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

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

[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 muscles and dilation of the left ventricle seen in ischemic heart disease, followed by displacement of the papillary muscles 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 a subsequent decline in the left ventricle due to volume overload and pressure overload of the left atrium.

Summary of the Invention

Means for Solving the Problems

[0006] This abstract 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 the examples in this abstract are not required by the claims unless those features are explicitly enumerated in the claims. Also, the features, components, steps, concepts, etc., described in this abstract and the examples elsewhere in this disclosure can be combined in various ways. The description herein relates to systems, assemblies, methods, devices, apparatus, combinations, etc., that may be used for valve repair. Various features and steps described elsewhere in this disclosure may be included in the examples summarized herein.

[0007] In some applications, a multi-component tubular system is provided for accessing a patient's heart. The system may comprise one or more maneuverable guide catheters (e.g., 1, 2, 3, or more) configured to direct the passage of a device into the heart through its interior. The multi-component tubular system may be configured to deliver an implant in a desired orientation relative to the patient's cardiac annulus and to facilitate the implant's attachment to the annulus. In some applications, the guide system can or may be advanced transtube or transthoracically to access the atria of the heart. In some applications, the guide system can be advanced surgically. The system may comprise two or more maneuverable catheters. A first catheter has a distal portion maneuverable to a first desired spatial orientation. A second catheter is positioned within the first catheter and has a distal portion maneuverable to a second desired spatial orientation. The system provides techniques and relative spatial orientation control devices 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 includes a rotation locking mechanism provided by the components of the catheter system.

[0008] The distal portion of the first catheter may be steered in a preferred direction after the first catheter has advanced through the patient's vascular structure. Following the advancement of the first catheter and the steer of the distal portion of the first catheter in any one or more preferred planes, the second catheter advances through the first catheter. The first and second catheters may be rotatably locked to allow the steer of the distal portion of the second catheter in any one or more preferred planes relative to the distal portion of the first catheter, in such a manner that the spatial orientation of the first catheter is substantially maintained during the steer of the second catheter. Furthermore, the first catheter may be steered further without substantially disrupting the spatial orientation of the distal portion of the second catheter.

[0009] The distal portions and / or distal ends of the first and second catheters may be configured such that, once they are positioned within the atria of the patient's heart, an implantable, adjustable annular formation structure (e.g., annular formation ring structure, closed annular formation structure, closed annular formation ring structure, open annular formation structure, partial annular formation ring structure, or other annular formation device) can be deployed, for example, from within the second catheter and attached to the patient's cardiac annulus. The annular formation structure may comprise a flexible main body portion and a retractable member having a first portion extending along the longitudinal length of the main body portion. The second portion of the retractable member may extend away from the main body portion of the annular formation structure and outside the patient's body. From an external position, the proximal end portion of the retractable member, positioned outside the patient's body, is fitted using the retractable member snare of the retractable member intake tool. Using the snare, the proximal end portion of the retractable member may then be supplied through the distal portion of the primary tube of the tool and subsequently through the lumen of the secondary tube of the tool. Next, the constrictor intake tool can advance along the constrictor toward the patient's valve annulus. As the tool advances toward the valve annulus, the secondary canal of the tool can move distally along the constrictor as the constrictor passes through the lumen of the secondary canal of the tool by being pulled by the snare.

[0010] The shrinkage member intake tool may include a movable ejector at the distal end of the tool. The ejector may be removably connected to a suture fastener having a tightening structure that can be bent into an open position through which the shrinkage member can pass, and that is biased to a closed position or closed position for tightening the shrinkage member once it has passed inside. The tool may have at least one fastener for holding the suture fastener (e.g., its tightening structure) in its open position.

[0011] The snare portion may be configured or adapted to capture and pull the shrinkage member proximal to the outside through a suture fastener and through aligned ports within the tool. The tool can then advance toward annular formation structures embedded along the valve annulus. The tool can then capture a continuous portion of the shrinkage member to shrink the annular formation structure. Subsequently, the tool's ejector can move, converting the suture fastener (e.g., its tightening structure) from its open state to its closed state to tighten the shrinkage member that has passed through.

[0012] The tool may include a handle portion which may be equipped with a shrink member take-in device for taking in a continuous portion of the shrink member. The handle portion may be equipped with a tension meter configured to measure the degree of tension in the shrink member.

[0013] In some applications, an annular forming structure (e.g., annular forming ring structure, closed annular forming structure, closed annular forming ring structure, open annular forming structure, partially annular forming ring structure, or other annular forming device) comprises a main body portion having a retractable sleeve, a retractable member passing along the retractable sleeve, and a housing through which the retractable member passes. Once the annular forming structure or annular forming ring structure is retracted, the fasteners are deployed within the housing to maintain the retraction of the annular forming structure or annular forming ring structure.

[0014] A shrink member cutting tool is provided, which allows the shrink member to be cut through the tool only once the shrink member is locked in place by a fastener connected to it. The shrink member cutting tool can be configured in various ways to apply a cutting surface to the shrink member, for example, by having a sharp edge that moves toward the shrink member, and / or multiple edges and / or surfaces that move toward each other with a scissor-like motion or like a wire cutter tool.

[0015] Accordingly, according to several applications, systems and / or apparatus including an embedded annular forming structure are provided. The annular forming structure includes a main body portion and a shrinking member. In some embodiments, the shrinking member may have (1) a first portion extending along the longitudinal length of the main body portion of the annular forming structure and (2) a second portion extending away from the main portion of the annular forming structure.

[0016] The system and / or apparatus may include a shrink member take-up tool. The shrink member take-up tool may include a primary tube terminating at the distal end portion of the shrink member take-up tool, a distal end portion of the shrink member take-up tool having a distal tip, and a secondary tube positioned alongside the primary tube, the secondary tube having a secondary lumen configured for the passage of a shrink member passing through it. In some embodiments, the shrink member take-up tool also includes a shrink member snare, which includes a distal snare portion and an elongated flexible body portion connected to the distal snare portion, the distal snare portion being configured to fit a portion of the shrink member. The shrink member snare may be sized to pass through the secondary lumen of the secondary tube in order to pull a 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 shrinking member through the distal tip of the shrinking member take-up 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 constriction member.

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

[0030] 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.

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

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

[0033] In some applications, the at least one constriction member fastener includes at least first and second constriction member fasteners disposed within the distal end portion of the constriction 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 the open shrink member fastener, and the snare portion is adapted to capture and pull the shrink member proximal through the shrink member fastener and through aligned ports at the distal end of the shrink member take-up tool.

[0035] In some applications, the shrink member intake tool includes a fastener ejector that is movable within the distal end portion of the shrink member intake tool, and the movement of the fastener ejector contacts the shrink member fastener and converts from an open to a closed state to tighten the shrink member as it passes through.

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

[0037] In some applications, the distal end of the shrink member intake tool is shaped to define a sharp edge, and the shrink member is positioned close to the sharp edge, so that the movement of the fastener ejector toward the sharp edge severs the shrink member extending through the fastener.

[0038] In some applications, the system and / or device further A shrink member fastener configured to surround a shrink member, the shrink member fastener comprising a tightening structure, the tightening structure being (a) biased to take a closed state, in the closed state the tightening structure is configured to tighten a shrink member passing through it, and (b) bendable to an open state in which the shrink member can move; and a stopper detachably connected to the shrink member fastener and configured to maintain the shrink member fastener in an open state.

[0039] In some applications, the shrink member intake tool includes a fastener ejector that is movable within the distal end portion of the shrink member intake tool, and the movement of the fastener ejector is configured to contact the shrink member fastener and convert from an open to a closed state to tighten the shrink member as it passes through.

[0040] In some applications, the fastener ejector is detachably connected to the fastener and moves the fastener that is detachably connected to the fastener.

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

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

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

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

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

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

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

[0048] In some applications, when the shrinking member intake tool is connected to the valve ring forming structure, the lock is positioned at least partially within the recess.

[0049] In some applications, when the shrinking member intake tool is connected to the valve ring forming structure, the lock is positioned entirely proximal to the recess.

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

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

[0052] Furthermore, systems and / or apparatus including an embedded annulus forming structure are provided according to several applications. An embedded annulus forming structure including a main body portion and a shrinking member. The shrinking member may have (1) a first portion extending along the longitudinal length of the main body portion of the annulus forming ring structure and (2) a second portion extending away from the main body portion of the annulus forming ring structure.

[0053] The system and / or apparatus may 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 may also include a shrink member fastener at least partially located within the housing, the shrink member fastener including a clamping structure, the clamping structure being (a) biased to take a closed position, in which case the clamping structure is configured to clamp a shrink member passing through the interior, and (b) bendable to an open position in which the shrink member can move.

[0055] The system and / or apparatus may also include a fastener that is detachably coupled to the fastener and configured to maintain the shrink member fastener in an open state, and a fastener ejector that is engageable with the fastener so that the movement of the fastener ejector moves the fastener that is detachably coupled to the fastener, converting the tightening structure from an open state to a closed state to tighten the shrink member that has passed through.

[0056] In some applications, the fastener ejector is shaped so that its movement facilitates the disintegration of the shrinkage member extending through the fastener.

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

[0058] In some applications, fasteners are shaped to define multiple teeth configured to increase friction between the contraction member and the fastener.

[0059] Furthermore, according to several applications, methods are provided that include advancing an implantable annular-forming structure, comprising a main body portion and a contraction member, toward the patient's heart. The contraction member is identical or similar to other contraction members herein and may have (1) a first portion extending along the longitudinal length of the main body portion of the annular-forming structure and (2) a second portion extending away from the main portion of the annular-forming ring structure.

[0060] The method further includes passing a second portion of the shrink member through a shrink member intake tool. The shrink member intake tool may include a primary tube terminating at the distal end portion of the shrink member intake tool, a distal end portion of the shrink member intake tool having a distal tip, and a secondary tube positioned alongside the primary tube, the secondary tube having a secondary lumen configured for the passage of the shrink member passing through it. The shrink member intake tool may also include a shrink member snare, which includes a distal snare portion and an elongated flexible body portion connected to the distal snare portion, the distal snare portion being configured to fit a portion of the shrink member and to pass through the secondary lumen of the secondary tube and to pull the second portion of the shrink member through the length of the secondary tube.

[0061] In some applications, the passing process involves using the distal snare portion to fit that portion of the shrink member, using the shrink member snare to pull that portion of the shrink member through the secondary tube, and subsequently advancing the shrink member intake tool along the shrink member toward the valve ring forming structure.

[0062] In some applications, passing through the second portion of the shrinking member includes passing through the second portion of the shrinking member following forward movement.

[0063] In some applications, pulling that portion of the shrink member through the secondary tube involves pulling a second portion of the shrink member through the distal tip of the shrink member take-up tool, and then through the length of the secondary tube.

[0064] In some applications, pulling that portion of the shrinking member through the secondary tube involves reinforcing the connection between the shrinking member and the snare portion.

[0065] In some applications, the process further includes using the shrinking member acquisition tool to shrink the annular formation structure, following the advancement of the shrinking member acquisition tool.

[0066] In some applications, shrinking the annular formation structure using a shrink member intake tool involves advancing the continuous portion of the shrink member relative to the shrink member intake device.

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

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

[0069] In some applications, the method further includes maintaining the annular formation structure in a contracted state, followed by using the sharp edge of a contracted member intake tool to cleave the contracted member.

[0070] In some applications, advancing the constrictor intake tool involves advancing the constrictor intake tool through the patient's vascular structure.

[0071] In some applications, the shrink member acquisition tool includes a handle portion comprising a shrink member acquisition device configured to acquire a continuous portion of the shrink member, and a tension meter configured to measure the degree of tension in the shrink member.

[0072] In some applications, the method further includes using a shrinkable member intake device to increase the tension of the shrinkable member.

[0073] In some applications, the shrink member intake device includes a wheel having a groove, and the method further includes connecting the shrink member to the wheel.

[0074] In some applications, connecting the shrinking member to the wheel includes connecting the middle portion of the shrinking member to the wheel.

[0075] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0076] Furthermore, according to several applications, methods are provided that include advancing an implantable annular formation structure toward the patient's heart. The implantable annular formation structure may be identical or otherwise identical to other annular formation structures known herein or otherwise, and may include, for example, a main body portion, a retractable member, and a housing connected to the main body portion of the annular formation structure. In some applications, the retractable member has (1) a first portion extending along the longitudinal length of the main body portion of the annular formation structure, and (2) a second portion extending away from the main body portion of the annular formation structure.

[0077] In some applications, the shrink member fastener is located within the housing and includes a clamping structure which (a) is biased to assume a closed state, in which case the clamping structure is configured to clamp the shrink member as it passes through, and (b) can be bent into an open state in which the shrink member can move. In some applications, a stopper is removably connected to the fastener and configured to maintain the shrink member fastener in an open state.

[0078] In some applications, the method further includes converting the shrink member fastener from an open to a closed state to move a fastener ejector that is engageable with the fastener, thereby tightening the shrink member that has passed through by moving the fastener ejector, which is detachably connected to the fastener.

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

[0080] In some applications, shrinking the annular structure involves shrinking the annular structure using a shrinking member intake tool.

[0081] In some applications, shrinking the annular formation structure using a shrink member intake tool involves advancing the continuous portion of the shrink member relative to the shrink member intake device.

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

[0083] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0084] Furthermore, a system is provided which includes an embedded annular forming structure, depending on several applications, comprising a main body portion and a shrinking member extending at least partially along the longitudinal length of the main body portion of the annular forming structure. The system also includes a shrinking member intake tool. The shrinking member intake tool may include a tube having a lumen configured for the passage of a shrinking member and a shrinking member snare through which the shrinking member passes. The shrinking member may include a distal snare portion and an elongated flexible body portion connected to the distal snare portion, the distal snare portion being configured to fit a portion of the shrinking member and draw it into the lumen.

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

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

[0087] In some applications, the shrink material handling tool includes a handle portion, and the tube is connected to the handle portion.

[0088] In some applications, the handle portion includes a shrinking member intake device configured to take in a continuous portion of the shrinking member, and a tension meter configured to measure the degree of tension in the shrinking member.

[0089] In some applications, the shrinking member intake device can be operated to increase the tension of the shrinking member.

[0090] In some applications, the shrink member intake device includes a wheel having grooves, the grooves being configured to connect the shrink member to the wheel.

[0091] In some applications, the grooves are shaped to accommodate the intermediate portion of the shrinking member.

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

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

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

[0095] In some applications, the distal end of the shrinkage material capture tool is shaped to define a sharp edge, and the shrinkage material capture tool is positioned close to the sharp edge so that the sharp edge can cut through the shrinkage material.

[0096] In some applications, the shrink material handling tool is, A shrink member fastener positioned within the distal end portion of a shrink member intake tool, wherein the shrink member fastener includes a tightening structure, the tightening structure being (a) biased to assume a closed state, in which case the tightening structure is configured to tighten the shrink member that has passed through its interior, and (b) bendable to an open state in which the shrink member can move; The system includes a stopper that is detachably connected to the shrink member fastener and configured to maintain the shrink member fastener in an open state.

[0097] In some applications, the distal snare portion and that portion of the shrink member are sized to pass distally through the open shrink member fastener, and the distal snare portion is adapted to capture and pull proximal to that portion of the shrink member through the shrink member fastener and through aligned ports on the distal end of the shrink member take-up tool.

[0098] In some applications, the shrink member intake tool includes a fastener ejector that is movable within the distal end portion of the shrink member intake tool, and the movement of the fastener ejector can contact the shrink member fastener and convert its open state to its closed state to tighten the shrink member as it passes through.

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

[0100] In some applications, the distal end of the shrink member take-up tool is shaped to define a sharp edge, and the shrink member take-up tool is positioned close to the sharp edge so that the movement of the fastener ejector toward the sharp edge severs the shrink member after it has extended through the fastener.

[0101] In some applications, the embedded annulus-forming structure is a closed annulus-forming structure.

[0102] Furthermore, according to several applications, systems and / or apparatus are provided that include an embedded annulus forming structure, comprising a main body portion having side walls and a shrinking member. In some applications, the shrinking member has (1) a first portion extending along the longitudinal length of the main body portion of the annulus forming structure and (2) a second portion extending away from the main body portion of the annulus forming structure, and the shrinking member is configured to adjust the outer circumference of the annulus 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 on a first surface of the side wall of the main body portion toward a second surface opposite 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 not at a zero angle with respect to the recess axis, and the contraction member extending away from the main body portion of the valve ring forming structure through and via the recess.

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

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

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

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

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

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

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

[0111] In some applications, the recess defines a recessed lumen that extends along the recess axis. In some applications, the recess axis is positioned at a non-zero angle.

[0112] In some applications, the lock is shaped to define a slit extending from the proximal surface of the lock to the distal surface of the lock, defining a lock lumen extending from the proximal opening of the lock to the distal opening of the lock, and the lock lumen is configured to surround a shrinking member, and when the lock is placed in the recess, the slit allows the lock to close around the shrinking member, thereby locking the lock to the shrinking member.

[0113] In some applications, the recess is sized to compress the lock when it is at least partially positioned within the recess.

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

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

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

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

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

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

[0120] In some applications, the housing is shaped to provide a lumen wall of the shrinking member that is positioned along the lumen of the shrinking member, and when the lock is positioned in the recess, the distal end of the lock is configured to clamp a first portion of the shrinking member against the lumen wall of the shrinking member, thereby locking the shrinking member at least at a first clamping point.

[0121] In some applications, the recess is shaped to define the distal tapered portion of the recess. In some applications, the lock is shaped to define the lock lumen of the lock, which extends from the proximal opening of the lock toward the distal opening of the lock, and the distal tapered portion of the lock. The lock lumen may be configured to surround the shrinking member.

[0122] In some applications, when the lock is positioned within the recess, the distal tapered portion of the recess is configured to compress the distal tapered portion of the lock, and the distal tapered portion of the lock is configured to grip a second portion of the contraction member within the lumen of the lock within the distal tapered portion of the recess, thereby locking the contraction member at at least the second gripping point.

[0123] In some applications, the system and / or apparatus further includes a delivery tool, the delivery tool and the contraction member being slidable relative to each other, and the delivery tool is configured to deliver the annular formation structure to the patient's cardiac annulus.

[0124] In some applications, the delivery tool includes a knob connected to the proximal portion of the shrink member, which is configured to increase the tension of the shrink member by pulling the shrink member proximal.

[0125] In some applications, the knob is fixed and connected to the proximal portion of the contraction member.

[0126] In some applications, when the delivery tool is connected to the annular formation structure, a portion of the shrinking member is positioned within the lumen of the delivery tool, and the lock surrounds a portion of the shrinking member.

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

[0128] In some applications, when the delivery tool is connected to the valve annulus forming structure, the lock is positioned entirely proximal to the recess.

[0129] In some applications, the delivery tool includes a lock ejector that is movable within the distal end portion of the delivery tool, and the movement of the lock ejector contacts the lock, converting it from an open to a closed state to tighten the shrink 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 positioned close to the sharp edge, so that the movement of the lock ejector toward the sharp edge severs the shrink member extending through the lock.

[0131] Furthermore, according to several applications, systems and / or apparatus are provided that include an embedded annulus forming structure, comprising a main body portion and a shrinking member. The shrinking member may be identical or similar to other shrinking members herein and may, for example, have (1) a first portion extending along the longitudinal length of the main body portion of the annulus forming structure and (2) a second portion extending away from the main portion of the annulus forming structure. The systems and / or apparatus may include a lock slidable along the shrinking member, the lock being fixed and connectable to the shrinking member to prevent movement of the shrinking member. The lock may be shaped to define a slit extending from the proximal surface of the lock toward the distal surface of the lock.

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

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

[0134] In some applications, the valve ring forming structure is shaped to define a recess, and is dimensioned to compress the lock when the lock is at least partially positioned within the recess.

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

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

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

[0138] In some applications, the lumen of the lock 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 located distal to the proximal portion.

[0140] In some applications, the lock is shaped to define the lock thread portion, and the annular forming structure is shaped to define the annular forming structure thread portion configured to engage with the lock thread portion.

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

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

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

[0144] In some applications, the housing is shaped to provide a lumen wall of the shrinking member that is positioned along the lumen of the shrinking member, and when the lock is positioned in the recess, the distal end of the lock is configured to clamp a first portion of the shrinking member against the lumen wall of the shrinking member, thereby locking the shrinking member at least at a first clamping point.

[0145] In some applications, the recess is shaped to define the distal tapered portion of the recess, and the lock is shaped to define the lock lumen of the lock extending from the proximal opening of the lock toward the distal opening of the lock, and the distal tapered portion of the lock. The lock lumen may be configured to surround a shrinking member. When the lock is placed in the recess, the distal tapered portion of the recess may be configured to compress the distal tapered portion of the lock, and the distal tapered portion of the lock may be configured to clamp a second portion of the shrinking member in the lock lumen within the distal tapered portion of the recess, thereby locking the shrinking member at at least a second clamping point.

[0146] In some applications, the system and / or apparatus further includes a delivery tool, the delivery tool and the contraction member being slidable relative to each other, and the delivery tool is configured to deliver the annular formation structure to the patient's cardiac annulus.

[0147] In some applications, the delivery tool includes a knob connected to the proximal portion of the shrink member, which is configured to increase the tension of the shrink member by pulling the shrink member proximal.

[0148] In some applications, the knob is fixed and connected to the proximal portion of the contraction member.

[0149] In some applications, when the delivery tool is connected to the annular formation structure, a portion of the shrinking member is positioned within the lumen of the delivery tool, and the lock surrounds a portion of the shrinking member.

[0150] In some applications, the annular forming structure is sized to compress the lock when the lock is at least partially positioned within the recess, shaped to define the recess, and when a delivery tool is connected to the annular forming structure, the lock is at least partially positioned within the recess.

[0151] In some applications, the annular forming structure is sized to compress the lock when the lock is at least partially positioned within the recess, shaped to define the recess, and when the delivery tool is connected to the annular forming structure, the lock is positioned fully proximal to the recess.

[0152] In some applications, the delivery tool includes a lock ejector that is movable within the distal end portion of the delivery tool, and the movement of the lock ejector contacts the lock, converting it from an open to a closed state to tighten the shrink member that has passed through the interior.

