Annuloplasty systems and locking tools therefor

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, entitled "Annuloplasty system and locking tool therefor", by Brauon et al., filed on July 12, 2018, and b) U.S. Provisional Patent Application No. 62 / 811,693, entitled "Annuloplasty system and locking tool therefor", by Brauon et al., filed on February 28, 2019.

[0002] Both of these applications are hereby incorporated by reference into this specification.

[0003] The present invention generally relates to valve repair, for example, the repair of a patient's atrioventricular valve.

Background Art

[0004] Ischemic heart disease can cause valve regurgitation. For example, a combination of ischemic dysfunction of the papillary muscle and dilation of the left ventricle seen in ischemic heart disease, followed by displacement of the papillary muscle and dilation of the mitral annulus, can cause mitral valve regurgitation.

[0005] Dilation of the mitral annulus can prevent the valve leaflets from fully engaging when the valve is closed. Mitral valve regurgitation of blood from the left ventricle to the left atrium results in an increase in total cardiac output and a decrease in cardiac output, as well as left atrial volume overload and pressure overload, followed by eventual failure of the left ventricle.

Summary of the Invention

Means for Solving the Problems

[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 expressly enumerate those features. Also, the features, components, steps, concepts, etc. described in the examples in this summary and other places in this disclosure can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatuses, combinations, etc. that can be utilized for valve repair. The various features and steps described elsewhere in this disclosure can 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 comprise one or more steerable guide catheters (e.g., 1, 2, 3, or more) configured to direct the passage of a device through the interior thereof into the heart. The multi-component tubular system can be configured to deliver an implant in a desired orientation relative to the patient's heart valve annulus and to facilitate fixation of the implant to the valve annulus. In some applications, an induction system can be advanced transvascularly or transthoracically, or be advanceable, to access the atrium of the heart. In some applications, the induction system can be advanced surgically. The system can comprise two or more steerable catheters. The first catheter has a distal portion that is steerable to a first desired spatial orientation. The 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 a relative spatial orientation control device for controlling the orientation of the distal portion of the second catheter relative to the first catheter without substantially distorting the 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 components of the catheter system.

[0008] The distal portion of the first catheter can be maneuvered in a suitable direction after advancement of the first catheter through the patient's vasculature. After advancement of the first catheter in any one or more suitable planes and maneuvering of the distal portion of the first catheter, a second catheter advances through the first catheter. The first and second catheters can be rotationally locked in a manner that substantially maintains the spatial orientation of the first catheter during maneuvering of the second catheter to enable maneuvering of the distal portion of the second catheter in any one or more suitable planes relative to the distal portion of the first catheter. Further, the first catheter can be further maneuvered 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 can 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 structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, or other annuloplasty device) can be deployed, for example, from within the second catheter and secured to the patient's cardiac annulus. The annuloplasty structure can comprise a flexible main body portion and a constriction member having a first portion extending along the longitudinal length of the main body portion. A second portion of the constriction member can extend away from the main body portion of the annuloplasty structure and outside the patient's body. From a position outside the patient's body, the proximal end portion of the constriction member disposed outside the patient's body is fitted using a constriction member snare of a constriction member capture tool. Using the snare, the proximal end portion of the constriction member can then be fed through the distal portion of the primary tube of the tool and then through the lumen of the secondary tube of the tool. The constriction member capture tool can then be advanced along the constriction member toward the patient's annulus. As the constriction member is pulled by the snare and passes through the lumen of the secondary tube of the tool while advancing the tool toward the annulus, the secondary tube of the tool can move distally along the constriction member.

[0010] The shrink member capture tool can include an ejector movable at the distal end portion of the tool. The ejector can be bent to an open state through which the shrink member can pass and is removably connectable to a suture fastener having a clamping structure biased to a closed position or closed state for clamping the shrink member that has passed therethrough. The tool can have at least one stopper for maintaining the suture fastener (e.g., its clamping structure) in its open state.

[0011] The snare portion can be configured or adapted to capture the shrink member through the suture fastener and pull it proximally out through aligned ports in the tool. The tool can then advance toward a valve ring forming structure embedded along a valve ring. The tool can then take in a continuous portion of the shrink member to contract the valve ring forming structure. Thereafter, the ejector of the tool can move to convert the suture fastener (e.g., its clamping structure) from its open state to its closed state to clamp the shrink member that has passed therethrough.

[0012] The tool can include a handle portion that can include a shrink member capture device for taking in a continuous portion of the shrink member. The handle portion can include a tensiometer configured to measure the degree of tension of the shrink member.

[0013] In some applications, a valve ring forming structure (e.g., a valve ring forming loop structure, a closed valve ring forming structure, a closed valve ring forming loop structure, an open valve ring forming structure, a partial valve ring forming loop structure, or other valve ring forming device) includes a main body portion including a contractible sleeve, a shrink member passing along the contractible sleeve, and a housing including a fastener through which the shrink member passes. Once the valve ring forming structure or valve ring forming loop structure contracts, the fastener is deployed within the housing to maintain the contraction of the valve ring forming structure or valve forming ring structure.

[0014] A shrink member cutting tool is provided that enables the cutting of a shrink member passing through a tool only when the shrink member is locked in place by a fastener connected thereto. The shrink member cutting tool can be configured in various ways to apply a cutting surface to the shrink member, having, for example, a sharp edge moving toward the shrink member and / or multiple edges and / or surfaces moving relative to each other in a scissor-like motion or like a wire cutter tool.

[0015] Accordingly, systems and / or devices including an embedded valve ring forming structure are provided according to some applications. A valve ring forming structure including a main body portion and a shrink member. In some implementations, the shrink member can have (1) a first portion extending along the longitudinal length of the main body portion of the valve ring forming structure and (2) a second portion extending away from the main portion of the valve ring forming structure.

[0016] The system and / or device can include a shrink member insertion tool. The shrink member insertion tool can include a primary tube terminating at a distal end portion of the shrink member insertion tool, a distal end portion of the shrink member insertion 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 a shrink member therethrough. In some implementations, the shrink member insertion tool also includes a shrink member snare including a distal snare portion and an elongated flexible body portion connected to the distal snare portion, the distal snare portion being configured to fit around a portion of the shrink member. The shrink member snare can be sized to pass through the secondary lumen of the secondary tube to pull the second portion of the shrink member through the length of the secondary tube.

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

[0018] In some applications, the shrink member snare includes a wire including stainless steel. In some applications, the shrink member snare includes a wire with a diameter of 0.2 to 0.25 mm.

[0019] In some applications, the primary tube and / or the secondary tube is flexible.

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

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

[0022] In some applications, the shrink member intake tool includes a handle portion, and the first and second tubes are connected to the handle portion.

[0023] In some applications, the handle portion includes a shrink member intake device configured to take in a continuous portion of the shrink member, and a tensiometer configured to measure the degree of tension of the shrink member.

[0024] In some applications, the shrink member intake device is operable to increase the tension of the shrink member.

[0025] In some applications, the shrink member intake device includes a knob connected to the proximal portion of the shrink member, and the knob is configured to increase the tension of the shrink member by pulling the shrink member proximally. In some applications, the knob is fixedly connected to the proximal portion of the shrink member.

[0026] In some applications, the shrink member intake device includes a wheel having a groove, and the groove is configured to connect the shrink member to the wheel. In some applications, the groove is shaped to receive an intermediate portion of the shrink member.

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

[0028] In some applications, the snare portion includes a flexible loop, and when the elongated flexible body portion is pulled through the secondary lumen, the secondary lumen is configured to fold the loop around the contraction member. 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 contraction member snare includes a metal wire.

[0030] In some applications, at least the distal snare portion of the contraction member snare is wavy to increase the friction between the snare portion and the contraction member.

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

[0032] In some applications, the contraction member insertion tool includes at least one contraction member fastener disposed within the distal end portion of the contraction member insertion tool, the contraction member fastener including a clamping structure, the clamping structure being biased to assume a closed state, in which the clamping structure is configured to clamp the contraction member passing therethrough, and (b) being bendable to an open state in which the contraction member can move, at least one contraction member fastener, and a stopper removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state.

[0033] In some applications, 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 insertion tool.

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

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

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

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

[0038] In some applications, the system and / or device further includes at least one shrink member fastener configured to surround a shrink member, the shrink member fastener including a clamping structure biased to take a closed state in which the clamping structure is configured to clamp a shrink member passed therethrough, and bendable to an open state in which the shrink member can move, and a stopper removably connected to the shrink member fastener and configured to maintain the shrink member fastener in the open state.

[0039] In some applications, the shrink member insertion tool includes a fastener ejector movable within the distal end portion of the shrink member insertion tool, and movement of the fastener ejector contacts the shrink member fastener and is configured to convert from an open state to a closed state to clamp the shrink member that has passed therethrough.

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

[0041] In some applications, the tool includes a movable cutting element having a sharp edge, and movement of the stopper strikes the stopper against the movable cutting element, whereby movement of the movable cutting element divides a shrink 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 shrink member, and the lock can be fixedly coupled to the shrink member to prevent movement of the shrink member. The lock can be shaped to define a slit extending from the proximal surface of the lock toward the distal surface of the lock. The lock can define a lock lumen of the lock extending from the proximal opening of the lock toward the distal opening of the lock. The lock lumen can be configured to surround the shrink member. In some applications, when the lock is compressed, the slit allows the lock to close around the shrink member, thereby enabling the lock to lock to the shrink member.

[0043] In some applications, the valve ring forming structure is shaped to define a recess sized to compress the lock when the lock is at least partially disposed within the recess.

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

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

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

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

[0048] In some applications, when the shrink member capture tool is coupled to the valve ring forming structure, the lock is at least partially disposed within the recess.

[0049] In some applications, when the shrink member capture tool is coupled to the valve ring forming structure, the lock is disposed entirely proximal to the recess.

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

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

[0052] Further, according to some applications, a system and / or device including an implantable valve ring forming structure is provided. An implantable valve ring forming structure including a main body portion and a shrink member. The shrink member can have (1) a first portion extending along the longitudinal length of the main body portion of the valve ring forming ring structure and (2) a second portion extending away from the main body portion of the valve ring forming ring structure.

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

[0054] The system and / or apparatus can also include a shrink member fastener at least partially disposed within the housing, the shrink member fastener including a clamping structure that is biased to take a closed state in which the clamping structure is configured to clamp a shrink member passing therethrough and that can be bent to an open state in which the shrink member can move.

[0055] The system and / or apparatus can also include a stopper removably coupled to the fastener and configured to maintain the shrink member fastener in an open state, and a fastener ejector whose movement removably couples to the stopper to move the stopper and engage with the stopper to convert the clamping structure from an open state to a closed state to clamp a shrink member passing therethrough.

[0056] In some applications, the fastener ejector is shaped such that its movement facilitates severance of a shrink member extending through the fastener.

[0057] In some applications, the fastener includes a deformable element having an inclined state and a linear state, the stopper is configured to maintain the fastener in the inclined state, and when the stopper is removed, the fastener transitions to the linear state and is configured to receive the shrink member between the fastener and a surface of the housing.

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

[0059] Further, according to some applications, a method is provided that includes advancing an implantable annuloplasty structure including a main body portion and a constriction member toward a patient's heart. The constriction member is the same as or similar to other constriction members herein and can have (1) a first portion extending along the 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 constriction member through a constriction member capture tool. The constriction member capture tool can include a primary tube terminating at a distal end portion of the constriction member capture tool, a distal end portion of the constriction 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 constriction member therethrough. The constriction member capture tool can also include a constriction member snare including a distal snare portion and an elongate flexible body portion coupled to the distal snare portion, the distal snare portion being sized to fit a portion of the constriction member and pull the second portion of the constriction member through the secondary lumen of the secondary tube and through the length of the secondary tube.

[0061] In some applications, passing includes using the distal snare portion to fit that portion of the constriction member, using the constriction member snare to pull that portion of the constriction member through the secondary tube, and subsequent to passing, advancing the constriction member capture tool along the constriction member toward the annuloplasty structure.

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

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

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

[0065] In some applications, following advancement of the shrink member insertion tool, the method further includes using the shrink member insertion tool to contract the valve ring forming structure.

[0066] In some applications, using the shrink member insertion tool to contract the valve ring forming structure includes advancing a continuous portion of the shrink member relative to the shrink member insertion device.

[0067] In some applications, the method further includes maintaining the valve ring forming structure in a contracted state by tightening a shrink member fastener around a portion of the shrink member following contraction.

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

[0069] In some applications, the method further includes severing the shrink member using a sharp edge of the shrink member insertion tool following maintaining the valve ring forming structure in a contracted state.

[0070] In some applications, advancing the shrink member insertion tool includes advancing the shrink member insertion tool through a patient's vasculature.

[0071] In some applications, the shrink member insertion tool includes a handle portion that includes a shrink member insertion device configured to receive a continuous portion of the shrink member and a tensiometer configured to measure the degree of tension of the shrink member.

[0072] In some applications, the method further includes increasing the tension of the shrink member using the shrink member insertion device.

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

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

[0075] The method can be performed in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic ghost, etc.).

[0076] Further, according to some applications, a method is provided that includes advancing an implantable annuloplasty structure toward a patient's heart. The implantable annuloplasty structure may be the same as or identical to other annuloplasty structures known herein or by other methods and can include, for example, a main body portion, a constriction member, and a housing coupled to the main body portion of the annuloplasty structure. In some applications, the constriction member has (1) a first portion extending along the 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.

[0077] In some applications, a constriction member fastener is disposed within the housing, the constriction member fastener includes a clamping structure, the clamping structure is biased to assume a closed state, in which the clamping structure is configured to clamp the constriction member passing therethrough, and (b) can be bent to an open state in which the constriction member can move. In some applications, a stopper is removably coupled to the fastener and is configured to maintain the constriction member fastener in the open state.

[0078] In some applications, the method further includes converting the constriction member fastener from an open state to a closed state and moving a fastener ejector engageable with the stopper, whereby the movement of the fastener ejector moves the stopper removably coupled to the fastener to clamp the constriction member passing therethrough.

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

[0080] In some applications, contraction of the valve ring forming structure includes using a contraction member engagement tool to contract the valve ring forming structure.

[0081] In some applications, using a contraction member engagement tool to contract the valve ring forming structure includes advancing a continuous portion of the contraction member relative to a contraction member engagement device.

[0082] In some applications, the method further includes, following conversion of the contraction member from an open state to a closed state, using a sharp edge of the contraction member engagement tool to sever the contraction member.

[0083] The method can be performed in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic ghost, etc.).

[0084] Further, in accordance with some applications, a system is provided that includes an implantable valve ring forming structure that includes a main body portion and a contraction member that extends at least partially along the longitudinal length of the main body portion of the valve ring forming structure. The system also includes a contraction member engagement tool. The contraction member engagement tool can include a tube having a lumen configured for passage of a contraction member and a contraction member snare therethrough. The contraction member can include a distal snare portion and an elongate flexible body portion coupled to the distal snare portion, the distal snare portion being configured to fit a portion of the contraction member and draw it into the lumen.

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

[0086] In some applications, the constriction member snare includes a wire including stainless steel. In some applications, the tube is flexible.

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

[0088] In some applications, the handle portion includes a constriction member insertion device configured to receive a continuous portion of the constriction member and a tensiometer configured to measure the degree of tension of the constriction member.

[0089] In some applications, the constriction member insertion device is operable to increase the tension of the constriction member.

[0090] In some applications, the constriction member insertion device includes a wheel having a groove, and the groove is configured to connect the constriction member to the wheel.

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

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

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

[0094] In some applications, at least the distal snare portion of the constriction member snare is wavy to increase the friction between the snare portion and the constriction member.

[0095] In some applications, the distal end portion of the shrink member capture tool is shaped to define a sharp edge, and the shrink member capture tool is disposed proximate to the sharp edge such that the sharp edge is configured to be able to sever the shrink member.

[0096] In some applications, the shrink member capture tool includes a shrink member fastener disposed within the distal end portion of the shrink member capture tool, the shrink member fastener including a clamping structure biased to assume a closed state in which the clamping structure is configured to clamp a shrink member passing therethrough and (b) bendable to an open state in which the shrink member can move, the shrink member fastener; and a stopper removably coupled to the shrink member fastener and configured to maintain the shrink member fastener in the open state.

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

[0098] In some applications, the shrink member capture tool includes a fastener ejector movable within the distal end portion of the shrink member capture tool, movement of the fastener ejector contacting the shrink member fastener to convert it from its open state to its closed state to clamp a shrink member passing therethrough.

[0099] In some applications, the fastener ejector is coupled to the stopper to move the stopper removably coupled to the fastener.

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

[0101] In some applications, the embedded valve ring forming structure is a closed valve ring forming structure.

[0102] Further, in accordance with some applications, a system and / or apparatus is provided that includes an embedded valve ring forming structure that includes a main body portion having side walls and a shrink member. In some applications, the shrink member has (1) a first portion that extends along a longitudinal length of the main body portion of the valve ring forming structure and (2) a second portion that extends away from the main body portion of the valve ring forming structure, and the shrink member is configured to adjust an outer perimeter of the valve ring forming structure.

[0103] The main body portion of the valve ring forming structure may be shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of the side wall of the main body portion toward a second surface on an opposite side of the side wall of the main body portion, the side walls 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 shrink member extending through the recess and away from the main body portion of the valve ring forming structure via the recess.

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

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

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

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

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

[0109] In some applications, the main body portion includes a housing that defines at least a portion of a side wall and that defines a recess.

[0110] In some applications, the lock is shaped to define a lock thread portion, and the valve ring forming structure is shaped to define a valve ring forming structure thread portion configured to engage the lock thread portion.

[0111] In some applications, the recess defines a recess inner cavity that extends 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 that extends from a proximal surface of the lock toward a distal surface of the lock, and the lock defines a lock inner cavity that extends from a proximal opening of the lock toward a distal opening of the lock, the lock inner cavity being configured to surround the shrink member, and when the lock is disposed within the recess, the slit allows the lock to close around the shrink member, thereby enabling the lock to lock to the shrink member.

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

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

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

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

[0117] In some applications, the valve ring forming structure includes a housing, the housing is shaped to define a recess, and the recess has a recess axis.

[0118] In some applications, the lock is shaped to define a lock thread portion, and the housing is shaped to define a valve ring forming structure thread portion configured to engage the lock thread portion.

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

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

[0121] In some applications, the recess is shaped to define a recess distal taper portion. In some applications, the lock is shaped to define a lock lumen of the lock that extends from a proximal opening of the lock toward a distal opening of the lock, and a lock distal taper portion. The lock lumen can be configured to surround the shrink member.

[0122] In some applications, when the lock is disposed within the recess, the recess distal taper portion is configured to compress the lock distal taper portion, and the lock distal taper portion is configured to sandwich a second portion of the contraction member within the lock lumen at the recess distal taper 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, the delivery tool and the contraction member are slidable relative to each other, and the delivery tool is configured to deliver a valve annulus forming structure to a patient's heart valve annulus.

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

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

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

[0127] In some applications, when the delivery tool is coupled to the valve annulus forming structure, the lock is at least partially disposed within the recess.

[0128] In some applications, when the delivery tool is coupled to the valve annulus forming structure, the lock is disposed completely proximally to the recess.

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

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

[0131] Further, in accordance with some applications, a system and / or device is provided that includes an embedded valve ring forming structure that includes a main body portion and a shrink member. The shrink member can be the same or similar to other shrink members herein and can have, for example, (1) a first portion that extends along the longitudinal length of the main body portion of the valve ring forming structure and (2) a second portion that extends away from the main portion of the valve ring forming structure. The system and / or device can include a lock that is slidable along the shrink member and that can be fixedly coupled to the shrink member to prevent movement of the shrink member. The lock can 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 of the lock that extends from a proximal opening of the lock toward a distal opening of the lock. The lock lumen can be configured to surround the shrink member. When the lock is compressed, the slit can allow the lock to close around the shrink member, thereby enabling the lock to lock onto the shrink member.

