to define a recess distal tapered portion. For some applications, the lock is shaped to define a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock, and a lock distal tapered portion. The lock lumen may be configured to surround the contraction member.

[0122] In some applications, when the lock is disposed within the recess, the recess distal tapered portion is configured to compress the lock distal tapered portion and the lock distal tapered portion is configured to clamp a second portion of the contraction member within the lock lumen at the recess distal tapered portion to lock the contraction member at least at a second clamping point.

[0123] In some applications, the system and / or device further includes a delivery tool, wherein the delivery tool and the constriction member are slidable relative to one another, and the delivery tool is configured to deliver the annuloplasty structure to the patient's heart valve annulus.

[0124] In some applications, the delivery tool includes a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally.

[0125] In some applications, the knob is fixedly coupled to a proximal portion of the contraction member.

[0126] In some applications, when the delivery tool is coupled to the annuloplasty structure, a portion of the retraction member is disposed within a lumen of the delivery tool and the lock surrounds a portion of the retraction member.

[0127] For some applications, the lock is at least partially disposed within the recess when the delivery tool is coupled to the annuloplasty structure.

[0128] In some applications, when the delivery tool is coupled to the annuloplasty structure, the lock is positioned completely proximal to the recess.

[0129] In some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, where movement of the lock ejector contacts the lock and converts it from an open state to a closed state, clamping a contraction member passed therethrough.

[0130] In some applications, the distal end portion of the delivery tool is shaped to define a sharp edge and the retraction member is disposed proximate to the sharp edge such that movement of the lock ejector relative to the sharp edge severs the retraction member extending through the lock.

[0131] Further, according to some applications, a system and / or device is provided that includes an implantable annuloplasty structure including a main body portion and a contraction member. The contraction member may be the same or similar to other contraction members herein, for example, having (1) a first portion that extends along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion that extends away from the main portion of the annuloplasty structure. The system and / or device may include a lock that is slidable along the contraction member, and the lock is fixedly connectable to the contraction member to prevent movement of the contraction member. The lock may be shaped to define a slit that extends from a proximal surface of the lock toward a distal surface of the lock.

[0132] In some applications, the lock defines a lock lumen extending from a proximal opening of the lock toward a distal opening of the lock. The lock lumen may be configured to surround the contraction member. When the lock is compressed, the slits may allow the lock to close around the contraction member, thereby locking the lock to the contraction member.

[0133] In some applications, the annuloplasty structure includes a complete annuloplasty ring structure, and in other applications, the annuloplasty structure includes a partial annuloplasty ring structure.

[0134] For some applications, the annuloplasty structure is shaped to define a recess dimensioned to compress the lock when the lock is at least partially disposed within the recess.

[0135] In some applications, the lock is at least partially disposable within the recess.

[0136] In some applications, the lock is configured to fit completely within the recess.

[0137] For some applications, the slit is shaped to define a distal portion that is wider than a proximal portion of the slit.

[0138] For some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen.

[0139] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0140] For some applications, the lock is configured to define a locking thread portion and the annuloplasty structure is configured to define an annuloplasty structure thread portion configured to engage with the locking thread portion.

[0141] For some applications, the annuloplasty structure includes a housing, the housing shaped to define a recess, the recess having a recess axis.

[0142] For some applications, the lock is shaped to define a locking thread portion and the housing is shaped to define an annuloplasty structure thread portion configured to engage with the locking thread portion.

[0143] In some applications, the housing is shaped to define a constriction member lumen disposed at a non-zero angle relative to the recess axis.

[0144] In some applications, the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, a distal end of the lock is configured to clamp a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at least at a first clamping point.

[0145] In some applications, the recess is shaped to define a recess distal tapered portion, and the lock is shaped to define a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock, and a lock distal tapered portion. The lock lumen can be configured to enclose the contraction member. When the lock is disposed within the recess, the recess distal tapered portion can be configured to compress the lock distal tapered portion, and the lock distal tapered portion is configured to pinch a second portion of the contraction member within the lock lumen at the recess distal tapered portion to lock the contraction member at least at a second pinch point.

[0146] In some applications, the system and / or device further includes a delivery tool, wherein the delivery tool and the constriction member are slidable relative to one another, and the delivery tool is configured to deliver the annuloplasty structure to the patient's heart valve annulus.

[0147] In some applications, the delivery tool includes a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally.

[0148] In some applications, the knob is fixedly coupled to a proximal portion of the contraction member.

[0149] In some applications, when the delivery tool is coupled to the annuloplasty structure, a portion of the retraction member is disposed within a lumen of the delivery tool and the lock surrounds a portion of the retraction member.

[0150] In some applications, the annuloplasty structure is shaped to define a recess dimensioned to compress the lock when the lock is at least partially disposed within the recess, and when the delivery tool is coupled to the annuloplasty structure, the lock is at least partially disposed within the recess.

[0151] In some applications, the annuloplasty structure is shaped to define a recess dimensioned to compress the lock when the lock is at least partially disposed within the recess, and when the delivery tool is coupled to the annuloplasty structure, the lock is disposed fully proximal to the recess.

[0152] In some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, where movement of the lock ejector contacts the lock and converts it from an open state to a closed state, clamping a contraction member passed therethrough.

[0153] In some applications, the distal end portion of the delivery tool is shaped to define a sharp edge and the retraction member is disposed proximate to the sharp edge such that movement of the lock ejector relative to the sharp edge severs the retraction member extending through the lock.

[0154] Additionally, according to some applications, methods are provided that include advancing an implantable annuloplasty structure toward a patient's heart. The implantable annuloplasty structure may be the same as or similar to other annuloplasty structures herein or otherwise known, such as, for example, one having a main body portion having a sidewall and a contraction member having (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure and (2) a second portion extending away from the main body portion of the annuloplasty structure, the contraction member configured to adjust a circumference of the annuloplasty structure.

[0155] The main body portion of the annuloplasty structure may be shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of a sidewall of the main body portion toward an opposing second surface of the sidewall of the main body portion, the sidewall of the main body portion extending away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, and the contraction member extending away from the main body portion of the annuloplasty structure through and via the recess.

[0156] The method may further include locking the contraction member by sliding a lock along the contraction member to fit into the recess, the lock being fixedly connectable to the contraction member to prevent movement of the contraction member, the recess being shaped to facilitate fixed connection of the lock to the contraction member.

[0157] For some applications, advancing includes advancing the annuloplasty structure while the lock is at least partially disposed within the recess.

[0158] In some applications, advancing includes advancing the annuloplasty structure while the lock is positioned fully proximally in the recess.

[0159] In some applications, locking the contraction member includes sliding the lock completely within the recess.

[0160] In some applications, the annuloplasty structure includes a complete annuloplasty ring structure or a partial annuloplasty ring structure.

[0161] In some applications, the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock, the lock defines a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock, the lock lumen configured to surround the contraction member, and when the lock is disposed within the recess, the slit enables the lock to close around the contraction member, thereby locking the lock to the contraction member.

[0162] In some applications, the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess, and locking includes positioning the lock at least partially within the recess so as to compress the lock.

[0163] For some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen.

[0164] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0165] In some applications, advancing includes advancing the annuloplasty structure using a delivery tool, and the method further includes sliding the delivery tool and the constriction member relative to one another.

[0166] In some applications, advancing includes advancing the lock within a delivery tool and locking includes sliding the lock using the delivery tool.

[0167] In some applications, the delivery tool includes a knob coupled to a proximal portion of the contraction member, and the method further includes increasing tension in the contraction member by pulling the contraction member proximally using the knob.

[0168] In some applications, the knob is fixedly coupled to a proximal portion of the contraction member.

[0169] In some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, and the method further includes moving the lock ejector to contact the lock and convert it from an open state to a closed state, thereby tightening the contraction member passed therethrough.

[0170] In some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, the contraction member is disposed proximate to the sharp edge, and moving the lock ejector includes moving the lock ejector relative to the sharp edge and, by moving the lock ejector relative to the sharp edge, severing the contraction member extending through the lock.

[0171] The methods may be performed in procedures on live animals or in simulations / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0172] Further provided, according to some applications, is a method that includes advancing an implantable annuloplasty structure toward a patient's heart. The annuloplasty structure may be the same or identical to other annuloplasty structures herein or otherwise known, and may include, for example, a main body portion having a sidewall and a contraction member. The contraction member may have (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure and (2) a second portion extending away from the main body portion of the annuloplasty structure, the contraction member configured to adjust a circumference of the annuloplasty structure.

[0173] The method further includes locking the contraction member by sliding a lock along the contraction member, the lock being fixedly connectable to the contraction member to prevent movement of the contraction member. The lock may be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock may define a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock. The lock lumen may be configured to surround the contraction member. In some applications, when the lock is compressed, the slit allows the lock to close around the contraction member, thereby locking the lock to the contraction member.

[0174] In some applications, the annuloplasty structure includes a complete annuloplasty ring structure or a partial annuloplasty ring structure.

[0175] In some applications, the annuloplasty structure is shaped to define a recess dimensioned to compress the lock when the lock is at least partially disposed within the recess, and locking the contraction member includes sliding the lock at least partially within the recess.

[0176] For some applications, advancing includes advancing the annuloplasty structure while the lock is at least partially disposed within the recess.

[0177] In some applications, advancing includes advancing the annuloplasty structure while the lock is positioned fully proximally in the recess.

[0178] In some applications, locking the contraction member includes sliding the lock completely within the recess.

[0179] For some applications, the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess.

[0180] For some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen.

[0181] For some applications, the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion.

[0182] In some applications, advancing includes advancing the annuloplasty structure using a delivery tool, and the method further includes sliding the delivery tool and the constriction member relative to one another.

[0183] In some applications, advancing includes advancing the lock within a delivery tool and locking includes sliding the lock using the delivery tool.

[0184] In some applications, the delivery tool includes a knob coupled to a proximal portion of the contraction member, and the method further includes increasing tension in the contraction member by pulling the contraction member proximally using the knob.

[0185] In some applications, the knob is fixedly coupled to a proximal portion of the contraction member.

[0186] In some applications, the delivery tool includes a lock ejector movable within a distal end portion of the delivery tool, and the method further includes moving the lock ejector to contact the lock and convert it from an open state to a closed state, thereby tightening the contraction member passed therethrough.

[0187] In some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, the contraction member is disposed proximate to the sharp edge, and moving the lock ejector includes moving the lock ejector relative to the sharp edge and, by moving the lock ejector relative to the sharp edge, severing the contraction member extending through the lock.

[0188] The methods may be performed in procedures on live animals or in simulations / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0189] Additionally, in accordance with some applications, systems and / or devices are provided that include an implantable annuloplasty structure that includes a main body portion and a constriction member. The constriction member may be the same as or similar to other constriction members herein or otherwise known, and may, for example, have (1) a first portion that extends along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion that extends away from the main portion of the annuloplasty structure.

[0190] The system and / or apparatus further comprises at least one contraction member fastener configured to encircle the contraction member. The contraction member fastener can include a clamping structure that (a) is biased to assume a closed state in which the clamping structure is configured to clamp the contraction member passed therethrough, and (b) can be bent to an open state in which the contraction member can move.

[0191] The system and / or apparatus further comprises a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener open, and a contraction member severing tool. The contraction member severing tool can include a static cutting element having a first cutting surface, a dynamic cutting element having a second cutting surface opposite the first cutting surface, and one or more grippers configured to pull the stop proximally and remove the stop from the contraction member fastener. In some applications, a portion of the contraction member passes through the static cutting element and the dynamic cutting element, and once pulled proximally, the stop is configured to contact the cutting element and push and move the dynamic cutting element relative to the static cutting element to facilitate severing of the contraction member.

[0192] In some applications, the first and second cutting surfaces are each concave. In some applications, the first and second cutting surfaces are each diagonal.

[0193] In some applications, the tool provides a safety mechanism whereby the tool is positioned such that movement of the dynamic cutting element relative to the static cutting element is only possible by pressing a stop against the dynamic cutting element.

[0194] In some applications, the system and / or apparatus further includes a housing that houses the fastener and the stop, and the tool is coupled to the housing when the gripper grips the stop.

[0195] For some applications, the tool is configured to deliver the housing, the fastener, and the stop to the implantable annuloplasty structure.

[0196] For some applications, the implantable annuloplasty structure includes a housing.

[0197] In some applications, the stop is shaped to define a protrusion and the gripper is configured to grasp the protrusion to initially couple the tool to the fastener.

[0198] For some applications, the system and / or device further includes an outer sleeve portion configured to surround the grasper to lock the grasper against the protrusion.

[0199] Further, according to some applications, a system and / or device is provided that includes a contraction member fastener configured to fasten to the contraction member. In some applications, at least one contraction member fastener is configured to surround the contraction member. The contraction member fastener can include a clamping structure that (a) is biased to assume a closed state in which the clamping structure is configured to clamp the contraction member passed therethrough, and (b) can be bent to an open state in which the contraction member can move.

[0200] The system and / or apparatus may include a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in an open state.

[0201] The system and / or device can include a contraction member severing tool. The contraction member severing tool can include a cutting element configured to sever the contraction member and one or more graspers configured to pull the stop proximally and remove the stop from the contraction member fastener. In some applications, once pulled proximally, the stop is configured to contact, push and move the cutting element to facilitate severing of the contraction member by the cutting element.

[0202] In some applications, the tool provides a safety mechanism whereby the tool is positioned such that movement of the cutting element is only possible by pressing a stop against the cutting element.

[0203] In some applications, the system and / or apparatus further includes a housing that houses the fastener and the stop, and the tool is coupled to the housing when the gripper grips the stop.

[0204] For some applications, the system and / or device further includes an implantable annuloplasty structure, and the tool is configured to deliver the housing, the fastener, and the stop to the implantable annuloplasty structure.

[0205] For some applications, the system and / or device further includes an implantable annuloplasty structure, the implantable annuloplasty structure including a housing.

[0206] In some applications, the stop is shaped to define a protrusion and the gripper is configured to grasp the protrusion to initially couple the tool to the fastener.

[0207] For some applications, the system and / or device further includes an outer sleeve portion configured to surround the grasper to lock the grasper against the protrusion.

[0208] Further, according to some applications, a method is provided that includes passing a contraction member severing tool along the contraction member, the contraction member severing tool including a cutting element proximate the contraction member during the passing. The method can also include engaging the tool with a stop removably coupled to a contraction member fastener surrounding a portion of the contraction member, the stop configured to maintain the contraction member fastener in an open state.

[0209] In some applications, the method further includes using the tool to disengage the stop from the contraction member fastener by pulling the stop with the tool, the pulling bringing the stop into contact with the cutting element to facilitate pushing the stop against the cutting element, and the pushing facilitating movement of the cutting element, thereby facilitating severing of the contraction member by the cutting element.

[0210] In some applications, the tool provides a safety mechanism whereby the tool is positioned such that movement of the cutting element is only possible by pressing a stop against the cutting element.

[0211] In some applications, the method further includes a housing that houses the fastener and the stop, and the method includes coupling the tool to the housing by squeezing the stop with the tool.

[0212] In some applications, the method further includes delivering the housing, the fastener, and the stop to the implantable annuloplasty structure using the tool.

[0213] For some applications, coupling the tool to the housing includes coupling the tool to a housing that is coupled to the implantable annuloplasty structure.

[0214] In some applications, the stop is shaped to define a protrusion, and engaging the tool with the stop includes initially coupling the tool to the fastener by grasping the protrusion with the tool having a gripper.

[0215] In some applications, the method further includes locking the grasper against the protrusion by passing the outer sleeve portion over the grasper.

[0216] The methods may be performed in procedures on live animals or in simulations / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0217] Further, according to some applications, a system and / or device is provided that includes an implant including an implantable structure and a flexible elongated contraction member extending away from the implantable structure, and a contraction member introduction tool including an outer housing, a tubular shaft at least partially disposed within the outer housing, and a handle portion including an inner shaft.

[0218] In some applications, the inner shaft is (a) partially disposed within the proximal longitudinal portion of the tubular shaft, such that the inner shaft is axially slidable relative to the tubular shaft, (b) shaped to define an inner shaft contraction member receiving channel, and (c) includes a lock configured to (i) allow sliding of the contraction member relative to the inner shaft contraction member receiving channel when in an unlocked state, and (ii) axially lock the contraction member relative to the inner shaft when in a locked state.

[0219] In some applications, the system and / or device (e.g., in the handle) further includes a distal force applicator that is (a) at least partially disposed within the distal longitudinal portion of the tubular shaft and (b) shaped to define a distal force applicator contraction member receiving channel that permits sliding movement of the contraction member therethrough.

[0220] In some applications, the system and / or device (e.g., in the handle) further includes a spring disposed within the tubular shaft connecting the distal force applicator and a distal portion of the inner shaft, and a contraction promotion knob accessible from outside the outer housing.

[0221] In some applications, the handle portion is shaped to define a handle contraction member receiving channel from the distal end to the proximal end of the handle portion, the handle contraction member receiving channel including an inner shaft contraction member receiving channel and a distal force applicator contraction member receiving channel.

[0222] In some applications, the handle portion is configured such that, when the contraction member is positioned completely through the handle contraction member receiving channel and the lock is in a locked state, actuation of the contraction promotion knob advances the tubular shaft proximally relative to the outer housing, which advances the distal force applicator proximally relative to the outer housing, which applies a proximal force to the spring, which pushes the inner shaft proximally relative to the outer housing, which pulls the contraction member proximally, thereby incorporating a continuous portion of the contraction member into the handle portion.

[0223] In some applications, the handle is configured such that when the contraction member is positioned completely through the handle contraction member receiving channel, the lock is in an engaged state, and the contraction member is tensioned, actuation of the contraction promotion knob causes the spring to push the inner shaft proximally, causing the inner shaft to pull the contraction member proximally, increasing tension in the contraction member to a lesser extent than the tubular shaft advances proximally relative to the outer housing.

[0224] In some applications, the retraction enhance knob is configured to be actuated by rotation thereof.

[0225] In some applications, the tubular shaft and the retraction enhancer knob are threadedly connected to one another and the handle portion is configured such that actuation of the retraction enhancer knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

[0226] In some applications, the inner shaft protrudes partially out of the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, and the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contractile member.

[0227] In some applications, the inner shaft is marked with a number of fiducial markers disposed along the inner shaft to indicate the relative axial position of the tubular shaft with respect to the inner shaft.

[0228] In some applications, the handle portion further includes a tension limiting locking assembly configured to axially lock the inner shaft relative to the outer housing when the handle portion increases the tension in the contraction member to a predetermined threshold level, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0229] In some applications, the tension limiting locking assembly is configured to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0230] In some applications, the tension limiting locking assembly includes a detent positioned to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0231] In some applications, the detent is axially fixedly coupled to the inner shaft and is configured to move radially outwardly to engage the outer housing to axially lock the inner shaft relative to the outer housing.

[0232] In some applications, the tension limit locking assembly further includes a plurality of recesses shaped to be defined by the outer housing, the detents are engageable with the recesses to axially lock the inner shaft relative to the outer housing, and the handle portion is arranged such that when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, the particular one of the recesses with which the detents engage depends on the relative axial position of the inner shaft with respect to the outer housing.

[0233] In some applications, the proximal longitudinal portion of the tubular shaft is shaped to define an elongated opening through which the detent passes when the detent axially locks the inner shaft relative to the outer housing.

[0234] In some applications, the tubular shaft extends along a longitudinal portion of the elongated opening; (a) when the tubular shaft is disposed distally at a predetermined relative axial position with respect to the inner shaft, the detent prevents axial locking of the inner shaft with respect to the outer housing; and (b) including one or more tracks arranged to enable the detent to axially lock the inner shaft when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft.

[0235] In some applications, the one or more tracks are shaped to define one or more individual angled portions such that when the tubular shaft is disposed at a predetermined relative axial position with respect to the inner shaft, after a detent axially locks the inner shaft relative to the outer housing, subsequent distal movement of the tubular shaft, and therefore the one or more tracks, relative to the inner shaft disengages the detent from the outer housing.

[0236] In some applications, the inner shaft protrudes partially out of the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, and the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contractile member.

[0237] For some applications, the implantable structure includes an implantable annuloplasty structure.

[0238] For some applications, the implantable annuloplasty structure includes a flexible sleeve, with the contraction member extending along and away from the sleeve.

[0239] Further, according to some applications, a system and / or device is provided that includes an implant including an implantable structure and a flexible elongated contraction member extending away from the implantable structure, and a contraction member intake tool. The contraction member intake tool can include a handle portion including (a) a distal end to a proximal end of the handle portion shaped to define a contraction member receiving channel, and (b) an outer housing, a non-electromechanical force gauge, a lock, and a contraction promotion knob accessible from outside the outer housing. The lock can be configured (i) to allow sliding of the contraction member relative to the force gauge when in an unlocked state, and (ii) to axially lock the contraction member relative to the axially movable portion of the force gauge when in a locked state, the axially movable portion of the force gauge being axially movable relative to the outer housing.

[0240] In some applications, the handle portion is configured such that when the contraction member is positioned completely through the handle contraction member receiving channel and the lock is in a locked state, actuation of the contraction promotion knob advances the force gauge proximally relative to the outer housing, pulling the contraction member proximally, thereby causing the handle portion to incorporate a continuous portion of the contraction member.

[0241] In some applications, the handle portion is configured such that when the contraction member is positioned completely through the handle contraction member receiving channel, the lock is in an engaged state, and the contraction member is tensioned, actuation of the contraction promotion knob causes the axially movable portion of the force gauge to pull the contraction member proximally, increasing the tension in the contraction member, and the force gauge is configured to provide a visual indication of a measure of the tension in the contraction member.

[0242] In some applications, the force gauge includes a spring.

[0243] For some applications, the force gauge is configured such that the spring applies a proximal force to an axially movable portion of the force gauge.

[0244] For some applications, the handle portion further includes a tension limit locking assembly configured to axially lock the axially movable portion of the force gauge relative to the outer housing when the handle portion increases the tension in the contraction member to a predetermined threshold level, thereby limiting the maximum tension that the axially movable portion of the force gauge can apply to the contraction member.

[0245] Further, according to some applications, a method is provided that includes advancing an implantable structure of the implant and a flexible elongate contraction member extending away from the implantable structure toward the patient's heart and threading a portion of the contraction member through a handle contraction member receiving channel of a handle portion of a contraction member introduction tool. The contraction member introduction tool may be the same as or similar to other contraction member introduction tools described elsewhere herein, and may include, for example, one, all, or a portion of an outer housing, a tubular shaft at least partially disposed within the outer housing, an inner shaft, a distal force applicator, a spring, and a contraction enhancement knob accessible from outside the outer housing.

[0246] The inner shaft may be (a) partially disposed within the proximal longitudinal portion of the tubular shaft, such that the inner shaft is axially slidable relative to the tubular shaft, (b) shaped to define an inner shaft contraction member receiving channel, and (c) may include a lock configured to (i) allow sliding of the contraction member relative to the inner shaft contraction member receiving channel when in an unlocked state, and (ii) axially lock the contraction member relative to the inner shaft when in a locked state.

[0247] The distal force applicator may (a) be at least partially disposed within the distal longitudinal portion of the tubular shaft and (b) be shaped to define a distal force applicator contraction member receiving channel that enables sliding movement of the contraction member therethrough, the handle contraction member receiving channel (a) extending from the distal end to the proximal end of the handle portion and (b) including an inner shaft contraction member receiving channel and a distal force applicator contraction member receiving channel.

[0248] A spring can be disposed within the tubular shaft and connect the distal force applicator and a distal portion of the inner shaft.

[0249] The method further includes transitioning the lock from an unlocked state to a locked state.

[0250] In some applications, the method then includes actuating a retraction enhance knob to advance the tubular shaft proximally relative to the outer housing, which advances a distal force applicator proximally relative to said outer housing, which applies a proximal force to a spring, which pushes the inner shaft proximally relative to the outer housing, which pulls the retraction member proximally, causing the handle portion to capture successive portions of the retraction member until the retraction member is taut, and then, once the retraction member is taut, actuating a retraction enhance knob to increase tension in the retraction member due to proximal pulling of the retraction member by the inner shaft caused by the spring pushing the inner shaft proximally relative to the outer housing to a lesser extent than the tubular shaft is advanced proximally relative to the outer housing.