[0153] In some applications, the distal end portion of the delivery tool is shaped to define a sharp edge, and the shrink member is positioned close to the sharp edge, so that the movement of the lock ejector toward the sharp edge severs the shrink member extending through the lock.

[0154] Furthermore, methods are provided, depending on the application, that include advancing an implantable annular formation structure toward the patient's heart. The implantable annular formation structure may be identical or similar to other annular formation structures known herein or otherwise, for example, having a main body portion having side walls and a retractable member having (1) a first portion extending along the longitudinal length of the main body portion of the annular formation structure and (2) a second portion extending away from the main body portion of the annular formation structure, wherein the retractable member is configured to adjust the outer circumference of the annular formation structure.

[0155] 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 on a first surface of the side wall of the main body portion toward a second surface opposite 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 not at a zero angle with respect to the recess axis, and the contraction member extending away from the main body portion of the valve ring forming structure through and via the recess.

[0156] The method may further include locking the shrinking member by sliding the lock along the shrinking member so that it fits into a recess, the lock being fixably connected to the shrinking member to prevent movement of the shrinking member, and the recess being shaped to facilitate the fixed connection of the lock to the shrinking member.

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

[0158] In some applications, advancement involves advancing the annular forming structure while the lock is positioned fully proximal to the recess.

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

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

[0161] In some applications, the lock is shaped to define a slit extending from the proximal surface of the lock to the distal surface of the lock, defining a lock lumen extending from the proximal opening of the lock to the distal opening of the lock, and the lock lumen is configured to surround a shrinking member, and when the lock is placed in the recess, the slit allows the lock to close around the shrinking member, thereby locking the lock to the shrinking member.

[0162] In some applications, the recess is sized to compress the lock when the lock is at least partially positioned within the recess, and the locking involves positioning the lock at least partially within the recess to compress the lock.

[0163] In some applications, the lumen of the lock 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 located distal to the proximal portion.

[0165] In some applications, advancement involves advancing the annular forming structure using a delivery tool, and the method further involves sliding the delivery tool and the contraction member relative to each other.

[0166] In some applications, advancement involves moving the lock forward within the delivery tool, while locking involves sliding the lock using the delivery tool.

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

[0168] In some applications, the knob is fixed and connected to the proximal portion of the contraction member.

[0169] In some applications, the delivery tool includes a lock ejector that is movable within the distal end portion of the delivery tool, and the method further includes moving the lock ejector to contact a lock and tighten a shrink member that has passed through by converting it from an open state to a closed state.

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

[0171] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0172] Furthermore, methods are provided, depending on the application, that include advancing an implantable annular formation structure toward the patient's heart. The annular formation structure may be identical or identical to other annular formation structures known herein or otherwise, and may include, for example, a main body portion having side walls and a shrinking member. The shrinking member may have (1) a first portion extending along the longitudinal length of the main body portion of the annular formation structure and (2) a second portion extending away from the main body portion of the annular formation structure, and the shrinking member is configured to adjust the outer circumference of the annular formation structure.

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

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

[0175] 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 positioned within the recess, and the locking of the compression member involves sliding the lock at least partially within the recess.

[0176] In some applications, advancement involves advancing the valve ring forming structure while the lock is at least partially positioned within the recess.

[0177] In some applications, advancement involves advancing the annular forming structure while the lock is positioned fully proximal to the recess.

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

[0179] In some applications, the recess is sized to compress the lock when it is at least partially positioned within the recess.

[0180] In some applications, the lumen of the lock 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 located distal to the proximal portion.

[0182] In some applications, advancement involves advancing the annular forming structure using a delivery tool, and the method further involves sliding the delivery tool and the contraction member relative to each other.

[0183] In some applications, advancement involves moving the lock forward within the delivery tool, while locking involves sliding the lock using the delivery tool.

[0184] In some applications, the delivery tool includes a knob connected to the proximal portion of the shrink member, and the method further includes increasing the tension of the shrink member by using the knob to pull the shrink member proximal.

[0185] In some applications, the knob is fixed and connected to the proximal portion of the contraction member.

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

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

[0188] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0189] Furthermore, according to several applications, systems and / or apparatus are provided that include an embedded annulus forming structure, comprising a main body portion and a shrinking member. The shrinking member may be identical or similar to other shrinking members known herein or otherwise, and may have, for example, (1) a first portion extending along the longitudinal length of the main body portion of the annulus forming structure, and (2) a second portion extending away from the main portion of the annulus forming structure.

[0190] A system and / or apparatus further comprising at least one shrink member fastener configured to surround a shrink member. The shrink member fastener may include a clamping structure, the clamping structure being (a) biased to take a closed state, in which the clamping structure is configured to clamp a shrink member passing through it, and (b) bendable to an open state in which the shrink member can move.

[0191] A system and / or apparatus further comprising a fastener, which is detachably connected to a shrink member fastener and configured to keep the shrink member fastener in an open state, and a shrink member splitting tool. The shrink member splitting tool may include a static cutting element having a first cutting surface, a dynamic cutting element having a second cutting surface opposite the first cutting surface, and one or more grippers configured to pull the fastener proximal and to remove the fastener 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 proximal, the fastener is configured to contact the cutting elements, push the dynamic cutting elements relative to the static cutting elements, and move them to facilitate the splitting of the shrink member.

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

[0193] In some applications, the tool is positioned to provide a safety mechanism, thereby ensuring that the movement of a dynamic cutting element relative to a static cutting element is only possible by pressing a stopper against the dynamic cutting element.

[0194] In some applications, the system and / or apparatus further includes a housing for fasteners and stoppers, and the tool is connected to the housing when the gripper grips the stopper.

[0195] In some applications, the tool is configured to deliver housings, fasteners, and stoppers to embedded valve ring forming structures.

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

[0197] In some applications, the fastener is shaped to define a protrusion, and the gripper is configured to grasp the protrusion in order to first connect the tool to the fastener.

[0198] In some applications, the system and / or apparatus further includes an outer sleeve portion configured to surround the gripper in order to lock the gripper against a protrusion.

[0199] Furthermore, according to several applications, systems and / or devices are provided that include shrink member fasteners configured to remain attached to a shrink member. In some applications, at least one shrink member fastener is configured to surround the shrink member. The shrink member fastener may include a clamping structure, the clamping structure being (a) biased to take a closed state, in which case the clamping structure is configured to clamp a shrink member passing through it, and (b) bendable to an open state in which the shrink member can move.

[0200] The system and / or apparatus may include a fastener that is detachably connected to the shrink member fastener and configured to hold the shrink member fastener in an open state.

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

[0202] In some applications, the tool is positioned to provide a safety mechanism, thereby ensuring that movement of the cutting element is only possible by pressing a stopper against the cutting element.

[0203] In some applications, the system and / or apparatus further includes a housing for fasteners and stoppers, and the tool is connected to the housing when the gripper grips the stopper.

[0204] In some applications, the system and / or apparatus further includes an embedded annular forming structure, and the tool is configured to deliver the housing, fasteners, and stoppers to the embedded annular forming structure.

[0205] In some applications, the system and / or apparatus further includes an embedded annular forming structure, the embedded annular forming structure including a housing.

[0206] In some applications, the fastener is shaped to define a protrusion, and the gripper is configured to grasp the protrusion in order to first connect the tool to the fastener.

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

[0208] Furthermore, according to several applications, methods are provided that include passing a shrinkage member cutting tool along a shrinkage member, the shrinkage member cutting tool including a cutting element that is in close proximity to the shrinkage member while passing it. The method may also include engaging the tool with a fastener that is detachably connected to a shrinkage member fastener surrounding a portion of the shrinkage member, the fastener being configured to keep the shrinkage member fastener in an open state.

[0209] In some applications, the method further includes using a tool to disengage the fastener from the shrink member fastener by pulling the fastener with the tool, thereby facilitating the fastener to come into contact with the cutting element by pulling, facilitating the fastener to push against the cutting element, and thereby facilitating the movement of the cutting element, thereby promoting the separation of the shrink member by the cutting element.

[0210] In some applications, the tool is positioned to provide a safety mechanism, thereby ensuring that movement of the cutting element is only possible by pressing a stopper against the cutting element.

[0211] In some applications, the method further includes a housing for fasteners and stoppers, and the method includes connecting the tool to the housing by holding the stopper with the tool.

[0212] In some applications, the method further includes using a tool to deliver the housing, fasteners, and stoppers to the embedded valve ring forming structure.

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

[0214] In some applications, the fastener is shaped to define a projection, and engaging the tool with the fastener involves first connecting the tool to the fastener by grasping the projection with a tool equipped with a gripper.

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

[0216] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0217] Furthermore, according to several applications, systems and / or apparatus are provided that include an implant comprising an embedded structure and a flexible, elongated shrinkable member extending away from the embedded structure, and a shrinkable member intake tool comprising 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 includes a lock that (a) is partially positioned within the proximal longitudinal portion of the tubular shaft so that the inner shaft is axially slidable relative to the tubular shaft, (b) is shaped to define an inner shaft retractor receiving channel, and (c) is configured to (i) allow the retractor to slide relative to the inner shaft retractor receiving channel when in the unlocked state, and (ii) axially lock the retractor relative to the inner shaft when in the locked state.

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

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

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

[0222] In some applications, the handle portion is configured such that the retractable member is positioned to pass completely through the handle retractable member receiving channel, and when the lock is engaged, the operation of the retraction-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 force to the spring, which pushes the inner shaft proximally relative to the outer housing and also pulls the retractable member proximally, thereby causing the handle portion to engage with the continuous portion of the retractable member.

[0223] In some applications, the handle is configured such that the contraction member is positioned to pass completely through the handle contraction member receiving channel, the lock is engaged, and the contraction member is under tension, and the operation of the contraction-promoting knob causes the spring to push the inner shaft proximally, and the inner shaft pulls the contraction member proximally, to a degree less than the tubular shaft advances proximally relative to the outer housing, thereby increasing the tension in the contraction member.

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

[0225] In some applications, the tubular shaft and the retraction-accelerating knob are threaded to each other, and the handle portion is configured such that the operation of the retraction-accelerating knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

[0226] In some applications, the inner shaft partially protrudes outward from the proximal end of the outer housing, and both the tubular shaft and the inner shaft provide a non-electromechanical force gauge, with the relative axial position of the tubular shaft to the inner shaft providing a visual indication of the tension in the contraction member.

[0227] In some applications, the inner shaft is marked with multiple reference markers positioned 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 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 to the outer housing when the tubular shaft is positioned 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 stopper positioned to axially lock the inner shaft to the outer housing when the tubular shaft is positioned 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 retaining element is configured to be axially fixed and connected to the inner shaft, and to move radially outward to engage with the outer housing, thereby axially locking the inner shaft to the outer housing.

[0232] In some applications, the tension limiting locking assembly further includes a plurality of recesses shaped to define the outer housing, and the retainer is engageable with the recesses to axially lock the inner shaft to the outer housing, and the handle portion is positioned such that when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, the specific one of the recesses with which the retainer engages depends on the relative axial position of the inner shaft with respect to the outer housing.

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

[0234] In some applications, the tubular shaft extends along the longitudinal portion of the elongated opening. (a) When the tubular shaft is positioned distally at a predetermined relative axial position with respect to the inner shaft, the stopper prevents the inner shaft from locking axially with respect to the outer housing, (b) Includes one or more tracks, which are arranged such that a stopper can axially lock the inner shaft when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft.

[0235] In some applications, one or more tracks are shaped to define one or more individual inclined portions, so that when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, the retaining arm axially engages the inner shaft with respect to the outer housing, and then subsequent distal movement of the tubular shaft relative to the inner shaft, and consequently the one or more tracks, disengages the retaining arm from the outer housing.

[0236] In some applications, the inner shaft partially protrudes outward from the proximal end of the outer housing, and both the tubular shaft and the inner shaft provide a non-electromechanical force gauge, with the relative axial position of the tubular shaft to the inner shaft providing a visual indication of the 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] Furthermore, according to several applications, systems and / or apparatus are provided, including an implant comprising an embedded structure and a flexible, elongated shrink member extending away from the embedded structure, and a shrink member intake tool. The shrink member intake tool may include a handle portion that (a) is shaped to define a shrink member receiving channel from the distal end to the proximal end of the handle portion, and (b) comprises an outer housing, a non-electromechanical force gauge, a lock, and a shrinkage-promoting knob accessible from the outside of the outer housing. The lock may be configured to (i) allow the shrink member to slide against the force gauge when in the unlocked state, and (ii) axially lock the shrink member against an axially movable portion of the force gauge when in the locked state, the axially movable portion of the force gauge being axially movable relative to the outer housing.

[0240] In some applications, the retractable member is positioned to pass completely through the handle retractable member receiving channel, and the handle portion is configured such that, when the lock is engaged, the operation of the retraction-promoting knob advances the force gauge proximally relative to the outer housing, pulling the retractable member proximally and causing the handle portion to engage the continuous portion of the retractable member.

[0241] In some applications, the handle portion is configured such that the contraction member is positioned to pass completely through the handle contraction member receiving channel, the lock is engaged, and when the contraction member is under tension, the operation of the contraction-proximally pulling the contraction member by the axially movable portion of the force gauge increases the tension in the contraction member, and the force gauge is configured to provide a visual indication of the measure of tension in the contraction member.

[0242] In some applications, force gauges include springs.

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

[0244] In some applications, the handle portion further includes a tension limiting locking assembly configured to axially lock an axially movable portion of a force gauge 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] Furthermore, depending on the application, methods are provided that include advancing an implantable structure of an implant and a flexible, elongated contractile member extending away from the implantable structure toward the patient's heart, and passing a portion of the contractile member through a handle contractile member receiving channel on the handle portion of a contractile member intake tool. The contractile member intake tool may be identical or similar to other contractile member intake tools described elsewhere in this specification and may include, for example, one, all, or some of an outer housing, a tubular shaft at least partially located within the outer housing, an inner shaft, a distal force applicator, a spring, and a contraction-promoting knob accessible from outside the outer housing.

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

[0247] The distal force applicator may (a) be at least partially located within the distal longitudinal portion of a tubular shaft, and (b) be shaped to define a distal force applicator contraction member receiving channel, the distal force applicator contraction member receiving channel allowing a contraction member to slide through its interior, and the handle contraction member receiving channel may (a) extend from the distal end to the proximal end of the handle portion, and (b) include an internal shaft contraction member receiving channel and a distal force applicator contraction member receiving channel.

[0248] The spring is positioned inside the tubular shaft and can 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 involves activating a contraction-accelerating knob to advance the tubular shaft proximal to the outer housing, which in turn advances the distal force applicator proximal to the outer housing, which in turn applies a proximal force to a spring, which in turn pushes the inner shaft proximal to the outer housing, which in turn pulls the contraction member proximal to the contraction member, thereby causing the continuous portion of the contraction member to be taken into the handle portion until the contraction member is taut; and then, once the contraction member is taut, activating the contraction-accelerating knob to increase the tension in the contraction member by the proximal pull of the inner shaft caused by the spring pushing the inner shaft proximal to the outer housing to a degree less than the advance of the tubular shaft proximal to the outer housing.

[0251] In some applications, activating the contraction-enhancing knob involves rotating the contraction-enhancing knob.

[0252] In some applications, the tubular shaft and the retraction-accelerating knob are threaded to each other, and the handle portion is configured such that the operation of the retraction-accelerating 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 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, and the method further includes viewing the visual indication.

[0254] In some applications, the inner shaft is marked with multiple reference markers positioned 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 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 to the outer housing when the tubular shaft is positioned 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 stopper positioned to axially lock the inner shaft to the outer housing when the tubular shaft is positioned 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 retaining element is configured to be axially fixed and connected to the inner shaft, and to move radially outward to engage with the outer housing, thereby axially locking the inner shaft to the outer housing.

[0259] In some applications, the tension limiting locking assembly further includes a plurality of recesses shaped to define the outer housing, and the retainer is engageable with the recesses to axially lock the inner shaft to the outer housing, and the handle portion is positioned such that when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, the specific one of the recesses with which the retainer engages depends on the relative axial position of the inner shaft with respect to the outer housing.

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

[0261] In some applications, the tubular shaft extends along the longitudinal portion of the elongated opening. (a) When the tubular shaft is positioned distally at a predetermined relative axial position with respect to the inner shaft, the stopper prevents the inner shaft from locking axially with respect to the outer housing, (b) Includes one or more tracks, which are arranged such that a stopper can axially lock the inner shaft when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft.

[0262] In some applications, one or more tracks are shaped to define one or more individual inclined portions, so that when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, the retaining arm axially engages the inner shaft with respect to the outer housing, and then subsequent distal movement of the tubular shaft relative to the inner shaft, and consequently the one or more tracks, disengages the retaining arm from the outer housing.

[0263] In some applications, the inner shaft partially protrudes 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, and the method further includes viewing the visual indication.

[0264] In some applications, the implanted structure includes an implanted annular formation structure, and advancing the implanted structure includes advancing the implanted annular formation structure toward the heart.

[0265] In some applications, the implanted annular forming structure includes a flexible sleeve, and involves advancing the implanted annular forming structure and the contractile member toward the heart such that the contractile member extends along and away from the sleeve.

[0266] Furthermore, according to several applications, methods are provided that include advancing an implantable structure of an implant and a flexible, elongated retractable member extending away from the implantable structure toward the patient's heart, and passing a portion of the retractable member through a handle retractable member receiving channel on the handle portion of a retractable member intake tool.

[0267] Shrink member take-up tools may be identical or similar to other shrink member take-up tools described elsewhere in this specification or otherwise known. For example, in some applications, a shrink member take-up tool comprises an outer housing, a non-electromechanical force gauge, a lock, and a shrinkage acceleration knob. The lock may be configured to (i) allow the shrink member to slide relative to the force gauge when in the unlocked state, and (ii) axially lock the shrink member to an axially movable portion of the force gauge when in the locked state, the axially movable portion of the force gauge being axially movable relative to the outer housing. The shrinkage acceleration knob may 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 activating the contraction acceleration knob to advance the force gauge proximally relative to the outer housing, thereby pulling the contraction member proximally and causing the continuous portion of the contraction member to be incorporated into the handle portion.

[0269] The method may then include, once the contraction member is tensed, activating a contraction acceleration knob to pull the contraction member proximal to it by an axially movable portion of a force gauge, thereby increasing the tension in the contraction member, and observing a visual indication of the tension in the contraction member, which is provided by the force gauge.

[0270] In some applications, force gauges include springs.

[0271] In some applications, force gauges are configured such that a spring applies a proximal force to a portion of the force gauge that is movable in the axial direction.

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

[0273] The method may be carried out in the form of treatment on living animals or in simulations / simulated treatments (e.g., simulators with corpses, cadaveric hearts, dummy hearts, tissues, etc., anthropomorphic ghosts, etc.).

[0274] Furthermore, systems and / or apparatus are provided that may include, depending on the application, embedded annular forming structures (e.g., annular forming ring structures, closed annular forming structures, closed annular forming ring structures, open annular forming structures, partial annular forming ring structures, or other annular forming devices). An embedded annular forming structure may comprise a main body portion and a retractable member extending at least partially along the longitudinal length of the main body portion of the annular forming structure. An embedded annular forming structure may be identical or similar to other annular forming structures described elsewhere in this specification.

[0275] The system and / or apparatus may also include a shrink member intake tool. The shrink member intake tool may be identical or similar to other shrink member intake tools described elsewhere in this specification. The shrink member intake tool may comprise one or more tubes (e.g., one tube, a primary tube, and a secondary tube). At least one tube has a lumen configured for the passage of a shrink member through it. The tube may be flexible, semi-rigid, or rigid. The shrink member intake tool may also comprise a shrink member snare. The shrink member snare may comprise a distal snare portion and an elongated flexible body portion connected to the distal snare portion. The distal snare portion may be configured to fit a portion of the shrink member and draw it into the lumen. The distal snare portion may be configured to pull that portion of the shrink member through a portion of the lumen or through the entire length of the lumen (e.g., end to end). The shrink member snare may 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 retractable member.

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

[0277] The distal snare portion may be provided with a flexible loop. The lumen may be configured to fold the flexible loop around the contraction member when that portion of the contraction member is pulled through the lumen. At least the distal snare portion of the contraction member snare may be corrugated to increase friction between the snare portion and the contraction member.

[0278] The distal end portion of the shrinkage member intake tool may be shaped to define a sharp edge, and the shrinkage member intake tool may be positioned close to the sharp edge so that the sharp edge can cut through the shrinkage member.

[0279] The shrink member intake tool may include a shrink member fastener located within the distal end portion of the shrink member intake tool. The shrink member fastener may include a clamping structure. The clamping structure may be biased to assume a closed state or closed position, and in the closed state / position, the clamping structure may be configured to clamp the shrink member as it passes through. The clamping structure may also be configured to bend to an open state or open position, and in the open state / position, the shrink member may move through. The shrink member intake tool may also include a stopper that is detachably connected 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 shrink member, and the clamping structure may be configured and sized to pass distally through the shrink member fastener and clamping structure in the open state / position. The distal snare portion may be adapted to capture and pull proximal through the shrink member fastener and clamping structure and through aligned ports on the distal end of the shrink member take-up tool.

[0281] The shrink member intake tool may include a fastener ejector that is movable within the distal end portion of the shrink member intake tool, which may be configured such that the movement of the fastener ejector contacts a shrink member fastener and converts it from an open / closed state / position to a closed state / position, thereby tightening the shrink member as it passes through. The fastener ejector may be connected to a fastener and may be configured to move a fastener that is detachably connected to the fastener. The distal end portion of the shrink member intake tool may be shaped to define a sharp edge, and the shrink member intake tool may be positioned close to the sharp edge so that the movement of the fastener ejector relative to the sharp edge may be configured to sever the shrink member after it has extended through the fastener or as it is about to extend.