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

[0134] In some applications, the valve ring forming structure is shaped to define a recess that is sized 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 entirely within the recess.

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

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

[0139] In 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] In some applications, the lock is shaped to define a lock thread portion, and the valve ring forming structure is shaped to define a valve ring forming structure thread portion configured to engage the lock thread portion.

[0141] In some applications, the valve ring forming structure includes a housing, the housing is shaped to define a recess, and the recess has a recess axis.

[0142] In some applications, the lock is shaped to define a lock thread portion, and the housing is shaped to define a valve ring forming structure thread portion configured to engage the lock thread portion.

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

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

[0145] In some applications, the recess is shaped to define a recess distal taper portion, and the lock is shaped to define a lock lumen of the lock that extends from a proximal opening of the lock toward a distal opening of the lock, and a lock distal taper portion. The lock lumen can be configured to surround a constriction member. When the lock is disposed within the recess, the recess distal taper portion can be configured to compress the lock distal taper portion, and the lock distal taper portion is configured to sandwich a second portion of the constriction member within the lock lumen at the recess distal taper portion to lock the constriction member at at least a second clamping point.

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

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

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

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

[0150] In some applications, the annuloplasty structure is shaped to define a recess that is sized 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 valve annulus forming 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 valve annulus forming structure, the lock is disposed completely proximal to the recess.

[0152] In some applications, the delivery tool includes a lock ejector movable within the 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 to clamp a contraction member that has passed therethrough.

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

[0154] Further, in accordance with some applications, a method is provided that includes advancing an implantable valve annulus forming structure toward a patient's heart. The implantable valve annulus forming structure can be the same or similar to other valve annulus forming structures known herein, such as those having, for example, a main body portion with side walls and a contraction member having (1) a first portion extending along the longitudinal length of the main body portion of the valve annulus forming structure and (2) a second portion extending away from the main body portion of the valve annulus forming structure, and the contraction member is configured to adjust the outer perimeter of the valve annulus forming structure.

[0155] The main body portion of the valve annulus forming structure can be shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of the side wall of the main body portion toward a second surface on the opposite side of the side wall of the main body portion, and the side walls of the main body portion extend away from the recess along a longitudinal axis that is at a non-zero angle relative to the recess axis, and the contraction member extends through and away from the main body portion of the valve annulus forming structure through the recess. Also,

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

[0157] In some applications, advancing includes advancing the valve ring forming structure while the lock is at least partially disposed within the recess.

[0158] In some applications, advancing includes advancing the valve ring forming structure while the lock is disposed completely proximally to the recess.

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

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

[0161] In some applications, the lock is shaped to define a slit extending from the proximal surface of the lock towards the distal surface of the lock, the lock defining a lock lumen of the lock extending from the proximal opening of the lock towards the distal opening of the lock, the lock lumen being configured to surround the contraction member, and when the lock is disposed within the recess, the slit allows the lock to close around the contraction member, thereby enabling the lock to be locked 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] In some applications, the lock lumen is shaped to define a distal portion that is wider than the proximal portion of the lock lumen.

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

[0165] In some applications, advancement includes advancing the valve ring forming structure using a delivery tool, and the method further includes sliding the delivery tool and the constriction member relative to each other.

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

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

[0168] In some applications, the knob is fixedly connected to the proximal portion of the constriction member.

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

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

[0171] The method can be performed in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic ghost, etc.).

[0172] Further, according to some applications, a method is provided that includes advancing an implantable annuloplasty structure toward a patient's heart. The annuloplasty structure may be the same as or identical to other annuloplasty structures known herein or by other methods, and may include, for example, a main body portion having side walls and a contraction member. The contraction member can have (1) a first portion extending along the 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, and the contraction member is configured to adjust the outer perimeter of the annuloplasty structure.

[0173] The method further includes locking the contraction member by sliding a lock along the contraction member, and the lock can be fixedly coupled to the contraction member to prevent movement of the contraction member. The lock can be shaped to define a slit extending from a proximal surface of the lock toward a distal surface of the lock. The lock can 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 can 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 enabling the lock to lock to the contraction member.

[0174] In some applications, the annuloplasty structure includes a complete valve-forming ring structure or a partial valve-forming 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 at least partially sliding the lock within the recess.

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

[0177] In some applications, advancement includes advancing the valve ring forming structure while the lock is disposed completely proximally within the recess.

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

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

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

[0181] In 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, advancement includes advancing the valve ring forming structure using a delivery tool, and the method further includes sliding the delivery tool and the contraction member relative to each other.

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

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

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

[0186] In some applications, the delivery tool includes a lock ejector movable within the distal end portion of the delivery tool, and the method further includes moving the lock ejector to contact the lock and converting from an open state to a closed state to clamp a shrink member that has passed therethrough.

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

[0188] The method can be performed in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic ghost, etc.).

[0189] Further, according to some applications, a system and / or device is provided that includes an implantable valve annulus forming structure that includes a main body portion and a shrink member. The shrink member can be the same or similar to other shrink members known herein or in another manner, and can have, for example, (1) a first portion extending along the longitudinal length of the main body portion of the valve annulus forming structure and (2) a second portion extending away from the main portion of the valve annulus forming structure.

[0190] A system and / or device further comprising at least one shrink member fastener configured to surround the shrink member. The shrink member fastener can include a clamping structure that is (a) biased to take a closed state in which the clamping structure is configured to clamp a shrink member that has passed therethrough and (b) can be bent to an open state in which the shrink member can move.

[0191] A system and / or apparatus further comprising a stopper removably coupled to a shrink member fastener and configured to maintain the shrink member fastener in an open state, and a shrink member cutting tool. The shrink member cutting tool can include a static cutting element having a first cutting surface, a dynamic cutting element having a second cutting surface facing the first cutting surface, and one or more grippers configured to pull the stopper proximally and remove the stopper from the shrink member fastener. In some applications, a portion of the shrink member passes through the static and dynamic cutting elements, and once pulled proximally, the stopper contacts the cutting elements, presses, and moves the dynamic cutting element against the static cutting element to facilitate severance of the shrink 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 is arranged such that the tool provides a safety mechanism whereby movement of the dynamic cutting element relative to the static cutting element is only possible by pressing the stopper against the dynamic cutting element.

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

[0195] In some applications, the tool is configured to deliver the housing, the fastener, and the stopper to an embedded valve ring forming structure.

[0196] In some applications, the embedded valve ring forming structure includes the housing.

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

[0198] In some applications, the system and / or device further includes an outer sleeve portion configured to surround the gripper for locking the gripper to the protrusion.

[0199] Further, in accordance with some applications, a system and / or device is provided that includes a shrink member fastener configured to stay on the shrink member. In some applications, at least one shrink member fastener is configured to surround the shrink member. The shrink member fastener can include a clamping structure, and the clamping structure is (a) biased to take a closed state, in which the clamping structure is configured to clamp the shrink member passing through the interior, and (b) can be bent to an open state in which the shrink member can move.

[0200] The system and / or device can include a stopper removably coupled to the shrink member fastener and configured to maintain the shrink member fastener in an open state.

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

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

[0203] In some applications, the system and / or device further includes a housing for accommodating the fastener and the stopper, and the tool is coupled to the housing when the gripper grips the stopper.

[0204] In some applications, the system and / or device further includes an embedded valve ring forming structure, and the tool is configured to deliver the housing, fastener, and stopper to the embedded valve ring forming structure.

[0205] In some applications, the system and / or device further includes an embedded valve ring forming structure, and the embedded valve ring forming structure includes a housing.

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

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

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

[0209] In some applications, the method further includes disengaging the stopper from the shrink member fastener by using the tool to pull the stopper with the tool, and by the pulling, bringing the stopper into contact with the cutting element and facilitating pushing the stopper against the cutting element and by the pushing, facilitating movement of the cutting element, thereby promoting severance of the shrink member by the cutting element.

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

[0211] In some applications, the method further includes a housing that houses a fastener and a stopper, and the method includes connecting a tool to the housing by gripping the stopper with the tool.

[0212] In some applications, the method further includes using a tool to deliver the housing, fastener, and stopper to an implantable valve ring forming structure.

[0213] In some applications, connecting the tool to the housing includes connecting the tool to a housing that is connected to an implantable valve ring forming structure.

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

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

[0216] The method can be performed in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic ghost, 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 elongate shrinkage member extending away from the implantable structure, and a shrinkage member capture 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 shrink member receiving channel, and (c) configured to (i) allow sliding of the shrink member relative to the inner shaft shrink member receiving channel when in the unlocked state and (ii) axially lock the shrink member relative to the inner shaft when in the locked state, and includes a lock.

[0219] In some applications, the system and / or device (e.g., within a 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 shrink member receiving channel that allows sliding of the shrink member therethrough.

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

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

[0222] In some applications, when the shrink member is disposed to completely pass through the handle shrink member receiving channel and the lock is in the locked state, actuation of the shrinkage promoting 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 direction force to the spring, which pushes the inner shaft proximally relative to the outer housing, and which pulls the shrink member proximally, such that the handle portion is configured to incorporate a continuous portion of the shrink member into the handle portion.

[0223] In some applications, when the contraction member is disposed so as to completely pass through the handle contraction member receiving channel, the lock is in the locked state, and the contraction member is tense, the spring presses the inner shaft proximally and the inner shaft pulls the contraction member proximally by operating the contraction promoting knob to a lesser extent than the tubular shaft advances proximally relative to the outer housing, so that the handle is configured to increase the tension in the contraction member.

[0224] In some applications, the contraction promoting knob is configured to be actuated by its rotation.

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

[0226] In some applications, the inner shaft partially projects outward from the proximal end of the outer housing, and both the tubular shaft and the inner shaft 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 the measure of the tension in the contraction member.

[0227] In some applications, the inner shaft is marked with a plurality of reference 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 at 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 arranged to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed at 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 configured to be axially fixed and connected to the inner shaft and to move radially outward to engage the outer housing to axially lock the inner shaft relative to the outer housing.

[0232] In some applications, the tension limiting locking assembly further includes a plurality of recesses shaped as defined by the outer housing, and the detent is 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 at a predetermined relative axial position with respect to the inner shaft, a particular one of the recesses with which the detent engages depends on the relative axial position of the inner shaft relative 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 the longitudinal portion of the elongated opening, (a) to prevent the detent from axially locking the inner shaft relative to the outer housing when the tubular shaft is distally disposed at a predetermined relative axial position with respect to the inner shaft, and (b) including one or more tracks arranged such that when the tubular shaft is disposed at a predetermined relative axial position with respect to the inner shaft, the detent is capable of axially locking the inner shaft.

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

[0236] In some applications, the inner shaft projects partially outward from the proximal end of the outer housing, and both the tubular shaft and the inner shaft 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 the measure of tension in the contraction member.

[0237] In some applications, the embedded structure includes an embedded valve ring forming structure.

[0238] In some applications, the embedded valve ring forming structure includes a flexible sleeve, and the contraction member extends along and away from the sleeve.

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

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

[0241] In some applications, when the contraction member is disposed to completely pass through the handle contraction member receiving channel, the lock is in a locked state, and the contraction member is under tension, actuation of the contraction promoting knob causes the axially movable portion of the force gauge to pull the contraction member proximally, such that the handle portion is configured to increase the tension in the contraction member, and the force gauge is configured to provide a visual indication of the measure of the tension in the contraction member.

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

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

[0244] In some applications, the handle portion further includes a tension limiting locking assembly configured to axially lock a portion of the force gauge movable axially 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 an implant and a flexible elongate contraction member extending away from the implantable structure toward a patient's heart, and passing a portion of the contraction member through a handle contraction member receiving channel of a handle portion of a contraction member capture tool. The contraction member capture tool can be the same as or similar to other contraction member capture tools described elsewhere herein and can 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 promoting knob accessible from the outside of the outer housing.

[0246] The inner shaft can include a lock configured to (a) be partially disposed within a proximal longitudinal portion of the tubular shaft such that the inner shaft can be axially slidable relative to the tubular shaft, (b) be shaped to define an inner shaft contraction member receiving channel, and (c) (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 can be at least partially disposed within the distal longitudinal portion of the tubular shaft and can be shaped to define a distal force applicator shrink member receiving channel that allows sliding of the shrink member therethrough, and the handle shrink member receiving channel extends from the distal end to the proximal end of the handle portion and includes an inner shaft shrink member receiving channel and a distal force applicator shrink member receiving channel.

[0248] The spring can be disposed within the tubular shaft and connect the distal force applicator to the 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 the shrinkage promoting knob to advance 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 shrink member proximally, thereby taking in successive portions of the shrink member into the handle portion until the shrink member is tensioned, and then, once the shrink member is tensioned, actuating the shrinkage promoting knob to increase the tension in the shrink member by the proximal pull of the inner shaft on the shrink member caused by the spring that pushes the inner shaft proximally relative to the outer housing to a lesser extent than the tubular shaft advances proximally relative to the outer housing.

[0251] In some applications, actuating the shrinkage promoting knob includes rotating the shrinkage promoting knob.

[0252] In some applications, the tubular shaft and the shrinkage promoting knob are threaded together and the handle portion is configured such that actuation of the shrinkage promoting knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

[0253] In some applications, the inner shaft partially protrudes outwardly from the proximal end of the outer housing, and both the tubular shaft and the inner shaft 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 the measure of tension in the contraction member, and the method further includes viewing the visual indication.

[0254] In some applications, the inner shaft is marked with a plurality of reference 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 at 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 arranged to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed at 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 configured to be axially fixedly connected to the inner shaft and 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 limiting latching assembly further includes a plurality of recesses shaped to be defined by the outer housing, the detent being engagable with the recesses to axially lock the inner shaft relative to the outer housing, and the handle portion being positioned such that when the tubular shaft is disposed at a predetermined relative axial position relative to the inner shaft, a particular one of the recesses with which the detent engages depends on the relative axial position of the inner shaft relative 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) to prevent the detent from axially locking the inner shaft relative to the outer housing when the tubular shaft is distally disposed at a predetermined relative axial position relative to the inner shaft, and (b) includes one or more tracks arranged to enable the detent to axially lock the inner shaft when the tubular shaft is disposed at a predetermined relative axial position relative to the inner shaft.

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

[0263] In some applications, the inner shaft partially protrudes outwardly from the proximal end of the outer housing, and both 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 the measure of tension in the contraction member, and the method further includes viewing the visual indication.

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

[0265] In some applications, the implantable valve ring forming structure includes a flexible sleeve, and advancing the implantable valve ring forming 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, there is provided a method including advancing an implantable structure of an implant and a flexible elongate contraction member extending away from the implantable structure toward a patient's heart, and passing a portion of the contraction member through a handle contraction member receiving channel of a handle portion of a contraction member capture tool.

[0267] The contraction member capture tool can be the same or similar to other contraction member capture tools described elsewhere in this specification or known in another manner. For example, in some applications, the contraction member capture tool includes an outer housing, a non-electromechanical force gauge, a lock, and a contraction promoting knob. The lock can be configured to (i) enable sliding of the contraction member with respect to the force gauge when in the unlocked state, and (ii) axially lock the contraction member with respect to an axially movable portion of the force gauge when in the locked state, and the axially movable portion of the force gauge is axially movable with respect to the outer housing. The contraction promoting knob can be accessible from the outside of the outer housing.

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

[0269] The method can further include, after the contraction member is once tensioned, actuating the contraction promoting knob to pull the contraction member proximally by an axially movable portion of the force gauge to increase the tension in the contraction member and viewing a visual indication of the measure of the tension in the contraction member, the visual indication being provided by the force gauge.

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

[0271] In 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] In some applications, the handle portion further includes a tension limiting locking assembly configured to axially lock an axially movable portion of the force gauge relative to the outer housing when the handle portion has increased 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 method can be practiced in the treatment of a living animal or in a simulation / simulated treatment (e.g., a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., an anthropomorphic dummy, etc.).

[0274] Also, according to some applications, systems and / or devices are provided that can include an embedded valve ring forming structure (e.g., a valve ring forming ring structure, a closed valve ring forming structure, a closed valve ring forming ring structure, an open valve ring forming structure, a partial valve ring forming ring structure, or other valve ring forming devices). The embedded valve ring forming structure can include a main body portion and a contraction member that extends at least partially along the longitudinal length of the main body portion of the valve ring forming structure. The embedded valve ring forming structure can be the same or similar to other valve ring forming structures described elsewhere in this specification.

[0275] The system and / or device can also include a contraction member insertion tool. The contraction member insertion tool can be the same or similar to other contraction member insertion tools described elsewhere in this specification. The contraction member insertion tool can 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 contraction member therethrough. The tube can be flexible, semi-rigid, or rigid. The contraction member insertion tool can also include a contraction member snare. The contraction member snare can include a distal snare portion and an elongate flexible body portion connected to the distal snare portion. The distal snare portion can be configured to fit a portion of the contraction member and draw it into the lumen. The distal snare portion can be configured to pull that portion of the contraction member through a part of the lumen or through the entire length of the lumen (e.g., from end to end). The contraction member snare can include a wire including stainless steel. The lumen of the tube can be sized to maintain the connection between the distal snare portion and the contraction member.

[0276] The shrink member intake tool can comprise a handle portion, and a tube can be connected to the handle portion. The handle portion can comprise a shrink member intake device configured to take in a continuous portion of the shrink member. The handle portion can also include a tensiometer configured to measure the degree of tension of the shrink member. The shrink member intake device can be operable to increase the tension of the shrink member. The shrink member intake device can optionally comprise a wheel having a groove, the groove being configured to couple the shrink member to the wheel. The groove can be shaped to receive an intermediate portion of the shrink member.

[0277] The distal snare portion can comprise a flexible loop. The lumen can be configured to fold the flexible loop around the shrink member when that portion of the shrink member is pulled through the lumen. At least the distal snare portion of the shrink member snare can be wavy so as to increase the friction between the snare portion and the shrink member.

[0278] The distal end portion of the shrink member intake tool can be shaped to define a sharp edge, and the shrink member intake tool can be configured such that the sharp edge is disposed proximate to the shrink member so that the sharp edge can sever the shrink member.

[0279] The shrink member intake tool can comprise a shrink member fastener disposed within the distal end portion of the shrink member intake tool. The shrink member fastener can comprise a clamping structure. The clamping structure can be biased to assume a closed state or a closed position, in which the clamping structure is configured to clamp a shrink member passing therethrough. The clamping structure can also be configured to be bent to an open state or an open position, in which the shrink member can move therethrough. The shrink member intake tool can also comprise a stopper removably coupled to the shrink member fastener and configured to maintain the shrink member fastener in the open state / position.

[0280] The distal snare portion, that portion of the contraction member, and the clamping structure can be configured and sized to pass distally through the contraction member fastener and the clamping structure. The distal snare portion can be adapted to capture that portion of the contraction member through the contraction member fastener and the clamping structure and through the aligned ports of the distal end portion of the contraction member capture tool and pull it proximally.

[0281] The contraction member capture tool can include a fastener ejector movable within the distal end portion of the contraction member capture tool, which can be configured such that movement of the fastener ejector contacts the contraction member fastener and converts it from the open state / position to the closed state / position to clamp the contraction member when it passes through the interior. The fastener ejector can be connected to a stopper and can be configured to move a stopper removably connected 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 adjacent to the sharp edge such that movement of the fastener ejector relative to the sharp edge can be configured to sever the contraction member after or when it 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 in this specification.

[0283] The present invention will be more fully understood from the following detailed description taken in conjunction with the drawings.