[0251] In some applications, actuating the deflate enhance knob includes rotating the deflate enhance knob.

[0252] In some applications, the tubular shaft and the retraction enhancer knob are threadedly connected to one another and the handle portion is configured such that actuation of the retraction enhancer knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

[0253] In some applications, the inner shaft protrudes partially out from the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, and the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contracting member, and the method further includes viewing the visual indication.

[0254] In some applications, the inner shaft is marked with a number of fiducial markers disposed along the inner shaft to indicate the relative axial position of the tubular shaft with respect to the inner shaft.

[0255] In some applications, the handle portion further includes a tension limiting locking assembly configured to axially lock the inner shaft relative to the outer housing when the handle portion increases the tension in the contraction member to a predetermined threshold level, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0256] In some applications, the tension limiting locking assembly is configured to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0257] In some applications, the tension limiting locking assembly includes a detent positioned to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, thereby limiting the maximum tension that the inner shaft can apply to the contraction member.

[0258] In some applications, the detent is axially fixedly coupled to the inner shaft and is configured to move radially outwardly to engage the outer housing to axially lock the inner shaft relative to the outer housing.

[0259] In some applications, the tension limit locking assembly further includes a plurality of recesses shaped to be defined by the outer housing, the detents are engageable with the recesses to axially lock the inner shaft relative to the outer housing, and the handle portion is arranged such that when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft, the particular one of the recesses with which the detents engage depends on the relative axial position of the inner shaft with respect to the outer housing.

[0260] In some applications, the proximal longitudinal portion of the tubular shaft is shaped to define an elongated opening through which the detent passes when the detent axially locks the inner shaft relative to the outer housing.

[0261] In some applications, the tubular shaft extends along a longitudinal portion of the elongated opening; (a) when the tubular shaft is disposed distally at a predetermined relative axial position with respect to the inner shaft, the detent prevents axial locking of the inner shaft with respect to the outer housing; and (b) including one or more tracks arranged to enable the detent to axially lock the inner shaft when the tubular shaft is disposed in a predetermined relative axial position with respect to the inner shaft.

[0262] In some applications, the one or more tracks are shaped to define one or more individual angled portions such that when the tubular shaft is disposed at a predetermined relative axial position with respect to the inner shaft, after a detent axially locks the inner shaft relative to the outer housing, subsequent distal movement of the tubular shaft, and therefore the one or more tracks, relative to the inner shaft disengages the detent from the outer housing.

[0263] In some applications, the inner shaft protrudes partially out from the proximal end of the outer housing, and the tubular shaft and the inner shaft together provide a non-electromechanical force gauge, and the relative axial position of the tubular shaft with respect to the inner shaft provides a visual indication of a measure of tension in the contracting member, and the method further includes viewing the visual indication.

[0264] In some applications, the implantable structure includes an implantable annuloplasty structure, and advancing the implantable structure includes advancing the implantable annuloplasty structure toward the heart.

[0265] In some applications, the implantable annuloplasty structure includes a flexible sleeve and includes advancing the implantable annuloplasty structure and the contraction member toward the heart such that the contraction member extends along and away from the sleeve.

[0266] Further, according to some applications, a method is provided that includes advancing an implantable structure of the implant and a flexible elongated contractile member extending away from the implantable structure toward the patient's heart and passing a portion of the contractile member through a handle contractile member receiving channel of a handle portion of a contractile member capture tool.

[0267] The contraction member loading tool may be the same or similar to other contraction member loading tools described elsewhere herein or otherwise known. For example, in some applications, the contraction member loading tool includes an outer housing, a non-electromechanical force gauge, a lock, and a contraction enhance knob. The lock may be configured to (i) allow sliding of the contraction member relative to the force gauge when in an unlocked state, and (ii) axially lock the contraction member relative to the axially movable portion of the force gauge when in a locked state, the axially movable portion of the force gauge being axially movable relative to the outer housing. The contraction enhance knob may be accessible from outside the outer housing.

[0268] The method further includes transitioning the lock from an unlocked state to a locked state and then actuating a retraction enhance knob to proximally advance the force gauge relative to the outer housing to pull the retraction member proximally, thereby causing the handle portion to engage a continuous portion of the retraction member.

[0269] The method may then include increasing tension in the contraction member by actuating a contraction enhance knob to pull the contraction member proximally with an axially movable portion of the force gauge once the contraction member is taut, and viewing a visual indication of a measure of the tension in the contraction member, the visual indication provided by the force gauge.

[0270] In some applications, the force gauge includes a spring.

[0271] For some applications, the force gauge is configured such that the spring applies a proximal force to an axially movable portion of the force gauge.

[0272] For some applications, the handle portion further includes a tension limit locking assembly configured to axially lock the axially movable portion of the force gauge relative to the outer housing when the handle portion increases the tension in the contraction member to a predetermined threshold level, thereby limiting the maximum tension that the axially movable portion of the force gauge can apply to the contraction member.

[0273] The methods may be performed in procedures on live animals or in simulations / mock procedures (eg, cadavers, cadaver hearts, mock hearts, simulators with tissue, anthropomorphic ghosts, etc.).

[0274] Also provided are systems and / or apparatus that, according to some applications, may include an implantable annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device). The implantable annuloplasty structure may comprise a main body portion and a contraction member extending at least partially along a longitudinal length of the main body portion of the annuloplasty structure. The implantable annuloplasty structure may be the same as or similar to other annuloplasty structures described elsewhere herein.

[0275] The system and / or device may also include a retraction member capture tool. The retraction member capture tool may be the same or similar to other retraction member capture tools described elsewhere herein. The retraction member capture tool may include one or more tubes (e.g., one tube, a primary tube, and a secondary tube, etc.). At least one tube has a lumen configured for passage of the retraction member therethrough. The tubes may be flexible, semi-rigid, or rigid. The retraction member capture tool may also include a retraction member snare. The retraction member snare may include a distal snare portion and an elongated flexible body portion coupled to the distal snare portion. The distal snare portion may be configured to engage a portion of the retraction member and pull it into the lumen. The distal snare portion may be configured to pull the portion of the retraction member through a portion of the lumen or through the entire length of the lumen (e.g., end to end). The retraction member snare may include a wire including stainless steel. The lumen of the tube may be sized to maintain a connection between the distal snare portion and the retraction member.

[0276] The contraction member capture tool can include a handle portion, and the tube can be connected to the handle portion. The handle portion can include a contraction member capture device configured to capture successive portions of the contraction member. The handle portion can also include a tensiometer configured to measure a degree of tension in the contraction member. The contraction member capture device can be operable to increase tension in the contraction member. The contraction member capture device can optionally include a wheel having a groove, the groove configured to couple the contraction member to the wheel. The groove can be shaped to receive an intermediate portion of the contraction member.

[0277] The distal snare portion can include a flexible loop. The lumen can be configured to collapse the flexible loop around the retraction member when that portion of the retraction member is pulled through the lumen. At least the distal snare portion of the retraction member snare can be corrugated to increase friction between the snare portion and the retraction member.

[0278] A distal end portion of the contraction member capturing tool may be shaped to define a sharp edge, and the contraction member capturing tool may be configured to be positioned proximate to the sharp edge such that the sharp edge can sever the contraction member.

[0279] The contraction member capture tool can include a contraction member fastener disposed within a distal end portion of the contraction member capture tool. The contraction member fastener can include a clamping structure. The clamping structure can be biased to a closed state or position, in which the clamping structure can be configured to clamp a contraction member passed therethrough. The clamping structure can also be configured to be bent to an open state or position, in which the contraction member can move therethrough. The contraction member capture tool can also include a stop removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state / position.

[0280] The distal snare portion, that portion of the retraction member, and the fastening structure may be configured and sized to pass distally through the retraction member fastener and fastening structure in the open state / position, and the distal snare portion may be adapted to capture and pull that portion of the retraction member proximally through the retraction member fastener and fastening structure and through aligned ports in the distal end portion of the retraction member capture tool.

[0281] The contraction member capture tool can include a fastener ejector movable within a distal end portion of the contraction member capture tool, which can be configured such that movement of the fastener ejector can contact and convert the contraction member fastener from an open state / position to a closed state / position to tighten the contraction member as it passes therethrough. The fastener ejector can be coupled to a stop and configured to move the stop removably coupled to the fastener. The distal end portion of the contraction member capture tool can be shaped to define a sharp edge, and the contraction member capture tool can be disposed proximate the sharp edge such that movement of the fastener ejector relative to the sharp edge can sever the contraction member after it has extended or is about to extend through the fastener.

[0282] The various devices, systems, methods, etc. described above can incorporate and / or substitute various features and components of other embodiments described elsewhere herein.

[0283] The present invention will be more fully understood from the following detailed description taken in conjunction with the drawings, in which: [Brief description of the drawings]

[0284] [Figure 1] FIG. 1 is a schematic diagram of an example of a multi-component tubular system for delivering and anchoring an implant and for controlling the relative spatial orientation of components of a catheter system. [Diagram 2]FIG. 1 is a schematic diagram of an example of a multi-component tubular system for delivering and anchoring an implant and for controlling the relative spatial orientation of components of a catheter system. [Figure 3A] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3B] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3C] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3D] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3E] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3F] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3G] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3H] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 3I] 1A-1C are schematic diagrams of an exemplary procedure for implanting an annuloplasty structure to repair a mitral valve. [Figure 4A] FIG. 4 is a schematic diagram of an exemplary constriction member capture tool configured to constrict the constriction member of the annuloplasty structure of FIGS. 3A-I and sever any excess portions of the constriction member. [Figure 4B] FIG. 4 is a schematic diagram of an exemplary constriction member capture tool configured to constrict the constriction member of the annuloplasty structure of FIGS. 3A-I and sever any excess portions of the constriction member. [Figure 5A] FIG. 4C is a schematic diagram of the exemplary contraction member loading tool of FIGS. 4A-B used to load a contraction member. [Figure 5B] FIG. 4C is a schematic diagram of the exemplary contraction member loading tool of FIGS. 4A-B used to load a contraction member. [Figure 5C] FIG. 4C is a schematic diagram of the exemplary contraction member loading tool of FIGS. 4A-B used to load a contraction member. [Figure 5D] FIG. 4C is a schematic diagram of the exemplary contraction member loading tool of FIGS. 4A-B used to load a contraction member. [Figure 6A] FIG. 4B is a schematic diagram of the exemplary retraction member loading tool of FIGS. 4A-B used to load a retraction member to retract an annuloplasty structure coupled to the retraction member. [Figure 6B] FIG. 4B is a schematic diagram of the exemplary retraction member loading tool of FIGS. 4A-B used to load a retraction member to retract an annuloplasty structure coupled to the retraction member. [Figure 7A] FIG. 4B is a schematic diagram of the exemplary contraction member capture tool of FIGS. 4A-B used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 7B] FIG. 4B is a schematic diagram of the exemplary contraction member capture tool of FIGS. 4A-B used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 7C] FIG. 4B is a schematic diagram of the exemplary contraction member capture tool of FIGS. 4A-B used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 7D] FIG. 4B is a schematic diagram of the exemplary contraction member capture tool of FIGS. 4A-B used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 7E] FIG. 4B is a schematic diagram of the exemplary contraction member capture tool of FIGS. 4A-B used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 8A] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 8B]1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 8C] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 8D] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 9A] FIG. 8B is a schematic diagram of an exemplary contraction member capture tool used to lock and secure the annuloplasty structure of FIGS. 8A-D in its contracted state and then sever the excess portion of the contraction member. [Figure 9B] FIG. 8B is a schematic diagram of an exemplary contraction member capture tool used to lock and secure the annuloplasty structure of FIGS. 8A-D in its contracted state and then sever the excess portion of the contraction member. [Figure 9C] FIG. 8B is a schematic diagram of an exemplary contraction member capture tool used to lock and secure the annuloplasty structure of FIGS. 8A-D in its contracted state and then sever the excess portion of the contraction member. [Figure 9D] FIG. 8B is a schematic diagram of an exemplary contraction member capture tool used to lock and secure the annuloplasty structure of FIGS. 8A-D in its contracted state and then sever the excess portion of the contraction member. [Figure 10A] 1 is a schematic diagram of one example of a contraction member capture tool that can be used to engage the contraction member and sever any excess portions of the contraction member. [Figure 10B] 1 is a schematic diagram of one example of a contraction member capture tool that can be used to engage the contraction member and sever any excess portions of the contraction member. [Figure 11A] FIG. 13 is a schematic diagram of an example of a contraction member capture tool used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 11B]FIG. 13 is a schematic diagram of an example of a contraction member capture tool used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 11C] FIG. 13 is a schematic diagram of an example of a contraction member capture tool used to lock and secure the annuloplasty structure in its contracted state and then sever the excess portion of the contraction member. [Figure 12A] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 12B] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 12C] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 13A] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 13B] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 13C] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 14] 1A-1C are schematic diagrams of exemplary locks that can be used to lock the circumference of an annuloplasty structure. [Figure 15A] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 15B] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 15C] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 16] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 17] 1 is a schematic diagram of an example of a system comprising an exemplary annuloplasty structure comprising a sleeve, a constriction member, and a lock. [Figure 18] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 19A] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 19B] 1 is a schematic diagram of an example of a system for constricting a patient's annulus using an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20A] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20B] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20C] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20D] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20E] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 20F] 1 is a schematic diagram of an example of a constriction member capture and constriction member severing tool for use with an annuloplasty structure that includes a housing that receives a constriction member fastener. [Figure 21A] FIG. 22 is a schematic diagram of an example of a contraction member intake tool for the multi-component tubular system of FIGS. 20A-F prior to insertion of a flexible elongate contraction member, according to some applications. [Figure 21B]FIG. 22 is a schematic diagram of an example of a contraction member intake tool for the multi-component tubular system of FIGS. 20A-F prior to insertion of a flexible elongate contraction member, according to some applications. [Figure 22A] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after insertion of a flexible elongate contraction member, according to some applications. [Figure 22B] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after insertion of a flexible elongate contraction member, according to some applications. [Figure 23A] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 23B] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 24A] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 24B] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 25A] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 25B] 21A-B are schematic diagrams of the contraction member intake tool of FIGS. 21A-B after successive actuation levels of the tool's contraction enhancement knob, according to some applications. [Figure 26A] 21A-B are schematic diagrams of a portion of an outer housing and tubular shaft of the contraction member capture tool of FIG. 21A-B, according to some applications. [Figure 26B] 21A-B are schematic diagrams of a portion of an outer housing and tubular shaft of the contraction member capture tool of FIG. 21A-B, according to some applications. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0285] Reference is now made to FIGS. 1-2, which are schematic illustrations of an example of a multi-component tubular system 10 providing one or more rotationally controlled steerable catheters configured to deliver an implant to a patient's heart. The system 10 provides an implant delivery tool. The system 10 can include a first outer catheter 12 including a sheath configured to be advanced through the patient's vasculature. In some applications, the outer catheter 12 includes a sheath configured to be advanced through the femoral artery toward the atrial septum of the patient's heart. A steerable distal end portion of the outer catheter 12 is configured to pass through the septum and be oriented in a desired spatial orientation. The system 10 includes a second catheter, or guide catheter 14, including a steerable distal end portion. The catheter 14 is configured to be advanced through a lumen of the outer catheter 12. The outer catheter 12 provides a first coupling 152 (e.g., slit 52) ​​at a distal portion thereof (e.g., a portion of the catheter 12 proximal to the steerable distal end portion). The guide catheter 14 can include a second coupling 154 (e.g., a pushable engagement portion 54) coupled to a displaceable tab 56 coupled to the base. As described herein, the pushable engagement portion 54 (or the second coupling 154) is configured to protrude within the slit 52 (or the first coupling 152). Thus, the slit 52 defines a second coupling receiving element.

[0286] In some embodiments, the first coupling 152 of the catheter 12 defines a longer coupling and the second coupling 154 of the catheter 14 defines a shorter coupling. The first and second couplings 152 and 154 of the outer catheter 12 and the guide catheter 14, respectively, allow for axial advancement and rotational movement of the guide catheter 14 through the lumen of the outer catheter 12 until the engagement portion 54 of the catheter 14 aligns and engages with the slit 52 of the catheter 12, as described below. As shown in cross section AA of FIG. 1, the guide catheter 14 is configured to be concentrically disposed within the lumen of the outer catheter 12. In some embodiments, the catheter 12 provides a shorter coupling and the catheter 14 provides a longer coupling. For example, the catheter 14 can be shaped to provide a slit 52 and the catheter 12 can include an engagement portion 54 configured to engage the slit 52 of the catheter 14.

[0287] As shown in the exploded view of FIG. B, the first coupling 152 may be shaped to define a slit 52. In some applications, the slit 52 is provided by a metal frame 50, as shown. The metal frame 50 may have a length L22, for example, between 7 and 15 mm, for example, 13 mm. In such applications, a slit is made in the material of the catheter 12 (e.g., by making a slit in the polymeric material of the catheter 12 during manufacture of the catheter 12) and the frame 50 is coupled to the catheter 12. The second coupling 154 may include an engagement portion 54, which may include a protrusion disposed at a distal portion of a displaceable tab 56 at a base of the engagement portion 54. The base of the engagement portion 54 may be shaped to define a slit 57 that forms the tab 56. The engagement portion 54 is depressible when a force is applied thereto, and the tab 56 facilitates movement of the engagement portion 54 in response to and in the absence of a force applied to the engagement portion 54. In some applications, during manufacture of catheter 14, catheter 14 is manipulated to attach engaging portion 54 and tab 56 thereto, for example, engaging portion 54 and tab 56 are embedded within a polymer of catheter 14.

[0288] Although slits 52 and pushable engagement portions 54 are shown on outer catheter 12 and guide catheter 14, respectively, in the distal portions of catheters 12 and 14, slits 52 and engagement portions 54 may be provided along any suitable portion of each of catheters 12 and 14 (e.g., the proximal portions of each of catheters 12 and 14).

[0289] The first and second couplings 152 and 154, respectively, may be provided on any standard catheter. That is, the coupling 152 comprises a frame 50 that may be coupled to the outer surface of any standard catheter (in which case a corresponding slit is made in the standard catheter). Furthermore, the coupling 154 may be coupled to any standard catheter by coupling the base portion of the coupling 154 to the standard catheter. Suitable adjustments to the standard catheter are made to accommodate the displacement of the tab 56 and the engagement portion 54 in response to a compressive force applied to the engagement portion 54.

[0290] FIG. 2 illustrates an exemplary concentric relationship between the components of the tubular system 10 (in an exploded view on the left side of FIG. 2). As described above, the distal end portion of the outer catheter 12 is steerable. The distal end portion of the outer catheter 12 may include a pull ring 11 coupled to two or more steering or pull wires 29a and 29b disposed within respective secondary lumens in the wall of the catheter 12 (as shown in cross section AA). As shown in the exploded view, the guide catheter 14 may be configured to be concentrically disposed within the lumen of the catheter 12. As described above, the distal end portion of the guide catheter 14 is steerable. The distal end portion of the guide catheter 14 may include a pull ring 13 coupled to two or more pull wires 31a and 31b disposed within respective secondary lumens in the wall of the catheter 14 (as shown in cross sections AA and BB).

[0291] The guide catheter 14 is steerable to a desired spatial orientation to facilitate advancement and implantation of the implant within the patient's body cavity. As shown, the implant comprises an annuloplasty structure 222 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) that comprises a flexible sleeve 26 (shown in an exploded view in FIG. 2). The sleeve 26 may comprise a braided tissue mesh, including, for example, DACRON™. The sleeve 26 may be configured to be only partially disposed around the heart valve annulus (i.e., to assume a C-shape) and to contract to circumferentially tighten the annulus once secured in place. However, the annulus structure may also be configured to be fully disposed around the annulus. To tighten the annulus, the annuloplasty structure or annuloplasty ring structure 222 comprises a flexible elongated contraction member 226 extending along the sleeve 26. The elongated contraction member 226 can include a wire, ribbon, rope, or band, which can include one or more of a variety of materials, such as, for example, a flexible and / or superelastic material, e.g., Nitinol, polyester, stainless steel, or cobalt chrome. In some applications, the wire includes a radiopaque material. In some applications, the contraction member 226 includes a braided polyester suture (e.g., Ticron). In some applications, the contraction member 226 is coated with polytetrafluoroethylene (PTFE). In some applications, the contraction member 226 includes multiple wires that intertwine to form a rope structure.

[0292] In applications in which the system 10 is used to deliver an implant to a patient's mitral valve, the outer catheter 12 may be configured to be initially advanced through the patient's vasculature until the distal end 102 (which may be the most distal end or tip) of the catheter 12 is positioned in the left atrium. The steerable distal end of the catheter 12 is then steered so that the distal end 102 of the catheter 12 is positioned in a desired spatial orientation within the left atrium. The steering procedure may be performed using imaging such as fluoroscopy, transesophageal echo, and / or echocardiography. Following steering of the distal end portion of the catheter 12, the guide catheter 14 (containing the annuloplasty structure 222) is advanced through the catheter 12 to facilitate delivery and implantation of the structure 222 along the mitral valve annulus. During delivery, at least a portion of the steerable distal end portion of the catheter 14 may be exposed from the distal end 102 of the catheter 12 and thus may be freely steered toward the mitral valve annulus, as described below.

[0293] Additionally, the system 10 includes an attachment mechanism such as a plurality of anchors 32 (e.g., anchor(s), adhesive, clamp(s), clip(s), fastener(s), etc.), which may be about 5 to about 20 anchors, e.g., about 10 or about 16 anchors. Each anchor 32 may include a tissue-engaging element 60 (e.g., a helical tissue-engaging element) and a tool coupling head 62 secured to one end of the tissue-engaging element. One anchor 32 is shown in FIG. 2 as being reversibly coupled to a deployment element 38 of a rotating anchor driver 36 of an anchor deployment manipulator 61. When the sleeve 26 is positioned along the heart valve annulus, the deployment manipulator 61 is configured to advance within the lumen of the sleeve 26 and deploy each anchor 32 from within the sleeve 26, through the wall of the sleeve 26, and into the heart tissue, thereby anchoring the sleeve 26 around a portion of the annulus. Insertion of the anchors into the sleeve and deployment of the anchors into the heart tissue are described in more detail below.

[0294] Anchor 32 may comprise a biocompatible material, such as stainless steel 316 LVM. In some applications, anchor 32 comprises Nitinol. In some applications, anchor 32 is fully or partially coated with a non-conductive material.

[0295] The deployment manipulator 61 includes an anchor driver 36 and a deployment element 38, as shown in FIG.

[0296] As shown in the exploded view of FIG. 2, the sleeve 26 is disposed within the lumen of the guide catheter 14. A force is applied to the proximal end of the sleeve 26 by the distal end of the reference force tube 19. As shown, the implant separation channel 18 is advanceable within the lumen of the reference force tube 19 and through the lumen of the sleeve 26 such that the portion of the channel 18 disposed within the sleeve is coaxial with the sleeve. As shown in the enlarged view of FIG. 1, the distal end 17 of the implant separation channel 18 is disposed in contact with the inner wall of the sleeve 26 at its distal end. Additionally, the distal end portion of the channel 18 includes a radiopaque marker 1018. As shown, the tube 19 and the sleeve 26 are disposed longitudinally and coaxially with respect to one another.

[0297] An anchor driver 36 may be advanced within the channel 18. In some applications, the system 10 includes multiple anchor drivers 36, each coupled to a respective anchor 32. Each driver 36 may be advanced within the channel 18 to advance and implant the anchor 32 within tissue. After implantation of the anchor 32, the anchor 32 is separated from the driver 36 as described herein, and the driver 36 is removed from within the channel 18. Thereafter, a new driver 36 coupled to another anchor 32 is then advanced within the channel 18.