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

[0283] The present invention will be better understood from the following embodiments for carrying out the invention, along with the drawings. [Brief explanation of the drawing]

[0284] [Figure 1] This is a schematic diagram of an example of a multi-component tubular system for delivering and securing implants, and for controlling the relative spatial orientation of the components of a catheter system. [Figure 2]Schematic diagram of an example of a multi-component tubular system for delivering and fixing an implant and for controlling the relative spatial orientation of the components of a catheter system. [Figure 3A] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3B] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3C] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3D] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3E] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3F] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3G] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3H] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 3I] Schematic diagram of an exemplary procedure for repairing a mitral valve by implanting an annuloplasty structure. [Figure 4A] Schematic diagram of an exemplary shrink member insertion tool configured to shrink the shrink member of the annuloplasty structure of FIGS. 3A-I and sever any excess portion of the shrink member. <00|00897>Schematic diagram of an exemplary shrink member insertion tool configured to shrink the shrink member of the annuloplasty structure of FIGS. 3A-I and sever any excess portion of the shrink member. [Figure 5A] Schematic diagram of an exemplary shrink member insertion tool of FIGS. 4A-B used to insert a shrink member. [Figure 5B] Schematic diagram of an exemplary shrink member insertion tool of FIGS. 4A-B used to insert a shrink member. [Figure 5C] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to insert a shrink member. [Figure 5D] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to insert a shrink member. [Figure 6A] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to insert a shrink member and contract a valve ring forming structure connected to the shrink member. [Figure 6B] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to insert a shrink member and contract a valve ring forming structure connected to the shrink member. [Figure 7A] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to lock and fix a valve ring forming structure in its contracted state and then sever an excess portion of the shrink member. [Figure 7B] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to lock and fix a valve ring forming structure in its contracted state and then sever an excess portion of the shrink member. [Figure 7C] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to lock and fix a valve ring forming structure in its contracted state and then sever an excess portion of the shrink member. [Figure 7D] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to lock and fix a valve ring forming structure in its contracted state and then sever an excess portion of the shrink member. [Figure 7E] Schematic diagrams of exemplary shrink member insertion tools of FIGS. 4A - B used to lock and fix a valve ring forming structure in its contracted state and then sever an excess portion of the shrink member. [Figure 8A] Schematic diagram of an example of a system for contracting a patient's valve ring using a valve ring forming structure including a housing for accommodating a shrink member fastener. [Figure 8B]This is a schematic diagram of an example of a system for contracting a patient's valve annulus using a valve annulus forming structure that includes a housing for a contraction member fastener. [Figure 8C] This is a schematic diagram of an example of a system for contracting a patient's valve annulus using a valve annulus forming structure that includes a housing for a contraction member fastener. [Figure 8D] This is a schematic diagram of an example of a system for contracting a patient's valve annulus using a valve annulus forming structure that includes a housing for a contraction member fastener. [Figure 9A] These are schematic diagrams of exemplary shrink member intake tools used to lock and fix the valve ring forming structures shown in Figures 8A-D in their contracted state, and then to separate the excess portion of the shrink member. [Figure 9B] These are schematic diagrams of exemplary shrink member intake tools used to lock and fix the valve ring forming structures shown in Figures 8A-D in their contracted state, and then to separate the excess portion of the shrink member. [Figure 9C] These are schematic diagrams of exemplary shrink member intake tools used to lock and fix the valve ring forming structures shown in Figures 8A-D in their contracted state, and then to separate the excess portion of the shrink member. [Figure 9D] These are schematic diagrams of exemplary shrink member intake tools used to lock and fix the valve ring forming structures shown in Figures 8A-D in their contracted state, and then to separate the excess portion of the shrink member. [Figure 10A] This is a schematic diagram of an example of a shrinkage member intake tool that can be used to engage with a shrinkage member and separate any excess portion of the shrinkage member. [Figure 10B] This is a schematic diagram of an example of a shrinkage member intake tool that can be used to engage with a shrinkage member and separate any excess portion of the shrinkage member. [Figure 11A] This is a schematic diagram of an example of a shrink member intake tool used to lock and fix a valve ring forming structure in its contracted state, and then to separate the excess portion of the shrink member. [Figure 11B]This is a schematic diagram of an example of a shrink member intake tool used to lock and fix a valve ring forming structure in its contracted state, and then to separate the excess portion of the shrink member. [Figure 11C] This is a schematic diagram of an example of a shrink member intake tool used to lock and fix a valve ring forming structure in its contracted state, and then to separate the excess portion of the shrink member. [Figure 12A] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 12B] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 12C] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 13A] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 13B] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 13C] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 14] This is a schematic diagram of an exemplary lock that can be used to lock the outer circumference of a valve ring forming structure. [Figure 15A] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 15B] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 15C] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 16] This is a schematic diagram of an example system comprising an exemplary valve ring forming structure including a sleeve, a shrinking member, and a lock. [Figure 17] A schematic diagram of an example of a system comprising an exemplary valve annulus forming structure comprising a sleeve, a constriction member, and a lock. [Figure 18] A schematic diagram of an example of a system for constricting a patient's valve annulus using a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 19A] A schematic diagram of an example of a system for constricting a patient's valve annulus using a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 19B] A schematic diagram of an example of a system for constricting a patient's valve annulus using a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20A] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20B] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20C] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20D] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20E] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 20F] A schematic diagram of an example of a constriction member insertion and constriction member severing tool for use in combination with a valve annulus forming structure comprising a housing for accommodating a constriction member fastener. [Figure 21A] A schematic diagram of an example of a constriction member insertion tool of the multi-component tubular system of FIGS. 20A - F prior to insertion of a flexible elongate constriction member according to some applications. [Figure 21B]Figures 20A-F show schematic diagrams of examples of shrinkage member intake tools for multi-component tubular systems, before the insertion of flexible, elongated shrinkage members according to several applications. [Figure 22A] Figures 21A and 21B show schematic diagrams of the shrink member insertion tool after inserting a flexible, elongated shrink member, according to several applications. [Figure 22B] Figures 21A and 21B show schematic diagrams of the shrink member insertion tool after inserting a flexible, elongated shrink member, according to several applications. [Figure 23A] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 23B] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 24A] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 24B] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 25A] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 25B] Figures 21A and 21B show schematic diagrams of the shrinking member intake tool after the continuous operation level of the tool's shrinkage acceleration knob, according to several applications. [Figure 26A] Figures 21A and 21B are schematic diagrams of the outer casing and a portion of the tubular shaft of the shrinkage member intake tool, according to several applications. [Figure 26B] Figures 21A and 21B are schematic diagrams of the outer casing and a portion of the tubular shaft of the shrinkage member intake tool, according to several applications. [Modes for carrying out the invention]

[0285] Refer here to Figures 1-2, schematic diagrams of an example of a multi-component tubular system 10 that provides one or more rotation-controlled maneuverable catheters configured to deliver an implant to a patient's heart. System 10 provides an implant delivery tool. System 10 may include a first outer catheter 12 having a sheath configured to advance through the patient's vascular structure. In some applications, the outer catheter 12 has a sheath configured to advance through the femoral artery toward the atrial septum of the patient's heart. The maneuverable distal end portion of the outer catheter 12 is configured to pass through the septum and be oriented to a desired spatial orientation. System 10 includes a second catheter, or guide catheter 14, having a maneuverable distal end portion. The catheter 14 is configured to advance through the lumen of the outer catheter 12. The outer catheter 12 is provided with a first coupling 152 (e.g., a slit 52) ​​on its distal portion (e.g., a portion of the catheter 12 proximal to the maneuverable distal end portion). The guide catheter 14 may include a second coupling 154 (e.g., a pushable engagement portion 54) connected to a displaceable tab 56 connected to its base. As described herein, the pushable engagement portion 54 (or the second coupling 154) is configured to protrude within a slit 52 (or the first coupling 152). Thus, the slit 52 defines the second coupling receiving element.

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

[0287] As shown in the exploded view of Figure B, the first coupling 152 may be shaped to define a slit 52. In some applications, the slit 52 is provided by a metal frame 50, as shown. The metal frame 50 may have a length L22 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 (for example, by making a slit in the polymer material of the catheter 12 during the manufacture of the catheter 12), and the frame 50 is connected to the catheter 12. The second coupling 154 may include an engaging portion 54, which may include a projection located on the distal portion of a displaceable tab 56 at the base of the engaging portion 54. The base of the engaging portion 54 may be shaped to define a slit 57 that forms the tab 56. The engaging portion 54 is pressable when a force is applied to it, and the tab 56 facilitates the movement of the engaging portion 54 in response to the force applied to it and, in its absence. In some applications, during the manufacturing of the catheter 14, the catheter 14 is manipulated to connect the engaging portion 54 and tab 56 to it, for example, the engaging portion 54 and tab 56 are embedded within the polymer of the catheter 14.

[0288] The slit 52 and the pushable engagement portion 54 are shown on the outer catheter 12 and the guide catheter 14, respectively, but in the distal portions of catheters 12 and 14, the slit 52 and the engagement portion 54 may be provided along any preferred portion of catheters 12 and 14, respectively (for example, the proximal portions of catheters 12 and 14, respectively).

[0289] The first and second couplings 152 and 154 can each be provided on any standard catheter. That is, coupling 152 comprises a frame 50 that can be connected to the outer surface of any standard catheter (in which case a corresponding slit is created in the standard catheter). Furthermore, coupling 154 can be connected to any standard catheter by connecting the base portion of coupling 154 to any standard catheter. Suitable adjustment to the standard catheter is made to adapt to the displacement of the tab 56 and the engaging portion 54 in response to the pressing force applied to the engaging 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 maneuverable. The distal end portion of the outer catheter 12 may include a pull ring 11 connected to two or more maneuvering wires or pull wires 29a and 29b, which are located in the respective secondary lumens within the wall of the catheter 12 (as shown in section AA). As shown in the exploded view, the guide catheter 14 may be configured to be positioned concentrically within the lumen of the catheter 12. As described above, the distal end portion of the guide catheter 14 is maneuverable. The distal end portion of the guide catheter 14 may include a pull ring 13 connected to two or more pull wires 31a and 31b, which are located in the respective secondary lumens within the wall of the catheter 14 (as shown in sections AA and BB).

[0291] The guide catheter 14 is maneuverable to a desired spatial orientation to facilitate the advancement and implantation of the implant within the patient's body cavity. As shown, the implant comprises an annular forming structure 222 (e.g., an annular forming ring structure, closed annular forming structure, closed annular forming ring structure, open annular forming structure, partial annular forming ring structure, etc.) comprising a flexible sleeve 26 (shown in the exploded view of Figure 2). The sleeve 26 may include a knitted mesh, for example, DACRON®. The sleeve 26 may be configured to be positioned only partially around the annulus (i.e., to take a C-shape) and, once fixed in place, to contract to tightly constrict the annulus in the circumferential direction. However, the ring structure may also be configured to be positioned completely around the annulus. To tightly constrict the annulus, the annular forming structure or annular forming ring structure 222 comprises a flexible, elongated, contractible member 226 extending along the sleeve 26. The elongated shrinkable member 226 may include a wire, ribbon, rope, or band, which may include one or more of various materials such as flexible and / or superelastic materials, e.g., Nitinol, polyester, stainless steel, or cobalt-chromium. In some applications, the wire may include an X-ray opaque material. In some applications, the shrinkable member 226 may include braided polyester suture (e.g., Ticron). In some applications, the shrinkable member 226 may be coated with polytetrafluoroethylene (PTFE). In some applications, the shrinkable member 226 may include multiple wires intertwined to form a rope structure.

[0292] In applications where system 10 is used to deliver an implant to a patient's mitral valve, the outer catheter 12 may be configured to first advance through the patient's vascular structure until the distal end 102 (which may be the most distal end or tip) of the catheter 12 is positioned in the left atrium. The maneuverable distal end of the catheter 12 is then maneuvered so that the distal end 102 of the catheter 12 is positioned in a desired spatial orientation within the left atrium. The maneuvering procedure may be performed using imaging such as fluoroscopy, transesophageal echocardiography, and / or echocardiography. Following the maneuvering of the distal end portion of the catheter 12, the guide catheter 14 (housing the annular formation 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 maneuverable distal end portion of the catheter 14 may be exposed from the distal end 102 of the catheter 12 and thus freely maneuverable toward the mitral annulus as described below.

[0293] Furthermore, the system 10 includes mounting mechanisms such as multiple anchors 32 (e.g., anchors, adhesives, clamps, clips, fasteners, etc.), which may number from about 5 to about 20 anchors, for example, about 10 or about 16 anchors. Each anchor 32 may comprise 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 Figure 2 as being reversibly coupled to a deployment element 38 of a rotary anchor driver 36 of an anchor deployment manipulator 61. When the sleeve 26 is positioned along the annulus of the heart valve, the deployment manipulator 61 is configured to advance within the lumen of the sleeve 26 and deploy each anchor 32 from within the sleeve 26 through the wall of the sleeve 26 into the cardiac tissue, thereby securing the sleeve 26 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 described in detail below.

[0294] The anchor 32 may contain biocompatible materials such as stainless steel 316 LVM. In some applications, the anchor 32 contains nitinol. In some applications, the anchor 32 is fully or partially coated with a non-conductive material.

[0295] The deployment manipulator 61 comprises an anchor driver 36 and a deployment element 38, as shown in Figure 2.

[0296] As shown in the exploded view of Figure 2, the sleeve 26 is positioned 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 isolation channel 18 is advancing 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 positioned within the sleeve is coaxial with the sleeve. As shown in the enlarged view of Figure 1, the distal end 17 of the implant isolation channel 18 is positioned in contact with the inner wall of the sleeve 26 at its distal end. Furthermore, the distal end portion of the channel 18 is equipped with a radiopaque marker 1018. As shown, the tube 19 and the sleeve 26 are positioned 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 comprises multiple anchor drivers 36, each driver being connected to a respective anchor 32. Each driver 36 can advance within the channel 18 to advance and embed the anchor 32 into the tissue. After the embedding 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. A new driver 36, connected to another anchor 32, then advances within the channel 18.

[0298] As described below, the first anchor 32 is configured to deploy into cardiac tissue through the wall of the sleeve when the sleeve 26 is positioned along the valve annulus. Following the deployment of the first anchor, the distal portion of the sleeve 26 slides distally away from a portion of the implant isolation channel 18. To isolate the sleeve 26 distally from a portion of the outer surface of the channel 18, (1) a proximal force is applied to the channel 18, while (2) a reference force tube 19 is held in place such that the distal end of the tube 19 provides a reference force to the sleeve 26, facilitating the release of the continuous portion of the sleeve 26 from around the channel 18. The channel 18 is then positioned in a continuous position within the lumen of the sleeve 26 (as described below) while either the tube 19 and / or the catheter 14 is maneuvered toward a continuous position along the valve annulus. As a result, the continuous portion of the sleeve 26 provides a free lumen for the advancement of the continuous anchor 32 and the deployment of the anchor through the wall of the sleeve in that continuous portion. Such release of the continuous portion of sleeve 26 creates distance between the continuous anchors deployed from the lumen of sleeve 26.

[0299] In some applications, the sleeve 26 includes a plurality of radiopaque markers 25 positioned along the sleeve in each longitudinal portion. The markers can provide indication in radiographic images (such as fluoroscopic images) of the degree to which the sleeve is deployed at any given point in time during the implantation procedure, allowing for the setting of a desired distance between anchors 32 along the sleeve. In some applications, the markers contain radiopaque ink.

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

[0301] Each anchor 32 can be connected to a deployment element 38 of an anchor driver 36. The anchor driver 36 comprises an elongated tube having at least a flexible distal end portion. The elongated tube of the driver 36 extends through the system 10 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 sliding forward movement through the interior of an elongated rod 130. The rod 130 facilitates the locking and unlocking of the anchors 32 to the deployment element 38, as described below. As shown in section EE of Figure 2, the proximal end of the rod 130 is connected to a component of an anchor release mechanism 28 at the proximal end of the system 10. The mechanism 28 comprises a housing 135 and a finger engagement portion 131 connected to the proximal end of the rod 130. The finger engagement portion 131 is connected to the housing 135 via a spring 133 (section EE of Figure 2). The proximal end of the tube of the anchor driver 36 is connected to the housing 135. As described below, the user (e.g., a doctor, medical professional, etc.) releases the anchor 32 from the deployment element 38 when the finger engagement portion 131 is pulled proximal, thereby pulling the rod 130 proximal.

[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, for example, by using an external control device and / or electric motor connected to the proximal end of the anchor driver and / or housing 135.

[0303] The proximal handle portion 101 may be supported by a stand having support legs 91 and a handle sliding track 90. ​​The handle portion 101 comprises an outer catheter handle 22, a guide catheter handle 24, an implant manipulation handle 126, and an anchor release mechanism 28. Handle 22 is connected to the proximal end of the outer catheter 12. Handle 24 is connected to the proximal end of the guide catheter 14. Handle 126 is connected to the proximal portion of the reference force tube 19, and linear movement of handle 126 relative to 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 concentrically arranged components of the system 10 are shown in the exploded view and sections AA, BB, CC, and DD of Figure 2.

[0304] The stand supporting the proximal handle portion 101 can be moved distally and proximal to control the position of the entire multi-component system 10, in particular, to adjust the distance of the distal end 102 of the catheter 12 from the atrial septum. The handle 22 is equipped with a steering knob 210 connected to pull wires 29a and 29b positioned in the respective secondary lumen of the wall of the outer catheter 12. Rotation of the knob 210 adjusts the degree of tension in the wires 29a and 29b, which applies force to the pull ring 11 at the distal end portion of the outer catheter 12. Such force steers the distal end portion of the catheter 12 within the atrium of the patient's heart in such a way that the distal end portion of the catheter 12 is steered in a first plane parallel to the plane of the valve annulus (for example, in the direction from the atrial septum toward the wall surrounding the atrium). In some applications, the distal end portion of the catheter 12 may be pre-shaped to face downward toward the valve. In other applications, the distal end of the catheter 12 can be pulled to orient it downward toward the valve. In some applications, the distal end of the catheter 12 is not manufactured to face downward toward the valve.

[0305] The handle 24 may be connected to the track 90 via a first mount 92. The mount 92 may be slidable proximal and distal along the track 90 to control the axial position of the guide catheter 14 relative to the outer catheter 12. The mount 92 may be slidable via a control knob 216. For example, the control knob 216 of the mount 92 can control the proximal and distal axial movement of the maneuverable distal portion of the guide catheter 14 relative to the distal end 102 of the outer catheter 12. The handle 24 may include a maneuver knob 214 connected to pull wires 31a and 31b positioned in the respective secondary lumen of the wall of the guide catheter 14. Rotation of the knob 214 adjusts the degree of tension in the wires 31a and 31b, which applies force to the pull ring 13 at the distal end portion of the guide catheter 14. Such force maneuvers the distal end portion of the catheter 14 downward toward the second plane in 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 the first plane on which the distal end portion of the outer catheter 12 is steered.

[0306] The combined maneuvers of the distal ends of catheters 12 and 14 direct the sleeve 26 downward toward the valve annulus (for example, via the maneuver of the distal end of catheter 14) and along the outer circumference of the valve annulus (for example, from the rear of the valve to the front of the valve, or vice versa) via the maneuver of the distal end of catheter 12.

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

[0308] In some applications, the handle 22 includes an indicator showing the degree of manipulation (e.g., bending) of the distal end portion of the catheter 12 brought forth using the knob 210. In some applications, the handle 24 includes an indicator showing the degree of manipulation (e.g., bending) of the distal end portion of the catheter 12 brought forth 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., the slit 52 and the engagement portion 54), provide a controlled maneuverable system, so that during the maneuvering 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 maneuvered configuration or spatial orientation without substantially affecting the maneuvering 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 maneuvering and bending of the catheter 14. In other words, the first and second couplings 152 and 154 of the outer catheter 12 and the guide catheter 14 each collectively define a relative spatial orientation control device, which rotationally locks the relative spatial orientation of the maneuverable distal end portion and bending section of the outer catheter 12 with respect to the maneuverable distal end portion and bending section of the guide catheter 14.

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

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

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

[0313] The handle portion 101 may include a release decision facilitator 127, such as a latch or button, which often automatically engages just before the sleeve 26 is completely separated from the channel 18 when the sleeve 26 has advanced a given length beyond the channel 18 (for example, when the channel 18 is in a given position relative to the tube 19). 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 accidental 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 operating physician) must disengage the member 127, such as by pressing a button, before continuing to pull the channel 18 proximal. 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 65–85 cm, for example, 76 cm. As shown, the majority of the body portion of the outer catheter handle 22 can be positioned at a non-zero angle with respect to the longitudinal axis 7 of the multiple components of the system 10. The maneuvering mechanism provided by the handle 22 for maneuvering the distal end portion of the catheter 12 is located within that portion of the handle 22 positioned at a non-zero angle with respect to the axis 7. The handle 22 includes a series of tubular portions 21 arranged in a longitudinal line along and coaxially with respect to handles 24 and 126 and the release mechanism 28. The tubular portions 21 are shaped to define a lumen for inserting the guide catheter 14 through to the lumen of the outer catheter 12. The tubular portions 21 have a length L24 of 7–11 cm, for example, 7 cm. Such spatial orientation of most of the handle 22 at a certain angle with respect to the axis 7 reduces the overall functional length of the handle portion 101.

[0315] Here, refer to Figures 3A-I, which are schematic diagrams of an example of a procedure for repairing the mitral valve 230 by implanting an annular formation structure 222 (e.g., annular formation ring structure, closed annular formation structure, closed annular formation ring structure, open annular formation structure, partial annular formation ring structure, etc.). This procedure is an example of a procedure that can be performed using system 10.

[0316] An annular forming structure or annular forming ring structure 222 may be used to repair a dilated annulus of an atrioventricular valve such as the mitral valve 230. In some applications, the annular forming structure is configured to be positioned only partially around the annulus (e.g., to take a C-shape) and, once fixed in place or otherwise secured, to contract to tightly constrict the annulus circumferentially. In some applications, the annular forming structure is configured to be positioned completely around the annulus (e.g., to take a closed shape such as a circular, elliptical, or D-shape) and, once fixed in place, to contract to tightly constrict the annulus circumferentially. The annular forming structure may comprise a flexible sleeve 26. The annular forming structure may also include and / or be used with mounting means such as a plurality of anchors 32 (e.g., anchors, fasteners, clamps, sutures, clips, etc.). The anchor deployment manipulator 61 advances into the lumen of the sleeve 26 and, from within the lumen, deploys the anchor through the sleeve wall into the cardiac tissue, thereby securing the sleeve around a portion of the annulus. In some applications, the annulus-forming structure or annulus-forming ring structure 222 is realized using the technology described in U.S. Application No. 12 / 437,103 (obtained as U.S. 8,715,342), filed on 7 May 2009, and / or U.S. Application No. 12 / 689,635 (obtained as U.S. 8,545,553), filed on 19 January 2010, both of which have been assigned to the assignee of this application and are incorporated herein by reference.