Brief Description of the Drawings

[0284]

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DETAILED DESCRIPTION OF THE INVENTION

[0285] Referring to FIGS. 1-2, which is a schematic view of an example of a multi-component tubular system 10 that provides one or more rotationally controlled steering 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 having a sheath configured to advance through a patient's vasculature. In some applications, the outer catheter 12 has a sheath configured to advance through the femoral artery towards the atrial septum of the patient's heart. The 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, having a steerable distal end portion. The catheter 14 is configured to advance through the lumen of the outer catheter 12. The outer catheter 12 provides a first coupling 152 (e.g., slit 52) at its distal portion (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 depressible engagement portion 54) coupled to a displaceable tab 56 coupled to the base. As described herein, the depressible engagement portion 54 (or second coupling 154) is configured to project within the slit 52 (or 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 is aligned and engaged with the slit 52 of the catheter 12, as described below. As shown in cross-section A-A 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 may be shaped to provide the slit 52 and the catheter 12 may 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 can be shaped to define a slit 52. In some applications, the slit 52 is provided by the metal frame 50 as shown. The metal frame 50 can have a length L22 of, for example, 7 to 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 can comprise an engagement portion 54, which can comprise a protrusion disposed at the distal portion of a displaceable tab 56 at the base of the engagement portion 54. The base of the engagement portion 54 can 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 the catheter 14, the catheter 14 is manipulated to couple the engagement portion 54 and the tab 56 thereto, e.g., the engagement portion 54 and the tab 56 are embedded within the polymer of the catheter 14.

[0288] The slit 52 and the depressible engagement portion 54 are shown on the outer catheter 12 and the guide catheter 14 respectively, but at the distal portions of the catheters 12 and 14, the slit 52 and the engagement portion 54 can be provided along any suitable portion of the respective catheters 12 and 14 (e.g., the proximal portions of the respective catheters 12 and 14).

[0289] The first and second couplings 152 and 154 can each be provided on any standard catheter. That is, the coupling 152 comprises a frame 50 that can be coupled to the outer surface of any standard catheter (in which case a corresponding slit is made in the standard catheter). Further, the coupling 154 can be coupled to any standard catheter by coupling the base portion of the coupling 154 to any standard catheter. A suitable adjustment to the standard catheter is made in response to the pressing force applied to the engagement portion 54 so as to adapt to the displacement of the tab 56 and the engagement portion 54.

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

[0291] The guide catheter 14 is maneuverable into a desired spatial orientation to facilitate the advancement and implantation of an implant within a patient's body cavity. As shown, the implant comprises an annuloplasty structure 222 (e.g., an annuloplasty ring structure, a closed annuloplasty structure, a closed annuloplasty ring structure, an open annuloplasty structure, a partial annuloplasty ring structure, etc.) that includes a flexible sleeve 26 (shown in the exploded view of FIG. 2). The sleeve 26 can include a braided fabric mesh, for example, including DACRON™. The sleeve 26 is configured to be disposed only partially around the cardiac annulus (i.e., to take a C-shape) and, once fixedly positioned, to contract to tightly circumferentially constrict the annulus. However, the ring structure can also be configured to be disposed completely around the annulus. To tightly constrict the annulus, the annuloplasty structure or annuloplasty ring structure 222 includes a flexible elongate constriction member 226 that extends along the sleeve 26. The elongate constriction member 226 can include a wire, ribbon, rope, or band, which can include one or more of various materials, such as a flexible and / or superelastic material, for example, nitinol, polyester, stainless steel, or cobalt chrome. In some applications, the wire includes a radiopaque material. In some applications, the constriction member 226 includes a braided polyester suture (e.g., Ticron). In some applications, the constriction member 226 is coated with polytetrafluoroethylene (PTFE). In some applications, the constriction member 226 includes a plurality of wires that are intertwined to form a rope structure.

[0292] In the use for which the system 10 is used to deliver an implant to a patient's mitral valve, the outer catheter 12 can be configured to first advance through the patient's vasculature until the distal end 102 (which can be the most distal end or tip) of the catheter 12 is positioned in the left atrium. Next, the steerable distal end of the catheter 12 is manipulated so that the distal end 102 of the catheter 12 is positioned in a desired spatial orientation within the left atrium. The manipulation procedure can be performed using imaging such as fluoroscopy, transesophageal echo, and / or cardiac echo. Following the manipulation of the distal end portion of the catheter 12, the guide catheter 14 (which houses the annuloplasty structure 222) advances through the catheter 12 to facilitate the delivery and implantation of the structure 222 along the mitral annulus. During delivery, at least a portion of the steerable distal end portion of the catheter 14 can be exposed from the distal end 102 of the catheter 12 and thus can be freely manipulated towards the mitral annulus as described below.

[0293] Further, the system 10 includes attachment mechanisms such as a plurality of anchors 32 (e.g., anchors (plural), adhesives, clamps (plural), clips (plural), fasteners (plural), etc.), which can be from about 5 to about 20 anchors, for example, about 10 or about 16 anchors. Each anchor 32 can include a tissue engagement element 60 (e.g., a helical tissue engagement element) and a tool coupling head 62 fixed to one end of the tissue engagement element. One anchor 32 is shown in FIG. 2 as being reversibly coupled to the deployment element 38 of the rotary anchor driver 36 of the anchor deployment manipulator 61. When the sleeve 26 is positioned along the cardiac annulus, the deployment manipulator 61 advances within the lumen of the sleeve 26 and deploys each anchor 32 from within the sleeve 26 through the wall of the sleeve 26 into the cardiac tissue, thereby configuring the sleeve 26 to be fixed around a portion of the annulus. The insertion of the anchors into the sleeve and the deployment of the anchors into the cardiac tissue are detailed below.

[0294] The anchor 32 can include a biocompatible material such as stainless steel 316LVM. In some applications, the anchor 32 includes nitinol. In some applications, the 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. 2.

[0296] As shown in the exploded view of FIG. 2, the sleeve 26 is disposed within the lumen of the guide catheter 14. 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 a 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. Further, 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 each other.

[0297] The anchor driver 36 can advance within the channel 18. In some applications, the system 10 includes a plurality of anchor drivers 36, each driver being coupled to a respective anchor 32. Each driver 36 can advance within the channel 18 to advance and implant the anchor 32 into 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 then advances within the channel 18.

[0298] As described below, the first anchor 32 is configured to deploy into the heart tissue through the wall of the sleeve when the sleeve 26 is positioned along the valve annulus of the valve. 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 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 in such a way that the distal end of the tube 19 provides a reference force to the sleeve 26 to facilitate release of a continuous portion of the sleeve 26 from around the channel 18. Then, while either the tube 19 and / or the catheter 14 is being maneuvered toward a continuous position along the valve annulus of the valve, the channel 18 is positioned in a continuous position within the lumen of the sleeve 26 (as described below). As a result, the continuous portion of the sleeve 26 provides a free lumen for advancement of the continuous anchor 32 and deployment of the anchor through the wall of the sleeve in its continuous portion. Such release of the continuous portion of the sleeve 26 creates a distance between the continuous anchors deployed from the lumen of the sleeve 26.

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

[0300] In many cases, at least a portion (e.g., three, at least three, a part, all, etc.) of the longitudinal portion of the radiopaque marker is 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 the desired distance between adjacent anchors. For example, the markers can include a first marker, a second marker, and a third marker, the first marker and the second marker are adjacent, 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 to 15 mm, such as 6 mm, and the longitudinal length of each marker can be 0.1 to 14 mm, such as 2 mm. (For example, if the distance is 6 mm and the length is 2 mm, the longitudinal spacing between adjacent markers has a length of 4 mm.)

[0301] Each anchor 32 can be coupled to the deployment element 38 of an anchor driver 36. The anchor driver 36 comprises an elongate tube having at least a flexible distal end portion. The elongate 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 the elongate rod 130. The rod 130 facilitates the locking and unlocking of the anchor 32 to the deployment element 38 as described below. As shown in cross-section E-E of FIG. 2, the proximal end of the rod 130 is coupled at the proximal end of the system 10 to a component of the anchor release mechanism 28. 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 E-E of FIG. 2). The proximal end of the tube of the anchor driver 36 is coupled to the housing 135. As described below, a user (e.g., a physician, a healthcare provider, etc.) releases the anchor 32 from the deployment element 38 when the finger engagement portion 131 is pulled proximally, thereby pulling the 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 electronically controlled, such as by using an extracorporeal control device and / or motor connected to the proximal end of the anchor driver and / or housing 135.

[0303] The proximal handle portion 101 can 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 operation handle 126, and an anchor release mechanism 28. The handle 22 is connected to the proximal end of the outer catheter 12. The handle 24 is connected to the proximal end of the guide catheter 14. The handle 126 is connected to the 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 the structure 222) through the catheter 14. As described above, the housing 135 of the anchor release mechanism 28 is connected to the proximal portion of the tube of the anchor driver 36. The relative positions of each of the concentric components of the system 10 are shown in the exploded view of FIG. 2 and cross-sections A-A, B-B, C-C, and D-D.

[0304] The stand that supports the proximal handle portion 101 is movable distally and proximally, particularly to control the position of the entire multi-component system 10 so as to adjust the distance of the distal end 102 of the catheter 12 from the atrial septum. The handle 22 comprises a steering knob 210 coupled to pull wires 29a and 29b disposed within respective secondary lumens of the wall of the outer catheter 12. Rotation of the knob 210 adjusts the degree of tension of 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 a force steers the distal end portion of the catheter 12 within the atrium of the patient's heart in a manner in which 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 towards the surrounding wall of the atrium). In some applications, the distal end portion of the catheter 12 may be pre-shaped to face downwardly towards the valve. In other applications, the distal end portion of the catheter 12 can be pulled to assume an orientation in which the distal end portion faces downwardly towards the valve. In some applications, the distal end portion of the catheter 12 is not made to face downwardly towards the valve.

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

[0306] The combined steering of the respective distal end portions of the catheters 12 and 14 directs the sleeve 26 downwardly toward the valve annulus (e.g., via steering of the distal end portion of the catheter 14) and along the outer periphery of the valve annulus (e.g., from the posterior of the valve to the anterior of the valve or vice versa) via steering of the distal end portion of the catheter 12.

[0307] In some applications, the handle 22 can be tilted by a user (e.g., a physician, etc.) to further adjust the position of the distal end of the catheter 12.

[0308] In some applications, the handle 22 includes an indicator indicating the degree of steering (e.g., bending) of the distal end portion of the catheter 12 provided by using the knob 210. In some applications, the handle 24 includes an indicator indicating the degree of steering (e.g., bending) of the distal end portion of the catheter 12 provided by using the 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., each of the slits 52 and the engagement portions 54) provide a controlled steerable system, and during the 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 each 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 collectively define a relative spatial orientation control device, which rotationally locks the relative spatial orientation of the steerable distal end portion and the bending section of the outer catheter 12 with respect to the steerable distal end portion and the bending section of the guide catheter 14.

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

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

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

[0313] The handle portion 101 can include a release determination facilitating member 127, such as a latch or button, that automatically engages when a given length of the sleeve 26 has advanced out of the channel 18 (e.g., when the channel 18 is in a given position relative to the tube 19), often just prior to the sleeve 26 being completely separated from the channel 18. Engagement of the member 127 prevents 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 surgeon) must disengage the member 127, such as by pressing a button, before continuing to pull the channel 18 proximally. When engaged, the member 127 can also prevent distal movement of the channel 18 relative to the tube 19.

[0314] The handle portion 101 (comprising 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, most of the body portion of the outer catheter handle 22 can be arranged at a non-zero angle with respect to the longitudinal axis 7 of the plurality of components of the system 10. The steering mechanism provided by the handle 22 for steering the distal end portion of the catheter 12 is arranged within that portion of the handle 22 that is arranged at a non-zero angle with respect to the axis 7. The handle 22 comprises a series of tubular portions 21 arranged longitudinally in line along and coaxial with the axis 7 with respect to the handles 24 and 126 and the release mechanism 28. The tubular portion 21 is shaped to define a lumen through which, and then into the lumen of the outer catheter 12, a guide catheter 14 can be inserted. The tubular portion 21 has a length L24 of 7 to 11 cm, for example 7 cm. Such a spatial orientation of most of the handle 22 at an angle with respect to the axis 7 reduces the overall functional length of the handle portion 101.

[0315] Referring to FIGS. 3A - I, which are schematic views of an example of a procedure for repairing the mitral valve 230 by implanting a valve annulus forming structure 222 (for example, a valve annulus forming ring structure, a closed valve annulus forming structure, a closed valve annulus forming ring structure, an open valve annulus forming structure, a partial valve annulus forming ring structure, etc.). This procedure is an example of a procedure that can be performed using the system 10.

[0316] The annuloplasty structure or annuloplasty ring structure 222 can be used to repair the enlarged annulus of an atrioventricular valve such as the mitral valve 230. In some applications, the annuloplasty structure is configured to be disposed only partially around the annulus (e.g., to take a C-shape) and, once fixed or otherwise secured in place, to contract to tightly circumferentially constrict the annulus. In some applications, the annuloplasty structure is configured to be disposed completely around the annulus (e.g., to take a closed shape such as circular, oval, D-shape, etc.) and, once fixed in place, to contract to tightly circumferentially constrict the annulus. The annuloplasty structure can comprise a flexible sleeve 26. The annuloplasty structure can 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.). The anchor deployment manipulator 61 advances within the lumen of the sleeve 26 and deploys an anchor from within the lumen through the wall of the sleeve into the heart tissue, thereby securing the sleeve around a portion of the annulus. In some applications, the annuloplasty structure or annuloplasty ring structure 222 is implemented using the techniques described in U.S. Application No. 12 / 437,103, filed May 7, 2009 (issued as US 8,715,342), and / or U.S. Application No. 12 / 689,635, filed January 19, 2010 (issued as US 8,545,553), both of which are assigned to the assignee of the present application and incorporated herein by reference.

[0317] As shown in FIG. 3A, the procedure can be initiated by advancing a semi-rigid guidewire 202 into the patient's right atrium 220. The procedure can be performed using imaging such as fluoroscopy, transesophageal echo, and / or cardiac echo.

[0318] As shown in FIG. 3B, the guide wire 202 provides a guide along which and for the subsequent advancement of the outer catheter 12 into the right atrium. Once the distal portion of the catheter 12 enters the right atrium, the guide wire 202 is retracted from the patient's body. The catheter 12 can include a 14-24F sheath, although any size can be selected as needed for a given patient. The catheter 12 advances through the vasculature into the right atrium using an appropriate starting point determined for the given patient. For example, ● The catheter 12 can 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 can be introduced into the ulnar cutaneous 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 can 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 advances through the patient's inferior vena cava 223 (as shown) into the right atrium 220 using a starting point suitable for the given patient.

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

[0321] As shown in FIG. 3D, the elastic needle 206 and a dilator (not shown) advance through the catheter 12 and into the heart. To advance the catheter 12 transseptally into the left atrium 224, the dilator advances to the septum and the needle 206 is pushed out of the dilator to pierce the septum and create an opening that facilitates passage of the dilator and subsequently the catheter 12 therethrough and into the left atrium 224. The dilator passes through the septal hole created by the needle. The dilator can be shaped to define a hollow shaft for passage along the needle 206, and the hollow shaft is shaped to define a tapered distal end. This tapered distal end first advances through the hole created by the needle 206. As the distal end of the dilator, which gradually increases in diameter, is pushed through the septal hole, the hole expands. In some applications, the distal end 102 of the catheter 12 is tapered to facilitate passage of the 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, as shown in FIG. 3E, the dilator and the needle 206 can be withdrawn from within the catheter 12. 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 bend section 1203 of the catheter 12) can 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 towards the surrounding wall of the atrium, as indicated by the arrow in the atrium 224. As described above, steering of the distal portion of the catheter 12 can be performed via the steering knob 210 (shown in FIGS. 1 and 2) of the handle 22 of the handle portion 101.

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

[0324] As shown in FIG. 3G, the distal end 251 of the sleeve 26 is positioned near the left fibrous trigone 242 of the valve annulus 240 of the mitral valve 230. (For clarity of illustration, the distal end 251 of the sleeve 26 is schematically shown in a cross-sectional view of the heart, but it should be noted that the left trigone 242 is actually located outside of the plane of the cross-section shown and closer to the viewer on a page not shown.) Alternatively, the distal end of the sleeve 26 is positioned near the right fibrous trigone 244 of the mitral valve (not shown in the configuration). Further alternatively, the distal end of the sleeve is not positioned near either trigone, but instead is positioned at another location 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 into the heart tissue near the trigone by (passing through the wall of the sleeve 26 in a direction parallel to the central longitudinal axis of the deployment manipulator 61 or the anchor driver 36 passing through the distal end of the channel 18 and / or parallel to the central longitudinal axis of the tissue engagement element 60 of the anchor 32). Following the deployment of the anchor 32 into the heart tissue, the deployment element 38 is separated from the anchor 32 by moving the rod 130 proximally.

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

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

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

[0328] With reference now to FIGS. 3G and 2, following deployment of the first anchor, the distal portion of the sleeve 26 can 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 can be pulled proximally while (2) the reference force tube 19 is maintained in a fixed position in such a way 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 can be pulled proximally while (2) the reference force tube 19 is maintained in a fixed position. An indicator on the handle 126 (such as the indicator 2120 described in Sheps et al., PCT Patent Application No. PCT / IL2012 / 050451, published as WO / 2013 / 069019, which is incorporated herein by reference) provides an indication of the extent to which the channel 18 is withdrawn from within the sleeve 26 (i.e., the extent to which the delivery tool is separated from the sleeve 26 and the sleeve is disengaged from the channel 18 and advanced relative to the tissue). The proximal end of the channel 18 is connected 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 valve annulus 240 to another site selected for deployment of the second anchor 32. Here, reference is made to FIGS. 1 and 3H. Such repositioning of the manipulator 61 is accomplished as follows. (1) Manipulating the distal end portion of the catheter 12 (e.g., by the steering knob 210 of the handle 22) in a desired spatial orientation in a first plane parallel to the valve annulus 240 of the valve 230 and by bending the bend section 1203 of the catheter 12, (2) Manipulating the distal end portion of a portion of the catheter 14 (e.g., by the steering knob 214 of the handle 24) in a desired spatial orientation in a second plane perpendicular to the valve annulus 240 of the valve 230 and by bending the bend section 1405 (in particular, the bend section 1403) of the catheter 14, (3) Axially moving the catheter 14 relative to the catheter 12 via the 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 the 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 by the actuation knob 94.

[0329] Often, the first anchor is deployed most distally within the sleeve (generally, within a few millimeters or less of the distal tip of the sleeve), and each subsequent anchor is disposed more proximally, such that the sleeve is gradually separated from the channel 18 of the deployment manipulator 61 in the 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 to prepare the successive proximal portion of the sleeve 26 for the implantation of the subsequent anchor). The already deployed first anchor 32 holds the fixed 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. When the sleeve 26 is separated from the channel 18, the deployment manipulator 61 can move substantially laterally along the heart tissue, as shown in FIG. 3H. The deployment manipulator 61 deploys the second anchor at a second site into the heart tissue through the wall of the sleeve 26. Depending on the tension applied between the first anchor site and the second anchor site, the portion of the sleeve 26 therebetween can remain tubular or can become flat, which can help reduce any interference of the loop with the blood flow.

[0330] As shown in FIG. 3I, the deployment manipulator 61 can be repositioned along the valve annulus to another site where each anchor is disposed until the last anchor is deployed near the right fibrous triangle 244 (or the left fibrous triangle 242 if the fixation starts from the right triangular portion). Optionally, the last anchor is not deployed near the triangular portion but instead at another location near the mitral valve, such as near the anterior commissure or posterior commissure. Then, the system 10 is removed leaving the implant structure 222 and the contraction member 226. As described below, the contraction member engagement tool then passes over the contraction member 226, advances along the contraction member 226 and towards the structure 222, and is used to contract the structure 222 by adjusting the degree of tension of the contraction member 226 (not shown in FIG. 3I, but (i) the advancement of the contraction member engagement tool over the contraction member 226 is described with reference to FIGS. 4A - 5D, and (ii) the application of tension to the member 226 is described below with reference to FIGS. 6A - B).