[0298] As described below, the first anchor 32 is configured to be deployed through the wall of the sleeve 26 into the cardiac tissue when the sleeve 26 is positioned along the valve annulus. Following deployment of the first anchor, the distal portion of the sleeve 26 slides distally out of a portion of the implant separation channel 18. To distally separate the sleeve 26 from a portion of the outer surface of the channel 18, (1) a proximal force is applied to the channel 18 while (2) the reference force tube 19 is maintained in a fixed position such that the distal end of the tube 19 provides a reference force to the sleeve 26 to facilitate release of successive portions of the sleeve 26 from around the channel 18. The channel 18 is then positioned at successive positions within the lumen of the sleeve 26 while either the tube 19 and / or the catheter 14 are steered toward successive positions along the valve annulus (as described below). As a result, the successive portions of the sleeve 26 provide a free lumen for advancement of the successive anchors 32 and deployment of the anchors through the wall of the sleeve in the successive portions. Such release of successive portions of sleeve 26 creates a distance between successive anchors deployed from the lumen of sleeve 26 .

[0299] In some applications, sleeve 26 includes a plurality of radiopaque markers 25 positioned along the sleeve at respective longitudinal locations. The markers can provide an indication in an x-ray image (such as a fluoroscopic image) of the extent to which the sleeve has been deployed at any given time during the implantation procedure to enable setting of a desired distance between anchors 32 along the sleeve. In some applications, the markers include radiopaque ink.

[0300] In many cases, at least a portion (e.g., three, at least three, some, all, etc.) of the longitudinal portions of the radiopaque markers are longitudinally spaced apart at regular intervals. The longitudinal distance between the distal edges of adjacent markers and / or the distance between the proximal edges of adjacent markers can be set equal to a desired distance between adjacent anchors. For example, the markers can include a first marker, a second marker, and a third marker, where the first marker and the second marker are adjacent, and the second marker and the third marker are adjacent, and the distance between the proximal and / or distal edges of the first marker and the second marker is equal to the corresponding distance between the proximal and / or distal edges of the second marker and the third marker. For example, the distance can be 3-15 mm, e.g., 6 mm, and the longitudinal length of each marker can be 0.1-14 mm, e.g., 2 mm. (For example, if the distance is 6 mm and the length is 2 mm, then the longitudinal spacing between adjacent markers has a length of 4 mm.)

[0301] Each anchor 32 may be coupled to a deployment element 38 of an anchor driver 36. The anchor driver 36 comprises an elongated tube having at least a flexible distal end portion. The elongated tube of the driver 36 extends through the system 10 and into the lumen of the channel 18 toward the proximal end of the proximal handle portion 101 of the system 10. The tube of the anchor driver 36 provides a lumen for slidable advancement through the interior of an elongated rod 130. The rod 130 facilitates locking and unlocking of the anchors 32 to the deployment element 38, as described below. As shown in cross-section EE of FIG. 2, the proximal end of the rod 130 is coupled to a component of an anchor release mechanism 28 at the proximal end of the system 10. The mechanism 28 comprises a housing 135 and a finger engagement portion 131 coupled to the proximal end of the rod 130. The finger engagement portion 131 is coupled to the housing 135 via a spring 133 (cross-section EE of FIG. 2). The proximal end of the tube of anchor driver 36 is coupled to housing 135. As described below, a user (e.g., a physician, medical professional, etc.) releases anchor 32 from deployment element 38 when finger engagement portion 131 is pulled proximally, thereby pulling rod 130 proximally.

[0302] In some applications, the anchor driver 36 (e.g., its rotation and / or proximal-distal movement and / or release of the anchor 32) can be controlled electronically, such as by using an extracorporeal control device and / or motor coupled to the proximal end of the anchor driver and / or housing 135.

[0303] The proximal handle portion 101 may be supported by a stand having support legs 91 and a handle sliding track 90. ​​The handle portion 101 includes an outer catheter handle 22, a guide catheter handle 24, an implant manipulation handle 126, and an anchor release mechanism 28. The handle 22 is coupled to a proximal end of the outer catheter 12. The handle 24 is coupled to a proximal end of the guide catheter 14. The handle 126 is coupled to a proximal portion of the reference force tube 19, and linear movement of the handle 126 relative to the handle 24 moves the reference force tube 19 (and thereby, typically, structure 222) through the catheter 14. As mentioned above, the housing 135 of the anchor release mechanism 28 is coupled to a proximal portion of the tube of the anchor driver 36. The relative positions of each of the concentrically arranged components of the system 10 are shown in an exploded view in FIG. 2 as well as in cross sections AA, BB, CC, and DD.

[0304] A stand supporting the proximal handle portion 101 can be moved distally and proximally to control the position of the entire multi-component system 10, particularly to adjust the distance of the distal end 102 of the catheter 12 from the atrial septum. The handle 22 includes a steering knob 210 coupled to pull wires 29a and 29b disposed within respective secondary lumens in the wall of the outer catheter 12. Rotation of the knob 210 adjusts the degree of tension in the wires 29a and 29b, which applies a force to the pull ring 11 at the distal end portion of the outer catheter 12. Such force steers the distal end portion of the catheter 12 within the atrium of the patient's heart in a manner such that the distal end portion of the catheter 12 is steered in a first plane that is parallel to the plane of the valve annulus (e.g., in a direction from the atrial septum toward the surrounding wall of the atrium). In some applications, the distal end portion of the catheter 12 can be preshaped to point downward toward the valve. In other applications, the distal end portion of the catheter 12 can be pulled to an orientation in which the distal end portion points downward toward the valve. In some applications, the distal end portion of the catheter 12 is not fabricated to point downward toward the valve.

[0305] The handle 24 may be coupled to the track 90 via a first mount 92. The mount 92 may be slidable proximally and distally along the track 90 to control the axial position of the guide catheter 14 relative to the outer catheter 12. The mount 92 may be slidable via a control knob 216. For example, the control knob 216 of the mount 92 may control the proximal and distal axial movement of the steerable distal portion of the guide catheter 14 relative to the distal end 102 of the outer catheter 12. The handle 24 may include a steering knob 214 coupled to pull wires 31a and 31b disposed within respective secondary lumens in the wall of the guide catheter 14. Rotation of the knob 214 adjusts the degree of tension in the wires 31a and 31b, which applies a force to the pull ring 13 at the distal end portion of the guide catheter 14. Such force steers the distal end portion of the catheter 14 downward in a second plane within the atrium of the patient's heart and toward the heart valve annulus. As described below, the distal end portion of the guide catheter 14 may be steered in a second plane that is substantially perpendicular to the first plane in which the distal end portion of the outer catheter 12 is steered.

[0306] The combined steering of the distal end portions of catheters 12 and 14 directs sleeve 26 down toward the valve annulus (e.g., via steering of the distal end portion of catheter 14) and along the circumference of the valve annulus (e.g., from the back of the valve to the front of the valve, or vice versa), via steering of the distal end portion of catheter 12.

[0307] In some applications, the handle 22 may be tilted by a user (eg, a practitioner) to further adjust the position of the distal end of the catheter 12.

[0308] In some applications, handle 22 includes an indicator that indicates the degree of steering (e.g., bending) of the distal end portion of catheter 12 provided using knob 210. In some applications, handle 24 includes an indicator that indicates the degree of steering (e.g., bending) of the distal end portion of catheter 12 provided using knob 214.

[0309] As described herein, the first and second couplings 152 and 154 of the outer catheter 12 and the guide catheter 14, respectively (e.g., the slit 52 and the engagement portion 54, respectively) provide a controlled steerable system such that during steering and bending of the distal end portion of the guide catheter 14, the distal end portion of the outer catheter 12 is maintained in its steered configuration or spatial orientation without substantially affecting the steering or bending of the distal end portion of the guide catheter 14. Thus, the first and second couplings 152 and 154, respectively, minimize the influence of the distal end portion of the outer catheter 12 on the steering and bending of the catheter 14. That is, the first and second couplings 152 and 154 of the outer catheter 12 and the guide catheter 14, respectively, collectively define a relative spatial orientation control device that rotationally locks the relative spatial orientation of the steerable distal end portion and bending section of the outer catheter 12 relative to the steerable distal end portion and bending section of the guide catheter 14.

[0310] The constriction member 226 exits from a lumen in the wall of the guide catheter 14 at a portion of the handle portion 101 that is between the handles 22 and 24 .

[0311] The handle 126 may be coupled to the track 90 via a second mount 93. The mount 93 may be slidable proximally and distally along the track to control the axial position of the reference force tube 19 and at least a proximal portion of the sleeve 26 relative to the guide catheter 14. The mount 93 may be slidable via a control knob. For example, the control knob of the mount 93 may control proximal and distal axial movement of the tube 19 and at least a proximal portion of the sleeve 26 relative to the distal end 104 of the guide catheter 14. Such movement of the tube 19 and at least a proximal portion of the sleeve 26, together with manipulation of the distal end portion of the guide catheter 14, moves the proximal portion of the sleeve 26 from within the lumen of the sleeve 26 and toward a desired portion of the tissue of the valve annulus during delivery of the anchor 32, as described below.

[0312] As described above, to separate sleeve 26 from a portion of the exterior surface of channel 18, (1) channel 18 may be pulled proximally while (2) reference force tube 19 is maintained in a fixed position. The proximal end of channel 18 may be coupled to knob 94 that adjusts the axial position of channel 18 proximally and distally relative to reference force tube 19 and sleeve 26.

[0313] The handle portion 101 may include a release decision prompting member 127, such as a latch or button, that automatically engages when a given length of the sleeve 26 has been advanced out of the channel 18 (e.g., when the channel 18 is in a given position relative to the tube 19), often just before the sleeve 26 is fully separated from the channel 18. Engagement of the member 127 blocks proximal movement of the channel 18 relative to the tube 19, thereby reducing (e.g., preventing) the possibility of inadvertent release of the sleeve 26. To release the sleeve 26 (e.g., to separate the channel 18 from the sleeve), the user (e.g., the practitioner) must disengage the member 127, such as by pressing a button, before continuing to withdraw the channel 18 proximally. When engaged, the member 127 may also block distal movement of the channel 18 relative to the tube 19.

[0314] The handle portion 101 (including the handles 22, 24, and 126, and the anchor release mechanism 28) can have a length L1 of 65 to 85 cm, for example 76 cm. As shown, a majority of the body portion of the outer catheter handle 22 can be disposed at a non-zero angle relative to the longitudinal axis 7 of the components of the system 10. The steering mechanism provided by the handle 22 for steering the distal end portion of the catheter 12 is disposed within that portion of the handle 22 disposed at a non-zero angle relative to the axis 7. The handle 22 includes a serial tubular portion 21 disposed longitudinally in line along and coaxially with the handles 24 and 126, and the release mechanism 28. The tubular portion 21 is shaped to define a lumen for inserting the guide catheter 14 therethrough and thereafter into the lumen of the outer catheter 12. The tubular portion 21 has a length L24 of 7 to 11 cm, for example 7 cm. Such a spatial orientation of the majority of the handle 22 at an angle relative to the axis 7 reduces the overall working length of the handle portion 101 .

[0315] Reference is now made to Figures 3A-I, which are schematic illustrations of an example of a procedure for implanting an annuloplasty structure 222 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) to repair a mitral valve 230. This procedure is an example of a procedure that may be performed using system 10.

[0316] The annuloplasty structure or annuloplasty ring structure 222 may be used to repair a dilated annulus of an atrioventricular valve, such as the mitral valve 230. In some applications, the annuloplasty structure is configured to be only partially disposed around the annulus (e.g., to assume a C-shape) and to contract to circumferentially tighten the annulus once anchored or otherwise secured in place. In some applications, the annuloplasty structure is configured to be fully disposed around the annulus (e.g., to assume a closed shape, such as a circular, elliptical, D-shape, etc.) and to contract to circumferentially tighten the annulus once anchored in place. The annuloplasty structure may comprise a flexible sleeve 26. The annuloplasty structure may also include and / or be used with attachment means, such as a plurality of anchors 32 (e.g., anchor(s), fastener(s), clamp(s), suture(s), clip(s), etc.). An anchor deployment manipulator 61 advances into the lumen of the sleeve 26 and deploys anchors from within the lumen, through the wall of the sleeve and into the cardiac tissue, thereby anchoring the sleeve about a portion of the valve annulus. In some applications, the annuloplasty structure or annuloplasty ring structure 222 is realized using techniques described in U.S. Application No. 12 / 437,103, filed May 7, 2009 (granted as U.S. 8,715,342), and / or U.S. Application No. 12 / 689,635, filed January 19, 2010 (granted as U.S. 8,545,553), both of which are assigned to the assignee of the present application and incorporated herein by reference.

[0317] 3A, the procedure may begin by advancing a semi-rigid guidewire 202 into the patient's right atrium 220. The procedure may be performed using imaging, such as fluoroscopy, transesophageal echo, and / or echocardiography.

[0318] As shown in FIG. 3B, the guidewire 202 provides a guide for subsequent advancement of the outer catheter 12 along and into the right atrium. Once the distal portion of the catheter 12 enters the right atrium, the guidewire 202 is retracted from the patient's body. The catheter 12 may include a 14-24F sheath, although any size may be selected as needed for a given patient. The catheter 12 is advanced through the vasculature into the right atrium using the appropriate origin determined for a given patient. For example, The catheter 12 may be introduced into the patient's femoral vein, through the inferior vena cava 223, into the right atrium 220, and transseptally into the left atrium 224, for example through the fossa ovalis; The catheter 12 may be introduced into the basilic vein, through the subclavian vein into the superior vena cava, into the right atrium 220, and transseptally into the left atrium 224, for example, through the fossa ovalis; or • The catheter 12 may be introduced into the external jugular vein, through the subclavian vein into the superior vena cava, into the right atrium 220, and transseptally into the left atrium 224, for example through the fossa ovalis.

[0319] In some applications, the catheter 12 is advanced through the patient's inferior vena cava 223 (as shown) into the right atrium 220, using an origin suitable for a given patient.

[0320] As shown in FIG. 3C, the catheter 12 can be advanced distally until the sheath reaches the interatrial septum, and the guidewire 202 is withdrawn.

[0321] As shown in FIG. 3D, the resilient needle 206 and dilator (not shown) are advanced through the catheter 12 and into the heart. To advance the catheter 12 transseptally into the left atrium 224, the dilator is advanced to the septum and the needle 206 is pushed from within the dilator, allowing it to puncture the septum and create an opening that facilitates passage of the dilator and subsequent catheter 12 therethrough and into the left atrium 224. The dilator passes through the hole in the septum created by the needle. The dilator may be shaped to define a hollow shaft for passage along the needle 206, the hollow shaft being shaped to define a tapered distal end. The tapered distal end is initially advanced through the hole created by the needle 206. As the distal end of the dilator, which is of gradually increasing diameter, is pushed through the hole in the septum, the hole is enlarged. In some applications, the distal end 102 of the catheter 12 is tapered to facilitate passage of a distal portion of the catheter 12 through the septal opening.

[0322] Following advancement of the catheter 12 through the septum and into the left atrium, the dilator and needle 206 may be withdrawn from within the catheter 12, as shown in FIG. 3E. Once the distal portion of the catheter 12 is positioned within the atrium 224, the steerable distal end portion of the catheter 12 (e.g., the bent section 1203 of the catheter 12) may be steered in a first plane that is parallel to the plane of the annulus of the mitral valve 230. Such steering moves the distal end portion of the catheter 12 in a direction from the atrial septum toward the surrounding wall of the atrium, as shown by the arrow in the atrium 224. As discussed above, steering of the distal portion of the catheter 12 may be effected via the steering knob 210 (in FIGS. 1 and 2) of the handle 22 of the handle portion 101.

[0323] As shown in FIG. 3F, annuloplasty structure or annuloplasty ring structure 222 (not shown for clarity of illustration, including anchor deployment manipulator 61 therein) is advanced through guide catheter 14, which is advanced through catheter 12 and into left atrium 224. As shown in FIG. 3F, exposed distal end portion 114 (e.g., bent section 1403) of catheter 14 extends beyond distal end 102 of catheter 12. Exposed distal end portion 114 is then (1) steered toward the annulus of valve 230 along a plane perpendicular to the steering plane of catheter 12 and perpendicular to valve 230, and (2) bent toward valve 230 via bent section 1403. As described above, steering of the distal portion of catheter 14 is accomplished via steering knob 214 (in FIGS. 1 and 2) of handle 24 of handle portion 101.

[0324] 3G, the distal end 251 of the sleeve 26 is positioned near the left fibrous trigone 242 of the annulus 240 of the mitral valve 230. (Note that for clarity of illustration, the distal end 251 of the sleeve 26 is shown diagrammatically in a cross-sectional view of the heart, but the left trigone 242 is actually located off the page closer to the viewer, rather than in the cross-sectional plane shown.) Alternatively, the distal end of the sleeve 26 is positioned near the right fibrous trigone 244 of the mitral valve (configuration not shown). Further alternatively, the distal end of the sleeve is not positioned near any of the trigone, but instead is positioned elsewhere near the mitral valve, such as near the anterior commissure or posterior commissure. Once positioned at the desired site near the selected trigone, the deployment manipulator 61 deploys the first anchor 32 through the wall of the sleeve 26 (by penetrating the wall of the sleeve in a direction parallel to a central longitudinal axis of the deployment manipulator 61 or anchor driver 36 through the distal end of the channel 18 and / or parallel to a central longitudinal axis of the tissue engaging element 60 of the anchor 32) and into the cardiac tissue near the trigone. Following deployment of the anchor 32 in the cardiac tissue, the deployment element 38 is separated from the anchor 32 by moving the rod 130 proximally.

[0325] The anchors 32 may be deployed from the distal end of the manipulator 61, the distal end being positioned such that a central longitudinal axis passing through the distal end of the manipulator 61 forms an angle of about 20-90 degrees, such as about 45-90 degrees, such as about 75-90 degrees, such as about 90 degrees, with the surface of the cardiac tissue. The anchors 32 may be deployed from the distal end of the manipulator 61 into the cardiac tissue in a direction parallel to the central longitudinal axis passing through the distal end of the manipulator 61. Such an angle may be provided and / or maintained by the channel 18 being stiffer than the sleeve 26. The distal end 17 (shown in FIG. 2) of the channel 18 may be brought close to the surface of the cardiac tissue (and the wall of the sleeve 26 disposed against the surface of the cardiac tissue) such that most of each anchor 32 is not exposed from the channel 18 prior to penetrating the sleeve and tissue. For example, the distal end 17 of the channel 18 may be disposed (e.g., pressed) against the wall of the sleeve to pinch the sleeve against the cardiac tissue.

[0326] In some applications, this positioning of the distal end 17 of the channel 18 against the cardiac tissue (through the wall of the sleeve) stabilizes the distal end during deployment and anchoring of each anchor 32, thereby facilitating anchoring. In some applications, pressing the distal end 17 against the cardiac tissue (through the wall of the sleeve) temporarily deforms the cardiac tissue at the contact site. This deformation can facilitate identification of the contact site using imaging techniques (e.g., by identifying deformation of the interface between the cardiac tissue and blood), thereby facilitating correct positioning of the anchor.

[0327] In some applications, the anchor 32 may be deployed from a lateral portion of the manipulator 61.

[0328] 3G and 2. Following deployment of the first anchor, a distal portion of the sleeve 26 may be separated from a portion of the implant separation channel 18. To separate that portion of the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 may be pulled proximally while (2) the reference force tube 19 is maintained in a fixed position such that the distal end of the tube 19 provides a reference force to the sleeve 26 to facilitate retraction release of the continuous portion of the sleeve 26 from around the channel 18. To separate the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 may be pulled proximally while (2) the reference force tube 19 is maintained in a fixed position. An indicator on the handle 126 (such as indicator 2120 described in PCT Patent Application No. PCT / IL2012 / 050451 (published as WO / 2013 / 069019) to Sheps et al., incorporated herein by reference) provides an indication of the extent to which the channel 18 has been withdrawn from within the sleeve 26 (i.e., the extent to which the delivery tool has been separated from the sleeve 26 and the extent to which the sleeve has been cleared of the channel 18 and advanced against the tissue). The proximal end of the channel 18 is coupled to a knob 94 (FIG. 2) that adjusts the axial position of the channel 18 proximally and distally relative to the reference force tube 19 and the sleeve 26. As shown in FIG. 3H, the deployment manipulator 61 is repositioned along the annulus 240 to another site selected for deployment of the second anchor 32. Referring now to FIGS. 1 and 3H. Such repositioning of the manipulator 61 is accomplished by: (1) steering the distal end portion of catheter 12 (e.g., by steering knob 210 of handle 22) to a desired spatial orientation in a first plane that is parallel to annulus 240 of valve 230 and in a manner that bends bending section 1203 of catheter 12; (2) steering a distal end portion of a portion of catheter 14 (e.g., by steering knob 214 of handle 24) to a desired spatial orientation in a second plane that is perpendicular to annulus 240 of valve 230 and in a manner that bends bending section 1405 (particularly bending section 1403) of catheter 14; (3) axially moving catheter 14 relative to catheter 12 via knob 216; (4) axially moving the stand support handles 22 and 24 to move both catheters 12 and 14; (5) axially moving the tube 19 and sleeve 26 by sliding the mount 93 along the track 90 via the knob 95; and / or (6) Moving the channel 18 relative to the tube 19 via the actuation knob 94 .

[0329] In many cases, the first anchor is deployed most distally within the sleeve (generally at or within a few millimeters of the distal tip of the sleeve), with each subsequent anchor being placed more proximally, such that the sleeve is gradually separated from the channel 18 of the deployment manipulator 61 in a distal direction during the anchoring procedure (i.e., the channel 18 is withdrawn from within the sleeve 26, and the handle 126 is moved distally to retract the tool, leaving successive proximal portions of the sleeve 26 ready for implantation of subsequent anchors). The already deployed first anchor 32 holds the anchored end of the sleeve 26 in place, such that the sleeve is pulled from the site of the first anchor toward the site of the second anchor. Once the sleeve 26 is separated from the channel 18, the deployment manipulator 61 can be moved generally laterally along the cardiac tissue, as shown in FIG. 3H. The deployment manipulator 61 deploys the second anchor at the second site through the wall of the sleeve 26 and into the cardiac tissue. Depending on the tension applied between the first and second anchor sites, the portion of sleeve 26 between them may remain in a tubular shape or may flatten, which may help reduce any interference of the ring with blood flow.

[0330] As shown in FIG. 3I, the deployment manipulator 61 may be repositioned along the annulus to another site where each anchor is located until the last anchor is deployed near the right fibrous trigone 244 (or left fibrous trigone 242 if anchorage was initiated from the right trigone). Optionally, the last anchor is not deployed near the trigone, but instead is deployed elsewhere near the mitral valve, such as near the anterior or posterior commissure. The system 10 is then removed, leaving behind the implant structure 222 and the contraction member 226. As described below, a contraction member capture tool is then used to contract the structure 222 by passing over, advancing along and toward the contraction member 226 and adjusting the degree of tension of the contraction member 226 (although not shown in FIG. 3I, (i) advancement of the contraction member capture tool over the contraction member 226 is described with reference to FIGS. 4A-5D, and (ii) application of tension to the member 226 is described below with reference to 6A-B).

[0331] Once the desired level of adjustment of structure 222 is achieved (e.g., by monitoring the degree of valve regurgitation under echocardiographic and / or fluoroscopic guidance), the retraction member capture tool (1) locks retraction member 226 to maintain a degree of tension in member 226 to maintain structure 222 in a retracted state, and (2) severs any excess portions of retraction member 226 which are then removed from the heart. In some applications, a distal portion of guide member 86 may be left within the patient's heart and a proximal end may be accessible outside the body, for example, using a port. In such applications, adjustment mechanism 40 may be accessed at a later stage following the initial implantation and adjustment of ring structure 222.

[0332] In some applications, the re-access wire 288 may be provided coupled to a proximal portion of the implant (e.g., a portion of the implant that is deployed last), such as the final anchor 32 (as shown in FIG. 3I) or sleeve 26, such that upon anchoring, the wire extends proximally out of the subject's body, such as through the catheter 14 and / or catheter 12. If it is determined after implantation (e.g., and after adjustment) of the annuloplasty structure 222 that one or more anchors 32 require adjustment or retrieval, the re-access wire 288 may facilitate guidance of an anchor manipulation tool into and / or into the lumen of the annuloplasty structure 222. For example, such anchor manipulation tools may include those described in PCT Patent Application No. PCT / IL2013 / 050861, entitled "Percutaneous tissue anchor techniques," to Herman et al., filed Oct. 23, 2013, and incorporated herein by reference. The systems, devices, and techniques described in this patent application may be used in combination with the systems, devices, and techniques described in the aforementioned PCT Patent Application No. PCT / IL2013 / 050861.