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

[0318] As shown in Figure 3B, the guidewire 202 provides a guide for the subsequent advancement of the lateral catheter 12 along it into the right atrium. Once the distal portion of the catheter 12 enters the right atrium, the guidewire 202 retracts from the patient's body. The catheter 12 may contain a 14–24F sheath, but any size may be selected as needed for a given patient. The catheter 12 advances into the right atrium through the vascular structure using an appropriate starting point determined for a given patient. For example, ● The catheter 12 can be introduced transseptally into the right atrium 220 and left atrium 224, for example, through the fossa ovalis, via the inferior vena cava 223 into the patient's femoral vein. ● The catheter 12 can be introduced into the ulnar cutaneous vein, into the superior vena cava via the subclavian vein, into the right atrium 220, and into the left atrium 224 transseptally, for example, through the fossa ovale, or ● The catheter 12 can be introduced into the external jugular vein, into the superior vena cava via the subclavian vein, into the right atrium 220, and into the left atrium 224 transseptally, for example, through the fossa ovale.

[0319] In some applications, the catheter 12 advances into the right atrium 220 through the patient's inferior vena cava 223 (as illustrated) using an appropriate starting point for a given patient.

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

[0321] As shown in Figure 3D, the elastic needle 206 and 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 from within the dilator, allowing it to puncture the septum and create an opening that facilitates the passage of the dilator and the subsequent catheter 12 through and into the left atrium 224. The dilator passes through the hole in the septum created by the needle. The dilator may be shaped to define a hollow shaft for passage along the needle 206, 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 hole in the septum, the hole expands. In some applications, the distal end 102 of the catheter 12 is tapered to facilitate the passage of the distal portion of the catheter 12 through the opening in the septum.

[0322] Following the advancement of the catheter 12 through the septum and into the left atrium, the dilator and needle 206 may be withdrawn from the catheter 12, as shown in Figure 3E. Once the distal portion of the catheter 12 is positioned within the atrium 224, the maneuverable distal end portion of the catheter 12 (e.g., the bent section 1203 of the catheter 12) may be maneuvered in a first plane parallel to the plane of the annulus of the mitral valve 230. Such maneuvering moves the distal end portion of the catheter 12 toward the periwall of the atrium, as indicated by the arrow in the atrium 224. As described above, the maneuvering of the distal portion of the catheter 12 may be performed via the maneuvering knob 210 (in Figures 1 and 2) of the handle 22 of the handle portion 101.

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

[0324] As shown in Figure 3G, the distal end 251 of the sleeve 26 is positioned near the left fibrous triangle 242 of the annulus 240 of the mitral valve 230. (For clarity of the illustration, the distal end 251 of the sleeve 26 is schematically shown in the cross-sectional view of the heart, but note that the left fibrous triangle 242 is actually located off-page, closer to the viewer, rather than within the shown cross-sectional plane.) Alternatively, the distal end of the sleeve 26 is positioned near the right fibrous triangle 244 of the mitral valve (configuration not shown). Furthermore, alternatively, the distal end of the sleeve is not positioned near any of the triangles, but instead at another location near the mitral valve, such as near the anterior or posterior commissure. Once positioned at a desired location near the selected triangular region, the deployment manipulator 61 deploys the first anchor 32 into the cardiac tissue near the triangular region through the wall of the sleeve 26 (by penetrating the sleeve wall in a direction parallel to the central longitudinal axis of the deployment manipulator 61 or anchor driver 36 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 cardiac tissue, the deployment element 38 is separated from the anchor 32 by moving the rod 130 proximal.

[0325] Anchors 32 can be deployed from the distal end of the manipulator 61, but the distal end is positioned such that the central longitudinal axis passing through the distal end of the manipulator 61 forms an angle with the surface of the cardiac tissue of approximately 20–90 degrees, e.g., approximately 45–90 degrees, e.g., approximately 75–90 degrees, e.g., approximately 90 degrees. Anchors 32 can be deployed from the distal end of the manipulator 61 into the cardiac tissue in a direction parallel to the central longitudinal axis passing through the distal end of the manipulator 61. Such an angle can be provided and / or maintained by a channel 18 which is rigider than the sleeve 26. The distal end 17 of the channel 18 (shown in Figure 2) can be positioned close to the surface of the cardiac tissue (and the wall of the sleeve 26 positioned against the surface of the cardiac tissue), so that most of each anchor 32 does not come out of the channel 18 before penetrating the sleeve and tissue. For example, the distal end 17 of the channel 18 can be positioned (e.g., pressed) against the wall of the sleeve, so that the sleeve can be clamped against the cardiac tissue.

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

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

[0328] Refer here to Figures 3G and 32. Following the deployment of the first anchor, the distal portion of the sleeve 26 can be separated from a portion of the implant isolation channel 18. To separate that portion of the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 may be pulled proximal, while (2) the reference force tube 19 is held in place such that the distal end of the tube 19 provides a reference force to the sleeve 26, facilitating the retraction and release of the continuous portion of the sleeve 26 from around the channel 18. To separate the sleeve 26 from the outer surface of the channel 18, (1) the channel 18 may be pulled proximal, while (2) the reference force tube 19 is held in place. An indicator on the handle 126 (such as indicator 2120 described in PCT Patent Application No. PCT / IL2012 / 050451 (published as WO / 2013 / 069019) of Sheps et al., incorporated herein by reference) provides an indication of the extent to which the channel 18 is pulled out from within the sleeve 26 (i.e., the extent to which the delivery tool is separated from the sleeve 26, and to the extent to which the sleeve has detached from the channel 18 and advanced toward the tissue). The proximal end of the channel 18 is connected to a knob 94 (Figure 2) that adjusts the axial position of the channel 18 proximal and distal to the reference force tube 19 and the sleeve 26. As shown in Figure 3H, the deployment manipulator 61 is repositioned along the valve ring 240 to another site selected for the deployment of the second anchor 32. Hereinafter, refer to Figures 1 and 3H. Such repositioning of the manipulator 61 is achieved by: (1) Maneuvering the distal end portion of the catheter 12 (for example, by the control knob 210 of the handle 22) in a manner that bends the bent section 1203 of the catheter 12 in a first plane parallel to the valve annulus 240 of the valve 230 to a desired spatial orientation, (2) Maneuvering the distal end portion of a portion of the catheter 14 (for example, by the steering knob 214 of the handle 24) to a desired spatial orientation in a second plane perpendicular to the valve ring 240 of the valve 230, and by bending the bent section 1405 (in particular, the bent section 1403) of the catheter 14, (3) Moving the catheter 14 axially relative to the catheter 12 via the knob 216, (4) Move the stand support handles 22 and 24 axially to move both catheters 12 and 14. (5) Moving the tube 19 and sleeve 26 axially by sliding the mount 93 along the track 90 via the knob 95, and / or (6) Move the channel 18 relative to the tube 19 using the operating knob 94.

[0329] In most cases, the first anchor is deployed most distally within the sleeve (generally within a few millimeters of the distal tip of the sleeve), and each subsequent anchor is positioned more proximal, thereby gradually separating the sleeve distally from the channel 18 of the deployment manipulator 61 during the fixation procedure (i.e., the channel 18 is pulled out from within the sleeve 26, and the handle 126 moves distally to retract the tool, preparing the continuous proximal portion of the sleeve 26 for subsequent anchor implantation). The already deployed first anchor 32 holds the fixed end of the sleeve 26 in place, thereby pulling the sleeve from the site of the first anchor toward the site of the second anchor. Once the sleeve 26 is separated from the channel 18, the deployment manipulator 61 can move substantially laterally along the cardiac tissue, as shown in Figure 3H. The deployment manipulator 61 deploys the second anchor at the second site into the cardiac tissue through the wall of the sleeve 26. Depending on the tension applied between the first and second anchor points, the portion of the sleeve 26 between them may remain tubular or flatten, which may help reduce any interference of the ring with blood flow.

[0330] As shown in Figure 3I, the deployment manipulator 61 may be repositioned along the annulus to other locations where each anchor is located, until the last anchor is deployed near the right fibrous triangle 244 (or the left fibrous triangle 242 if the fixation began in the right triangular region). Optionally, the last anchor is not deployed near the triangular region, but instead at another location near the mitral valve, such as near the anterior or posterior commissure. The system 10 is then removed, leaving the implant structure 222 and the contraction member 226. As described below, the contraction member take-up tool is then used to contract the structure 222 by moving over the contraction member 226, along the contraction member 226, and toward the structure 222, thereby adjusting the degree of tension on the contraction member 226 (not shown in Figure 3I, but (i) the advancement of the contraction member take-up tool over the contraction member 226 is described with reference to Figures 4A-5D, and (ii) the application of tension to the member 226 is described below with reference to Figures 6A-B).

[0331] Once the desired level of adjustment of the structure 222 is achieved (for example, by monitoring the degree of valve regurgitation under echocardiographic and / or fluoroscopic guidance), the deflation member acquisition tool (1) locks the deflation member 226 to maintain the degree of tension of the member 226 and keeps the structure 222 in a deflated state, and (2) detaches any excess portion of the deflation member 226 to be subsequently removed from the heart. In some applications, the distal portion of the guide member 86 may be left in 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 may be accessed in a later stage following the initial implantation and adjustment of the ring structure 222.

[0332] In some applications, the reaccess wire 288 may be supplied connected to the proximal portion of the implant (e.g., the last part of the implant to be deployed), such as the last anchor 32 (as shown in Figure 3I) or sleeve 26, so that, once fixed, the wire extends proximal out of the body of the subject via, for example, catheter 14 and / or catheter 12. If it is determined that one or more anchors 32 require adjustment or retrieval after implantation (e.g., and after adjustment) of the annular formation structure 222, or if this is determined after implantation (e.g., after adjustment) of the annular formation structure 222, the reaccess wire 288 facilitates guidance of an anchor manipulation tool to and / or into the annular formation structure 222. For example, such an anchor manipulation tool may include the anchor manipulation tool described in PCT Patent Application No. PCT / IL2013 / 050861, “Percutaneous tissue anchor techniques,” filed on 23 October 2013 and incorporated herein by reference. The systems, apparatus, and technologies described in this patent application may be used in combination with the systems, apparatus, and technologies described in the aforementioned PCT patent application PCT / IL2013 / 050861.

[0333] As shown, the sleeve 26 of the ring structure 222 includes a plurality of radiopaque markers 25, which are positioned along the sleeve at their respective longitudinal portions to indicate the target region of the anchor designation. The markers can provide indication in radiographic images (such as fluoroscopic images) of the degree to which the sleeve 26 has been unfolded at any given point in time during the implantation procedure, allowing for the setting of a 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 in the longitudinal portion of the sleeve 26 where the radiopaque marker 25 is placed (for example, the anchor is driven through the radiopaque ink of the radiopaque marker). Alternatively, the anchor 32 may be deployed in the longitudinal portion of the sleeve 26 between the markers 25. For example, when distributing the sleeve 26 from the channel 18 (i.e., when 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 aligning with the marker 1018 of the channel 18) can indicate that the correct length of the sleeve 26 has been distributed. Subsequent limited movement of the channel relative to the sleeve may occur. For example, when channel 18 is positioned relative to the valve annulus, the channel may exert tension on the portion of sleeve 26 between the already deployed anchor and the distal end of the channel, so 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 annular structure 222 can be implanted via right or left thoracotomy with necessary modifications.

[0336] In some applications, after the sleeve 26 is embedded along the valve annulus, an excess portion of the sleeve 26 may be present in the proximal part of the sleeve. In such applications, after the manipulator 61 is removed, a cutting tool (not shown) can be advanced through the channel 18 and into the lumen of the excess portion of the sleeve 26 (for example, from inside the sleeve 26) to cut the proximal sleeve of the anchor 32 deployed in the nearest position.

[0337] Refer here to Figures 4A-B, schematic diagrams of an exemplary system 10, which includes an exemplary shrink member intake tool 300 configured to shrink a shrink member 226 and separate any excess portion of the shrink member 226. The tool 300 comprises a handle portion 320 and an elongated sheath 310 connected thereto. The sheath 310 encloses a primary tube 330 and a secondary tube 340 positioned along the primary tube 330. Both the primary tube 330 and the secondary tube 340 are connected to the handle portion 320 at their respective proximal ends. The secondary tube 340 has a secondary lumen configured for the passage of the shrink member 226 through which it passes. The tool 300 defines a longitudinal axis 301.

[0338] In some applications, the sheath 310 is shaped to define the lumen of the wall of the sheath 310. In such applications, the tool 300 does not have a secondary tube 340; rather, the lumen of 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, thereby configuring them to pass through the patient's vascular structure during transvascular, transcatheter procedures. However, similar features can be used in surgical procedures. In some applications, the sheath 310, primary tube 330, and secondary tube 340 contain silicone. In some applications, the sheath 310, primary tube 330, and secondary tube 340 contain polyurethane.

[0340] The tool 300 may include a shrinkable snare 350 comprising a distal snare portion 352 and an elongated flexible body portion 354 connected to the distal snare portion 352. The distal snare portion 352 is configured to fit a portion of the shrinkable member 226, as described below, and is sized to pass through the secondary lumen of the secondary tube 340 and pull the shrinkable member 226 through the length of the secondary tube 340.

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

[0342] The tool 300 may 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 detachably connect to a shrink member fastener 360. The shrink member fastener 360 includes a clamping structure that can be biased to assume a closed state or closed position, and in the closed state / position, the clamping structure may be configured to clamp a shrink member 226 (not shown) passing through its interior. The clamping structure may also be configured to be bent into an open state that allows the shrink member 226 (not shown) to move inside.

[0343] The tool 300 may include a fastener ejector 335 that is movable within the distal end portion 333 of the shrink member intake tool 300. The movement of the fastener ejector 335 converts the shrink member fastener 360 (or its tightening structure) from its open state to its closed state, thereby tightening the shrink member 226 as it passes through. The tool 300 includes a stopper 362 that is detachably connected to the shrink member fastener 360 and configured to keep the shrink member fastener 360 in an open state, as shown in section AA of Figure 4A. The stopper 362 includes one or more, for example, two prongs 337 that keep the fastener 360 in an open state. The ejector 335 moves the stopper 362, which is connected to and detachably connected to the fastener 360, converting the fastener 360 from an open state to a closed state, as described below.

[0344] Figure 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 take-up device 322 configured to take up a continuous portion of a shrink member 226 (not shown), as described below. The shrink member take-up 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 tension meter 324 on the handle portion 320.

[0345] The shrink member receiving device 322 may optionally be equipped with a wheel, which may have two opposing wedge-shaped portions 325 that together define a groove 326 configured to connect the shrink member 226 to the wheel of the device 322. The wedge-shaped portions 325 may be shaped to receive any portion of the shrink member 226, such as the proximal end and / or the middle 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 may have a numerical indicator showing the number of rotations of the wheel.

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

[0347] The handle portion 320 may be shaped to define a lumen 328 for the passage of a snare 350 through the interior of the lumen of the secondary tube 340. The snare 350 passes through the lumen 328 and over the groove 326 of the shrink member take-up device 322. In many but not always cases, the device 322 does not take up the snare 350; rather, the snare 350 passes through the groove 326. As described below, pulling the snare 350 pulls the shrink member 226 connected to it, thereby pulling the shrink member 226 through the secondary tube 340, through the lumen 328, and finally towards the shrink member take-up 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 shrink member take-up device 322 by being fed into the groove 326. Next, the shrinking member intake device 322 is activated to apply tension to the shrinking member 226 and the valve ring forming structure 222 embedded along the valve ring by it. With each rotation of the wheel of the device 322, the continuous portion of the shrinking member 226 is drawn into the groove 326 of the device 322.

[0348] Figures 5A–D are schematic diagrams of exemplary condenser intake tools 300 that can be used to take in the condenser member 226. At this stage, the annular forming structure or annular forming ring structure 222 is embedded along the annulus 240 as described above with reference to Figures 3A–I. Once the structure 222 is embedded along the annulus, the condenser member 226 extends away from the structure 222 and through the patient's vascular structure so that the proximal end portion of member 226 is located outside the patient's body.

[0349] The shrink member 226 can exit the sleeve 26 of the structure 222 at any preferred position along the structure 222. For example, as shown, the shrink member 226 can exit the sleeve 26 of the structure 222 in a portion of the structure 222 near the left fiber triangle of the valve. In some applications, the shrink member 226 can exit the sleeve 26 of the structure 222 in a portion of the structure 222 near the right fiber triangle of the valve. In some applications, the shrink member 226 exits the sleeve 26 of the structure 222 in the middle portion of the structure 222.

[0350] As shown in the figure, the structure 222 includes a sleeve 26 that defines the main body portion of the structure 222. The shrinking 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 and curved state, as shown in Figure 5A. The shrinking 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 Figure 5A, the user (e.g., a practicing physician) can hold the distal end of the tool 300 with one hand and the proximal end portion of the shrinking member 226 with the other hand. The user or physician passes the proximal end portion of the shrinking member 226 through the distal snare portion 352 of the shrinking member snare 350.

[0352] Figure 5B shows the tool 300 with the distal snare portion 352 fitted onto the shrinking member 226. In some applications, the distal snare portion 352 is shaped to increase the connection between the snare 350 and the shrinking member 226. For example, in some applications, the distal snare portion 352 is corrugated to increase friction between the snare portion 352 and the shrinking member 226. In some applications, the distal snare portion 352 may have a coiled section to increase friction between the snare portion 352 and the shrinking member 226. In some applications, the snare 350 includes a metal wire. In some applications, the snare 350 includes a metal wire, including stainless steel. The snare 350 (including the distal snare portion 352) can have various sizes, for example, a diameter of 0.15 to 0.5 mm or 0.15 to 0.35 mm.

[0353] Now, refer to Figures 4A and 5B. As shown in section AA of Figure 4A, the shrinking member snare 350 passes through aligned ports 339 and 341 of the distal end portion 333 of the tool 300.

[0354] The snare 350 can be pulled proximal by, for example, a user or physician holding the proximal exposed end portion 351 of the snare 350 proximal away from the tool 300. As shown in Figure 5C, pulling the snare 350 proximal pulls the distal snare portion 352 and the looped contraction member 226 through the interior, through the distal tip 331 of the tool 300, through the fasteners located within the distal end portion 333 of the tool 300, through the aligned ports 339 and 341 of the distal end portion 333 of the tool 300, and subsequently through the lumen of the secondary tube 340.

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

[0356] In Figure 5D, the snare 350 is pulled completely through the secondary tube 340, through the lumen 328 of the handle portion 320, and beyond the groove 326 of the shrink member intake device 322, pulling the shrink member 226 along this path. All the while, the sheath 310 of the tool 300 advances through the vascular structure and toward the annular forming structure 222 embedded along the annular 240. Once the distal snare portion 352 and the portion of the shrink member 226 connected to it have exited the lumen 328 of the handle portion 320, that portion of the shrink member 226 is connected to the shrink member intake device 322 by being positioned within the groove 326. In some applications, the proximal end portion of the shrink member 226 is fed into the groove 326. In some applications, the middle portion of the shrink member 226 (e.g., the portion near the proximal end of the shrink member 226) is fed into the groove 326. Next, the shrinkable member 226 is tightly compressed by operating the shrinkable member intake device 322, for example by rotating it, so that the continuous portion of the shrinkable member 226 is drawn into the shrinkable member intake device 322 and the shrinkable member intake device 322 takes in the continuous portion.

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

[0358] Refer here to Figures 6A-B, schematic diagrams of an exemplary tool 300 used to pull the shrinking member 226 and thereby shrink the shrinking member 226 and the valve ring forming structure or valve forming ring structure 222 connected to it. The shrinking member take-up device 322 rotates to facilitate the take-up of the continuous portion of the shrinking member 226.

[0359] As shown in Figure 6A, before rotating the contraction member take-up device 322, the tension meter 324 on the handle portion 320 reads the tension of the contraction member 226 at or near zero. Similarly, the sleeve 26 of the annular forming structure 222 connected to the annulus 240 is in a relaxed, non-tensioned state. At this point, the tool 300 has advanced sufficiently through the patient's vascular structure so that the proximal portion of the contraction member 226 is outside the patient's body, while the distal tip 331 is in close proximity to the structure 222 positioned along the annulus.

[0360] In Figure 6B, the shrink member intake device 322 rotates to shrink the shrink member 226 and apply tension to it. The tension meter 324 on the handle portion 320 reads the tension of the shrink member 226 at positions 4 and 5. Similarly, the sleeve 26 of the valve ring forming structure 222 connected to the valve ring 240 is in a taut, contracted state. As shown in Figure 6B, the shrink member 226 is under tension relative to the tool 300.

[0361] Refer here to Figures 7A-E, schematic diagrams of exemplary tools 300 used to lock and fix the valve ring forming structure 222 in its contracted state, and then to separate the excess portion of the contracted member 226.

[0362] Figure 7A shows the valve ring forming structure or valve forming ring structure 222 in an uncontracted state. The distal tip 331 of the tool 300 can be brought close to the structure 222. The shrinking member 226 can be passed along the sleeve 26 and out of a portion of the sleeve 26 of the structure 222. As described above, the shrinking member 226 can be passed through the tool 300 by passing the shrinking member 226 through the distal tip 331, the shrinking member fastener 360 which can be held open by the prongs 337 of the fastener 362, the aligned ports 339 and 341 in 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. The fastener 360 is not deployed during the contraction of the structure 222.