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

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

[0333] As shown, the sleeve 26 of the annuloplasty structure 222 includes a plurality of radiopaque markers 25, which are positioned along the sleeve at respective longitudinal sites to indicate the target regions for anchor placement. The markers can provide an indication in an X-ray image (such as a fluoroscopic image) of the extent to which the sleeve 26 is deployed at any given time during the implantation procedure, in order to enable setting of the desired distance between the anchors 32 along the sleeve 26.

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

[0335] Alternatively, the valve annulus forming structure 222 is implanted by right thoracotomy or left thoracotomy with the necessary modifications.

[0336] In some applications, after implanting the sleeve 26 along the valve annulus, there may be an extra portion of the sleeve 26 present in the proximal portion of the sleeve. In such applications, after removal of the manipulator 61, a cutting tool (not shown) can advance within the channel 18 and within the lumen of the extra portion of the sleeve 26 (e.g., from within the sleeve 26) to cut the proximal sleeve of the most proximally deployed anchor 32.

[0337] Refer to FIGS. 4A - B, which are schematic diagrams of an exemplary system 10 comprising an exemplary shrink member capture tool 300 configured to contract the shrink member 226 and sever any excess portions of the shrink member 226. The tool 300 comprises a handle portion 320 and an elongate sheath 310 coupled thereto. The sheath 310 encloses 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 their respective proximal ends. The secondary tube 340 has a secondary lumen configured for passage of the shrink member 226 therethrough. The tool 300 defines a longitudinal axis 301.

[0338] In some applications, the sheath 310 is shaped to define a lumen within the wall of the sheath 310. In such applications, the tool 300 does not comprise a secondary tube 340; rather, the lumen within 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, primary tube 330, and secondary tube 340 may be flexible, such that the sheath 310, primary tube 330, and 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, primary tube 330, and secondary tube 340 comprise silicone. In some applications, the sheath 310, primary tube 330, and secondary tube 340 comprise polyurethane.

[0340] The tool 300 can comprise a shrink member snare 350 comprising a distal snare portion 352 and an elongate flexible body portion 354 coupled to the distal snare portion 352. The distal snare portion 352 is configured to fit around a portion of the shrink member 226 and is sized to pass through the secondary lumen of the secondary tube 340 and pull the shrink member 226 through the length of the secondary tube 340 as described below.

[0341] The distal snare portion 352 can 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 the 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 shrink member fastener 360. The shrink member fastener 360 includes a clamping structure that can be biased to take a closed state or position, and in the closed state / position, the clamping structure can be configured to clamp a shrink member 226 (not shown) that has passed therethrough. The clamping structure can also be configured to be bent to an open state in which the shrink member 226 (not shown) can move therethrough.

[0343] The tool 300 can include a fastener ejector 335 movable within the distal end portion 333 of the shrink member uptake tool 300. Movement of the fastener ejector 335 converts the shrink member fastener 360 (or its clamping structure) from its open state to its closed state to clamp a shrink member 226 that has passed therethrough, as described below. The tool 300 includes a stopper 362 removably coupled to the shrink member fastener 360 and configured to maintain the shrink member fastener 360 in an open state, as shown in cross-section A-A of FIG. 4A. The stopper 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 stopper 362 and moves the stopper 362, which is removably coupled to the fastener 360, to convert the fastener 360 from its open state to its closed state, as described below.

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

[0345] The shrink member receiving device 322 can optionally include a wheel having two opposing wedge-shaped portions 325 that together define a groove 326 configured to couple the shrink member 226 to the wheel of the device 322. The wedge-shaped portions 325 can be shaped to receive any portion of the shrink member 226, such as, for example, the 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 shrink member 226. As shown, the wheel of the device 322 can have a numerical indicator indicating the number of revolutions of the wheel.

[0346] As shown, the handle portion 320 is connected to the proximal portions of the primary tube 330 and the secondary tube 340, respectively.

[0347] The handle portion 320 can be shaped to define a lumen 328 for passage of a snare 350 through the interior from within the lumen of the secondary tube 340. The snare 350 passes through the lumen 328 and past the groove 326 of the snare member capture device 322. Although not necessarily, often the device 322 does not capture the snare 350; rather, the snare 350 passes through the groove 326. As described below, pulling on the snare 350 pulls on the shrink member 226 connected thereto, such that the shrink member 226 is pulled through the secondary tube 340, through the lumen 328, and ultimately towards the snare member capture device 322. Once the proximal end of the shrink member 226 (or a portion near the proximal end of the member 226) is pulled through the tube 340 and the lumen 328, the shrink member 226 is connected to the snare member capture device 322 by being fed into the groove 326. The snare member capture device 322 then operates to apply tension to the shrink member 226 and thereby to the valve ring forming structure 222 embedded along the valve ring. With each rotation of the wheel of the device 322, successive portions of the shrink member 226 are wound into the groove 326 of the device 322.

[0348] Figures 5A - D are schematic views of an exemplary snare member capture tool 300 that can be used to capture the shrink member 226. At this stage, the valve ring forming structure or valve ring forming loop structure 222 is embedded along the valve ring 240 as described above with reference to Figures 3A - I. Once the structure 222 is embedded along the valve ring, the shrink member 226 extends away from the structure 222 and through the patient's vasculature such that the proximal end portion of the member 226 is positioned outside the patient's body.

[0349] The contraction member 226 can exit the sleeve 26 of the structure 222 at any suitable position along the structure 222. For example, as shown in the illustration, the contraction member 226 can exit the sleeve 26 of the structure 222 at a portion of the structure 222 near the left fibrous triangle of the valve. 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 triangle of the valve. In some applications, the contraction member 226 exits the sleeve 26 of the structure 222 at an intermediate portion of the structure 222.

[0350] As shown in the illustration, 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 valve ring forming 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 valve ring forming structure 222.

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

[0352] FIG. 5B shows tool 300 with distal snare portion 352 fitting over contraction member 226. In some applications, distal snare portion 352 is shaped to increase the connection between snare 350 and contraction member 226. For example, in some applications, distal snare portion 352 is wavy to increase the friction between snare portion 352 and contraction member 226. In some applications, distal snare portion 352 can include a coiled section to increase the friction between snare portion 352 and contraction member 226. In some applications, snare 350 includes a metal wire. In some applications, snare 350 includes a metal wire including stainless steel. Snare 350 (including distal snare portion 352) can have various sizes, for example, a diameter of 0.15-0.5 mm or 0.15-0.35 mm.

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

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

[0355] The snare 350 is pulled until the distal snare portion 352 enters the lumen of the secondary tube 340. As a result, the loop portion of the distal snare portion 352 is compressed and folded around the looped contraction member 226 passing therethrough, maintaining the connection between the snare portion 352 and the contraction member 226 when the elongated flexible body portion 354 (shown in FIG. 5B) is pulled through the lumen of the secondary tube 340. When the loop portion of the snare portion 352 is folded within the lumen of the secondary tube 340, the portion of the contraction member 226 fitted by the snare portion 352 bends, strengthening the connection between the contraction member 226 and the snare portion 352. This strengthening is also brought about as a result of the relatively small diameter of the secondary tube 340, which is 0.5 to 1.0 mm.

[0356] In FIG. 5D, the snare 350 is pulled completely through the secondary tube 340, through the lumen 328 of the handle portion 320, and over the groove 326 of the contraction member intake device 322, pulling the contraction member 226 along this path. Throughout this process, the sheath 310 of the tool 300 advances through the vascular structure and toward the valve ring forming structure 222 embedded along the valve ring 240. Once the distal snare portion 352 and the portion of the contraction member 226 connected thereto exit the lumen 328 of the handle portion 320, that portion of the contraction member 226 is connected to the contraction member intake device 322 by being positioned within the groove 326. In some applications, the proximal end portion of the contraction member 226 is supplied into the groove 326. In some applications, an intermediate portion of the contraction member 226 (e.g., a portion near the proximal end of the contraction member 226) is supplied into the groove 326. Then, the contraction member 226 is tightly tightened by operating, e.g., rotating, the contraction member intake device 322 such that successive portions of the contraction member 226 are wound into the contraction member intake device 322 and the contraction member intake device 322 takes in the successive portions.

[0357] Once the snare 350 is pulled through the tool 300, the snare 350 can be discarded.

[0358] Referring to FIGS. 6A - B, which are schematic views of an exemplary tool 300 used to pull the contraction member 226 and thereby contract the contraction member 226 and the valve ring forming structure or valve forming ring structure 222 connected thereto. The contraction member intake device 322 rotates to facilitate intake of a continuous portion of the contraction member 226.

[0359] As shown in FIG. 6A, before rotating the contraction member intake device 322, the tension gauge 324 of the handle portion 320 reads the tension of the contraction member 226 at zero or near zero. Similarly, the sleeve 26 of the valve ring forming structure 222 connected to the valve ring 240 is in a relaxed, non - tensioned state. At this point, the tool 300 has advanced sufficiently through the patient's vasculature such that the proximal portion of the contraction member 226 is outside the patient's body while the distal tip 331 is close to the structure 222 disposed along the valve ring.

[0360] In FIG. 6B, the contraction member intake device 322 rotates to contract the contraction member 226 and apply tension thereto. The tension gauge 324 of the handle portion 320 reads a tension of 4 - 5 for the contraction member 226. Similarly, the sleeve 26 of the valve ring forming structure 222 connected to the valve ring 240 is in a tensioned, contracted state. As shown in FIG. 6B, the contraction member 226 is in a tensioned state with respect to the tool 300.

[0361] Referring to FIGS. 7A - E, which are schematic views of an exemplary tool 300 used to lock and fix the valve ring forming structure 222 in its contracted state and then sever the excess portion of the contraction member 226.

[0362] Figure 7A shows the non-contracted valve ring forming structure or valve forming ring structure 222. The distal tip 331 of the tool 300 can be brought closer to the structure 222. The contraction member 226 can be passed along the sleeve 26 and out from a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 can be passed through the tool 300 in such a way that the contraction member 226 can be held in an open state by the distal tip 331, a prong 337 of the stopper 362, etc., a contraction member fastener 360, aligned ports 339 and 341 within the distal end portion 333 of the tool 300, and the secondary tube 340.

[0363] As shown in Figure 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 pulling the contraction member 226 by the tool 300. During the contraction of the structure 222, the fastener 360 is not deployed.

[0364] In Figure 7C, the contraction member 226 is tightly pulled, the valve ring forming structure 222 contracts, and is in a tightly tensioned contracted state. Then, the distal end portion 333 of the tool 300 is used to push out and deploy the fastener 360 from within the tool 300 in order to lock the structure 222 in the contracted state.

[0365] Referring now to FIGS. 6A and 7C, once the distal tip 331 contacts the sleeve 26, the trigger 321 (shown in FIG. 6B) in the handle portion 320 of the tool 300 is partially pulled to facilitate pushing out and deploying the shrink 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 shrink member engaging tool 300. The movement of the fastener ejector 335 converts the shrink member fastener 360 from its open state to its closed state to clamp the shrink member 226 that has passed therethrough. The fastener ejector 335 is connected to the prong 337 of the retainer 362 in such a way that as the ejector 335 moves proximally within the portion 333 and the prong 337 of the ejector moves proximally away from the shrink member fastener 360, the retainer 362 is separated from the shrink member fastener 360. Once the shrink member fastener 360 is no longer held in the open state by the retainer 362, the fastener 360 closes and, as it tends to close, clamps around the shrink member 226 passing therethrough.

[0366] The proximal portion of the fastener ejector 335 can be connected to the distal end of the movement tube 343, and the movement tube 343 can be connected to the trigger 321 at its proximal end. The movement tube 343 is movable proximally in response to the movement of the trigger 321, and as a result, the fastener ejector 335 moves proximally relative to the distal tip 331 and the fastener 360 of the tool 300. As shown in FIG. 7B, the fastener 360 is 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 an excess portion of the shrink member 226. The tool 300 can be shaped to define a cutting - promoting edge 370 at the distal end portion 333 of the tool 300. In some applications, the cutting - promoting edge 370 defines a sharp edge. The shrink member 226 passes through the aligned ports 339 and 341 of the distal end portion 333 of the tool 300 as shown in FIGS. 7A - C, but the shrink member 226 is in proximity to the cutting - promoting edge 370. Movement of the fastener ejector 335 draws the cutting - promoting edge 372 of the ejector 335 proximally relative to the cutting - promoting edge 370 of the tool 300, thus sandwiching a portion of the shrink member 226 between the edges 370 and 372 and severing and cutting the shrink member 226 that extends through the ports 339 and 341. In some applications, the cutting - promoting edge 372 defines a sharp edge. FIG. 7D shows the shrink member 226 being severed when the cutting - promoting edge 372 of the ejector 335 is drawn proximally relative to the cutting - promoting edge 370 of the tool 300.

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

[0369] Referring to FIGS. 8A - D, which is a schematic diagram of an example of a system 510 for contracting a patient's annulus 240 using an annulus - forming structure 522 (e.g., an annulus - forming ring structure, a closed - type annulus - forming structure, a closed - type annulus - forming ring structure, an open - type annulus - forming structure, a partial annulus - forming ring structure, etc.) that can include a housing 530. The housing 530 can accommodate a shrink - member fastener 360. Except for the differences described below, the annulus - forming structure 522 can be the same as or generally similar to the annulus - forming structure 222 described above with reference to FIGS. 1 - 7E, and like reference numerals refer to like parts.

[0370] The valve ring forming structure or valve ring forming 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 the longitudinal length of the main body portion of the valve ring forming structure 522. The first portion 526 can extend along the 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 valve ring forming structure 522.

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

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

[0373] The housing 530 can be connected to the sleeve 26 of the structure 522 at any suitable position along the structure 522. For example, the housing 530 can be connected to the sleeve 26 of the structure 522 at a portion of the structure 522 near the left fibrous triangle of the valve, as shown. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 at a portion of the structure 522 near the right fibrous triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 at an intermediate portion of the structure 522. As shown, the housing 530 can be connected to the 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] FIG. 8B shows a shrink member intake tool 600 with the shrink member 226 passing therethrough. The shrink member 226 can be fitted by a tool 600 using a snare as described above with respect to the snare 350 with reference to FIGS. 4A - 5D. The tool 600 can advance along the shrink member 226 towards the housing 530 of the structure 522 in a similar manner as the tool 300 advancing along the shrink member 226 as described above with reference to FIGS. 4A - 5D.

[0375] The tool 600 can include a distal tip 631 and a distal end portion 633 that is generally similar to the distal end portion 533 of the tool 300 described above with reference to FIGS. 4A - 7E, and like reference numerals refer to like components. Since the valve ring forming structure 522 includes a shrink member fastener 360 and a stopper 570 removably coupled to the fastener 360, the distal end portion 633 of the tool 600 is different from the distal end portion 533 of the tool 300 in FIGS. 4A - 7E, while the remaining parts of the tool 600 correspond to the remaining parts of the tool 300.

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

[0377] The stopper coupler 672 of the tool 600 threadedly engages with the threaded portion 572 of the stopper 570 coupled to the shrink member fastener 360 disposed within the housing 530 of the structure 522.

[0378] As described above with reference to FIGS. 6A - B, a shrink member intake device (not shown, but similar to the shrink member intake device 322 of tool 300) of tool 600 can be used to shrink the shrink member 226. As shown in FIG. 8C, once the shrink member 226 has shrunk and the structure 522 has contracted, the tool 600 removes the stopper 570 by pulling it proximally away from the fastener 360. Since the fastener 360 has a tendency to close, without the stopper 570, the fastener 360 closes and clamps around the shrink member 226 passing through it. In such a way, the structure 522 is locked by the fastener 360 and the contracted state of the structure 522 is maintained.

[0379] FIG. 8D shows the shrink member 226 severed proximal to the fastener 360 and the excess portion of the shrink member 226 removed from the patient's body using the tool 600. The severing of the shrink member 226 is performed in a manner as described above with reference to FIGS. 7A - E with the necessary modifications.

[0380] Now refer to FIGS. 9A - D, which are schematic views of an exemplary shrink member intake tool 600 used to lock and fix the valve ring forming structure 522 of FIGS. 8A - D in its contracted state and then sever the excess portion of the shrink member 226.

[0381] FIG. 9A shows the valve ring forming structure 522 in a partially contracted state. The shrink member 226 can be passed along the sleeve 26 and out from a portion of the sleeve 26 of the structure 222. As described above, the shrink member 226 can be passed through the tool 600 in such a way that the shrink member 226 passes through the stopper coupler 672, distal tip 631, aligned ports 339 and 341 within the distal end portion 633 of the tool 600, and the secondary tube 340.

[0382] In FIG. 9B, the contraction member 226 is tightly pulled, the valve ring forming structure 522 contracts, and is in a tense contracted state. The distal end portion 633 of the tool 300 is brought close to the valve ring forming structure 522 (for example, as shown in the figure, the tip 631 contacts or approaches the housing 530), and the fastener 360 is pushed out and deployed within the housing 530 to lock the structure 522 in the contracted state.

[0383] Once the distal end portion 633 approaches the sleeve 26, a trigger on the handle portion of the tool 600 (similar to the trigger 321 of the tool 300 shown in FIG. 6B) can be partially pulled to facilitate pushing the contraction member fastener 360 distally and deploying it within the housing 530 of the valve ring forming structure 522. The fastener ejector 335 is movable within the distal end portion 633 of the contraction member capturing tool 600. The movement of the fastener ejector 335 converts the contraction member fastener 360 (for example, its clamping structure) from its open state to its closed state to clamp the contraction member 226 that has passed through it. The fastener ejector 335 is connected to the fastener coupler 672 of the tool 600 that threadedly engages the threaded portion 572 of the stopper 600 of the tool 600 in such a way that when the ejector 335 moves proximally within the portion 633 of the tool 600, the stopper 570 is pulled away from and then separated from the fastener 630. Once the contraction member fastener 360 is no longer held in the open state by the stopper 570, the fastener 360 closes and, as it tends to close, clamps around the contraction member 226 passing through it.

[0384] In FIG. 9C, the fastener ejector 335 can move further proximally (in response to further pulling of the trigger of the handle portion of the tool 600) to sever the excess portion of the shrink member 226. The tool 600 can be shaped to define a cutting - promoting edge 370 at the distal - end portion 633 of the tool 600. In some applications, the cutting - promoting edge 370 defines a sharp edge. The shrink member 226 passes through the aligned ports 339 and 341 of the distal - end portion 633 of the tool 600 as shown in FIG. 9B, but the shrink member 226 is close to the cutting - promoting edge 370. The movement of the fastener ejector 335 draws the cutting - promoting edge 372 of the ejector 335 proximally relative to the cutting - promoting edge 370 of the tool 300, and thus sandwiches a portion of the shrink member 226 between the edges 370 and 372, severing and cutting the shrink member 226 that extends through the ports 339 and 341. In some applications, the cutting - promoting edge 372 defines a sharp edge. FIG. 9C shows the shrink member 226 being severed when the cutting - promoting edge 372 of the ejector 335 is drawn proximally relative to the cutting - promoting edge 370 of the tool 600.

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

[0386] Now, referring to FIGS. 8A - 9D. The system 510 provides a valve - ring forming structure 522 (e.g., valve - ring forming ring structure, closed - type valve - ring forming structure, closed - type valve - ring forming ring structure, open - type valve - ring forming structure, partial valve - ring forming ring structure, etc.) in which the housing 530 houses the shrink - member fastener 360 rather than having the fastener 360 disposed outside the sleeve 26. In such a manner, the system 510 reduces the likelihood of embolism and / or coagulation.