[0333] As shown, sleeve 26 of ring structure 222 includes a plurality of radiopaque markers 25 positioned along the sleeve at respective longitudinal locations to indicate target areas for anchor designation. The markers can provide an indication on an x-ray image (such as a fluoroscopic image) of the extent to which sleeve 26 has been deployed at any given time during the implantation procedure to enable setting of a desired distance between anchors 32 along sleeve 26.

[0334] In some applications, and as shown in FIG. 3I , anchors 32 are deployed at longitudinal portions of sleeve 26 where radiopaque markers 25 are located (e.g., anchors are driven through radiopaque ink of radiopaque markers). Alternatively, anchors 32 may be deployed at longitudinal portions of sleeve 26 between markers 25. For example, when dispensing sleeve 26 from channel 18 (i.e., when advancing sleeve 26 relative to channel 18 and / or when withdrawing channel 18 from sleeve 26), appearance of marker 25 at the distal end of channel 18 (e.g., marker 25 aligns with marker 1018 of channel 18) can indicate that the correct length of sleeve 26 has been dispensed. Subsequent limited movement of the channel relative to the sleeve may occur. For example, when channel 18 is positioned against the annulus, the channel may tension the portion of sleeve 26 between the already deployed anchor and the distal end of the channel, such that when the anchor is deployed, the channel passes through the sleeve slightly proximal to marker 25 (e.g., 1-2 mm proximal to the marker).

[0335] Alternatively, the annuloplasty structure 222 is implanted via a right or left thoracotomy, mutatis mutandis.

[0336] In some applications, after implantation of sleeve 26 along the valve annulus, excess sleeve 26 may be present at the proximal portion of the sleeve. In such applications, after removal of manipulator 61, a cutting tool (not shown) may be advanced within channel 18 and within the lumen of the excess sleeve 26 (e.g., from within sleeve 26) to cut the sleeve proximal to the most proximal deployed anchor 32.

[0337] Reference is now made to FIGS. 4A-B, which are schematic illustrations of an exemplary system 10 including an exemplary constriction member entrapment tool 300 configured to constrict the constriction member 226 and sever any excess portions of the constriction member 226. The tool 300 includes a handle portion 320 and an elongate sheath 310 coupled thereto. The sheath 310 encases a primary tube 330 and a secondary tube 340 disposed along the primary tube 330. Both the primary tube 330 and the secondary tube 340 are coupled to the handle portion 320 at respective proximal ends of the tubes 330 and 340. The secondary tube 340 has a secondary lumen configured for passage of the constriction member 226 therethrough. The tool 300 defines a longitudinal axis 301.

[0338] In some applications, the sheath 310 is shaped to define a lumen in the wall of the sheath 310. In such applications, the tool 300 does not include a secondary tube 340; rather, the lumen in the wall of the sheath 310 functions as the secondary tube 340, and the primary lumen defined by the wall of the sheath 310 functions as the primary tube 330.

[0339] The sheath 310, the primary tube 330, and the secondary tube 340 may be flexible such that the sheath 310, the primary tube 330, and the secondary tube 340 are configured to pass through a patient's vasculature during a transvascular, transcatheter procedure. However, similar features may be used in surgical procedures. In some applications, the sheath 310, the primary tube 330, and the secondary tube 340 include silicone. In some applications, the sheath 310, the primary tube 330, and the secondary tube 340 include polyurethane.

[0340] Tool 300 can include a retraction member snare 350 comprising a distal snare portion 352 and an elongated flexible body portion 354 coupled to distal snare portion 352. Distal snare portion 352 is configured to receive a portion of retraction member 226 and is sized to pass through the secondary lumen of secondary tube 340 and pull retraction member 226 through the length of secondary tube 340, as described below.

[0341] The distal snare portion 352 may define a loop portion, as shown, In some applications, the distal snare portion 352 is shaped to define a hook.

[0342] The tool 300 can include a distal end portion 333 having a distal tip 331 that defines a distal end of the tool 300. The primary tube 330 terminates at the distal end portion 333. The distal end portion 333 includes a housing 332 shaped to hold and removably couple to a contraction member fastener 360. The contraction member fastener 360 includes a clamping structure that can be biased to assume a closed state or position, in which the clamping structure can be configured to clamp the contraction member 226 (not shown) passed therethrough. The clamping structure can also be configured to be bent to an open state in which the contraction member 226 (not shown) can move therethrough.

[0343] The tool 300 can include a fastener ejector 335 movable within a distal end portion 333 of the contraction member capture tool 300. Movement of the fastener ejector 335 converts the contraction member fastener 360 (or its fastening structure) from its open state to a closed state to tighten the contraction member 226 passed therethrough, as described below. The tool 300 includes a stop 362 removably coupled to the contraction member fastener 360 and configured to maintain the contraction member fastener 360 in an open state, as shown in cross-section AA of FIG. 4A. The stop 362 includes one or more, e.g., two, prongs 337 that maintain the fastener 360 in an open state. The ejector 335 is coupled to the stop 362 and moves the stop 362 removably coupled to the fastener 360 to convert the fastener 360 from an open state to a closed state, as described below.

[0344] 4B shows handle portion 320 of tool 300 with the casing removed to view the inside of handle portion 320. Handle portion 320 includes a contraction member capture device 322 configured to capture a continuous portion of contraction member 226 (not shown), as described below. Contraction member capture device 322 is operable to increase the tension of the contraction member, as described below. The tension of contraction member 226 is measured by a tension meter 324 in handle portion 320.

[0345] The contraction member capture device 322 can optionally include a wheel that can have two opposing wedge-shaped portions 325 that together define a groove 326 configured to couple the contraction member 226 to the wheel of the device 322. The wedge-shaped portions 325 can be shaped to receive any portion of the contraction member 226, such as, for example, a proximal end of the member 226 and / or an intermediate portion of the member 226. In some applications, the opposing wedge-shaped portions 325 are configured to grip the contraction member 226. As shown, the wheel of the device 322 can have a numerical indicator that indicates the number of revolutions of the wheel.

[0346] As shown, handle portion 320 is coupled to a proximal portion of each of primary tube 330 and secondary tube 340 .

[0347] The handle portion 320 may be shaped to define a lumen 328 for passage of a snare 350 therethrough from within the lumen of the secondary tube 340. The snare 350 passes through the lumen 328 and over a groove 326 of the retraction member capture device 322. Often, but not necessarily, the device 322 does not capture the snare 350; rather, the snare 350 passes through the groove 326. As described below, pulling the snare 350 pulls the retraction member 226 coupled thereto, which pulls the retraction member 226 through the secondary tube 340, through the lumen 328, and ultimately towards the retraction member capture device 322. Once the proximal end of the retraction member 226 (or a portion of the member 226 near its proximal end) has been pulled through the tube 340 and the lumen 328, the retraction member 226 is coupled to the retraction member capture device 322 by being fed into the groove 326. The contraction member entrapment device 322 is then actuated to apply tension to the contraction member 226 and thereby to the implanted annuloplasty structure 222 along the annulus. With each rotation of the wheel of the device 322, successive portions of the contraction member 226 are entrapped within the grooves 326 of the device 322.

[0348] 5A-D are schematic diagrams of an exemplary retraction member introduction tool 300 that can be used to introduce the retraction member 226. At this stage, the annuloplasty structure or annuloplasty ring structure 222 has been implanted along the valve annulus 240, as described above with reference to Figures 3A-I. Once the structure 222 is implanted along the valve annulus, the retraction member 226 extends away from the structure 222 and through the patient's vasculature such that a proximal end portion of the member 226 is disposed outside the patient's body.

[0349] The contraction member 226 can exit the sleeve 26 of the structure 222 at any suitable location along the structure 222. For example, the contraction member 226 can exit the sleeve 26 of the structure 222 at a portion of the structure 222 near the left fibrous trigone of the valve, as shown. In some applications, the contraction member 226 can exit the sleeve 26 of the structure 222 at a portion of the structure 222 near the right fibrous trigone of the valve. In some applications, the contraction member 226 exits the sleeve 26 of the structure 222 at a middle portion of the structure 222.

[0350] As shown, the structure 222 includes a sleeve 26 that defines a main body portion of the structure 222. The contraction member 226 has a first portion 420 that extends along the longitudinal length of the main body portion of the annuloplasty structure 222. The first portion 420 can extend along the longitudinal length of the structure 222 when the structure 222 is in a straight state as well as a curved state, as shown in FIG. 5A. The contraction member 226 also defines a second portion 422 that extends away from the main body portion of the annuloplasty structure 222.

[0351] 5A, a user (e.g., a practitioner, etc.) can hold the distal end of tool 300 in one hand and the proximal end portion of retraction member 226 in the other hand. The user or practitioner threads the proximal end portion of retraction member 226 through distal snare portion 352 of retraction member snare 350.

[0352] FIG. 5B illustrates the tool 300 with the distal snare portion 352 engaging the retraction member 226. In some applications, the distal snare portion 352 is shaped to increase the coupling between the snare 350 and the retraction member 226. For example, in some applications, the distal snare portion 352 is corrugated to increase the friction between the snare portion 352 and the retraction member 226. In some applications, the distal snare portion 352 can include a coiled section to increase the friction between the snare portion 352 and the retraction member 226. In some applications, the snare 350 includes a metal wire. In some applications, the snare 350 includes a metal wire including stainless steel. The snare 350 (including the distal snare portion 352) can have a variety of sizes, for example, a diameter of 0.15-0.5 mm or 0.15-0.35 mm.

[0353] 4A and 5B, as shown in cross-section AA of FIG. 4A, a retractable member snare 350 passes through aligned ports 339 and 341 in the distal end portion 333 of the tool 300.

[0354] The snare 350 may be pulled proximally, for example, by a user or physician holding a proximally exposed end portion 351 of the snare 350 proximally away from the tool 300. As shown in FIG. 5C, pulling the snare 350 proximally pulls the distal snare portion 352 and the looped retraction member 226 through the distal tip 331 of the tool 300, through a fastener disposed in the distal end portion 333 of the tool 300, through aligned ports 339 and 341 in the distal end portion 333 of the tool 300, and then through the lumen of the secondary tube 340.

[0355] The snare 350 is pulled until the distal snare portion 352 enters the lumen of the secondary tube 340. As a result, the looped portion of the distal snare portion 352 is compressed and folded around the looped contraction member 226 therethrough to maintain a connection between the snare portion 352 and the contraction member 226 as the elongated flexible body portion 354 (shown in FIG. 5B) is pulled through the lumen of the secondary tube 340. As the looped portion of the snare portion 352 is folded within the lumen of the secondary tube 340, the portion of the contraction member 226 engaged by the snare portion 352 flexes and the connection between the contraction member 226 and the snare portion 352 is strengthened. This strengthening also results from the relatively small diameter of the secondary tube 340, between 0.5 and 1.0 mm.

[0356] 5D, the snare 350 is pulled completely through the secondary tube 340, through the lumen 328 of the handle portion 320, and past the groove 326 of the retraction member capture device 322 to pull the retraction member 226 along this path. All the while, the sheath 310 of the tool 300 advances through the vasculature and along the annulus 240 toward the implanted annuloplasty structure 222. Once the distal snare portion 352 and the portion of the retraction member 226 coupled thereto exits the lumen 328 of the handle portion 320, that portion of the retraction member 226 is coupled to the retraction member capture device 322 by being positioned within the groove 326. In some applications, a proximal end portion of the retraction member 226 is provided within the groove 326. In some applications, an intermediate portion of the retraction member 226 (e.g., a portion near the proximal end of the retraction member 226) is provided within the groove 326. The contraction member 226 is then tightened by actuating, eg, rotating, the contraction member capture device 322 such that a continuous portion of the contraction member 226 is wound within the contraction member capture device 322 such that the contraction member capture device 322 captures the continuous portion.

[0357] Once the snare 350 has been pulled through the tool 300, the snare 350 may be discarded.

[0358] 6A-B, which are schematic illustrations of an exemplary tool 300 used to pull on the retraction member 226 to retract the retraction member 226 and thereby the annuloplasty structure or annulus structure 222 coupled thereto. The retraction member capture device 322 rotates to facilitate capture of successive portions of the retraction member 226.

[0359] 6A, prior to rotating the constriction member capture device 322, the tension meter 324 on the handle portion 320 reads a zero or near-zero tension in the constriction member 226. Similarly, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 is in a relaxed, untensioned state. At this point, the tool 300 has been advanced sufficiently through the patient's vasculature such that the proximal portion of the constriction member 226 is positioned outside the patient's body while the distal tip 331 is adjacent to the structure 222 positioned along the annulus.

[0360] In Figure 6B, the constriction member capture device 322 rotates to constrict and apply tension to the constriction member 226. The tension meter 324 on the handle portion 320 reads the tension in the 4-5 constriction members 226. Similarly, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 is in a taut, constricted state. As shown in Figure 6B, the constriction member 226 is in tension relative to the tool 300.

[0361] Reference is now made to FIGS. 7A-E, which are schematic illustrations of an exemplary tool 300 used to lock and secure the annuloplasty structure 222 in its contracted state and then sever the excess portion of the contraction member 226.

[0362] 7A shows the annuloplasty structure or annuloplasty ring structure 222 in an unconstricted state. A distal tip 331 of the tool 300 may be brought close to the structure 222. The constriction member 226 may be threaded along the sleeve 26 and out of a portion of the sleeve 26 of the structure 222. As described above, the constriction member 226 may be threaded through the tool 300 in such a way that the constriction member 226 passes through the distal tip 331, the constriction member fastener 360 which may be held open such as by the prongs 337 of the stop 362, the aligned ports 339 and 341 in the distal end portion 333 of the tool 300, and the secondary tube 340.

[0363] 7B, once the distal tip 331 of the tool 300 contacts the sleeve 26 of the structure 222, the tool 300 can be used to contract the structure 222 by the tool 300 pulling on the contraction member 226. During contraction of the structure 222, the fasteners 360 are not deployed.

[0364] 7C, the contraction member 226 is pulled tight and the annuloplasty structure 222 is contracted and in a taut, contracted state. The distal end portion 333 of the tool 300 is then used to push and deploy the fasteners 360 from within the tool 300 to lock the structure 222 in the contracted state.

[0365] 6A and 7C. Once the distal tip 331 contacts the sleeve 26, a trigger 321 (shown in FIG. 6B) on the handle portion 320 of the tool 300 is partially pulled to facilitate ejecting and deploying the contraction member fastener 360 from within the housing 332 of the distal end portion 333. As described above, the fastener ejector 335 is movable within the distal end portion 333 of the contraction member introduction tool 300. Movement of the fastener ejector 335 transforms the contraction member fastener 360 from its open state to a closed state, tightening the contraction member 226 passed therethrough. The fastener ejector 335 is coupled to the prongs 337 of the stop 362 in such a way that when the ejector 335 moves proximally within the portion 333, the stop 362 is disengaged from the contraction member fastener 360 as the prongs 337 move proximally away from the contraction member fastener 360. When contraction member fastener 360 is no longer held open by stop 362, fastener 360 closes, tightening around contraction member 226 passing therethrough as it tends to close.

[0366] A proximal portion of the fastener ejector 335 may be coupled to a distal end of a travel tube 343, which may be coupled at its proximal end to the trigger 321. The travel tube 343 is movable proximally in response to movement of the trigger 321, such that the fastener ejector 335 moves proximally relative to the distal tip 331 of the tool 300 and the fastener 360. As shown in FIG. 7B, the fastener 360 has been pushed out and deployed from within the housing 332 of the ejector 335.

[0367] In FIG. 7D, the fastener ejector 335 can move further proximally in response to further pulling of the trigger 321 to sever the excess portion of the retraction member 226. The tool 300 can be shaped to define a cut-promoting edge 370 at the distal end portion 333 of the tool 300. In some applications, the cut-promoting edge 370 defines a sharp edge. The retraction member 226 passes through aligned ports 339 and 341 at the distal end portion 333 of the tool 300, as shown in FIGS. 7A-C, while the retraction member 226 is proximate to the cut-promoting edge 370. Movement of the fastener ejector 335 draws the cut-facilitating edge 372 of the ejector 335 proximally against the cut-facilitating edge 370 of the tool 300, thus sandwiching a portion of the contraction member 226 between edges 370 and 372 and shearing and severing the contraction member 226 extending through ports 339 and 341. In some applications, the cut-facilitating edge 372 defines a sharp edge. FIG. 7D shows the contraction member 226 being sheared as the cut-facilitating edge 372 of the ejector 335 is drawn against the cut-facilitating edge 370 of the tool 300.

[0368] As shown in FIG. 7E, once contraction member 226 is severed, tool 300, along with the excess portion of contraction member 226, is withdrawn proximally.

[0369] Reference is now made to FIGS. 8A-D, which are schematic illustrations of one example of a system 510 for constricting a patient's annulus 240 using an annuloplasty structure 522 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.), which may include a housing 530. The housing 530 may accommodate a constriction member fastener 360. Except for the differences described below, the annuloplasty structure 522 may be the same as or generally similar to the annuloplasty structure 222 described above with reference to FIGS. 1-7E, with like reference numbers referring to like parts.

[0370] The annuloplasty structure or annuloplasty ring structure 522 can include a sleeve 26 that can define a main body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion 526 that extends along a longitudinal length of the main body portion of the annuloplasty structure 522. The first portion 526 can extend along a longitudinal length of the structure 522 when the structure 522 is in a straight state as well as a curved state, as shown in FIG. 8A. The contraction member 226 also defines a second portion 524 that extends away from the main body portion of the annuloplasty structure 522.

[0371] The contraction member 226 can extend through the housing 530 and through a stop 570 (e.g., a holder) disposed within an opening in the contraction member fastener 360. The stop 570 is shown as being cylindrical, by way of example and not limitation. An outer surface of the stop 570 maintains the fastener 360 in an open state. The stop 570 is shaped to define a threaded portion 572 that allows for connection of a contraction member intake tool to the stop 570, as described below.

[0372] The annuloplasty structure or annuloplasty ring structure 522 is implanted as described above with reference to Figures 3A-I using the system described above with reference to Figures 1-3I.

[0373] The housing 530 may be coupled to the sleeve 26 of the structure 522 at any suitable location along the structure 522. For example, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a portion of the structure 522 near the left fibrous trigone of the valve, as shown. In some applications, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a portion of the structure 522 near the right fibrous trigone of the valve. In some applications, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a middle portion of the structure 522. As shown, the housing 530 may be coupled to an outer surface of the sleeve 26. In such applications, the housing 530 does not block the lumen of the sleeve 26 of the structure 522.

[0374] 8B shows a retraction member capture tool 600 with the retraction member 226 therethrough. The retraction member 226 may be engaged by the tool 600 using a snare, as described above with respect to the snare 350 with reference to Figures 4A-5D. The tool 600 may be advanced along the retraction member 226 toward the housing 530 of the structure 522 in a manner similar to the tool 300 advancing along the retraction member 226, as described above with reference to Figures 4A-5D.

[0375] Tool 600 can include a distal tip 631 and a distal end portion 633 that is generally similar to distal end portion 533 of tool 300 described above with reference to Figures 4A-7E, with like reference numbers referring to like parts. Distal end portion 633 of tool 600 differs from distal end portion 533 of tool 300 of Figures 4A-7E because annuloplasty structure 522 includes constriction member fastener 360 and stop 570 removably coupled to fastener 360, with the remaining parts of tool 600 corresponding to the remaining parts of tool 300.

[0376] Once the tool 600 is threaded along the contraction member 226, the contraction member 226 extends from the sleeve 26, through the stop 570, the stop coupler 672 of the tool 600, the distal tip 631, and then through aligned ports 339 and 341 in the distal end portion 633 of the tool 600.

[0377] The fastener coupler 672 of the tool 600 threadingly engages a threaded portion 572 of a fastener 570 that is coupled to a contraction member fastener 360 disposed within the housing 530 of the structure 522 .

[0378] As described above with reference to Figures 6A-B, a contraction member capture device of tool 600 (not shown, but similar to contraction member capture device 322 of tool 300) can be used to contract contraction member 226. As shown in Figure 8C, once contraction member 226 has contracted and structure 522 has contracted, tool 600 removes stop 570 by pulling stop 570 proximally, away from fastener 360. Without stop 570, fastener 360 would close as fastener 360 would tend to close, and would clamp around contraction member 226 passing through fastener 360. In such a way, structure 522 is locked by fastener 360 and structure 522 is maintained in a contracted state.

[0379] Figure 8D shows contraction member 226 being severed proximal to fastener 360 and the excess portion of contraction member 226 being removed from the patient's body using tool 600. Severing of contraction member 226 is performed in a manner as described above with reference to Figures 7A-E, mutatis mutandis.

[0380] Reference is now made to Figures 9A-D, which are schematic illustrations of an exemplary contraction member capture tool 600 used to lock and secure the annuloplasty structure 522 of Figures 8A-D in its contracted state and then sever the excess portion of the contraction member 226.

[0381] 9A shows the annuloplasty structure 522 in a partially contracted state. The contraction member 226 may be threaded along the sleeve 26 and out of a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 may be threaded through the tool 600 in such a way that the contraction member 226 passes through the stop coupler 672 of the tool 600, the distal tip 631, the aligned ports 339 and 341 in the distal end portion 633 of the tool 600, and the secondary tube 340.

[0382] 9B, the contraction member 226 is pulled tight and the annuloplasty structure 522 is contracted and in a taut contracted state. The distal end portion 633 of the tool 300 is brought close to the annuloplasty structure 522 (e.g., tip 631 contacts or is brought close to the housing 530 as shown) to expel and deploy the fasteners 360 within the housing 530 to lock the structure 522 in the contracted state.

[0383] Once the distal end portion 633 is proximate the sleeve 26, a trigger on the handle portion of the tool 600 (similar to trigger 321 of tool 300 shown in FIG. 6B ) can be partially pulled to facilitate distally pushing and deploying the contraction member fastener 360 within the housing 530 of the annuloplasty structure 522. A fastener ejector 335 is movable within the distal end portion 633 of the contraction member introduction tool 600. Movement of the fastener ejector 335 transforms the contraction member fastener 360 (e.g., its clamping structure) from its open state to a closed state, clamping the contraction member 226 passed therethrough. The fastener ejector 335 is coupled to a stop coupler 672 of the tool 600 that threadingly engages a threaded portion 572 of the stop 600 in such a manner that the stop 570 is pulled away from and separated from the fastener 630 when the ejector 335 moves proximally within the portion 633 of the tool 600. When the contraction member fastener 360 is no longer held open by the stop 570, the fastener 360 closes and as it tends to close, it tightens around the contraction member 226 passing therethrough.

[0384] In FIG. 9C, the fastener ejector 335 can move further proximally (in response to further pulling of a trigger on the handle portion of the tool 600) to sever the excess portion of the retraction member 226. The tool 600 can be shaped to define a cut-promoting edge 370 on the distal end portion 633 of the tool 600. In some applications, the cut-promoting edge 370 defines a sharp edge. The retraction member 226 passes through aligned ports 339 and 341 on the distal end portion 633 of the tool 600, as shown in FIG. 9B, while the retraction member 226 is proximate to the cut-promoting edge 370. Movement of the fastener ejector 335 draws the cut-facilitating edge 372 of the ejector 335 proximally against the cut-facilitating edge 370 of the tool 300, thus sandwiching a portion of the contraction member 226 between edges 370 and 372 and shearing and severing the contraction member 226 extending through ports 339 and 341. In some applications, the cut-facilitating edge 372 defines a sharp edge. FIG. 9C illustrates the contraction member 226 being sheared as the cut-facilitating edge 372 of the ejector 335 is drawn against the cut-facilitating edge 370 of the tool 600.

[0385] As shown in FIG. 9D, once contraction member 226 is severed, tool 600, along with the excess portion of contraction member 226, is withdrawn proximally.

[0386] 8A-9D, the system 510 provides an annuloplasty structure 522 (e.g., annuloplasty ring structure, closed annuloplasty ring structure, closed annuloplasty ring structure, open annuloplasty ring structure, partial annuloplasty ring structure, etc.) in which the housing 530 houses the constriction member fastener 360, rather than the fastener 360 being disposed on the outside of the sleeve 26. In such a manner, the system 510 reduces the likelihood of embolism and / or clotting.