[0364] In Figure 7C, the contraction member 226 is pulled tight, and the valve ring forming structure 222 is contracted and in a taut, contracted state. The distal end portion 333 of the tool 300 is then 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] Refer to Figures 6A and 7C here. Once the distal tip 331 makes contact with the sleeve 26, a trigger 321 (shown in Figure 6B) on the handle portion 320 of the tool 300 is partially pulled, facilitating the ejection of 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 intake tool 300. The movement of the fastener ejector 335 converts the shrink member fastener 360 from its open state to its closed state, tightening the shrink member 226 as it passes through. The fastener ejector 335 is connected to the prongs 337 of the fastener 362 in such a way that as the ejector 335 moves proximally within the portion 333, the fastener 362 is separated from the shrink member fastener 360 as the prongs 337 move proximally away from the shrink member fastener 360. When the shrinkage member fastener 360 is no longer held open by the stopper 362, the fastener 360 closes, and as it tends to close, it constricts the shrinkage member 226 passing through it.

[0366] The proximal portion of the fastener ejector 335 may be connected to the distal end of the sliding tube 343, which may be connected to the trigger 321 at its proximal end. The sliding tube 343 is movable proximal in response to the movement of the trigger 321, and as a result, the fastener ejector 335 moves proximal to the distal tip 331 of the tool 300 and the fastener 360. As shown in Figure 7B, the fastener 360 is pushed out and deployed from within the housing 332 of the ejector 335.

[0367] In Figure 7D, the fastener ejector 335 can move further proximal in response to further pulling of the trigger 321 to sever the excess portion of the shrink member 226. The tool 300 may be shaped to define a cutting-promoting edge 370 on 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 on the distal end portion 333 of the tool 300, as shown in Figures 7A-C, but the shrink member 226 is close to the cutting-promoting edge 370. The movement of the fastener ejector 335 pulls the cutting-proximity edge 372 of the ejector 335 proximal to the cutting-proximity edge 370 of the tool 300, and thus intercepts a portion of the shrink member 226 between the edges 370 and 372, thereby severing and cutting the shrink member 226 extending through the ports 339 and 341. In some applications, the cutting-proximity edge 372 defines a sharp edge. Figure 7D shows the shrink member 226 being severed when the cutting-proximity edge 372 of the ejector 335 is pulled relative to the cutting-proximity edge 370 of the tool 300.

[0368] As shown in Figure 7E, once the shrinking member 226 is cut, the tool 300 pulls it and the excess portion of the shrinking member 226 together towards the proximal end.

[0369] Herein, refer to Figures 8A-D, schematic diagrams of an example of a system 510 for deflating a patient's annulus 240 using an annulus forming structure 522 (e.g., annulus forming ring structure, closed annulus forming structure, closed annulus forming ring structure, open annulus forming structure, partial annulus forming ring structure, etc.), which may comprise a housing 530. The housing 530 can accommodate a deflating member fastener 360. Except for the differences described below, the annulus forming structure 522 may be identical or generally similar to the annulus forming structure 222 described above with reference to Figures 1-7E, and similar reference numbers refer to similar parts.

[0370] The annular forming structure or annular forming ring structure 522 may include a sleeve 26 that can define the main body portion of the structure 522. The structure 522 includes a retractable member 226 having a first portion 526 that extends along the longitudinal length of the main body portion of the annular 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 and curved state, as shown in Figure 8A. The retractable member 226 also defines a second portion 524 that extends away from the main body portion of the annular forming structure 522.

[0371] The shrinking member 226 may extend through the housing 530 and through a fastener 570 (e.g., a holder) positioned within the opening of the shrinking member fastener 360. The fastener 570 is shown as cylindrical, not limitingly, but exemplifyingly. The outer surface of the fastener 570 maintains the fastener 360 in an open position. The fastener 570 is shaped to define a threaded portion 572 that allows connection of the shrinking member take-up tool to the fastener 570, as described below.

[0372] The annular formation structure or annular formation ring structure 522 is embedded using the system described above with reference to Figures 1-3I, and as described above with reference to Figures 3A-I.

[0373] The housing 530 can be connected to the sleeve 26 of the structure 522 at any preferred location along the structure 522. For example, as shown, the housing 530 can be connected to the sleeve 26 of the structure 522 in a portion of the structure 522 near the left fiber triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 in a portion of the structure 522 near the right fiber triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 in the middle 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 obstruct the lumen of the sleeve 26 of the structure 522.

[0374] Figure 8B shows the shrink member intake tool 600 through which the shrink member 226 passes. The shrink member 226 can be fitted by the snare tool 600, as described above with respect to the snare 350 with reference to Figures 4A-5D. The tool 600 can advance along the shrink member 226 toward the housing 530 of the structure 522 in the same manner as the tool 300, which advances along the shrink member 226, as described above with reference to Figures 4A-5D.

[0375] Tool 600 may comprise a distal tip 631 and a distal end portion 633 which is generally similar to the distal end portion 533 of tool 300 described above with reference to Figures 4A-7E, where similar reference numbers refer to similar parts. Since the valve ring forming structure 522 comprises a contraction member fastener 360 and a stopper 570 detachably connected to the fastener 360, the distal end portion 633 of tool 600 differs from the distal end portion 533 of tool 300 in Figures 4A-7E, and the remaining parts of tool 600 correspond to the remaining parts of 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 fastener 570, the fastener coupler 672 of the tool 600, the distal tip 631, and then through the aligned ports 339 and 341 of the distal end portion 633 of the tool 600.

[0377] The fastener coupler 672 of tool 600 screws into and engages with the threaded portion 572 of fastener 570, which is connected to a shrink member fastener 360 located inside the housing 530 of structure 522.

[0378] As described above with reference to Figures 6A-B, the shrink member 226 can be shrunk using the shrink member take-up device of tool 600 (similar to the shrink member take-up device 322 of tool 300, although not shown). As shown in Figure 8C, once the shrink member 226 has shrunk and the structure 522 has shrunk, tool 600 removes the fastener 570 by pulling it proximally away from the fastener 360. Because the fastener 360 tends to close, in the absence of the fastener 570, the fastener 360 would close and tighten around the shrink member 226 passing through the fastener 360. In this way, the structure 522 is locked by the fastener 360 and the shrunk state of the structure 522 is maintained.

[0379] Figure 8D shows the shrink member 226 being severed proximal to the clamp 360, and the excess portion of the shrink member 226 being removed from the patient's body using the tool 600. The severance of the shrink member 226 is carried out in the manner described above with reference to Figures 7A-E, with the necessary modifications.

[0380] Here, refer to Figures 9A-D, schematic diagrams of an exemplary shrink member intake tool 600 used to lock and fix the valve ring forming structure 522 in its contracted state and then to separate the excess portion of the shrink member 226.

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

[0382] In Figure 9B, the contraction member 226 is pulled tight, and the annulus forming structure 522 is contracted and in a taut, contracted state. The distal end portion 633 of the tool 300 is brought close to the annulus forming structure 522 (for example, as shown, the tip 631 contacts or is brought close to the housing 530), pushing out and unfolding the fastener 360 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 Figure 6B) can be partially pulled to facilitate the distal pushing and deployment of the shrink member fastener 360 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 shrink member intake tool 600. The movement of the fastener ejector 335 converts the shrink member fastener 360 (e.g., its clamping structure) from its open state to its closed state, thereby clamping the shrink member 226 that has passed through it. The fastener ejector 335 is connected to the fastener coupler 672 of the tool 600, which screws into the threaded portion 572 of the fastener 600, in such a way that when the ejector 335 moves proximal within the portion 633 of the tool 600, the fastener 570 is pulled away from the fastener 630 and separated therefrom. When the shrink member fastener 360 is no longer held open by the fastener 570, the fastener 360 closes, and as it tends to close, it tightens around the shrink member 226 passing inside.

[0384] In Figure 9C, the fastener ejector 335 can move further proximal (in response to further pulling of the trigger on the handle portion of the tool 600) to sever the excess portion of the shrink member 226. The tool 600 may be shaped to define a cutting-promoting edge 370 on 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 on the distal end portion 633 of the tool 600, as shown in Figure 9B, but the shrink member 226 is in close proximity to the cutting-promoting edge 370. The movement of the fastener ejector 335 pulls the cutting-proximity edge 372 of the ejector 335 proximal to the cutting-proximity edge 370 of the tool 300, and thus intercepts a portion of the shrink member 226 between the edges 370 and 372, thereby severing and cutting the shrink member 226 extending through the ports 339 and 341. In some applications, the cutting-proximity edge 372 defines a sharp edge. Figure 9C shows the shrink member 226 being severed when the cutting-proximity edge 372 of the ejector 335 is pulled relative to the cutting-proximity edge 370 of the tool 600.

[0385] As shown in Figure 9D, once the shrinking member 226 is cut, the tool 600 pulls it and the excess portion of the shrinking member 226 together towards the proximal end.

[0386] Refer to Figures 8A-9D here. System 510 provides an annular forming structure 522 (e.g., annular forming ring structure, closed annular forming structure, closed annular forming ring structure, open annular forming structure, partial annular forming ring structure, etc.) in which the housing 530 accommodates the shrink member fastener 360 rather than the fastener 360 being located outside the sleeve 26. In such a way, system 510 reduces the possibility of embolism and / or coagulation.

[0387] Refer to Figures 4A to 9D here. Using the shrink member intake tools 300 and 600, (1) tension can be applied to the shrink member, (2) the lock can be deployed to ensure tension on the shrink member, and (3) the shrink member can then be cut and separated, such as any annular forming structure, e.g., a complete annular forming ring structure, a partial annular forming ring structure, etc.

[0388] Refer again to Figures 8A-D and 9A-D. Although the tool 600 is described as being advancing toward a housing 530 already connected to the annulus forming structure 522, it should be noted that the scope of this specification includes the tool 600 being connected to the housing 530 from a site outside the patient's body and configured to deliver the housing 530 to the sleeve 26 of the structure 522 already embedded in the annulus along the contraction member 226. In such applications, the housing 530 is configured to be positionable relative to the main body portion of the structure 522.

[0389] Refer to Figures 10A-B, schematic diagrams of an exemplary system 700, which includes an exemplary shrink member take-up tool 702 configured to shrink the shrink member 226 and separate any excess portion of the shrink member 226.

[0390] Except for the differences described below, the shrink member take-up tool 702 may be identical or generally similar to the shrink member take-up tools 300 and 600 described above with reference to Figures 4A to 9D, used to (1) apply tension to the shrink member, (2) deploy a lock to ensure tension on the shrink member, and (3) subsequently cut and separate the shrink member of any annular forming structure, e.g., a fully (or closed) annular forming ring structure or a partially (or open) annular forming ring structure.

[0391] An exemplary defibrillator intake tool 702 can be used to take in the defibrillator 226 of the annular formation structure 730. The annular formation structure 730 may be identical or generally similar to the annular formation structures 222 or 522 described above with reference to Figures 1-9D, where similar reference numbers refer to similar parts. At this stage, the annular formation structure 730 (e.g., annular formation ring structure, closed annular formation structure, closed annular formation ring structure, open annular formation structure, partial annular formation ring structure, etc.) is embedded along the annulus as described above with reference to Figures 3A-I. Once the structure 730 is embedded along the annulus, the defibrillator 226 extends away from the structure 730 and through the patient's vascular structure so that the proximal end portion of the member 226 is located outside the patient's body.

[0392] Except for the differences described below, the annular formation structure 730 may be identical or generally similar to the annular formation structures 222 and 522 described above with reference to Figures 1-9D, where similar reference numbers refer to similar parts. The annular formation structure 730 may be a fully (or closed) or partially (or open) annular formation structure.

[0393] As shown in the figure, the structure 730 includes a sleeve 26 that defines the main body portion of the structure 730. The shrinking 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 shrinking member 226 also defines a second portion 734 that extends away from the main body portion of the valve ring forming structure 730.

[0394] Tool 702 is used to embed a complete (or closed) annulus-forming structure 730, as shown in the figure, but the annulus-forming structure may be an annulus-forming ring structure or may include a partial (or open) annulus-forming structure.

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

[0396] The tool 702 can be configured in various ways. In some applications, the tool 702 comprises an elongated sheath 310. In some applications, the sheath 310 encloses a primary tube 330 and a secondary tube 340 positioned 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 slit 740 along its longitudinal axis. The slit 740 facilitates the connection and engagement of the shrink member 226 within the lumen of the tube 340. The slit 740 also allows for the release of the shrink member 226 from within the lumen of the tube 340. In some applications, the slit 740 facilitates the connection and / or release of the shrink member snare, as described above with reference to Figures 4A-B. In some applications, the most distal section of the slit 740 is located in a longitudinal position along the tube 340, proximal to the most distal end of the tube 340, for example, in a portion of the tube 340 configured to be positioned proximal to the patient's ventricle, thereby preventing blood from leaking out of 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 to or identical to fastener 360 described above with reference to Figures 4A-9D. The use of two fasteners 360a and 360b can provide redundant and more secure fastening of the outer circumference of the structure 730 after it has shrunk. Fasteners 360a and 360b may be arranged coaxially around a portion of the shrink member 226.

[0398] In some applications, a pressure tube (not shown) is used to deploy the shrink member fasteners 360a and 360b. The pressure tube contains a semi-rigid material used to deploy the fasteners 360a and 360b by pressing them. The fasteners 360a and 360b may be coaxially positioned around a portion of the shrink member 226 and distally at the distal end of the pressure tube. In some applications, the fasteners 360a and 360b are detachably positioned around a portion of the pressure tube.

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

[0400] In some applications, the oversheath 710 is not used, and the tool 702 is connected to the annular formation structure using male and female couplings, as shown below with reference to Figures 12, 13, and 15.

[0401] Herein, refer to Figures 11A-C, schematic diagrams of an exemplary system 800, which includes an exemplary shrink member take-up tool 810 used to lock and secure the valve ring forming structure 222 in its contracted state and then to separate the excess portion of the shrink member 226, according to several applications.

[0402] Except for the differences described below, the shrink member take-up tool 810 may be identical or generally similar to the shrink member take-up tools 300 and 600 described above with reference to Figures 4A to 9D, used to (1) apply tension to the shrink member, (2) deploy a lock to ensure tension on the shrink member, and (3) subsequently cut and separate the shrink member, such as any annular forming structure, e.g., a fully (or closed) annular forming ring structure, a partially (or open) annular forming structure, etc.

[0403] Figure 11A shows the valve ring forming structure or valve forming ring structure 222 in its non-contracted state. The distal tip 331 of tool 810 can be brought close to the structure 222. The contraction member 226 can be passed along the sleeve 26 and out of a portion of the sleeve 26 of the structure 222. As described above, the contraction member 226 can be passed through tool 810 in such a way that the contraction member 226 passes through the distal tip 331, the contraction member fastener 360 which can be held open by the prongs 337 of the fastener 362, the aligned ports 339 and 341 in the distal end portion 333 of tool 810, and the secondary tube 340. In some applications, the distal end portion of tool 810 is similar to the distal end portion of tool 702 described above with reference to Figures 10A-B. In some applications, the distal end portion of tool 810 is similar to the distal end portion of tool 920 shown below with reference to Figures 12, 13, and 15. In such applications, the tool 920 comprises a male coupling 925, and the valve ring forming structure 222 comprises 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 contraction-promoting knob 830. The knob 830 is fixedly connected to the proximal end 832 of the contraction member 226. Rotation of the contraction-promoting knob 830, as shown in Figure 11A, moves the knob 830 proximal. When the knob 830 is pulled proximal, the contraction member 226 is pulled proximal. In response, the annular-forming structure 222 contracts. The tool 810 includes a gauge 834 that indicates the level of annular contraction in response to the number of rotations of the knob 830.

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

[0406] In Figure 11C, the contraction member 226 is pulled tight, and the valve ring forming structure 222 is contracted and in a taut, 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 in order to lock the structure 222 in the contracted state.

[0407] In some applications, once the distal tip 331 makes contact with the sleeve 26, the trigger knob 840 on the handle portion 820 of the tool 810 is partially pulled, facilitating the ejection of 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 intake tool 810. The proximal portion of the ejector 335 is connected to the distal portion of the actuarial wire 842. The proximal end 844 of the actuarial wire 842 is connected to the trigger knob 840. Proximal movement of the trigger knob 840 pulls the actuarial wire 842 proximal, 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, tightening the shrink member 226 that has passed through it. The fastener ejector 335 is connected to the prong 337 of the fastener 362 in such a way that as the ejector 335 moves proximally within section 333, the prong 337 moves proximally away from the shrink member fastener 360, and the fastener 362 separates from the shrink member fastener 360. When the shrink member fastener 360 is no longer held open by the fastener 362, the fastener 360 closes, and as it tends to close, it tightens around the shrink member 226 passing through it.

[0408] The actuating wire 842 is located within an inner sheath 841 that extends over the length of the elongated sheath 310. In such applications, as shown in Figures 11A-C, the elongated sheath 310 comprises a multi-lumen sheath defining (1) a first lumen for passage through the inner sheath 841 that houses the actuating wire 842, and (2) a second lumen for passage of the retractable member 226 that passes through the interior.

[0409] As shown in Figure 11C, the fastener 360 is pushed out and deployed from within the housing 332 of the ejector 335. The fastener ejector 335 can then move further proximal in response to further proximal pulling of the trigger knob 840 to sever the excess portion of the shrink member 226. Similar to the tools 300 and 600 described above, the tool 810 is shaped to define a cutting-enhancing edge 370 on the distal end portion 333 of the tool 810. In some applications, the cutting-enhancing edge 370 defines a sharp edge. The shrink member 226 passes through the aligned ports 339 and 341 on the distal end portion 333 of the tool 810, as shown in Figures 11A-C, but the shrink member 226 is in close proximity to the cutting-enhancing edge 370. The movement of the fastener ejector 335 pulls the cutting-promoting edge 372 of the ejector 335 proximal to the cutting-promoting edge 370 of the tool 810, and thus intercepts a portion of the shrink member 226 between the edges 370 and 372, thereby severing and cutting the shrink member 226 extending through the ports 339 and 341. In some applications, the cutting-promoting edge 372 defines a sharp edge. Figure 11C shows the shrink member 226 being severed when the cutting-promoting edge 372 of the ejector 335 is pulled relative to the cutting-promoting edge 370 of the tool 300.

[0410] Following the separation of the shrinking member 226, the tool 810 is removed from the patient's body by being pulled proximal to it and the excess portion of the shrinking member 226 together.

[0411] Refer to Figures 11A-C here. In some applications, the trigger knob 840 is connected to a safety mechanism to prevent unintended deployment of the fastener 360.

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

[0413] Except for the differences described below, the annular formation structure 910 may be identical or generally similar to the annular formation structures 222, 522, and 730 described above with reference to Figures 1-11C, where similar reference numbers refer to similar parts. The annular formation structure 910 may be a fully (or closed) or partially (or open) annular formation structure.

[0414] The main body portion 912 of the structure 910 has a side wall 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 toward a second surface 936 on the opposite side of the side wall of the main body portion 912 (as shown in Figure 12C). The side wall of the main body portion 912 extends away from the recess 960 along a longitudinal axis 942 that is not at a zero angle with respect to the recess axis 940. The contraction member 226 extends through and away from the main body portion 912 of the valve ring forming structure 910 via the recess 960.

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

[0416] In some applications, the main body portion 912 comprises a housing 930 connected to a 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 have a 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 dimensional to compress the lock 950 when it is at least partially positioned within the recess 960. The lock 950 is shaped to define a series of tapered segments 951. Each segment 951 has a maximum length L1 of 0.2 to 1.5 mm. The nearest section of the lock 950 has a length L2 of 0.2 to 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, so that the walls defining the recess 960 compress the lock 950 as it slides within the recess 960. That is, the section of the recess 960 that receives the maximum length L1 of the segment 951 has a maximum length L3 of 0.2 to 1.5 mm. The nearest section of the recess 960 has a length L4 of 0.2 to 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 toward 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 push into a 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 into the shrink member 226.

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

[0421] As illustrated, 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 proximal section of the recess 960 is narrower than any other portion of the recess 960 distal to the proximal portion.

[0422] The delivery tool 920 is used to deliver the lock 950 into the recess 960. Except for the differences described below, the delivery tool 920 may be identical or generally similar to the tools 300, 600, 702, and 810 described above with reference to Figures 4A to 4C, and similar reference numbers refer to similar parts. The tool 920 includes a shrink member cutting section 921 which may have the elements of the tools 300, 600, 702, and 810 described above with respect to the cutting elements.

[0423] As shown in Figure 12A, the delivery tool 920 delivers the annular formation structure or the annular formation structure 910 and the lock 950 together toward the annulus. The delivery tool 920 and the shrinking member 226 are slidable relative to each other. When the delivery tool 920 is connected to the annular formation structure 910, a portion of the shrinking member 226 (e.g., a second portion 916) is positioned within the lumen of the delivery tool 920, and the lock 950 surrounds a portion of the shrinking member. When the delivery tool 920 is connected to the annular formation structure 910, the lock 950 is positioned perfectly proximal to the recess 960.

[0424] Figure 12B shows the 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. Because 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 shrinking member 226, and as a result the lock 950 is not locked to the shrinking member 226 at this stage, it pulls the shrinking member as the lock 950 is pushed further distally within the recess 960. Only when the lock 950 is fully pressed within the recess 960 is the nearest section of the recess 960 narrower than any other portion of the recess 960 distal to the nearest portion, and the lock lumen of the lock 950 is narrower in the proximal portion 953 of the lock 950, so that at least the proximal portion 953 of the lock 950 closes around the contraction member 226, locking 950 to the contraction member and thereby maintaining the outer circumference of the valve ring forming structure 910. That is, the tool 920 presses the lock 950 using a lock ejector 923, which is often similar to the fastener ejector 335 described above. The lock ejector 923 is movable within the distal end portion of the tool 920. The movement of the lock ejector 923 contacts the lock 950, converting it from an open state (shown in Figure 12A) to a closed state (shown in Figure 12C), thereby tightening the lock 950 onto the contraction member 226 that has passed through it.

[0425] As shown in Figure 12C, the lock 950 is shaped to fit completely within the recess 960. As described above with reference to tools 300, 600, 702, and 810 described above with reference to Figures 4A-41C, the tool 920 is positioned within the recess 960, thereby severing the excess portion of the shrink member 226 after engaging the lock 950 with the shrink member 226. 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. Furthermore, as described above, the shrink member 226 is positioned close to the sharp edge, so that the movement of the lock ejector 923 relative to the sharp edge severs the shrink member 226 extending through the lock 950.