[0387] Here, refer to FIGS. 4A - 9D. Using the shrink member capture tools 300 and 600, (1) tension can be applied to the shrink member, (2) a lock can be deployed to secure the tension of the shrink member, and (3) thereafter, the shrink member of any valve ring forming structure, such as a complete valve ring forming ring structure, a partial valve ring forming ring structure, etc., can be cut and separated.

[0388] Referring again to FIGS. 8A - D and 9A - D. The tool 600 is described as being able to advance towards the housing 530 already connected to the valve ring forming structure 522, but it should be noted that the scope of this specification includes a tool 600 configured to be connected to the housing 530 from a location outside the patient's body and delivered along the shrink member 226 to the sleeve 26 of the structure 522 already embedded in the valve ring. In such an application, the housing 530 is configured to be positionable relative to the main body portion of the structure 522.

[0389] Referring to FIGS. 10A - B, which is a schematic diagram of an exemplary system 700 including an exemplary shrink member capture tool 702 configured to contract the shrink member 226 and sever any excess portion of the shrink member 226.

[0390] Except for the differences described below, the shrink member capture tool 702 can be the same as or generally similar to the shrink member capture tools 300 and 600 described above with reference to FIGS. 4A - 9D, and is used to (1) apply tension to the shrink member, (2) deploy a lock to secure the tension of the shrink member, and (3) thereafter, cut and separate the shrink member of any valve ring forming structure, such as a complete (or closed - type) valve ring forming ring structure, or a partial (or open - type) valve ring forming ring structure.

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

[0392] Except for the differences described below, the valve ring forming structure 730 can be the same as or generally similar to the valve ring forming structures 222 and 522 described above with reference to FIGS. 1-9D, and like reference numerals refer to like components. The valve ring forming structure 730 can be a complete (or closed) or partial (or open) valve ring forming structure.

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

[0394] The tool 702 is used to embed a complete (or closed) valve ring forming structure 730 as shown, although the valve ring forming structure may be a valve ring forming ring structure or may include a partial (or open) valve ring forming structure.

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

[0396] The tool 702 can be configured in various ways. In some applications, the tool 702 includes an elongate sheath 310. In some applications, the sheath 310 encloses a primary tube 330 and a secondary tube 340 disposed along the primary tube 330. In such applications, the sheath 310 is shaped to define the secondary tube 340. The secondary tube 340 is shaped to define a longitudinal axis slit 740. The slit 740 facilitates the connection and engagement of the contraction member 226 within the lumen of the tube 340. The slit 740 also enables the easy release of the contraction member 226 from within the lumen of the tube 340. In some applications, the slit 740 facilitates the connection and / or release of the contraction member snare as described above with reference to FIGS. 4A - B. In some applications, the most distal section of the slit 740 is in a longitudinal position along the tube 340 proximal to the most distal end of the tube 340, e.g., in a portion of the tube 340 configured to be disposed proximal to the patient's ventricle, thereby preventing blood leakage from the heart through the slit 740.

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

[0398] In some applications, a compression tube (not shown) is used to deploy shrink member fasteners 360a and 360b. The compression tube includes a semi-rigid material used to deploy by pushing on fasteners 360a and 360b. Fasteners 360a and 360b can be coaxially and distally disposed around a portion of shrink member 226 and distally of the distal end of the compression tube. In some applications, fasteners 360a and 360b are removably disposed around a portion of the compression tube.

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

[0400] In some applications, oversheath 710 is not used and tool 702 is coupled to the valve ring forming structure using male and female couplings as shown below with reference to FIGS. 12, 13, and 15.

[0401] Referring now to FIGS. 11A-C, a schematic view of an exemplary system 800 including an exemplary shrink member capture tool 810 used to lock and secure valve ring forming structure 222 in its contracted state and then sever excess portions of shrink member 226, according to some applications.

[0402] Except for the differences described below, the shrink member insertion tool 810 may be the same as or generally similar to the shrink member insertion tools 300 and 600 described above with reference to FIGS. 4A-9D, which are used to (1) apply tension to the shrink member, (2) deploy a lock to secure the tension of the shrink member, and (3) then cut and sever the shrink member for any valve ring forming structure, such as a complete (or closed type) valve ring forming ring structure, a partial (or open type) valve ring forming structure, etc.

[0403] FIG. 11A shows a non-shrunk valve ring forming structure or valve forming ring structure 222. The distal tip 331 of the tool 810 can be brought close to the structure 222. The shrink member 226 can be passed along the sleeve 26 and out from a portion of the sleeve 26 of the structure 222. As described above, the shrink member 226 can be passed through the tool 810 in such a way that the shrink member 226 can be held in an open state by the distal tip 331, a shrink member fastener 360 such as the prong 337 of the stopper 362, the aligned ports 339 and 341 within 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 valve ring forming 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 shrinkage promoting knob 830. The knob 830 is fixedly connected to the proximal end 832 of the shrink member 226. Rotation of the shrinkage promoting knob 830 as shown in FIG. 11A moves the knob 830 proximally. When the knob 830 is pulled proximally, the shrink member 226 is pulled proximally. In response, the valve ring forming structure 222 shrinks. The tool 810 includes a gauge 834 that indicates the level of shrinkage of the ring in response to the number of rotations of the knob 830.

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

[0406] In FIG. 11C, the shrink member 226 is tightly pulled, the valve ring forming structure 222 contracts, and is in a tightly tensioned contracted state. The distal end portion 333 of the tool 810 is then used to push out and deploy the fastener 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, the trigger knob 840 in the handle portion 820 of the tool 810 is partially pulled to facilitate pushing out and deploying the shrink member fastener 360 from within the housing 332 of the distal end portion 333. The fastener ejector 335 is movable within the distal end portion 333 of the shrink member capture tool 810. The proximal portion of the ejector 335 is connected to the distal portion of the actuating wire 842. The proximal end 844 of the actuating wire 842 is connected to the trigger knob 840. Proximal movement of the trigger knob 840 pulls the actuating wire 842 proximally, which pulls the fastener ejector 335 to its maximum extent. Proximal movement of the fastener ejector 335 converts the shrink member fastener 360 from its open state to its closed state and tightens the shrink member 226 that has passed therethrough. The fastener ejector 335 is connected to the prong 337 of the retainer 362 in such a way that as the prong 337 of the ejector 335 moves proximally away from the shrink member fastener 360 within the portion 333, the retainer 362 is separated from the shrink member fastener 360. Once the shrink member fastener 360 is no longer held in the open state by the retainer 362, the fastener 360 closes and tightens around the shrink member 226 passing therethrough as it tends to close.

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

[0409] As shown in FIG. 11C, the fastener 360 has been extruded and deployed from within the housing 332 of the ejector 335. Thereafter, the fastener ejector 335 can move further proximally in response to further proximal pulling of the trigger knob 840 to sever the excess portion of the contraction member 226. Similar to the tools 300 and 600 described above, the tool 810 is shaped to define a cutting - facilitating edge 370 at the distal end portion 333 of the tool 810. In some applications, the cutting - facilitating edge 370 defines a sharp edge. The contraction member 226 passes through the aligned ports 339 and 341 at the distal end portion 333 of the tool 810 as shown in FIGS. 11A - C, and the contraction member 226 is in proximity to the cutting - facilitating edge 370. Movement of the fastener ejector 335 draws the cutting - facilitating edge 372 of the ejector 335 proximally relative to the cutting - facilitating edge 370 of the tool 810, and thus sandwiches a portion of the contraction member 226 between the edges 370 and 372 to sever and cut the contraction member 226 that extends through the ports 339 and 341. In some applications, the cutting - facilitating edge 372 defines a sharp edge. FIG. 11C shows the contraction member 226 being severed when the cutting - facilitating edge 372 of the ejector 335 is drawn proximally relative to the cutting - facilitating edge 370 of the tool 300.

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

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

[0412] Here, refer to FIGS. 12A - C, which is a schematic diagram of an example of a system 900 comprising an exemplary valve ring forming structure 910 (e.g., valve ring forming ring structure, closed valve ring forming structure, closed valve ring forming ring structure, open valve ring forming structure, partial valve ring forming ring structure, etc.) comprising a sleeve 26, a shrink member 226, and a lock 950. The embedded valve ring forming structure 910 comprises a main body portion 912. The shrink member 226 has a first portion 914 extending along the longitudinal length of the main body portion 912 of the valve ring forming structure 910 and a second portion 916 extending away from the main body portion 912 of the valve ring forming structure 910. The shrink member 226 is configured to adjust the outer circumference of the valve ring forming structure 910.

[0413] Except for the differences described below, the valve ring forming structure 910 may be the same as or generally similar to the valve ring forming structures 222, 522, and 730 described above with reference to FIGS. 1 - 11C, and like reference numerals refer to like components. The valve ring forming structure 910 may be a complete (or closed - type) or partial (or open - type) valve ring forming structure.

[0414] The main body portion 912 of the structure 910 has side walls 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 side wall of the main body portion 912 towards a second surface 936 on the opposite side of the side wall of the main body portion 912 (shown in FIG. 12C). The side walls of the main body portion 912 extend away from the recess 960 along a longitudinal axis 942 that is at a non - zero angle to the recess axis 940. The shrink member 226 extends through and via the recess 960 away from the main body portion 912 of the valve ring forming structure 910.

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

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

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

[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 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 within the recess 960. That is, the section of the recess 960 that receives the longest length L1 of the segment 951 has a longest length L3 of 0.2 - 1.5 mm. The proximal section of the recess 960 has a length L4 of 0.2 - 2 mm.

[0419] The lock 950 is shaped to define a lock lumen configured to surround the shrink member 226. The lock 950 is shaped to define a longitudinal slit 952 extending from the proximal surface of the lock 950 towards the distal surface of the lock 950. In some applications, the slit 952 defines the lock lumen of the lock 950. The slit 952 allows the lock 950 to be pushed 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 shrink member 226, thereby locking the 950 to the shrink member 226.

[0420] In some applications (not shown), the lock lumen has a consistent dimension (e.g., 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 lock lumen is shaped to define a distal portion that is wider than the proximal portion of the lock lumen. In such applications, the most proximal section of the recess 960 is narrower than any other portion of the recess 960 that is distal to the proximal portion.

[0422] Delivery tool 920 is used to deliver lock 950 into recess 960. Except for the differences described below, delivery tool 920 can be identical or generally similar to tools 300, 600, 702, and 810 described above with reference to FIGS. 4A - 11C, and like reference numerals refer to like components. Tool 920 includes a shrink member severing section 921 that can include the elements of tools 300, 600, 702, and 810 described above with respect to the cutting element.

[0423] As shown in FIG. 12A, delivery tool 920 delivers the valve ring forming structure or valve ring forming structure 910 and lock 950 together toward the valve ring. Delivery tool 920 and shrink member 226 are slidable relative to each other. When delivery tool 920 is coupled to valve ring forming structure 910, a portion of shrink member 226 (e.g., second portion 916) is disposed within the lumen of delivery tool 920 and lock 950 surrounds a portion of the shrink member. When delivery tool 920 is coupled to valve ring forming structure 910, lock 950 is disposed completely proximally relative to recess 960.

[0424] FIG. 12B shows a partial position of the lock 950 within the proximal portion of the recess 960. During the partial positioning of the lock 950, the distal portion of the lock 950 (e.g., the most distal tapered segment 951) is compressed. Since the distal portion of the lock lumen of the lock 950 is wider than the proximal portion of the lock lumen, when the distal portion of the lock 950 is compressed within the proximal portion of the recess 960, the distal portion of the lock 950 does not completely close around the contraction member 226, and thus at this stage, the lock 950 is not locked to the contraction member 226, which pulls the contraction member as the lock 950 is pushed further distally within the recess 960. Only when the lock 950 is fully pushed within the recess 960, since the most proximal section of the recess 960 is narrower than any other portion of the recess 960 distal to the proximal portion and the lock lumen of the lock 950 is narrower at the proximal portion 953 of the lock 950, at least the proximal portion 953 of the lock 950 closes around the contraction member 226 to lock 950 to the contraction member, thereby maintaining the outer periphery of the valve ring forming structure 910. That is, the tool 920 often uses a lock ejector 923 similar to the fastener ejector 335 described above to push the lock 950. The lock ejector 923 is movable within the distal end portion of the tool 920. The movement of the lock ejector 923 contacts the lock 950, converts it from the open state (shown in FIG. 12A) to the closed state (shown in FIG. 12C), and clamps the lock 950 to the contraction member 226 that has passed through the interior.

[0425] As shown in FIG. 12C, the lock 950 is shaped to fit entirely within the recess 960. As described above with reference to the tools 300, 600, 702, and 810 described above with reference to FIGS. 4A - 11C, the tool 920 is configured to sever the excess portion of the shrink member 226 after locking the lock 950 to the shrink 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 the edge 370 of the tool 300 as described above. Further, as described above, the shrink member 226 is disposed proximate to the sharp edge, whereby movement of the lock ejector 923 relative to the sharp edge severs the shrink member 226 extending through the lock 950.

[0426] Referring to FIGS. 13A - C, which is a schematic diagram of an example of a system 1000 comprising a sleeve 26, a shrink member 226, and a lock 1950, and an exemplary valve ring forming structure or valve ring forming structure 910 (e.g., valve ring forming ring structure, closed valve ring forming structure, closed valve ring forming ring structure, open valve ring forming structure, partial valve ring forming ring structure, etc.). Except for the differences described hereinafter in this specification, the system 1000 is the same or generally similar to the system 900 described above with reference to FIGS. 12A - C, except that when the delivery tool 920 is coupled to the valve ring forming structure 910, the lock 1950 is at least partially disposed and retained within the recess 1960. As shown, the most distal 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] Here, refer to FIGS. 10A - 13C. In FIG. 10A, tool 702 includes an over - sheath 710 at at least the distal portion of tool 702. Over - sheath 710 includes a gripper 720 configured to surround at least a portion of a valve - ring forming structure coupled to tool 702. In some applications, any of the tools 300, 600, and 810 described herein includes an over - sheath 710 that includes a gripper 720. To deploy fastener 360 and / or lock 950, since fastener 360 and / or lock 950 is pushed by the tool, gripper 720 and over - sheath 710 are configured to provide a reaction force to the valve - ring forming structure during the deployment of fastener 360 and / or lock 950 described herein. In some applications, the tools described herein do not include a gripper 720.

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

[0429] Lock 1110 can be used to lock any of the valve - ring forming structures described herein. For example, lock 1110 can be used to lock any of the valve - ring forming structures 222, 522, 730, and 910 described above with reference to FIGS. 1 - 13C.

[0430] The delivery tool can be used to deliver the lock 1110 towards the valve ring forming structure or the valve ring forming ring structure. The delivery tool can be the same as or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to FIGS. 4A - 13C, and like reference numerals refer to like parts. The delivery tool can comprise a shrink member severance section that can comprise elements of the tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

[0431] Referring to FIGS. 15A - C, there is a schematic diagram of an exemplary system 1480 comprising an exemplary valve ring forming structure 910 (e.g., valve ring forming ring structure, closed valve ring forming structure, closed valve ring forming ring structure, open valve ring forming structure, partial valve ring forming ring structure, etc.) comprising a sleeve 26, a shrink member 226, and a lock 1490 according to some applications. Except for the differences described below in this specification, 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 the proximal end portion of the lock 1490 and wider at the distal end portion of the lock 1490. Cross - section A - A of FIG. 15A shows a wider lock lumen around the shrink member 226 at the proximal end portion of the lock 1490 than the width of the lock lumen around the shrink member 226 at the distal end portion of the lock 1490 shown in cross - section B - B. As shown in FIG. 15C, once the lock 1490 is fully disposed within the recess 960, as shown in cross - section C - C, the proximal end portion closes tightly around the shrink member 226, while the distal end portion closes around the shrink member 226, which may not close as tightly as the proximal end portion closes around the shrink member 226, as shown in cross - section D - D.

[0432] As shown, the lock 1490 is shaped to define a slit 952 that is narrower at the proximal end portion of the lock 1490 and wider at the 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. 14.

[0434] In some applications, when the delivery tool 920 is coupled to the valve ring forming structure 910, the lock 1490 is disposed entirely proximally within the recess 1960, as shown in FIGS. 12A - C.

[0435] Referring to FIG. 16, there is shown a schematic view of an exemplary system 1200 comprising an exemplary valve ring forming structure 1210 (e.g., valve ring forming ring structure, closed valve ring forming structure, closed valve ring forming ring structure, open valve ring forming structure, partial valve ring forming ring structure, etc.) comprising a sleeve 26, a shrink member 226, and a lock 1220. The embedded valve ring forming structure 1210 comprises a main body portion. The shrink member 226 has a first portion extending along the longitudinal length of the main body portion of the valve ring forming structure 1210 and a second portion extending away from the main portion of the valve ring forming structure 1210. The shrink member 226 is configured to adjust the outer circumference of the valve ring forming structure 1210.

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

[0437] The structure 1210 includes 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 a second surface opposite the housing 1202. The housing 1202 is shaped to provide a shrink member inner cavity wall 1205 disposed along a shrink member inner cavity 1204. The shrink member inner cavity 1204 is disposed at a non-zero angle with respect to the recess axis 1207 of the recess 1230. The recess 1230 is shaped to define a recess inner cavity disposed along the recess axis 1207.

[0438] The lock 1220 is shaped to define a lock thread portion 1222. The housing 1202 of the valve ring forming structure 1210 is shaped to define a valve ring forming structure thread portion 1232 configured to engage the lock thread portion 1222. To advance the lock 1220 within the recess 1230 of the housing 1202, a physician threads the lock 1220 within the housing 1202 using a delivery tool. The delivery tool can be the same as or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to FIGS. 4A - 13C, and like reference numerals refer to like components. The delivery tool can include a shrink member severing section that can include elements of the 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, the distal surface of the distal end of the lock 1220 is configured to sandwich a first portion of the shrink member 226 against the shrink member inner cavity wall 1205 to lock the shrink member 226 at at least a first clamping point 1212.

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

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

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

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

[0444] Now refer to FIGS. 12A - C, 13A - C, 15A - C, and 16. In some applications, the slit of lock 1220 is wider at a distal end portion of lock 1220 and narrower at a proximal end portion of lock 1220.

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

[0446] Referring to FIG. 17, which is a schematic view of an exemplary system 1300 comprising an exemplary valve ring forming structure 1310 (e.g., a valve ring forming ring structure, a closed valve ring forming structure, a closed valve ring forming ring structure, an open valve ring forming structure, a partial valve ring forming ring structure, etc.) including a sleeve 26, a shrink member 226, and a lock 1320. The embedded valve ring forming structure 1310 includes a main body portion. The shrink member 226 has a first portion extending along the longitudinal length of the main body portion of the valve ring forming structure 1310 and a second portion extending away from the main portion of the valve ring forming structure 1310. The shrink member 226 is configured to adjust the outer circumference of the valve ring forming structure 1310.

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

[0448] The structure 1310 includes a housing 1302 shaped to define a sidewall and 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 a second surface opposite the housing 1302. The housing 1302 is shaped to provide a shrink member inner cavity wall 1305 disposed along a shrink member inner cavity 1304. The shrink member inner cavity 1304 is disposed at a non-zero angle with respect to the recess axis 1307 of the recess 1330. The recess 1330 is shaped to define a recess inner cavity disposed along the recess axis 1307.

[0449] Lock 1320 is shaped to define a lock thread portion 1222. The housing 1302 of the valve ring forming structure 1310 is shaped to define a valve ring forming structure thread portion 1332 configured to engage the lock thread portion 1322. To advance the lock 1320 within the recess 1330 of the housing 1302, a physician uses a delivery tool to thread the lock 1320 within the housing 1302. The delivery tool can be the same as or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to FIGS. 4A - 13C, and like reference numerals refer to like components. The delivery tool can comprise a shrink member severing section that can comprise elements of the tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

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

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

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

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

[0454] Now refer to FIGS. 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 most proximal section of the recess 1330 may be narrower than any other portion of the recess 1330 that is distal to the proximal portion.