[0387] 4A-9D, the constriction member capture tools 300 and 600 can be used to (1) apply tension to the constriction member, (2) deploy a lock to ensure tension in the constriction member, and (3) thereafter cut and sever the constriction member of any annuloplasty structure, e.g., a complete annuloplasty ring structure, a partial annuloplasty ring structure, etc.

[0388] 8A-D and 9A-D. It should be noted that while tool 600 is described as being advanceable towards housing 530 already coupled to annuloplasty structure 522, the scope of this specification includes tool 600 configured to couple to housing 530 from a site outside the patient's body and deliver housing 530 along constriction member 226 to sleeve 26 of structure 522 already implanted in the annulus. In such applications, housing 530 is configured to be positionable relative to a main body portion of structure 522.

[0389] Reference is now made to FIGS. 10A-B, which are schematic illustrations of an exemplary system 700 including an exemplary contraction member capture tool 702 configured to contract the contraction member 226 and sever any excess portions of the contraction member 226.

[0390] Except for the differences described below, the constriction member capture tool 702 may be the same as or generally similar to the constriction member capture tools 300 and 600 described above with reference to Figures 4A-9D, which are used to (1) apply tension to the constriction member, (2) deploy a lock to ensure tension in the constriction member, and (3) thereafter cut and sever the constriction member of any annuloplasty structure, e.g., a complete (or closed) annuloplasty ring structure, or a partial (or open) annuloplasty ring structure.

[0391] The exemplary constriction member capture tool 702 can be used to capture the constriction member 226 of the annuloplasty structure 730. The annuloplasty structure 730 can be the same as or generally similar to the annuloplasty structures 222 or 522 described above with reference to FIGS. 1-9D, with like reference numbers referring to like parts. At this stage, the annuloplasty structure 730 (e.g., annuloplasty ring structure, closed annuloplasty structure, closed annuloplasty ring structure, open annuloplasty structure, partial annuloplasty ring structure, etc.) is implanted along the annulus, as described above with reference to FIGS. 3A-I. Once the structure 730 is implanted along the annulus, the constriction member 226 extends away from the structure 730 and through the patient's vasculature such that a proximal end portion of the member 226 is disposed outside the patient's body.

[0392] Except for the differences described below, the annuloplasty structure 730 may be the same as or generally similar to the annuloplasty structures 222 and 522 described above with reference to Figures 1-9D, and like reference numbers refer to like parts. The annuloplasty structure 730 may be a complete (or closed) or partial (or open) annuloplasty structure.

[0393] As shown, the structure 730 includes a sleeve 26 that defines a main body portion of the structure 730. The contraction member 226 has a first portion 732 that extends along the longitudinal length of the main body portion of the annuloplasty structure 730. The contraction member 226 also defines a second portion 734 that extends away from the main body portion of the annuloplasty structure 730.

[0394] As shown, the tool 702 is used to implant a complete (or closed) annuloplasty structure 730, although the annuloplasty structure may also be an annuloplasty ring structure or may include a partial (or open) annuloplasty structure.

[0395] In some applications, the annuloplasty structure 730 is realized using techniques described in U.S. Application No. 12 / 341,960, filed December 22, 2008 (published as U.S. 8,241,351), U.S. Application No. 12 / 437,103, filed May 7, 2009 (published as U.S. 8,715,342), and / or U.S. Application No. 12 / 689,635, filed January 19, 2010 (published as U.S. 8,545,553), both of which are assigned to the assignee of the present application and are incorporated herein by reference.

[0396] Tool 702 may be configured in a variety of ways. In some applications, tool 702 comprises an elongate sheath 310. In some applications, sheath 310 encases primary tube 330 and secondary tube 340 disposed along primary tube 330. In such applications, sheath 310 is shaped to define secondary tube 340. Secondary tube 340 is shaped to define a longitudinal slit 740. Slit 740 facilitates ease of coupling and engagement of retraction member 226 within the lumen of tube 340. Slit 740 also allows ease of release of retraction member 226 from within the lumen of tube 340. In some applications, slit 740 facilitates ease of coupling and / or release of a retraction member snare, as described above with reference to FIGS. 4A-B. In some applications, the distal-most section of slit 740 is at a longitudinal position along tube 340 proximal to the distal-most end of tube 340, e.g., in a portion of tube 340 that is configured to be positioned proximal to a patient's ventricle, thereby preventing blood from leaking out from within the heart through slit 740.

[0397] Tool 702 is used to deploy one or more (e.g., two as shown) contraction member fasteners 360a and 360b. Fasteners 360a and 360b are similar or identical to fastener 360 described above with reference to FIGS. 4A-9D. The use of two fasteners 360a and 360b can provide redundant and more secure fastening of the periphery of structure 730 after it is contracted. Fasteners 360a and 360b can be coaxially disposed around a portion of contraction member 226.

[0398] In some applications, a push tube (not shown) is used to deploy the contraction member fasteners 360a and 360b. The push tube comprises a semi-rigid material that is used to deploy the fasteners 360a and 360b by pushing them. The fasteners 360a and 360b may be coaxially disposed about a portion of the contraction member 226 and distally disposed at a distal end of the push tube. In some applications, the fasteners 360a and 360b are removably disposed about a portion of the push tube.

[0399] Following deployment of fasteners 360a and 360b, tool 702 is used to sever any excess portions of contraction member 226, as described above with reference to tools 300 and 600 described above with reference to Figures 4A-9D.

[0400] In some applications, the oversheath 710 is not used and the tool 702 is coupled to the annuloplasty structure using male and female couplings, as shown below with reference to FIGS.

[0401] Reference is now made to FIGS. 11A-C, which are schematic illustrations of an exemplary system 800 including an exemplary contraction member capture tool 810 that is used to lock and secure the annuloplasty structure 222 in its contracted state and then sever excess portions of the contraction member 226, according to some applications.

[0402] Except for the differences described below, the constriction member capture tool 810 may be the same as or generally similar to the constriction member capture tools 300 and 600 described above with reference to Figures 4A-9D, which are used to (1) apply tension to the constriction member, (2) deploy a lock to ensure tension in the constriction member, and (3) thereafter cut and sever the constriction member of any annuloplasty structure, e.g., a complete (or closed) annuloplasty ring structure, a partial (or open) annuloplasty structure, etc.

[0403] FIG. 11A shows the annuloplasty structure or annuloplasty ring structure 222 in an unconstricted state. A distal tip 331 of the tool 810 may be brought close to the structure 222. The constriction member 226 may be threaded along the sleeve 26 and out of a portion of the sleeve 26 of the structure 222. As described above, the constriction member 226 may be threaded through the tool 810 in such a way that the constriction member 226 passes through the distal tip 331, the constriction member fastener 360, which may be held open such as by the prongs 337 of the stop 362, the aligned ports 339 and 341 in the distal end portion 333 of the tool 810, and the secondary tube 340. In some applications, the distal end portion of the tool 810 is similar to the distal end portion of the tool 702 described above with reference to FIGS. 10A-B. In some applications, the distal end portion of the tool 810 is similar to the distal end portion of the tool 920 shown below with reference to FIGS. 12, 13, and 15. In such applications, the tool 920 includes a male coupling 925 and the annuloplasty structure 222 includes a housing 930 shaped to define a female coupling 927 .

[0404] The tool 810 includes a proximal handle portion 820. The handle portion 820 includes a proximal constriction enhancer knob 830. The knob 830 is fixedly coupled to a proximal end 832 of the constriction member 226. Rotation of the constriction enhancer knob 830, as shown in FIG. 11A, moves the knob 830 proximally. As the knob 830 is pulled proximally, the constriction member 226 is pulled proximally. In response, the annuloplasty structure 222 constricts. The tool 810 includes a gauge 834 that indicates the level of constriction of the annulus in response to the number of turns of the knob 830.

[0405] 11B, once distal tip 331 of tool 810 contacts sleeve 26 of structure 222 (or in some applications, the housing of an annuloplasty structure described above with reference to FIGS. 12, 13, and 15), tool 810 may be used to contract structure 222 by tool 810 pulling on contraction member 226 in response to rotation of knob 830, as described above with reference to FIG. 11A. During contraction of structure 222, fastener 360 is not deployed.

[0406] 11C, the contraction member 226 is pulled tight and the annuloplasty structure 222 is contracted and in a taut, contracted state. The distal end portion 333 of the tool 810 is then used to push and deploy the fasteners 360 from within the tool 810 to lock the structure 222 in the contracted state.

[0407] In some applications, once the distal tip 331 contacts the sleeve 26, a trigger knob 840 on the handle portion 820 of the tool 810 is partially pulled to facilitate pushing and deploying the contraction member fastener 360 from within the housing 332 of the distal end portion 333. A fastener ejector 335 is movable within the distal end portion 333 of the contraction member introduction tool 810. A proximal portion of the ejector 335 is coupled to a distal portion of an actuation wire 842. A proximal end 844 of the actuation wire 842 is coupled to the trigger knob 840. Proximal movement of the trigger knob 840 pulls the actuation wire 842 proximally, which maximally pulls the fastener ejector 335. Proximal movement of the fastener ejector 335 transforms the contraction member fastener 360 from its open state to a closed state, clamping the contraction member 226 passing therethrough. Fastener ejector 335 is coupled to prongs 337 of stop 362 in such a way that when ejector 335 moves proximally within portion 333, stop 362 separates from contraction member fastener 360 as prong 337 moves proximally away from contraction member fastener 360. When contraction member fastener 360 is no longer held open by stop 362, fastener 360 closes and as it tends to close, it tightens around contraction member 226 passing therethrough.

[0408] The actuation wire 842 is disposed within an inner sheath 841 that spans the length of the elongate sheath 310. In such applications, as shown in Figures 11A-C, the elongate sheath 310 comprises a multi-lumen sheath defining (1) a first lumen for passage through the interior of the inner sheath 841 that houses the actuation wire 842 therein, and (2) a second lumen for passage of the contraction member 226 therethrough.

[0409] 11C, the fastener 360 is deployed by being pushed out from within the housing 332 of the ejector 335. The fastener ejector 335 can then move further proximally in response to further proximal pulling of the trigger knob 840 to sever the excess portion of the retraction member 226. Similar to the tools 300 and 600 described above, the tool 810 is shaped to define a cut-promoting edge 370 at the distal end portion 333 of the tool 810. In some applications, the cut-promoting edge 370 defines a sharp edge. The retraction member 226 passes through aligned ports 339 and 341 at the distal end portion 333 of the tool 810, as shown in FIGS. 11A-C, while the retraction member 226 is proximate to the cut-promoting edge 370. Movement of the fastener ejector 335 draws the cut-facilitating edge 372 of the ejector 335 proximally against the cut-facilitating edge 370 of the tool 810, thus sandwiching a portion of the contraction member 226 between edges 370 and 372 and shearing and severing the contraction member 226 extending through ports 339 and 341. In some applications, the cut-facilitating edge 372 defines a sharp edge. FIG. 11C illustrates the contraction member 226 being sheared as the cut-facilitating edge 372 of the ejector 335 is drawn against the cut-facilitating edge 370 of the tool 300.

[0410] Following severing of the contraction member 226, the tool 810, together with the excess portion of the contraction member 226, is removed from the patient's body by withdrawing it proximally.

[0411] 11A-C, in some applications, the trigger knob 840 is coupled to a safety mechanism to prevent unintentional deployment of the fastener 360.

[0412] Reference is now made to FIGS. 12A-C, which are schematic illustrations of one example of a system 900 comprising an exemplary annuloplasty structure 910 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) comprising a sleeve 26, a contraction member 226, and a lock 950. The implantable annuloplasty structure 910 comprises a main body portion 912. The contraction member 226 has a first portion 914 extending along a longitudinal length of the main body portion 912 of the annuloplasty structure 910 and a second portion 916 extending away from the main body portion 912 of the annuloplasty structure 910. The contraction member 226 is configured to adjust a circumference of the annuloplasty structure 910.

[0413] Except for the differences described below, the annuloplasty structure 910 may be the same as or generally similar to the annuloplasty structures 222, 522, and 730 described above with reference to Figures 1-11C, and like reference numbers refer to like parts. The annuloplasty structure 910 may be a complete (or closed) or partial (or open) annuloplasty structure.

[0414] The main body portion 912 of the structure 910 has a sidewall and is shaped to define a recess 960 having a recess axis 940. The recess 960 extends from an opening 932 in a first surface 934 of the sidewall of the main body portion 912 toward an opposing second surface 936 of the sidewall of the main body portion 912 (shown in FIG. 12C ). The sidewall of the main body portion 912 extends away from the recess 960 along a longitudinal axis 942 that is at a non-zero angle relative to the recess axis 940. The contraction member 226 extends away from the main body portion 912 of the annuloplasty structure 910 through and via the recess 960.

[0415] The recess 960 is shaped to define a recess lumen 962. The recess lumen 962 is disposed along the recess axis 940.

[0416] For some applications, main body portion 912 includes a housing 930 coupled to sleeve 26. In such applications, housing 930 defines at least a portion of the sidewall, and housing 930 defines recess 960. Sleeve 26 defines the remaining portion of the sidewall.

[0417] In some applications, the structure 910 does not include a housing 930 and the sleeve 26 defines the sidewall.

[0418] The recess 960 is shaped to receive the lock 950. The recess 960 is dimensioned to compress the lock 950 when the lock 950 is at least partially disposed within the recess 960. The lock 950 is shaped to define a series of tapered segments 951. Each segment 951 has a longest length L1 of 0.2-1.5 mm. The proximal-most section of the lock 950 has a length L2 of 0.2-2 mm. Accordingly, the recess 960 corresponds to the shape of the lock 950 and is slightly smaller than the shape of the lock 950, such that the walls defining the recess 960 compress the lock 950 as the lock 950 slides into the recess 960. That is, the section of the recess 960 that receives the longest length L1 of the segments 951 has a longest length L3 of 0.2-1.5 mm. The proximal-most section of the recess 960 has a length L4 of 0.2-2 mm.

[0419] The lock 950 is shaped to define a locking lumen configured to surround the contraction member 226. The lock 950 is shaped to define a longitudinal slit 952 extending from a proximal surface of the lock 950 toward a distal surface of the lock 950. In some applications, the slit 952 defines the locking lumen of the lock 950. The slit 952 allows the lock 950 to push into the smaller recess 960 and thereby be compressed. When the lock 950 is compressed, the slit 952 allows the lock 950 to close around the contraction member 226, thereby locking the lock 950 to the contraction member 226.

[0420] In some applications (not shown), the lock lumen has a consistent dimension (eg, diameter) along the length of the lock lumen from the proximal surface of the lock 950 to the distal surface of the lock 950.

[0421] As shown, in some applications, the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen, and in such applications, the proximal-most section of the recess 960 is narrower than any other portion of the recess 960 distal to the proximal-most portion.

[0422] Delivery tool 920 is used to deliver lock 950 into recess 960. Except for differences described below, delivery tool 920 may be the same as or generally similar to tools 300, 600, 702, and 810 described above with reference to Figures 4A-11C, with like reference numbers referring to like parts. Tool 920 includes a contraction member disruption section 921, which may include elements of tools 300, 600, 702, and 810 described above with respect to the cutting elements.

[0423] 12A, the delivery tool 920 delivers the annuloplasty structure or the annuloplasty structure 910 and the lock 950 together toward the annulus. The delivery tool 920 and the contraction member 226 are slidable relative to one another. When the delivery tool 920 is coupled to the annuloplasty structure 910, a portion of the contraction member 226 (e.g., the second portion 916) is disposed within the lumen of the delivery tool 920 and the lock 950 surrounds a portion of the contraction member. When the delivery tool 920 is coupled to the annuloplasty structure 910, the lock 950 is disposed fully proximal to the recess 960.

[0424] 12B illustrates partial positioning of lock 950 within the proximal portion of recess 960. During partial positioning of lock 950, a distal portion of lock 950 (e.g., distal-most tapered segment 951) is compressed. Because the distal portion of the lock lumen of lock 950 is wider than the proximal portion of the lock lumen, when the distal portion of lock 950 is compressed within the proximal portion of recess 960, the distal portion of lock 950 does not completely close around retraction member 226, such that at this stage, lock 950 is not locked against retraction member 226, which pulls on the retraction member as lock 950 is pushed further distally within recess 960. Only when the lock 950 is fully pushed within the recess 960, because the proximal-most section of the recess 960 is narrower than any other portion of the recess 960 distal to the proximal-most portion, and because the lock lumen of the lock 950 is narrower at the proximal portion 953 of the lock 950, does at least the proximal portion 953 of the lock 950 close around the contraction member 226 to lock the lock 950 to the contraction member, thereby maintaining the outer periphery of the annuloplasty structure 910. That is, the tool 920 pushes the lock 950 using a lock ejector 923, which is often similar to the fastener ejector 335 described above. The lock ejector 923 is movable within a distal end portion of the tool 920. The movement of the lock ejector 923 contacts the lock 950 and transforms it from an open state (shown in FIG. 12A) to a closed state (shown in FIG. 12C) to clamp the lock 950 to the contraction member 226 that has passed therethrough.

[0425] As shown in FIG. 12C, the lock 950 is shaped to fit completely within the recess 960. As described above with reference to tools 300, 600, 702, and 810 described above with reference to FIGS. 4A-11C, the tool 920 is configured to sever excess portions of the contraction member 226 after locking the lock 950 to the contraction member 226 by being positioned within the recess 960. That is, the distal end portion of the tool 920 is shaped to define a sharp edge similar to edge 370 of the tool 300, as described above. Additionally, as described above, the contraction member 226 is disposed proximate to the sharp edge such that movement of the lock ejector 923 relative to the sharp edge severs the contraction member 226 extending through the lock 950.

[0426] Reference is now made to FIGS. 13A-C, which are schematic illustrations of one example of a system 1000 comprising an exemplary annuloplasty structure or annuloplasty structure 910 (e.g., annuloplasty ring structure, closed annuloplasty ring structure, closed annuloplasty ring structure, open annuloplasty ring structure, partial annuloplasty ring structure, etc.) comprising a sleeve 26, a constriction member 226, and a lock 1950. Except for the differences described herein below, the system 1000 is the same as or generally similar to the system 900 described above with reference to FIGS. 12A-C, except that the lock 1950 is at least partially disposed and retained within the recess 1960 when the delivery tool 920 is coupled to the annuloplasty structure 910. As shown, the distal-most tapered segment 951 is disposed within the proximal section of the recess 1960. In such a manner, the system 1000 reduces the likelihood of embolism and / or clotting.

[0427] Reference is now made to Figures 10A-13C. In Figure 10A, the tool 702 includes an oversheath 710 at least at a distal portion of the tool 702. The oversheath 710 includes a gripper 720 configured to surround at least a portion of an annuloplasty structure coupled to the tool 702. In some applications, any of the tools 300, 600, and 810 described herein include an oversheath 710 including a gripper 720. The gripper 720 and oversheath 710 are configured to provide a counter force to the annuloplasty structure during deployment of the fasteners 360 and / or locks 950 described herein as the fasteners 360 and / or locks 950 are pushed by the tool to deploy the fasteners 360 and / or locks 950. In some applications, the tools described herein do not include a gripper 720.

[0428] Reference is now made to FIG. 14, which is a schematic diagram of an exemplary system 1100 including a lock 1110 configured to lock the circumference of an exemplary annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) according to some applications. Except for the differences described below, the lock 1110 may be generally similar to the lock 950 described above with reference to FIGS. 12A-13C, and like reference numbers refer to like parts. The slit 952 of the lock 1110 is uniform along the longitudinal axis of the lock 1110 from the proximal end of the lock 1110 to the distal end of the lock 1110. In some applications, the lock lumen is uniform, as shown in FIGS. 12A-13C. In some applications, the lock lumen is narrower at the proximal end portion of the lock and wider at the distal end portion, as shown in FIGS. 15A-C.

[0429] The lock 1110 may be used to lock any of the annulus formation structures described herein, for example, the lock 1110 may be used to lock any of the annulus formation structures 222, 522, 730, and 910 described above with reference to Figures 1-13C.

[0430] The delivery tool may be used to deliver the lock 1110 towards the annuloplasty structure or annuloplasty ring structure. The delivery tool may be the same as or generally similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, with like reference numbers referring to like parts. The delivery tool includes a constriction member disruption section that may include elements of tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

[0431] Reference is now made to FIGS. 15A-C, which are schematic illustrations of an exemplary system 1480 comprising an exemplary annuloplasty structure 910 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) comprising a sleeve 26, a constriction member 226, and a lock 1490, according to certain applications. Except for the differences described herein below, the system 1480 is the same as or generally similar to the system 1000 described above with reference to FIGS. 13A-C, except that the lock 1490 has a lumen that is narrower at a proximal end portion of the lock 1490 and wider at a distal end portion of the lock 1490. Cross section AA of FIG. 15A illustrates a wider lock lumen around the constriction member 226 at the proximal end portion of the lock 1490 than the width of the lock lumen around the constriction member 226 at the distal end portion of the lock 1490 shown in cross section BB. As shown in FIG. 15C, once lock 1490 is fully positioned within recess 960, the proximal end portion closes tightly around contraction member 226, as shown in cross section CC, while the distal end portion closes around contraction member 226, although it may not close as tightly as the proximal end portion closes around contraction member 226, as shown in cross section DD.

[0432] As shown, the lock 1490 is shaped to define a slit 952 that is narrower at a proximal end portion of the lock 1490 and wider at a distal end portion of the lock 1490 .

[0433] In some applications, the lock 1490 is shaped to define a slit 952 that is uniform along the length of the lock 1490, as shown in FIG.

[0434] In some applications, when the delivery tool 920 is coupled to the annuloplasty structure 910, the lock 1490 is positioned completely proximal to the recess 1960, as shown in Figures 12A-C.

[0435] Reference is now made to FIG. 16, which is a schematic diagram of an exemplary system 1200 comprising an exemplary annuloplasty structure 1210 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) comprising a sleeve 26, a contraction member 226, and a lock 1220. The implantable annuloplasty structure 1210 comprises a main body portion. The contraction member 226 has a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 1210 and a second portion extending away from the main portion of the annuloplasty structure 1210. The contraction member 226 is configured to adjust a circumference of the annuloplasty structure 1210.

[0436] Except for the differences described below, the annuloplasty structure 1210 may be the same as or generally similar to the annuloplasty structures 222, 522, 730, and 910 described above with reference to Figures 1-15C, and like reference numbers refer to like parts. The annuloplasty structure 1210 may be a complete (or closed) or partial (or open) annuloplasty structure.

[0437] The structure 1210 comprises a housing 1202 shaped to define a sidewall and is shaped to define a recess 1230 having a recess axis. The recess 1230 extends from an opening in a first surface of the housing toward an opposite second surface of the housing 1202. The housing 1202 is shaped to provide a contraction member lumen wall 1205 disposed along a contraction member lumen 1204. The contraction member lumen 1204 is disposed at a non-zero angle relative to a recess axis 1207 of the recess 1230. The recess 1230 is shaped to define a recess lumen disposed along the recess axis 1207.

[0438] The lock 1220 is shaped to define a locking threaded portion 1222. The housing 1202 of the annuloplasty structure 1210 is shaped to define an annuloplasty structure threaded portion 1232 configured to engage with the locking threaded portion 1222. To advance the lock 1220 within the recess 1230 of the housing 1202, the physician screws the lock 1220 within the housing 1202 using a delivery tool. The delivery tool may be the same as or generally similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, with like reference numbers referring to like parts. The delivery tool includes a contraction member disruption section that may include elements of tools 300, 600, 702, 810, and 920 described above with respect to the cutting elements.

[0439] When the lock 1220 is disposed within the recess, a distal surface of the distal end of the lock 1220 is configured to clamp a first portion of the contraction member 226 against the contraction member lumen wall 1205 to lock the contraction member 226 at least at a first clamping point 1212.

[0440] In some applications, the housing 1202 defines at least a portion of a sidewall of the annuloplasty structure 1210 , and the housing 1202 defines a recess 1230 .