[0426] Refer to Figures 13A-C, schematic diagrams of an example of system 1000 comprising an exemplary annular forming structure or annular forming structure 910 (e.g., annular forming ring structure, closed annular forming structure, closed annular forming ring structure, open annular forming structure, partial annular forming ring structure, etc.), comprising a sleeve 26, a shrinking member 226, and a lock 1950. Except for the differences described below herein, system 1000 is identical or generally similar to system 900 described above with reference to Figures 12A-C, except that when the delivery tool 920 is connected to the annular forming structure 910, the lock 1950 is at least partially positioned and held within the recess 1960. As shown, the most distal tapered segment 951 is positioned within the proximal section of the recess 1960. In this manner, system 1000 reduces the possibility of embolism and / or coagulation.

[0427] Refer here to Figures 10A to 13C. In Figure 10A, the tool 702 comprises an oversheath 710 on at least the distal portion of the tool 702. The oversheath 710 comprises a gripper 720 configured to surround at least a portion of the annular forming structure connected to the tool 702. In some applications, any of the tools 300, 600, and 810 described herein comprises an oversheath 710 including a gripper 720. Since the fastener 360 and / or lock 950 is pressed by the tool to deploy the fastener 360 and / or lock 950, the gripper 720 and oversheath 710 are configured to provide a reaction force to the annular forming structure during the deployment of the fastener 360 and / or lock 950 described herein. In some applications, the tools described herein do not comprise a gripper 720.

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

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

[0430] A delivery tool may be used to deliver the lock 1110 toward the annular forming structure or annular forming ring structure. The delivery tool may be identical or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, where similar reference numbers refer to similar parts. The delivery tool may include a shrink member cutting section comprising the elements of the tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

[0431] Refer to Figures 15A-C, schematic diagrams of exemplary system 1480, which comprises exemplary annular formation structures 910 (e.g., annular formation ring structure, closed annular formation structure, closed annular formation ring structure, open annular formation structure, partial annular formation ring structure, etc.) according to several applications, comprising a sleeve 26, a shrinking member 226, and a lock 1490. Except for the differences described below herein, system 1480 is identical or generally similar to system 1000 described above with reference to Figures 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. Section AA in Figure 15A shows a lock lumen that is wider around the shrinking member 226 at the proximal end portion of the lock 1490 than the width of the lock lumen around the shrinking member 226 at the distal end portion of the lock 1490 shown in section BB. As shown in Figure 15C, once the lock 1490 is fully positioned within the recess 960, the proximal end closes tightly around the shrinking member 226, as shown in section CC, while the distal end closes around the shrinking member 226, although it does not need to close as tightly as the proximal end closes around the shrinking member 226, as shown in section DD.

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

[0434] In some applications, when the delivery tool 920 is connected to the valve ring forming structure 910, the lock 1490 is positioned entirely proximal to the recess 1960, as shown in Figures 12A-C.

[0435] Refer to Figure 16, a schematic diagram of an exemplary system 1200 comprising an exemplary annular forming structure 1210 (e.g., an annular forming ring structure, a closed annular forming structure, a closed annular forming ring structure, an open annular forming structure, a partially annular forming ring structure, etc.), which comprises a sleeve 26, a shrinking member 226, and a lock 1220. The embedded annular forming structure 1210 comprises a main body portion. The shrinking member 226 has a first portion extending along the longitudinal length of the main body portion of the annular forming structure 1210 and a second portion extending away from the main portion of the annular forming structure 1210. The shrinking member 226 is configured to adjust the outer circumference of the annular forming structure 1210.

[0436] Except for the differences described below, the annulus forming structure 1210 may be identical or generally similar to the annulus forming structures 222, 522, 730, and 910 described above with reference to Figures 1-15C, where similar reference numbers refer to similar parts. The annulus forming structure 1210 may be a fully (or closed) or partially (or open) annulus forming structure.

[0437] Structure 1210 comprises a housing 1202 shaped to define a side wall and shaped to define a recess 1230 having a recess axis. The recess 1230 extends from an opening on a first surface of the housing to a second surface opposite the housing 1202. The housing 1202 is shaped to provide a shrinkable member lumen wall 1205 positioned along a shrinkable member lumen 1204. The shrinkable member lumen 1204 is positioned 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 lumen positioned along the recess axis 1207.

[0438] The lock 1220 is shaped to define the lock thread portion 1222. The housing 1202 of the annular forming structure 1210 is shaped to define the annular forming structure thread portion 1232 configured to engage with the lock thread portion 1222. To advance the lock 1220 within the recess 1230 of the housing 1202, the physician uses a delivery tool to screw the lock 1220 into the housing 1202. The delivery tool may be identical or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, where similar reference numbers refer to similar parts. The delivery tool includes a shrink member cutting section which may comprise the elements of the tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

[0439] When the lock 1220 is positioned in the recess, the distal surface of the distal end of the lock 1220 is configured to clamp the first portion of the shrinking member 226 against the inner wall 1205 of the shrinking member, thereby locking the shrinking member 226 at least at the first clamping point 1212.

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

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

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

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

[0444] Refer here to Figures 12A-C, 13A-C, 15A-C, and 16. In some applications, the slit of the lock 1220 is wider at the distal end and narrower at the proximal end.

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

[0446] Refer to Figure 17, a schematic diagram of an exemplary system 1300 comprising an exemplary annular forming structure 1310 (e.g., an annular forming ring structure, a closed annular forming structure, a closed annular forming ring structure, an open annular forming structure, a partially annular forming ring structure, etc.), which comprises a sleeve 26, a shrinking member 226, and a lock 1320. The embedded annular forming structure 1310 comprises a main body portion. The shrinking member 226 has a first portion that extends along the longitudinal length of the main body portion of the annular forming structure 1310 and a second portion that extends away from the main portion of the annular forming structure 1310. The shrinking member 226 is configured to adjust the outer circumference of the annular forming structure 1310.

[0447] Except for the differences described below, the annular formation structure 1310 may be identical or generally similar to the annular formation structures 222, 522, 730, and 910 described above with reference to Figures 1-15C, where similar reference numbers refer to similar parts. The annular formation structure 1310 may be a fully (or closed) or partially (or open) annular formation structure.

[0448] Structure 1310 comprises a housing 1302 shaped to define a side wall, and is shaped to define a recess 1330 having a recess axis. The recess 1330 extends from an opening on a first surface of the housing to a second surface opposite the housing 1302. The housing 1302 is shaped to provide a shrinkable member lumen wall 1305 positioned along a shrinkable member lumen 1304. The shrinkable member lumen 1304 is positioned 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 lumen positioned along the recess axis 1307.

[0449] The lock 1320 is shaped to define the lock thread portion 1222. The housing 1302 of the annular forming structure 1310 is shaped to define the annular forming structure thread portion 1332 configured to engage with the lock thread portion 1322. To advance the lock 1320 within the recess 1330 of the housing 1302, the physician uses a delivery tool to screw the lock 1320 into the housing 1302. The delivery tool may be identical or generally similar to the tools 300, 600, 702, 810, and 920 described above with reference to Figures 4A-13C, where similar reference numbers refer to similar parts. The delivery tool includes a shrink member cutting section which may comprise the elements of the tools 300, 600, 702, 810, and 920 described above with respect to the cutting element.

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

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

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

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

[0454] Refer here to Figures 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 the proximal portion of the lock lumen 1321. In such applications, the proximal section of the recess 1330 may be narrower than any other portion of the recess 1330 distal to the proximal portion.

[0455] Refer here to Figures 12A-C, 13A-C, 15A-C, and 17. In some applications, the slit of the lock 1320 is wider at the distal end of the lock 1320 and narrower at the proximal end of the lock 1320.

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

[0457] Refer to Figures 16-17 here. Systems 1200 and 1300 provide locking assemblies that allow the operating physician to readjust the outer circumference of the annular formation structure after locking. For example, if the physician wishes to readjust when the locks 1220 and 1320 are in their fixed position, the physician can readjust the outer circumference of the annular formation structure by unscrewing the respective screws of the locks 1220 and 1230 to give slack to the contraction member 226 or tighten it, without disengaging the locks 1220 and 1300 from their respective recesses 1230 and 1330. Following the readjustment of the contraction member 226, the locks 1220 and 1320 are repositioned within their respective recesses 1230 and 1330.

[0458] Herein, refer to Figure 18, a schematic diagram of an example of a system 1350 for deflating a patient's annulus 240 using an annulus forming structure 522 (e.g., an annulus forming ring structure, closed annulus forming structure, closed annulus forming ring structure, open annulus forming structure, partial annulus forming ring structure, etc.) which may comprise a housing 530. The housing 530 can accommodate a deflating member fastener 1360. Except for the differences described below, the annulus forming structure 522 may be identical or generally similar to the annulus forming structure 222 described above with reference to Figures 1-7E, and similar reference numbers refer to similar parts.

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

[0460] The shrinking member 226 may extend through the housing 530 and through a fastener 570 (e.g., a holder) positioned within the opening of the shrinking member fastener 1360. The fastener 570 is shown as cylindrical, not limitingly but exemplifyingly. The outer surface of the fastener 570 maintains the fastener 1360 in an open position. The fastener 570 is shaped to define a threaded portion that allows the shrinking member take-up tool 600 to be connected to the fastener 570, as described above.

[0461] The annular formation structure or annular formation ring structure 522 is embedded using the system described above with reference to Figures 1-3I, and as described above with reference to Figures 3A-I.

[0462] The housing 530 can be connected to the sleeve 26 of the structure 522 at any preferred location along the structure 522. For example, as shown, the housing 530 can be connected to the sleeve 26 of the structure 522 in a portion of the structure 522 near the left fiber triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 in a portion of the structure 522 near the right fiber triangle of the valve. In some applications, the housing 530 can be connected to the sleeve 26 of the structure 522 in the middle 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 obstruct the lumen of the sleeve 26 of the structure 522.

[0463] The fastener 1360 is generally similar to the fastener 360 in Figures 8A-D, except that the fastener 1360 is shaped to define a cross slit 1362, the cross slit 1362 forming an opening through which the shrinking member 226 transitions into an approximately "X" or approximately "+" (plus) shape internally.

[0464] Figure 18 shows the shrink member 226 being separated proximal to the clamp 1360, and the excess portion of the shrink member 226 being removed from the patient's body using the tool 600. Separation of the shrink member 226 can be carried out in the manner described above with reference to Figures 7A-E, with necessary modifications.

[0465] Refer here to Figures 19A-B, schematic diagrams of an example of a system 1400 for deflating a patient's annulus using an annulus forming structure (e.g., annulus forming ring structure, closed annulus forming structure, closed annulus forming ring structure, open annulus forming structure, partial annulus forming ring structure, etc.) which can be connected to a housing 1430. The housing 1430 can accommodate a deflating member fastener 1460. In some applications, the annulus forming structure may be identical or generally similar to the annulus forming structure 222 described above with reference to Figures 1-7E, where similar reference numbers refer to similar parts. In some applications, the annulus forming structure comprises the housing 1430. In some applications, the housing 1430 is separate from the annulus forming structure and can only be delivered to and connected to the annulus forming structure if the annulus forming structure is fixed to the annulus.

[0466] The housing 1430 can be connected to the sleeve 26 of the annular formation structure at any preferred position along the annular formation structure. For example, as shown, the housing 1430 can be connected to the sleeve 26 of the annular formation structure in a portion of the annular formation structure near the left fiber triangle of the valve. In some applications, the housing 1430 can be connected to the sleeve 26 of the annular formation structure in a portion of the annular formation structure near the right fiber triangle of the valve. In some applications, the housing 1430 can be connected to the sleeve 26 of the annular formation structure in the middle portion of the annular formation structure. As shown, the housing 1430 can be connected to the outer surface of the sleeve. In such applications, the housing 1430 does not obstruct the lumen of the sleeve of the annular formation structure.

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

[0468] The fastener 1460 is shaped to define a substantially rectangular planar clip made of 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 allow the clip to transition between an inclined state (Figure 19A) and a straight state (Figure 19B). The shrink wire engagement surface of the clip 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 flat and does not have teeth 1464. The teeth 1464 are configured to increase friction between the shrink member 226 and the fastener 1460.

[0469] The fastener 1460 includes a clamping structure that is biased to (a) take a closed position (Figure 19B). In the closed position, the clamping structure is configured to clamp the shrinkable member 226 as it passes through, and (b) can be bent into an open position (Figure 19A) in which the shrinkable member 226 can move through.

[0470] The shrink member 226 may extend through a channel 1434 of the housing 1430 and through a fastener 1470 (e.g., a holder) positioned within the opening of the shrink member fastener 1460. The channel 1434 extends along the longitudinal axis 1410 of the housing 1430. The fastener 1470 may be shaped to define a lumen passing through the interior to enclose the shrink member 226, and is shown as shaped to define a larger cylindrical section that can be engaged by a tool, and a narrower cylindrical engaging portion 1472. The engaging portion 1472 may be shaped to fit snugly within the channel 1434, so that the engaging portion 1472 presses against the shrink wire engaging surface of the clip, holding the fastener 1460 in an inclined state, i.e., in an unlocked state of the fastener 1460. In the inclined state shown in Figure 19A, the clip deforms and does not press against the shrink member 226. In the inclined state, the contraction member 226 moves freely relative to the fastener 1460, housing 1430, and stopper 1470. The contraction member 226 is pulled until it sufficiently contracts the valve ring forming structure.

[0471] In Figure 19B, the fastener 1470 is separated and removed from the housing 1430. When no force is applied to the shrink wire engagement surface of the clip by the engaging portion 1472, the clip returns to its stationary straight state, trapping the shrink member 226 between the shrink wire engagement surface of the clip and the surface 1432 of the housing 1430, for example, the inner wall. Thus, the fastener 1460 is now in a locked state in which the clip locks and crimps the shrink member 226.

[0472] Here, refer to Figures 20A-F, schematic diagrams of an example of a part of a multi-component tubular system 1500, comprising a shrink member cutting tool 1502 and a shrink member intake tool 1600, as described below with reference to Figures 21A-26B. The shrink member 226 is passed through and into the shrink member cutting tool 1502 and the shrink member intake tool 1600. The shrink member 226 can be fitted by the snare-equipped tool 1502 as described above with reference to the snare 350 with reference to Figures 4A-5D. The tool 1502 can advance along the shrink member 226 toward the annular forming structure 1522 (e.g., annular forming ring structure, closed annular forming structure, closed annular forming ring structure, open annular forming structure, partial annular forming ring structure, etc.). In some applications, tool 1502 advances toward a housing 1530 already connected to structure 1522 in a similar manner to tool 300, which advances along the retractable member 226, as described above with reference to Figures 4A-5D. The annulus forming structure 1522 may comprise a flexible main body portion. The retractable member 226 has a first portion that extends along the longitudinal length of the main body portion. A second portion of the retractable member 226 may extend away from the main body portion of the annulus forming structure 1522 and outside the patient's body.

[0473] System 1500 is used to deflate a patient's annulus using an annulus forming structure 1522 (e.g., annulus forming ring structure, closed annulus forming structure, closed annulus forming ring structure, open annulus forming structure, partial annulus forming ring structure, etc.), which may comprise a housing 1530. The housing 1530 can accommodate a deflation member fastener 1560. Except for the differences described below, the annulus forming structure 1522 may be identical or generally similar to the annulus forming structure 222 described above with reference to Figures 1-7E, and similar reference numbers refer to similar parts.

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

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

[0476] The shrinking member 226 may extend through the housing 1530 and through a fastener 1570 (e.g., a holder) positioned within the opening of the shrinking member fastener 1560. The fastener 1570 is shaped to define a lumen passing through the interior to enclose the shrinking member 226 and is shown as shaped to define a larger cylindrical section that can be engaged by a tool, and a narrower cylindrical engaging portion 1574. The outer surface of the engaging portion 1574 keeps the fastener 1560 open, as shown in Figures 20A-D. The fastener 1570 is shaped to define a projection 1572, which allows the shrinking member cutting tool 1502 to be connected to the fastener 1570, as described below.

[0477] The annular formation structure or annular formation ring structure 1522 is embedded using the system described above with reference to Figures 1-3I, and as described above with reference to Figures 3A-I.

[0478] The housing 1530 can be connected to the sleeve 26 of the structure 1522 at any preferred location along the structure 1522. For example, as shown, the housing 1530 can be connected to the sleeve 26 of the structure 1522 in a portion of the structure 1522 near the left fiber triangle of the valve. In some applications, the housing 1530 can be connected to the sleeve 26 of the structure 1522 in a portion of the structure 1522 near the right fiber triangle of the valve. In some applications, the housing 1530 can be connected to the sleeve 26 of the structure 1522 in the middle 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 obstruct the lumen of the sleeve 26 of the structure 1522.

[0479] Figure 20A shows the shrink member cutting tool 1502 through which the shrink member 226 is passed. The shrink member 226 can be fitted by the snare tool 1502 as described above with respect to the snare 350 with reference to Figures 4A-5D. The tool 1502 can advance along the shrink member 226 toward the housing 1530 of the structure 1522 in a similar manner to the tool 300 which advances along the shrink member 226 as described above with reference to Figures 4A-5D.

[0480] Once the tool 1502 is passed along the shrink member 226, the shrink member 226 extends from the sleeve 26 through the engagement portion 1574, the proximal portion of the fastener 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 positioned near the cutting elements. The shrink member 226 is positioned along the entire length of the tool 1502 and along the longitudinal axis 1511 of the tool 1502. The relative spatial orientation of the components of the tool 1502 allows the shrink member 226 to pass straight and directly through the lumen of the tool 1502 and along the axis 1511, without taking a winding path through the tool 1502. This straight and unwinding path of the member 226 through the tool 1502 reduces its friction as it moves within the tool 1502. This direct path of the shrinking member 226 is made possible by the orientation of the components of tool 1502, in contrast to the winding path member 226 passing through tools 300, 600, 810, and 920 described above. The reduction of friction on the shrinking member 226 reduces noise during the measurement of tension on the shrinking member 226, as described below with reference to Figures 21A-26B.

[0481] The tool 1502 includes an inner tube 1504 that is slidable relative to the 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 the gripper 1505 is inclined so that the gripper 1505 tends to be pushed radially outward when there is no force applied to it by the projection 1572. Once the tube 1504 is pushed sufficiently distally, the gripper 1505 passes distally around the projection 1572 and closes around the fastener 1570 at the distal portion of the projection 1572, as shown in Figure 20B. The gripper 1505 provides primary and initial connection and locking of the tool 1502 to the housing 1530 by gripping the projection 1572.

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

[0483] Once the fastener 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 Figure 20C. Such distal movement of portion 1508 locks the tube 1504 in place with respect to the fastener 1570, thereby locking the tool 1502 in place with respect to the housing 1530. Because the gripper 1505 is inclined, the gripper 1505 is able to slide proximal to the projection 1572 in response to the proximal pull of the tool 1502. Therefore, 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 in response to the application of a proximal pulling force by the tool 1502 to the stopper 1570 during the release of the fastener 1560, as described below, locking the contraction member 226 in place and holding the valve ring forming structure 1522 under tension. Thus, the outer sleeve portion 1508 locks the gripper 1505 against the projection 1572 and provides secondary connection and locking of the tool 1502 against the housing 1530.

[0484] The static cutting element 1510 includes a pin 1513 that slides proximal and distally within the slit 1515 of the pipe 1404. Thus, the static cutting element 1510 is connected to the pipe 1404 and the pipe surrounding the pipe 1404. That is, the pin 1513 is connected to the outer sleeve portion 1508. As the outer sleeve portion 1508 moves distally as shown in Figure 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 pipe 1404. In this state, the distal surface 1523 of the dynamic cutting element 1520 is still positioned slightly away from the proximal surface 1571 of the fastener 1570.

[0485] Figure 20D shows the contraction of the annulus-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 remains connected to the housing 1530, with the outer sleeve portion 1508 surrounding the distal portion of the inner tube 1504 and surrounding the gripper 1505, while the gripper 1505 grips the projection 1572.

[0486] Tool 1502 may be equipped with a shrink member take-up device 322 of tool 300, as described above with reference to Figures 4A-B. The shrink member take-up device may be used to shrink the shrink member 226. Once the shrink member 226 has shrunk and the structure 1522 has shrunk, as shown in Figure 20D, tool 1502 removes the fastener 1570 by pulling it proximal to the fastener 1560, as shown in Figure 20E. While maintaining a distal force on the outer sleeve portion 1508, the tube 1404 is pulled proximal to the portion 1508. As the tube 1504 is pulled, the gripper 1505 pulls the fastener 1570 proximal to it, as the presence of the outer sleeve portion 1508 keeps gripping the projection 1572 of the fastener 1570. While the tube 1504 is pulled proximally, the outer sleeve portion 1508 prevents radial outward movement of the gripper 1505 because a proximal force is applied to the tube 1504. The tube 1504 is pulled proximally until the fastener 1570 is disengaged from the housing 1530, i.e., until the engaging portion 1574 of the fastener 1570 is separated and disengaged from the fastener 1560, as shown in Figure 20E. Because the fastener 1560 tends to close, in the absence of the fastener 1570, the fastener 1560 would close and tighten around the contraction member 226 passing through the fastener 1560. In this way, the structure 1522 is locked by the fastener 1560 and the contracted state of the structure 1522 is maintained.

[0487] When the fastener 1570 is pulled proximal, the proximal surface of the fastener 1570 strikes into the distal surface 1523 of the dynamic cutting element 1520. In response to pushing the fastener 1570 against the dynamic cutting element 1520, the dynamic cutting element 1520 is pushed proximal, thereby moving diagonally proximal. The cutting surface 1521 of the dynamic cutting element 1520 and the cutting element 1520 slide diagonally proximal along the cutting surface 1512 of the static cutting element 1510. The portion of the shrinkage member 226 positioned between the cutting surfaces 1512 and 1521 is separated. Because the cutting surfaces 1512 and 1521 are concave and face each other, the surfaces 1512 and 1521 compress the shrinkage member 226 during cutting, thereby separating the shrinkage member 226 cleanly and without fraying.