[0455] Now refer to FIGS. 12A - C, 13A - C, 15A - C, and 17. In some applications, the slit of the lock 1320 is wider at a distal end portion of the lock 1320 and narrower at a proximal end portion of the lock 1320.

[0456] Now refer to FIGS. 14 and 17. In some applications, the slit of 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] Here, refer to FIGS. 16 - 17. Systems 1200 and 1300 provide a locking assembly that enables a surgeon to readjust the outer perimeter of the valve annulus forming structure after locking. For example, if the surgeon desires to readjust when locks 1220 and 1320 are in a fixed position, the surgeon can loosen or tighten the respective screws of locks 1220 and 1230 without disengaging them from their respective recesses 1230 and 1330 to slacken or tightly fasten the shrinkage member 226, thereby enabling readjustment of the outer perimeter of the valve annulus forming structure. Following readjustment of the shrinkage member 226, locks 1220 and 1320 are repositioned within their respective recesses 1230 and 1330.

[0458] Here, refer to FIG. 18, which is a schematic view of an example of a system 1350 for contracting a patient's valve annulus 240 using a valve annulus forming structure 522 (e.g., a valve annulus forming ring structure, a closed valve annulus forming structure, a closed valve annulus forming ring structure, an open valve annulus forming structure, a partial valve annulus forming ring structure, etc.) that can include a housing 530. The housing 530 can accommodate a shrinkage member fastener 1360. Except for the differences described below, the valve annulus forming structure 522 can be the same as or generally similar to the valve annulus forming structure 222 described above with reference to FIGS. 1 - 7E, and like reference numerals refer to like parts.

[0459] The valve annulus forming structure or valve annulus forming ring structure 522 can include a sleeve 26 that can define a main body portion of the structure 522. The structure 522 includes a shrinkage member 226 having a first portion that extends along the longitudinal length of the main body portion of the valve annulus forming structure 522. The shrinkage member 226 also defines a second portion that extends away from the main body portion of the valve annulus forming structure 522.

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

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

[0462] The housing 530 can be connected to the sleeve 26 of the structure 522 at any suitable location along the structure 522. For example, the housing 530 can be connected to the sleeve 26 of the structure 522 at a portion of the structure 522 near the left fibrous triangle of the valve, as shown. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 at a portion of the structure 522 near the right fibrous triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 at an intermediate portion of the structure 522. As shown, the housing 530 can be connected to the 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] The fastener 1360 is shaped such that the fastener 1360 defines an intersecting slit 1362, which is generally similar to the fastener 360 of FIGS. 8A - D except that the intersecting slit 1362 forms an opening through which the contraction member 226 transitions to a generally "X" or generally "+" (plus) shape internally.

[0464] FIG. 18 shows the contraction member 226 severed proximal to the fastener 1360 and the excess portion of the contraction member 226 removed from the patient's body using the tool 600. The severance of the contraction member 226 can be performed in a manner as described above with reference to FIGS. 7A - E with necessary modifications.

[0465] Referring to FIGS. 19A - B, which is a schematic diagram of an example of a system 1400 for contracting a patient's annulus using an annulus - forming structure (e.g., an annulus - forming ring structure, a closed - type annulus - forming structure, a closed - type annulus - forming ring structure, an open - type annulus - forming structure, a partial annulus - forming ring structure, etc.) that can be connected to the housing 1430. The housing 1430 can accommodate a contraction member fastener 1460. In some applications, the annulus - forming structure can be the same as or generally similar to the annulus - forming structure 222 described above with reference to FIGS. 1 - 7E, and like reference numerals refer to like parts. In some applications, the annulus - forming structure includes the housing 1430. In some applications, the housing 1430 is separated from the annulus - forming structure and can be delivered to and connected to the annulus - forming structure only when the annulus - forming structure is fixed to the annulus.

[0466] The housing 1430 can be connected to the sleeve 26 of the annulus - forming structure at any suitable position along the annulus - forming structure. For example, as shown, the housing 1430 can be connected to the sleeve 26 of the annulus - forming structure at a portion of the annulus - forming structure near the left fibrous trigone of the valve. In some applications, the housing 1430 can be connected to the sleeve 26 of the annulus - forming structure at a portion of the annulus - forming structure near the right fibrous trigone of the valve. In some applications, the housing 1430 can be connected to the sleeve 26 of the annulus - forming structure at an intermediate portion of the annulus - forming structure. As shown, the housing 1430 can be connected to the outer surface of the sleeve. In such applications, the housing 1430 does not block the lumen of the sleeve of the annulus - forming structure.

[0467] The annulus - forming structure or annulus - forming 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 the longitudinal length of the main body portion of the annulus - forming structure. The contraction member also defines a second portion that extends away from the main body portion of the annulus - forming structure.

[0468] The fastener 1460 is shaped to define a generally rectangular planar clip that includes a superelastic material, such as nitinol. The fastener 1460 comprises a deformable element shaped to define a plurality of slits surrounded by a plurality of flexible legs 1462 that enable the clip to transition between an inclined state (FIG. 19A) and a straight state (FIG. 19B). The clip's shrink wire engagement surface is shaped to define a plurality of teeth 1464. In some applications, the teeth 1464 are serrated. In some applications, the top surface of the clip is toothless and flat. The teeth 1464 are configured to increase the friction between the shrink member 226 and the fastener 1460.

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

[0470] The shrink member 226 can extend through the channel 1434 of the housing 1430 and through a stopper 1470 (e.g., a holder) disposed within the opening of the shrink member fastener 1460. The channel 1434 extends along the longitudinal axis 1410 of the housing 1430. The stopper 1470 can be shaped to define an internal lumen for surrounding the shrink member 226 and is shown as being shaped to define a larger cylindrical section that can be engaged by a tool and a narrower cylindrical engagement portion 1472. The engagement portion 1472 can be shaped to fit snugly within the channel 1434, whereby the engagement portion 1472 presses against the clip's shrink wire engagement surface and maintains the fastener 1460 in an inclined state, i.e., a released state of the fastener 1460. In the inclined state shown in FIG. 19A, the clip is deformed and does not press against the shrink member 226. In the inclined state, the shrink member 226 is free to move relative to the fastener 1460, the housing 1430, and the stopper 1470. The shrink member 226 is pulled until it sufficiently contracts the valve ring forming structure.

[0471] In FIG. 19B, the stopper 1470 is separated and removed from the housing 1430. When there is no force applied by the engaging portion 1472 to the shrink wire engaging surface of the clip, the clip returns to its stationary linear state and captures the shrink member 226 between the shrink wire engaging surface of the clip and the surface 1432 of the housing 1430, e.g., the inner wall. Thus, the fastener 1460 is here in a locked state where the clip locks and crimps the shrink member 226.

[0472] Referring now to FIGS. 20A - F, which are schematic views of an example of a portion of a multi - component tube system 1500 comprising a shrink member severing tool 1502 and a shrink member engaging tool 1600, as described below with reference to FIGS. 21A - 26B. The shrink member 226 is passed through and through the shrink member severing tool 1502 and the shrink member engaging tool 1600. The shrink member 226 can be fitted by a tool 1502 using a snare as described above with respect to the snare 350 in FIGS. 4A - 5D. The tool 1502 can advance along the shrink member 226 towards a valve ring forming structure 1522 (e.g., a valve ring forming ring structure, a closed valve ring forming structure, a closed valve ring forming ring structure, an open valve ring forming structure, a partial valve ring forming ring structure, etc.). In some applications, the tool 1502 advances towards a housing 1530 already connected to the structure 1522 in a manner similar to the tool 300 advancing along the shrink member 226 as described above with reference to FIGS. 4A - 5D. The valve ring forming structure 1522 can comprise a flexible main body portion. The shrink member 226 has a first portion extending along the longitudinal length of the main body portion. A second portion of the shrink member 226 can extend away from the main body portion of the valve ring forming structure 1522 and outside the patient's body.

[0473] System 1500 can be used to contract a patient's annulus using an annulus forming structure 1522 (e.g., an annulus forming ring structure, a closed annulus forming structure, a closed annulus forming ring structure, an open annulus forming structure, a partial annulus forming ring structure, etc.) that can include a housing 1530. The housing 1530 can accommodate a shrink member fastener 1560. Except for the differences described below, the annulus forming structure 1522 can be the same as or generally similar to the annulus forming structure 222 described above with reference to FIGS. 1 - 7E, and like reference numerals refer to like parts.

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

[0475] The annulus forming structure or annulus forming ring structure 1522 can include a sleeve 26 that can define a main body portion of the structure 1522. The structure 1522 includes a shrink member 226 having a first portion that extends along the longitudinal length of the main body portion of the annulus forming structure 1522. The shrink member 226 also defines a second portion that extends away from the main body portion of the annulus forming structure 1522.

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

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

[0478] The housing 1530 can be connected to the sleeve 26 of the structure 1522 at any suitable location along the structure 1522. For example, the housing 1530 can be connected to the sleeve 26 of the structure 1522 at a portion of the structure 1522 near the left fibrous triangle of the valve as shown. In some applications, the housing 1530 can be connected to the sleeve 26 of the structure 1522 at a portion of the structure 1522 near the right fibrous triangle of the valve. In some applications, the housing 1530 can be connected to the sleeve 26 of the structure 1522 at an intermediate portion of the structure 1522. As shown, the housing 1530 can be connected to the 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] Figure 20A shows a shrink member severing tool 1502 with a shrink member 226 passed therethrough. The shrink member 226 can be fitted by a tool 1502 using a snare as described above with respect to the snare 350 with reference to FIGS. 4A - 5D. The tool 1502 can advance along the shrink member 226 towards the housing 1530 of the structure 1522 in a manner similar to the tool 300 advancing along the shrink member 226 as described above with reference to FIGS. 4A - 5D.

[0480] Once the tool 1502 is passed along the shrink member 226, the shrink member 226 extends through the sleeve 26, the engagement portion 1574, the proximal portion of the stopper 1570, the cutting elements 1510 and 1520 of the tool 1502, and the remaining proximal portion of the tool 1502. Thus, the shrink member 226 is disposed near the cutting elements. The shrink member 226 is disposed along the longitudinal axis 1511 of the tool 1502 along the entire length of the tool 1502. The relative spatial orientation of the components of the tool 1502 enables the shrink 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 non - tortuous path of the member 226 through the tool 1502 reduces its friction when the member 226 moves within the tool 1502. This direct path of the shrink member 226 is enabled by the orientation of the components of the tool 1502 as opposed to the tortuous path member 226 through the tools 300, 600, 810, and 920 described above. The reduction of friction on the shrink member 226 reduces the noise during the measurement of the tension of the shrink member 226 as described below with reference to FIGS. 21A - 26B.

[0481] Tool 1502 includes 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 a fastener ejector. The distal end portion of the tube 1504 is grooved, and because the gripper 1505 is inclined, the gripper 1505 tends to be pushed radially outward in the absence of a force applied to it by the protrusion 1572. Once the tube 1504 is pushed sufficiently distally, the gripper 1505 passes distally around the protrusion 1572 and closes around the stopper 1570 at a location distal to the protrusion 1572, as shown in FIG. 20B. The gripping mechanism 1505 provides primary and initial connection and locking of the tool 1502 to the housing 1530 by gripping the protrusion 1572.

[0482] Tool 1502 includes 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) that faces 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 retainer 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 the distal end of the outer sleeve portion 1508 contacts the proximal end of the housing 1530, as shown in FIG. 20C. Such distal movement of portion 1508 locks the tube 1504 in position relative to the retainer 1570, thereby locking the tool 1502 in position relative to the housing 1530. Because the gripper 1505 is inclined, the gripper 1505 is capable of sliding proximally around the protrusion 1572 in response to proximal pulling of the tool 1502. Thus, surrounding the grooved distal end portion of the tube 1504 and the gripper 1505 around the tube 1504 with the outer sleeve portion 1508 prevents radial movement of the gripper 1505 and locks the shrink member 226 in position and holds the valve ring forming structure 1522 in tension in response to applying a proximal pulling force to the retainer 1570 by the tool 1502 during release of the fastener 1560, as described below. Thus, the outer sleeve portion 1508 locks the gripper 1505 relative to the protrusion 1572 and provides secondary connection and locking of the tool 1502 relative to the housing 1530.

[0484] The static cutting element 1510 includes a pin 1513 that slides proximally and distally within a slit 1515 in the tube 1404. Thus, the static cutting element 1510 is connected to the tube 1404 and the tube surrounding the tube 1404. That is, the pin 1513 is connected 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 slightly spaced from the proximal surface 1571 of the retainer 1570.

[0485] FIG. 20D shows the contraction of the valve ring forming structure 1522 in response to proximal pulling of the contraction member 226 by the tool 1502. During the pulling of the contraction member 226, the tool 1502 has the outer sleeve portion 1508 surround the distal portion of the inner tube 1504 and surround the gripper 1505, while the gripper 1505 remains connected to the housing 1530 by gripping the protrusion 1572.

[0486] The tool 1502 can include a contraction member capturing device 322 of the tool 300 as described above with reference to FIGS. 4A - B. The contraction member capturing device can be used to contract the contraction member 226. As shown in FIG. 20D, once the contraction member 226 contracts and the structure 1522 contracts, the tool 1502 removes the stopper 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 on the tube 1504 causes the gripper 1505 to pull the stopper 1570 proximally because the outer sleeve portion 1508 causes the gripper 1505 to continue gripping the protrusion 1572 of the stopper 1570. While pulling the tube 1504 proximally, the outer sleeve portion 1508 prevents the radial outward movement of the gripper 1505 because a proximal force is being applied to the tube 1504. The tube 1504 is pulled proximally until the stopper 1570 is disengaged from the housing 1530, i.e., until the engaging portion 1574 of the stopper 1570 is separated and disengaged from the fastener 1560 as shown in FIG. 20E. Since the fastener 1560 tends to close, without the stopper 1570, the fastener 1560 closes and clamps around the contraction member 226 passing through the fastener 1560. In such a way, the structure 1522 is locked by the fastener 1560 and the contracted state of the structure 1522 is maintained.

[0487] When the stopper 1570 is pulled proximally, the proximal surface of the stopper 1570 is struck into the distal surface 1523 of the dynamic cutting element 1520. In response to pushing the stopper 1570 against the dynamic cutting element 1520, the dynamic cutting element 1520 is pushed proximally, whereby the dynamic cutting element 1520 moves proximally diagonally. The cutting surface 1521 of the dynamic cutting element 1520 and the cutting element 1520 slide proximally diagonally along the cutting surface 1512 of the static cutting element 1510. The portion of the constriction member 226 disposed between the cutting surfaces 1512 and 1521 is severed. Since the cutting surfaces 1512 and 1521 are concave and face each other, the surfaces 1512 and 1521 compress the constriction member 226 during cutting, whereby the constriction member 226 is severed cleanly and without fraying.

[0488] Thus, the tool 1502 is advantageously arranged such that after the fastener 1560 has been shifted to the fastened or locked state or has locked the constriction member 226 in place, the constriction member 226 can only be severed by the proximal force applied thereto by the stopper 1570, i.e., the tool 1502 cannot inadvertently sever the constriction member 226 while the tool 1502 is not connected to the stopper 1570 and while the stopper 1570 is not pushing on the cutting element 1520. In one quick motion, the tool 1502 (1) locks the constriction member 226 in place by shifting the fastener 1560 to the locked state and (2) severs the constriction member 226.

[0489] FIG. 20F shows the constriction member 226 after being severed proximal to the fastener 1560 and the extra portion of the constriction 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 stopper 1570 within the lumen of the tool 1502. Since the stopper 1570 is no longer connected to the housing 1530, a simple proximal pull on the tool 1502 is sufficient to separate the tool 1502 from the valve ring forming structure 1522.

[0490] Referring again to FIGS. 20A - F, the tool 1502 has been described as being capable of advancing toward the housing 1530 already connected to the valve ring forming structure 1522. It should be noted that the scope of this specification includes a tool 1502 configured to be connected to the housing 1530 from a location outside the patient's body and to deliver the housing 1530 along the contraction member 226 of the structure 1522 already embedded in the valve ring. In such an application, the housing 1530 is configured to be positionable relative to the main body portion of the structure 1522.

[0491] Referring to FIGS. 21A - 26B, which are schematic views of another portion of the multi - component tube system 1500 described above with reference to FIGS. 20A - F, there is provided a contraction member insertion tool 1600 configured to contract a flexible elongated contraction member 226 according to some applications. FIGS. 21A - B show the contraction member insertion tool 1600 before the insertion of the flexible elongated contraction member 226, and FIGS. 22A - 26B show the contraction member insertion tool 1600 after the insertion of the flexible elongated contraction member 226.

[0492] The multi - component tube system 1500 is used with an implant that includes an implantable structure and a flexible elongated contraction member 226 extending away from the implantable structure. The implant may include any of the implants described herein, such as an implantable valve ring forming structure 222 that may include, for example, a flexible sleeve 26. Alternatively, the implant may include another implant known in the art (including those described in patents and patent application publications incorporated herein by reference), which may or may not include a sleeve.

[0493] The contraction member insertion tool 1600 includes a handle portion 1620 that may be optionally supported by a stand as described above with reference to FIGS. 1 - 2. The handle portion 1620 can comprise one, some, or all of the following. ● An outer housing 1632 that can be ergonomically shaped for holding by a user (e.g., a doctor, a medical worker, etc.), ● A tubular shaft 1634 at least partially disposed within the outer housing 1632, ● An inner shaft 1636 that is (a) partially disposed within the proximal longitudinal portion 1637 of the tubular shaft 1634, whereby the inner shaft 1636 is axially slidable relative to the tubular shaft 1634, and (b) shaped to define an inner shaft shrink member receiving channel 1638, ● A distal force applicator 1642 that is (a) at least partially disposed within the distal longitudinal portion of the tubular shaft 1634, and (b) shaped to define a distal force applicator shrink member receiving channel 1644 that enables sliding of a shrink member 226 therethrough, ● A spring 1646 disposed within the tubular shaft 1634 and connecting the distal force applicator 1642 and the distal portion 1647 of the inner shaft 1636, and ● A shrinkage promoting knob 1630 accessible from the outside of the outer housing 1632.

[0494] The handle portion 1620 is shaped to define a handle shrink member receiving channel 1650 from the distal end to the proximal end of the handle portion 1620 (when used in this application including the claims, "proximal" means the direction of the user, i.e., the direction away from the implant. Referring to FIGS. 21A - 26B, "proximal" means the right side of the drawing). The handle shrink member receiving channel 1650 includes the inner shaft shrink member receiving channel 1638, the distal force applicator shrink member receiving channel 1644, and optionally additional shrink member receiving channels of the handle portion 1620. A portion of the shrink member 226 is passed through the handle shrink member receiving channel 1650 either before or after the embedded structure and the shrink member 226 advances toward the patient's heart.

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

[0496] The handle portion 1620 is configured such that actuation of the shrinkage promoting knob 1630, when the shrinkage member 226 is disposed completely through the handle shrinkage member receiving channel 1650 and the lock 1640 is in the locked state, causes the continuous portion of the shrinkage member 226 to be incorporated into the handle portion 1620. FIGS. 22A - B show the handle portion 1620 prior to actuation of the shrinkage promoting knob 1630 when the shrinkage member 226 is disposed completely through the handle shrinkage member receiving channel 1650 and the lock 1640 is in the locked state. FIGS. 23A - B, 24A - B, and 25A - B show the handle portion 1620 after successive actuation levels of the shrinkage promoting knob 1630, as described below.