[0441] The lock 1220 is shaped to define a lock lumen 1221 configured to surround the contraction member 226. The lock 1220 is shaped to define a longitudinal slit extending from a proximal surface of the lock 1220 toward a distal surface of the lock 1220. In some applications, the slit defines the lock lumen 1221 of the lock 1220. The slit allows the lock 1220 to push into the smaller recess 1230 and thereby be compressed. When the lock 1220 is compressed, the slit allows the lock 1220 to close around the contraction member 226, thereby locking the 1220 to the contraction member 226.

[0442] In some applications, the lock lumen 1221 has a consistent dimension (eg, diameter) along the length of the lock lumen 1221 from the proximal surface of the lock 1220 to the distal surface of the lock 1220.

[0443] 15A-C and 16. In some applications, the lock lumen 1221 of the lock 1220 is shaped to define a distal portion that is wider than a proximal portion of the lock lumen 1221. In such applications, the proximal-most section of the recess 1230 may be narrower than any other portion of the recess 1230 distal to the proximal-most portion.

[0444] 12A-C, 13A-C, 15A-C, and 16. In some applications, the slits in the lock 1220 are wider at a distal end portion of the lock 1220 and narrower at a proximal end portion of the lock 1220.

[0445] 14 and 16. In some applications, the slit in the lock 1220 is uniform along the length of the slit. In some applications, the lock lumen 1221 is uniform along the length of the lock 1220.

[0446] Reference is now made to FIG. 17, which is a schematic diagram of an exemplary system 1300 comprising an exemplary annuloplasty structure 1310 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) comprising a sleeve 26, a contraction member 226, and a lock 1320. The implantable annuloplasty structure 1310 comprises a main body portion. The contraction member 226 has a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 1310 and a second portion extending away from the main portion of the annuloplasty structure 1310. The contraction member 226 is configured to adjust a circumference of the annuloplasty structure 1310.

[0447] Except for the differences described below, the annuloplasty structure 1310 may be the same as or generally similar to the annuloplasty structures 222, 522, 730, and 910 described above with reference to Figures 1-15C, and like reference numbers refer to like parts. The annuloplasty structure 1310 may be a complete (or closed) or partial (or open) annuloplasty structure.

[0448] The structure 1310 comprises a housing 1302 shaped to define a sidewall and is shaped to define a recess 1330 having a recess axis. The recess 1330 extends from an opening in a first surface of the housing toward an opposite second surface of the housing 1302. The housing 1302 is shaped to provide a contraction member lumen wall 1305 disposed along a contraction member lumen 1304. The contraction member lumen 1304 is disposed at a non-zero angle relative to a recess axis 1307 of the recess 1330. The recess 1330 is shaped to define a recess lumen disposed along the recess axis 1307.

[0449] The lock 1320 is shaped to define a locking threaded portion 1222. The housing 1302 of the annuloplasty structure 1310 is shaped to define an annuloplasty structure threaded portion 1332 configured to engage with the locking threaded portion 1322. To advance the lock 1320 within the recess 1330 of the housing 1302, the physician screws the lock 1320 within the housing 1302 using a delivery tool. The delivery tool may be the same as or generally similar to tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, with like reference numbers referring to like parts. The delivery tool includes a contraction member disruption section that may include elements of tools 300, 600, 702, 810, and 920 described above with respect to the cutting elements.

[0450] When the lock 1320 is disposed within the recess, a distal surface of the distal end of the lock 1320 is configured to clamp a first portion of the contraction member 226 against the contraction member lumen wall 1305 to lock the contraction member 226 at least at a first clamping point 1312. The lock 1320 is shaped to define a lock lumen 1321 along its longitudinal length and a lock distal tapered portion 1334. The housing 1302 and the recess 1330 are shaped to define a recess distal tapered portion 1324. When the lock 1320 is positioned within the recess 1330 and the lock distal tapered portion 1334 is within the recess distal tapered portion 1324, the recess distal tapered portion 1324 is configured to compress the lock distal tapered portion 1334, and the lock distal tapered portion 1334 is configured to clamp a second portion of the contraction member 226 within the lock lumen 1321 at the recess distal tapered portion 1324 to lock the contraction member 226 at least at the second clamping point 1314.

[0451] In some applications, the housing 1302 defines at least a portion of a sidewall of the annuloplasty structure 1310 , and the housing 1302 defines a recess 1330 .

[0452] Lock lumen 1321 configured to surround contraction member 226. Lock 1320 is shaped to define a longitudinal slit extending from a proximal surface of lock 1320 toward a distal surface of lock 1320. In some applications, the slit defines lock lumen 1321 of lock 1320. The slit allows lock 1320 to push into smaller recess 1330 and thereby be compressed. When lock 1320 is compressed, the slit allows lock 1320 to close around contraction member 226, thereby locking 1320 to contraction member 226.

[0453] In some applications, the lock lumen 1321 has a consistent dimension (eg, diameter) along the length of the lock lumen 1321 from the proximal surface of the lock 1320 to the distal surface of the lock 1320.

[0454] 15A-C and 17. In some applications, the lock lumen 1321 of the lock 1320 is shaped to define a distal portion that is wider than a proximal portion of the lock lumen 1321. In such applications, the proximal-most section of the recess 1330 may be narrower than any other portion of the recess 1330 distal to the proximal-most portion.

[0455] 12A-C, 13A-C, 15A-C, and 17. In some applications, the slits in the lock 1320 are wider at a distal end portion of the lock 1320 and narrower at a proximal end portion of the lock 1320.

[0456] 14 and 17. In some applications, the slit in the lock 1320 is uniform along the length of the slit. In some applications, the lock lumen 1321 is uniform along the length of the lock 1320.

[0457] 16-17. Systems 1200 and 1300 provide a locking assembly that allows the practitioner to readjust the circumference of the annuloplasty structure after locking. For example, if the practitioner desires to readjust once locks 1220 and 1320 are in place, the practitioner can readjust the circumference of the annuloplasty structure by unscrewing each of locks 1220 and 1230 and providing slack or tightening contraction member 226 without disengaging locks 1220 and 1300 from their respective recesses 1230 and 1330. Following readjustment of contraction member 226, locks 1220 and 1320 are repositioned within their respective recesses 1230 and 1330.

[0458] Reference is now made to FIG. 18, which is a schematic diagram of one example of a system 1350 for constricting a patient's annulus 240 using an annuloplasty structure 522 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.), which may include a housing 530. The housing 530 may accommodate a constriction member fastener 1360. Except for the differences described below, the annuloplasty structure 522 may be the same as or generally similar to the annuloplasty structure 222 described above with reference to FIGS. 1-7E, and like reference numbers refer to like parts.

[0459] The annuloplasty structure or annuloplasty ring structure 522 can include a sleeve 26, which can define a main body portion of the structure 522. The structure 522 includes a contraction member 226 having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 522. The contraction member 226 also defines a second portion extending away from the main body portion of the annuloplasty structure 522.

[0460] The contraction member 226 can extend through the housing 530 and through a stop 570 (e.g., a holder) disposed within an opening in the contraction member fastener 1360. The stop 570 is shown as being cylindrical, by way of example and not limitation. An outer surface of the stop 570 maintains the fastener 1360 in an open state. The stop 570 is shaped to define a threaded portion that allows for connection of the contraction member intake tool 600 to the stop 570, as described above.

[0461] The annuloplasty structure or annuloplasty ring structure 522 is implanted as described above with reference to Figures 3A-I using the system described above with reference to Figures 1-3I.

[0462] The housing 530 may be coupled to the sleeve 26 of the structure 522 at any suitable location along the structure 522. For example, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a portion of the structure 522 near the left fibrous trigone of the valve, as shown. In some applications, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a portion of the structure 522 near the right fibrous trigone of the valve. In some applications, the housing 530 may be coupled to the sleeve 26 of the structure 522 at a middle portion of the structure 522. As shown, the housing 530 may be coupled to an outer surface of the sleeve 26. In such applications, the housing 530 does not block the lumen of the sleeve 26 of the structure 522.

[0463] Fastener 1360 is generally similar to fastener 360 of FIGS. 8A-D, except that fastener 1360 is shaped to define an intersecting slit 1362, which forms an opening through which contraction member 226 transitions into a general "X" or general "+" (plus) shape.

[0464] Figure 18 shows contraction member 226 being severed proximal to fastener 1360 and the excess portion of contraction member 226 being removed from the patient's body using tool 600. Severing of contraction member 226 may be performed in a manner as described above with reference to Figures 7A-E, mutatis mutandis.

[0465] Reference is now made to FIGS. 19A-B, which are schematic illustrations of one example of a system 1400 for constricting a patient's annulus using an annuloplasty structure (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.) that may be coupled to a housing 1430. The housing 1430 may accommodate a constriction member fastener 1460. In some applications, the annuloplasty structure may be the same as or generally similar to the annuloplasty structure 222 described above with reference to FIGS. 1-7E, with like reference numbers referring to like parts. In some applications, the annuloplasty structure comprises the housing 1430. In some applications, the housing 1430 is separate from the annuloplasty structure and may be delivered to and coupled to the annuloplasty structure only once the annuloplasty structure has been secured to the annulus.

[0466] The housing 1430 may be coupled to the annuloplasty structure sleeve 26 at any suitable location along the annuloplasty structure. For example, the housing 1430 may be coupled to the annuloplasty structure sleeve 26 at a portion of the annuloplasty structure near the left fibrous trigone of the valve, as shown. In some applications, the housing 1430 may be coupled to the annuloplasty structure sleeve 26 at a portion of the annuloplasty structure near the right fibrous trigone of the valve. In some applications, the housing 1430 may be coupled to the annuloplasty structure sleeve 26 at a middle portion of the annuloplasty structure. As shown, the housing 1430 may be coupled to an outer surface of the sleeve. In such applications, the housing 1430 does not block the lumen of the annuloplasty structure sleeve.

[0467] The annuloplasty structure or annuloplasty ring structure can include a sleeve that can define a main body portion of the structure. The structure includes a contraction member 226 having a first portion that extends along a longitudinal length of the main body portion of the annuloplasty structure. The contraction member also defines a second portion that extends away from the main body portion of the annuloplasty structure.

[0468] The fastener 1460 is shaped to define a generally rectangular planar clip comprising a superelastic material, such as Nitinol. The fastener 1460 comprises a deformable element shaped to define a number of slits surrounded by a number of flexible legs 1462 that allow the clip to transition between an inclined state (FIG. 19A) and a straight state (FIG. 19B). The contraction wire engaging surface of the clip is shaped to define a number of teeth 1464. In some applications, the teeth 1464 are jagged. In some applications, the top surface of the clip is flat without the teeth 1464. The teeth 1464 are configured to increase friction between the contraction member 226 and the fastener 1460.

[0469] The fastener 1460 comprises a clamping structure that is biased to (a) a closed state (FIG. 19B) in which the clamping structure is configured to clamp the contraction member 226 passing therethrough, and (b) can be bent to an open state (FIG. 19A) in which the contraction member 226 can move therethrough.

[0470] The contraction member 226 can extend through a channel 1434 in the housing 1430 and through a stop 1470 (e.g., a holder) disposed within an opening in the contraction member fastener 1460. The channel 1434 extends along the longitudinal axis 1410 of the housing 1430. The stop 1470 can be shaped to define a lumen through the interior for surrounding the contraction member 226, and is shown shaped to define a larger cylindrical section that is engageable by a tool, and a narrower cylindrical engagement portion 1472. The engagement portion 1472 can be shaped to fit snugly within the channel 1434 such that the engagement portion 1472 presses against the contraction wire engagement surface of the clip and maintains the fastener 1460 in the tilted state, i.e., in the unlocked state of the fastener 1460. In the tilted state shown in FIG. 19A, the clip is deformed and does not press against the contraction member 226. In the tilted state, the contraction member 226 is free to move relative to the fastener 1460, the housing 1430, and the stop 1470. The contraction member 226 is pulled until it sufficiently contracts the annuloplasty structure.

[0471] 19B, the stop 1470 has been disengaged and removed from the housing 1430. In the absence of force applied by the engagement portion 1472 to the contraction wire engaging surface of the clip, the clip returns to its resting, straight state, capturing the contraction member 226 between the contraction wire engaging surface of the clip and a surface 1432, e.g., an inner wall, of the housing 1430. Thus, the fastener 1460 is now in a locked state in which the clip locks and crimps the contraction member 226.

[0472] Reference is now made to Figures 20A-F, which are schematic illustrations of one example of a portion of a multi-component tubing system 1500 including a constriction member disruption tool 1502 and a constriction member introduction tool 1600, described below with reference to Figures 21A-26B. The constriction member 226 is threaded and passed through the constriction member disruption tool 1502 and the constriction member introduction tool 1600. The constriction member 226 may be engaged by the tool 1502 using a snare, as described above with respect to the snare 350 with reference to Figures 4A-5D. The tool 1502 may be advanced along the constriction member 226 toward the annuloplasty structure 1522 (e.g., annuloplasty ring structure, closed annuloplasty ring structure, closed annuloplasty ring structure, open annuloplasty ring structure, partial annuloplasty ring structure, etc.). In some applications, the tool 1502 advances toward the housing 1530 already coupled to the structure 1522 in a manner similar to the tool 300 advancing along the contraction member 226, as described above with reference to Figures 4A-5D. The annuloplasty structure 1522 can comprise a flexible main body portion. The contraction member 226 has a first portion extending along a longitudinal length of the main body portion. A second portion of the contraction member 226 can extend away from the main body portion of the annuloplasty structure 1522 and outside the patient's body.

[0473] The system 1500 is used to constrict a patient's annulus using an annuloplasty structure 1522 (e.g., an annuloplasty ring structure, a closed annuloplasty ring structure, a closed annuloplasty ring structure, an open annuloplasty ring structure, a partial annuloplasty ring structure, etc.), which may include a housing 1530. The housing 1530 may house a constriction member fastener 1560. Except for differences described below, the annuloplasty structure 1522 may be the same as or generally similar to the annuloplasty structure 222 described above with reference to Figures 1-7E, and like reference numbers refer to like parts.

[0474] Fastener 1560 may include fastener 360 described above with reference to Figures 4A-B, 7A-E, 8A-D, 9A-D, 10A-B, and 11A-C, lock 950 described above with reference to Figures 12A-C, lock 1950 described above with reference to Figures 12A-C, lock 1110 described above with reference to Figure 14, lock 1490 described above with reference to Figures 15A-C, lock 1220 described above with reference to Figure 16, lock 1320 described above with reference to Figure 17, or any other fastener, lock, and / or crimp known in the art.

[0475] The annuloplasty structure or annuloplasty ring structure 1522 can include a sleeve 26, which can define a main body portion of the structure 1522. The structure 1522 includes a contraction member 226 having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure 1522. The contraction member 226 also defines a second portion extending away from the main body portion of the annuloplasty structure 1522.

[0476] The contraction member 226 can extend through the housing 1530 and through a stop 1570 (e.g., a holder) disposed within an opening in the contraction member fastener 1560. The stop 1570 is shown as being shaped to define a lumen through the interior for surrounding the contraction member 226, a larger cylindrical section engageable by a tool, and a narrower cylindrical engagement portion 1574. The exterior surface of the engagement portion 1574 maintains the fastener 1560 in an open state, as shown in FIGS. 20A-D. The stop 1570 is shaped to define a protrusion 1572 that allows for coupling of a contraction member severing tool 1502 to the stop 1570, as described below.

[0477] The annuloplasty structure or annuloplasty ring structure 1522 is implanted as described above with reference to Figures 3A-I using the system described above with reference to Figures 1-3I.

[0478] The housing 1530 may be coupled to the sleeve 26 of the structure 1522 at any suitable location along the structure 1522. For example, the housing 1530 may be coupled to the sleeve 26 of the structure 1522 at a portion of the structure 1522 near the left fibrous trigone of the valve, as shown. In some applications, the housing 1530 may be coupled to the sleeve 26 of the structure 1522 at a portion of the structure 1522 near the right fibrous trigone of the valve. In some applications, the housing 1530 may be coupled to the sleeve 26 of the structure 1522 at a middle portion of the structure 1522. As shown, the housing 1530 may be coupled to an outer surface of the sleeve 26. In such applications, the housing 1530 does not block the lumen of the sleeve 26 of the structure 1522.

[0479] 20A shows a contraction member severing tool 1502 with the contraction member 226 threaded therethrough. The contraction member 226 may be engaged by the tool 1502 using a snare, as described above with respect to the snare 350 with reference to FIGS. 4A-5D. The tool 1502 may be advanced along the contraction member 226 toward the housing 1530 of the structure 1522 in a manner similar to the tool 300 advancing along the contraction member 226, as described above with reference to FIGS. 4A-5D.

[0480] Once the tool 1502 is threaded along the contraction member 226, the contraction member 226 extends from the sleeve 26 through the engagement portion 1574, the proximal portion of the stop 1570, the cutting elements 1510 and 1520 of the tool 1502, and the remaining proximal portion of the tool 1502. Thus, the contraction member 226 is disposed near the cutting elements. The contraction member 226 is disposed along the entire length of the tool 1502 and along the longitudinal axis 1511 of the tool 1502. The relative spatial orientation of the components of the tool 1502 allows the contraction member 226 to pass straight and directly through the lumen of the tool 1502 and along the axis 1511 without taking a tortuous path through the tool 1502. This direct and untortuous path of the member 226 through the tool 1502 reduces friction of the member 226 as it moves within the tool 1502. This direct path of contraction member 226 is made possible by the orientation of the components of tool 1502, as opposed to the tortuous path member 226 through tools 300, 600, 810, and 920 described above. The reduced friction on contraction member 226 reduces noise in measuring the tension of contraction member 226, as described below with reference to FIGS.

[0481] The tool 1502 comprises an inner tube 1504 that is slidable relative to an outer sleeve portion 1508. The distal end of the inner tube 1504 is shaped to define a gripper 1505 or fastener ejector. The distal end portion of the tube 1504 is grooved and the gripper 1505 is angled so that the gripper 1505 tends to be pushed radially outward in the absence of a force applied thereto by the protrusions 1572. Once the tube 1504 is pushed distally enough, the gripper 1505 passes distally around the protrusions 1572 and closes around the stop 1570 at a location distal to the protrusions 1572, as shown in FIG. 20B. The gripper 1505 provides a primary and initial connection and locking of the tool 1502 to the housing 1530 by gripping the protrusions 1572.

[0482] The tool 1502 comprises a static cutting element 1510 and a movable dynamic cutting element 1520. The static cutting element 1510 is shaped to define a concave cutting surface 1512 (i.e., a sharp edge), and the dynamic cutting element 1520 is shaped to define a concave cutting surface 1521 (i.e., a sharp edge) opposite the concave cutting surface 1512 of the static cutting element 1510. As described below, the dynamic cutting element 1520 slides proximally and diagonally relative to the static cutting element 1510 along the concave cutting surface 1512 of the static cutting element 1510.

[0483] Once the stop 1570 is engaged by the inner tube 1504, the outer sleeve portion 1508 moves distally along the inner tube 1504 and toward the housing 1530 until a distal end of the outer sleeve portion 1508 contacts a proximal end of the housing 1530, as shown in FIG. 20C. Such distal movement of portion 1508 locks the tube 1504 in place relative to the stop 1570, thereby locking the tool 1502 in place relative to the housing 1530. Because the gripper 1505 is angled, it is able to slide proximally around the protrusion 1572 in response to a proximal pull on the tool 1502. Thus, encasing the grooved distal end portion of tube 1504 and the gripper 1505 around tube 1504 with outer sleeve portion 1508 prevents radial movement of the gripper 1505 to lock the contraction member 226 in place and hold the annuloplasty structure 1522 in tension in response to application of a proximal pulling force to stop 1570 by tool 1502 during release of fastener 1560, as described below. The outer sleeve portion 1508 thus locks the gripper 1505 against projection 1572 and provides a secondary connection and locking of the tool 1502 to the housing 1530.

[0484] The static cutting element 1510 comprises a pin 1513 that slides proximally and distally within a slit 1515 in the tube 1404. The static cutting element 1510 is thus coupled to the tube 1404 and the tube surrounding the tube 1404. That is, the pin 1513 is coupled to the outer sleeve portion 1508. When the outer sleeve portion 1508 moves distally as shown in FIG. 20C, the pin 1513 moves distally within the slit 151 and the static cutting element 1510 and the dynamic cutting element 1520 are pushed distally within the tube 1404. In this state, the distal surface 1523 of the dynamic cutting element 1520 is still positioned some distance away from the proximal surface 1571 of the stop 1570.

[0485] 20D shows contraction of the annuloplasty structure 1522 in response to proximal pulling of the contraction member 226 by the tool 1502. During pulling of the contraction member 226, the tool 1502 remains coupled to the housing 1530 by the outer sleeve portion 1508 surrounding a distal portion of the inner tube 1504 and surrounding the grasper 1505, which in turn grasps the protrusion 1572.

[0486] The tool 1502 can include the contraction member capture device 322 of the tool 300, as described above with reference to FIGS. 4A-B. The contraction member capture device can be used to contract the contraction member 226. Once the contraction member 226 contracts and the structure 1522 contracts, as shown in FIG. 20D, the tool 1502 removes the stop 1570 by pulling it proximally away from the fastener 1560, as shown in FIG. 20E. While maintaining a distal force on the outer sleeve portion 1508, the tube 1404 is pulled proximally relative to the portion 1508. Pulling the tube 1504 pulls the stop 1570 proximally as the gripper 1505 continues to grip the protrusion 1572 of the stop 1570 due to the presence of the outer sleeve portion 1508. While pulling tube 1504 proximally, outer sleeve portion 1508 prevents radial outward movement of gripper 1505 as a proximal force is applied to tube 1504. Tube 1504 is pulled proximally until stop 1570 disengages from housing 1530, i.e., until engagement portion 1574 of stop 1570 separates and disengages from fastener 1560, as shown in FIG. 20E. As fastener 1560 tends to close, in the absence of stop 1570, fastener 1560 would close and squeeze around contraction member 226 passing through fastener 1560. In such a way, structure 1522 is locked by fastener 1560 and the contracted state of structure 1522 is maintained.

[0487] As the stop 1570 is pulled proximally, the proximal surface of the stop 1570 is driven into the distal surface 1523 of the dynamic cutting element 1520. In response to pushing the stop 1570 against the dynamic cutting element 1520, the dynamic cutting element 1520 is pushed proximally, which causes the dynamic cutting element 1520 to move diagonally proximally. The cutting surface 1521 of the dynamic cutting element 1520 and the cutting element 1520 slide diagonally proximally along the cutting surface 1512 of the static cutting element 1510. The portion of the contraction member 226 disposed between the cutting surfaces 1512 and 1521 is severed. Because the cutting surfaces 1512 and 1521 are concave and face each other, the surfaces 1512 and 1521 compress the contraction member 226 during cutting, which causes the contraction member 226 to be severed cleanly and without fraying.

[0488] Thus, tool 1502 is advantageously positioned to provide a safety mechanism in that contraction member 226 can only be severed by a proximal force applied thereto by stop 1570 after fastener 1560 has been transitioned to a fastening or locked state or has otherwise locked contraction member 226 in place. That is, tool 1502 cannot inadvertently severe contraction member 226 all the while tool 1502 is not coupled to stop 1570 and stop 1570 is not pushing against cutting element 1520. In one swift motion, tool 1502 (1) locks contraction member 226 in place by transitioning fastener 1560 to a locked state and (2) severs contraction member 226.

[0489] 20F shows the retraction member 226 after it has been severed proximally of the fastener 1560, and the excess portion of the retraction member 226 removed from the patient's body using the tool 1502. The entire tool 1502 is pulled proximally to separate the tool 1502 from the housing 1530 and the structure 1522, carrying the stop 1570 within the lumen of the tool 1502. Because the stop 1570 is no longer coupled to the housing 1530, a simple proximal pull on the tool 1502 is sufficient to separate the tool 1502 from the annuloplasty structure 1522.

[0490] 20A-F. It should be noted that while the tool 1502 is described as being advanceable towards a housing 1530 already coupled to an annuloplasty structure 1522, the scope of the present specification includes a tool 1502 coupled to the housing 1530 from a site outside the patient's body and configured to deliver the housing 1530 along the contraction member 226 of a structure 1522 already implanted in the annulus. In such applications, the housing 1530 is configured to be positionable relative to a main body portion of the structure 1522.