[0488] Therefore, advantageously for tool 1502, tool 1502 is positioned to provide a safety mechanism such that, after fastener 1560 is engaged or locked, or after the shrink member 226 is locked in place, the shrink member 226 can only be separated by a proximal force applied to it by stopper 1570. That is, tool 1502 cannot inadvertently separate the shrink member 226 while tool 1502 is not connected to stopper 1570 and while stopper 1570 is not pressing the cutting element 1520. In one rapid movement, tool 1502 (1) locks the shrink member 226 in place by engaging fastener 1560, and (2) separates the shrink member 226.

[0489] Figure 20F shows the shrink member 226 after being separated proximal to the fastener 1560, and the excess portion of the shrink member 226 removed from the patient's body using the tool 1502. The entire tool 1502 is pulled proximal to separate the tool 1502 from the housing 1530 and structure 1522, carrying the fastener 1570 within the lumen of the tool 1502. Since the fastener 1570 is no longer connected to the housing 1530, a simple proximal pull of the tool 1502 is sufficient to separate the tool 1502 from the annular forming structure 1522.

[0490] Refer again to Figures 20A-F. Although the tool 1502 is described as being advancing toward a housing 1530 already connected to the annular formation structure 1522, it should be noted that the scope of this specification includes the tool 1502 connected to the housing 1530 from a site outside the patient's body and configured to deliver the housing 1530 along the contraction member 226 of the structure 1522 already embedded in the annular structure. In such applications, the housing 1530 is configured to be positionable relative to the main body portion of the structure 1522.

[0491] Refer to Figures 21A-26B, schematic diagrams of another part of the multi-component pipe system 1500 described above, with reference to Figures 20A-F, which includes a shrink member intake tool 1600 configured to shrink a flexible, elongated shrink member 226 according to several applications. Figures 21A-B show the shrink member intake tool 1600 before insertion of the flexible, elongated shrink member 226, and Figures 22A-26B show the shrink member intake tool 1600 after insertion of the flexible, elongated shrink member 226.

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

[0493] The shrinking member intake tool 1600 includes a handle portion 1620, which may be optionally supported by a stand as described above with reference to Figures 1-2. The handle portion 1620 may include 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, medical professional, etc.), ● A tubular shaft 1634 is at least partially located inside the outer housing 1632. ● An inner shaft 1636, wherein (a) it is partially positioned within the proximal longitudinal portion 1637 of the tubular shaft 1634, thereby allowing the inner shaft 1636 to slide axially relative to the tubular shaft 1634, and (b) its shape is determined to define an inner shaft contraction member receiving channel 1638. ●Distal force applicator 1642, wherein (a) is at least partially located within the distal longitudinal portion of a tubular shaft 1634, and (b) is shaped to define a distal force applicator contraction member receiving channel 1644 that allows a contraction member 226 passing through the interior to slide, ●A spring 1646 is positioned inside the tubular shaft 1634 and connects the distal force applicator 1642 and the distal portion 1647 of the inner shaft 1636, and ●A contraction-promoting knob 1630 that can be accessed from the outside of the outer housing 1632.

[0494] The handle portion 1620 is shaped to define a handle defibrillator receiving channel 1650 from the distal end to the proximal end of the handle portion 1620 (wherein used in this application as in claims, “proximal” means the direction from the user, i.e., away from the implant; referring to Figures 21A–26B, “proximal” means the right side of the drawing). The handle defibrillator receiving channel 1650 includes an internal shaft defibrillator receiving channel 1638, a distal force applicator defibrillator receiving channel 1644, and optionally additional defibrillator receiving channels of the handle portion 1620. A portion of the defibrillator 226 is passed through the handle defibrillator receiving channel 1650 either before or after the implanted structure and the defibrillator 226 advance toward the patient’s heart.

[0495] The inner shaft 1636 may be provided with a lock 1640 configured to (i) allow the contraction member 226 to slide against the inner shaft contraction member receiving channel 1638 when in the unlocked state, and (ii) axially lock the contraction member 226 against the inner shaft 1636 when in the locked state. Optionally, the lock 1640 applies friction to axially lock the contraction member 226 against 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 when the contraction member 226 is positioned to fully pass through the handle contraction member receiving channel 1650 and the lock 1640 is engaged, the operation of the contraction acceleration knob 1630 causes the handle portion 1620 to take in the continuous portion of the contraction member 226. Figures 22A-B show the handle portion 1620 before the operation of the contraction acceleration knob 1630 when the contraction member 226 is positioned to fully pass through the handle contraction member receiving channel 1650 and the lock 1640 is engaged. Figures 23A-B, 24A-B, and 25A-B show the handle portion 1620 after the continuous operation level of the contraction acceleration knob 1630, as described below.

[0497] As shown in Figures 21A-B and 22A-B, prior to the initial action of the contraction-promoting knob 1630, the portion of the contraction member 226 between the handle portion 1620 and the implant may be somewhat slack or at most minimally tensed. The proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are positioned at an initial offset distance D1 between them, indicating that there is substantially no tension in the contraction member 226, i.e., the contraction member 226 is not tensed. In applications where the implant has an embedded annular-forming structure 222 including a flexible sleeve 26, the sleeve 26 (connected to the annulus 240) is in a relaxed, untensed state. At this point, the tool has advanced sufficiently through the patient's vascular structure so that the distal tip of the tool is close to the structure 222 positioned along the annulus.

[0498] As shown in the illustration, for example, in the transition between Figures 22A-B and 23A-B, the operation of the contraction-promoting knob 1630 is as follows: The tubular shaft 1634 is advanced proximally relative to the outer housing 1632. This advances the distal force applicator 1642 proximal to the outer housing 1632 (the distal force applicator 1642 can be fixed axially to the tubular shaft 1634 during normal use of the handle portion 1620), This applies a proximal force to spring 1646, The inner shaft 1636 is pushed proximally against the outer housing 1632 (by the spring 1646 which applies a proximal force to the inner shaft 1636), This pulls the retractable member 226 (which, as described above, is axially locked to the inner shaft 1636 by the lock 1640) proximal, causing the handle portion 1620 to take in the continuous portion of the retractable member 226.

[0499] At times, during the initial proximal movement of the distal force applicator 1642 relative to the outer housing 1632, as shown in the transition between Figures 22A-B and 23A-B, the contraction member 226 is relatively slack as described above. Therefore, the inner shaft 1636 offers little to no resistance to the proximal force applied to it by the spring 1646, and the spring 1646 is not compressed axially, or is compressed only minimally axially. As a result, when the tubular shaft 1634 advances proximal to the outer housing 1632, the inner shaft 1636 advances proximal to the outer housing 1632 to the same or nearly the same extent, the offset distance remains at its initial value (D1), indicating that there is still virtually no tension in the contraction member 226. This initial proximal advance of the tubular shaft 1634 and inner shaft 1636 relative to the outer housing 1632 helps to accommodate different initial slack levels in the contraction member 226.

[0500] At a certain distance of proximal advance of the distal force applicator 1642 relative to the outer housing 1632, the contraction member 226 becomes taut (at an initial low tension level), thereby gradually providing the inner shaft 1636 with increasing resistance to the proximal force applied to the inner shaft 1636 by the spring 1646, causing the spring 1646 to become increasingly compressed. As used in the present application as defined in the claims, the contraction member 226 is considered “taut” even when taut at a low tension level.

[0501] As shown in the transition between Figures 23A-B and 24A-B, as the spring 1646 is compressed further, the distal force applicator 1642 moves closer axially to the inner shaft 1636, causing the tubular shaft 1634 to move proximal to the inner shaft 1636. As a result, the spring 1646 pushes the inner shaft 1636 proximal to the outer housing 1632 to a degree less than the proximal advance of the tubular shaft 1634 relative to the outer housing 1632, and the proximal tension of the contraction member 226 by the inner shaft 1636 increases the tension in the contraction member 226. Therefore, 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 the tension offset distance D2, as shown in Figures 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 smaller 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 shrinkage acceleration 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 shrinkage acceleration knob 1630 is configured to act by its rotation about the central longitudinal axis of a tubular shaft 1634, for example, as shown in the drawing. Optionally, in some applications, the shrinkage acceleration knob 1630 is configured to act by its axial sliding relative to the outer housing 1632 (configuration not shown). The shrinkage acceleration knob 1630 may be non-electric, i.e., entirely mechanical, or may optionally include electrical components, such as a circuit.

[0503] In some applications, the tubular shaft 1634 and the retraction-accelerating knob 1630 are threaded to each other, and the handle portion 1620 is configured such that the operation of the retraction-accelerating knob 1630 rotates the tubular shaft 1634, thereby advancing the tubular shaft 1634 proximal to the outer housing 1632. In some of these applications, the retraction-accelerating knob 1630 is configured to be actuated by its rotation about the central longitudinal axis of the tubular shaft 1634, for example, as shown in the drawing.

[0504] In some applications, the handle portion 1620 further comprises an inner stabilizing tube 1680 that (a) extends proximal to the distal force applicator 1642 and is axially fixed to it, and (b) defines a portion of the handle retraction member receiving channel 1650 through its interior. A portion of the inner stabilizing tube 1680 is located within the inner shaft retraction member receiving channel 1638, the length of which varies with the distance between the distal force applicator 1642 and the inner shaft 1636. A spring 1646 may be configured to surround a portion of the inner stabilizing tube 1680 and to move freely axially 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 so that a portion of the inner shaft 1636 is visible to the user. In these applications, the tubular shaft 1634 and the inner shaft 1636 together provide a non-electromechanical force gauge 1624, and the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 (i.e., the offset distance D between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636) provides a visible indication of the measure of tension in the contraction member 226. The tubular shaft 1634 may also protrude outside the proximal end 1639 of the outer housing 1632 after it has begun to advance at least proximal. In these applications, the inner shaft 1636 may be marked with multiple reference markers 1626 positioned 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 marker 1626 may provide a reading of zero or near zero after the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are positioned as an initial offset distance D1 between them, as shown in Figures 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] It should be noted that the force gauge 1624 does not measure the length of the retractable member 226 that the handle portion 1620 takes in. (This take-in length is equal to the distance the inner shaft 1636 moves proximally.) As described above, the initial portion of the take-in length is sometimes due to the proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally, almost parallel to the inner shaft 1636, before the retractable member 226 is tensioned. During this arbitrary initial movement, the tension in the retractable member 226 does not substantially increase even as the handle portion 1620 takes in the retractable member 226.

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

[0508] In some applications, the inner shaft 1636 does not protrude beyond 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 perfectly useful for adjusting the tension in the retractable member 226, such as in a configuration where the handle portion 1620 further comprises a tension limiting locking assembly 1658 to limit the maximum tension that the inner shaft 1636 can apply to the retractable member 226, as described below.

[0509] Refer again to Figures 24A-B and 25A-B. Also refer to Figures 26A-B, which are schematic diagrams of parts of the outer housing 1632 and tubular shaft 1634 according to several applications. For clarity of the examples, the inner shaft 1636 is not shown. In some applications, the handle portion 1620 further comprises a tension limiting locking assembly 1658 configured to axially lock the inner shaft 1636 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 to the outer housing 1632 when the tubular shaft 1634 is positioned 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 to the outer housing 1632 when the tubular shaft 1634 is positioned at a predetermined relative axial position with respect to the inner shaft 1636.

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

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

[0512] In applications where the implant comprises an embedded annular formation structure 222 with a flexible sleeve 26, the sleeve 26 of the annular formation structure 222 connected to the annulus 240 may be in a relaxed, non-tensioned state.

[0513] The tension limiting locking assembly 1658 optionally eliminates the need for the non-electromechanical force gauge 1624 described above. Furthermore, in applications where the force gauge 1624 is provided, the tension limiting locking assembly 1658 eliminates the need for the user to repeatedly check the readings of the force gauge 1624, thereby allowing the user to concentrate on other aspects of the procedure, such as fluoroscopic imaging. In many cases, a predetermined relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 has the effect of setting a predetermined maximum tension that can be applied to the shrink member 226 using the shrink member take-up 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 retraction member 226 that the handle portion 1620 takes in. (This take-in length is equal to the distance the inner shaft 1636 moves proximally.) Furthermore, 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 take-in length is sometimes due to the proximal movement of the inner shaft 1636 while the tubular shaft 1634 moves proximally, almost parallel to the inner shaft 1636, before the retraction member 226 is tensioned. The tension limiting locking assembly 1658 is often configured to axially lock the inner shaft 1636 to the outer housing 1632 when the tubular shaft 1634 is positioned at a predetermined relative axial position with respect to the inner shaft 1636, so that 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 retaining element 1660 is fixedly connected to the inner shaft 1636 in the axial direction and is configured to move radially outward, as shown in Figures 24A-B, to engage with the outer housing 1632 and axially lock the inner shaft 1636 to the outer housing 1632. For example, a retaining spring 1684 may be provided to apply a radially outward force to the retaining element 1660. When the tubular shaft 1634 is not positioned at a predetermined relative axial position with respect to the inner shaft 1636, as shown in Figures 22A-23B, the handle portion 1620 is configured such that elements of the handle portion 1620 prevent radially outward movement of the retaining element 1660, as described below, for example. As used in this application as a claim, “radially outward” means the direction further away 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 locking assembly 1658 further comprises a plurality of recesses 1662 shaped to define the outer housing 1632. The retaining arm 1660 is engageable with the recesses 1662 to axially lock the inner shaft 1636 to the outer housing 1632. The handle portion 1620 is positioned such that when the tubular shaft 1634 is positioned at a predetermined relative axial position with respect to the inner shaft 1636, the particular one of the recesses 1662 with which the retaining arm 1660 engages depends on the relative axial position of the inner shaft 1636 with respect to the outer housing 1632. In this configuration, even if the relative axial position of the tubular shaft 1634 with respect to the inner shaft 1636 is predetermined, such that the retaining arm 1660 axially locks the inner shaft 1636 with respect to the outer housing 1632, the relative positions of the tubular shaft 1634 and the inner shaft 1636 with respect to the outer housing 1632 can change to correspond to different initial slack levels in the shrinking 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 retaining arm 1660 passes when the retaining arm 1660 axially locks the inner shaft 1636 to the outer housing 1632. In some applications, the tubular shaft 1634 extends along the longitudinal portion of the elongated opening 1664, ●When the tubular shaft 1634 is positioned distally at a predetermined relative axial position with respect to the inner shaft 1636, the return stopper 1660 is prevented from axially locking the inner shaft 1636 to the outer housing 1632 (by blocking the radially outward movement of the return stopper 1660), and ● When the tubular shaft 1634 is positioned at a predetermined relative axial position with respect to the inner shaft 1636, the system includes one or more tracks 1666 arranged to allow the retaining arm 1660 to axially lock the inner shaft 1636 (by allowing the retaining arm 1660 to move radially outward).

[0518] One or more portions of the track 1666 that prevent the retaining arm 1660 from axially locking the inner shaft 1636 against the outer housing 1632 may be arranged radially inward of one or more portions of the track 1666 that allow the retaining arm 1660 to axially lock the inner shaft 1636.

[0519] In some of these applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 is provided with one or more retaining supports 1688, which are fixed to a stopper 1660 and configured to slide axially along one or more tracks 1666. When the tubular shaft 1634 is distally positioned at a predetermined relative axial position, one or more tracks 1666 prevent radially outward movement of one or more retaining supports 1688, thereby preventing radially outward movement of the stopper 1660. In some applications, the proximal longitudinal portion 1637 of the tubular shaft 1634 is provided with one or more retaining posts 1690 that stabilize one or more retaining supports 1688 while they are moving radially, and one or more retaining supports 1688 can slide radially relative to one or more retaining posts 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 positioned at a predetermined relative axial position with respect to the inner shaft 1636, the retaining arm 1660 axially locks the inner shaft 1636 against the outer housing 1632. Subsequent distal movement of the tubular shaft 1634, and the corresponding distal movement of one or more tracks 1666 relative to the inner shaft 1636, disengages the retaining arm 1660 from the outer housing 1632. For example, this disengagement may occur by one or more inclined portions 1668 sliding one or more retaining arm supports 1688 radially inward and on a portion of one or more tracks 1665 positioned radially inward. The distal movement of the tubular shaft 1634 may occur by the operation of the retraction-promoting knob 1630 in the opposite direction to the operation for the proximal movement described above. This allows the user to reduce the tension in the shrink member 226 as needed during the procedure, even if the tension level is high enough to trigger the tension limiting lock of the retaining arm 1660. Naturally, the user can also reduce the tension in the shrink member 226 before the tension limiting lock of the retaining arm 1660 engages, if necessary.

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

[0522] In some applications, as perhaps best seen in the enlarged Figure 25B, the stopper 1660 and / or recess 1662 are angled slightly with respect to the direction perpendicular to the central longitudinal axis of the handle portion 1620 (e.g., 1 to 45 degrees, e.g., 1 to 30 degrees, e.g., 1 to 15 degrees, e.g., about 5 degrees), so that the stopper 1660 faces slightly proximal and / or the opening of the recess 1662 faces slightly distal. This angle facilitates the capture and engagement of the stopper with the recess 1662, as the stopper 1660 moves proximal just before engaging with one of the recesses 1662, and also facilitates disengagement if necessary, as described above. Alternatively, the stopper 1660 and / or recess 1662 are not angled and are perpendicular to the central longitudinal axis of the handle portion 1620.

[0523] Refer again to Figures 21A-B. In some applications, the spring 1646 is preloaded when the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 are positioned at an initial offset distance D1 between them. Often, the handle portion 1620 is configured to maintain this preload before use by preventing the proximal advance of the inner shaft 1636 relative to the tubular shaft 1634 beyond a predetermined maximum distance. For example, the proximal end of an elongated opening 1664 (e.g., shown in Figure 22B) may block the advance of an element of the tension limiting locking assembly 1658 (e.g., one or more of the anti-return posts 1690 or the proximal portions of one or more anti-return supports 1688, shown in Figure 26A). The setting of the preload is described immediately below.

[0524] Refer again to Figure 21B. In some applications, the radially inward surface of the tubular shaft 1634 near its distal end 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 for precise axial positioning of the distal force applicator 1642 relative to the tubular shaft 1634 during the calibration procedure in the manufacturing 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 before inserting the tubular shaft 1634, inner shaft 1636, distal force applicator 1642, spring 1646, and other elements fixed to the inner shaft 1636 into the outer housing 1632. As described above, during the use of the handle portion 1620 in medical procedures, the distal force applicator 1642 is rotatably fixed relative to the tubular shaft 1634 and therefore fixed in the axial direction.

[0525] In some applications, adjusting 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 compressing 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 may be applied to the proximal end 1654 of the inner shaft 1636 until the offset distance between the proximal end 1652 of the tubular shaft 1634 and the proximal end 1654 of the inner shaft 1636 decreases to the maximum tension offset distance D3 (which triggers the tension limiting locking assembly 1658 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 exert on the contraction member 226, before the tension limiting locking assembly 1658 is triggered during subsequent use. When this distal force of calibration is removed, the spring 1646 extends until further advance of the inner shaft 1636 is blocked, as described above, and the spring 1646 has the desired pre-load level.

[0526] Refer again to Figures 1-26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500, as well as methods for repairing dilated valve annules in patients, may be used to treat the heart valves of patients, such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve. Furthermore, the systems described herein for treating valves may be used to treat other annular muscles in the body of a patient. For example, the systems described herein may be used to treat the sphincter in the stomach of a patient.

[0527] Refer again to Figures 1-26B. Systems 10, 510, 700, 800, 900, 1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 may be attached to the annular tissue using one of the attachment devices described in U.S. Patent Application Publication 2015 / 0272734 of Sheps et al., including an anchor driver and an deployment manipulator.

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

[0529] Here, refer to Figures 1-26B. The tools described herein may be used to deploy, fix, and adjust the outer circumference of any annular forming structure, such as a fully (or closed) annular forming structure or a partially (or open) annular forming structure. Any tools described herein may be coupled to the annular forming structure using any coupling described herein, with reference to Figures 7A-26B. For example, any annular forming structure described herein may comprise a housing 930 having a female coupling 927, and the tools described herein may comprise the male coupling 925 tool described above, with reference to Figures 12, 13, and 15. The annular forming structures described herein may include elements and structures described in PCT Publication WO 10 / 073246 by Cabiri et al., which are incorporated herein by reference.

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

[0531] All of these applications are incorporated herein by reference. The techniques described herein may be carried out in combination with the techniques described in one or more of these applications. Furthermore, any and all of the methods, techniques, steps, etc., described herein may be carried out on living animals or in a simulation / mimetic manner (e.g., on a corpse, a corpse heart, a simulated heart, tissue, etc., a simulator, an anthropomorphic ghost, etc.).

[0532] The present invention is not limited to those specifically illustrated and described above. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described above, as well as changes and modifications thereto that are not in the prior art and would be conceivable by those skilled in the art by reading the above description.