[0497] As shown in FIGS. 21A - B and 22A - B, prior to initial actuation of the shrinkage promoting knob 1630, the portion of the shrinkage member 226 between the handle portion 1620 and the implant may be slack to some degree or at most minimally tensioned. 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, indicating that there is substantially no tension in the shrinkage member 226, i.e., the shrinkage member 226 is not tensioned. In applications where the implant includes an implanted valve ring forming structure 222 that includes the flexible sleeve 26, the sleeve 26 (connected to the valve ring 240) is in a relaxed, non - tensioned state. At this point, the tool has advanced sufficiently through the patient's vasculature such that the distal tip of the tool is proximate to the structure 222 disposed along the valve ring.

[0498] As shown, for example, during the transition between FIGS. 22A - B and 23A - B, the actuation of the contraction - promoting knob 1630 advances the tubular shaft 1634 proximally relative to the outer housing 1632, which advances the distal - force applicator 1642 proximally relative to the outer housing 1632 (the distal - force applicator 1642 can be axially fixed to the tubular shaft 1634 during normal use of the handle portion 1620), which applies a proximal - direction force to the spring 1646, pushing the inner shaft 1636 proximally relative to the outer housing 1632 (by the spring 1646 that applies a proximal - direction force to the inner shaft 1636), which, by pulling the contraction member 226 proximally (axially locked to the inner shaft 1636 by the lock 1640 as described above), causes the handle portion 1620 to incorporate the continuous portion of the contraction member 226.

[0499] Sometimes, during the initial proximal movement of the distal - force applicator 1642 relative to the outer housing 1632, as shown in the transition between FIGS. 22A - B and 23A - B, the contraction member 226 is relatively slack as described above, and thus the inner shaft 1636 offers little or relatively little resistance to the proximal - direction force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 is either not axially compressed or is axially compressed only minimally. As a result, when 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 advance of the tubular shaft 1634 and the inner shaft 1636 relative to the outer housing 1632 serves 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 is tensioned (at an initial low tension level), whereby the inner shaft 1636 gradually provides increased resistance to the proximal force applied to the inner shaft 1636 by the spring 1646, and the spring 1646 is gradually compressed further. When used in the present application including the claims, the contraction member 226 is considered to be "tensioned" even when tensioned at a low tension level.

[0501] As shown in the transition between FIGS. 23A - B and 24A - B, as the spring 1646 is compressed further, the distal force applicator 1642 moves axially closer to the inner shaft 1636, whereby the tubular shaft 1634 moves proximally relative to the inner shaft 1636. As a result, the spring 1646 presses 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 tension offset distance D2, as shown in FIGS. 24A - B. (In actual use of the handle, many tension offset distances D2 occur. A single offset is shown for illustrative purposes.) The tension offset distance D2 is less than the initial offset distance D1, reflecting the fact that the portion of the inner shaft 1636 protruding from the proximal end 1652 of the tubular shaft 1634 has decreased.

[0502] The contraction promoting knob 1630 can have any shape that enables its operation and is not necessarily circular, tubular, or substantially cylindrical. For example, in some applications, the contraction promoting knob 1630 is configured to operate by its rotation about the central longitudinal axis of the tubular shaft 1634, as shown in the drawings. Optionally, in some applications, the contraction promoting knob 1630 is configured to operate by its axial sliding relative to the outer housing 1632 (the configuration is not shown). The contraction promoting knob 1630 may be non-electric, i.e., completely mechanical, or may optionally include electrical components including a circuit, for example.

[0503] In some applications, the tubular shaft 1634 and the contraction promoting knob 1630 are threadedly connected to each other, and the handle portion 1620 is configured such that the operation of the contraction promoting 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 contraction promoting knob 1630 is configured to operate by its rotation about the central longitudinal axis of the tubular shaft 1634, as shown in the drawings.

[0504] In some applications, the handle portion 1620 further includes an inner stabilizing tube 1680 that (a) extends proximally from the distal force applicator 1642 and is axially fixed thereto, and (b) defines a portion of the handle contraction member receiving channel 1650 through its interior. A portion of the inner stabilizing tube 1680 is disposed within the inner shaft contraction member receiving channel 1638, and the length of that portion varies depending on the distance between the distal force applicator 1642 and the inner shaft 1636. A spring 1646 may surround a portion of the inner stabilizing tube 1680 and be configured to move axially freely relative to the outer surface of the inner stabilizing tube 1680.

[0505] In some applications, the inner shaft 1636 partially protrudes outside 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, both the tubular shaft 1634 and the inner shaft 1636 provide a non-electrical mechanical 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 the measure of tension in the contraction member 226. The tubular shaft 1634 can also protrude outside the proximal end 1639 of the outer housing 1632, at least after it begins to advance proximally. In these applications, the inner shaft 1636 can be marked with a plurality of reference 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, the reference markers 1626 can provide a reading value of zero or close to zero after the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are disposed as the initial offset distance D1 therebetween, as shown in FIGS. 22A-B. (The force applied to the spring 1646 at any given compression level of the spring is equal to the tension in the contraction member 226.)

[0506] Note that the force gauge 1624 does not measure the length of the contraction member 226 taken in by the handle portion 1620. (This taken-in length is equal to the distance that the inner shaft 1636 moves proximally.) As described above, the initial portion of the taken-in length is sometimes due to the proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally substantially parallel to the inner shaft 1636 before the contraction member 226 becomes tense. During any such initial movement, the tension in the contraction member 226 does not substantially increase even if the handle portion 1620 takes in the contraction member 226.

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

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

[0509] Refer again to FIGS. 24A - B and 25A - B. Also refer to FIGS. 26A - B, which are schematic views 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 includes a tension - limiting locking 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 - limiting locking assembly 1658 is configured to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at 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 - limiting locking assembly 1658 may also be configured to axially lock the tubular shaft 1634 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at a predetermined relative axial position with respect to the inner shaft 1636.

[0510] In some applications, as shown in FIGS. 25A - B, the tension - limiting locking assembly 1658 includes a detent 1660 arranged to axially lock the inner shaft 1636 relative to the outer housing 1632 when the tubular shaft 1634 is disposed at 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.

[0511] As shown in the transition between FIGS. 24A - B and 25A - B, as spring 1646 is further compressed, distal force applicator 1642 moves axially closer to inner shaft 1636, whereby tubular shaft 1634 moves proximally relative to inner shaft 1636. As a result, the offset distance between proximal end 1652 of tubular shaft 1634 and proximal end 1654 of inner shaft 1636 decreases to a maximum tension offset distance D3 (optionally, it may be zero or near zero as shown), which is less than tension offset distance D2 and equal to the above - described predetermined relative axial position of tubular shaft 1634 relative to inner shaft 1636. In many cases, but not necessarily, a relatively small portion of inner shaft 1636 still protrudes from proximal end 1652 of tubular shaft 1634, particularly in the configuration where handle portion 1620 provides non - electromechanical force gauge 1624 as described above.

[0512] In an application where the implant comprises an implantable valve ring forming structure 222 with flexible sleeve 26, sleeve 26 of valve ring forming structure 222 connected to valve ring 240 can be in a relaxed, non - tensioned state.

[0513] Tension - limiting locking assembly 1658 optionally obviates the need for non - electromechanical force gauge 1624 described above. Further, in applications where force gauge 1624 is provided, tension - limiting locking assembly 1658 obviates the need for the user to repeatedly check the reading of force gauge 1624, thereby allowing the user to focus attention on other aspects of the procedure such as fluoroscopic images. In many cases, the predetermined relative axial position of tubular shaft 1634 relative to inner shaft 1636 has the effect of setting a predetermined maximum tension that can be applied to shrink member 226 using shrink member incorporating tool 1600.

[0514] It should be noted that the tension limiting locking assembly 1658 often does not axially lock the inner shaft 1636 in direct response to the length of the shrink member 226 taken in by the handle portion 1620. (This taken-in length is equal to the distance the inner shaft 1636 moves proximally.) Further, the tension limiting locking assembly 1658 often does not axially lock the inner shaft 1636 in direct response to the relative axial movement between the inner shaft 1636 and the outer housing 1632 or in direct response to the relative axial movement between the tubular shaft 1634 and the outer housing 1632. As described above, the initial portion of the taken-in length is sometimes due to the proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally substantially parallel to the inner shaft 1636 before the shrink member 226 is tensioned. Since the tension limiting locking 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 at a predetermined relative axial position with respect to the inner shaft 1636, the tension limiting locking assembly 1658 is not affected or induced by any parallel movement of the inner shaft 1636 and the tubular shaft 1634 relative to each other.

[0515] In some applications, the detent 1660 is axially fixedly connected to the inner shaft 1636 and is configured to move radially outward and 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 to apply a radially outward force to the detent 1660. When the tubular shaft 1634 is not disposed at a predetermined relative axial position with respect to the inner shaft 1636, as shown in FIGS. 22A - 23B, the handle portion 1620 is configured to prevent the radially outward movement of the detent 1660, for example, as described below. As used in this application, including the claims, "radially outward" means a direction farther from the central longitudinal axis of the outer housing 1632, and "radially inward" means the opposite direction closer to the central longitudinal axis.

[0516] In some applications, the tension limiting latching assembly 1658 further includes a plurality of recesses 1662 shaped to be defined by the outer housing 1632. The detent 1660 is engageable with the recess 1662 to axially latch the inner shaft 1636 relative to the outer housing 1632. When the tubular shaft 1634 is disposed at a predetermined relative axial position with respect to the inner shaft 1636, the handle portion 1620 is disposed such that a particular one of the recesses 1662 with which the detent 1660 engages depends on the relative axial position of the inner shaft 1636 with respect to the outer housing 1632. In this arrangement, even if the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 that causes the detent 1660 to axially latch the inner shaft 1636 relative 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 vary to correspond to different initial slack levels in the shrink 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 latches 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, to prevent the detent 1660 from axially latching the inner shaft 1636 relative to the outer housing 1632 (by blocking the radially outward movement of the detent 1660), and ● When the tubular shaft 1634 is disposed at a predetermined relative axial position with respect to the inner shaft 1636, one or more tracks 1666 are provided and arranged to enable the detent 1660 to axially latch the inner shaft 1636 (by allowing the radially outward movement of the detent 1660).

[0518] A portion of one or more tracks 1666 that prevents the detent 1660 from axially locking the inner shaft 1636 relative to the outer housing 1632 can be disposed radially inwardly of a portion of 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 comprises one or more detent supports 1688 that are fixed to the detent 1660 and configured to slide axially along one or more tracks 1666. When the tubular shaft 1634 is distally disposed in a predetermined relative axial position, the one or more tracks 1666 prevent a radially outward movement of the one or more detent supports 1688 and thereby prevent a radially outward movement of the detent 1660. In some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 comprises one or more detent struts 1690 that stabilize the one or more detent supports 1688 while it is moving radially, and the one or more detent supports 1688 can slide radially relative to the one or more detent struts 1690.

[0520] In some of these applications, one or more tracks 1666 are shaped to define one or more respective inclined portions 1668. When the tubular shaft 1634 is disposed at a predetermined relative axial position with respect to the inner shaft 1636, after the detent 1660 axially locks the inner shaft 1636 with respect to the outer housing 1632, subsequent distal movement of the tubular shaft 1634, and the corresponding distal movement of one or more tracks 1666 with respect to the inner shaft 1636, disengages the detent 1660 from the outer housing 1632. For example, this disengagement can occur by one or more inclined portions 1668 sliding radially inwardly on a portion of one or more tracks 1665 that are radially inwardly and radially inwardly disposed detent supports 1688. The distal movement of the tubular shaft 1634 can be caused by actuation of the contraction promoting knob 1630 in the opposite direction of actuation with respect to the proximal movement described above. Thereby, the user can reduce the tension in the contraction member 226 as needed during the procedure, even if the tension level is high enough to induce the tension limiting lock of the detent 1660. Of course, if desired, the user can also reduce the tension in the contraction member 226 even before the tension limiting lock of the detent 1660.

[0521] In some applications, once the desired tension level in the contraction member 226 is achieved (by monitoring the force gauge 1624, by the detent 1660 that limits the maximum tension, and / or by monitoring the degree of valve backflow, for example, under echocardiogram 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 to maintain the contraction member 226 (and optionally, structure 222 if provided) in a contracted state.

[0522] In some applications, the detent 1660 and / or the recess 1662 are angled slightly (e.g., 1 to 45 degrees, e.g., 1 to 30 degrees, e.g., 1 to 15, e.g., about 5 degrees) relative to a direction perpendicular to the central longitudinal axis of the handle portion 1620, such that, perhaps most visibly in the stretch of FIG. 25B, the detent 1660 is angled slightly proximally and / or the opening of the recess 1662 is angled slightly distally. This angling facilitates capture and engagement of the detent with the recess 1662, and, as described above, can also facilitate disengagement, as needed, because the detent 1660 moves proximally immediately prior to engaging one of the recesses 1662. Alternatively, the detent 1660 and / or the recess 1662 are not angled and are perpendicular to the central longitudinal axis of the handle portion 1620.

[0523] Referring again to FIGS. 21A - B. In some applications, the spring 1646 is pre - loaded when the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are positioned at their initial offset distance D1 therebetween. Often, the handle portion 1620 is configured to maintain this pre - load 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) can block the advancement of an element of the tension - limiting locking assembly 1658 (e.g., one or more of the detent struts 1690 or the proximal portion of one or more detent supports 1688, as shown in FIG. 26A). The setting of the pre - load is described immediately below.

[0524] Referring again to FIG. 21B. In some applications, the radially inward surface near the distal end of the tubular shaft 1634 is shaped to define a thread 1682, and the radially outward surface of the distal force applicator 1642 is shaped to define a corresponding thread 1686. The threads allow adjustment of the exact 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 can be easily performed prior to insertion of the tubular shaft 1634, the inner shaft 1636, the distal force applicator 1642, the spring 1646, and other elements fixed to the inner shaft 1636 into the outer housing 1632. As described above, during use of the handle portion 1620 during a medical procedure, the distal force applicator 1642 is rotationally fixed relative to the tubular shaft 1634 and is thus axially fixed.

[0525] In some applications, adjustment of the axial position of the distal force applicator 1642 relative to the tubular shaft 1634 during the calibration procedure adjusts the preload of the spring 1646 (by compression of the spring) to set the desired maximum tension level that the inner shaft 1636 can apply to the contraction member 226. For example, a distal force can 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 limiting 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 limiting locking assembly 1658 is triggered during subsequent use. Removing this calibrated distal force, the spring 1646 extends as described above until further advancement of the inner shaft 1636 is blocked, and the spring 1646 has the desired preload level.

[0526] Refer again to FIGS. 1 - 26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500, and methods can be used to treat a patient's heart valve, e.g., the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. Further, the systems described herein for valve treatment can be used to treat other circular muscles within a patient's body. For example, the systems described herein can be used to treat the sphincter muscle within a patient's stomach.

[0527] Refer again to FIGS. 1 - 26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 can be secured to valve ring tissue using any of the anchoring devices described in U.S. Patent Application Publication No. 2015 / 0272734 to Sheps et al., which includes an anchor driver and deployment manipulator.

[0528] Refer again to FIGS. 1 - 26B. The above-described systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500, and methods can be used on any suitable tissue of a patient (e.g., stomach tissue, urinary tract, and prostate tissue).

[0529] Here, refer to FIGS. 1 to 26B. The tools described herein can be used to deploy, affix, and adjust the outer perimeter of any annuloplasty structure, such as a complete (or closed-type) annuloplasty structure or a partial (or open-type) annuloplasty structure. Any tool described herein can be coupled to an annuloplasty structure using any coupling described herein with reference to FIGS. 7A to 26B. For example, any annuloplasty structure described herein can comprise a housing 930 having a female coupling 927, and the tool described herein can comprise the male coupling 925 tool described above with reference to FIGS. 12, 13, and 15. The annuloplasty structures described herein can include elements and structures described in Cabiri et al.'s PCT Publication No. WO 10 / 073246, which is incorporated herein by reference.

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

[0531] All of these applications are incorporated herein by reference. The techniques described herein can be implemented in combination with the techniques described in one or more of these applications. Further, any and all of the methods, techniques, steps, etc. described herein can be implemented on a living animal or by simulation / simulation methods (e.g., on a simulator having a cadaver, cadaver heart, simulated heart, tissue, etc., on an anthropomorphic ghost, etc.).

[0532] The present invention is not limited to what has been specifically illustrated and described above. Rather, the scope of the present invention includes both the combinations and sub - combinations of the various features described above, as well as those changes and modifications thereof that would occur to one of ordinary skill in the art upon reading the above description and that are not in the prior art.