[0491] Reference is now made to Figures 21A-26B, which are schematic illustrations of another portion of the multi-component pipe system 1500 described above with reference to Figures 20A-F, including a contraction member intake tool 1600 configured to contract the flexible elongate contraction member 226, according to some applications. Figures 21A-B show the contraction member intake tool 1600 prior to insertion of the flexible elongate contraction member 226, and Figures 22A-26B show the contraction member intake tool 1600 after insertion of the flexible elongate contraction member 226.

[0492] The multi-component conduit system 1500 is used with an implant that includes an implantable structure and a flexible elongate contractile member 226 that extends away from the implantable structure. The implant may include any of the implants described herein, such as, for example, the implantable annuloplasty structure 222, which may include a flexible sleeve 26. Alternatively, the implant may include another implant known in the art, including those described in the patents and published patent applications incorporated by reference below, which may or may not include a sleeve.

[0493] The contraction member introduction tool 1600 comprises a handle portion 1620, which may optionally be supported by a stand as described above with reference to Figures 1-2. The handle portion 1620 may comprise one, some, or all of the following: ● An outer housing 1632, which may be ergonomically shaped to be held by a user (e.g., a physician, medical professional, etc.); A tubular shaft 1634 disposed at least partially within the outer housing 1632; an inner shaft 1636, (a) partially disposed within a proximal longitudinal portion 1637 of the tubular shaft 1634 such that the inner shaft 1636 is axially slidable relative to the tubular shaft 1634, and (b) shaped to define an inner shaft contraction member receiving channel 1638; a distal force applicator 1642 that is (a) at least partially disposed within a distal longitudinal portion of the tubular shaft 1634, and (b) shaped to define a distal force applicator contraction member receiving channel 1644 that permits sliding movement of the contraction member 226 therethrough; a spring 1646 disposed within the tubular shaft 1634 and connecting the distal force applicator 1642 to a distal portion 1647 of the inner shaft 1636; and • A deflation enhancer knob 1630 that is accessible from outside the outer housing 1632.

[0494] The handle portion 1620 is shaped to define a handle contraction member receiving channel 1650 from the distal end to the proximal end of the handle portion 1620 (as used in this application, including the claims, "proximal" means toward the user, i.e., away from the implant. With reference to FIGS. 21A-26B, "proximal" means to the right in the drawings). The handle contraction member receiving channel 1650 includes the inner shaft contraction member receiving channel 1638, the distal force applicator contraction member receiving channel 1644, and optionally additional contraction member receiving channels in the handle portion 1620. A portion of the contraction member 226 is threaded through the handle contraction member receiving channel 1650 either before or after the implantable structure and the contraction member 226 are advanced toward the patient's heart.

[0495] The inner shaft 1636 can include a lock 1640 configured to (i) allow sliding of the contraction member 226 relative to the inner shaft contraction member receiving channel 1638 when in an unlocked state, and (ii) axially lock the contraction member 226 relative to the inner shaft 1636 when in a locked state. Optionally, the lock 1640 applies friction to axially lock the contraction member 226 relative to the inner shaft 1636, such as using a set screw or lever, as known in the art.

[0496] The handle portion 1620 is configured such that actuation of the retraction enhance knob 1630 when the retraction member 226 is disposed completely through the handle retraction member receiving channel 1650 and the lock 1640 is in a locked state causes the handle portion 1620 to incorporate successive portions of the retraction member 226. Figures 22A-B show the handle portion 1620 prior to actuation of the retraction enhance knob 1630 when the retraction member 226 is disposed completely through the handle retraction member receiving channel 1650 and the lock 1640 is in a locked state. Figures 23A-B, 24A-B, and 25A-B show the handle portion 1620 after successive levels of actuation of the retraction enhance knob 1630, as described below.

[0497] As shown in FIGS. 21A-B and 22A-B, prior to initial actuation of the contraction enhance knob 1630, the portion of the contraction member 226 between the handle portion 1620 and the implant may be somewhat slack or at most minimally tense. The proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are positioned with an initial offset distance D1 therebetween, indicating that there is substantially no tension in the contraction member 226, i.e., the contraction member 226 is not tense. In applications where the implant includes an implantable annuloplasty structure 222 including a flexible sleeve 26, the sleeve 26 (coupled to the annulus 240) is in a relaxed, non-tensioned state. At this point, the tool has been advanced sufficiently through the patient's vasculature such that the distal tip of the tool is proximate to the structure 222 positioned along the annulus.

[0498] As shown, for example, in the transition between FIGS. 22A-B and 23A-B, actuation of the deflation enhance knob 1630 Proximally advancing the tubular shaft 1634 relative to the outer housing 1632; This advances the distal force applicator 1642 proximally relative to the outer housing 1632 (the distal force applicator 1642 may be axially secured to the tubular shaft 1634 during normal use of the handle portion 1620), This exerts a proximal force on spring 1646, Pushing the inner shaft 1636 proximally against the outer housing 1632 (by the spring 1646 exerting a proximal force on the inner shaft 1636); This causes the handle portion 1620 to capture a continuous portion of the retraction member 226 (which is axially locked to the inner shaft 1636 by the lock 1640, as described above) by pulling the retraction member 226 proximally.

[0499] 22A-B and 23A-B, the contraction member 226 is relatively slack, as discussed above, such that the inner shaft 1636 offers no, or relatively little, resistance to the proximal force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 is not axially compressed, or is only minimally axially compressed. As a result, as the tubular shaft 1634 advances proximally relative to the outer housing 1632, the inner shaft 1636 advances proximally relative to the outer housing 1632 to the same or approximately the same extent, and the offset distance remains at its initial value (D1), indicating that there is still substantially no tension in the contraction member 226. This initial proximal advancement of the tubular shaft 1634 and the inner shaft 1636 relative to the outer housing 1632 helps to accommodate different initial slack levels in the contraction member 226 .

[0500] At a certain distance of proximal advancement of the distal force applicator 1642 relative to the outer housing 1632, the contraction member 226 becomes taut (at an initial low tension level), which causes the inner shaft 1636 to gradually provide increasing resistance to the proximal force applied to the inner shaft 1636 by the spring 1646, causing the spring 1646 to become gradually more compressed. As used in this application, including the claims, the contraction member 226 is considered to be "taut" even when it is taut at a low tension level.

[0501] 23A-B and 24A-B, as the spring 1646 becomes more compressed, the distal force applicator 1642 moves axially closer to the inner shaft 1636, which causes the tubular shaft 1634 to move proximally relative to the inner shaft 1636. As a result, the spring 1646 pushes the inner shaft 1636 proximally relative to the outer housing 1632 to a lesser extent than the tubular shaft 1634 advances proximally relative to the outer housing 1632, and the proximal pulling of the contraction member 226 by the inner shaft 1636 increases the tension in the contraction member 226. Thus, the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 decreases to a tensioned offset distance D2, as shown in FIGS. 24A-B. (In actual use of the handle, many tensioned offset distances D2 will result. A single offset is shown for illustrative purposes.) The tensioned offset distance D2 is smaller than the initial offset distance D1, reflecting the fact that the portion of the inner shaft 1636 that protrudes from the proximal end 1652 of the tubular shaft 1634 has been reduced.

[0502] The deflation enhancer knob 1630 can have any shape that allows for its actuation, and is not necessarily circular, tubular, or generally cylindrical. For example, in some applications, the deflation enhancer knob 1630 is configured to be actuated by its rotation, for example, about a central longitudinal axis of the tubular shaft 1634 as shown in the drawings. Optionally, in some applications, the deflation enhancer knob 1630 is configured to be actuated by its axial sliding relative to the outer housing 1632 (configuration not shown). The deflation enhancer knob 1630 may be non-electrical, i.e., entirely mechanical, or may optionally include electrical components, including, for example, circuitry.

[0503] In some applications, the tubular shaft 1634 and the retraction enhance knob 1630 are threadedly connected to one another and the handle portion 1620 is configured such that actuation of the retraction enhance knob 1630 rotates the tubular shaft 1634, thereby advancing the tubular shaft 1634 proximally relative to the outer housing 1632. In some of these applications, the retraction enhance knob 1630 is configured to be actuated by rotation thereof, for example, about a central longitudinal axis of the tubular shaft 1634 as shown in the figures.

[0504] For some applications, the handle portion 1620 further comprises an inner stabilizing tube 1680 that (a) extends proximally from and is axially secured to the distal force applicator 1642, and (b) defines a portion of the handle contraction member receiving channel 1650 therethrough. A portion of the inner stabilizing tube 1680 is disposed within the inner shaft contraction member receiving channel 1638, the length of which portion varies with the distance between the distal force applicator 1642 and the inner shaft 1636. A spring 1646 surrounds a portion of the inner stabilizing tube 1680 and may be configured to move freely axially relative to an outer surface of the inner stabilizing tube 1680.

[0505] In some applications, the inner shaft 1636 protrudes partially out of the proximal end 1639 of the outer housing 1632 such that a portion of the inner shaft 1636 is visible to the user. In these applications, the tubular shaft 1634 and the inner shaft 1636 together provide a non-electromechanical force gauge 1624, and the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 (i.e., the offset distance D between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636) provides a visual indication of a measure of tension in the contraction member 226. The tubular shaft 1634 may also protrude out of the proximal end 1639 of the outer housing 1632, at least after it begins to advance proximally. In these applications, the inner shaft 1636 may be marked with a number of fiducial markers 1626 disposed along the inner shaft 1636 to indicate the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636. For example, fiducial marker 1626 may provide a zero or near-zero reading after proximal end 1652 of tubular shaft 1634 and proximal end 1654 of inner shaft 1636 are positioned with an initial offset distance D1 therebetween, as shown in FIGS. 22A-B. (The force applied to spring 1646 at any given compression level of the spring is equal to the tension in contraction member 226.)

[0506] It should be noted that the force gauge 1624 does not measure the length of the contraction member 226 that the handle portion 1620 takes up. (This take-up length is equal to the distance the inner shaft 1636 moves proximally.) As noted above, the initial portion of the take-up length is sometimes due to the proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally generally parallel to the inner shaft 1636 before the contraction member 226 goes taut. During this any initial movement, the tension in the contraction member 226 does not increase substantially as the handle portion 1620 takes up the contraction member 226.

[0507] More generally, the inner shaft 1636 may be considered to be the axially movable portion of the force gauge 1624. The axially movable portion of the force gauge 1624 is axially movable relative to the outer housing 1632 (and often relative to one or more other portions of the force gauge 1624 (which may or may not themselves be axially movable relative to the outer housing 1632).

[0508] In some applications, the inner shaft 1636 does not protrude outside the proximal end 1639 of the outer housing 1632, in which case the handle portion 1620 does not provide a non-electromechanical force gauge 1624. Nevertheless, the handle portion 1620 may still be fully useful for adjusting the tension in the contraction member 226, such as in a configuration in which the handle portion 1620 further comprises a tension limiting lock assembly 1658 to limit the maximum tension that the inner shaft 1636 can apply to the contraction member 226, as described below.

[0509] 24A-B and 25A-B. Also see FIGS. 26A-B, which are schematic diagrams of a portion of the outer housing 1632 and the tubular shaft 1634, according to some applications. For clarity of illustration, the inner shaft 1636 is not shown. In some applications, the handle portion 1620 further comprises a tension limit lock assembly 1658 configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the handle portion 1620 increases the tension in the contraction member 226 to a predetermined threshold level, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226. The tension limit lock assembly 1658 is configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226. The tension limit lock assembly 1658 can also be configured to axially lock the tubular shaft 1634 relative to the outer housing 1632 when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636 .

[0510] In some applications, the tension limiting locking assembly 1658 includes a detent 1660 positioned to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636, thereby limiting the maximum tension that the inner shaft 1636 can apply to the contraction member 226, as shown in Figures 25A-B.

[0511] 24A-B and 25A-B, as the spring 1646 becomes more compressed, the distal force applicator 1642 moves axially closer to the inner shaft 1636, which causes the tubular shaft 1634 to move proximally relative to the inner shaft 1636. As a result, the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 decreases to a maximum tensioned offset distance D3 (which may, optionally, be zero or close to zero, as shown), which is less than the tensioned offset distance D2 and equal to the above-mentioned predetermined relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636. Often, but not necessarily, a relatively small portion of the inner shaft 1636 still protrudes from the proximal end 1652 of the tubular shaft 1634, particularly in configurations in which the handle portion 1620 provides a non-electromechanical force gauge 1624, as described above.

[0512] In applications in which the implant comprises an implantable annuloplasty structure 222 comprising a flexible sleeve 26, the sleeve 26 of the annuloplasty structure 222 coupled to the annulus 240 may be in a relaxed, untensioned state.

[0513] The tension limit lock assembly 1658 optionally eliminates the need for the non-electromechanical force gauge 1624 described above. Additionally, in applications in which a force gauge 1624 is provided, the tension limit lock assembly 1658 eliminates the need for a user to repeatedly check the readings of the force gauge 1624, thereby allowing the user to focus their attention on other aspects of the procedure, such as fluoroscopic imaging. In many cases, the predetermined relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 has the effect of setting a predetermined maximum tension that may be applied to the contraction member 226 using the contraction member capture tool 1600.

[0514] It should be noted that the tension limit lock assembly 1658 often does not axially lock the inner shaft 1636 in direct response to the length of the contraction member 226 that the handle portion 1620 captures. (This capture length is equal to the distance the inner shaft 1636 moves proximally.) Additionally, the tension limit lock assembly 1658 often does not axially lock the inner shaft 1636 in direct response to relative axial movement between the inner shaft 1636 and the outer housing 1632, or in direct response to relative axial movement between the tubular shaft 1634 and the outer housing 1632. As discussed above, the initial portion of the capture length sometimes results from proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally generally parallel to the inner shaft 1636 before the contraction member 226 becomes taut. The tension limit lock assembly 1658 is often configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636, such that the tension limit lock assembly 1658 is not affected or induced by any movement of the inner shaft 1636 and the tubular shaft 1634 in parallel with each other.

[0515] In some applications, the detents 1660 are fixedly axially coupled to the inner shaft 1636 and are configured to move radially outwardly to engage the outer housing 1632 to axially lock the inner shaft 1636 relative to the outer housing 1632, as shown in FIGS. 24A-B. For example, a detent spring 1684 may be provided that applies a radially outward force to the detents 1660. The handle portion 1620 is configured such that elements of the handle portion 1620 prevent radially outward movement of the detents 1660, for example, as described below, when the tubular shaft 1634 is not disposed in a predetermined relative axial position with respect to the inner shaft 1636, as shown in FIGS. 22A-23B. As used in this application, including the claims, "radially outward" means in a direction further away from a central longitudinal axis of the outer housing 1632, and "radially inward" means in the opposite direction closer to the central longitudinal axis.

[0516] For some applications, the tension limit lock assembly 1658 further comprises a plurality of recesses 1662 that the outer housing 1632 is shaped to define. The detents 1660 are engageable with the recesses 1662 to axially lock the inner shaft 1636 relative to the outer housing 1632. The handle portion 1620 is positioned such that when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636, the particular one of the recesses 1662 that the detents 1660 engage depends on the relative axial position of the inner shaft 1636 with respect to the outer housing 1632. In this arrangement, although the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636, in which the detent 1660 axially locks the inner shaft 1636 with respect to the outer housing 1632, is predetermined, the relative positions of the tubular shaft 1634 and the inner shaft 1636 with respect to the outer housing 1632 can be varied to accommodate different initial slack levels in the contraction member 226.

[0517] In some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 is shaped to define an elongated opening 1664 through which the detent 1660 passes when the detent 1660 axially locks the inner shaft 1636 relative to the outer housing 1632. In some applications, the tubular shaft 1634 extends along a longitudinal portion of the elongated opening 1664, when the tubular shaft 1634 is distally disposed at a predetermined relative axial position with respect to the inner shaft 1636, the detents 1660 are prevented from axially locking the inner shaft 1636 relative to the outer housing 1632 (by blocking radially outward movement of the detents 1660); and ● Provided with one or more tracks 1666 arranged to enable the detents 1660 to axially lock the inner shaft 1636 (by allowing radial outward movement of the detents 1660) when the tubular shaft 1634 is positioned at a predetermined relative axial position with respect to the inner shaft 1636.

[0518] A portion of the one or more tracks 1666 that prevents the detent 1660 from axially locking the inner shaft 1636 relative to the outer housing 1632 may be positioned radially inward of a portion of the one or more tracks 1666 that allows the detent 1660 to axially lock the inner shaft 1636.

[0519] In some of these applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 includes one or more detent supports 1688 that are secured to the detents 1660 and configured to slide axially along one or more tracks 1666. When the tubular shaft 1634 is disposed distally at a predetermined relative axial position, the one or more tracks 1666 prevent radially outward movement of the one or more detent supports 1688, thereby preventing radially outward movement of the detents 1660. In some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 includes one or more detent posts 1690 that stabilize the one or more detent supports 1688 during radial movement thereof, and the one or more detent supports 1688 can slide radially relative to the one or more detent posts 1690.

[0520] In some of these applications, the one or more tracks 1666 are shaped to define one or more respective angled portions 1668. After the detents 1660 axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed in a predetermined relative axial position with respect to the inner shaft 1636, subsequent distal movement of the tubular shaft 1634 and corresponding distal movement of the one or more tracks 1666 relative to the inner shaft 1636 disengages the detents 1660 from the outer housing 1632. For example, this disengagement may occur by the one or more angled portions 1668 sliding the one or more detent supports 1688 radially inward and over a portion of the one or more radially inwardly disposed tracks 1665. Distal movement of the tubular shaft 1634 may occur by actuation of the retraction enhance knob 1630 in a direction opposite to the actuation for the proximal movement described above. This allows the user to reduce the tension in the contraction member 226 as needed during the procedure, even if the tension level is high enough to trigger the tension limit lock of the detent 1660. Of course, the user can also reduce the tension in the contraction member 226 prior to the tension limit lock of the detent 1660, as needed.

[0521] In some applications, once a desired tension level in the contraction member 226 is achieved (by monitoring the force gauge 1624, by detents 1660 limiting the maximum tension, and / or by monitoring the degree of valvular regurgitation, e.g., under echocardiographic and / or fluoroscopic guidance), the contraction member capture tool 1600 locks the contraction member 226 to maintain the degree of tension in the contraction member 226 and maintain the contraction member 226 (and optionally, structure 222, if provided) in the contracted state.

[0522] In some applications, perhaps best seen in the blown-up view of FIG. 25B, the detents 1660 and / or recesses 1662 are angled slightly (e.g., 1-45 degrees, e.g., 1-30 degrees, e.g., 1-15, e.g., about 5 degrees) relative to a direction perpendicular to a central longitudinal axis of the handle portion 1620, such that the detents 1660 face slightly proximally and / or the openings of the recesses 1662 face slightly distally. This angling facilitates capture and engagement of the detents with the recesses 1662, as the detents 1660 move proximally just prior to engaging one of the recesses 1662, and may also facilitate disengagement, if desired, as described above. Alternatively, the detents 1660 and / or recesses 1662 are not angled and are perpendicular to a central longitudinal axis of the handle portion 1620.

[0523] Referring again to FIGS. 21A-B, in some applications, the spring 1646 is preloaded when the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are disposed at an initial offset distance D1 therebetween. Often, the handle portion 1620 is configured to maintain this preload prior to use of the handle portion 1620 by preventing proximal advancement of the inner shaft 1636 relative to the tubular shaft 1634 beyond a predetermined maximum distance. For example, the proximal end of the elongated opening 1664 (e.g., as shown in FIG. 22B) may block advancement of an element of the tension limit lock assembly 1658 (e.g., one or more of the detent posts 1690 or a proximal portion of one or more detent supports 1688, displayed in FIG. 26A). Setting the preload is described immediately below.

[0524] Referring again to FIG. 21B, in some applications, a radially inwardly facing surface of the tubular shaft 1634 near its distal end is shaped to define a thread 1682, and a radially outwardly facing surface of the distal force applicator 1642 is shaped to define a corresponding thread 1686. The thread allows for adjustment of the precise axial position of the distal force applicator 1642 relative to the tubular shaft 1634 during a calibration procedure during manufacture of the handle portion 1620 by rotating the distal force applicator 1642 relative to the tubular shaft 1634. For example, this rotation may be easily performed prior to insertion of the tubular shaft 1634, inner shaft 1636, distal force applicator 1642, spring 1646, and other elements secured to the inner shaft 1636 into the outer housing 1632. As discussed above, during use of handle portion 1620 during a medical procedure, distal force applicator 1642 is rotationally fixed, and thus axially fixed, relative to tubular shaft 1634.

[0525] In some applications, adjustment of the axial position of the distal force applicator 1642 relative to the tubular shaft 1634 during a calibration procedure adjusts the preload of the spring 1646 (by compressing the spring) to set a desired maximum tension level that the inner shaft 1636 can apply to the contraction member 226. For example, a distal force may be applied to the proximal end 1654 of the inner shaft 1636 until the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 is reduced to a maximum tension offset distance D3 (at which the tension limit locking assembly 1658 is triggered during subsequent use). This applied distal force can be measured with a force gauge, and the axial position of the distal force applicator 1642 relative to the tubular shaft 1634 can be adjusted until the applied distal force equals the desired maximum tension level that the inner shaft 1636 can apply to the contraction member 226 before the tension limit lock assembly 1658 is triggered during subsequent use. Upon removal of this calibration distal force, the spring 1646 will extend until further advancement of the inner shaft 1636 is blocked, as described above, and the spring 1646 has a desired preload level.

[0526] Referring again to Figures 1-26B, the systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods for repairing a dilated valve annulus of a patient can be used to treat a patient's heart valves, such as the aortic valve, the pulmonary valve, the mitral valve, and the tricuspid valve. Additionally, the systems described herein for treating valves can be used to treat other annular muscles within a patient's body. For example, the systems described herein can be used to treat sphincters within a patient's stomach.

[0527] 1-26B, the systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 may be anchored to tissue of the annulus using any of the anchoring devices described in U.S. Patent Application Publication No. 2015 / 0272734 to Sheps et al., including anchor drivers and deployment manipulators.

[0528] 1-26B, the systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods described above may be used on any suitable tissue of a patient, such as stomach tissue, urinary tract, and prostate tissue.

[0529] Reference is now made to Figures 1-26B. The tools described herein may be used to deploy, anchor, and adjust the circumference of any annuloplasty structure, for example, a complete (or closed) annuloplasty structure or a partial (or open) annuloplasty structure. Any of the tools described herein may be coupled to the annuloplasty structure using any of the couplings described herein with reference to Figures 7A-26B. For example, any of the annuloplasty structures described herein may include a housing 930 having a female coupling 927, and the tools described herein may include a male coupling 925 tool as described above with reference to Figures 12, 13, and 15. The annuloplasty structures described herein may include elements and structures described in PCT Publication No. WO 10 / 073246 to Cabiri et al., which is incorporated herein by reference.

[0530] Additionally, one or more of the applications described below may be used in conjunction with various embodiments of the present disclosure. U.S. patent application Ser. No. 12 / 435,291, entitled “Adjustable repair chords and spool mechanism therefor,” filed May 4, 2009 by Maisano et al. (issued as U.S. Patent No. 8,147,542); No. 12 / 437,103, filed May 7, 2009, by Zipory et al., entitled “Annuloplasty ring with intra-ring anchoring” (issued as U.S. Patent No. 8,715,342); U.S. patent application Ser. No. 12 / 548,991, filed Aug. 27, 2009, entitled “Implantation of repair chords in the heart,” by Maisano et al. (issued as U.S. Patent No. 8,808,368); PCT Patent Application No. PCT / IL2009 / 001209, entitled “Adjustable annuloplasty devices and mechanisms therefor,” filed on December 22, 2009, to Cabiri et al. (published as PCT Publication No. WO 10 / 073246); ● PCT Patent Application No. PCT / IL2010 / 000357, entitled “Implantation of repair chords in the heart,” filed May 4, 2010 by Maisano et al. (published as WO 10 / 128502); Zipory et al., PCT Patent Application No. PCT / IL2010 / 000358, entitled “Deployment techniques for annuloplasty ring and over-wire rotation tool,” filed May 4, 2010 (published as WO 10 / 128503); US Patent Application Publication No. 2014 / 0309661 to Sheps et al.; and / or • U.S. Patent Application Publication No. 2015 / 0272734 to Sheps et al.