[0533] [Additional note 1] It is a device, An embedded valve ring forming structure, Main body part, and An embedded valve ring forming structure comprising a shrinkable 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, A tool for taking in shrinkable material, A primary tube terminating at the distal end portion of the shrinking member intake tool, wherein the distal end portion of the shrinking member intake tool has a distal tip, A secondary tube arranged along the primary tube, having a secondary lumen configured for the passage of the shrinking member passing through its interior, and A shrinkable member snare comprising a shrinkable member snare having a distal snare portion and an elongated flexible body portion connected to the distal snare portion, wherein the distal snare portion is configured to fit a portion of the shrinkable member and is sized to pass through the secondary lumen of the secondary tube and pull the second portion of the shrinkable member through the length of the secondary tube, and a shrinkable member intake tool comprising a shrinkable member snare. [Additional note 2] The apparatus according to Appendix 1, wherein the distal snare portion is configured to pull the second portion of the shrinking member through the distal tip of the shrinking member intake tool and then through the length of the secondary tube. [Additional note 3] The apparatus according to Appendix 1 or 2, wherein the shrinking snare comprises a wire having a diameter of 0.2 to 0.25 mm. [Additional note 4] The apparatus according to any one of the appendices 1 to 3, wherein the primary tube is flexible and the secondary tube is flexible. [Additional note 5] The apparatus according to any one of the appendices 1 to 4, wherein the valve ring forming structure defines a partial valve ring forming ring structure. [Additional note 6] The apparatus according to any one of the appendices 1 to 5, wherein the secondary tube is shaped to define a longitudinal slit. [Additional note 7] The apparatus according to any one of the appendices 1 to 6, wherein the shrinking member intake tool comprises a handle portion, and the first and second tubes are connected to the handle portion. [Additional note 8] The aforementioned handle portion, A shrinking member intake device configured to take in the continuous portion of the shrinking member, The apparatus according to Appendix 7, comprising a tension meter configured to measure the degree of tension of the contraction member. [Additional note 9] The apparatus according to Appendix 8, wherein the shrinking member intake device is operable to increase the tension of the shrinking member. [Additional Note 10] The apparatus according to Appendix 8, wherein the shrinking member intake device comprises a knob connected to the proximal portion of the shrinking member, and the knob is configured to increase the tension of the shrinking member by pulling the shrinking member proximal. [Additional Note 11] The apparatus according to appendix 10, wherein the shrinking member intake device comprises a wheel having a groove, and the groove is configured to connect the shrinking member to the wheel. [Additional Note 12] The apparatus according to Appendix 11, wherein the groove is shaped to receive the intermediate portion of the shrinking member. [Additional Note 13] The apparatus according to any one of the appendices 1 to 12, wherein the secondary lumen of the secondary tube is sized to maintain the connection between the distal snare portion and the shrinking member. [Additional Note 14] The apparatus according to Appendix 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 contraction member. [Additional Note 15] The apparatus according to any one of the appendices 1 to 14, wherein at least the distal snare portion of the shrinking member snare is corrugated to increase friction between the snare portion and the shrinking member. [Additional Note 16] The apparatus according to any one of the appendices 1 to 15, wherein the distal snare portion is configured to pull the second portion of the contraction member through the entire length of the secondary tube. [Additional Note 17] The shrinking member intake tool, At least one shrink member fastener disposed within the distal end portion of the shrink member intake tool, wherein the shrink member fastener comprises a tightening structure, the tightening structure being (a) biased to assume a closed state, in which case the tightening structure is configured to tighten the shrink member as it passes through, and (b) bendable to an open state in which the shrink member can move, The apparatus according to any one of the appendices 1 to 16, comprising a stopper detachably connected to the shrinking member fastener and configured to maintain the shrinking member fastener in the open state. [Additional Note 18] The apparatus according to Appendix 17, wherein the at least one shrink member fastener includes at least first and second shrink member fasteners positioned within the distal end portion of the shrink member take-up tool. [Additional Note 19] The apparatus according to Appendix 18, wherein the distal snare portion and the elongated flexible body portion of the shrink member snare are sized to pass distally through the open shrink member fastener, and the snare portion is adapted to capture and pull the shrink member proximal through the shrink member fastener and through the aligned ports of the distal end portion of the shrink member take-up tool. [Additional Note 20] The apparatus according to Appendix 19, wherein the shrink member intake tool comprises a fastener ejector that is movable within the distal end portion of the shrink member intake tool, and the movement of the fastener ejector contacts the shrink member fastener, converting from the open state to the closed state and tightening the shrink member that has passed through the interior. [Additional Note 21] The apparatus according to Appendix 20, wherein the fastener ejector is connected to the fastener and moves the fastener which is detachably connected to the fastener. [Additional note 22] The apparatus according to appendix 20 or 21, wherein the distal end portion of the shrink member intake tool is shaped to define a sharp edge, and the shrink member is positioned close to the sharp edge, so that the movement of the fastener ejector relative to the sharp edge severs the shrink member extending through the fastener. [Additional Note 23] At least one shrink member fastener configured to surround the shrink member, wherein the shrink member fastener comprises a tightening structure, the tightening structure being (a) biased to take a closed state, in the closed state, the tightening structure is configured to tighten the shrink member as it passes through, and (b) can be bent to an open state in which the shrink member can move, The apparatus according to any one of appendices 1 to 22, further comprising a stopper detachably connected to the shrinking member fastener and configured to maintain the shrinking member fastener in the open state. [Additional note 24] The apparatus according to Appendix 23, wherein the tool comprises a movable cutting element having a sharp edge, and the movement of the fastener strikes the fastener against the movable cutting element, thereby the movement of the movable cutting element severs the shrinkage member extending through the fastener and through the movable cutting element. [Additional note 25] The system further comprises a lock that is slidable along the contraction member, and the lock can be fixedly connected to the contraction member to prevent the contraction member from moving. 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 the lock lumen of the lock, which extends from the proximal opening of the lock toward the distal opening of the lock. The locking cavity is configured to surround the contraction member, The apparatus according to any one of the appendices 1 to 24, wherein when the lock is compressed, the slit closes the lock around the shrinking member, thereby enabling the lock to be locked to the shrinking member. [Additional note 26] The apparatus according to appendix 25, wherein the valve ring forming structure is shaped to define the recess, and is dimensionally determined to compress the lock when the lock is at least partially positioned within the recess. [Additional note 27] The apparatus according to Appendix 26, wherein the recess is sized to compress the lock when the lock is at least partially positioned within the recess. [Additional note 28] The apparatus according to Appendix 25, wherein the shape of the lock lumen is determined to define a distal portion that is wider than the proximal portion of the lock lumen. [Additional note 29] The apparatus according to appendix 28, wherein the recess is shaped to define the proximal portion which is narrower than any other portion of the recess distal to the proximal portion. [Additional note 30] The apparatus according to Appendix 25, wherein the lock is located within the distal end portion of the shrinking member intake tool. [Additional note 31] The apparatus according to appendix 30, wherein when the shrinking member intake tool is connected to the valve ring forming structure, the lock is at least partially positioned within the recess. [Additional note 32] The apparatus according to appendix 30, wherein when the shrinking member intake tool is connected to the valve ring forming structure, the lock is positioned entirely proximal to the recess. [Additional note 33] The apparatus according to Appendix 25, wherein the lock is located within the distal end portion of the shrinking member intake tool. [Additional note 34] The apparatus according to Appendix 33, wherein the distal snare portion and the elongated flexible body portion of the shrinking member snare are sized to pass distally through the lock, and the snare portion is adapted to capture and pull the shrinking member proximal through the lock and through aligned ports at the distal end of the shrinking member capture tool. [Additional note 35] It is a device, An embedded valve ring forming structure, Main body part, and An embedded valve ring forming structure comprising a shrinkable 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 with respect to the main body portion of the valve ring forming ring structure, A shrinkable member fastener, at least partially disposed within the housing, wherein the shrinkable member fastener comprises a tightening structure, the tightening structure being (a) biased to assume a closed state, in the closed state, the tightening structure is configured to tighten the shrinkable member that has passed through its interior, and (b) can be bent into an open state in which the shrinkable member can move; A stopper that is detachably connected to the fastener and configured to maintain the contraction member fastener in the open state, A device comprising a fastener ejector that is engageable with a fastener such that the movement of the fastener ejector moves the fastener, which is detachably connected to the fastener, thereby converting the tightening structure from the open state to the closed state and tightening the contraction member that has passed through the interior. [Additional note 36] The apparatus according to Appendix 35, wherein the fastener ejector is shaped such that its movement facilitates the separation of the shrinkage member extending through the fastener. [Additional note 37] The apparatus according to Appendix 35, wherein the fastener comprises a deformable element having an inclined state and a straight state, the stopper is configured to maintain the fastener in the inclined state, and when the stopper is removed, the fastener is configured to transition to the straight state, requiring the shrinking member between the fastener and the surface of the housing. [Additional note 38] The apparatus according to appendix 37, wherein the fastener is shaped to define a plurality of teeth configured to increase friction between the contraction member and the fastener. [Additional note 39] It is a system, An embedded valve ring forming structure, Main body part, and An embedded valve ring forming structure comprising a contraction member that extends at least partially along the longitudinal length of the main body portion of the valve ring forming structure, A tool for taking in shrinkable material, A tube having a lumen configured for the passage of the shrinking member passing through it, and A system comprising a shrinkable member snare having a distal snare portion and an elongated flexible body portion connected to the distal snare portion, wherein the distal snare portion is configured to fit a portion of the shrinkable member and pull it into the lumen, and a shrinkable member intake tool. [Additional note 40] The system according to appendix 39, wherein the distal snare portion is configured to pull the portion of the retractable member through the entire length of the lumen. [Additional note 41] The system according to Appendix 39, wherein the pipe is flexible. [Additional note 42] The system according to any one of the appendices 39 to 41, wherein the shrinking member intake tool comprises a handle portion, and the tube is connected to the handle portion. [Additional note 43] The aforementioned handle portion, A shrinking member intake device configured to take in the continuous portion of the shrinking member, The system according to Appendix 42, comprising a tension meter configured to measure the degree of tension of the contraction member. [Additional note 44] The system according to appendix 43, wherein the shrinking member intake device is operable to increase the tension of the shrinking member. [Additional note 45] The system according to appendix 43 or 44, wherein the shrinking member intake device comprises a wheel having grooves, and the grooves are configured to connect the shrinking member to the wheel. [Additional note 46] The system according to appendix 45, wherein the groove is shaped to receive the intermediate portion of the shrinking member. [Additional note 47] The system according to any one of appendices 39 to 46, wherein the lumen of the tube is sized to maintain the connection between the distal snare portion and the shrinking member. [Additional note 48] The system according to any one of appendices 39 to 47, wherein the distal snare portion comprises a flexible loop, and when the portion of the retractable member is pulled through the lumen, the lumen is configured to fold the loop around the retractable member. [Additional note 49] The system according to any one of appendices 39 to 48, wherein at least the distal snare portion of the contraction member snare is corrugated to increase friction between the snare portion and the contraction member. [Additional Note 50] The system according to any one of the appendices 39 to 49, wherein the distal end portion of the shrink member intake tool is shaped to define a sharp edge, and the shrink member intake tool is configured to position the shrink member close to the sharp edge, thereby allowing the sharp edge to cleave the shrink member. [Additional note 51] The shrinking member intake tool, A shrink member fastener disposed within the distal end portion of the shrink member intake tool, wherein the shrink member fastener comprises a tightening structure, the tightening structure being (a) biased to assume a closed state, in the closed state, the tightening structure is configured to tighten the shrink member that has passed through its interior, and (b) can be bent into an open state in which the shrink member can move, The system according to any one of the appendices 39 to 50, comprising: a fastener detachably connected to the shrink member fastener and configured to maintain the shrink member fastener in the open state. [Additional note 52] The system according to Appendix 51, wherein the distal snare portion and the portion of the shrinking member are sized to pass distally through the open shrinking member fastener, and the distal snare portion is adapted to capture and pull proximal to the portion of the shrinking member through the shrinking member fastener and through the aligned ports of the distal end portion of the shrinking member take-up tool. [Additional note 53] The system according to Appendix 52, wherein the shrink member intake tool comprises a fastener ejector movable within the distal end portion of the shrink member intake tool, and the movement of the fastener ejector contacts the shrink member fastener, converting it from an open state to a closed state, thereby tightening the shrink member as it passes through the interior. [Additional note 54] The system according to appendix 53, wherein the fastener ejector is connected to the fastener and moves the fastener which is detachably connected to the fastener. [Additional note 55] It is a device, An embedded valve ring forming structure, Main body portion having side walls, and A shrinking 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, wherein the shrinking member is configured to adjust the outer circumference of the valve ring forming structure, The main body portion of the valve ring forming structure is shaped to define a recess having a recess axis, the recess extends from an opening on the first surface of the side wall of the main body portion toward a second surface opposite to the side wall of the main body portion, the side wall of the main body portion extends away from the recess along a longitudinal axis that is not at a zero angle with respect to the recess axis, and the shrinking member extends through and via the recess away from the main body portion of the valve ring forming structure, A device comprising: a lock that is slidable along the shrinking member and toward the recess, wherein the lock can be fixedly connected to the shrinking member to prevent the movement of the shrinking member, and the recess is shaped to facilitate the fixed connection of the lock to the shrinking member. [Additional note 56] The apparatus according to appendix 55, wherein the lock is disposable, at least partially, within the recess. [Additional note 57] The apparatus according to appendix 55, wherein the valve ring forming structure includes a partially valve ring forming ring structure. [Additional note 58] The apparatus according to any one of the appendices 55 to 57, wherein the lock is configured to engage the contraction member when the lock moves at least partially within the recess. [Additional note 59] The apparatus according to any one of the appendices 55 to 57, wherein the lock is configured to fit completely within the recess. [Additional note 60] The main body portion includes a housing, The housing defines at least a portion of the side wall, The apparatus according to any one of the appendices 55 to 59, wherein the housing defines the recess. [Additional note 61] The apparatus according to any one of the appendices 55 to 60, wherein 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 with the lock thread portion. [Additional note 62] The apparatus according to any one of the appendices 55 to 61, wherein the recess defines a recessed lumen extending along the axis of the recess. [Additional note 63] The apparatus according to appendix 62, wherein the recessed axis is arranged at a non-zero angle. [Additional note 64] 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 the lock lumen of the lock, which extends from the proximal opening of the lock toward the distal opening of the lock. The locking cavity is configured to surround the contraction member, The apparatus according to any one of the appendices 55 to 63, wherein when the lock is positioned in the recess, the slit closes the lock around the contraction member, thereby enabling the lock to be locked to the contraction member. [Additional note 65] The apparatus according to appendix 64, wherein the recess is sized to compress the lock when the lock is at least partially positioned within the recess. [Additional note 66] The apparatus according to appendix 64, wherein at least one of the slit and the lock lumen is shaped to define a distal portion that is wider than its proximal portion. [Additional note 67] The apparatus according to appendix 64, wherein the recess is shaped to define the nearest portion which is narrower than any other portion of the recess which is distal to the nearest portion. [Additional note 68] The apparatus according to any one of the appendices 55 to 67, wherein the valve ring forming structure comprises a housing, the housing is shaped to define the recess, and the recess has a recess axis. [Additional note 69] The apparatus according to Appendix 68, wherein 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 with the lock thread portion. [Additional note 70] The apparatus according to Appendix 68, wherein the housing is shaped to define a lumen of a shrinkable member positioned at a non-zero angle with respect to the axis of the recess. [Additional note 71] The apparatus according to appendix 70, wherein the housing is shaped to provide a wall of the shrinking member that is positioned along the lumen of the shrinking member, and when the lock is positioned in the recess, the distal end of the lock is configured to clamp a first portion of the shrinking member against the wall of the shrinking member, thereby locking the shrinking member at at least a first clamping point. [Additional note 72] The shape of the recess is determined to define the distal tapered portion of the recess. The aforementioned lock, The lumen of the lock extends from the proximal opening of the lock toward the distal opening of the lock, The shape is determined to define the distal tapered portion of the lock, The locking cavity is configured to surround the contraction member, The apparatus according to appendix 71, wherein when the lock is positioned in the recess, the distal tapered portion of the recess is configured to compress the distal tapered portion of the lock, and the distal tapered portion of the lock is configured to grip a second portion of the contraction member in the lumen of the lock at the distal tapered portion of the recess, thereby locking the contraction member at at least a second gripping point. [Additional note 73] The apparatus according to any one of the appendices 55 to 72, further comprising a delivery tool, wherein the delivery tool and the shrinking member are slidable relative to each other, and the delivery tool is configured to deliver the annulus forming structure to the annulus of the patient's heart. [Additional note 74] The apparatus according to Appendix 73, wherein the delivery tool comprises a knob connected to the proximal portion of the shrinking member, the knob being configured to increase the tension of the shrinking member by pulling the shrinking member proximal. [Additional note 75] The apparatus according to appendix 73, wherein when the delivery tool is connected to the valve ring forming structure, a portion of the shrinking member is positioned within the lumen of the delivery tool, and the lock surrounds a portion of the shrinking member. [Additional note 76] The apparatus according to appendix 75, wherein when the delivery tool is connected to the valve ring forming structure, the lock is at least partially positioned within the recess. [Additional note 77] The apparatus according to Appendix 75, wherein the delivery tool comprises a lock ejector movable within the distal end portion of the delivery tool, and the movement of the lock ejector contacts the lock, converting it from an open state to a closed state, thereby tightening the contraction member that has passed through the interior. [Additional note 78] The apparatus according to Appendix 77, wherein the distal end portion of the delivery tool is shaped to define a sharp edge, and the shrinking member is positioned close to the sharp edge, so that the movement of the lock ejector relative to the sharp edge severs the shrinking member extending through the lock. [Additional note 79] It is a device, An embedded valve ring forming structure, Main body part, and An embedded valve ring forming structure comprising a shrinkable 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, A lock that is slidable along the contraction member and can be fixed and connected to the contraction member to prevent the contraction member ...

Claims

1. - An implant comprising an embedded structure and a flexible, elongated, shrinkable member (226) extending away from the embedded structure, - A shrinkage member intake tool (1600) equipped with a handle portion (1620), Equipped with, The shrinking member intake tool, - Outer casing (1632), - A tubular shaft (1634) is at least partially disposed within the outer housing, - An inner shaft (1636) comprising (a) at least partially positioned within the proximal longitudinal portion of the tubular shaft, thereby allowing the inner shaft (1636) to slide axially relative to the tubular shaft (1634), (b) shaped to define an inner shaft contraction member receiving channel (1638), and (c) equipped with a lock (1640), the lock being configured such that (i) when in the unlocked state, the contraction member slides relative to the inner shaft contraction member receiving channel, and (ii) when in the locked state, the contraction member is axially locked to the inner shaft, - A distal force applicator (1642) wherein (a) it is at least partially positioned within the distal longitudinal portion of the tubular shaft, and (b) its shape is determined to define a distal force applicator contraction member receiving channel (1644) that allows the contraction member to slide through the interior, - A spring (1646) is positioned inside the tubular shaft (1634) and connects the distal force applicator and the distal portion of the inner shaft, - A contraction-promoting knob (1630) accessible from the outside of the outer housing, Equipped with, The handle portion (1620) is shaped to define a handle contraction member receiving channel (1650) from the distal end to the proximal end of the handle portion. The handle retraction member receiving channel includes the inner shaft retraction member receiving channel and the distal force applicator retraction member receiving channel, When the handle portion is positioned such that the contraction member completely passes through the handle contraction member receiving channel and the lock is engaged, the operation of the contraction promotion knob is performed. * The tubular shaft is advanced proximally relative to the outer housing, thereby advancing the distal force applicator proximally relative to the outer housing, thereby applying a force in the proximal direction to the spring. * By pushing the inner shaft proximal to the outer housing, the contraction member is pulled proximal to the outer housing, The handle portion is configured to incorporate a continuous portion of the retractable member. The handle portion is configured such that when the contraction-promoting knob is operated, (i) the contraction member is positioned so as to fully pass through the handle contraction member receiving channel, (ii) the lock is in a locked state, and (iii) the contraction member is tensed. The spring pushes the inner shaft proximally to such an extent that it is less than the tubular shaft advances proximally relative to the outer housing. The apparatus is characterized in that pulling the contraction member proximal to the contraction member by the inner shaft increases the tension in the contraction member.

2. The apparatus according to claim 1, characterized in that the contraction-promoting knob is configured to be operated by the rotation of the contraction-promoting knob itself.

3. The tubular shaft and the contraction-promoting knob are connected to each other by screw threads. The apparatus according to claim 1, characterized in that the handle portion is configured such that the operation of the contraction-promoting knob rotates the tubular shaft, thereby advancing the tubular shaft proximally relative to the outer housing.

4. The inner shaft partially protrudes outward from the proximal end of the outer housing, The apparatus according to any one of claims 1 to 3, wherein 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 tension in the contraction member.

5. The inner shaft is marked with multiple reference markers. The apparatus according to claim 4, characterized in that the reference marker is arranged along the inner shaft and indicates the relative axial position of the tubular shaft with respect to the inner shaft.

6. The handle portion further comprises a tension limiting locking assembly, The apparatus according to any one of claims 1 to 3, characterized in that the tension limiting locking assembly is configured to axially lock the inner shaft 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.

7. The apparatus according to claim 6, characterized in that the tension limiting locking assembly is configured to lock the inner shaft axially with respect to the outer housing when the tubular shaft is positioned 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.

8. The tension limiting locking assembly includes a stopper, The apparatus according to claim 7, characterized in that the stopper is arranged to axially lock the inner shaft to the outer housing when the tubular shaft is positioned 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.

9. The apparatus according to claim 8, characterized in that the stopper is fixedly connected to the inner shaft in the axial direction and is configured to move radially outward so as to engage with the outer housing to axially lock the inner shaft to the outer housing.

10. The tension limiting locking assembly further comprises a plurality of recesses whose shape is determined to define the outer housing, The retaining element is capable of engaging with the recess in order to axially lock the inner shaft with respect to the outer housing. The apparatus according to claim 9, characterized in that the handle portion is arranged such that, when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, a specific one of the recesses with which the stopper 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. The apparatus according to claim 9, characterized in that when the stopper locks the inner shaft axially with respect to the outer housing, the stopper passes through the elongated opening.

12. The tubular shaft comprises one or more tracks, The track extends along the longitudinal portion of the elongated opening, The aforementioned truck (a) When the tubular shaft is positioned distal to the inner shaft at the predetermined relative axial position, the stopper prevents the inner shaft from locking axially to the outer housing, (b) When the tubular shaft is positioned at the predetermined relative axial position with respect to the inner shaft, the stopper is designed to allow the inner shaft to be locked in the axial direction. The apparatus according to claim 11, characterized by being arranged in a particular manner.

13. The apparatus according to claim 12, wherein one or more tracks are shaped to define one or more inclined portions, so that when the tubular shaft is positioned at a predetermined relative axial position with respect to the inner shaft, the retaining arm engages the inner shaft axially with respect to the outer housing, and thereafter the distal movement of the tubular shaft and the corresponding distal movement of one or more tracks with respect to the inner shaft disengages the retaining arm from the outer housing.

14. The inner shaft partially protrudes outward from the proximal end of the outer housing, The apparatus according to claim 6, characterized in that 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 tension in the contraction member.

15. The apparatus according to any one of claims 1 to 3, characterized in that the embedded structure comprises an embeddable valve ring forming structure.

16. The aforementioned embeddable valve ring forming structure includes a flexible sleeve, The apparatus according to claim 15, characterized in that the shrinking member extends along the sleeve and away from the sleeve.

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