[0533] [Additional Item 1] An apparatus comprising: An embedded valve ring forming structure, comprising: A main body portion, and A shrink member having (1) a first portion extending along the longitudinal length of the main body portion of the valve ring forming structure, and (2) a second portion extending away from the main portion of the valve ring forming structure; and an embedded valve ring forming structure; A shrink member capturing tool, comprising: A primary tube terminating at a distal end portion of the shrink member capturing tool, the distal end portion of the shrink member capturing tool having a distal tip; a primary tube; A secondary tube disposed along the primary tube and having a secondary tube lumen configured for passage of the shrink member therethrough; a secondary tube; and A shrink member snare comprising a distal snare portion and an elongate flexible body portion coupled to the distal snare portion, the distal snare portion being configured to fit a portion of the shrink member, sized to pass through the secondary tube lumen of the secondary tube and pull the second portion of the shrink member through the length of the secondary tube; and a shrink member capturing tool; and an apparatus. [Additional Item 2] The apparatus according to claim 1, wherein the distal snare portion is configured to pull the second portion of the shrink member through the distal tip of the shrink member capturing tool and then through the length of the secondary tube. [Additional Item 3] The apparatus according to claim 1 or 2, wherein the shrink member snare comprises a wire having a diameter of 0.2 to 0.25 mm. [Additional Item 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 Item 5] The apparatus according to any one of claims 1 to 4, wherein the valve ring forming structure defines a partial valve ring forming ring structure. [Additional Item 6] The device according to any one of claims 1 to 5, wherein the secondary tube is shaped to define a longitudinal slit. [Claim 7] The device according to any one of claims 1 to 6, wherein the shrink member intake tool comprises a handle portion, and the first and second tubes are connected to the handle portion. [Claim 8] The handle portion a shrink member intake device configured to take in a continuous portion of the shrink member, and a tensiometer configured to measure the degree of tension of the shrink member, the device according to claim 7. [Claim 9] The device according to claim 8, wherein the shrink member intake device is operable to increase the tension of the shrink member. [Claim 10] The device according to claim 8, wherein the shrink member intake device comprises a knob connected to a proximal portion of the shrink member, and the knob is configured to increase the tension of the shrink member by pulling the shrink member proximally. [Claim 11] The device according to claim 10, wherein the shrink member intake device comprises a wheel having a groove, and the groove is configured to connect the shrink member to the wheel. [Claim 12] The device according to claim 11, wherein the groove is shaped to receive an intermediate portion of the shrink member. [Claim 13] The device according to 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 shrink member. [Claim 14] The device according to claim 13, wherein the snare portion comprises a flexible loop, and when the elongated flexible body portion is pulled through the secondary lumen, the secondary lumen is configured to fold the loop around the shrink member. [Claim 15] The apparatus according to any one of claims 1 to 14, wherein at least the distal snare portion of the contraction member snare is wavy so as to increase the friction between the snare portion and the contraction member. [Claim 16] The apparatus according to 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. [Claim 17] The contraction member capture tool is At least one contraction member fastener disposed within the distal end portion of the contraction member capture tool, the contraction member fastener having a clamping structure, the clamping structure being (a) biased to take a closed state, in which the clamping structure is configured to clamp the contraction member passing therethrough, and (b) bendable to an open state in which the contraction member can move, at least one contraction member fastener; The apparatus according to 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. [Claim 18] The apparatus according to 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 capture tool. [Claim 19] The distal snare portion and the elongated flexible body portion of the contraction member snare are sized to pass distally through the contraction member fastener in the open state, and the snare portion is adapted to capture and pull proximally the contraction member through the contraction member fastener and through aligned ports in the distal end portion of the contraction member capture tool. [Claim 20] The apparatus according to claim 19, wherein the shrink member intake tool comprises a fastener ejector movable within the distal end portion of the shrink member intake tool, and movement of the fastener ejector contacts the shrink member fastener and converts from the open state to the closed state to clamp the shrink member that has passed therethrough. [Claim 21] The apparatus according to claim 20, wherein the fastener ejector is connected to the stopper and moves the stopper removably connected to the fastener. [Claim 22] The distal end portion of the shrink member intake tool is shaped to define a sharp edge, and the shrink member is disposed adjacent to the sharp edge, whereby movement of the fastener ejector relative to the sharp edge cuts the shrink member extending through the fastener. The apparatus according to claim 20 or 21. [Claim 23] At least one shrink member fastener configured to surround the shrink member, the shrink member fastener having a clamping structure, the clamping structure being (a) biased to take a closed state, in which the clamping structure is configured to clamp the shrink member that has passed therethrough, and (b) bendable to an open state in which the shrink member can move. At least one shrink member fastener. The apparatus according to any one of claims 1 to 22, further comprising a stopper removably connected to the shrink member fastener and configured to maintain the shrink member fastener in the open state. [Claim 24] The tool comprises a movable cutting element having a sharp edge, and movement of the stopper strikes the stopper against the movable cutting element, whereby movement of the movable cutting element cuts the shrink member extending through the fastener and through the movable cutting element. The apparatus according to claim 23. [Claim 25] The apparatus further comprises a lock slidable along the shrink member, the lock being fixedly connectable to the shrink member to prevent movement of the shrink 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 of the lock extending from a proximal opening of the lock toward a distal opening of the lock, the lock lumen is configured to surround the contraction member, The apparatus according to any one of claims 1 to 24, wherein when the lock is compressed, the slit allows the lock to close around the contraction member, thereby enabling the lock to be locked to the contraction member. [Claim 26] The apparatus according to claim 25, wherein the valve ring forming structure is shaped to define the recess and is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Claim 27] The apparatus according to claim 26, wherein the recess is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Claim 28] The apparatus according to claim 25, wherein the lock lumen is shaped to define a distal portion that is wider than a proximal portion of the lock lumen. [Claim 29] The apparatus according to 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. [Claim 30] The apparatus according to claim 25, wherein the lock is disposed within the distal end portion of the contraction member capturing tool. [Claim 31] The apparatus according to claim 30, wherein when the contraction member capturing tool is coupled to the valve ring forming structure, the lock is at least partially disposed within the recess. [Claim 32] The apparatus according to claim 30, wherein when the contraction member capturing tool is coupled to the valve ring forming structure, the lock is disposed entirely proximal to the recess. [Appended Item 33] The apparatus according to appended item 25, wherein the lock is disposed within the distal end portion of the shrink member capture tool. [Appended Item 34] The apparatus according to appended item 33, wherein the distal snare portion and the elongated flexible body portion of the shrink member snare are sized to pass the lock distally, and the snare portion is adapted to capture the shrink member through the lock and through aligned ports of the distal end portion of the shrink member capture tool and pull it proximally. [Appended Item 35] An apparatus, An embedded valve ring forming structure, A main body portion, and An embedded valve ring forming structure comprising a shrink member having (1) a first portion extending along the longitudinal length of the main body portion of the valve ring forming ring structure, and (2) a second portion extending away from the main body portion of the valve ring forming ring structure. A housing configured to be positionable relative to the main body portion of the valve ring forming ring structure. A shrink member fastener at least partially disposed within the housing, the shrink member fastener comprising a clamping structure, the clamping structure being (a) biased to take a closed state, in which the clamping structure is configured to clamp the shrink member passing therethrough, and (b) bendable to an open state in which the shrink member can move, a shrink member fastener. A stopper removably coupled to the fastener and configured to maintain the shrink member fastener in the open state. An apparatus comprising a fastener ejector engageable with the stopper such that movement of the fastener ejector moves the stopper removably coupled to the fastener and converts the clamping structure from the open state to the closed state to clamp the shrink member passing therethrough. [Appended Item 36] The apparatus according to claim 35, wherein the fastener ejector is shaped such that its movement facilitates severance of the contraction member extending through the fastener. [Claim 37] The apparatus according to claim 35, wherein the fastener comprises a deformable element having an inclined state and a linear state, the stopper is configured to maintain the fastener in the inclined state, and when the stopper is removed, the fastener transitions to the linear state and is configured to require the contraction member between the fastener and the surface of the housing. [Claim 38] The apparatus according to claim 37, wherein the fastener is shaped to define a plurality of teeth configured to increase friction between the contraction member and the fastener. [Claim 39] A system comprising: An embedded valve ring forming structure comprising: A main body portion, and An embedded valve ring forming structure comprising a contraction member extending at least partially along the longitudinal length of the main body portion of the valve ring forming structure; and A contraction member insertion tool comprising: A tube having a lumen configured for passage of the contraction member therethrough, and A contraction member snare comprising a distal snare portion and an elongate flexible body portion connected to the distal snare portion, the distal snare portion being configured to fit a portion of the contraction member and draw it into the lumen. [Claim 40] The system according to claim 39, wherein the distal snare portion is configured to pull the portion of the contraction member through the entire length of the lumen. [Claim 41] The system according to claim 39, wherein the tube is flexible. [Claim 42] The system according to any one of claims 39 to 41, wherein the contraction member intake tool comprises a handle portion and the tube is connected to the handle portion. [Claim 43] The handle portion a contraction member intake device configured to take in a continuous portion of the contraction member, and a tensiometer configured to measure the degree of tension of the contraction member, the system according to claim 42. [Claim 44] The system according to claim 43, wherein the contraction member intake device is operable to increase the tension of the contraction member. [Claim 45] The system according to claim 43 or 44, wherein the contraction member intake device comprises a wheel having a groove, and the groove is configured to connect the contraction member to the wheel. [Claim 46] The system according to claim 45, wherein the groove is shaped to receive an intermediate portion of the contraction member. [Claim 47] The system according to any one of claims 39 to 46, wherein the inner cavity of the tube is sized to maintain the connection between the distal snare portion and the contraction member. [Claim 48] The system according to any one of claims 39 to 47, wherein the distal snare portion comprises a flexible loop, and when the portion of the contraction member is pulled through the inner cavity, the inner cavity is configured to fold the loop around the contraction member. [Claim 49] The system according to any one of claims 39 to 48, wherein at least the distal snare portion of the contraction member snare is wavy so as to increase the friction between the snare portion and the contraction member. [Claim 50] The distal end portion of the contraction member capture tool is shaped to define a sharp edge, and the contraction member capture tool is configured to place the contraction member proximate to the sharp edge such that the sharp edge is capable of severing the contraction member, the system according to any one of appended claims 39-49. [Appended claim 51] The contraction member capture tool A contraction member fastener disposed within the distal end portion of the contraction member capture tool, the contraction member fastener having a clamping structure, the clamping structure being (a) biased to assume a closed state in which the clamping structure is configured to clamp the contraction member passing therethrough and (b) bendable to an open state in which the contraction member can move, a contraction member fastener; A stopper removably coupled to the contraction member fastener and configured to maintain the contraction member fastener in the open state, the system according to any one of appended claims 39-50. [Appended claim 52] The distal snare portion and the portion of the contraction member are sized to pass distally through the contraction member fastener in its open state, and the distal snare portion is adapted to capture and pull proximally the portion of the contraction member through the contraction member fastener and through aligned ports in the distal end portion of the contraction member capture tool, the system according to claim 51. [Appended claim 53] The contraction member capture tool includes a fastener ejector movable within the distal end portion of the contraction member capture tool, movement of the fastener ejector contacting the contraction member fastener and converting it from its open state to its closed state to clamp the contraction member passing therethrough, the system according to claim 52. [Appended claim 54] The fastener ejector is coupled to the stopper and moves the stopper removably coupled to the fastener, the system according to claim 53. [Appended claim 55] An apparatus An embedded valve ring forming structure, a main body portion having side walls, and a shrinkage member having (1) a first portion extending along the longitudinal length of the main body portion of the valve ring forming structure and (2) a second portion extending away from the main body portion of the valve ring forming structure, the shrinkage member being configured to adjust the outer circumference of the valve ring forming structure, wherein the main body portion of the valve ring forming structure is shaped to define a recess having a recess axis, the recess extending from an opening in a first surface of the side wall of the main body portion toward a second surface on the opposite side of the side wall of the main body portion, the side wall of the main body portion extending away from the recess along a longitudinal axis that is at a non-zero angle to the recess axis, and the shrinkage member extending through the recess and away from the main body portion of the valve ring forming structure via the recess, an embedded valve ring forming structure; a lock slidable along the shrinkage member and toward the recess, the lock being fixedly connectable to the shrinkage member to prevent movement of the shrinkage member, the recess being shaped to facilitate the fixed connection of the lock to the shrinkage member, a device comprising the lock. [Claim 56] The device according to claim 55, wherein the lock is at least partially disposable within the recess. [Claim 57] The device according to claim 55, wherein the valve ring forming structure includes a partial valve ring forming ring structure. [Claim 58] The device according to any one of claims 55 to 57, wherein when the lock moves at least partially within the recess, the lock is configured to lock the shrinkage member. [Claim 59] The device according to any one of claims 55 to 57, wherein the lock is configured to fit completely within the recess. [Claim 60] wherein the main body portion includes a housing, the housing defining at least a portion of the side wall, The apparatus according to any one of claims 55 to 59, wherein the housing defines the recess. [Claim 61] The apparatus according to any one of claims 55 to 60, wherein the lock is shaped to define a locking thread portion, and the valve ring forming structure is shaped to define a valve ring forming structure thread portion configured to engage with the locking thread portion. [Claim 62] The apparatus according to any one of claims 55 to 61, wherein the recess defines a recess inner cavity extending along the recess axis. [Claim 63] The apparatus according to claim 62, wherein the recess axis is disposed at the non-zero angle. [Claim 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 inner cavity of the lock extending from a proximal opening of the lock toward a distal opening of the lock, the lock inner cavity is configured to surround the contraction member, when the lock is disposed in the recess, the slit allows the lock to close around the contraction member, thereby enabling the lock to be locked to the contraction member, according to any one of claims 55 to 63. [Claim 65] The apparatus according to claim 64, wherein the recess is dimensioned to compress the lock when the lock is at least partially disposed in the recess. [Claim 66] The apparatus according to claim 64, wherein at least one of the slit and the lock inner cavity is shaped to define a distal portion wider than a proximal portion thereof. [Claim 67] The apparatus according to claim 64, wherein the recess is shaped to define a proximal portion that is narrower than any other portion of the recess distal to the most proximal portion. [Claim 68] The valve ring forming structure includes a housing, the housing is shaped to define the recess, the recess has a recess axis, the device according to any one of appended claims 55 to 67. [Appended claim 69] The lock is shaped to define a lock thread portion, the housing is shaped to define a valve ring forming structure thread portion configured to engage with the lock thread portion, the device according to appended claim 68. [Appended claim 70] The housing is shaped to define a shrink member inner cavity disposed at a non-zero angle with respect to the recess axis, the device according to appended claim 68. [Appended claim 71] The housing is shaped to provide a shrink member inner cavity wall disposed along the shrink member inner cavity, when the lock is disposed in the recess, a distal end of the lock clamps a first portion of the shrink member against the shrink member inner cavity wall and is configured to lock the shrink member at at least a first clamping point, the device according to appended claim 70. [Appended claim 72] The recess is shaped to define a recess distal taper portion, The lock is, a lock inner cavity of the lock extending from a proximal opening of the lock toward a distal opening of the lock, and a lock distal taper portion, are shaped to define, the lock inner cavity is configured to surround the shrink member, when the lock is disposed in the recess, the recess distal taper portion is configured to compress the lock distal taper portion, the lock distal taper portion clamps a second portion of the shrink member in the lock inner cavity at the recess distal taper portion and is configured to lock the shrink member at at least a second clamping point, the device according to appended claim 71. [Appended claim 73] The apparatus according to any one of claims 55 to 72, further comprising a delivery tool, wherein the delivery tool and the contraction member are slidable relative to each other, and the delivery tool is configured to deliver the valve annulus forming structure to the valve annulus of a patient's heart. [Claim 74] The apparatus according to claim 73, wherein the delivery tool comprises a knob connected to a proximal portion of the contraction member, and the knob is configured to increase the tension of the contraction member by pulling the contraction member proximally. [Claim 75] The apparatus according to claim 73, wherein when the delivery tool is connected to the valve annulus forming structure, a portion of the contraction member is disposed within the lumen of the delivery tool, and the lock surrounds a portion of the contraction member. [Claim 76] The apparatus according to claim 75, wherein when the delivery tool is connected to the valve annulus forming structure, the lock is at least partially disposed within the recess. [Claim 77] The apparatus according to 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 to clamp the contraction member that has passed therethrough. [Claim 78] The apparatus according to claim 77, wherein the distal end portion of the delivery tool is shaped to define a sharp edge, and the contraction member is disposed adjacent to the sharp edge, whereby movement of the lock ejector relative to the sharp edge severs the contraction member extending through the lock. [Claim 79] An apparatus, An implantable valve annulus forming structure, A main body portion, and (1) a first portion extending along the longitudinal length of the main body portion of the valve annulus forming structure, and (2) a contraction member having a second portion extending away from the main portion of the valve annulus forming structure. A lock slidable along the contraction member and connectable and fixed to the contraction member to prevent movement of the contraction member, and a lock. The lock is shaped to define a slit extending from the proximal surface of the lock toward the distal surface of the lock. The lock defines a lock lumen of the lock extending from the proximal opening of the lock toward the distal opening of the lock. The lock lumen is configured to surround the contraction member. When the lock is compressed, the slit allows the lock to close around the contraction member, thereby enabling the lock to be locked to the contraction member. [Appendix Item 80] The device according to Appendix Item 79, wherein the valve ring forming structure includes a partial valve ring forming ring structure. [Appendix Item 81] The device according to Appendix Item 79 or 80, wherein the valve ring forming structure is dimensioned to compress the lock when the lock is at least partially disposed within the recess. [Appendix Item 82] ...

Claims

1. an implant comprising an implantable structure and a flexible elongate contractile member (226) extending away from said implantable structure; a contraction member capture tool (1600) comprising a handle portion (1620); Equipped with The contraction member taking tool comprises: - an outer housing (1632); - a tubular shaft (1634) disposed at least partially within said outer housing; an inner shaft (1636), (a) at least partially disposed within a proximal longitudinal portion of said tubular shaft, whereby said inner shaft (1636) is axially slidable relative to said tubular shaft (1634); (b) shaped to define an inner shaft contraction member receiving channel (1638); and (c) comprising a lock (1640), said lock configured (i) when in an unlocked state to allow sliding of said contraction member relative to said inner shaft contraction member receiving channel, and (ii) when in a locked state to axially lock said contraction member relative to said inner shaft; - a distal force applicator (1642) (a) at least partially disposed within a distal longitudinal portion of said tubular shaft, and (b) shaped to define a distal force applicator contraction member receiving channel (1644) that permits sliding movement of said contraction member therethrough; - a spring (1646) disposed within said tubular shaft (1634) and connecting said distal force applicator and a distal portion of said inner shaft; - a contraction promotion knob (1630) accessible from the outside of said outer housing; Equipped with the handle portion (1620) is shaped to define a handle contraction member receiving channel (1650) from a distal end to a proximal end of the handle portion; the handle contraction member receiving channel includes the inner shaft contraction member receiving channel and the distal force applicator contraction member receiving channel; When the handle portion is disposed with the contraction member completely passing through the handle contraction member receiving channel and the lock is in a locked state, actuation of the contraction enhance knob advancing the tubular shaft proximally relative to the outer housing, thereby advancing the distal force applicator proximally relative to the outer housing, thereby applying a proximal force to the spring; by pushing the inner shaft proximally against the outer housing, thereby pulling the contraction member proximally; configured to incorporate a continuous portion of a contraction member into the handle portion; the handle portion is configured such that, upon actuation of the contraction enhance knob, (i) the contraction member is disposed completely through the handle contraction member receiving channel, (ii) the lock is in a locked state, and (iii) the contraction member is tensioned; the spring urges the inner shaft proximally to a lesser extent than the tubular shaft advances proximally relative to the outer housing; The device, wherein pulling the contraction member proximally with the inner shaft increases tension in the contraction member.

2. 2. The device of claim 1, wherein the deflation enhancer knob is configured to be actuated by rotation of the deflation enhancer knob itself.

3. the tubular shaft and the retraction enhancer knob are threadably connected to one another; 2. The device of claim 1, wherein the handle portion is configured such that actuation of the retraction enhance knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

4. the inner shaft partially projects outside the proximal end of the outer housing; 4. An apparatus as described in any one of claims 1 to 3, wherein 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.

5. the inner shaft is marked with a plurality of fiducial markers; 5. The apparatus of claim 4, wherein the fiducial markers are disposed along the inner shaft to indicate a relative axial position of the tubular shaft with respect to the inner shaft.

6. the handle portion further comprising a tension limit lock assembly; 4. The device of claim 1, wherein the tension limiting locking assembly is configured to axially lock the inner shaft relative to the outer housing when the handle portion increases 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.

7. 7. The device of claim 6, wherein 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 a maximum tension that the inner shaft can apply to the contraction member.

8. the tension limit lock assembly includes a detent; 8. The device of claim 7, wherein the detent is positioned to axially lock the inner shaft relative to the outer housing when the tubular shaft is disposed in the 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.

9. 9. The device of claim 8, wherein the detent is fixedly axially coupled to the inner shaft and configured to move radially outwardly to engage the outer housing to axially lock the inner shaft relative to the outer housing.

10. the tension limit lock assembly further comprising a plurality of recesses shaped to be defined by the outer housing; the detent is engageable with the recess to axially lock the inner shaft relative to the outer housing; 10. The device of claim 9, wherein the handle portion is positioned such that when the tubular shaft is disposed in the predetermined relative axial position with respect to the inner shaft, the particular one of the recesses that the detent engages depends on the relative axial position of the inner shaft with respect to the outer housing.

11. the proximal longitudinal portion of the tubular shaft is shaped to define an elongated opening; 10. The device of claim 9, wherein the detent passes through the elongated opening when the detent axially locks the inner shaft relative to the outer housing.

12. the tubular shaft includes one or more tracks; the track extends along a longitudinal portion of the elongated opening; The track is (a) when the tubular shaft is disposed distally at the predetermined relative axial position with respect to the inner shaft, the detent prevents the inner shaft from axially locking relative to the outer housing; and (b) allowing the detent to axially lock the inner shaft when the tubular shaft is disposed in the predetermined relative axial position with respect to the inner shaft; 12. The apparatus according to claim 11, characterized in that

13. 13. The device of claim 12, wherein one or more of the tracks are shaped to define one or more respective inclined portions such that when the tubular shaft is disposed in the predetermined relative axial position with respect to the inner shaft, after the detent axially locks the inner shaft relative to the outer housing, subsequent distal movement of the tubular shaft and corresponding distal movement of the one or more of the tracks relative to the inner shaft disengages the detent from the outer housing.

14. the inner shaft partially projects outside the proximal end of the outer housing; 7. The device of claim 6, wherein 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.

15. 4. The device of claim 1, wherein the implantable structure comprises an implantable annuloplasty structure.

16. the implantable annuloplasty structure comprises a flexible sleeve; 16. The apparatus of claim 15, wherein the constriction member extends along and away from the sleeve.

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