[0531] All of these applications are incorporated herein by reference. The techniques described herein may be practiced in combination with the techniques described in one or more of these applications. Additionally, any and all of the methods, techniques, steps, etc. described herein may be practiced on live animals or in a simulated / mock manner (e.g., on cadavers, cadaver hearts, mock hearts, simulators with tissue, etc., anthropomorphic ghosts, etc.).

[0532] The present invention is not limited to what has been specifically illustrated and described above, but rather the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that would occur to one skilled in the art upon reading the above description and that are not in the prior art.

[0533] [Additional note 1] An apparatus comprising: 1. An implantable annuloplasty structure, comprising: A main body portion, and an implantable annuloplasty structure comprising: (1) a constriction member having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure; and (2) a second portion extending away from the main portion of the annuloplasty structure; 1. A contraction member capture tool, comprising: a primary tube terminating at a distal end portion of the constriction member capture tool, the distal end portion of the constriction member capture tool having a distal tip; a secondary tube disposed along the primary tube, the secondary tube having a secondary lumen configured for passage of the constriction member therethrough; and and a retraction member capture tool comprising a retraction member snare comprising a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion configured to engage a portion of the retraction member and sized to pass through the secondary lumen of the secondary tube and pull the second portion of the retraction member through a length of the secondary tube. [Additional note 2] 2. The device of claim 1, wherein the distal snare portion is configured to pull the second portion of the constriction member through the distal tip of the constriction member intake tool and then through the length of the secondary tube. [Additional note 3] 3. The device of claim 1 or 2, wherein the retractable member snare comprises a wire having a diameter of 0.2 to 0.25 mm. [Additional note 4] 4. The apparatus according to any one of claims 1 to 3, wherein the primary tube is flexible and the secondary tube is flexible. [Additional note 5] 5. The device of any one of claims 1 to 4, wherein the annuloplasty structure defines a partial annuloplasty ring structure. [Additional note 6] 6. The apparatus of any one of claims 1 to 5, wherein the secondary tube is shaped to define a longitudinal slit. [Additional note 7] 7. The apparatus of any one of claims 1 to 6, wherein the contraction member incorporating tool comprises a handle portion, and the first and second tubes are connected to the handle portion. [Additional note 8] The handle portion is a contraction member capture device configured to capture a continuous portion of the contraction member; and a tension meter configured to measure a degree of tension in the contractile member. [Additional note 9] 9. The apparatus of claim 8, wherein the contraction member entrapment device is operable to increase tension in the contraction member. [Additional Note 10] 9. The apparatus of claim 8, wherein the contraction member capture device comprises a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally. [Additional Note 11] 11. The apparatus of claim 10, wherein the contraction member capture device comprises a wheel having a groove, the groove configured to couple the contraction member to the wheel. [Additional Note 12] 12. The apparatus of claim 11, wherein the groove is shaped to receive an intermediate portion of the contraction member. [Additional Note 13] 13. The device of any one of claims 1 to 12, wherein the secondary lumen of the secondary tube is sized to maintain a connection between the distal snare portion and the contraction member. [Additional Note 14] 14. The device of claim 13, wherein the snare portion comprises a flexible loop, the secondary lumen being configured to collapse the loop around the contraction member when the elongate flexible body portion is pulled through the secondary lumen. [Additional Note 15] 15. The device of any one of claims 1 to 14, wherein at least the distal snare portion of the retractable member snare is corrugated to increase friction between the snare portion and the retractable member. [Additional Note 16] 16. The device of any one of claims 1 to 15, wherein the distal snare portion is configured to pull the second portion of the contraction member through the entire length of the secondary tube. [Additional Note 17] The contraction member taking tool comprises: at least one contraction member fastener disposed within the distal end portion of the contraction member capture tool, the contraction member fastener comprising a clamping structure, the clamping structure (a) biased to a closed state, in which the clamping structure is configured to clamp the contraction member passed therethrough, and (b) capable of being bent to an open state in which the contraction member is movable; 17. The apparatus of any one of claims 1 to 16, further comprising: a stopper removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state. [Additional Note 18] 18. The apparatus of claim 17, wherein the at least one contraction member fastener includes at least first and second contraction member fasteners disposed within the distal end portion of the contraction member introduction tool. [Additional Note 19] 19. The device of claim 18, wherein the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through the retraction member fastener in the open state, and the snare portion is adapted to capture and pull the retraction member proximally through the retraction member fastener and through aligned ports in the distal end portion of the retraction member capture tool. [Additional Note 20] 20. The apparatus of claim 19, wherein the contraction member entrapping tool comprises a fastener ejector movable within the distal end portion of the contraction member entrapping tool, and movement of the fastener ejector contacts and converts the contraction member fastener from the open state to the closed state, tightening the contraction member passing therethrough. [Additional Note 21] 21. The apparatus of claim 20, wherein the fastener ejector is coupled to the stop and moves the stop removably coupled to the fastener. [Additional Note 22] 22. The apparatus of claim 20 or 21, wherein the distal end portion of the constriction member intake tool is shaped to define a sharp edge and the constriction member is positioned proximate to the sharp edge such that movement of the fastener ejector relative to the sharp edge severs the constriction member extending through the fastener. [Additional Note 23] at least one contraction member fastener configured to encircle the contraction member, the contraction member fastener comprising a clamping structure, the clamping structure (a) being biased to a closed state, in which the clamping structure is configured to clamp the contraction member passing therethrough, and (b) being capable of being bent to an open state in which the contraction member is movable; 23. The apparatus of any one of claims 1 to 22, further comprising a stopper removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state. [Additional note 24] 24. The apparatus of claim 23, wherein the tool comprises a movable cutting element having a sharp edge, and movement of the stop strikes the stop against the movable cutting element, whereby movement of the movable cutting element severs the contraction member extending through the fastener and through the movable cutting element. [Additional note 25] a lock slidable along the contraction member, the lock fixedly connectable to the contraction member to prevent movement of the contraction member; the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock; the lock defines a lock lumen extending from a proximal opening of the lock toward a distal opening of the lock; the locking lumen is configured to surround the contraction member; 25. The device of any one of claims 1 to 24, wherein when the lock is compressed, the slits allow the lock to close around the contraction member, thereby locking the lock to the contraction member. [Additional note 26] 26. The device of claim 25, wherein the annuloplasty structure is shaped to define a recess that is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Additional note 27] 27. The apparatus of claim 26, wherein the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Additional note 28] 26. The device of claim 25, wherein the locking lumen is shaped to define a distal portion that is wider than a proximal portion of the locking lumen. [Additional note 29] 30. The device of claim 28, wherein the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion. [Additional note 30] 26. The apparatus of claim 25, wherein the lock is disposed within the distal end portion of the contraction member ingesting tool. [Additional note 31] 31. The device of claim 30, wherein the lock is at least partially disposed within the recess when the constriction member introduction tool is coupled to the annuloplasty structure. [Additional note 32] 31. The device of claim 30, wherein the lock is positioned completely proximal to the recess when the constriction member introduction tool is coupled to the annuloplasty structure. [Additional note 33] 26. The apparatus of claim 25, wherein the lock is disposed within the distal end portion of the contraction member ingesting tool. [Additional note 34] 34. The device of claim 33, wherein the distal snare portion and the elongated flexible body portion of the retraction member snare are sized to pass distally through a lock, and the snare portion is adapted to capture and pull the retraction member proximally through the lock and through aligned ports in the distal end portion of the retraction member capture tool. [Additional note 35] An apparatus comprising: 1. An implantable annuloplasty structure, comprising: A main body portion, and an implantable annuloplasty structure comprising: (1) a constriction member having a first portion extending along a longitudinal length of the main body portion of the annuloplasty ring structure; and (2) a second portion extending away from the main body portion of the annuloplasty ring structure; a housing configured to be positionable relative to the main body portion of the annuloplasty ring structure; a contraction member fastener at least partially disposed within the housing, the contraction member fastener comprising a clamping structure, the clamping structure (a) biased to a closed state, in which the clamping structure is configured to clamp the contraction member passing therethrough, and (b) capable of being bent to an open state in which the contraction member is movable; a stop removably coupled to the fastener and configured to maintain the contraction member fastener in the open state; a fastener ejector engageable with a stop such that movement of the fastener ejector moves the stop removably connected to the fastener and transforms the clamping structure from the open state to the closed state to clamp the contraction member passed therethrough. [Additional note 36] 36. The apparatus of claim 35, wherein the fastener ejector is configured such that movement thereof facilitates severing of the contraction member extending through the fastener. [Additional note 37] 36. The apparatus of claim 35, wherein the fastener comprises a deformable element having an inclined state and a straight state, the stop being configured to maintain the fastener in the inclined state, and when the stop is removed, the fastener is configured to transition to the straight state and require the contraction member between the fastener and the surface of the housing. [Additional note 38] 38. The apparatus of claim 37, wherein the fastener is shaped to define a plurality of teeth configured to increase friction between the contraction member and the fastener. [Additional note 39] 1. A system comprising: 1. An implantable annuloplasty structure, comprising: a main body portion; and an implantable annuloplasty structure comprising a constriction member extending at least partially along a longitudinal length of the main body portion of the annuloplasty structure; 1. A contraction member capture tool, comprising: a tube having an internal lumen configured for passage of the contraction member therethrough; and a retraction member capture tool comprising a retraction member snare comprising a distal snare portion and an elongated flexible body portion coupled to the distal snare portion, the distal snare portion configured to engage a portion of the retraction member and draw it into the lumen. [Additional note 40] 40. The system of claim 39, wherein the distal snare portion is configured to pull the portion of the contraction member through the entire length of the lumen. [Additional note 41] 40. The system of claim 39, wherein the tube is flexible. [Additional note 42] 42. The system of any one of claims 39 to 41, wherein the contraction member incorporating tool comprises a handle portion, and the tube is connected to the handle portion. [Additional note 43] The handle portion is a contraction member capture device configured to capture a continuous portion of the contraction member; and a tension meter configured to measure a degree of tension in the contractile member. [Additional note 44] 44. The system of claim 43, wherein the contraction member entrapment device is operable to increase tension in the contraction member. [Additional note 45] 45. The system of claim 43 or 44, wherein the contraction member capture device comprises a wheel having a groove, the groove configured to couple the contraction member to the wheel. [Additional note 46] 46. ​​The system of claim 45, wherein the groove is shaped to receive an intermediate portion of the contraction member. [Additional note 47] 47. The system of any one of claims 39 to 46, wherein the inner lumen of the tube is sized to maintain a connection between the distal snare portion and the contraction member. [Additional note 48] 48. The system of any one of claims 39 to 47, wherein the distal snare portion comprises a flexible loop, and the lumen is configured to fold the loop around the contraction member when the portion of the contraction member is pulled through the lumen. [Additional note 49] 49. The system of any one of claims 39 to 48, wherein at least the distal snare portion of the contraction member snare is corrugated to increase friction between the snare portion and the contraction member. [Additional Note 50] 50. The system of any one of claims 39 to 49, wherein a distal end portion of the contraction member intake tool is shaped to define a sharp edge, and the contraction member intake tool is configured to position the contraction member proximate to the sharp edge such that the sharp edge can sever the contraction member. [Additional note 51] The contraction member taking tool comprises: a contraction member fastener disposed within a distal end portion of the contraction member capture tool, the contraction member fastener comprising a clamping structure, the clamping structure (a) biased to a closed state, in which the clamping structure is configured to clamp the contraction member passed therethrough, and (b) capable of being bent to an open state in which the contraction member is movable; The system of any one of claims 39 to 50, further comprising: a stopper removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state. [Additional note 52] 52. The system of claim 51, wherein the distal snare portion and the portion of the retraction member are sized to pass distally through the retraction member fastener in its open state, and the distal snare portion is adapted to capture and pull the portion of the retraction member proximally through the retraction member fastener and through aligned ports in the distal end portion of the retraction member capture tool. [Additional note 53] 53. The system of claim 52, wherein the contraction member capture tool comprises a fastener ejector movable within the distal end portion of the contraction member capture tool, and movement of the fastener ejector can contact and convert the contraction member fastener from its open state to its closed state, tightening the contraction member as it passes therethrough. [Additional note 54] 54. The system of claim 53, wherein the fastener ejector is coupled to the stop and moves the stop removably coupled to the fastener. [Additional note 55] An apparatus comprising: 1. An implantable annuloplasty structure, comprising: a main body portion having a sidewall; a contraction member having (1) a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure, and (2) a second portion extending away from the main body portion of the annuloplasty structure, the contraction member being configured to adjust a circumference of the annuloplasty structure; an implantable annuloplasty structure, wherein the main body portion of the annuloplasty structure is shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of the sidewall of the main body portion toward an opposing second surface of the sidewall of the main body portion, the sidewall of the main body portion extending away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, and the contraction member extending away from the main body portion of the annuloplasty structure through and via the recess; a lock slidable along the contraction member and toward the recess, the lock fixedly connectable to the contraction member to prevent movement of the contraction member, the recess shaped to facilitate fixed connection of the lock to the contraction member. [Additional note 56] 56. The device of claim 55, wherein the lock is at least partially disposable within the recess. [Additional note 57] 56. The device of claim 55, wherein the annuloplasty structure comprises a partial annuloplasty ring structure. [Additional note 58] 58. The device of any one of clauses 55 to 57, wherein the lock is configured to lock the contraction member when the lock moves at least partially within the recess. [Additional note 59] 58. The device of any one of clauses 55 to 57, wherein the lock is configured to fit completely within the recess. [Additional note 60] the main body portion comprises a housing; the housing defines at least a portion of the sidewall; 60. The device of any one of claims 55 to 59, wherein the housing defines the recess. [Additional note 61] 61. The device of any one of clauses 55-60, wherein the lock is shaped to define a locking thread portion and the annuloplasty structure is shaped to define an annuloplasty structure thread portion configured to engage the locking thread portion. [Additional note 62] 62. The device of any one of clauses 55 to 61, wherein the recess defines a recess lumen extending along the recess axis. [Additional note 63] 63. The apparatus of claim 62, wherein the recess axis is disposed at the non-zero angle. [Additional note 64] the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock; the lock defines a lock lumen extending from a proximal opening of the lock toward a distal opening of the lock; the locking lumen is configured to surround the contraction member; 64. The device of any one of claims 55 to 63, wherein when the lock is disposed within the recess, the slit allows the lock to close around the contraction member, thereby locking the lock to the contraction member. [Additional note 65] 65. The apparatus of claim 64, wherein the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Additional note 66] 65. The device of claim 64, wherein at least one of the slit and the locking lumen is shaped to define a distal portion that is wider than its proximal portion. [Additional note 67] 65. The device of claim 64, wherein the recess is shaped to define a proximal-most portion that is narrower than any other portion of the recess distal to the proximal-most portion. [Additional note 68] 68. The device of any one of clauses 55 to 67, wherein the annuloplasty structure comprises a housing, the housing shaped to define the recess, the recess having a recess axis. [Additional note 69] 70. The device of claim 68, wherein the lock is shaped to define a locking thread portion and the housing is shaped to define an annuloplasty structure thread portion configured to engage with the locking thread portion. [Additional note 70] 70. The device of claim 68, wherein the housing is shaped to define a constriction member lumen disposed at a non-zero angle relative to the recess axis. [Additional note 71] The device of claim 70, wherein the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, a distal end of the lock is configured to clamp a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at at least a first clamping point. [Additional note 72] the recess is shaped to define a recess distal tapered portion; The lock, a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock; a locking distal tapered portion; and the locking lumen is configured to surround the contraction member; 72. The device of claim 71, wherein when the lock is disposed within the recess, the recess distal tapered portion is configured to compress the lock distal tapered portion, and the lock distal tapered portion is configured to clamp a second portion of the contraction member within the lock lumen at the recess distal tapered portion to lock the contraction member at at least a second clamping point. [Additional note 73] The device of any one of clauses 55 to 72, further comprising a delivery tool, the delivery tool and the contraction member being slidable relative to one another, and the delivery tool being configured to deliver the annuloplasty structure to an annulus of the patient's heart. [Additional note 74] 74. The device of claim 73, wherein the delivery tool comprises a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally. [Additional note 75] 74. The device of claim 73, wherein when the delivery tool is coupled to the annuloplasty structure, a portion of the contraction member is disposed within an inner lumen of the delivery tool and the lock surrounds a portion of the contraction member. [Additional note 76] 76. The device of claim 75, wherein the lock is at least partially disposed within the recess when the delivery tool is coupled to the annuloplasty structure. [Additional note 77] 76. The device of claim 75, wherein the delivery tool comprises a lock ejector movable within a distal end portion of the delivery tool, and movement of the lock ejector contacts the lock and converts it from an open state to a closed state, constricting the contraction member passing therethrough. [Additional note 78] 78. The apparatus of claim 77, wherein the distal end portion of the delivery tool is shaped to define a sharp edge and the contraction member is positioned proximate to the sharp edge such that movement of the lock ejector relative to the sharp edge severs the contraction member extending through the lock. [Additional note 79] An apparatus comprising: 1. An implantable annuloplasty structure, comprising: A main body portion, and an implantable annuloplasty structure comprising: (1) a constriction member having a first portion extending along a longitudinal length of the main body portion of the annuloplasty structure; and (2) a second portion extending away from the main portion of the annuloplasty structure; a lock slidable along the contraction member, the lock being fixedly connectable to the contraction member to prevent movement of the contraction member; the lock is shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock; the lock defines a lock lumen extending from a proximal opening of the lock toward a distal opening of the lock; the locking lumen is configured to surround the contraction member; When the lock is compressed, the slits allow the lock to close around the contraction member, thereby locking the lock to the contraction member. [Additional note 80] The device of claim 79, wherein the annuloplasty structure includes a partial annuloplasty ring structure. [Additional note 81] 81. The device of claim 79 or 80, wherein the annuloplasty structure is shaped to define a recess that is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Additional note 82] 82. The device of claim 81, wherein the lock is at least partially disposable within the recess. [Additional note 83] 82. The device of claim 81, wherein at least one of the slit and the locking lumen is shaped to define a distal portion that is wider than its proximal portion. [Additional note 84] 82. The device of claim 81, wherein the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the proximal portion. [Additional note 85] 82. The device of claim 81, wherein the lock is shaped to define a locking thread portion and the annuloplasty structure is shaped to define an annuloplasty structure thread portion configured to engage with the locking thread portion. [Additional note 86] 82. The device of claim 81, wherein the annuloplasty structure comprises a housing, the housing shaped to define the recess, the recess having a recess axis. [Additional note 87] 87. The device of claim 86, wherein the lock is shaped to define a locking thread portion and the housing is shaped to define an annuloplasty structure thread portion configured to engage with the locking thread portion. [Additional note 88] 87. The device of claim 86, wherein the housing is shaped to define a constriction member lumen disposed at a non-zero angle relative to the recess axis. [Additional note 89] 89. The device of claim 88, wherein the housing is shaped to provide a contraction member lumen wall disposed along the contraction member lumen, and when the lock is disposed within the recess, a distal end of the lock is configured to clamp a first portion of the contraction member against the contraction member lumen wall to lock the contraction member at least at a first clamping point. [Additional Note 90] the recess is shaped to define a recess distal tapered portion; The lock, a lock lumen of the lock extending from a proximal opening of the lock toward a distal opening of the lock; a locking distal tapered portion; and the locking lumen is configured to surround the contraction member; 90. The device of claim 89, wherein when the lock is disposed within the recess, the recess distal tapered portion is configured to compress the lock distal tapered portion, and the lock distal tapered portion is configured to clamp a second portion of the contraction member within the lock lumen at the recess distal tapered portion to lock the contraction member at at least a second clamping point. [Additional Note 91] The device of any one of clauses 79 to 90, further comprising a delivery tool, the delivery tool and the contraction member being slidable relative to one another, and the delivery tool being configured to deliver the annuloplasty structure to an annulus of the patient's heart. [Additional note 92] 92. The device of claim 91, wherein the delivery tool comprises a knob coupled to a proximal portion of the contraction member, the knob configured to increase tension in the contraction member by pulling the contraction member proximally. [Additional Note 93] 93. The device of claim 92, wherein the kn...

Claims

1. 1. A system for use on a subject's heart, comprising: an annuloplasty structure (222; 1522) comprising a constriction member (226); A housing (1430; 1530), a fastener (1460; 1560) at least partially disposed within the housing, the fastener comprising a clamping structure having: (i) an open state in which the contraction member is slidable through the fastener; and (ii) a closed state in which the clamping structure is biased toward the closed state to prevent the contraction member from sliding through the fastener; a stop (1470; 1570) disposed within the fastener in a manner to maintain the fastener in the open state; a multi-component system (10; 1500) configured to anchor a main body portion of the annuloplasty structure along an annulus of the heart valve, the main body portion comprising a first portion of the contraction member and a second portion of the contraction member extending away from the main body portion; Equipped with The multi-component system comprises: a contraction member intake tool (1600) configured to apply tension to the contraction member while the housing is disposed in the main body portion; A contraction member severing tool (1502), While the housing remains disposed in the main body portion, locking tension in the first portion of the contraction member by removing the stop from the fastener, thereby transitioning the clamping structure from the open state to the closed state; and To sever the contraction member proximally from the fastener. Consisted of A contraction member severing tool; A system comprising:

2. the stopper having a narrow cylindrical engagement portion; 2. The system of claim 1, wherein the cylindrical engagement portion has an exterior surface that extends through the fastener when the stop is coupled to the fastener to hold the fastener in the open state, whereby the exterior surface restrains the fastener.

3. The system of claim 2 , wherein the contraction member capture tool is configured to apply tension to the contraction member by pulling the contraction member through the narrow cylindrical engagement portion.

4. the contraction member severing tool further comprising a gripper providing a connection between the contraction member severing tool and the housing; the system having a state for locking a connection between the contraction member severing tool and the housing; 2. The system of claim 1, wherein the contraction member severing tool is capable of separating the stop from the housing by pulling the stop proximally out from the fastener and pulling the contraction member severing tool proximally away from the housing.

5. 2. The system of claim 1, wherein the contractile member severing tool comprises a static cutting element and a dynamic cutting element, and is configured to separate the contractile member proximal to the lock by moving the dynamic cutting element relative to the static cutting element.

6. The system of claim 5 , wherein the contraction member introduction tool is configured to apply tension to the contraction member by pulling the contraction member through the static cutting element.

7. The system of claim 6 , wherein the contraction member introduction tool is configured to apply tension to the contraction member by pulling the contraction member through the dynamic cutting element.

8. 6. The system of claim 5, wherein the static cutting element defines a static cutting element lumen for extending the contraction member therethrough.

9. 10. The system of claim 8, wherein the dynamic cutting element defines a dynamic cutting element lumen for extending the constriction member therethrough.

10. The contraction member severing tool is locking tension in the contraction member by pulling the stop proximally out from the fastener along the axis of the contraction member severing tool; and separating the retraction member proximal to a lock by obliquely moving the dynamic cutting element proximally relative to the axis.

6. The system according to claim 5, characterized in that:

11. 6. The system of claim 5, wherein the contraction member severing tool is configured to separate the contraction member proximal to the lock by sliding the dynamic cutting element relative to the static cutting element.

12. the static cutting element defines a first cutting surface; the dynamic cutting element defines a second cutting surface; 6. The system of claim 5, wherein each of the first and second cutting surfaces is oblique to an axis along which the contraction member severing tool pulls the stop.

13. the contraction member severing tool comprises a tube; 6. The system of claim 5, wherein the stop, the static cutting element, and the dynamic cutting element are disposed within the tube.

14. 14. The system of claim 13, wherein the dynamic cutting element is positioned within the vessel distally from the static cutting element.

15. the static cutting element defines a first cutting surface; the dynamic cutting element defines a second cutting surface; 6. The system of claim 5, wherein each of the first and second cutting surfaces is concave.

16. the annuloplasty structure further comprises a first anchor and a second anchor slidably coupled to the contraction member; 2. The system of claim 1, wherein the fastener is configured to maintain a distance between the first anchor and the second anchor in the closed state by locking tension in the contraction member.

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